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
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X            Form 40-F  __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):            
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes  __                 No X
 
 
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b):   82-_____________
 
 
 
AstraZeneca PLC
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
 
MEDI3726#
PSMA antibody drug conjugate
prostate cancer
I
Q1 2017
 
MEDI4276
HER2 bi-specific antibody drug conjugate
solid tumours
I
Q4 2015
 
MEDI5083
immune activator
solid tumours
I
Q1 2017
 
MEDI7247
antibody drug conjugate
haematological malignancies
I
Q2 2017
 
MEDI9197#
TLR 7/8 agonist
solid tumours
I
Q4 2015
 
MEDI9447
CD73 mAb
solid tumours
I
Q3 2015
 
Cardiovascular & Metabolic Diseases
 
 
 
 
verinurad
URAT1 inhibitor
chronic kidney disease
II
Q2 2017
 
MEDI0382
GLP-1/
glucagon dual agonist
type-2 diabetes / obesity
II
Q3 2016
 
MEDI6012
LCAT
cardiovascular
II
Q4 2015
 
AZD4831
myeloperoxidase
HF with a preserved ejection fraction
I
Q3 2016
 
AZD5718
FLAP
coronary artery disease
I
Q1 2016
 
AZD8601#
VEGF-A
cardiovascular
I
Q1 2017
 
MEDI5884#
cholesterol modulation
cardiovascular
I
Q1 2017
 
MEDI8111
Rh-factor II
trauma / bleeding
I
Q1 2014
 
Respiratory
 
 
 
 
 
abediterol#
LABA
asthma/chronic obstructive pulmonary disorder
II
Q4 2007
 
tezepelumab#
TSLP mAb
asthma / atopic dermatitis
II
Q2 2014
 
AZD1419#
inhaled TLR9 agonist
asthma
II
Q4 2016
 
AZD7594
inhaled SGRM
asthma/ chronic obstructive pulmonary disorder
II
Q3 2015
 
AZD8871#
MABA
chronic obstructive pulmonary disease
II
Q1 2017
 
PT010
LABA/LAMA/ICS
asthma
II
Q2 2014
 
AZD0284
RORg
psoriasis/respiratory
I
Q4 2016
 
AZD5634
inhaled ENaC
cystic fibrosis
I
Q1 2016
 
AZD7594+abediterol#
inhaled SGRM+LABA
asthma/chronic obstructive pulmonary disease
I
Q4 2016
 
AZD7986#
DPP1
chronic obstructive pulmonary disease
I
Q4 2014
 
AZD9567
oral SGRM
rheumatoid arthritis/respiratory
I
Q4 2015
 
AZD9898
LTC4S
asthma
I
Q2 2017
 
MEDI3506
IL-33 mAb
chronic obstructive pulmonary disease
I
Q2 2017
 
Other
 
 
 
 
 
anifrolumab#
IFN-alphaR mAb
lupus nephritis
II
Q4 2015
 
anifrolumab#
IFN-alphaR mAb
systemic lupus erythematosus (subcutaneous)
II
Q1 2017
 
inebilizumab#
CD19 mAb
neuromyelitis optica
II
(Orphan drug US, EU)
Q1 2015
 
 
mavrilimumab#
GM-CSFR mAb
rheumatoid arthritis
II
Q1 2010
 
MEDI3902
Psl/PcrV bispecific mAb
prevention of nosocomial Pseudomonas aeruginosa pneumonia
II
(Fast Track, US)
Q2 2016
 
 
MEDI4893
mAb binding to S. aureus toxin
prevention of nosocomial Staphylococcus aureus pneumonia
II
(Fast Track, US)
Q4 2014
 
