H1 2015
|
Q2 2015
|
||||||
$m
|
% change
|
$m
|
% change
|
||||
CER1
|
Actual
|
CER1
|
Actual
|
||||
Total Revenue2
|
12,364
|
1
|
(6)
|
6,307
|
2
|
(7)
|
|
Core3 Op. Profit
|
3,618
|
(4)
|
(9)
|
1,813
|
(4)
|
(11)
|
|
Core EPS
|
$2.29
|
-
|
(7)
|
$1.21
|
3
|
(8)
|
|
Reported Op. Profit
|
1,856
|
1
|
(5)
|
923
|
(10)
|
(17)
|
|
Reported EPS
|
$0.99
|
2
|
(4)
|
$0.55
|
(4)
|
(13)
|
·
|
Total H1 Revenue up 1%; Core Gross margin over 83%, up 1% point
|
·
|
Robust top-line performance, supported by externalisation, underpins accelerated investment in R&D to progress pipeline, up 24% in H1
|
·
|
Core SG&A efficiency programme - early progress: Core SG&A 35% of Q2 Total Revenue (Q4 2014: 44%)
|
-
|
Sales & marketing effectiveness, centralisation of functions, process improvements, third-party spend, further efficiencies across support areas, footprint optimisation
|
·
|
Core H1 EPS stable, up 3% in Q2, enhanced by one-off tax benefit
|
·
|
FY 2015 Total Revenue guidance at CER improved: Now expected to decline by low single-digit percent (prior guidance - mid single-digit). Core EPS guidance at CER is unchanged: Expected to increase by low single-digit percent, reflecting the continued accelerated investment in R&D
|
·
|
The Board recommends an unchanged first interim dividend of $0.90
|
1.
|
Brilinta/Brilique: +42%. Achieved 10% new-to-brand prescription market share in the US
|
2.
|
Diabetes: +32%, including 88% sales growth in Emerging Markets
|
3.
|
Respiratory: +9%, ahead of market growth. Q2 sales up 11%
|
4.
|
Emerging Markets: +14%. China sales growth of +19%
|
5.
|
Japan: +2%, with Q2 sales growth of +6%
|
Regulatory Approvals
|
Iressa - lung cancer (US)
Faslodex 500mg - breast cancer (China)
|
Regulatory Submissions* and/or Regulatory Submission Acceptances
|
saxagliptin/dapagliflozin - diabetes (EU)
AZD9291 - lung cancer (US*, EU)
cediranib - ovarian cancer (EU)
Ceftazidime Avibactam (CAZ AVI) - serious infections (EU)
|
Phase III Read-outs
|
selumetinib - uveal melanoma: Primary endpoint not met
|
Other Key Developments
|
Brilinta/Brilique - post-myocardial infarction (MI):
Granted FDA Priority Review
|
“We made good progress in the period, delivering a robust underlying business performance. This represents six successive quarters of top-line growth. The initiatives introduced to increase efficiency are starting to reduce SG&A costs, supporting our continued strategic investment in science and the acceleration of our pipeline which has positive momentum across all key areas.
|
I’m particularly pleased by the pace of progress in Oncology, with new approvals for both Iressa and Faslodex accompanied by regulatory submissions for AZD9291 and cediranib. The strong performance of the growth platforms and the subsequent upgrade to top-line guidance, together with increased R&D productivity reaffirm the confidence we have in our ability to navigate the final impacts from the loss of exclusivity and meet our revenue targets.”
|
1.
|
All growth rates are shown at constant exchange rates (CER) unless specified otherwise.
|
2.
|
Total Revenue defined as Product Sales and Externalisation Revenue. For further details on the presentation of Total Revenue, see the announcement published by the Company on 6 March 2015.
|
3.
|
See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
|
Media Enquiries
|
||
Esra Erkal-Paler
|
UK/Global
|
+44 20 7604 8030
|
Vanessa Rhodes
|
UK/Global
|
+44 20 7604 8037
|
Ayesha Bharmal
|
UK/Global
|
+44 20 7604 8034
|
Jacob Lund
|
Sweden
|
+46 8 553 260 20
|
Michele Meixell
|
US
|
+1 302 885 2677
|
Investor Enquiries
|
|||
UK
|
|||
Thomas Kudsk Larsen
|
+44 20 7604 8199
|
+44 7818 524185
|
|
Eugenia Litz
|
RIA
|
+44 20 7604 8233
|
+44 7884 735627
|
Nick Stone
|
CVMD
|
+44 20 7604 8236
|
+44 7717 618834
|
Karl Hård
|
Oncology
|
+44 20 7604 8123
|
+44 7789 654364
|
Craig Marks
|
ING
|
+44 20 7604 8591
|
+44 7881 615764
|
Christer Gruvris
|
+44 20 7604 8126
|
+44 7827 836825
|
|
US
|
|||
Dial / Toll-Free
|
+1 301 398 3251
|
+1 866 381 7277
|
Regulatory Approvals
|
2
|
- Iressa - lung cancer (US)
- Faslodex 500mg - breast cancer (China)
|
Regulatory Submissions* and/or Regulatory Submission Acceptances
|
4
|
- saxagliptin/dapagliflozin - diabetes (EU)
- AZD9291 - lung cancer (US*, EU)
- cediranib - ovarian cancer (EU)
- CAZ AVI - serious infections (EU)
|
Phase III Read-outs
|
1
|
- selumetinib - uveal melanoma: Primary endpoint not met
|
Other Key Developments
|
1
|
- Brilinta/Brilique - post-MI (PEGASUS trial): Granted FDA Priority Review
|
Forthcoming Regulatory Submissions
|
3
|
- brodalumab - psoriasis, PT003 - COPD,
AZD9291 - lung cancer (JP)
|
Forthcoming Regulatory Decisions
|
5
|
- lesinurad - gout, saxagliptin/dapagliflozin, Brilinta/Brilique, AZD9291, CAZ-AVI
|
Pivotal Trial Starts
|
6
|
- PT010 - COPD
- anifrolumab - lupus
- durvalumab (MEDI4736) + tremelimumab - 2nd-line SCCHN** (CONDOR trial), 2nd and 3rd-line gastric cancer, 1st-line NSCLC
(MYSTIC trial) - AZD9291 - 2nd-line EGFRm NSCLC (CAURAL trial)
|
New Molecular Entities (NMEs) in Pivotal Studies or under Regulatory Review
|
15
|
RIA
- lesinurad - gout
- PT003 - COPD
- PT010 - COPD (new)
- brodalumab - psoriasis
- benralizumab - severe asthma
- tralokinumab - severe asthma
- anifrolumab - lupus (new)
CVMD
- roxadustat - anaemia
Oncology
- AZD9291 - lung cancer
- cediranib - ovarian cancer
- selumetinib - lung cancer
- tremelimumab - mesothelioma
- durvalumab - lung cancer
- moxetumomab pasudotox - leukaemia
ING
- CAZ AVI - serious infections
|
Projects in clinical pipeline
|
119
|
1.
|
Respiratory, Inflammation and Autoimmunity (RIA)
|
a)
|
PT010 (COPD)
|
b)
|
Anifrolumab (lupus)
|
c)
|
Benralizumab (severe asthma)
|
d)
|
Tralokinumab (severe asthma)
|
e)
|
Brodalumab (psoriasis)
|
2.
|
Cardiovascular and Metabolic Disease (CVMD)
|
a)
|
Brilinta/Brilique (CV disease)
|
b)
|
Onglyza (type-2 diabetes)
|
c)
|
SGLT2 Inhibitors (type-2 diabetes)
|
d)
|
Tenapanor (chronic kidney disease)
|
3.
|
Oncology
|
·
|
Data presented on durvalumab (formerly MEDI4736) as monotherapy in heavily pre-treated patients with non-small cell lung cancer (NSCLC) or SCCHN were encouraging and suggested that patients with PD-L1 positive tumours may have an improved overall response rate (ORR) compared to patients with PD-L1 negative tumours, highlighting the unmet medical need for the majority of tumours that are PD-L1 negative
|
·
|
Data presented on durvalumab plus tremelimumab confirmed the Phase III trial dose and schedule for this combination. The combination demonstrated an ORR of 38% at doses selected for the Phase III trials versus a 5% ORR for patients receiving durvalumab monotherapy in the 1108 trial. The combination was well tolerated with a very low 7% drug-related discontinuation rate
|
·
|
In addition, durvalumab is demonstrating strong potential to combine with small molecules
|
Medicine
|
Indication
|
Status
|
Iressa
|
Lung cancer
|
Earlier this month the Company announced that the FDA had approved Iressa (gefitinib) tablets, a 250mg once-daily 1st-line treatment for patients with metastatic epidermal growth-factor receptor (EGFR) mutated NSCLC. Iressa was granted Orphan Drug Designation by the FDA in 2014.
|
AZD9291
|
Lung cancer
|
In June 2015, the Company submitted the rolling new-drug application (NDA) for AZD9291 as a potential medicine for the 2nd-line treatment of patients with advanced or metastatic T790M-mutated NSCLC. The EMA also accepted the regulatory submission for AZD9291.
CAURAL, a randomised Phase III trial in 2nd-line metastatic EGFR T790M-mutation positive NSCLC testing AZD9291 plus durvalumab versus AZD9291 monotherapy is being prepared for dosing. The trial has a primary endpoint of progression-free survival (PFS).
At the ASCO meeting, preliminary efficacy and safety data for AZD9291 in the 1st-line treatment of EGFRm-positive advanced NSCLC were presented. Data showed that 81% (95% confidence interval (CI) 68% to 89%) of patients on a once-daily dose of AZD9291 were progression-free at nine months; the ORR was 73% (95% CI 60% to 84%). The longest duration of response was ongoing at 13.8 months at the time of data cut-off. These data support the ongoing development of AZD9291 in 1st-line lung cancer, including the Phase III FLAURA trial.
|
Cediranib
|
Ovarian cancer
|
The Company received acceptance from the EU this month for the marketing authorisation application for cediranib with an intended indication in platinum-sensitive relapsed ovarian cancer. The application was based on the ICON6 trial. ICON6 results showed that, compared to platinum chemotherapy alone, cediranib given with platinum-based chemotherapy and continued as maintenance, significantly improves PFS in women with recurrent ovarian cancer.
