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 July 2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X
Form
40-F __
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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
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Indicate
by check mark whether the registrant by furnishing the information
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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Yes __ No
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“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule
12g3-2(b): 82-_____________
AstraZeneca PLC
27 July
2017 07:00
H1 2017 Results
AstraZeneca performed in line with expectations as the pipeline
continued to deliver
Financial Summary
|
H1 2017
|
Q2 2017
|
$m
|
% change
|
$m
|
% change
|
|
Actual1
|
CER2
|
Actual
|
CER
|
Total
Revenue
|
10,456
|
(11)
|
(9)
|
5,051
|
(10)
|
(8)
|
Product Sales
|
9,783
|
(11)
|
(10)
|
4,940
|
(10)
|
(8)
|
Externalisation Revenue
|
673
|
(2)
|
(1)
|
111
|
(17)
|
(15)
|
|
|
|
|
|
|
|
Reported
Operating Profit
|
1,842
|
37
|
22
|
925
|
n/m
|
n/m
|
Core
Operating Profit3
|
3,215
|
7
|
3
|
1,548
|
10
|
8
|
|
|
|
|
|
|
|
Reported
Earnings Per Share (EPS)
|
$0.80
|
58
|
41
|
$0.38
|
n/m
|
n/m
|
Core
EPS3
|
$1.86
|
5
|
1
|
$0.87
|
5
|
6
|
Financial Highlights
●
The residual effects of the
Crestor and Seroquel XR loss of exclusivity in the
US impacted Product Sales
●
Cost discipline
continued:
o Reported R&D costs declined by 5%
(1% at CER) to $2,802m
o Core R&D costs declined by 7% (4%
at CER) to $2,617m
o Reported SG&A costs declined by 17%
(15% at CER) to $4,658m
o Core SG&A costs declined by 12% (9%
at CER) to $3,728m
●
Reported Other Operating Income
and Expense increased by 97% (101% at CER) to $839m; Core Other
Operating Income and Expense increased by 105% (108% at CER) to
$958m
●
Reported EPS increased by 58%
(41% at CER) to $0.80; Core EPS increased by 5% (1% at CER) to
$1.86
●
An unchanged first interim
dividend of $0.90 per share
●
Financial guidance for 2017
reiterated
Commercial Highlights
●
The Growth Platforms grew
by 2% (3% at CER) and represented 70% of Total
Revenue:
●
Emerging Markets: 3% growth
(6% at CER), underpinned by China sales growth of 3% (8% at CER).
Economic conditions in Latin America and Saudi Arabia limited
overall Emerging Markets growth
●
Respiratory: A decline of
6% (4% at CER), reflecting the competitive environment for
Symbicort in the
US
●
New CVMD4: Growth of 3% (4% at
CER). Brilinta growth of
26% (28% at CER) and Farxiga growth 22% (22% at CER), offset
by other Diabetes
●
Japan: Growth of 7% (6% at CER),
with an accelerated performance in Q2 2017 reflecting the strong
uptake of Tagrisso
●
New Oncology5: Sales of $537m (H1
2016: $251m); particularly encouraging growth of Tagrisso. Lynparza's US performance reflected the
current indication
Achieving Scientific Leadership
The
table below highlights the development of the late-stage pipeline
since the last results announcement:
Regulatory
Approvals
|
Imfinzi (durvalumab) - bladder cancer (US)
Faslodex - breast cancer (1st
line) (EU, JP)
Kyntheum (brodalumab) -
psoriasis (EU, received by partner)
|
Regulatory
Submission Acceptances
|
Lynparza - ovarian cancer (2nd
line) (EU, JP)
Bevespi - chronic obstructive pulmonary disease (COPD)
(EU)
|
Phase
III or Major Data Readouts
|
Imfinzi - lung cancer (PACIFIC)
Bydureon - type-2 diabetes cardiovascular outcomes trial
(met primary safety objective, did not meet primary efficacy
objective)
tralokinumab
- severe, uncontrolled asthma (did not meet primary
endpoint)
|
Pascal Soriot, Chief Executive Officer, commenting on the results
said:
"Our
performance in the first half was in line with expectations as we
experience the loss of exclusivity of Crestor and Seroquel XR in the US. We continued to
deliver transformative science across the pipeline, particularly in
Oncology. Imfinzi was
launched in bladder cancer while we published practice-changing
data in breast cancer for Lynparza, our first-in-class PARP
inhibitor. In lung cancer, we strengthened our unique portfolio
focused on both the genetic drivers of disease and immunotherapy.
In the first half, we shared positive results for Imfinzi in the PACIFIC trial and
reported more encouraging data for Tagrisso in patients with central
nervous system metastases.
"I'm
excited about our pipeline-driven transformation as we continue to
deliver for shareholders on our strategy to return to sustainable
long-term growth. In a pivotal year for AstraZeneca, we remain
focused on realising the potential of our pipeline, growing our new
launch medicines and bringing our strong science to
patients."
FY 2017 Guidance: Reiterated
The
Company provides guidance on Total Revenue and Core EPS only. All
commentary in this section is at CER and is unchanged from the
prior results announcement:
Total Revenue
|
A low
to mid single-digit percentage decline
|
Core EPS
|
A low
to mid teens percentage decline*
|
*The Core EPS guidance anticipates a normalised effective Core tax
rate in FY 2017 of 16-20% (FY 2016: 11%)
Guidance is subject to base-case assumptions of the progression of
the pipeline and the extensive level of news flow listed on the
following page. Variations in performance between quarters can be
expected, with year-on-year comparisons expected to begin to ease
in the second half of the year, given the recent annualisation of
the impact of the entry of multiple Crestor generic medicines in the US.
The Company presents Core EPS guidance only at CER. It is unable to
provide guidance on a Reported/GAAP basis because the Company
cannot reliably forecast material elements of the Reported/GAAP
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.
In addition to the unchanged guidance above, the Company also
provides unchanged indications in other areas of the Income
Statement. The sum of Externalisation Revenue and Other Operating
Income and Expense in
FY 2017 is anticipated to be ahead of that in FY 2016. Sustainable
and ongoing income6 is expected to increase further as a proportion of
total Externalisation Revenue in FY 2017 (FY 2016: 21%). Core
R&D costs are expected to be broadly in line with those in FY
2016 and the Company anticipates a further reduction in Core
SG&A costs in FY 2017, reflecting the evolving shape of the
business. A full explanation is listed in the Operating &
Financial Review.
FY 2017 Currency Impact
Based
only on average exchange rates in H1
2017 and the Company's published currency sensitivities, the
Company continues to expect a low single-digit percentage adverse
impact from currency movements on Total Revenue and a minimal
impact on Core EPS. Further details on currency sensitivities are
contained within the Operating and Financial
Review.
Notes
1. All
growth rates are shown at actual exchange rates, unless stated
otherwise.
2.
Constant exchange rates. These are non-GAAP measures because they
remove the effects of currency movements from Reported
results.
3. Core
financial measures. These are non-GAAP measures because, unlike
Reported performance, they cannot be derived directly from the
information in the Group Financial Statements. See the Operating
and Financial Review for a definition of Core financial measures
and a reconciliation of Core to Reported financial
measures.
4. New
Cardiovascular and Metabolic Diseases, incorporating Brilinta and Diabetes.
5. New
Oncology, comprising Lynparza, Tagrisso, Iressa (US) and Imfinzi.
6.
Sustainable and ongoing income is defined as Externalisation
Revenue, excluding initial revenue.
7. All
commentary in this announcement refers to the performance in H1
2017, unless stated otherwise.
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 results from the
pipeline.
Mid-2017
|
Imfinzi +/- tremelimumab
(treme) - lung cancer (MYSTIC): Data readout
|
H2
2017
|
Faslodex - breast cancer (1st line): Regulatory decision
(US)
Lynparza - ovarian cancer (2nd line): Regulatory decision
(US)
Lynparza - breast cancer: Regulatory submission
Tagrisso - lung cancer (1st
line): Data readout, regulatory submission
Imfinzi - lung cancer (PACIFIC): Regulatory
submission
Imfinzi +/- treme - lung cancer
(MYSTIC): Regulatory submission
Imfinzi +/- treme - lung cancer (ARCTIC): Data readout,
regulatory submission
acalabrutinib - blood cancer: Regulatory submission (US) (Phase
II)*
moxetumomab - leukaemia: Data readout
Bydureon - autoinjector: Regulatory decision (US),
regulatory submission (EU)
benralizumab - severe, uncontrolled asthma: Regulatory decision
(US)
tralokinumab - severe, uncontrolled asthma: Data
readout
|
H1
2018
|
Lynparza - ovarian cancer (2nd line): Regulatory decision
(EU, JP)
Lynparza - ovarian cancer (1st line): Data readout,
regulatory submission
Imfinzi +/- treme - head
& neck cancer (KESTREL): Data
readout
Imfinzi +/- treme - head & neck cancer (EAGLE): Data
readout
moxetumomab
- leukaemia: Regulatory submission
selumetinib
- thyroid cancer: Data readout, regulatory submission
Bevespi - COPD: Regulatory
submission (JP)
Duaklir - COPD: Regulatory submission (US)
benralizumab
- severe, uncontrolled asthma: Regulatory decision (EU,
JP)
tralokinumab
- severe, uncontrolled asthma: Regulatory submission
PT010 -
COPD: Data readout
|
H2
2018
|
Imfinzi + treme - lung cancer (NEPTUNE): Data readout,
regulatory submission
Imfinzi +/- treme - head
& neck cancer (KESTREL):
Regulatory submission
Imfinzi +/- treme - head & neck cancer (EAGLE):
Regulatory submission
Imfinzi +/- treme - bladder cancer (DANUBE): Data readout,
regulatory submission
roxadustat
- anaemia: Regulatory
submission (US)
Bevespi - COPD: Regulatory
decision (EU)
benralizumab - COPD: Data readout, regulatory
submission
PT010 -
COPD: Regulatory submission (JP)
anifrolumab
- lupus: Data
readout
|
The term 'data readout' in this section refers to Phase III data
readouts, unless stated otherwise.
*Potential
fast-to-market opportunity ahead of randomised, controlled
trials.
Conference Call
A
conference call and webcast for investors and analysts, hosted by
management, will begin at 13:30 UK time today. Details can be
accessed via astrazeneca.com/investors.
Reporting Calendar
The
Company intends to publish its year-to-date and third-quarter
financial results on 9 November 2017.
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
three main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please
visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
|
|
|
Esra
Erkal-Paler
|
UK/Global
|
+44 203
749 5638
|
Rob
Skelding
|
UK/Global
|
+44 203
749 5821
|
Karen
Birmingham
|
UK/Global
|
+44 203
749 5634
|
Matt
Kent
|
UK/Global
|
+44 203
749 5906
|
Jacob
Lund
|
Sweden
|
+46
8 553 260 20
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
Investor Relations
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
Craig
Marks
|
Finance,
Fixed Income, M&A
|
+44
7881 615 764
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
Mitchell
Chan
|
Oncology
|
+1 240
477 3771
|
Lindsey
Trickett
|
Cardiovascular
& Metabolic Diseases
|
+1 240
543 7970
|
Nick
Stone
|
Respiratory
|
+44 203
749 5716
|
Christer
Gruvris
|
Autoimmunity,
Neuroscience & Infection
|
+44 203
749 5711
|
US toll
free
|
|
+1 866
381 7277
|
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 six and three-month periods to 30 June 2017 (the half or
the quarter, respectively) compared to the six and three-month
periods to 30 June 2016. All commentary in the Operating and
Financial Review relates to the half, unless stated
otherwise.
Core
financial measures are non-GAAP measures because, unlike reported
performance, they cannot be derived directly from the Group
Condensed Consolidated Financial Statements. These non-GAAP
measures are not a substitute for, or superior to, measures of
financial performance 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
global restructuring programmes (this will include such charges
that relate to the impact of global restructuring programmes on
capitalised IT assets)
●
Other specified items, principally
comprising legal settlements and acquisition-related costs, which
include fair value adjustments and the imputed finance charge
relating to contingent consideration on business
combinations
Details
on the nature of these measures are provided on page 64 of
the Annual Report
and Form 20-F Information 2016.
Reference should be made to the reconciliation of Core to Reported
financial information included therein and in the Reconciliation of
Reported to Core Performance table listed later in this
announcement. The Company strongly encourages readers not to rely
on any single financial measure, but to review AstraZeneca's
financial statements, including the notes thereto, and other
publicly-filed Company reports, carefully and in their
entirety.