 
MEDI5872#
B7RP1 mAb
primary Sjögren's syndrome
II
Q3 2015
 
MEDI8852
influenza A mAb
influenza A treatment
II
(Fast Track, US)
Q4 2015
 
 
MEDI8897#
RSV mAb-YTE
passive RSV prophylaxis
II
(Fast Track, US)
Q1 2015
 
 
MEDI0700#
BAFF/B7RP1 bispecific mAb
systemic lupus erythematosus
I
Q1 2016
 
MEDI1814#
amyloid beta mAb
alzheimer's disease
I
Q2 2014
 
MEDI4920
anti-CD40L-Tn3 fusion protein
primary Sjögren's syndrome
I
Q2 2014
 
MEDI7352
NGF/TNF bispecific mAb
osteoarthritis pain
I
Q1 2016
 
MEDI7734
ILT7 mAb
myositis
I
Q3 2016
 
MEDI9314
IL-4R mAb
atopic dermatitis
I
Q1 2016
 
#  Collaboration
 
 
Significant Lifecycle Management
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Acceptance Date / Submission Status      
US
EU
Japan
China
Oncology
 
 
 
 
 
 
 
Faslodex
FALCON
oestrogen receptor antagonist
1st-line hormone receptor +ve advanced breast cancer
 
               
Accepted
Approved1
Approved
H2 2017
Imfinzi# (durvalumab#)PACIFIC
PD-L1 mAb
stage III non-small cell lung cancer
Q2 2014
H2 2017
 
H2 2017
H2 2017
 
Imfinzi# (durvalumab#)
PEARL (China)
PD-L1 mAb
1st-line non-small cell lung cancer
Q1 2017
 
 
 
2019
Lynparza OlympiAD
PARP inhibitor
gBRCA metastatic breast cancer
Q2 2014
H2 2017
2018
H2 2017
2018
LynparzaSOLO-2
PARP inhibitor
2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
Q3 2013
Accepted
(Priority Review)
Accepted
Accepted
(Orphan Drug Designation)
2018
LynparzaSOLO-1
PARP inhibitor
1st-line BRCAm ovarian cancer
Q3 2013
2018
2018
2018
 
LynparzaSOLO-3
PARP inhibitor
gBRCA PSR ovarian cancer
Q1 2015
2018
 
 
 
LynparzaPOLO
PARP inhibitor
pancreatic cancer
Q1 2015
2019
2019
 
 
Lynparza
PROfound
 
PARP inhibitor
prostate cancer
Q1 2017
 
2020
(Breakthrough Therapy)
2020
2020
2020
Lynparza
OlympiA
PARP inhibitor
gBRCA adjuvant breast cancer
Q2 2014
2020
2020
2020
 
Tagrisso
FLAURA
EGFR inhibitor
1st-line advanced EGFRm non-small cell lung cancer
Q1 2015
H2 2017
H2 2017
H2 2017
2018
Tagrisso
ADAURA
EGFR inhibitor
adjuvant EGFRm non-small cell lung cancer
Q4 2015
2022
2022
2022
2022
Cardiovascular & Metabolic Diseases
 
 
 
 
 
Brilinta2
THEMIS
P2Y12 receptor antagonist
cardiovascular outcomes trial in patients with type-2 diabetes and coronary artery disease without a previous history of myocardial infarction or stroke
Q1 2014
2019
2019
2019
2020
Brilinta2
HESTIA
P2Y12 receptor antagonist
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
Q1 2014
2020
2020
 
 
Kombiglyze XR/Komboglyze3
DPP-4 inhibitor/ metformin FDC
type-2 diabetes
 
Launched
Launched
 
Approved
Farxiga4DECLARE-TIMI 58
SGLT2 inhibitor
cardiovascular outcomes trial in patients with type-2 diabetes
Q2 2013
2020
2020
 
 
Farxiga4
SGLT2 inhibitor
type-1 diabetes
Q4 2014
2018
2018
2018
 
Farxiga4
SGLT2 inhibitor
worsening heart failure or cardiovascular death in patients with chronic heart failure
Q1 2017
2020
2020
2020
2020
Farxiga4
SGLT2 inhibitor
renal outcomes and cardiovascular mortality in patients with chronic kidney disease
Q1 2017
2021
2021
N/A
2021
Xigduo XR/
Xigduo5
SGLT2 inhibitor/ metformin FDC
type-2 diabetes
 