Subsequent secondary-efficacy measures supported significant sustained efficacy, leading to a strong overall survival trend.
|
Selumetinib
|
Uveal melanoma
|
The Phase III SUMIT trial of selumetinib (MEK inhibitor) in combination with dacarbazine did not meet its primary endpoint of PFS. This combination therapy showed an adverse event profile generally consistent with current knowledge of the safety profiles of dacarbazine and selumetinib. A full evaluation of the data is ongoing.
Outside uveal melanoma, selumetinib is in a Phase III trial in 2nd-line KRAS-mutant advanced NSCLC in combination with docetaxel, in a Phase III trial in differentiated thyroid cancer and in a Phase II registration trial in patients with neurofibromatosis Type 1. These trials have a different scientific rationale and selumetinib is being tested in alternative combinations. The findings from SUMIT are not expected to have any impact on the other studies.
|
Durvalumab
|
Lung cancer
|
ATLANTIC, a Phase II trial in PD-L1 positive 3rd-line metastatic NSCLC, is now fully recruited and scheduled to deliver data in the second half. This trial could potentially, if positive, support the first regulatory submission for durvalumab.
ARCTIC, a Phase III trial in 3rd-line metastatic NSCLC is recruiting patients and contains a randomised durvalumab monotherapy sub-study for PD-L1 positive patients versus SoC and a sub-study with a concurrent-combination treatment with tremelimumab versus the contribution of components and SoC in PD-L1 negative patients.
MYSTIC, which is being prepared for dosing, is a 1st-line NSCLC durvalumab-tremelimumab trial in PD-L1 unselected, EGFR/ALK wild-type patients and includes a sub-group analysis of PD-L1 positive and PD-L1 low/negative patients. The primary endpoint is PFS and the trial includes durvalumab monotherapy and the durvalumab-tremelimumab combination versus SoC.
NEPTUNE, a further durvalumab-tremelimumab versus SoC trial with overall survival (OS) as the primary endpoint complements the MYSTIC PFS trial and will commence in due course.
A third 1st-line NSCLC trial of durvalumab plus chemotherapy in PD-L1 unselected, EGFR/ALK wild-type NSCLC will also be initiated after a lead-in phase.
PD-L1 status is being assessed by a proprietary (SP263) immunohistochemistry diagnostic test jointly developed with Ventana Medical Systems, Inc., a member of the Roche Group.
|
Head and Neck cancer
|
In the CONDOR trial for patients with recurrent or metastatic SCCHN the first patient was dosed in the quarter. The CONDOR trial is a Phase II, randomised, global trial of durvalumab monotherapy, tremelimumab monotherapy and durvalumab in combination with tremelimumab in PD-L1 negative patients. It is designed to complement the HAWK trial which targets PD-L1 positive patients.
|
|
Gastric cancer
|
A Phase II trial in 2nd and 3rd-line gastric cancer was also initiated in the period. This trial explores durvalumab-tremelimumab versus durvalumab versus tremelimumab.
|
|
Pancreatic cancer
|
A pancreatic cancer uncontrolled Phase II trial will explore combinations of immunotherapies, in particular durvalumab plus tremelimumab, in 2nd-line metastatic pancreatic ductal adenocarcinoma (PDAC). In addition, the programme will explore combinations of immunotherapy with both chemotherapy in 1st-line PDAC and with targeted therapies in 2nd-line PDAC; the first targeted therapy included in this trial is AZD5069 (CXCR2).
|
|
Bladder cancer
|
A 1st-line bladder cancer Phase III, randomised and controlled trial will evaluate both durvalumab monotherapy and durvalumab-tremelimumab in metastatic, urothelial bladder cancer.
|
4.
|
Infection, Neuroscience and Gastrointestinal (ING)
|
a)
|
CAZ-AVI (serious infections)
|
b)
|
AZD3293 (Alzheimer’s disease)
|
a)
|
Haematology Collaboration with Celgene
|
b)
|
NKG2A Antibody Collaboration with Innate
|
c)
|
Joint Venture with Fujifilm Kyowa Kirin Biologics
|
d)
|
Entocort Divestment
|
e)
|
Benralizumab: Japan
|
f)
|
Caprelsa Divestment
|
g)
|
Creation of Antibiotics Business Unit
|
h)
|
Change In Senior Executive Team
|
i)
|
Future Infrastructure
|
H1 2015
|
Q2 2015
|
||||||
% Change
|
% Change
|
||||||
$m
|
CER
|
Actual
|
$m
|
CER
|
Actual
|
||
Respiratory, Inflammation and Autoimmunity
|
|||||||
Symbicort
|
1,687
|
-
|
(9)
|
842
|
-
|
(9)
|
|
Pulmicort
|
518
|
18
|
10
|
232
|
19
|
11
|
|
Tudorza/Eklira
Daliresp
|
85
39
|
n/m
n/m
|
n/m
n/m
|
55
32
|
n/m
n/m
|
n/m
n/m
|
|
Duaklir
|
7
|
n/m
|
n/m
|
5
|
n/m
|
n/m
|
|
Cardiovascular and Metabolic Disease
|
|||||||
Brilinta/Brilique
|
275
|
42
|
27
|
144
|
38
|
23
|
|
Onglyza
|
391
|
4
|
(2)
|
208
|
(7)
|
(13)
|
|
Bydureon
|
263
|
41
|
37
|
140
|
29
|
25
|
|
Byetta
|
172
|
8
|
4
|
82
|
(1)
|
(7)
|
|
Farxiga/Forxiga
|
205
|
n/m
|
n/m
|
129
|
n/m
|
n/m
|
|
Legacy:
|
|||||||
Crestor
|
2,477
|
(5)
|
(11)
|
1,310
|
(3)
|
(10)
|
|
Seloken/Toprol-XL
|
378
|
7
|
(2)
|
184
|
6
|
(5)
|
|
Atacand
|
194
|
(11)
|
(26)
|
99
|
(13)
|
(29)
|
|
Oncology
|
|||||||
Iressa
|
273
|
(3)
|
(14)
|
129
|
(1)
|
(12)
|
|
Lynparza
|
30
|
n/m
|
n/m
|
21
|
n/m
|
n/m
|
|
Legacy:
|
|||||||
Zoladex
|
409
|
9
|
(11)
|
215
|
14
|
(9)
|
|
Faslodex
|
333
|
5
|
(5)
|
172
|
9
|
(4)
|
|
Casodex
|
139
|
(5)
|
(16)
|
69
|
(5)
|
(17)
|
|
Arimidex
|
126
|
(9)
|
(19)
|
64
|
(6)
|
(18)
|
|
Infection, Neuroscience and Gastrointestinal
|
|||||||
Nexium
|
1,291
|
(27)
|
(32)
|
647
|
(27)
|
(33)
|
|
Seroquel XR
|
526
|
(7)
|
(12)
|
264
|
(8)
|
(13)
|
|
Synagis
|
270
|
(28)
|
(28)
|
66
|
40
|
40
|
|
Losec/Prilosec
|
181
|
(6)
|
(16)
|
85
|
(9)
|
(19)
|
|
FluMist/Fluenz
|
21
|
75
|
75
|
14
|
180
|
180
|
|
Movantik/Moventig
|
4
|
n/m
|
n/m
|
1
|
n/m
|
n/m
|
H1 2015
|
Q2 2015
|
||||||||||
% Change
|
% Change
|
||||||||||
$m
|
CER
|
Actual
|
$m
|
CER
|
Actual
|
||||||
US
|
4,525
|
(9)
|
(9)
|
2,356
|
(3)
|
(3)
|
|||||
Europe
|
2,601
|
(5)
|
(20)
|
1,261
|
(5)
|
(23)
|
|||||
Established ROW1
|
1,491
|
(2)
|
(15)
|
785
|
-
|
(14)
|
|||||
Japan
|
977
|
2
|
(12)
|
522
|
6
|
(10)
|
|||||
Canada
|
273
|
6
|
(5)
|
138
|
5
|
(6)
|
|||||
Other Established ROW
|
241
|
(23)
|
(33)
|
125
|
(22)
|
(34)
|
|||||
Emerging Markets2
|
2,967
|
14
|
2
|
1,434
|
9
|
(2)
|
|||||
China
|
1,309
|
19
|
18
|
583
|
10
|
11
|
|||||
Ex.China
|
1,658
|
10
|
(7)
|
851
|
8
|
(10)
|
|||||
Total
|
11,584
|
(2)
|
(10)
|
5,836
|
(1)
|
(10)
|
|||||
1 Established ROW comprises Japan, Canada, Australia and New Zealand.
2 Emerging Markets comprises all remaining Rest of World markets, including Brazil, China, India, Mexico, Russia, and Turkey.