Total Revenue
|
H1 2017
|
Q2 2017
|
$m
|
% change
|
$m
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Total Revenue
|
10,456
|
(11)
|
(9)
|
5,051
|
(10)
|
(8)
|
|
|
|
|
|
|
|
Product Sales
|
9,783
|
(11)
|
(10)
|
4,940
|
(10)
|
(8)
|
Externalisation Revenue
|
673
|
(2)
|
(1)
|
111
|
(17)
|
(15)
|
Product Sales
The
residual effects of the Crestor and Seroquel XR loss of exclusivity in the
US impacted Product Sales in the half. Global Product Sales
declined by 11% (10% at CER) from $11,034m to $9,783m. Of the
$1,251m difference, $891m was represented by the 43% decline (42%
at CER) in Crestor sales;
$265m was represented by the 62% decline (62% at CER) in
Seroquel XR
sales.
Emerging Markets
sales grew by 3% (6% at CER) to $3,004m, with China sales
increasing by 3% (8% at CER) to $1,419m. US sales declined by 28%
to $3,013m and were, alongside the effects of the Crestor and Seroquel XR losses of exclusivity, also
impacted by the sales of Symbicort, which declined by 19% in the
US to $554m. Product Sales in Europe declined by 8% (5% at CER) to
$2,272m. Representing 70% of Total Revenue, the Growth Platforms
grew by 2% (3% at CER) to $7,295m. For further details, see the
following table:
|
H1 2017
|
Q2 2017
|
$m
|
% change
|
$m
|
% change
|
|
Actual
|
CER
|
Actual
|
CER
|
Emerging Markets
|
3,004
|
3
|
6
|
1,442
|
-
|
2
|
Respiratory
|
2,280
|
(6)
|
(4)
|
1,099
|
(10)
|
(9)
|
New
CVMD
|
1,670
|
3
|
4
|
872
|
2
|
3
|
Japan
|
1,067
|
7
|
6
|
617
|
8
|
8
|
New
Oncology
|
537
|
n/m
|
n/m
|
301
|
97
|
99
|
|
|
|
|
|
|
|
Total*
|
7,295
|
2
|
3
|
3,723
|
(1)
|
1
|
*Total Product Sales for Growth Platforms are adjusted to remove
duplication on a medicine and regional basis.
Externalisation Revenue
Where
AstraZeneca retains a significant ongoing interest in medicines or
potential new medicines, income arising from externalisation
agreements is reported as Externalisation Revenue in the Company's
financial statements.
A
breakdown of Externalisation Revenue in the half is shown
below:
Medicine
|
Partner
|
Region
|
$m
|
Zoladex
|
TerSera
Therapeutics LLC (TerSera)- initial revenue
|
US and
Canada
|
250
|
Siliq (brodalumab)
|
Valeant
Pharmaceuticals International, Inc. (Valeant)
-
milestone revenue
|
US
|
130
|
MEDI8897
|
Sanofi
Pasteur Inc. (Sanofi Pasteur)
-
initial revenue
|
Global
|
127
|
Tudorza/Duaklir
|
Circassia
Pharmaceuticals plc (Circassia)
-
initial revenue
|
US
|
64
|
Other
|
|
|
102
|
|
|
|
|
Total
|
|
|
673
|
The
following table illustrates the level of sustainable and ongoing
income within the total of Externalisation Revenue. The Company
anticipates that sustainable and ongoing income will grow as a
proportion of Externalisation Revenue over time.
|
H1 2017
|
Q2 2017
|
|
$m
|
% of total
|
% change
|
$m
|
% of total
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Royalties
|
83
|
12
|
30
|
32
|
38
|
34
|
46
|
39
|
Milestones
|
145
|
22
|
(27)
|
(22)
|
9
|
8
|
(91)
|
(90)
|
|
|
|
|
|
|
|
|
|
Total Sustainable and Ongoing Externalisation Revenue
|
228
|
34
|
(13)
|
(8)
|
47
|
42
|
(64)
|
(63)
|
|
|
|
|
|
|
|
|
|
Initial Revenue
|
445
|
66
|
5
|
4
|
64
|
58
|
n/m
|
n/m
|
|
|
|
|
|
|
|
|
|
Total Externalisation Revenue
|
673
|
100
|
(2)
|
(1)
|
111
|
100
|
(17)
|
(15)
|
A
number of AstraZeneca medicines were externalised or disposed after
H1 2016, adversely impacting the overall year-on-year Product Sales
performance in the half:
Medicine
|
Region
|
Completion
|
Product Sales inImpacted Regionsin H1 2016 ($m)
|
Anaesthetics
|
Global
(excl. US)
|
September 2016
|
276
|
Toprol-XL
|
US
|
October 2016
|
53
|
Bydureon/Byetta
|
China
|
October 2016
|
6
|
Zoladex
|
US and
Canada
|
March 2017
|
35
|
|
|
|
|
Total
|
|
|
370
|
Examples
of sustainable and ongoing income, as part of Externalisation
Revenue, are shown below:
Announcement
|
Medicine
|
Partner
|
Region
|
Externalisation Revenue
|
March 2017
|
MEDI8897
|
Sanofi
Pasteur
|
Global
|
●
Initial €120m milestone
●
Up to €495m in sales and
development-related milestones
|
February 2017
|
Zoladex
|
TerSera
|
US and
Canada
|
●
Initial $250m milestone
●
Up to $70m in sales-related
milestones
●
Mid-teen percentage royalties on
sales
|
October 2016
|
Toprol-XL
|
Aralez
Pharmaceuticals Inc.
|
US
|
●
Initial $175m milestone
●
Up to $48m milestone and sales-related
revenue
●
Mid-teen percentage royalties on
sales
|
July 2016
|
Tralokinumab - atopic dermatitis
|
LEO
Pharma A/S (LEO Pharma)
|
Global
|
●
Initial $115m milestone
●
Up to $1bn in commercially-related
milestones
●
Up to mid-teen tiered percentage royalties on
sales
|
June 2016
|
Anaesthetics
|
Aspen
Global Inc.
|
Global
(excl. US)
|
●
Initial $520m milestone
●
Up to $250m in sales-related
revenue
●
Double-digit percentage trademark royalties on
sales
|
September 2015
|
Siliq -
psoriasis
|
Valeant
|
Global,
later
amended
to US
|
●
Initial $100m milestone
●
Pre-launch milestone of $130m
●
Sales-related royalties up to
$175m
●
Profit sharing
|
March 2015
|
Movantik
|
Daiichi
Sankyo Company, Ltd (Daiichi
Sankyo)
|
US
|
●
Initial $200m milestone
●
Up to $625m in sales-related
revenue
|
Product Sales
_____________________________________________________________________________________
The
performance of key medicines is shown below, with a geographical
split shown in Note 6.
Therapy Area
|
Medicine
|
H1 2017
|
Q2 2017
|
$m
|
% of total*
|
% change
|
$m
|
% of total*
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Oncology
|
Tagrisso
|
403
|
4
|
n/m
|
n/m
|
232
|
5
|
n/m
|
n/m
|
Iressa
|
261
|
3
|
(3)
|
(3)
|
137
|
3
|
1
|
2
|
Lynparza
|
116
|
1
|
18
|
20
|
59
|
1
|
9
|
11
|
Imfinzi
|
1
|
-
|
n/m
|
n/m
|
1
|
-
|
n/m
|
n/m
|
Legacy:
|
|
|
|
|
|
|
|
|
Faslodex
|
462
|
5
|
15
|
16
|
248
|
5
|
18
|
18
|
Zoladex
|
363
|
4
|
(5)
|
(4)
|
178
|
4
|
(13)
|
(12)
|
Casodex
|
110
|
1
|
(12)
|
(10)
|
54
|
1
|
(14)
|
(11)
|
Arimidex
|
106
|
1
|
(11)
|
(8)
|
54
|
1
|
(13)
|
(10)
|
Others
|
56
|
1
|
17
|
17
|
30
|
1
|
11
|
11
|
Total Oncology
|
1,878
|
19
|
18
|
20
|
993
|
20
|
17
|
19
|
CVMD**
|
Brilinta
|
496
|
5
|
26
|
28
|
272
|
6
|
27
|
29
|
Farxiga
|
457
|
5
|
22
|
22
|
250
|
5
|
18
|
20
|
Onglyza
|
304
|
3
|
(24)
|
(24)
|
150
|
3
|
(21)
|
(21)
|
Bydureon
|
299
|
3
|
3
|
3
|
146
|
3
|
(6)
|
(6)
|
Byetta
|
89
|
1
|
(36)
|
(35)
|
43
|
1
|
(43)
|
(43)
|
Symlin
|
25
|
-
|
56
|
56
|
11
|
-
|
-
|
-
|
Legacy:
|
|
|
|
|
|
|
|
|
Crestor
|
1,191
|
12
|
(43)
|
(42)
|
560
|
11
|
(40)
|
(38)
|
Seloken/Toprol-XL
|
367
|
4
|
(2)
|
1
|
181
|
4
|
(4)
|
(1)
|
Atacand
|
147
|
2
|
(9)
|
(7)
|
72
|
1
|
(19)
|
(18)
|
Others
|
179
|
2
|
(20)
|
(17)
|
90
|
2
|
(13)
|
(9)
|
Total CVMD
|
3,554
|
36
|
(20)
|
(19)
|
1,775
|
36
|
(18)
|
(17)
|
Respiratory
|
Symbicort
|
1,383
|
14
|
(11)
|
(10)
|
706
|
14
|
(12)
|
(11)
|
Pulmicort
|
563
|
6
|
3
|
7
|
226
|
5
|
(5)
|
(3)
|
Daliresp/Daxas
|
92
|
1
|
30
|
30
|
48
|
1
|
20
|
20
|
Tudorza/Eklira
|
71
|
1
|
(18)
|
(16)
|
34
|
1
|
(29)
|
(27)
|
Duaklir
|
35
|
-
|
17
|
23
|
16
|
-
|
(6)
|
-
|
Bevespi
|
4
|
-
|
n/m
|
n/m
|
3
|
-
|
n/m
|
n/m
|
Others
|
132
|
1
|
(8)
|
(6)
|
66
|
1
|
(18)
|
(15)
|
Total Respiratory
|
2,280
|
23
|
(6)
|
(4)
|
1,099
|
22
|
(10)
|
(9)
|
Other
|
Nexium
|
1,056
|
11
|
3
|
4
|
595
|
12
|
6
|
7
|
Synagis
|
300
|
3
|
11
|
11
|
70
|
1
|
n/m
|
n/m
|
Losec/Prilosec
|
136
|
1
|
(6)
|
(3)
|
68
|
1
|
(3)
|
-
|
Seroquel XR
|
162
|
2
|
(62)
|
(62)
|
95
|
2
|
(58)
|
(58)
|
Movantik/Moventig
|
62
|
1
|
55
|
55
|
32
|
1
|
39
|
39
|
FluMist/Fluenz
|
-
|
-
|
n/m
|
n/m
|
-
|
-
|
n/m
|
n/m
|
Others
|
355
|
4
|
(44)
|
(44)
|
213
|
4
|
(32)
|
(31)
|
Total Other
|
2,071
|
21
|
(19)
|
(18)
|
1,073
|
22
|
(13)
|
(12)
|
|
Total
Product Sales
|
9,783
|
100
|
(11)
|
(10)
|
4,940
|
100
|
(10)
|
(8)
|
*Due to rounding, the sum of individual brand percentages may not
agree to totals.
**Cardiovascular & Metabolic Diseases
Product Sales Summary
_______________________________________________________________________________________
ONCOLOGY
Product
Sales of $1,878m; an increase of 18%
(20% at CER). Oncology Product Sales represented 19% of
total Product Sales, up from 14% in H1 2016.
Tagrisso
Product
Sales of $403m; an increase of
182% (183% at CER).
Regulatory approvals were achieved in a number of new markets in
the half, including Brazil, Hong Kong and Taiwan; the Company
anticipates additional regulatory approvals and reimbursement
decisions in due course. To date, Tagrisso has received regulatory approval in 53
countries.
In China, Tagrisso was approved in March 2017 as the first
AstraZeneca medicine under the China FDA's Priority Review pathway.
China sales were $23m in the half, with a better-than-expected
number of patients initiating treatment. China has a relatively
high prevalence of patients with an EGFR T790M
mutation.
Sales in the US and Europe were $180m and $76m,
respectively. While sales grew by 75% year-on-year in the US, they
were stable between the first and second quarters of 2017,
reflecting T790M-mutation testing rates in the half. Tagrisso was launched in Japan in H1
2016. Due to high testing rates, sales in Japan increased to $103m
in H1 2017 (FY 2016: $82m).
Iressa
Product
Sales of $261m; a decline of 3%
(3% at CER).
Emerging Markets
sales declined by 4% (1% at CER) to $129m. China Product Sales
increased by 6% (11% at CER) to $75m, reflecting new pricing
following the inclusion on the National Reimbursement Drug List
(NRDL) in the half; this was the first update to the NRDL in China
in many years. Growth in Emerging Markets was offset partly
by competition from branded and generic medicines in South
Korea.