Launched
Launched
 
2020
Qtern
DPP-4 inhibitor/ SGLT2 inhibitor FDC
type-2 diabetes
 
Approved
Launched
 
 
Bydureon weeklyautoinjector
GLP-1 receptor agonist
type-2 diabetes
Q1 2013
Accepted
H2 2017
 
 
Bydureon EXSCEL
GLP-1 receptor agonist
type-2 diabetes outcomes trial
Q2 2010
H2 2017
H2 2017
 
2018
saxagliptin/
dapagliflozin metformin
DPP-4 inhibitor/ SGLT2 inhibitor
type-2 diabetes
Q2 2017
2018
2018
 
 
Epanova
STRENGTH
omega-3 carboxylic acids
cardiovascular outcomes trial in statin-treated patients at high cardiovascular risk, with persistent hypertriglyceridemia plus low HDL-cholesterol
Q4 2014
2020
2020
2020
2020
Respiratory
 
 
 
 
 
 
 
Symbicort
SYGMA
ICS/LABA
as-needed use in mild asthma
Q4 2014
 
2018
 
2019
Duaklir Genuair#
LAMA/LABA
chronic obstructive pulmonary disease
 
2018
Launched
 
2019
Other
 
 
 
 
 
 
 
Nexium
proton pump inhibitor
stress ulcer prophylaxis
 
 
 
 
Accepted
Nexium
proton pump inhibitor
paediatrics
 
Launched
Launched
Accepted
 
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation(IBS-C)
 
 
 
 
Accepted
#    Collaboration
1    Approval received on 26 July 2017
2    Brilinta in the US and Japan; Brilique in ROW
3    Kombiglyze XR in the US; Komboglyze in the EU
4    Farxiga in the US; Forxiga in ROW
5    Xigduo XR in the US; Xigduo in the EU
 
 
Terminations (discontinued projects: 1 April 2017 to 30 June 2017)
 
NME / Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
AZD4076
anti-miR103/107 oligonucleotide
Safety/Efficacy
non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
MEDI4166
PCSK9/GLP-1 mAb + peptide fusion
Safety/Efficacy
diabetes/cardiovascular
verinurad
selective uric acid reabsorption inhibitor (URAT-1)
Strategic
chronic treatment of hyperuricemia in patients with gout
 
 
Completed Projects/Divestitures (1 April 2017 to 30 June 2017)
 
Compound
Mechanism
Area Under Investigation
Completed/
Divested
Estimated Regulatory Submission Acceptance      
US
EU
Japan
China
Farxiga*
SGLT2 inhibitor
type-2 diabetes
Completed
Launched
Launched
Launched
Launched
Imfinzi (durvalumab#)
PD-L1 mAb
≥2nd-line advanced bladder cancer
Completed
Approved, Launched
(Breakthrough Therapy & Priority Review)
N/A
N/A
N/A
*     Farxiga in the US; Forxiga in ROW
#    Collaboration
 
 
Condensed Consolidated Statement of Comprehensive Income
 
 
For the half year ended 30 June
 
2017 
$m 
 
2016 
$m 
Product sales
 
9,783 
 
11,034 
Externalisation revenue
 
673 
 
684 
Total revenue
 
10,456 
 
11,718 
Cost of sales
 
(1,844)
 
(2,066)
Gross profit
 
8,612 
 
9,652 
Distribution costs
 
(149)
 
(167)
Research and development expense
 
(2,802)
 
(2,945)
Selling, general and administrative costs
 
(4,658)
 
(5,624)
Other operating income and expense
 
839 
 
425 
Operating profit
 
1,842 
 
1,341 
Finance income
 
39 
 
31 
Finance expense
 
(781)
 
(667)
Share of after tax losses in associates and joint ventures
 
(26)
 
(12)
Profit before tax
 
1,074 
 
693 
Taxation
 
(116)
 
(99)
Profit for the period
 
958 
 
594
 
 
 
 
 
Other comprehensive income
 
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
 
Remeasurement of the defined benefit pension liability
 
(271)
 