|
|||||||||||
H1 2015
|
Reported
|
Restructuring
|
Intangible
Amortisation & Impairments
|
Diabetes Alliance
|
Other1
|
Core
|
% Change
|
||
H1 2015
|
H1 20142
|
CER
|
Actual
|
||||||
Product Sales
|
11,584
|
-
|
-
|
-
|
-
|
11,584
|
12,870
|
(2)
|
(10)
|
Externalisation Revenue
|
780
|
-
|
-
|
-
|
-
|
780
|
352
|
124
|
122
|
Total Revenue
|
12,364
|
-
|
-
|
-
|
-
|
12,364
|
13,222
|
1
|
(6)
|
Cost of Sales
|
(2,336)
|
101
|
317
|
-
|
-
|
(1,918)
|
(2,349)
|
(7)
|
(18)
|
Gross Profit
|
10,028
|
101
|
317
|
-
|
-
|
10,446
|
10,873
|
3
|
(4)
|
Gross Margin3
|
79.8%
|
83.4%
|
81.7%
|
+1.0
|
+1.7
|
||||
Distribution
|
(161)
|
-
|
-
|
-
|
-
|
(161)
|
(149)
|
23
|
8
|
% Total Revenue
|
1.3%
|
1.3%
|
1.1%
|
-0.2
|
-0.2
|
||||
R&D
|
(2,822)
|
124
|
62
|
-
|
-
|
(2,636)
|
(2,306)
|
24
|
14
|
% Total Revenue
|
22.8%
|
21.3%
|
17.4%
|
-3.8
|
-3.9
|
||||
SG&A
|
(5,765)
|
223
|
444
|
216
|
298
|
(4,584)
|
(4,777)
|
4
|
(4)
|
% Total Revenue
|
46.6%
|
37.1%
|
36.1%
|
-0.9
|
-1.0
|
||||
Other Operating Income
|
576
|
-
|
135
|
-
|
(158)
|
553
|
342
|
77
|
62
|
% Total Revenue
|
4.7%
|
4.5%
|
2.6%
|
+1.9
|
+1.9
|
||||
Operating Profit
|
1,856
|
448
|
958
|
216
|
140
|
3,618
|
3,983
|
(4)
|
(9)
|
% Total Revenue
|
15.0%
|
29.3%
|
30.1%
|
-1.5
|
-0.8
|
||||
Net Finance
Expense
|
(513)
|
-
|
-
|
204
|
59
|
(250)
|
(267)
|
||
Joint Ventures
|
(7)
|
-
|
-
|
-
|
-
|
(7)
|
-
|
||
Profit Before Tax
|
1,336
|
448
|
958
|
420
|
199
|
3,361
|
3,716
|
(3)
|
(10)
|
Taxation
|
(88)
|
(94)
|
(193)
|
(95)
|
(2)
|
(472)
|
(600)
|
||
Tax Rate
|
6.6%
|
14.0%
|
16.1%
|
||||||
Profit After Tax
|
1,248
|
354
|
765
|
325
|
197
|
2,889
|
3,116
|
-
|
(7)
|
Non-controlling Interests
|
(1)
|
-
|
-
|
-
|
-
|
(1)
|
(3)
|
||
Net Profit
|
1,247
|
354
|
765
|
325
|
197
|
2,888
|
3,113
|
-
|
(7)
|
Weighted Average Shares
|
1,263
|
1,263
|
1,263
|
1,263
|
1,263
|
1,263
|
1,261
|
||
Earnings Per Share
|
0.99
|
0.28
|
0.60
|
0.26
|
0.16
|
2.29
|
2.47
|
-
|
(7)
|
1 Other adjustments include provision charges and settlement income related to certain legal matters (see Note 5) and fair value adjustments to contingent consideration liabilities arising on business combinations (see Note 4).
|
2 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from Other Operating Income.
|
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
|
Q2 2015
|
Reported
|
Restructuring
|
Intangible
Amortisation & Impairments
|
Diabetes Alliance
|
Other1
|
Core
|
% Change
|
||
Q2 2015
|
Q2 20142
|
CER
|
Actual
|
||||||
Product Sales
|
5,836
|
-
|
-
|
-
|
-
|
5,836
|
6,454
|
(1)
|
(10)
|
Externalisation Revenue
|
471
|
-
|
-
|
-
|
-
|
471
|
308
|
54
|
53
|
Total Revenue
|
6,307
|
-
|
-
|
-
|
-
|
6,307
|
6,762
|
2
|
(7)
|
Cost of Sales
|
(1,067)
|
58
|
44
|
-
|
-
|
(965)
|
(1,156)
|
(7)
|
(16)
|
Gross Profit
|
5,240
|
58
|
44
|
-
|
-
|
5,342
|
5,606
|
4
|
(5)
|
Gross Margin3
|
81.7%
|
83.5%
|
82.1%
|
+1.1
|
+1.4
|
||||
Distribution
|
(84)
|
-
|
-
|
-
|
-
|
(84)
|
(77)
|
27
|
10
|
% Total Revenue
|
1.3%
|
1.3%
|
1.1%
|
-0.3
|
-0.2
|
||||
R&D
|
(1,466)
|
62
|
48
|
-
|
-
|
(1,356)
|
(1,208)
|
23
|
12
|
% Total Revenue
|
23.2%
|
21.5%
|
17.9%
|
-3.7
|
-3.6
|
||||
SG&A
|
(2,966)
|
115
|
242
|
108
|
285
|
(2,216)
|
(2,460)
|
(1)
|
(10)
|
% Total Revenue
|
47.0%
|
35.1%
|
36.4%
|
+1.2
|
+1.3
|
||||
Other Operating Income
|
199
|
-
|
86
|
-
|
(158)
|
127
|
170
|
(12)
|
(25)
|
% Total Revenue
|
3.2%
|
2.0%
|
2.5%
|
-0.3
|
-0.5
|
||||
Operating Profit
|
923
|
235
|
420
|
108
|
127
|
1,813
|
2,031
|
(4)
|
(11)
|
% Total Revenue
|
14.6%
|
28.7%
|
30.0%
|
-1.7
|
-1.3
|
||||
Net Finance
Expense
|
(263)
|
-
|
-
|
100
|
31
|
(132)
|
(141)
|
||
Joint Ventures
|
(2)
|
-
|
-
|
-
|
-
|
(2)
|
-
|
||
Profit Before Tax
|
658
|
235
|
420
|
208
|
158
|
1,679
|
1,890
|
(2)
|
(11)
|
Taxation
|
38
|
(49)
|
(104)
|
(47)
|
2
|
(160)
|
(247)
|
||
Tax Rate
|
-5.8%
|
9.5%
|
13.1%
|
||||||
Profit After Tax
|
696
|
186
|
316
|
161
|
160
|
1,519
|
1,643
|
3
|
(8)
|
Non-controlling Interests
|
1
|
-
|
-
|
-
|
-
|
1
|
(1)
|
||
Net Profit
|
697
|
186
|
316
|
161
|
160
|
1,520
|
1,642
|
3
|
(8)
|
Weighted Average Shares
|
1,264
|
1,264
|
1,264
|
1,264
|
1,264
|
1,264
|
1,262
|
||
Earnings Per Share
|
0.55
|
0.15
|
0.25
|
0.13
|
0.13
|
1.21
|
1.30
|
3
|
(8)
|
1 Other adjustments include provision charges and settlement income related to certain legal matters (see Note 5) and fair value adjustments to contingent consideration liabilities arising on business combinations (see Note 4).
|
2 2014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from Other Operating Income.
|
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
|
-
|
Sales, marketing and medical-cost effectiveness
|
-
|
Centralisation of selected functions and process improvements
|
-
|
Reduced third-party spend
|
-
|
Additional efficiencies gained across support functions and IT
|
-
|
Continued footprint optimisation, including presence in the UK and US
|
Average Exchange Rates Versus USD
|
Impact Of 5% Weakening In Exchange Rate Versus USD ($m)2
|
|||||||||||
Currency
|
Primary Relevance
|
FY
2014
|
H1 20151
|
Change %
|
Total Revenue
|
Core Operating Profit
|
||||||
EUR
|
Product Sales
|
0.75
|
0.89
|
(16)
|
(225)
|
(138)
|
||||||
JPY
|
Product Sales
|
105.87
|
120.25
|
(12)
|
(119)
|
(84)
|
||||||
CNY
|
Product Sales
|
6.16
|
6.22
|
(1)
|
(115)
|
(49)
|
||||||
SEK
|
Costs
|
6.86
|
8.37
|
(18)
|
(6)
|
114
|
||||||
GBP
|
Costs
|
0.61
|
0.66
|
(7)
|
(37)
|
112
|
||||||
Other3
|
(242)
|
(139)
|
||||||||||
For the half year ended 30 June
|
2015
$m
|
Restated 2014*
$m
|
||
Product sales
|
11,584
|
12,870
|
||
Externalisation revenue
|
780
|
352
|
||
Total revenue
|
12,364
|
13,222
|
||
Cost of sales
|
(2,336)
|
(2,760)
|
||
Gross profit
|
10,028
|
10,462
|
||
Distribution costs
|
(161)
|
(149)
|
||
Research and development expense
|
(2,822)
|
(2,528)
|
||
Selling, general and administrative costs
|
(5,765)
|
(5,784)
|
||
Other operating income and expense
|
576
|
(56)
|
||
Operating profit
|
1,856
|
1,945
|
||
Finance income
|
24
|
26
|
||
Finance expense
|
(537)
|
(467)
|
||
Share of after tax losses in joint ventures
|
(7)
|
-
|
||
Profit before tax
|
1,336
|
1,504
|
||
Taxation
|
(88)
|
(201)
|
||
Profit for the period
|
1,248
|
1,303
|
||
Other comprehensive income
|
||||
Items that will not be reclassified to profit or loss
|
||||
Remeasurement of the defined benefit pension liability
|
242
|
(288)
|
||
Tax on items that will not be reclassified to profit or loss
|
(57)
|
85
|
||
185
|
(203)
|
|||
Items that may be reclassified subsequently to profit or loss
|
||||
Foreign exchange arising on consolidation
|
(11)
|
64
|
||
Foreign exchange arising on designating borrowings in net investment hedges
|
(217)
|
(122)
|
||
Fair value movements on derivatives designated in net investment hedges
|
20
|
(11)
|
||
Amortisation of loss on cash flow hedge
|
1
|
1
|
||
Net available for sale (losses)/gains taken to equity
|
(29)
|
49
|
||
Tax on items that may be reclassified subsequently to profit or loss
|
43
|
5
|
||
(193)
|
(14)
|
|||
Other comprehensive income for the period, net of tax
|
(8)
|
(217)
|
||
Total comprehensive income for the period
|
1,240
|
1,086
|
||
Profit attributable to:
|
||||
Owners of the Parent
|
1,247
|
1,300
|
||
Non-controlling interests
|
1
|
3
|
||
1,248
|
1,303
|
|||
Total comprehensive income attributable to:
|
||||
Owners of the Parent
|
1,239
|
1,089
|
||
Non-controlling interests
|
1
|
(3)
|
||
1,240
|
1,086
|
|||
Basic earnings per $0.25 Ordinary Share
|
$0.99
|
$1.03
|
||
Diluted earnings per $0.25 Ordinary Share
|
$0.99
|
$1.03
|
||
Weighted average number of Ordinary Shares in issue (millions)
|
1,263
|
1,261
|
||
Diluted weighted average number of Ordinary Shares in issue (millions)
|
1,265
|
1,263
|
For the quarter ended 30 June
|
2015
$m
|
Restated
2014*
$m
|
||
Product sales
|
5,836
|
6,454
|
||
Externalisation revenue
|
471
|
308
|
||
Total revenue
|
6,307
|
6,762
|
||
Cost of sales
|
(1,067)
|
(1,307)
|
||
Gross profit
|
5,240
|
5,455
|
||
Distribution costs
|
(84)
|
(77)
|
||
Research and development expense
|
(1,466)
|
(1,328)
|
||
Selling, general and administrative costs
|
(2,966)
|
(3,058)
|
||
Other operating income and expense
|
199
|
117
|
||
Operating profit
|
923
|
1,109
|
||
Finance income
|
13
|
10
|
||
Finance expense
|
(276)
|
(253)
|
||
Share of after tax losses of joint ventures
|
(2)
|
-
|
||
Profit before tax
|
658
|
866
|
||
Taxation
|
38
|
(69)
|
||
Profit for the period