Sales
in the US increased to $17m (H1 2016: $10m), with sales in Europe declining by 11%
(11% at CER) to $54m. Given the significant future potential of
Tagrisso, the Company
continues to prioritise the ongoing launch of Tagrisso.
Lynparza
Product
Sales of $116m; an increase of 18% (20% at CER).
Lynparza was available to patients in
32 countries by the end of the half, with regulatory reviews
underway in six additional countries. In the US, where the label
for Lynparza is currently
in later-line, germline BRCA-mutated advanced ovarian cancer, sales
declined by 19% in the half to $50m,
reflecting the introduction of competing poly ADP ribose polymerase
(PARP)-inhibitor medicines in earlier lines of treatment. Sales in
Europe increased by 81% (81% at CER) to $58m, following a number of
successful launches.
Imfinzi
Product
Sales of $1m; launched in the US on 1 May 2017.
Approved
under the US FDA's accelerated-approval pathway and launched
commercially on the same day, Imfinzi is currently indicated for the
treatment of patients with locally advanced or metastatic
urothelial carcinoma (mUC) who have disease progression during or
following platinum-containing chemotherapy, or whose disease has
progressed within 12 months of receiving platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant) surgery. At
present, there are five immunotherapy medicines approved for the
treatment of bladder cancer in the US.
Legacy: Faslodex
Product
Sales of $462m; an increase of 15%
(16% at CER).
China
sales grew by 22% (33% at CER) to $11m in the half, which was
followed by the recent successful negotiation and subsequent
inclusion on the NRDL. The performance in China supported overall
Faslodex Emerging Markets
sales growth of 15% (9% at CER) to $54m. On 11 May 2017, the
Company received a label extension for Faslodex in Russia in the 1st-line
monotherapy setting, based on data from the FALCON trial. Russia
sales grew by 17% in the half (stable at CER) to $7m.
US sales increased by 14% to $241m, mainly
reflecting a continued strong uptake of the combination with
palbociclib, a medicine approved for the treatment of
hormone-receptor-positive (HR+) breast cancer. Europe sales
increased by 18% (22% at CER) to $133m. On 26 July 2017, the
Company announced that a label extension was approved in the EU
for Faslodex in the 1st-line monotherapy setting for HR+,
advanced breast cancer in post-menopausal patients, also based on
the FALCON trial.
On 5 June 2017, a similar label extension was approved in Japan and
sales grew by 14% (14% at CER) in the half to $32m.
Legacy: Zoladex
Product
Sales of $363m; a decline of 5% (4% at
CER).
Emerging Markets
sales growth of 10% (11% at CER) to $168m particularly reflected an
increase in China sales of 32% (38% at CER) to $79m. Sales in
Europe declined by 16% (11% at CER) to $67m.
Sales
in Established Rest Of World (ROW*) declined by 12% (14% at CER) to
$114m, driven by lower levels of use. Sales in the US declined by
26% to $14m as the Company committed resources elsewhere. On 31
March 2017, the Company completed an agreement with TerSera for the
commercial rights to Zoladex in the US and
Canada.
*Established ROW comprises Japan, Canada, Australia and New
Zealand
Cardiovascular & Metabolic Diseases
Product
Sales of $3,554m; a decline of
20% (19% at CER). CVMD Product Sales represented 36% of
total Product Sales, down from 40% in H1 2016.
Brilinta
Product
Sales of $496m; an increase of 26% (28% at CER).
Emerging Markets
sales of Brilinta in the
half grew by 33% (36% at CER) to $121m, with China Product Sales
increasing by 42% (49% at CER) to $61m. This was followed by the
recent successful negotiation and subsequent inclusion of
Brilinta on the NRDL.
Growth in Emerging Markets was underpinned by an improvement in
market share, beyond geographic expansion and the breadth of
hospital listings. Strong sales growth was delivered in many
markets outside China, including Russia and Australia.
US sales of Brilinta, at $215m, represented an increase of 35%.
The performance reflected updated preferred guidelines from the
American College of Cardiology and the American Heart Association
in 2016, as well as the narrowing of a competitor's label;
Brilinta remained the
branded oral anti-platelet market leader in the US. Sales of Brilique in Europe increased by 8% (13%
at CER) to $135m, reflecting indication leadership.
Farxiga
Product
Sales of $457m; an increase of 22%
(22% at CER).
Emerging Markets
sales increased by 89% (83% at CER) to $100m, driven by ongoing
launches and improved levels of patient access. In March 2017,
Forxiga became the first
sodium-glucose cotransporter 2 (SGLT2) inhibitor medicine to be
approved in China.
US
sales declined by 1% to $206m. Sales were subdued by affordability
programmes and managed-care access, while market share in the SGLT2
class remained stable. Overall, the SGLT2 class gained market share
from other classes of type-2 diabetes medicines, supported by
growing evidence around the cardiovascular benefits of the
class.
Sales
in Europe increased by 18% (24% at CER) to $105m, as the medicine
continued to lead the growing class. In Japan, where Ono
Pharmaceutical Co., Ltd is a partner and records in-market sales,
sales to the partner amounted to $20m.
Onglyza
Product
Sales of $304m; a decline of 24% (24%
at CER).
The
performance reflected adverse pressures on the dipeptidyl
peptidase-4 (DPP-4) class and an acceleration of the aforementioned
Diabetes market dynamics. Sales in Emerging Markets declined by 21%
(21% at CER) to $63m as the Company focused on Farxiga. However, Onglyza entered the NRDL in China in
the half. In China, the combination with metformin (Kombiglyze XR) was approved in May
2017, offering additional convenience for patients.
US
sales declined by 25% to $159m. Continued competitive pressures in
the DPP-4 class led to a lower market share and were only partially
offset by reduced levels of utilisation of patient-access
programmes. Sales in Europe declined by 29% (27% at CER) to $52m.
In Japan, in-market sales are recorded by Kyowa Hakko Kirin Co.,
Ltd, to whom sales totalled $8m.
Bydureon/Byetta
Product
Sales of $388m; a decline of 10% (9% at CER).
Sales
of Bydureon and
Byetta in Emerging Markets
were $5m and $5m, respectively. In 2016, AstraZeneca entered a
strategic collaboration with 3SBio Inc. for the rights to
commercialise Bydureon and
Byetta in
China.
Combined US sales for Bydureon and Byetta were $301m, despite intense levels of
competition. Bydureon US
sales increased by 4% to $243m, representing 81% of total
Bydureon/Byetta sales. The decline in US
Byetta sales continued in
the half; the decline of 35% to $58m reflected the Company's
promotional focus on once-weekly Bydureon over twice-daily Byetta. A new Bydureon autoinjector device is under
US regulatory review, with a regulatory decision (Prescription Drug
User Fee Act, or PDUFA) date in Q4 2017.
Combined
sales in Europe declined by 20% (17% at CER) to $60m, reflecting
the commercial focus on Forxiga.
Legacy: Crestor
Product
Sales of $1,191m; a decline of 43%
(42% at CER).
Sales
in China grew by 15% (21% at CER) to $179m, while Russia sales grew
to $16m. In the US, sales declined by 85% to $153m, reflecting the
market entry in July 2016 of multiple Crestor generic medicines. In Europe,
sales declined by 17% (15% at CER) to $362m, reflecting the
increasing presence of generic medicines. In Japan, where Shionogi
Co. Ltd is a partner, but sells its own version of the medicine,
Crestor maintained its
position as the leading statin, with growth of 4% (3% at CER) to
$260m.
RESPIRATORY
Product
Sales of $2,280m; a decline of
6% (4% at CER). Respiratory Product Sales represented 23% of total
Product Sales, up from 22% in H1 2016.
Symbicort
Product
Sales of $1,383m; a decline of 11%
(10% at CER).
Symbicort continued to lead the global market by volume
within the inhaled corticosteroids (ICS) / Long-Acting Beta Agonist
(LABA) class. Emerging Markets sales grew by 2% (4% at CER) to
$213m, partly reflecting growth in China of 11% (18% at CER) to
$89m and in Latin America (ex-Brazil), where sales grew by 29% (35%
at CER) to $22m.
In contrast, US sales declined by 19% to $554m, in
line with expectations of continued challenging conditions; these
conditions were a result of managed-care access within the class.
Competition also remained intense from other classes, such as
Long-Acting Muscarinic Antagonist (LAMA)/LABA combination
medicines. In Europe, sales declined by 14% (10% at CER) to $399m,
reflecting competition from other branded and Symbicort-analogue medicines. In Japan, where Astellas
Pharma Co. Ltd assists as a promotional partner, sales increased by
14% (13% at CER) to $100m.
Pulmicort
Product
Sales of $563m; an increase of 3% (7%
at CER).
Emerging Markets sales increased by 13% (19% at
CER) to $396m, reflecting strong underlying volume growth. Emerging
Markets represented 70% of total Pulmicort sales. China sales increased by 12% (18% at CER)
to $322m and represented 57% of global sales. Use in China
continued to increase, due to the prevalence of acute COPD and
paediatric asthma. Legacy sales in the US and Europe declined by
26% to $78m and by 11% (9% at CER) to $48m,
respectively.
Daliresp/Daxas
Product
Sales of $92m; an increase of 30% (30%
at CER).
US
sales increased by 20% to $79m, driven by greater use of the
medicine, the only oral, selective, long-acting inhibitor of the
enzyme phosphodiesterase-4 available for COPD. The US represented
86% of total sales.
Tudorza/Eklira
Product
Sales of $71m; a decline of 18% (16%
at CER).
Sales in the US declined by 29% to $29m, reflecting lower use of
inhaled monotherapy medicines for COPD and the Company's commercial
focus on the launch of Bevespi
Aerosphere. On 17 March
2017, AstraZeneca announced that it had entered a strategic
collaboration with Circassia for the development and
commercialisation of Tudorza and Duaklir in the US. Tudorza was approved and launched in
the US in 2012; Duaklir is
expected to be submitted for US regulatory review in 2018. The
transaction closed on 12 April 2017. Circassia began its promotion
of Tudorza in the US in May
2017, with market share stabilising thereafter; AstraZeneca will
continue to book Product Sales in the US. Sales in
Europe declined by 7% (5% at CER) to $38m.
Duaklir
Product
Sales of $35m; an increase of 17% (23%
at CER).
Duaklir, the Company's first inhaled dual bronchodilator,
is now available for patients in over 25 countries. The growth
in sales in the half was favourably impacted by the
performances in Germany and the UK and the recent launch in
Italy.
Bevespi
Product Sales of $4m; launched in 2017.
Bevespi Aerosphere was launched commercially in the US
during the first quarter of 2017. Prescriptions in the half
tracked in line with other LAMA/LABA launches. However, the overall
LAMA/LABA class in the US continued to grow more slowly than
anticipated. Bevespi is the
first product launched on the Aerosphere co-suspension Delivery
Technology delivered in a pressurised-metered device.
OTHER
Product
Sales of $2,071m; a decline of 19%
(18% at CER). Other Product Sales represented 21% of total
Product Sales, down from 23% in H1 2016.
Nexium
Product
Sales of $1,056m; an increase of 3%
(4% at CER).
Emerging
Markets sales declined by 6% (2% at CER) to $344m and increased by
15% to $339m in the US. The US performance was flattered by returns
adjustments related to the loss of exclusivity in 2015. Sales in
Europe declined by 6% (3% at CER) to $120m. In Japan, where Daiichi
Sankyo is a partner, sales increased by 14% (13% at CER) to
$210m.
Synagis
Product
Sales of $300m; an increase of 11%
(11% at CER).
US
sales increased by 2% to $167m in the half, despite restrictive
guidelines from the American Academy of Pediatrics Committee on
Infectious Disease, which reduced the number of patients eligible
for preventative therapy with Synagis. Product Sales to AbbVie Inc.,
which is responsible for the commercialisation of Synagis in over 80 countries outside
the US, increased by 23% (23% at CER) to $133m, flattered by an
element of true-up adjustments.
Seroquel XR
Product
Sales of $162m; a decline of 62% (62%
at CER).
Sales of Seroquel XR
in the US declined by 75% to $77m.
Since November 2016, several competitors have launched
generic Seroquel XR
medicines in the US. Sales of
Seroquel XR
in Europe declined by 43% (43% at CER)
to $43m, also reflecting the impact of generic-medicine
competition.
FluMist/Fluenz
As
influenza vaccinations occur seasonally, with sales typically
occurring in the second half of the year ahead of the annual
influenza season, no sales were recorded in the half.
The
Company confirmed in 2016 that the Advisory Committee on
Immunization Practices of the US Centers for Disease Control and
Prevention had provided its interim recommendation not to use
FluMist Quadrivalent Live
Attenuated Influenza Vaccine (FluMist Quadrivalent) in the US for the
2016-2017 influenza season. Fluenz continues to be recommended for
use outside the US.