(842)
Tax on items that will not be reclassified to profit or loss
 
71 
 
235 
 
 
(200)
 
(607)
Items that may be reclassified subsequently to profit or loss
 
 
 
 
Foreign exchange arising on consolidation
 
377 
 
(523)
Foreign exchange arising on designating borrowings in net investment hedges
 
383 
 
(67)
Fair value movements on cash flow hedges
 
127 
 
(103)
Fair value movements on cash flow hedges transferred to profit or loss
 
(200)
 
60 
Fair value movements on derivatives designated in net investment hedges
 
(35)
 
(79)
Amortisation of loss on cash flow hedge
 
1 
 
1 
Net available for sale losses taken to equity
 
(94)
 
(36)
Tax on items that may be reclassified subsequently to profit or loss
 
(70)
 
75 
 
 
489 
 
(672)
Other comprehensive income/(loss) for the period, net of tax
 
289 
 
(1,279)
Total comprehensive income/(loss) for the period
 
1,247 
 
(685)
 
 
 
 
 
Profit attributable to:
 
 
 
 
Owners of the Parent
 
1,014 
 
643 
Non-controlling interests
 
(56)
 
(49)
 
 
958 
 
594 
 
 
 
 
 
Total comprehensive income/(loss) attributable to:
 
 
 
 
Owners of the Parent
 
1,303 
 
(636)
Non-controlling interests
 
(56)
 
(49)
 
 
1,247
 
(685)
 
 
 
 
 
Basic earnings per $0.25 Ordinary Share
 
$0.80 
 
$0.51 
Diluted earnings per $0.25 Ordinary Share
 
$0.80 
 
$0.51 
Weighted average number of Ordinary Shares in issue (millions)
 
1,266 
 
1,264 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,266 
 
1,265 
 
 
Condensed Consolidated Statement of Comprehensive Income
 
 
 
For the quarter ended 30 June
 
Unreviewed*
2017 
$m 
 
 
2016 
$m 
Product sales
 
4,940 
 
5,469 
Externalisation revenue
 
111 
 
134 
Total revenue
 
5,051 
 
5,603 
Cost of sales
 
(950)
 
(1,062)
Gross profit
 
4,101 
 
4,541 
Distribution costs
 
(72)
 
(91)
Research and development expense
 
(1,349)
 
(1,465)
Selling, general and administrative costs
 
(2,358)
 
(3,052)
Other operating income and expense
 
603 
 
370 
Operating profit
 
925 
 
303 
Finance income
 
28 
 
17 
Finance expense
 
(448)
 
(342)
Share of after tax losses in associates and joint ventures
 
(13)
 
(8)
Profit/(loss) before tax
 
492 
 
(30)
Taxation
 
(46)
 
(1)
Profit/(loss) for the period
 
446 
 
(31)
 
 
 
 
 
Other comprehensive income
 
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
 
Remeasurement of the defined benefit pension liability
 
(272)
 
(651)
Tax on items that will not be reclassified to profit or loss
 
72 
 
194 
 
 
(200)
 
(457)
Items that may be reclassified subsequently to profit or loss
 
 
 
 
Foreign exchange arising on consolidation
 
223 
 
(356)
Foreign exchange arising on designating borrowings in net investment hedges
 
283 
 
(274)
Fair value movements on cash flow hedges
 
120 
 
(103)
Fair value movements on cash flow hedges transferred to profit or loss
 
(161)
 
60 
Fair value movements on derivatives designated in net investment hedges
 
(5)
 
(47)
Amortisation of loss on cash flow hedge
 
1 
 
1 
Net available for sale gains/(losses) taken to equity
 
56 
 
(7)
Tax on items that may be reclassified subsequently to profit or loss
 
(94)
 
65 
 
 
423 
 
(661)
Other comprehensive income/(loss) for the period, net of tax
 
223 
 
(1,118)
Total comprehensive income/(loss) for the period
 
669 
 
(1,149)
 
 
 
 
 
Profit/(loss) attributable to:
 
 
 
 
Owners of the Parent
 
477 
 
(3)
Non-controlling interests
 
(31)
 