|
696
|
797
|
||
Other comprehensive income
|
||||
Items that will not be reclassified to profit or loss
|
||||
Remeasurement of the defined benefit pension liability
|
259
|
(263)
|
||
Tax on items that will not be reclassified to profit or loss
|
(61)
|
79
|
||
198
|
(184)
|
|||
Items that may be reclassified subsequently to profit or loss
|
||||
Foreign exchange arising on consolidation
|
438
|
9
|
||
Foreign exchange arising on designating borrowings in net investment hedges
|
191
|
(121)
|
||
Fair value movements on derivatives designated in net investment hedges
|
(1)
|
(2)
|
||
Amortisation of loss on cash flow hedge
|
1
|
1
|
||
Net available for sale (losses)/gains taken to equity
|
(48)
|
47
|
||
Tax on items that may be reclassified subsequently to profit or loss
|
(57)
|
12
|
||
524
|
(54)
|
|||
Other comprehensive income for the period, net of tax
|
722
|
(238)
|
||
Total comprehensive income for the period
|
1,418
|
559
|
||
Profit attributable to:
|
||||
Owners of the Parent
|
697
|
796
|
||
Non-controlling interests
|
(1)
|
1
|
||
696
|
797
|
|||
Total comprehensive income attributable to:
|
||||
Owners of the Parent
|
1,418
|
558
|
||
Non-controlling interests
|
-
|
1
|
||
1,418
|
559
|
|||
Basic earnings per $0.25 Ordinary Share
|
$0.55
|
$0.63
|
||
Diluted earnings per $0.25 Ordinary Share
|
$0.55
|
$0.63
|
||
Weighted average number of Ordinary Shares in issue (millions)
|
1,264
|
1,262
|
||
Diluted weighted average number of Ordinary Shares in issue (millions)
|
1,265
|
1,264
|
At 30
Jun
2015
$m
|
At 31 Dec 2014
$m
|
At 30 Jun 2014
$m
|
||||
ASSETS
Non-current assets
|
||||||
Property, plant and equipment
|
6,134
|
6,010
|
6,150
|
|||
Goodwill
|
11,467
|
11,550
|
11,560
|
|||
Intangible assets
|
20,486
|
20,981
|
21,150
|
|||
Derivative financial instruments
|
471
|
465
|
349
|
|||
Investments in joint ventures
|
52
|
59
|
70
|
|||
Other investments
|
448
|
502
|
289
|
|||
Other receivables
|
957
|
1,112
|
1,380
|
|||
Deferred tax assets
|
1,342
|
1,219
|
1,387
|
|||
41,357
|
41,898
|
42,335
|
||||
Current assets
|
||||||
Inventories
|
2,198
|
1,960
|
2,249
|
|||
Trade and other receivables
|
6,615
|
7,232
|
7,817
|
|||
Other investments
|
531
|
795
|
819
|
|||
Derivative financial instruments
|
51
|
21
|
1
|
|||
Income tax receivable
|
450
|
329
|
360
|
|||
Cash and cash equivalents
|
3,967
|
6,360
|
4,958
|
|||
13,812
|
16,697
|
16,204
|
||||
Total assets
|
55,169
|
58,595
|
58,539
|
|||
LIABILITIES
Current liabilities
|
||||||
Interest-bearing loans and borrowings
|
(2,705)
|
(2,446)
|
(2,500)
|
|||
Trade and other payables
|
(10,659)
|
(11,886)
|
(10,304)
|
|||
Derivative financial instruments
|
(6)
|
(21)
|
(12)
|
|||
Provisions
|
(731)
|
(623)
|
(679)
|
|||
Income tax payable
|
(2,049)
|
(2,354)
|
(2,827)
|
|||
(16,150)
|
(17,330)
|
(16,322)
|
||||
Non-current liabilities
|
||||||
Interest-bearing loans and borrowings
|
(8,303)
|
(8,397)
|
(7,574)
|
|||
Deferred tax liabilities
|
(1,582)
|
(1,796)
|
(2,427)
|
|||
Retirement benefit obligations
|
(2,377)
|
(2,951)
|
(2,634)
|
|||
Provisions
|
(479)
|
(484)
|
(580)
|
|||
Other payables
|
(7,979)
|
(7,991)
|
(6,950)
|
|||
(20,720)
|
(21,619)
|
(20,165)
|
||||
Total liabilities
|
(36,870)
|
(38,949)
|
(36,487)
|
|||
Net assets
|
18,299
|
19,646
|
22,052
|
|||
EQUITY
|
||||||
Capital and reserves attributable to equity holders of the Company
|
||||||
Share capital
|
316
|
316
|
316
|
|||
Share premium account
|
4,281
|
4,261
|
4,236
|
|||
Other reserves
|
2,033
|
2,021
|
1,973
|
|||
Retained earnings
|
11,649
|
13,029
|
15,504
|
|||
18,279
|
19,627
|
22,029
|
||||
Non-controlling interests
|
20
|
19
|
23
|
|||
Total equity
|
18,299
|
19,646
|
22,052
|
For the half year ended 30 June
|
2015
$m
|
2014
$m
|
||
Cash flows from operating activities
|
||||
Profit before tax
|
1,336
|
1,504
|
||
Finance income and expense
|
513
|
441
|
||
Share of after tax losses in joint ventures
|
7
|
-
|
||
Depreciation, amortisation and impairment
|
1,565
|
1,410
|
||
(Increase)/decrease in working capital and short-term provisions
|
(767)
|
703
|
||
Non-cash and other movements
|
(612)
|
216
|
||
Cash generated from operations
|
2,042
|
4,274
|
||
Interest paid
|
(252)
|
(272)
|
||
Tax paid
|
(782)
|
(736)
|
||
Net cash inflow from operating activities
|
1,008
|
3,266
|
||
Cash flows from investing activities
|
||||
Movement in short-term investments and fixed deposits
|
273
|
34
|
||
Purchase of property, plant and equipment
|
(497)
|
(378)
|
||
Disposal of property, plant and equipment
|
16
|
133
|
||
Purchase of intangible assets
|
(1,222)
|
(1,490)
|
||
Disposal of intangible assets
|
350
|
-
|
||
Purchase of non-current asset investments
|
(30)
|
(5)
|
||
Disposal of non-current asset investments
|
56
|
-
|
||
Payments to joint ventures
|
-
|
(70)
|
||
Upfront payments on business acquisitions
|
-
|
(2,778)
|
||
Payment of contingent consideration on business acquisitions
|
(239)
|
(449)
|
||
Interest received
|
59
|
58
|
||
Payments made by subsidiaries to non-controlling interests
|
-
|
(10)
|
||
Net cash outflow from investing activities
|
(1,234)
|
(4,955)
|
||
Net cash outflow before financing activities
|
(226)
|
(1,689)
|
||
Cash flows from financing activities
|
||||
Proceeds from issue of share capital
|
20
|
254
|
||
Repayment of loans
|
(884)
|
(750)
|
||
Dividends paid
|
(2,357)
|
(2,425)
|
||
Hedge contracts relating to dividend payments
|
(43)
|
25
|
||
Repayment of obligations under finance leases
|
(34)
|
(17)
|
||
Payments to acquire non-controlling interest
|
-
|
(102)
|
||
Movement in short-term borrowings
|
910
|
445
|
||
Net cash outflow from financing activities
|
(2,388)
|
(2,570)
|
||
Net decrease in cash and cash equivalents in the period
|
(2,614)
|
(4,259)
|
||
Cash and cash equivalents at the beginning of the period
|
6,164
|
8,995
|
||
Exchange rate effects
|
(29)
|
3
|
||
Cash and cash equivalents at the end of the period
|
3,521
|
4,739
|
||
Cash and cash equivalents consists of:
|
||||
Cash and cash equivalents
|
3,967
|
4,958
|
||
Overdrafts
|
(446)
|
(219)
|
||
3,521
|
4,739
|
Share
capital
$m
|
Share
premium
account
$m
|
Other
reserves*
$m
|
Retained
earnings
$m
|
Total
$m
|
Non-
controlling
interests
$m
|
Total
equity
$m
|
||||||||
At 1 Jan 2014
|
315
|
3,983
|
1,966
|
16,960
|
23,224
|
29
|
23,253
|
|||||||
Profit for the period
|
-
|
-
|
-
|
1,300
|
1,300
|
3
|
1,303
|
|||||||
Other comprehensive income
|
-
|
-
|
-
|
(211)
|
(211)
|
(6)
|
(217)
|
|||||||
Transfer to other reserves
|
-
|
-
|
7
|
(7)
|
-
|
-
|
-
|
|||||||
Transactions with owners:
|
||||||||||||||
Dividends
|
-
|
-
|
-
|
(2,395)
|
(2,395)
|
-
|
(2,395)
|
|||||||
Issue of Ordinary Shares
|
1
|
253
|
-
|
-
|
254
|
-
|
254
|
|||||||
Share-based payments
|
-
|
-
|
-
|
(143)
|
(143)
|
-
|
(143)
|
|||||||
Transfer from non-controlling interests to payables
|
-
|
-
|
-
|
-
|
-
|
(3)
|
(3)
|
|||||||
Net movement
|
1
|
253
|
7
|
(1,456)
|
(1,195)
|
(6)
|
(1,201)
|
|||||||
At 30 Jun 2014
|
316
|
4,236
|
1,973
|
15,504
|
22,029
|
23
|
22,052
|
|||||||
Share
capital
$m
|
Share
premium
account
$m
|
Other
reserves*
$m
|
Retained
earnings
$m
|
Total
$m
|
Non-
controlling
interests
$m
|
Total
equity
$m
|
||||||||
At 1 Jan 2015
|
316
|
4,261
|
2,021
|
13,029
|
19,627
|
19
|
19,646
|
|||||||
Profit for the period
|
-
|
-
|
-
|
1,247
|
1,247
|
1
|
1,248
|
|||||||
Other comprehensive income
|
-
|
-
|
-
|
(8)
|
(8)
|
-
|
(8)
|
|||||||
Transfer to other reserves
|
-
|
-
|
12
|
(12)
|
-
|
-
|
-
|
|||||||
Transactions with owners:
|
||||||||||||||
Dividends
|
-
|
-
|
-
|
(2,400)
|
(2,400)
|
-
|
(2,400)
|
|||||||
Issue of Ordinary Shares
|
-
|
20
|
-
|
-
|
20
|
-
|
20
|
|||||||
Share-based payments
|
-
|
-
|
-
|
(207)
|
(207)
|
-
|
(207)
|
|||||||
Net movement
|
-
|
20
|
12
|
(1,380)
|
(1,348)
|
1
|
(1,347)
|
|||||||
At 30 Jun 2015
|
316
|
4,281
|
2,033
|
11,649
|
18,279
|
20
|
18,299
|
·
|
the condensed set of financial statements has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union and as issued by the International Accounting Standards Board;
|
·
|
the half-yearly management report includes a fair review of the information required by:
|
(a)
|
DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and
|
(b)
|
DTR 4.2.8R of the Disclosure and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the enterprise during that period; and any changes in the related party transactions described in the last annual report that could do so.