Regional Product Sales
_______________________________________________________________________________________
|
H1 2017
|
Q2 2017
|
$m
|
% of Total
|
% change
|
$m
|
% of Total
|
% change
|
Actual
|
CER
|
Actual
|
CER
|
Emerging
Markets*
|
3,004
|
31
|
3
|
6
|
1,442
|
29
|
-
|
2
|
|
China
|
1,419
|
15
|
3
|
8
|
634
|
13
|
4
|
10
|
|
Ex. China
|
1,585
|
16
|
4
|
4
|
808
|
16
|
(4)
|
(3)
|
|
|
|
|
|
|
|
|
|
US
|
3,013
|
31
|
(28)
|
(28)
|
1,528
|
31
|
(22)
|
(22)
|
|
|
|
|
|
|
|
|
|
Europe
|
2,272
|
23
|
(8)
|
(5)
|
1,143
|
23
|
(8)
|
(6)
|
|
|
|
|
|
|
|
|
|
Established
ROW
|
1,494
|
15
|
3
|
2
|
827
|
17
|
2
|
2
|
|
Japan
|
1,067
|
11
|
7
|
6
|
617
|
12
|
8
|
8
|
|
Canada
|
238
|
2
|
(3)
|
(4)
|
113
|
2
|
(12)
|
(9)
|
|
Other
Established ROW
|
189
|
2
|
(6)
|
(8)
|
97
|
2
|
(13)
|
(13)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
9,783
|
100
|
(11)
|
(10)
|
4,940
|
100
|
(10)
|
(8)
|
|
|
|
|
|
|
|
|
|
|
|
*Emerging
Markets comprises all remaining Rest of World markets, including
Brazil, China, India, Mexico, Russia and Turkey.
Emerging Markets
Product
Sales of $3,004m; an increase of 3% (6% at CER).
China
sales grew by 3% (8% at CER) to $1,419m, representing nearly half
of total Emerging Markets sales. Onglyza and Iressa were included on the NRDL in
China in the first quarter of the year; Brilinta, Faslodex and Seroquel XR were added at the end of
the half, achieving full reimbursement on the NRDL. Crestor also had its 2nd-line usage
restriction removed and Zoladex was reclassified from the
hormone and endocrine classification to oncology, which is expected
to continue to support growth.
Sales
in Latin America and Saudi Arabia were impacted by ongoing economic
conditions, with sales in Latin America (ex-Brazil) declining by
13% (11% at CER) to $219m. Brazil sales increased by 5% (but
declined by 12% at CER) to $185m. Russia sales increased by 11%
(but declined by 10% at CER) to $115m.
Despite
this, the Growth Platforms in Emerging Markets grew by 14% (18% at
CER) to $998m. Sales of Symbicort grew by 2% (4% at CER) to
$213m, reflecting higher prescription demand. Tagrisso launches in Emerging Markets
led to H1 2017 sales of $40m. Tagrisso was launched in China in April
2017; China sales of Tagrisso totalled $23m in the
half.
US
Product
Sales of $3,013m; a decline of
28%.
The decline in sales reflected generic-medicine
launches that impacted sales of Crestor and Seroquel XR. Unfavourable managed-care pricing and continued
competitive intensity impacted sales of Symbicort, which declined by 19% to $554m. However, the New
Oncology Growth Platform in the US grew by 42% to $248m, primarily
reflecting encouraging Tagrisso sales growth of 75% to $180m in the half (H1 2016:
$103m). The New CVMD Growth Platform in the US declined by 1% to
$906m, reflecting the competitive environment in
Diabetes.
Europe
Product
Sales of $2,272m; a decline of 8% (5%
at CER).
New Oncology in Europe grew by 135% (140% at CER)
to $134m, partly driven by Tagrisso sales of $76m; Tagrisso was launched in Europe in January 2016.
Lynparza
sales of $58m represented growth of
81% (81% at CER). Forxiga sales growth of 18% (24% at CER) to $105m was
accompanied by Brilique growth of 8% (13% at CER) to $135m. This growth
was more than offset by declines in other areas, including a 14%
decline (10% at CER) in Symbicort sales to $399m. However, Symbicort maintained its position as the number one ICS/LABA
medicine, despite competition from branded and analogue
medicines.
Established ROW
Product
Sales of $1,494m; an increase of 3%
(2% at CER).
Japan sales increased by 7% (6% at CER) to
$1,067m, with an accelerated performance in Q2 2017 reflecting the
launch of Tagrisso and sales of Symbicort, which offset the biennial price reduction,
effective from April 2016. Symbicort sales in Japan increased by 14% (13% at CER) to
$100m and, following the launch in Japan in May 2016,
Tagrisso
sales for the half amounted to
$103m.
Nexium sales increased by 7% (5% at CER) to $253m and
sales of Forxiga increased by 84% (84% at CER) to
$46m.
Financial Performance
________________________________________________________________________________________
H1 2017
|
Reported
|
H1 2017
|
H1 2016
|
Actual
|
CER
|
$m
|
$m
|
% change
|
Total Revenue
|
10,456
|
11,718
|
(11)
|
(9)
|
Product Sales
|
9,783
|
11,034
|
(11)
|
(10)
|
Externalisation Revenue
|
673
|
684
|
(2)
|
(1)
|
|
|
|
|
|
Cost
of Sales
|
(1,844)
|
(2,066)
|
(11)
|
(6)
|
\
|
|
|
|
|
Gross
Profit
|
8,612
|
9,652
|
(11)
|
(10)
|
Gross Margin*
|
81.5%
|
81.5%
|
-
|
-1
|
|
|
|
|
|
Distribution
Expense
|
(149)
|
(167)
|
(11)
|
(7)
|
% Total Revenue
|
1.4%
|
1.4%
|
-
|
-
|
R&D
Expense
|
(2,802)
|
(2,945)
|
(5)
|
(1)
|
% Total Revenue
|
26.8%
|
25.1%
|
-2
|
-2
|
SG&A
Expense
|
(4,658)
|
(5,624)
|
(17)
|
(15)
|
% Total Revenue
|
44.5%
|
48.0%
|
+3
|
+3
|
Other
Operating Income and Expense
|
839
|
425
|
97
|
101
|
% Total Revenue
|
8.0%
|
3.6%
|
+4
|
+4
|
|
|
|
|
|
Operating
Profit
|
1,842
|
1,341
|
37
|
22
|
% Total Revenue
|
17.6%
|
11.4%
|
+6
|
+4
|
Net
Finance Expense
|
(742)
|
(636)
|
17
|
3
|
Joint
Ventures and Associates
|
(26)
|
(12)
|
113
|
113
|
Profit
Before Tax
|
1,074
|
693
|
55
|
38
|
Taxation
|
(116)
|
(99)
|
|
|
Tax
Rate
|
11%
|
14%
|
|
|
Profit
After Tax
|
958
|
594
|
61
|
43
|
|
|
|
|
|
Earnings Per Share
($)
|
0.80
|
0.51
|
58
|
41
|
* Gross margin, as a percentage of Product Sales, reflects Gross
Profit derived from Product Sales, divided by Product Sales. In H1
2017 Cost of Sales included $41m of costs relating to
externalisation activities (H1 2016: $28m).
Q2 2017
|
Reported
|
Q2 2017
|
Q2 2016
|
Actual
|
CER
|
$m
|
$m
|
% change
|
Total Revenue
|
5,051
|
5,603
|
(10)
|
(8)
|
Product Sales
|
4,940
|
5,469
|
(10)
|
(8)
|
Externalisation Revenue
|
111
|
134
|
(17)
|
(15)
|
|
|
|
|
|
Cost
of Sales
|
(950)
|
(1,062)
|
(11)
|
(10)
|
\
|
|
|
|
|
Gross
Profit
|
4,101
|
4,541
|
(10)
|
(8)
|
Gross Margin*
|
80.8%
|
80.6%
|
-
|
-
|
|
|
|
|
|
Distribution
Expense
|
(72)
|
(91)
|
(20)
|
(17)
|
% Total Revenue
|
1.4%
|
1.6%
|
-
|
-
|
R&D
Expense
|
(1,349)
|
(1,465)
|
(8)
|
(4)
|
% Total Revenue
|
26.7%
|
26.1%
|
-1
|
-1
|
SG&A
Expense
|
(2,358)
|
(3,052)
|
(23)
|
(20)
|
% Total Revenue
|
46.7%
|
54.5%
|
+8
|
+7
|
Other
Operating Income and Expense
|
603
|
370
|
63
|
65
|
% Total Revenue
|
11.9%
|
6.6%
|
+5
|
+5
|
|
|
|
|
|
Operating
Profit
|
925
|
303
|
n/m
|
n/m
|
% Total Revenue
|
18.3%
|
5.4%
|
+13
|
+12
|
Net
Finance Expense
|
(420)
|
(325)
|
29
|
(3)
|
Joint
Ventures and Associates
|
(13)
|
(8)
|
55
|
55
|
Profit/(Loss)
Before Tax
|
492
|
(30)
|
n/m
|
n/m
|
Taxation
|
(46)
|
(1)
|
|
|
Tax
Rate
|
9%
|
(3)%
|
|
|
Profit/(Loss)
After Tax
|
446
|
(31)
|
n/m
|
n/m
|
|
|
|
|
|
Earnings Per Share
($)
|
0.38
|
0.00
|
n/m
|
n/m
|
* Gross margin, as a percentage of Product Sales, reflects Gross
Profit derived from Product Sales, divided by Product Sales. In Q2
2017 Cost of Sales included $3m of costs relating to
externalisation activities (Q2 2016: $nil).
H1 2017
|
Reported
|
Restructuring
|
Intangible Asset
Amortisation & Impairments
|
Diabetes Alliance
|
Other1
|
Core2
|
Core
|
Actual
|
CER
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
% change
|
Gross
Profit
|
8,612
|
81
|
58
|
-
|
-
|
8,751
|
(10)
|
(9)
|
Gross
Margin3
|
81.5%
|
|
|
|
|
83.0%
|
+1
|
-
|
|
|
|
|
|
|
|
|
|
Distribution
Expense
|
(149)
|
-
|
-
|
-
|
-
|
(149)
|
(11)
|
(7)
|
R&D
Expense
|
(2,802)
|
142
|
43
|
-
|
-
|
(2,617)
|
(7)
|
(4)
|
SG&A
Expense
|
(4,658)
|
197
|
508
|
133
|
92
|
(3,728)
|
(12)
|
(9)
|
Other
Operating Income and Expense
|
839
|
76
|
43
|
-
|
-
|
958
|
105
|
108
|
|
|
|
|
|
|
|
|
|
Operating
Profit
|
1,842
|
496
|
652
|
133
|
92
|
3,215
|
7
|
3
|
%
Total Revenue
|
17.6%
|
|
|
|
|
30.7%
|
+5
|
+4
|
|
|
|
|
|
|
|
|
|
Net
Finance Expense
|
(742)
|
-
|
-
|
164
|
221
|
(357)
|
13
|
7
|
|
|
|
|
|
|
|
|
|
Taxation
|
(116)
|
(104)
|
(162)
|
(107)
|
(40)
|
(529)
|
15
|
11
|
|
|
|
|
|
|
|
|
|
Earnings Per Share
($)
|
0.80
|
0.31
|
0.38
|
0.15
|
0.22
|
1.86
|
5
|
1
|
1 Other
adjustments include discount unwind on acquisition-related
liabilities (see Note 4), provision charges related to certain
legal matters (see Note 5) and foreign-exchange gains and losses
relating to the classification of certain non-structural
intra-group loans, pending the outcome of the current ongoing
review.
2 Each of
the measures in the Core column in the above table are non-GAAP
measures.
3 Gross
margin as a percentage of Product Sales reflects gross profit
derived from Product Sales, divided by Product Sales. In H1 2017
Cost of Sales included $41m of costs relating to externalisation
activities (H1 2016: $28m). Movements in Gross Margin are expressed
in percentage points.