(28)
 
 
446 
 
(31)
 
 
 
 
 
Total comprehensive income/(loss) attributable to:
 
 
 
 
Owners of the Parent
 
700 
 
(1,121)
Non-controlling interests
 
(31)
 
(28)
 
 
669 
 
(1,149)
 
 
 
 
 
Basic earnings per $0.25 Ordinary Share
 
$0.38 
 
$0.00 
Diluted earnings per $0.25 Ordinary Share
 
$0.38 
 
$0.00 
Weighted average number of Ordinary Shares in issue (millions)
 
1,266 
 
1,265 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,267 
 
1,265 
 
*The Q2 2017 information in respect of the three months ended 30 June 2017 included in the interim financial statements has not been reviewed by PricewaterhouseCoopers.
 
 
Condensed Consolidated Statement of Financial Position
 
 
 
 
At 30
Jun 2017
$m
 
At 31 Dec 2016
$m
 
Restated*
At 30 Jun 2016
$m
ASSETS
Non-current assets
 
 
 
 
 
 
Property, plant and equipment
 
7,079 
 
6,848 
 
6,613 
 
Goodwill
 
11,774 
 
11,658 
 
11,783 
 
Intangible assets
 
27,465 
 
27,586 
 
29,438 
 
Derivative financial instruments
 
336 
 
343 
 
337 
 
Investments in associates and joint ventures
 
86 
 
99 
 
105 
 
Other investments
 
989 
 
727 
 
470 
 
Other receivables
 
967 
 
901 
 
764 
 
Deferred tax assets
 
2,125 
 
1,102 
 
1,524 
 
 
 
50,821 
 
49,264 
 
51,034 
 
Current assets
 
 
 
 
 
 
Inventories
 
2,901 
 
2,334 
 
2,422 
 
Trade and other receivables
 
4,348 
 
4,573 
 
5,634 
 
Other investments
 
998 
 
884 
 
731 
 
Derivative financial instruments
 
26 
 
27 
 
5 
 
Income tax receivable
 
786 
 
426 
 
628 
 
Cash and cash equivalents
 
5,239 
 
5,018 
 
3,915 
 
 
 
14,298 
 
13,262 
 
13,335 
 
Total assets
 
65,119 
 
62,526 
 
64,369 
 
 
LIABILITIES
Current liabilities
 
 
 
 
 
 
Interest-bearing loans and borrowings
 
(2,933)
 
(2,307)
 
(1,060)
 
Trade and other payables
 
(10,072)
 
(10,486)
 
(10,259)
 
Derivative financial instruments
 
(6)
 
(18)
 
(57)
 
Provisions
 
(1,070)
 
(1,065)
 
(999)
 
Income tax payable
 
(1,576)
 
(1,380)
 
(1,960)
 
 
 
(15,657)
 
(15,256)
 
(14,335)
 
Non-current liabilities
 
 
 
 
 
 
Interest-bearing loans and borrowings
 
(16,792)
 
(14,501)
 
(16,519)
 
Derivative financial instruments
 
(3)
 
(117)
 
(103)
 
Deferred tax liabilities
 
(4,944)
 
(3,956)
 
(4,026)
 
Retirement benefit obligations
 
(2,534)
 
(2,186)
 
(2,628)
 
Provisions
 
(406)
 
(353)
 
(426)
 
Other payables
 
(9,371)
 
(9,488)
 
(10,942)
 
 
 
(34,050)
 
(30,601)
 
(34,644)
 
Total liabilities
 
(49,707)
 
(45,857)
 
(48,979)
 
Net assets
 
15,412 
 
16,669 
 
15,390 
 
 
EQUITY
 
 
 
 
 
 
Capital and reserves attributable to equity holders of the Company
 
 
 
 
 
 
Share capital
 
316 
 
316 
 
316 
 
Share premium account
 
4,374 
 
4,351 
 
4,326 
 
Other reserves
 
2,033 
 
2,047 
 
2,030 
 
Retained earnings
 
6,930 
 
8,140 
 
6,858 
 
 
 
13,653 
 
14,854 
 
13,530 
 
Non-controlling interests
 
1,759 
 
1,815 
 
1,860 
 
Total equity
 
15,412 
 
16,669 
 
15,390 
 
 
*30 June comparatives have been restated to reflect an adjustment to the acquisition-accounting for Acerta Pharma (as detailed in Note 4 of the Full Year and Fourth Quarter 2016 Results Announcement).
 