|
1
|
BASIS OF PREPARATION AND ACCOUNTING POLICIES
|
HY 2015
$m
|
HY 2014
$m
|
Q2 2015
$m
|
Q2 2014
$m
|
|||||
Cost of sales
|
101
|
24
|
58
|
13
|
||||
Research and development expense
|
124
|
190
|
62
|
105
|
||||
Selling, general and administrative costs
|
223
|
266
|
115
|
175
|
||||
Other operating income and expense
|
-
|
292
|
-
|
-
|
||||
Total
|
448
|
772
|
235
|
293
|
At 1 Jan
2015
$m
|
Cash
Flow
$m
|
Non-cash
Movements
$m
|
Exchange Movements
$m
|
At 30 Jun
2015
$m
|
||||||
Loans due after one year
|
(8,337)
|
-
|
19
|
62
|
(8,256)
|
|||||
Finance leases due after one year
|
(60)
|
-
|
12
|
1
|
(47)
|
|||||
Total long-term debt
|
(8,397)
|
-
|
31
|
63
|
(8,303)
|
|||||
Current instalments of loans
|
(912)
|
884
|
-
|
28
|
-
|
|||||
Current instalments of finance leases
|
(48)
|
34
|
(47)
|
1
|
(60)
|
|||||
Total current debt
|
(960)
|
918
|
(47)
|
29
|
(60)
|
|||||
Other investments – current
|
795
|
(286)
|
28
|
(6)
|
531
|
|||||
Net derivative financial instruments
|
465
|
56
|
(5)
|
-
|
516
|
|||||
Cash and cash equivalents
|
6,360
|
(2,363)
|
-
|
(30)
|
3,967
|
|||||
Overdrafts
|
(196)
|
(251)
|
-
|
1
|
(446)
|
|||||
Short-term borrowings
|
(1,290)
|
(910)
|
1
|
-
|
(2,199)
|
|||||
6,134
|
(3,754)
|
24
|
(35)
|
2,369
|
||||||
Net debt
|
(3,223)
|
(2,836)
|
8
|
57
|
(5,994)
|
Diabetes
Alliance
2015
|
Other
2015
|
Total
2015
|
Total
2014
|
|||||
$m
|
$m
|
$m
|
$m
|
|||||
At 1 January
|
5,386
|
1,513
|
6,899
|
514
|
||||
Additions through business combinations
|
-
|
-
|
-
|
5,249*
|
||||
Settlements
|
(103)
|
(136)
|
(239)
|
(449)
|
||||
Revaluations
|
-
|
82
|
82
|
6
|
||||
Discount unwind
|
204
|
59
|
263
|
174
|
||||
Foreign exchange
|
-
|
-
|
-
|
6
|
||||
At 30 June
|
5,487
|
1,518
|
7,005
|
5,500
|
World
|
US
|
Europe
|
Established ROW
|
Emerging Markets
|
||||||||||||||||
H1 2015
$m
|
CER
%
|
H1 2015
$m
|
CER
%
|
H1 2015
$m
|
CER
%
|
H1 2015
$m
|
CER
%
|
H1 2015
$m
|
CER
%
|
|||||||||||
Respiratory, Inflammation and Autoimmunity:
|
||||||||||||||||||||
Symbicort
|
1,687
|
-
|
717
|
(1)
|
582
|
(8)
|
201
|
9
|
187
|
28
|
||||||||||
Pulmicort
|
518
|
18
|
108
|
4
|
66
|
(7)
|
41
|
(2)
|
303
|
37
|
||||||||||
Tudorza/Eklira
|
85
|
n/m
|
45
|
n/m
|
36
|
n/m
|
4
|
n/m
|
-
|
-
|
||||||||||
Duaklir
|
7
|
n/m
|
-
|
n/m
|
6
|
n/m
|
1
|
n/m
|
-
|
-
|
||||||||||
Others
|
171
|
20
|
49
|
188
|
46
|
(7)
|
10
|
-
|
66
|
4
|
||||||||||
Total Respiratory, Inflammation and Autoimmunity
|
2,468
|
9
|
919
|
9
|
736
|
(3)
|
257
|
9
|
556
|
30
|
||||||||||
Cardiovascular and Metabolic disease:
|
||||||||||||||||||||
Brilinta/Brilique
|
275
|
42
|
101
|
60
|
110
|
21
|
17
|
36
|
47
|
80
|
||||||||||
Onglyza
|
391
|
4
|
211
|
(16)
|
71
|
23
|
32
|
30
|
77
|
56
|
||||||||||
Bydureon
|
263
|
41
|
222
|
35
|
35
|
71
|
3
|
33
|
3
|
200
|
||||||||||
Byetta
|
172
|
8
|
121
|
15
|
30
|
(13)
|
10
|
-
|
11
|
33
|
||||||||||
Farxiga/Forxiga
|
205
|
n/m
|
115
|
n/m
|
53
|
n/m
|
11
|
44
|
26
|
n/m
|
||||||||||
Legacy:
|
||||||||||||||||||||
Crestor
|
2,477
|
(5)
|
1,374
|
(7)
|
469
|
(7)
|
282
|
(3)
|
352
|
5
|
||||||||||
Seloken/Toprol-XL
|
378
|
7
|
48
|
(9)
|
49
|
(3)
|
7
|
(20)
|
274
|
14
|
||||||||||
Atacand
|
194
|
(11)
|
18
|
(10)
|
53
|
(33)
|
15
|
(23)
|
108
|
8
|
||||||||||
Others
|
327
|
(4)
|
35
|
(5)
|
75
|
(13)
|
30
|
(21)
|
187
|
6
|
||||||||||
Total Cardiovascular and Metabolic Disease
|
4,682
|
4
|
2,245
|
2
|
945
|
-
|
407
|
(2)
|
1,085
|
16
|
||||||||||
Oncology:
|
||||||||||||||||||||
Iressa
|
273
|
(3)
|
-
|
-
|
66
|
(5)
|
68
|
(11)
|
139
|
3
|
||||||||||
Lynparza
|
30
|
n/m
|
26
|
n/m
|
4
|
n/m
|
-
|
n/m
|
-
|
n/m
|
||||||||||
Legacy:
|
||||||||||||||||||||
Zoladex
|
409
|
9
|
14
|
27
|
85
|
(15)
|
133
|
(2)
|
177
|
32
|
||||||||||
Faslodex
|
333
|
5
|
165
|
2
|
101
|
1
|
25
|
4
|
42
|
32
|
||||||||||
Casodex
|
139
|
(5)
|
1
|
(67)
|
15
|
(18)
|
66
|
(14)
|
57
|
17
|
||||||||||
Arimidex
|
126
|
(9)
|
7
|
(22)
|
25
|
(27)
|
40
|
(15)
|
54
|
14
|
||||||||||
Others
|
71
|
23
|
13
|
-
|
15
|
13
|
29
|
79
|
14
|
(11)
|
||||||||||
Total Oncology
|
1,381
|
5
|
226
|
15
|
311
|
(7)
|
361
|
(4)
|
483
|
18
|
||||||||||
Infection, Neuroscience and Gastrointestinal:
|
||||||||||||||||||||
Nexium
|
1,291
|
(27)
|
479
|
(49)
|
143
|
(10)
|
272
|
(6)
|
397
|
(1)
|
||||||||||
Seroquel XR
|
526
|
(7)
|
353
|
2
|
113
|
(25)
|
14
|
(30)
|
46
|
10
|
||||||||||
Synagis
|
270
|
(28)
|
160
|
(38)
|
110
|
(6)
|
-
|
-
|
-
|
n/m
|
||||||||||
Losec/Prilosec
|
181
|
(6)
|
12
|
(7)
|
48
|
(12)
|
39
|
(17)
|
82
|
6
|
||||||||||
FluMist/Fluenz
|
21
|
75
|
21
|
110
|
-
|
-
|
-
|
n/m
|
-
|
-
|
||||||||||
Movantik/Moventig
|
4
|
n/m
|
4
|
n/m
|
-
|
n/m
|
-
|
n/m
|
-
|
n/m
|
||||||||||
Others
|
760
|
(8)
|
106
|
(28)
|
195
|
(13)
|
141
|
1
|
318
|
(1)
|
||||||||||
Total Infection, Neuroscience and Gastrointestinal
|
3,053
|
(18)
|
1,135
|
(34)
|
609
|
(14)
|
466
|
(7)
|
843
|
-
|
||||||||||
TOTAL PRODUCT SALES
|
11,584
|
(2)
|
4,525
|
(9)
|
2,601
|
(5)
|
1,491
|
(2)
|
2,967
|
14
|
World
|
US
|
Europe
|
Established ROW
|
Emerging Markets
|
||||||||||||||||
Q2 2015
$m
|
CER
%
|
Q2 2015
$m
|
CER
%
|
Q2 2015
$m
|
CER
%
|
Q2 2015
$m
|
CER
%
|
Q2 2015
$m
|
CER
%
|
|||||||||||
Respiratory, Inflammation and Autoimmunity:
|
||||||||||||||||||||
Symbicort
|
842
|
-
|
375
|
(1)
|
276
|
(9)
|
102
|
24
|
89
|
16
|
||||||||||
Pulmicort
|
232
|
19
|
56
|
8
|
28
|
(15)
|
21
|
5
|
127
|
44
|
||||||||||
Tudorza/Eklira
|
55
|
n/m
|
35
|
n/m
|
18
|
n/m
|
2
|
n/m
|
-
|
n/m
|
||||||||||
Duaklir
|
5
|
n/m
|
-
|
-
|
4
|
n/m
|
1
|
n/m
|
-
|
-
|
||||||||||
Others
|
91
|
32
|
37
|
n/m
|
21
|
(16)
|
7
|
60
|
26
|
(18)
|
||||||||||
Total Respiratory, Inflammation and Autoimmunity
|
1,225
|
11
|
503
|
16
|
347
|
(3)
|
133
|
23
|
242
|
20
|
||||||||||
Cardiovascular and Metabolic disease:
|
||||||||||||||||||||
Brilinta/Brilique
|
144
|
38
|
55
|
57
|
56
|
21
|
9
|
38
|
24
|
59
|
||||||||||
Onglyza
|
208
|
(7)
|
113
|
(22)
|
34
|
(5)
|
18
|
25
|
43
|
38
|
||||||||||
Bydureon
|
140
|
29
|
116
|
22