Q2 2017
|
Reported
|
Restructuring
|
Intangible Asset
Amortisation & Impairments
|
Diabetes Alliance
|
Other1
|
Core2
|
Core
|
Actual
|
CER
|
$m
|
$m
|
$m
|
$m
|
$m
|
$m
|
% change
|
Gross
Profit
|
4,101
|
43
|
29
|
-
|
-
|
4,173
|
(9)
|
(7)
|
Gross
Margin3
|
80.8%
|
|
|
|
|
82.3%
|
+1
|
+1
|
|
|
|
|
|
|
|
|
|
Distribution
Expense
|
(72)
|
-
|
-
|
-
|
-
|
(72)
|
(20)
|
(17)
|
R&D
Expense
|
(1,349)
|
38
|
32
|
-
|
-
|
(1,279)
|
(8)
|
(4)
|
SG&A
Expense
|
(2,358)
|
103
|
256
|
31
|
69
|
(1,899)
|
(10)
|
(7)
|
Other
Operating Income and Expense
|
603
|
-
|
22
|
-
|
-
|
625
|
60
|
61
|
|
|
|
|
|
|
|
|
|
Operating
Profit
|
925
|
184
|
339
|
31
|
69
|
1,548
|
10
|
8
|
%
Total Revenue
|
18.3%
|
|
|
|
|
30.6%
|
+6
|
+5
|
|
|
|
|
|
|
|
|
|
Net
Finance Expense
|
(420)
|
-
|
-
|
82
|
155
|
(183)
|
15
|
(1)
|
|
|
|
|
|
|
|
|
|
Taxation
|
(46)
|
(38)
|
(84)
|
(70)
|
(33)
|
(271)
|
28
|
24
|
|
|
|
|
|
|
|
|
|
Earnings Per Share
($)
|
0.38
|
0.12
|
0.19
|
0.03
|
0.15
|
0.87
|
5
|
6
|
1 Other
adjustments include discount unwind on acquisition-related
liabilities (see Note 4), provision charges related to certain
legal matters (see Note 5) and foreign-exchange gains and losses
relating to the classification of certain non-structural
intra-group loans, pending the outcome of the current ongoing
review.
2 Each of
the measures in the Core column in the above table are non-GAAP
measures.
3 Gross
margin as a percentage of Product Sales reflects gross profit
derived from Product Sales, divided by Product Sales. In Q2 2017
Cost of Sales included $3m of costs relating to externalisation
activities (Q2 2016: $nil). Movements in Gross Margin are expressed
in percentage points.
Profit and Loss Commentary for the Half
Gross Profit
Reported Gross
Profit declined by 11% (10% at CER) to $8,612m, partly reflecting
the residual effects of the Crestor and Seroquel XR loss of exclusivity in the
US on Product Sales. Excluding the impact of Externalisation
Revenue, the Reported Gross Profit Margin was stable (down one
percentage point at CER) at 81.5%.
Core
Gross Profit declined by 10% (9% at CER) to $8,751m and, excluding
the impact of Externalisation Revenue, the Core Gross Profit margin
increased by one percentage point to 83.0% (stable at CER),
reflecting the mix of sales, the growing influence of
specialty-care medicines, the impact of losses of exclusivity and
the resilience of some legacy medicines in established
markets.
Operating Expenses: R&D
Reported R&D
costs declined by 5% (1% at CER) to $2,802m, with the Company
continuing to focus on resource prioritisation and cost discipline.
Core R&D costs declined by 7% (4% at CER) to $2,617m.
Core R&D costs over the full year
are expected to be broadly in line with those in FY
2016.
Operating Expenses: SG&A
Reported SG&A
costs declined by 17% (15% at CER) to $4,658m, reflecting the
evolving shape of the business. Core SG&A costs declined by 12%
(9% at CER) to $3,728m. Core SG&A costs over the full year are
not expected to decline by the extent seen in the first
half.
The
Company has continued to consolidate its operations used by
multiple parts of the business. It is committed to driving
simplification and standardisation through centralisation in shared
services of back-office and some middle-office activities that are
currently performed in various enabling units, including Finance,
HR, Procurement and IT. Instead of operating numerous
shared-service centres and managing outsourced vendors
independently, the recently-launched Global Business Services
organisation will, over time, provide integration of governance,
locations and business practices to all shared services and
outsourcing activities across AstraZeneca.
Other Operating Income and Expense
Where
AstraZeneca does not retain a significant ongoing interest in
medicines or potential new medicines, income from disposal
transactions is reported within Other Operating Income and Expense
in the Company's financial statements.
Reported
Other Operating Income and Expense increased by 97% (101% at CER)
to $839m and included:
●
$291m resulting from the sale of
rights to Seloken in Europe
to Recordati S.p.A (Recordati)
●
$165m resulting from the sale of
the global rights to Zomig
outside Japan to the Grünenthal Group
(Grünenthal)
●
$161m of gains recognised on the
sale of short-term investments
●
A milestone receipt of $50m in
relation to the disposal of Zavicefta (ceftazidime and avibactam)
to Pfizer Inc.
●
Income from the monetisation of
an asset related to a previously-partnered legacy
medicine
Core
Other Operating Income and Expense increased by 105% (108% at CER)
to $958m, with the difference to Reported Other Operating Income
and Expense primarily driven by a restructuring charge taken
against land and buildings.
Operating Profit
Reported Operating
Profit increased by 37% (22% at CER) to $1,842m. The Reported
Operating Margin increased by six percentage points (four
percentage points at CER) at 18% of Total Revenue. Core Operating
Profit increased by 7% (3% at CER) to $3,215m. The Core Operating
Margin increased by five percentage points (four percentage points
at CER) to 31% of Total Revenue.
Net Finance Expense
Reported Net
Finance Expense increased by 17% to $742m, primarily reflecting an
adverse foreign-exchange impact caused by the strengthening of
sterling and euro against the dollar. Reported Net Finance Expense
increased by 3% at CER, reflecting the impact of a bond issuance in
the half and an increase in Net Debt that was driven by the
majority investment in Acerta Pharma in February 2016. Excluding
the discount unwind on acquisition-related liabilities and the
adverse foreign-exchange impact, Core Net Finance Expense increased
by 13% (7% at CER) to $357m.
Taxation
The Reported and Core tax rates for the half were 11% and 19%
respectively. The Reported tax rate was lower than the 2017 UK
Corporation Tax Rate of 19.25%, mainly due to the impact of tax
settlements and non-taxable fair value adjustments relating to
contingent consideration on business combinations. The Core tax
rate was lower than the aforementioned 2017 UK Corporation Tax
Rate, mainly due to the impact of tax settlements.
The net cash tax paid for the half was $336m, representing 31% of
Reported Profit Before Tax and 12% of Core Profit Before Tax.
Reduced net tax cash payments primarily reflected refunds following
a previously-disclosed agreement of inter-government transfer
pricing agreements. The Reported and Core tax rates for the
comparative period were 14% and 17%, respectively.
Earnings Per Share (EPS)
Reported EPS of
$0.80 represented an increase of 58% (41% at CER). Core EPS grew by
5% (1% at CER) to $1.86. The Core performance was driven by
continued progress on cost control and an increase in Other
Operating Income and Expense, partly offset by a decline in Total
Revenue.
Dividends
The
Board has recommended an unchanged first interim dividend of $0.90
(68.9 pence, 7.40 SEK) per Ordinary Share.
Cash Flow and Balance Sheet
Cash Flow
The
Company generated a net cash inflow from operating activities of
$338m in the half, compared with $1,374m in the comparative period.
The reduction reflected a lower profit, after deductions of gains
on disposal of intangible assets, as well as a higher increase in
working capital and short-term provisions due to a significant
increase in the level of debt factoring in the comparative
period.
Net
cash outflows from investing activities were $351m in the half
compared with $3,948m in the comparative period. The prior-period
outflow primarily reflected the upfront payment as part of the
majority investment in Acerta Pharma.
The
cash payment of contingent consideration in respect of the
Bristol-Myers Squibb Company share of the global Diabetes alliance
amounted to $185m in the half, comprising a $100m milestone payment
in respect of Qtern and
royalty payments.
Net
cash inflows from financing activities were $146m in the half
compared to outflows of $6m in the comparative period.
Capital Expenditure
Capital
expenditure amounted to $549m in the half, which included
investment in the new global headquarters in Cambridge, UK, as well
as strategic manufacturing capacity in the UK, the US, Sweden and
China.
Debt and Capital Structure
At 30
June 2017, outstanding gross debt (interest-bearing loans and
borrowings) was $19,725m (30 June 2016: $17,579m). Of the gross
debt outstanding at 30 June 2017, $2,933m was due within one year
(30 June 2016: $1,060m). The Company's net debt position at 30 June
2017 was $13,012m (30 June 2016: $12,734m).
On 5
June 2017, the Company announced that it had priced a global bond
offering totalling $2bn; the offering closed on 12 June 2017. The
intended use of the net proceeds of the issue was for general
corporate purposes, including the potential refinancing of existing
indebtedness. The transaction consisted of the following three
tranches:
●
$1bn of five-year fixed-rate
notes with a coupon of 2.375%
●
$0.75bn of 10-year fixed-rate
notes with a coupon of 3.125%
●
$0.25bn of five-year
floating-rate notes
Capital Allocation
The
Board's aim is to continue to strike a balance between the
interests of the business, financial creditors and the Company's
shareholders. After providing for investment in the business,
supporting the progressive dividend policy and maintaining a
strong, investment-grade credit rating, the Board will keep under
review potential investment in immediately earnings-accretive,
value-enhancing opportunities.
Foreign-Exchange Rates
Sensitivity
The
Company provides the following currency sensitivity
information:
|
|
|
|
Average
Exchange Rates Versus USD
|
|
|
|
Impact Of 5% Strengthening In Exchange Rate Versus
USD ($m)1
|
Currency
|
|
Primary Relevance
|
|
FY 2016
|
|
H1 20172
|
|
% change
|
|
Total Revenue
|
|
Core Operating Profit
|
EUR
|
|
Product Sales
|
|
0.90
|
|
0.92
|
|
-2%
|
|
+179
|
|
+123
|
JPY
|
|
Product Sales
|
|
108.84
|
|
112.43
|
|
-3%
|
|
+104
|
|
+71
|
CNY
|
|
Product Sales
|
|
6.65
|
|
6.87
|
|
-3%
|
|
+131
|
|
+74
|
SEK
|
|
Costs
|
|
8.56
|
|
8.86
|
|
-3%
|
|
+7
|
|
-98
|
GBP
|
|
Costs
|
|
0.74
|
|
0.79
|
|
-7%
|
|
+29
|
|
-131
|
Other3
|
|
|
|
|
|
|
|
|
|
+194
|
|
+124
|
1Based
on 2016 results at 2016 actual exchange rates.
2Based
on average daily spot rates between 1 January and 30 June
2017.
3Other
important currencies include AUD, BRL, CAD, KRW and
RUB.
|
Foreign-Exchange Hedging
AstraZeneca
monitors the impact of adverse currency movements on a portfolio
basis, recognising correlation effects. The Company may hedge to
protect against adverse impacts on cash flow over the short to
medium term. As at 30 June 2017, AstraZeneca had hedged 96% of
forecast short-term currency exposure that arises between the
booking and settlement dates on Product Sales and non-local
currency purchases.
Related-Party Transactions
There
have been no significant related-party transactions in the
period.
Principal Risks and Uncertainties
It is
not anticipated that the nature of the principal risks and
uncertainties that affect the business, and which are set out on
pages 20 to 21 of the Annual Report and Form 20-F Information 2016,
will change in respect of the second six months of the financial
year. Further information on our key risk management and assurance
processes are set out on pages 214 to 225 of the Annual Report and
Form 20-F Information 2016. In summary, the principal risks and
uncertainties listed in the Annual Report and 20-F Information 2016
are:
a) Medicine Pipeline and Intellectual Property Risks
Failure
or delay in delivery of pipeline and new medicines; failure to meet
quality, regulatory and ethical medicine approval and disclosure
requirements; failure to secure and protect product intellectual
property.
b) Commercialisation Risks
Competitive
pressures including externally driven demand, pricing and access;
failures or delays in quality execution of commercial
strategies.
c) Supply Chain and Business-Execution Risks
Failure
to maintain a supply of compliant, quality product; failure of
information technology and data security and privacy; delivery of
gains from productivity initiatives; failure to attract, develop,
engage and retain talented and capable employees at all
levels.
d) Legal, Regulatory and Compliance Risks
Safety
and efficacy of marketed products is questioned; adverse outcome of
defence of product, pricing and practices litigation; failure to
meet regulatory and ethical expectations on commercial practices,
including bribery and corruption, and scientific
exchanges.
e) Economic and Financial Risks
Failure
to achieve strategic plans and meet targets and
expectations.
Corporate and Business Development Update
________________________________________________________________________________________
The
highlights of the Company's corporate and business development
activities since the prior results announcement are shown
below:
a) Agreement for Seloken
In
Europe
On 22
May 2017, AstraZeneca announced that it had entered into an
agreement with Recordati for the commercial rights to Seloken/Seloken ZOK (metoprolol tartrate and
metoprolol succinate respectively) and associated Logimax fixed-dose combination
(metoprolol succinate and felodipine) treatments in Europe.
Metoprolol succinate is a beta-blocker for the control of
hypertension, angina and heart failure. AstraZeneca will continue
to commercialise the medicines in all other markets, where it holds
the rights.