Condensed Consolidated Statement of Cash Flows
 
 
For the half year ended 30 June
 
2017
$m 
 
2016 
$m 
 
Cash flows from operating activities
 
 
 
 
 
Profit before tax
 
1,074 
 
693 
 
Finance income and expense
 
742 
 
636 
 
Share of after tax losses in associates and joint ventures
 
26 
 
12 
 
Depreciation, amortisation and impairment
 
1,274 
 
1,156 
 
Increase in working capital and short-term provisions
 
(1,044)
 
(183)
 
Non-cash and other movements
 
(1,064)
 
(380)
 
Cash generated from operations
 
1,008 
 
1,934 
 
Interest paid
 
(334)
 
(298)
 
Tax paid
 
(336)
 
(262)
 
Net cash inflow from operating activities
 
338 
 
1,374 
 
Cash flows from investing activities
 
 
 
 
 
Movement in short-term investments and fixed deposits
 
(112)
 
(15)
 
Purchase of property, plant and equipment
 
(549)
 
(584)
 
Disposal of property, plant and equipment
 
57 
 
8 
 
Purchase of intangible assets
 
(167)
 
(723)
 
Disposal of intangible assets
 
728 
 
102 
 
Purchase of non-current asset investments
 
(131)
 
(66)
 
Disposal of non-current asset investments
 
14 
 
- 
 
Payments to joint ventures
 
(6)
 
(15)
 
Upfront payments on business acquisitions
 
- 
 
(2,564)
 
Payment of contingent consideration from business combinations
 
(260)
 
(141)
 
Interest received
 
75 
 
63 
 
Payments made by subsidiaries to non-controlling interests
 
- 
 
(13)
 
Net cash outflow from investing activities
 
(351)
 
(3,948)
 
Net cash outflow before financing activities
 
(13)
 
(2,574)
 
Cash flows from financing activities
 
 
 
 
 
Proceeds from issue of share capital
 
23 
 
22 
 
Issue of loans
 
1,992 
 
2,483 
 
Dividends paid
 
(2,368)
 
(2,409)
 
Hedge contracts relating to dividend payments
 
(32)
 
5 
 
Repayment of obligations under finance leases
 
(10)
 
(8)
 
Movement in short-term borrowings
 
541 
 
(99)
 
Net cash inflow/(outflow) from financing activities
 
146 
 
(6)
 
Net increase/(decrease) in cash and cash equivalents in the period
 
133 
 
(2,580)
 
Cash and cash equivalents at the beginning of the period
 
4,924 
 
6,051 
 
Exchange rate effects
 
(79)
 
34 
 
Cash and cash equivalents at the end of the period
 
4,978 
 
3,505 
 
Cash and cash equivalents consists of:
 
 
 
 
 
Cash and cash equivalents
 
5,239 
 
3,915 
 
Overdrafts
 
(261)
 
(410)
 
 
 
4,978 
 
3,505 
 
 
 
 
 
 
 
 
 
Condensed Consolidated Statement of Changes in Equity
 
 
 
Sharecapital$m
 
Sharepremiumaccount$m
 
Otherreserves*$m
 
Retainedearnings$m
 
Total $m 
 
Non-controllinginterests$m
 
Totalequity$m
At 1 Jan 2016
 
316
 
 
4,304
 
 
2,036 
 
 
11,834
 
 
18,490 
 
 
19 
 
 
18,509 
 
Profit for the period
 
-
 
 
-
 
 
-
 
 
643 
 
643 
 
(49)
 
594 
Other comprehensive income
 
-
 
-
 
- 
 
(1,279)
 
(1,279)
 