|
19
|
53
|
2
|
50
|
3
|
-
|
||||||||||
Byetta
|
82
|
(1)
|
53
|
-
|
15
|
(22)
|
6
|
14
|
8
|
60
|
||||||||||
Farxiga/Forxiga
|
129
|
n/m
|
78
|
n/m
|
29
|
n/m
|
8
|
n/m
|
14
|
n/m
|
||||||||||
Legacy:
|
||||||||||||||||||||
Crestor
|
1,310
|
(3)
|
760
|
(1)
|
226
|
(9)
|
150
|
(4)
|
174
|
(1)
|
||||||||||
Seloken/Toprol-XL
|
184
|
6
|
21
|
(28)
|
24
|
(3)
|
4
|
-
|
135
|
16
|
||||||||||
Atacand
|
99
|
(13)
|
7
|
(22)
|
23
|
(38)
|
8
|
(9)
|
61
|
4
|
||||||||||
Others
|
156
|
(4)
|
15
|
(25)
|
36
|
(13)
|
15
|
(26)
|
90
|
12
|
||||||||||
Total Cardiovascular and Metabolic Disease
|
2,452
|
4
|
1,218
|
3
|
462
|
(3)
|
220
|
(1)
|
552
|
14
|
||||||||||
Oncology:
|
||||||||||||||||||||
Iressa
|
129
|
(1)
|
-
|
-
|
31
|
(5)
|
36
|
10
|
62
|
(4)
|
||||||||||
Lynparza
|
21
|
n/m
|
18
|
n/m
|
3
|
n/m
|
-
|
n/m
|
-
|
n/m
|
||||||||||
Legacy:
|
||||||||||||||||||||
Zoladex
|
215
|
14
|
8
|
60
|
41
|
(17)
|
71
|
2
|
95
|
41
|
||||||||||
Faslodex
|
172
|
9
|
82
|
(4)
|
52
|
10
|
13
|
15
|
25
|
50
|
||||||||||
Casodex
|
69
|
(5)
|
1
|
(50)
|
7
|
(18)
|
34
|
(13)
|
27
|
20
|
||||||||||
Arimidex
|
64
|
(6)
|
4
|
-
|
12
|
(25)
|
21
|
(7)
|
27
|
8
|
||||||||||
Others
|
37
|
20
|
7
|
-
|
7
|
13
|
16
|
90
|
7
|
(30)
|
||||||||||
Total Oncology
|
707
|
9
|
120
|
17
|
153
|
(4)
|
191
|
4
|
243
|
20
|
||||||||||
Infection, Neuroscience and Gastrointestinal:
|
||||||||||||||||||||
Nexium
|
647
|
(27)
|
254
|
(44)
|
69
|
(14)
|
144
|
(9)
|
180
|
(16)
|
||||||||||
Seroquel XR
|
264
|
(8)
|
184
|
2
|
50
|
(30)
|
7
|
(18)
|
23
|
4
|
||||||||||
Synagis
|
66
|
40
|
(2)
|
n/m
|
68
|
51
|
-
|
-
|
-
|
n/m
|
||||||||||
Losec/Prilosec
|
85
|
(9)
|
5
|
(17)
|
22
|
(15)
|
20
|
(14)
|
38
|
3
|
||||||||||
FluMist/Fluenz
|
14
|
180
|
14
|
180
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||
Movantik/Moventig
|
1
|
n/m
|
1
|
n/m
|
-
|
-
|
-
|
-
|
-
|
-
|
||||||||||
Others
|
375
|
(11)
|
59
|
(19)
|
90
|
(18)
|
70
|
(13)
|
156
|
(2)
|
||||||||||
Total Infection, Neuroscience and Gastrointestinal
|
1,452
|
(17)
|
515
|
(28)
|
299
|
(12)
|
241
|
(10)
|
397
|
(8)
|
||||||||||
TOTAL PRODUCT SALES
|
5,836
|
(1)
|
2,356
|
(3)
|
1,261
|
(5)
|
785
|
-
|
1,434
|
9
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing†
|
||||
US
|
EU
|
Japan
|
China
|
|||||
Respiratory, Inflammation and Autoimmunity
|
||||||||
anifrolumab#
|
IFN-alphaR mAb
|
SLE
|
Q3 20151
|
2019
|
2019
|
2019
|
|
|
benralizumab#
CALIMA SIROCCO ZONDA BISE BORA
GREGALE
|
IL-5R mAb
|
severe asthma
|
Q4 2013
|
H2 2016
|
H2 2016
|
N/A
|
N/A
|
|
benralizumab#
TERRANOVA GALATHEA
|
IL-5R mAb
|
COPD
|
Q3 2014
|
2018
|
2018
|
N/A
|
N/A
|
|
brodalumab
AMAGINE-1,2,3
|
IL-17R mAb
|
psoriasis
|
Q3 2012
|
2015++
|
2015++
|
|||
brodalumab AMVISION-1,2
|
IL-17R mAb
|
psoriatic arthritis
|
Q1 2014
|
++
|
++
|
|||
lesinurad
CLEAR 1,2
CRYSTAL
|
selective uric acid reabsorption inhibitor (URAT-1)
|
chronic treatment of patients with gout
|
Q4 2011
|
Filed
|
Filed
|
|||
PT003 GFF PINACLE
|
LABA / LAMA
|
COPD
|
Q2 2013
|
Q3 2015
|
H1 2016
|
2017
|
2017
|
|
PT010
|
LABA / LAMA / ICS
|
COPD
|
Q3 20151
|
2018
|
2018
|
2018
|
2019
|
|
tralokinumab
STRATOS 1,2
TROPOS
|
IL-13 mAb
|
severe asthma
|
Q3 2014
|
2018
|
2018
|
2018
|
||
Cardiovascular and Metabolic Disease
|
||||||||
Brilinta/Brilique2
|
P2Y12 receptor antagonist
|
arterial thrombosis
|
Launched
|
Launched
|
Filed
|
Launched
|
||
Epanova#
|
omega-3 carboxylic acids
|
severe hypertriglyceridaemia
|
Approved
|
2017
|
2019
|
|||
Farxiga/Forxiga3
|
SGLT-2 inhibitor
|
type-2 diabetes
|
Launched
|
Launched
|
Launched
|
Filed
|
||
roxadustat# OLYMPUS ROCKIES
|
hypoxia-inducible factor prolyl hydroxylase inhibitor
|
anaemia in CKD/ESRD
|
Q3 2014
|
2018
|
N/A
|
N/A
|
H2 2016
|
|
Oncology
|
||||||||
AZD9291
AURA 2,3
|
EGFR tyrosine kinase inhibitor
|
≥2nd-line advanced EGFRm T790M NSCLC
|
Q2 2014
|
Filed 4
(Breakthrough designation)
|
Filed
|
Q3 2015
|
2017
|
|
AZD9291
FLAURA
|
EGFR tyrosine kinase inhibitor
|
1st-line advanced EGFRm NSCLC
|
Q1 2015
|
2017
|
2017
|
2017
|
2020
|
|
Caprelsa
|
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
|
medullary thyroid cancer
|
Launched
|
Launched
|
Filed
|
Filed
|
||
cediranib
ICON 6
|
VEGFR tyrosine kinase inhibitor
|
PSR ovarian cancer
|
Q2 2007
|
Filed5
(Orphan Drug)
|
||||
durvalumab (MEDI4736)#
PACIFIC
|
PD-L1 mAb
|
stage III NSCLC
|
Q2 2014
|
2017
|
2020
|
2020
|
||
durvalumab (MEDI4736)#
ATLANTIC¶
|
PD-L1 mAb
|
3rd-line NSCLC
|
Q1 2014
|
H1 2016
(Fast Track)
|
2017
|
2017
|
||
durvalumab (MEDI4736)# +
tremelimumab
ARCTIC
|
PD-L1 mAb + CTLA-4 mAb
|
3rd-line NSCLC
|
Q2 2015
|
2017
|
2017
|
2017
|
||
durvalumab (MEDI4736)#
HAWK¶
|
PD-L1 mAb
|
2nd-line SCCHN (PD-L1 positive)
|
Q1 2015
|
H2 2016
|
H2 2016
|
H2 2016
|
||
durvalumab (MEDI4736)# + tremelimumab
CONDOR¶
|
PD-L1 mAb + CTLA-4 mAb
|
2nd-line SCCHN (PD-L1 negative)
|
Q2 2015
|
2017
|
2017
|
2017
|
||
moxetumomab pasudotox#
|
anti-CD22 recombinant
immunotoxin
|
hairy cell leukaemia
|
Q2 2013
|
2018
|
2018
|
|||
selumetinib#
SELECT-1
|
MEK inhibitor
|
2nd-line KRASm NSCLC
|
Q4 2013
|
2017
|
2017
|
|||
selumetinib#
ASTRA
|
MEK inhibitor
|
differentiated thyroid cancer
|
Q3 2013
|
2018
|
2018
|
|||
tremelimumab¶ DETERMINE
|
CTLA-4 mAb
|
mesothelioma
|
Q2 2014
|
H1 2016
(Orphan Drug)
|
H2 2016
|
H2 2016
|
||
Infection, Neuroscience and Gastrointestinal
|
||||||||
CAZ AVI#
RECLAIM
|
cephalosporin/
beta lactamase inhibitor
|
serious infections
|
Q1 2012
|
N/A
|
Filed
|
2017
|
||
CAZ AVI# REPROVE
|
cephalosporin/ beta lactamase inhibitor
|
hospital-acquired pneumonia/ ventilator-associated pneumonia
|
Q2 2013
|
N/A
|
Filed
|
2017
|
||
Zinforo#
|
extended spectrum cephalosporin with affinity to penicillin-binding proteins
|
pneumonia/skin infections
|
N/A
|
Launched
|
N/A
|
Filed
|
++
|
Amgen recently announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab; AstraZeneca is proceeding with the transfer of the programme from Amgen and will communicate additional decisions in due course.