Recordati
paid AstraZeneca $291m upon completion of the agreement in June
2017 (completion pending in Romania). AstraZeneca will also receive
sales-related income through tiered royalties, initially at a
double-digit percentage of sales. AstraZeneca manufactures and
supplies the medicines to Recordati under a supply agreement. Based
on the level of ongoing interest AstraZeneca will retain in the
brands in Europe, the $291m upfront and tiered royalties are
reported under Other Operating Income and Expense in the Company's
financial statements.
b) Agreement with Grünenthal to divest rights to migraine
treatment Zomig
On 7
June 2017, AstraZeneca announced that it had entered an agreement
with Grünenthal for the global rights to Zomig (zolmitriptan) outside Japan.
Zomig is indicated for the
acute treatment of migraines and cluster headaches, an area of
medicine outside AstraZeneca's strategic focus.
Grünenthal
paid AstraZeneca consideration of $200m in June 2017, of which
$165m was reported within Other Operating Income and Expense in the
first half, with the remainder being deferred. AstraZeneca will
also receive up to an additional $102m in future milestone
payments. Grünenthal acquired the rights to Zomig in all markets outside Japan,
including the US, where the rights were previously licensed to
Impax Pharmaceuticals (Impax). Impax continues to market
Zomig in the US.
AstraZeneca continues to manufacture and supply the medicine to
Grünenthal during a transition period.
c) Collaboration to develop and commercialise anticalin-based
inhaled treatments for Respiratory Diseases
On 3
May 2017, AstraZeneca announced a strategic collaboration in
respiratory diseases with Pieris Pharmaceuticals, Inc. (Pieris) to
develop novel inhaled drugs that leverage Pieris's Anticalin
platform. Anticalin molecules are engineered proteins which can
mimic antibodies by binding to sites either on other proteins or on
small molecules. They are smaller than monoclonal antibodies,
offering the potential of direct delivery to the lung.
AstraZeneca
will make upfront and near-term milestone payments to Pieris in the
amount of $57.5m, anticipated in Q3 2017. Pieris has the potential
to receive development-dependent milestones and eventual commercial
payments for all products not exceeding $2.1bn, as well as tiered
royalties on the sales of any potential products commercialised by
AstraZeneca.
d) Senior Executive Team (SET) changes
On 28
April 2017, a number of changes to the SET took effect. Iskra Reic
was appointed Executive Vice President (EVP), Europe, with
responsibility for sales, marketing and commercial operations
across AstraZeneca's businesses in 30 European countries. Jamie
Freedman was appointed EVP & Head, Oncology Business Unit, with
responsibility for sales, marketing, and medical affairs and
diagnostics activities for Oncology medicines globally, as well as
Oncology commercial operations in the US, UK, Spain, Italy, Germany
and France. Both became members of the SET, reporting to the Chief
Executive Officer. In addition, having joined the SET in December
2016, the responsibilities of Leon Wang, EVP, International were
expanded to add Latin America & Brazil, Russia & Eurasia,
and the Middle East & Africa to his previous Asia-Pacific
territories. He continues to report to the Chief Executive
Officer.
Research and Development Update
________________________________________________________________________________________
A
comprehensive table with AstraZeneca's pipeline of medicines in
human trials can be found later in this document.
Since
the results announcement on 27 April 2017 (the
period):
Regulatory
Approvals
|
4
|
- Imfinzi -
bladder cancer (US)
- Faslodex - breast cancer (1st line) (EU,
JP)
- Kyntheum (broadalumab) - psoriasis (EU) (received by
partner)
|
Regulatory
Submission Acceptances
|
2
|
- Lynparza - ovarian cancer (2nd line) (EU,
JP)
- Bevespi -
COPD (EU)
|
Phase III or Major Data Readouts
|
3
|
-
Imfinzi - lung cancer (PACIFIC)
-
Bydureon - type-2 diabetes
CVOT (met primary safety objective, did not meet primary efficacy
objective)
-
tralokinumab - severe, uncontrolled
asthma (did not meet primary endpoint)
|
New Molecular Entities(NMEs) In Phase III Trials Or Under
Regulatory Review
|
12
|
Oncology
- Imfinzi + treme - multiple cancers
-
acalabrutinib - blood cancers
-
moxetumomab pasudotox - leukaemia
-
selumetinib - thyroid cancer
-
savolitinib - kidney cancer
Cardiovascular & Metabolic Diseases
- ZS-9 (sodium zirconium
cyclosilicate)* - hyperkalaemia
-
roxadustat* - anaemia
Respiratory
-
benralizumab - severe, uncontrolled asthma*, COPD
-
tralokinumab - severe, uncontrolled asthma
-
PT010 - COPD
Other
-
anifrolumab - lupus
-
lanabecestat - Alzheimer's disease
|
Projects in Clinical Pipeline
|
129
|
|
*Under Regulatory Review
The table shown as of 27 July 2017
ONCOLOGY
AstraZeneca has a deep-rooted heritage in Oncology
and offers a growing line of new medicines that has 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 Lynparza, Tagrisso and Imfinzi are already benefitting patients. An extensive
pipeline of small-molecule and biologic medicines is in development
and the Company is committed to advancing New Oncology, primarily
focused on lung, ovarian, breast and blood cancers, as one of
AstraZeneca's five Growth Platforms.
At the
recent 2017 American Society of
Clinical Oncology (ASCO) annual meeting, AstraZeneca presented new
data on its expanding line of cancer medicines through 100
Company-sponsored and supported abstracts, including five 'Best of
ASCO' presentations, 11 oral presentations and eight poster
discussions. Content highlighted new data on approved and potential
new medicines from the Company's pipeline across multiple
scientific platforms and tumour types.
a) Lynparza
(multiple
cancers)
During the period, the Company received regulatory submission
acceptance in the EU for Lynparza's SOLO-2 trial in women with germline
BRCA-mutated, platinum-sensitive relapsed ovarian cancer. Among
other objectives, this regulatory submission aimed at bringing the
new Lynparza tablets to patients in the EU. Furthermore, the
Company made a regulatory submission in Japan for the use of
Lynparza
in 2nd-line, BRCA-mutated advanced or
metastatic ovarian cancer. This followed an Orphan Drug Designation
received during the first quarter of 2017. Presently, there are no
approved medicines in Japan to treat BRCA-mutated ovarian
cancer.
At the 2017 ASCO annual meeting, the Company presented positive
results from the Phase III OlympiAD trial of patients with
HER2-negative, metastatic breast cancer, harbouring germline BRCA1
or BRCA2 mutations. Results showed a
statistically-significant and clinically-meaningful improvement in
progression-free survival (PFS) for patients treated
with Lynparza tablets (300mg twice daily), compared to treatment
with physician's choice of standard-of-care (SoC) chemotherapy. The
trial met its primary endpoint, showing that patients treated
with Lynparza had a 42% reduction in the risk of disease
worsening or death (hazard ratio, HR=0.58; 95% CI 0.43-0.80) and a
median PFS of 7.0 vs 4.2 months compared to those who received
chemotherapy (capecitabine, vinorelbine, eribulin). The primary
endpoint was assessed by blinded independent central review (BICR).
The OlympiAD trial was the first positive outcome in a Phase III
trial to evaluate the safety and efficacy of a PARP inhibitor
beyond ovarian cancer.
b) Tagrisso
(lung
cancer)
While the original results of the AURA3 trial were presented in
2016, a follow-on analysis at the 2017 ASCO meeting showed
that Tagrisso also demonstrated efficacy in those patients with
disease progression to the central nervous system (CNS). The data
were consistent with earlier clinical and pre-clinical findings
showing the potential of Tagrisso to penetrate the blood-brain barrier. In the
newly-shared results of AURA3, Tagrisso 80mg once-daily tablets demonstrated that, in
patients with CNS metastases, there was no significant imbalance in
the hazard ratio (HR=0.32 or 68% reduction in the risk of disease
worsening or death) compared to patients in AURA3 overall
(HR=0.30). In the AURA3 trial, the adverse-event profiles
for Tagrisso and platinum-based doublet chemotherapy were
consistent with previous trials.
c) Faslodex
(breast
cancer)
On 26
July 2017, the Company announced approval in the EU for the
expansion of Faslodex use
into 1st-line treatment of hormone-receptor positive, metastatic
breast cancer. The approval was based on data from the Phase III
FALCON trial, where Faslodex 500mg demonstrated superiority
over anastrozole 1mg in the treatment of locally-advanced or
metastatic breast cancer in post-menopausal patients who had not
received prior hormonal-based medicine for HR+ breast cancer. The
FALCON trial data showed that Faslodex significantly reduced the risk
of disease worsening or death by 20% (HR=0.80). This new indication
for Faslodex was approved
in Japan and Russia during the period and is under review in the
US.
d) Savolitinib (kidney cancer)
AstraZeneca, and its partner Hutchison China MediTech
Limited, announced in June 2017 that they had initiated a
global, pivotal Phase III, open-label, randomised multi-centre
registrational trial of the highly-selective inhibitor of c-MET
receptor tyrosine kinase, savolitinib, in c-MET-driven papillary
renal cell carcinoma (PRCC). This is the first pivotal trial ever
conducted in c-MET-driven PRCC and the first molecularly-selected
trial in renal cell carcinoma (RCC), a form of kidney cancer. The
SAVOIR trial is designed to support registration of this potential
medicine in the US and EU and is supported by the results of the
Phase II trial.
e) Imfinzi
(multiple
cancers)
The Company continues to advance multiple monotherapy trials
of Imfinzi and combination trials of Imfinzi with tremelimumab and other potential new
medicines. The combination of Imfinzi and tremelimumab is being
assessed in Phase III trials in bladder cancer, non-small cell lung
cancer NSCLC, small cell lung cancer (SCLC), head and neck squamous
cell carcinoma (HNSCC) and in Phase I/II trials in hepatocellular
carcinoma, gastric cancer, pancreatic cancer and haematological
malignancies.
Bladder Cancer
On 1
May 2017, Imfinzi received
accelerated approval in the US for the treatment of patients with
locally-advanced or mUC who have disease progression during or
following platinum-containing chemotherapy, or whose disease has
progressed within 12 months of receiving platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant) surgery.
Approval was granted in an 'all-comer' population based on both
tumour response rate and duration of response. Data from Study
1108, which supported this approval, was shared at the recent 2017
ASCO annual meeting and showed a 17.0% objective response rate
(ORR) by BICR in all-comers and a 26.3% ORR in patients with
PDL1-positive tumours.
The STRONG trial, a Phase IIIb, modular, five-year safety,
open-label trial commenced dosing in the period and will evaluate
the safety of the fixed dosing of Imfinzi + tremelimumab combination therapy or
Imfinzi
monotherapy in patients with advanced
solid tumours (via tumour specific modules). The first tumour
module dosed was bladder cancer.
Ongoing key trials include:
Name
|
Phase
|
Line of Treatment
|
Population
|
Design
|
Timelines
|
Status
|
DANUBE
|
III
|
1st line
|
Cisplatin chemo-
therapy- eligible/
ineligible bladder cancer
|
Imfinzi, Imfinzi + treme vs SoC chemotherapy
|
FPCD1
Q4 2015
LPCD2
Q1 20173
First data anticipated H2 2018
|
Recruitment completed
|
1First
Patient Commenced Dosing
2Last
Patient Commenced Dosing
3Global
trial, excluding China
Lung Cancer
During the period, the Company maintained strong momentum in its
immunotherapy efforts in lung cancer, with an early data readout
from the PACIFIC trial. This is a Phase III, randomised,
double-blinded, placebo-controlled multi-centre trial of
Imfinzi as sequential
treatment in patients with locally-advanced, unresectable (Stage
III) NSCLC, who had not progressed following standard
platinum-based chemotherapy concurrent with radiation therapy. A
planned interim analysis focused on PFS, conducted by an
Independent Data Monitoring Committee, concluded that the trial had
already met a primary endpoint by showing statistically-significant
and clinically-meaningful reduction in the risk of disease
worsening or death (PFS), as assessed by a blinded and independent
review panel, in patients receiving Imfinzi compared to placebo. The
results also demonstrated a favourable benefit/risk profile. The
trial will continue in order to evaluate overall survival (OS), the
other primary endpoint, which will be assessed in due course as
specified by the protocol. AstraZeneca plans to submit the initial
results from the PACIFIC trial for presentation at a forthcoming
medical meeting.