- 
 
(1,279)
Transfer to other reserves
 
-
 
-
 
(6)
 
6 
 
- 
 
- 
 
- 
Transactions with owners:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dividends
 
-
 
-
 
- 
 
(2,402)
 
(2,402)
 
- 
 
(2,402)
Dividends paid by subsidiary to non-controlling interest
 
-
 
-
 
- 
 
- 
 
- 
 
(13) 
 
(13)
Acerta put option
 
-
 
-
 
- 
 
(1,825)
 
(1,825)
 
- 
 
(1,825)
Changes in non-controlling interest
 
-
 
-
 
- 
 
- 
 
- 
 
1,903 
 
1,903 
Issue of Ordinary Shares
 
-
 
22
 
- 
 
- 
 
22 
 
- 
 
22 
Share-based payments
 
-
 
-
 
- 
 
(119)
 
(119)
 
- 
 
(119)
Net movement
 
-
 
 
22
 
 
(6)
 
 
(4,976)
 
 
(4,960)
 
 
1,841 
 
 
(3,119)
 
At 30 Jun 2016
 
316
 
 
4,326
 
 
2,030 
 
 
6,858 
 
 
13,530 
 
 
1,860 
 
 
15,390
 
 
 
 
 
Sharecapital$m
 
Sharepremiumaccount$m
 
Otherreserves*$m
 
Retainedearnings$m
 
Total $m 
 
Non-controllinginterests$m
 
Totalequity$m
At 1 Jan 2017
 
316
 
 
4,351
 
 
2,047 
 
 
8,140 
 
 
14,854 
 
 
1,815 
 
 
16,669 
 
Profit for the period
 
-
 
-
 
- 
 
1,014 
 
1,014 
 
(56)
 
958 
Other comprehensive income
 
-
 
-
 
- 
 
289 
 
289 
 
- 
 
289 
Transfer to other reserves
 
-
 
-
 
(14)
 
14 
 
- 
 
- 
 
- 
Transactions with owners:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dividends
 
-
 
-
 
- 
 
(2,404)
 
(2,404)
 
- 
 
(2,404)
Issue of Ordinary Shares
 
-
 
23
 
- 
 
- 
 
23 
 
- 
 
23 
Share-based payments
 
-
 
-
 
- 
 
(123)
 
(123)
 
- 
 
(123)
Net movement
 
-
 
 
23
 
 
(14)
 
 
(1,210)
 
 
(1,201)
 
 
(56) 
 
 
(1,257)
 
At 30 Jun 2017
 
316
 
 
4,374
 
 
2,033 
 
 
6,930 
 
 
13,653 
 
 
1,759 
 
 
15,412 
 
* Other reserves include the capital redemption reserve and the merger reserve.
 
 
Responsibility Statement of the Directors in Respect of the Half-Yearly Financial Report
 
We confirm that to the best of our knowledge:
●            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.
 
 
The Board
The Board of Directors that served during all or part of the six-month period to 30 June 2017 and their respective responsibilities can be found on the Leadership team section of astrazeneca.com. 
 
Approved by the Board and signed on its behalf by
 
Pascal Soriot
Chief Executive Officer
 
27 July 2017
 
Independent Review Report to AstraZeneca PLC
 
Report on the condensed consolidated interim financial statements
 
 
Our conclusion
We have reviewed AstraZeneca PLC's condensed consolidated interim financial statements (the "interim financial statements") in the half-yearly financial report of AstraZeneca PLC for the 6 month period ended 30 June 2017. Based on our review, nothing has come to our attention that causes us to believe that the interim financial statements are not prepared, in all material respects, in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as adopted by the European Union and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.
 
 
What we have reviewed
The interim financial statements comprise:
●          the Condensed Consolidated Statement of Financial Position as at 30 June 2017;
●          the Condensed Consolidated Statement of Comprehensive Income for the period then ended;
●          the Condensed Consolidated Statement of Cash Flows for the period then ended;
●          the Condensed Consolidated Statement of Changes in Equity for the period then ended; and
●          the explanatory notes to the interim financial statements.
The interim financial statements included in the half-yearly financial report have been prepared in accordance with International Accounting Standard 34, 'Interim Financial Reporting', as adopted by the European Union and the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.
 