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
Estimated Filing
|
|||
US
|
EU
|
Japan
|
China
|
|||||
Respiratory, Inflammation and Autoimmunity
|
||||||||
abediterol (AZD0548)
|
LABA
|
asthma/COPD
|
II
|
Q4 2007
|
||||
AZD7624
|
inhaled P38 inhibitor
|
COPD
|
II
|
Q4 2014
|
||||
AZD9412#
|
inhaled interferon beta
|
asthma/COPD
|
II
|
Q1 2010
|
||||
mavrilimumab#
|
GM-CSFR mAb
|
rheumatoid arthritis
|
II
|
Q1 2010
|
||||
MEDI-551#
|
CD19 mAb
|
neuromyelitis optica2
|
II
|
Q1 2015
|
||||
MEDI2070#
|
IL-23 mAb
|
Crohn’s disease
|
II
|
Q1 2013
|
||||
abrilimumab (MEDI7183)#
|
alpha(4)beta(7) mAb
|
Crohn’s disease / ulcerative colitis
|
II
|
Q4 2012
|
||||
MEDI9929#
|
TSLP mAb
|
asthma
|
II
|
Q2 2014
|
||||
PT010
|
LABA/LAMA/ICS
|
asthma
|
II
|
Q2 2014
|
||||
RDEA3170
|
selective uric acid reabsorption inhibitor (URAT-1)
|
chronic treatment of patients with hyperuricaemia or gout
|
II
|
Q3 2013
|
||||
sifalimumab#
|
IFN-alpha mAb
|
SLE3
|
II
|
Q3 2008
|
||||
tralokinumab
|
IL-13 mAb
|
IPF
|
II
|
Q4 2012
|
||||
tralokinumab
|
IL-13 mAb
|
atopic dermatitis
|
II
|
Q1 2015
|
||||
AZD1419#
|
TLR9 agonist
|
asthma
|
I
|
Q3 2013
|
||||
AZD7594
|
inhaled SGRM
|
asthma/COPD
|
I
|
Q3 2012
|
||||
AZD7986
|
DPP1
|
COPD
|
I
|
Q4 2014
|
||||
AZD8999
|
MABA
|
COPD
|
I
|
Q4 2013
|
||||
MEDI4920
|
anti-CD40L-Tn3 fusion protein
|
primary Sjögren’s syndrome
|
I
|
Q2 2014
|
||||
MEDI5872#
|
B7RP1 mAb
|
SLE
|
I
|
Q4 2008
|
||||
MEDI7836
|
IL-13 mAb-YTE
|
asthma
|
I
|
Q1 2015
|
||||
Cardiovascular and Metabolism
|
||||||||
AZD4901
|
NK3 receptor antagonist
|
polycystic ovarian syndrome
|
II
|
Q2 2013
|
||||
MEDI0382
|
GLP-1/
glucagon dual agonist
|
diabetes / obesity
|
I
|
Q1 2015
|
||||
MEDI6012
|
LCAT
|
ACS
|
I
|
Q1 2012
|
||||
MEDI8111
|
Rh-factor II
|
trauma / bleeding
|
I
|
Q1 2014
|
||||
Oncology
|
||||||||
AZD1775#
|
WEE-1 inhibitor
|
ovarian cancer
|
II
|
Q4 2012
|
||||
AZD2014
|
mTOR serine/ threonine kinase inhibitor
|
solid tumours
|
II
|
Q1 2013
|
||||
AZD4547
|
FGFR tyrosine kinase inhibitor
|
solid tumours
|
II
|
Q4 2011
|
||||
MEDI-551#
|
CD19 mAb
|
CLL / DLBCL
|
II
|
Q1 2012
|
||||
MEDI-573#
|
IGF mAb
|
metastatic breast cancer
|
II
|
Q2 2012
|
||||
selumetinib#
|
MEK inhibitor
|
2nd-line KRAS wt NSCLC
|
II
|
Q1 2013
|
||||
AZD5363#
|
AKT kinase inhibitor
|
breast cancer
|
II
|
Q1 2014
|
||||
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Date Commenced Phase
|
Estimated Filing
|
|||
US
|
EU
|
Japan
|
China
|
|||||
durvalumab (MEDI4736)#
|
PD-L1 mAb
|
solid tumours
|
II
|
Q3 2014
|
||||
durvalumab (MEDI4736)# + tremelimumab
|
PD-L1 mAb + CTLA-4 mAb
|
gastric cancer
|
II
|
Q2 2015
|
||||
moxetumomab
pasudotox#
|
anti-CD22 recombinant immunotoxin
|
pALL
|
II
|
Q3 2014
|
||||
savolitinib/
volitinib (AZD6094)#
|
MET tyrosine kinase inhibitor
|
papillary renal cell carcinoma
|
II
|
Q2 2014
|
||||
AZD3759
|
EGFR tyrosine kinase inhibitor
|
advanced EGFRm NSCLC
|
I
|
Q4 2014
|
||||
AZD5312#
|
androgen receptor inhibitor
|
solid tumours
|
I
|
Q2 2014
|
||||
AZD6738
|
ATR serine / threonine kinase inhibitor
|
solid tumours
|
I
|
Q4 2013
|
||||
AZD8186
|
PI3 kinase beta inhibitor
|
solid tumours
|
I
|
Q2 2013
|
||||
AZD8835
|
PI3 kinase alpha inhibitor
|
solid tumours
|
I
|
Q4 2014
|
||||
AZD9150#
|
STAT3 inhibitor
|
haematological malignancies
|
I
|
Q1 2012
|
||||
AZD9291 + (durvalumab (MEDI4736)# or selumetinib# or volitinib#)
TATTON
|
EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor)
|
advanced EGFRm NSCLC
|
I
|
Q3 2014
|
||||
AZD9496
|
selective oestrogen receptor downregulator (SERD)
|
ER+ breast cancer
|
I
|
Q4 2014
|
||||
durvalumab (MEDI4736)# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab)
|
PD-L1 mAb
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or CTLA-4 mAb)
|
NSCLC
|
I
|
Q3 2014
|
||||
durvalumab (MEDI4736)#
|
PD-L1 mAb
|
solid tumours
|
I
|
Q3 2014
|
||||
durvalumab (MEDI4736)# + MEDI0680
|
PD-L1 mAb + PD-1 mAb
|
solid tumours
|
I
|
Q2 2014
|
||||
durvalumab (MEDI4736)# + MEDI6383#
|
OX40 agonist + PD-L1 mAb
|
solid tumours
|
I
|
Q2 2015
|
||||
durvalumab (MEDI4736)# + MEDI6469#
|
PD-L1 mAb + murine OX40 agonist
|
solid tumours
|
I
|
Q3 2014
|
||||
durvalumab (MEDI4736)# + dabrafenib + trametinib1
|
PD-L1 mAb+ BRAF inhibitor + MEK inhibitor
|
melanoma
|
I
|
Q1 2014
|
||||
Iressa + durvalumab (MEDI4736)#
|
PD-L1 mAb+ EGFR tyrosine kinase inhibitor
|
NSCLC
|
I
|
Q2 2014
|
||||
durvalumab (MEDI4736)# + tremelimumab
|
PD-L1 mAb + CTLA-4 mAb
|
solid tumours
|
I
|
Q4 2013
|
||||
MEDI0562#
|
humanised OX40 agonist
|
solid tumours
|
I
|
Q1 2015
|
||||
MEDI-565#
|
CEA BiTE mAb
|
solid tumours
|
I
|
Q1 2011
|
||||
MEDI0639#
|
DLL-4 mAb
|
solid tumours
|
I
|
Q2 2012
|
||||
MEDI0680
|
PD-1 mAb
|
solid tumours
|
I
|
Q4 2013
|
||||
MEDI3617#
|
ANG-2 mAb
|
solid tumours
|
I
|
Q4 2010
|
||||
MEDI-551# +
MEDI0680
|
CD19 mAb + PD-1 mAb
|
DLBCL
|
I
|
Q4 2014
|
||||
MEDI-551# + rituximab
|
CD19 mAb + CD20 mAb
|
haematological malignancies
|
I
|
Q2 2014
|
||||
MEDI6383#
|
OX40 agonist
|
solid tumours
|
I
|
Q3 2014
|
||||
MEDI6469#
|
murine OX40 agonist
|
solid tumours
|
I
|
Q1 2006
|
||||
MEDI6469# + rituximab
|
murine OX40 agonist + CD20 mAb
|
solid tumours
|
I
|
Q1 2015
|
||||
MEDI6469# +
tremelimumab
|
murine OX40 agonist + CTLA-4 mAb
|
solid tumours
|
I
|
Q4 2014
|
||||
Infection, Neuroscience and Gastrointestinal
|
||||||||
AZD3241
|
myeloperoxidase inhibitor
|
multiple system atrophy
|
II
|
Q2 2012
|
||||
AZD3293#
|
beta-secretase inhibitor
|
Alzheimer’s disease
|
II
|
Q4 2014
|
||||
AZD5213
|
histamine-3 receptor antagonist
|
Tourette’s syndrome / neuropathic pain
|
II
|
Q4 2013
|
||||
AZD5847
|
oxazolidinone anti-bacterial inhibitor
|
tuberculosis
|
II
|
Q4 2012
|
||||
AZD8108
|
NMDA antagonist
|
suicidal ideation
|
I
|
Q4 2014
|
||||
CXL#
|
beta lactamase inhibitor / cephalosporin
|
MRSA
|
II
|
Q4 2010
|
||||
MEDI1814
|
amyloid beta mAb
|
Alzheimer’s disease
|
I
|
Q2 2014
|
||||
MEDI4893
|
MAb binding to S. aureus toxin
|
hospital-acquired pneumonia / serious S. aureus infection
|
II
|
Q4 2014
|
(Fast Track)
|
|||
MEDI8897#
|
RSV mAb-YTE
|
passive RSV prophylaxis
|
II
|
Q1 2015
|
(Fast Track)
|
|||
ATM AVI#
|
monobactam/ beta lactamase inhibitor
|
targeted serious bacterial infections
|
I
|
Q1 2015
|
||||
MEDI-550
|
pandemic influenza virus vaccine
|
pandemic influenza prophylaxis
|
I
|
Q2 2006
|
||||
MEDI3902
|
anti-Psl/PcrV
|