Additional progress was made in the treatment of lung cancer when
the last patient commenced dosing in the NEPTUNE trial, as well as
first patient commencing dosing in the POSEIDON trial. Ongoing key
trials are included in the following table:
Name
|
Phase
|
Line of Treatment
|
Population
|
Design
|
Timelines
|
Status
|
Monotherapy
|
ADJUVANT*
|
III
|
N/A
|
Stage Ib-IIIa NSCLC
|
Imfinzi vs
placebo
|
FPCD Q1 2015
First data anticipated 2020
|
Recruitment ongoing
|
PACIFIC
|
III
|
N/A
|
Stage III unresectable NSCLC
|
Imfinzi vs
placebo
|
FPCD Q2 2014
LPCD Q2 2016
Final OS data anticipated 2019
|
Recruitment completed
PFS data positive Q2 2017
|
PEARL
|
III
|
1st line
|
NSCLC (Asia)
|
Imfinzi vs SoC
chemotherapy
|
FPCD Q1 2017
First data anticipated 2020
|
Recruitment ongoing
|
Combination therapy
|
MYSTIC
|
III
|
1st line
|
NSCLC
|
Imfinzi, Imfinzi + treme vs SoC chemotherapy
|
FPCD Q3 2015
LPCD Q3 2016
First data anticipated mid-2017
|
Recruitment completed
|
NEPTUNE
|
III
|
1st line
|
NSCLC
|
Imfinzi + treme vs SoC
chemotherapy
|
FPCD Q4 2015
LPCD Q2 2017
First data anticipated H2 2018
|
Recruitment completed
|
POSEIDON
|
III
|
1st line
|
NSCLC
|
Imfinzi + SoC,
Imfinzi
+ treme + SoC vs SoC
chemotherapy
|
FPCD Q2 2017
First data anticipated 2019
|
Recruitment ongoing
|
ARCTIC
|
III
|
3rd line
|
PDL1- low/neg. NSCLC
|
Imfinzi, tremelimumab,
Imfinzi
+ treme vs SoC
chemotherapy
|
FPCD Q2 2015
LPCD Q3 2016
First data anticipated H2 2017
|
Recruitment completed
|
CASPIAN
|
III
|
1st line
|
Small-cell lung cancer (SCLC)
|
Imfinzi + SoC,
Imfinzi
+ treme + SoC vs SoC
chemotherapy
|
FPCD Q1 2017
First data anticipated 2020
|
Recruitment ongoing
|
*Conducted
by the National Cancer Institute of Canada
Head and Neck Cancer
During the period, there was no update from the ongoing programme.
Ongoing key trials include:
|
Name
|
Phase
|
Line of
Treatment
|
Population
|
Design
|
Timelines
|
Status
|
Combination
therapy
|
KESTREL
|
III
|
1st line
|
HNSCC
|
Imfinzi,
Imfinzi
+ treme vs
SoC
|
FPCD
Q4 2015
LPCD Q1
2017
First data
anticipated H1 2018
|
Recruitment completed
|
EAGLE
|
III
|
2nd line
|
HNSCC
|
Imfinzi,
Imfinzi
+ treme vs
SoC
|
FPCD Q4 2015
First data anticipated H1 2018
|
Recruitment ongoing
|
CARDIOVASCULAR & METABOLIC DISEASES
AstraZeneca
has been a driving force in cardiovascular (CV) science for more
than 100 years and continues to be a pioneer in the industry, both
with its current portfolio and innovation-rich pipeline.
This therapy area includes a broad
diabetes portfolio, differentiated devices and unique small and
large-molecule programmes to reduce morbidity, mortality and organ
damage across CV, renal and metabolic diseases.
a) Brilique
(CV
disease)
During
the period, a new formulation of Brilique 90mg, an orally-dispersable
tablet (ODT), was approved by the EMA, making Brilique the first and only P2Y12
receptor inhibitor to be made available in ODT form in Europe. This
approval will expand the use of Brilique in patients who are unable to
swallow traditional tablets of the medicine.
b) Farxiga
(type-2
diabetes)
At the
2017 American Diabetes Association (ADA) Scientific Sessions,
AstraZeneca presented over 50 abstracts, including updated safety data on the risk-benefit profile
of Farxiga and data from the DURATION-8 trial evaluating the
efficacy and safety of Farxiga in combination with Bydureon.
In the updated safety analysis of Farxiga, data pooled from 30 Phase IIb/III clinical
trials showed no new safety signals and the incidence of adverse
events was generally similar to that in the control groups.
Importantly, there was no imbalance in lower-limb amputations, with
eight (0.1%) patients and seven (0.2%) patients identified in
the Farxiga and control groups,
respectively.
c) Bydureon
(type-2
diabetes)
Data from the DURATION-7 trial were presented in the period at the
2017 ADA meeting. The trial assessed the efficacy and safety of
adding Bydureon or placebo to insulin, in patients whose type-2
diabetes was inadequately controlled with basal insulin and
metformin. The trial showed that a once-weekly injection of
Bydureon
is an effective and well-tolerated
option for patients with type-2 diabetes and shows benefits, such
as 25.1% of patients achieving target A1C levels, lower fasting
glucose levels, reduced body weight (1.5kg) and better glycaemic
control than patients on placebo. During the period, regulatory
submissions for adding these results to the existing
Bydureon
label were accepted in the US and the
EU.
The results from the Phase III EXSCEL cardiovascular outcomes
trials are covered below.
d) Medicines in CV outcomes trials
As a follow-up to the CVD-REAL real-world evidence study presented
at the 2017 American College of Cardiology Session and Expo,
AstraZeneca shared additional findings at the 2017 European Society
of Cardiology Heart Failure meeting and at the 2017 ADA meeting
from the main data set of over 300,000 patients. The findings
showed that patients with and without established CV disease were
at a lower risk of both death and heart failure after initiation of
treatment with SGLT2 medicines versus other oral anti-diabetic
(OAD) medicines. The lower risk of events with SGLT2 medicines
versus other OAD medicines was consistent across sub-groups and
geographies, suggesting that SGLT2 medicines may benefit a broad
population of patients.
In analyses specific to Farxiga, compared to DPP-4 medicines in a two-country
data set of approximately 34,000 patients, data showed that
Farxiga
was associated with lower risk of
hypertensive heart failure (HF) (37%) and death (27%), as well as a
Major Adverse Cardiac Events (MACE), a composite endpoint of CV
death, non-fatal myocardial infarction or non-fatal stroke (29%),
and hospitalisation for kidney disease (62%). In this
Farxiga-specific data set, the majority of patients (79%)
did not have established CV disease at the time their medical
records were first evaluated.
During the period, the Company announced that the EXSCEL trial had
met its primary safety objective of non-inferiority for MACE, in
adults with type-2 diabetes at a wide range of CV risk. These
results addressed the US FDA requirement that medicines to treat
type-2 diabetes are not associated with an increase in CV risk.
Fewer CV events were observed in the Bydureon arm of the trial; however, the efficacy objective
of a superior reduction in MACE did not reach statistical
significance. Data were consistent with the known safety profile
of Bydureon and will be presented at the September 2017
European Association for the Study of Diabetes meeting in Lisbon,
Portugal.
Ongoing outcomes trials for patients with type-2 diabetes or
dyslipidaemia (abnormal levels of lipids and lipoproteins in the
blood) are highlighted in the following table:
Medicine
|
Trial
|
Mechanism
|
Population
|
Primary Endpoint
|
Timeline
|
Bydureon
|
EXSCEL
|
GLP-1 agonist
|
~14,000 patients with type-2 diabetes
|
Time to first occurrence of CV death, non-fatal myocardial
infarction or non-fatal stroke
|
Data presentation: EASD1,
September 2017
|
Farxiga
|
DECLARE
|
SGLT2 inhibitor
|
~17,0002
patients with type-2
diabetes
|
Time to first occurrence of CV death, non-fatal myocardial
infarction or non-fatal stroke
|
H2 2018 (final analysis)
|
Farxiga
|
DAPA-HF
|
SGLT2 inhibitor
|
~4,500 patients with heart failure
|
Time to first occurrence of CV death or hospitalisation for HF or
an urgent HF visit
|
FPCD Q1 2017
|
Farxiga
|
DAPA-CKD
|
SGLT2 inhibitor
|
~4,000 patients with chronic kidney disease (CKD)
|
Time to first occurrence of ≥50% sustained decline in
eGFR3
or reaching ESRD4
or CV death or renal
death
|
FPCD Q1 2017
|
Epanova
|
STRENGTH
|
Omega-3 carboxylic acids
|
~13,000 patients with mixed dyslipidaemia
|
Time to first occurrence of CV death, non-fatal myocardial
infarction or non-fatal stroke
|
2019 (final analysis)
|
1European
Association for the Study of Diabetes
2Includes
~10,000 patients who have had no prior index event (primary
prevention) and ~7,000 patients who have suffered an index event
(secondary prevention)
3Estimated
Glomerular Filtration Rate
4End
Stage Renal Disease
e) ZS-9 (sodium zirconium cyclosilicate)
(hyperkalaemia)
In
April 2017, the EMA informed AstraZeneca that the Marketing
Authorisation Application decision process for ZS-9 was put on hold
until the agency had performed an inspection of the dedicated
substance-manufacturing facility in Texas. This followed receipt of
a second Complete Response Letter from the US FDA, as announced on
17 March 2017. During the period, the Company made progress in
addressing the manufacturing deficiencies identified by the FDA
inspection and expects to provide an update in due
course.
RESPIRATORY
AstraZeneca's
Respiratory portfolio is aimed at transforming the treatment of
asthma and COPD through combination inhaled therapies, biologics
for the unmet medical needs of specific patient populations and an
early pipeline focused on disease modification.
The
growing range of medicines includes up to four anticipated launches
between 2017 and 2020. The capability in inhalation technology
spans both pressurised metered-dose inhalers and dry-powder
inhalers to serve patient needs, as well as the innovative
Aerosphere co-suspension
Delivery Technology, a focus of AstraZeneca's future-platform
development for respiratory-disease combination
therapies.
a) Benralizumab (asthma)
During
the American Thoracic Society international conference in May 2017,
the Company presented data for the Phase III ZONDA trial, showing a
statistically-significant and clinically-meaningful reduction in
daily-maintenance, oral corticosteroid (OCS) use compared with
placebo for patients with severe, uncontrolled OCS-dependent
eosinophilic asthma receiving benralizumab. Patients treated with
benralizumab achieved a median reduction in OCS dose of 75% and
were more than four times as likely to reduce their OCS dose than
those on placebo. Benralizumab also reduced overall exacerbation
rates by 70% and exacerbations requiring emergency-department
visits or hospitalisations by 93%. These positive trial results
were published simultaneously in the New England Journal of
Medicine.
b) Tralokinumab (asthma)
During the period, the STRATOS 1 trial of tralokinumab, an
anti-interleukin-13 (IL-13) human monoclonal antibody, did not meet
its primary endpoint of a significant reduction in the annual
asthma exacerbation rate (AAER) in the overall population of
severe, uncontrolled-asthma patients, compared with placebo.
However, a clinically-relevant reduction in AAER was observed in a
sub-population of patients with an elevated biomarker associated
with increased IL-13 activity. This sub-group of patients will now
be the focus for the future analysis of STRATOS 2, the second
ongoing pivotal Phase III trial, which is anticipated to report
later this year. Potential future regulatory submissions for
tralokinumab will be dependent on the combined analysis of both
STRATOS 1 and STRATOS 2.
c) PT010 (COPD)
PT010 is currently in Phase III trials in patients with moderate to
severe COPD. During the period, the last patient commenced dosing
in both the KRONOS and TELOS trials. Data for PT010 is anticipated
in the first half of 2018.
OTHER
a) Brodalumab (psoriasis)
On 20
July 2017, AstraZeneca announced that its partner, LEO Pharma, was
granted full approval by the EMA for Kyntheum (brodalumab) for the
treatment of adult patients with moderate-to-severe plaque
psoriasis who are candidates for systemic therapy or phototherapy
and have failed to respond or no longer respond to other systemic
therapies. Through a collaboration agreement, LEO Pharma holds
exclusive rights to develop and commercialise Kyntheum in Europe.
In the
US, brodalumab is approved under the brand name Siliq and marketed by AstraZeneca's
partner, Valeant.
b) Anifrolumab (lupus)
During
the period, the Company completed the enrolment of the first of two
Phase III trials (TULIP 1) of anifrolumab in patients with
moderate-to-severe systemic lupus erythematosus (SLE, or lupus).
Data readouts from both the TULIP 1 and TULIP 2 trials are expected
in H2 2018, with anticipated regulatory submissions in
2019.
The
Company also enrolled the first patient into the SLE Prospective
Observational Cohort Study (SPOCS) trial, a unique, AstraZeneca-led
collaboration between industry and academic centres to characterise
SLE disease activity, treatment, patient reported outcomes,
comorbidities, healthcare resource use and the impact on quality of
life among the general population of patients with moderate to
severe SLE and by the type-I Interferon gene signature (IFNGS) test
high-versus-low patient groups. SPOCS will enrol c.1,500 patients
and provide important information about possible associations of
type-I IFNGS with disease characteristics and outcomes for patients
with moderate-to-severe SLE.
AstraZeneca Development Pipeline 30 June 2017
________________________________________________________________________________________
AstraZeneca-sponsored or -directed trials
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional
indications
Regulatory
submission dates shown for assets in Phase III and beyond. As
disclosure of compound information is balanced by the business need
to maintain confidentiality, information in relation to some
compounds listed here has not been disclosed at this
time.
Compound
|
Mechanism
|
Area Under Investigation |
Date Commenced Phase
|
Estimated Regulatory Acceptance Date / Submission
Status
|
US
|
EU
|
Japan
|
China
|
Oncology
|
|
|
|
|
|
|
|
acalabrutinib#
|
BTK
inhibitor
|
B-cell
malignancy
|
Q1
2015
|
H2
2017
(Orphan
drug)
|
|
|
|
acalabrutinib#
|
BTK
inhibitor
|
1st-line chronic
lymphocytic leukaemia
|
Q3
2015
|
2020
(Orphan
drug)
|
2020
(Orphan
drug)
|
|
|
acalabrutinib#
|
BTK
inhibitor
|
relapsed/refractory
chronic lymphocytic leukaemia, high risk
|
Q4
2015
|
2020
(Orphan
drug)
|
2020
(Orphan
drug)
|
|
|
acalabrutinib
|
BTK
inhibitor
|
1st-line mantle cell lymphoma
|
Q1
2017
|
2023
|
|
|
|
selumetinibASTRA
|
MEK
inhibitor
|
differentiated
thyroid cancer
|
Q3
2013
|
2018
(Orphan
drug)
|
2018
|
|
|
moxetumomab
pasudotox#
PLAIT
|
anti-CD22
recombinantimmunotoxin
|
hairy
cell leukaemia
|
Q2
2013
|
2018
(Orphan
drug)
|
|
|
|
Imfinzi#
(durvalumab#) +
tremelimumabARCTIC
|
PD-L1
mAb + CTLA-4 mAb
|
3rd-line non-small
cell lung cancer
|
Q2
2015
|
H2
2017
|
H2
2017
|
H2
2017
|
|
Imfinzi#
(durvalumab#) +
tremelimumab
MYSTIC
|
PD-L1
mAb + CTLA-4 mAb
|
1st-line non-small
cell lung cancer
|
Q3
2015
|
H2
2017
|
H2
2017
|
H2
2017
|
|
Imfinzi#
(durvalumab#) +
tremelimumab
NEPTUNE
|
PD-L1
mAb + CTLA-4 mAb
|
1st-line non-small
cell lung cancer
|
Q4
2015
|
2019
|
2019
|
2019
|
2020
|
Imfinzi#
(durvalumab#) + tremelimumab +
chemotherapy
POSEIDON
|
PD-L1
mAb + CTLA-4 mAb
|
1st-line non-small
cell lung cancer
|
Q2
2017
|
2019
|
2019
|
2019
|
2020
|
Imfinzi#
(durvalumab#) + tremelimumab +
SoC
CASPIAN
|
PD-L1
mAb + CTLA-4 mAb + SoC
|
1st-line small
cell lung cancer
|
Q1
2017
|
2019
|
2019
|
2019
|
|
Imfinzi#
(durvalumab#) +
tremelimumabKESTREL
|
PD-L1
mAb + CTLA-4 mAb
|
1st-line head and
neck squamous cell carcinoma
|
Q4
2015
|
H2
2018
|
H2
2018
|
H2
2018
|
|
Imfinzi#
(durvalumab#) +
tremelimumabEAGLE
|
PD-L1
mAb + CTLA-4 mAb
|
2nd-line head and
neck squamous cell carcinoma
|
Q4
2015
|
H2
2018
|
H2
2018
|
H2
2018
|
|
Imfinzi#
(durvalumab#) +
tremelimumab
DANUBE
|
PD-L1
mAb + CTLA-4 mAb
|
1st-line bladder
cancer
|
Q4
2015
|
H2
2018
|
H2
2018
|
H2
2018
|
|
Lynparza¶ + cediranib
CONCERTO
|
PARP
inhibitor + VEGF inhibitor
|
recurrent
platinum-resistant ovarian cancer
|
Q1
2017
|
2019
|
|
|
|
Cardiovascular & Metabolic Diseases
|
|
|
|
|
|
Epanova
|
omega-3 carboxylic acids
|
severe hypertriglyceridemia
|
|
Approved
|
|
2018
|
|
ZS-9 (sodium zirconium cyclosilicate)
|
potassium binder
|
hyperkalaemia
|
|
-
|
Accepted1
|
2019
|
|
roxadustat#
OLYMPUS (US) ROCKIES
(US)
|
hypoxia-inducible factor prolyl hydroxylase inhibitor
|
anaemia in chronic kidney disease/end stage renal
disease
|
Q3
2014
|
2018
|
|
|
Initiated2
|
Respiratory
|
Bevespi Aerosphere (PT003)
|
LABA/LAMA
|
chronic obstructive pulmonary disease
|
|
Launched
|
Accepted
|
2018
|
2018
|
benralizumab#
CALIMA SIROCCO ZONDA
BISE
BORA
GREGALE
|
IL-5R mAb
|
severe asthma
|
|
Accepted
|
Accepted
|
Accepted
|
2021
|
benralizumab#
TERRANOVA GALATHEA
|
IL-5R mAb
|
chronic obstructive pulmonary disease
|
Q3
2014
|
H2
2018
|
H2
2018
|
2019
|
|
PT010
|
LABA/LAMA/
ICS
|
chronic
obstructive pulmonary disease
|
Q3
2015
|
2019
|
2019
|
H2
2018
|
2019
|
tralokinumab
STRATOS 1,2
TROPOS
MESOS
|
IL-13 mAb
|
severe asthma
|
Q3
2014
|
2018
|
2018
|
2018
|
|
Other
|
|
|
|
|
|
|
|
anifrolumab#
TULIP
|
IFN-alphaR mAb
|
systemic lupus erythematosus
|
Q3
2015
|
2019
(Fast
Track)
|
2019
|
2019
|
|
lanabecestat#
AMARANTH + extension, DAYBREAK-ALZ
|
beta-secretase inhibitor
|
alzheimer's disease
|
Q2
2016
|
2020
(Fast
Track)
|
2020
|
2020
|
|
|
|
|
|
|
|
|
|
|
¶
Registrational Phase II
trial
# Collaboration
1 CHMP positive opinion received
2 Rolling New Drug Application (NDA) regulatory
submission initiated in Q4 2016
Phases I and II
NMEs and significant additional indications
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
|
|
Oncology
|
|
|
|
|
|
Imfinzi# (durvalumab#)
|
PD-L1 mAb
|
solid tumours
|
II
|
Q3
2014
|
|
Imfinzi#
(durvalumab#) +
tremelimumab
|
PD-L1
mAb + CTLA-4 mAb
|
hepatocellular carcinoma (liver cancer)
|
II
|
Q4
2016
|
|
Imfinzi#
(durvalumab#) +
tremelimumab
|
PD-L1
mAb + CTLA-4 mAb
|
gastric
cancer
|
II
|
Q2
2015
|
|
Imfinzi#
(durvalumab#)
+ AZD5069
|
PD-L1 mAb + CXCR2 antagonist
|
pancreatic ductal adenocarcinoma
|
II
|
Q2
2017
|
|
Imfinzi# (durvalumab#)
+ AZD5069 or Imfinzi#(durvalumab#) +
AZD9150#
|
PD-L1 mAb + CXCR2 antagonist or PD-L1 mAb + STAT3
inhibitor
|
head
and neck squamous cell carcinoma
|
II
|
Q3
2015
|
|
Imfinzi#
(durvalumab#)
+ dabrafenib + trametinib
|
PD-L1 mAb+ BRAF inhibitor + MEK inhibitor
|
melanoma
|
I
|
Q1
2014
|
|
Imfinzi#
(durvalumab#)
+ AZD1775#
|
PD-L1 mAb + Wee1 inhibitor
|
solid tumours
|
I
|
Q4 2015
|
|
Imfinzi#
(durvalumab#)
+ MEDI0680
|
PD-L1 mAb + PD-1 mAb
|
solid tumours
|
II
|
Q3
2016
|
|
Imfinzi#
(durvalumab#)
or Imfinzi#
(durvalumab#)
+ (tremelimumab or AZD9150#)
|
PD-L1 mAb or PD-L1 mAb + (CTLA-4 mAb or STAT3
inhibitor)
|
diffuse large B-cell lymphoma
|
I
|
Q3
2016
|
|
Imfinzi#
(durvalumab#)
+
Iressa
|
PD-L1 mAb+ EGFR inhibitor
|
non-small cell lung cancer
|
I
|
Q2
2014
|
|
Imfinzi#
(durvalumab#)
+ MEDI0562#
|
PD-L1 mAb + humanised OX40 agonist
|
solid tumours
|
I
|
Q2 2016
|
|
Imfinzi#
(durvalumab#)
+ MEDI9197#
|
PD-L1 mAb + TLR 7/8 agonist
|
solid tumours
|
I
|
Q2
2017
|
|
Imfinzi#
(durvalumab#)
+ MEDI9447
|
PD-L1 mAb + CD73 mAb
|
solid tumours
|
I
|
Q1
2016
|
|
Imfinzi#
(durvalumab#)
+ monalizumab
|
PD-L1 mAb + NKG2a mAb
|
solid tumours
|
I
|
Q1
2016
|
|
Imfinzi#
(durvalumab#)
+ selumetinib
|
PD-L1 mAb + MEK inhibitor
|
solid tumours
|
I
|
Q4
2015
|
|
Imfinzi#
(durvalumab#)
+ tremelimumab
|
PD-L1 mAb + CTLA-4 mAb
|
solid tumours
|
I
|
Q4
2013
|
|
tremelimumab + MEDI0562#
|
CTLA-4 mAb + humanised OX40 agonist
|
solid tumours
|
I
|
Q2 2016
|
|
Lynparza +
AZD6738
|
PARP inhibitor + ATR inhibitor
|
gastric cancer
|
II
|
Q3
2016
|
|
Lynparza
+ AZD1775#
|
PARP inhibitor + Wee1 inhibitor
|
solid tumours
|
I
|
Q3 2015
|
|
savolitinib#
|
MET inhibitor
|
papillary renal cell carcinoma
|
II
|
Q2
2014
|
|
Tagrisso
+
(selumetinib#
or
savolitinib#)
TATTON
|
EGFR inhibitor + (MEK inhibitor or MET inhibitor)
|
advanced EGFRm non-small cell lung cancer
|
II
|
Q2
2016
|
|
Tagrisso
BLOOM
|
EGFR inhibitor
|
CNS metastases in advanced EGFRm non-small cell lung
cancer
|
II
|
Q4
2015
|
|
AZD1775#
+
chemotherapy
|
Wee1 inhibitor + chemotherapy
|
ovarian cancer
|
II
|
Q4 2012
|
|
AZD1775#
|
Wee1 inhibitor
|
solid tumours
|
II
|
Q1 2016
|
|
vistusertib
|
mTOR inhibitor
|
solid tumours
|
II
|
Q1
2013
|
|
AZD5363#
|
AKT inhibitor
|
breast cancer
|
II
|
Q1
2014
|
|
AZD4547
|
FGFR inhibitor
|
solid tumours
|
II
|
Q4
2011
|
|
MEDI-573#
|
IGF mAb
|
metastatic breast cancer
|
II
|
Q2
2012
|
|
AZD0156
|
ATM inhibitor
|
solid tumours
|
I
|
Q4
2015
|
|
AZD2811#
|
Aurora B inhibitor
|
solid tumours
|
I
|
Q4
2015
|
|
AZD4635
|
A2aR inhibitor
|
solid tumours
|
I
|
Q2 2016
|
|
AZD4785
|
KRAS inhibitor
|
solid tumours
|
I
|
Q2
2017
|
|
AZD6738
|
ATR inhibitor
|
solid tumours
|
I
|
Q4
2013
|
|
AZD8186
|
PI3k inhibitor
|
solid tumours
|
I
|
Q2
2013
|
|
AZD9150#
|
STAT3 inhibitor
|
haematological malignancies
|
I
|
Q1
2012
|
|
AZD9496
|
selective oestrogen receptor downregulator (SERD)
|
ER+ breast cancer
|
I
|
Q4 2014
|
|
MEDI-565#
|
CEA BiTE mAb
|
solid tumours
|
I
|
Q1
2011
|
|
MEDI0562#
|
humanised OX40 agonist
|
solid tumours
|
I
|
Q1 2015
|
|
MEDI0680
|
PD-1 mAb
|
solid tumours
|
I
|
Q4
2013
|
|
MEDI1873
|
GITR agonist fusion protein
|
solid tumours
|
I
|
Q4
2015
|
|