prevention of nosocomial pseudomonas pneumonia
|
I
|
Q3 2014
|
(Fast Track)
|
|||
MEDI7510
|
RSV sF+GLA-SE
|
prevention of RSV disease in older adults
|
I
|
Q2 2014
|
||||
MEDI8852
|
influenza A mAb
|
influenza A treatment
|
I
|
Q1 2015
|
Compound
|
Mechanism
|
Area Under Investigation
|
Date Commenced Phase
|
Estimated Filing†
|
|||||
US
|
EU
|
Japan
|
China
|
||||||
Respiratory, Inflammation and Autoimmunity
|
|||||||||
Duaklir Genuair#
|
LAMA/LABA
|
COPD
|
2018
|
Launched
|
2018
|
2018
|
|||
Symbicort
SYGMA
|
ICS/LABA
|
as needed use in mild asthma
|
Q4 2014
|
N/A
|
2018
|
2019
|
|||
Symbicort1
|
ICS/LABA
|
breath actuated Inhaler asthma/COPD
|
|
2018
|
|||||
Cardiovascular and Metabolism
|
|||||||||
Brilinta/Brilique2 EUCLID
|
P2Y12 receptor antagonist
|
outcomes study in patients with peripheral artery disease
|
Q4 2012
|
2017
|
2017
|
2017
|
2018
|
||
Brilinta/Brilique2 HESTIA
|
P2Y12 receptor antagonist
|
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
|
Q4 2014
|
2020
|
2020
|
||||
Brilinta/Brilique2
PEGASUS-
TIMI 54
|
P2Y12 receptor antagonist
|
outcomes study in patients with prior myocardial infarction
|
Q4 2010
|
Filed
(Priority Review)
|
Filed
|
Q4 2015
|
2017
|
||
Brilinta/Brilique2 SOCRATES
|
P2Y12 receptor antagonist
|
outcomes study in patients with stroke or TIA
|
Q1 2014
|
H1 2016
|
H1 2016
|
H2 2016
|
2017
|
||
Brilinta/Brilique2 THEMIS
|
P2Y12 receptor antagonist
|
outcomes study in patients with type-2 diabetes and CAD, but without a previous history of MI or stroke
|
Q1 2014
|
2018
|
2018
|
2018
|
2018
|
||
Bydureon Dual
Chamber Pen
|
GLP-1 receptor agonist
|
type-2 diabetes
|
Launched
|
Launched
|
Approved
|
||||
Bydureon EXSCEL
|
GLP-1 receptor agonist
|
type-2 diabetes outcomes study
|
Q2 2010
|
2018
|
2018
|
2018
|
|||
Bydureon weekly
suspension
|
GLP-1 receptor agonist
|
type-2 diabetes
|
Q1 2013
|
Q4 2015
|
Q4 2015
|
||||
Epanova
STRENGTH
|
omega-3 carboxylic acids
|
outcomes study in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol
|
Q4 2014
|
2020
|
2020
|
2020
|
2020
|
||
Epanova/Farxiga/Forxiga3
|
omega-3 carboxylic acids/ SGLT-2 inhibitor
|
Non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
|
Q1 2015
|
||||||
Farxiga/Forxiga3
DECLARE-
TIMI 58
|
SGLT-2 inhibitor
|
type-2 diabetes outcomes study
|
Q2 2013
|
2020
|
2020
|
||||
Farxiga/Forxiga3
|
SGLT-2 inhibitor
|
type-1 diabetes
|
Q4 2014
|
2018
|
2017
|
2018
|
|||
Kombiglyze XR/Komboglyze4
|
DPP-4 inhibitor/ metformin FDC
|
type-2 diabetes
|
Launched
|
Launched
|
Filed
|
||||
Onglyza SAVOR-TIMI 53
|
DPP-4 inhibitor
|
type-2 diabetes outcomes study
|
Q2 2010
|
Filed
|
Launched
|
Q4 2015
|
|||
saxagliptin/
dapagliflozin FDC
|
DPP-4 inhibitor/ SGLT-2 inhibitor FDC
|
type-2 diabetes
|
Q2 2012
|
Filed
|
Filed
|
||||
Xigduo XR/
Xigduo5
|
SGLT-2 inhibitor/ metformin FDC
|
type-2 diabetes
|
Launched
|
Launched
|
Oncology
|
||||||||
Caprelsa
|
VEGFR/EGFR tyrosine kinase inhibitor with RET kinase activity
|
differentiated thyroid cancer
|
Q2 2013
|
H1 2016
|
H1 2016
|
H1 2016
|
||
Faslodex
FALCON
|
oestrogen receptor antagonist
|
1st-line hormone receptor +ve advanced breast cancer
|
Q4 2012
|
H2 2016
|
H2 2016
|
H2 2016
|
2017
|
|
Iressa
|
EGFR tyrosine kinase inhibitor
|
EGFRm NSCLC
|
Approved6
|
Launched
|
Launched
|
Launched
|
||
Lynparza (olaparib) SOLO-1
|
PARP inhibitor
|
1st-line BRCAm ovarian cancer
|
Q3 2013
|
2017
|
2017
|
2017
|
||
Lynparza (olaparib) SOLO-2
|
PARP inhibitor
|
2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
|
Q3 2013
|
H1 2016
|
H1 2016
|
H2 2016
|
||
Lynparza (olaparib) SOLO-3
|
PARP inhibitor
|
gBRCA PSR ovarian cancer
|
Q1 2015
|
2018
|
||||
Lynparza (olaparib) GOLD
|
PARP inhibitor
|
2nd-line gastric cancer
|
Q3 2013
|
2017
|
||||
Lynparza (olaparib)
OlympiA
|
PARP inhibitor
|
gBRCA adjuvant triple negative breast cancer
|
Q2 2014
|
2020
|
2020
|
2020
|
||
Lynparza (olaparib) OlympiAD
|
PARP inhibitor
|
gBRCA metastatic breast cancer
|
Q2 2014
|
H2 2016
|
H2 2016
|
H2 2016
|
||
Lynparza (olaparib) POLO
|
PARP inhibitor
|
pancreatic cancer
|
Q1 2015
|
2017
|
2017
|
2017
|
||
Lynparza (olaparib)
|
PARP inhibitor
|
prostate cancer
|
Q3 2014
|
|||||
Infection, Neuroscience and Gastrointestinal
|
||||||||
Diprivan#
|
sedative and anaesthetic
|
conscious sedation
|
N/A
|
Launched
|
Filed
|
Launched
|
||
Entocort
|
glucocorticoid steroid
|
Crohn’s disease / ulcerative colitis
|
Launched
|
Launched
|
Q3 2015
|
N/A
|
||
linaclotide#
|
GC-C receptor peptide agonist
|
irritable bowel syndrome with constipation
(IBS-C)
|
N/A
|
N/A
|
N/A
|
Q4 2015
|
||
Nexium
|
proton pump inhibitor
|
stress ulcer prophylaxis
|
2017
|
|||||
Nexium
|
proton pump inhibitor
|
paediatrics
|
Launched
|
Launched
|
H2 2016
|
NME / Line Extension
|
Compound
|
Reason for Discontinuation
|
Area Under Investigation
|
NME
|
selumetinib# SUMIT
|
Safety/efficacy
|
uveal melanoma
|
NME
|
tenapanor (AZD1722)#
|
Safety/efficacy
|
ESRD-Pi/CKD with T2DM
|
LCM
|
Nexium
|
Regulatory
|
refractory reflux oesphagitis (JP)
|
Compound
|
Mechanism
|
Area Under Investigation
|
Phase
|
Estimated Filing
|
|||
US
|
EU
|
Japan
|
China
|
||||
Neuroscience
|
|||||||
Movantik/
Moventig#1
|
oral peripherally-acting mu-opioid receptor antagonist
|
opioid-induced constipation
|
Launched
|
Launched
|
Announcements and Meetings
|
||
Announcement of nine months and third quarter results
|
5 November 2015
|
|
Announcement of full year and fourth quarter results
|
4 February 2016
|
Dividends
|
First interim
|
Announced with half year and second quarter results and paid in September
|
Second interim
|
Announced with full year and fourth quarter results and paid in March
|
ADR Programme
|
Trademarks
|
Addresses for Correspondence
|
||||
Registrar and
Transfer Office
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
|
US Depositary
Citibank Shareholder Services
PO Box 43077
Providence
RI 02940-3077
USA
|
Registered Office
2 Kingdom Street
London
W2 6BD
UK
|
Swedish Central Securities Depository
Euroclear Sweden AB
PO Box 191
SE-101 23 Stockholm
Sweden
|
|
Tel (freephone in UK):
0800 389 1580
Tel (outside UK):
+44 (0)121 415 7033
|
Tel: +44 (0)207 500 2030
or +1 877 248 4237
(1 877-CITI-ADR)/
E-mail: citiadr@citi.com
|
Tel: +44 (0)20 7604 8000
|
Tel: +46 (0)8 402 9000
|
|
Cautionary Statements Regarding Forward-Looking Statements
|
Date: 30 July 2015
|
By: /s/ Adrian Kemp
|
Name: Adrian Kemp
|
|
Title: Company Secretary
|