As disclosed in note 1 to the interim financial statements, the financial reporting framework that has been applied in the preparation of the full annual financial statements of the Group is applicable law and International Financial Reporting Standards (IFRSs) as adopted by the European Union.
 
Responsibilities for the interim financial statements and the review
 
 
Our responsibilities and those of the directors
The half-yearly financial report, including the interim financial statements, is the responsibility of, and has been approved by, the directors. The directors are responsible for preparing the half-yearly financial report in accordance with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority.
 
Our responsibility is to express a conclusion on the interim financial statements in the half-yearly financial report based on our review. This report, including the conclusion, has been prepared for and only for the company for the purpose of complying with the Disclosure Guidance and Transparency Rules sourcebook of the United Kingdom's Financial Conduct Authority and for no other purpose. We do not, in giving this conclusion, accept or assume responsibility for any other purpose or to any other person to whom this report is shown or into whose hands it may come save where expressly agreed by our prior consent in writing.
 
 
What a review of interim financial statements involves
We conducted our review in accordance with International Standard on Review Engagements (UK and Ireland) 2410, 'Review of Interim Financial Information Performed by the Independent Auditor of the Entity' issued by the Auditing Practices Board for use in the United Kingdom. A review of interim financial information consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures.
 
A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing (UK and Ireland) and, consequently, does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
 
We have read the other information contained in the half-yearly financial report and considered whether it contains any apparent misstatements or material inconsistencies with the information in the interim financial statements.
 
 
PricewaterhouseCoopers LLP
Chartered Accountants
London
27 July 2017
 
a)   The maintenance and integrity of the AstraZeneca PLC website is the responsibility of the directors; the work carried out by the auditors does not involve consideration of these matters and, accordingly, the auditors accept no responsibility for any changes that may have occurred to the interim financial statements since they were initially presented on the website.
 
b)   Legislation in the United Kingdom governing the preparation and dissemination of financial statements may differ from legislation in other jurisdictions.
 
 
Notes to the Interim Financial Statements
 
1   BASIS OF PREPARATION AND ACCOUNTING POLICIES
 
These unaudited condensed consolidated interim financial statements (interim financial statements) for the six months ended 30 June 2017 have been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the European Union (EU) and as issued by the International Accounting Standards Board (IASB).
 
The annual financial statements of the Group are prepared in accordance with International Financial Reporting Standards (IFRSs) as adopted by the EU and as issued by the IASB. The interim financial statements have been prepared applying the accounting policies and presentation that were applied in the preparation of the Group's published consolidated financial statements for the year ended 31 December 2016. There have been no significant new or revised accounting standards applied in the six months ended 30 June 2017.
 
We have revised the balance sheet presentation of deferred tax with effect from 1 January 2017 with no impact upon net deferred tax, balance sheet net assets, the cashflow statement or the income statement. This presentation change, which is not considered material under IAS 8, has resulted in us showing gross, rather than net, deferred tax assets and deferred tax liabilities of a group entity. This change has been made as that entity has transactions that are subject to tax by two different taxation authorities and has the effect of separately disclosing the deferred tax effects for each country. The comparative balance sheet has not been revised for this presentational change. If the 31 December 2016 and 30 June 2016 balances were presented in a comparable way the deferred tax assets would have been $2,093m and $2,249m, respectively. The deferred tax liabilities would have been $4,947m and $4,751m, respectively.
 
As disclosed in our 2016 Annual Report on Page 181, the Group has entered into a number of financial derivative transactions with commercial banks. The Group has agreement with some bank counterparties whereby the parties agree to post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative positions above a predetermined threshold. We have revised the balance sheet presentation of these collateral balances with effect from the 1 January 2017, so that the cash collateral is included in Cash and cash equivalents, with an offsetting liability presented in Current Interest-bearing loans and borrowings. This revision has no impact on our balance sheet net assets, or the income statement. If the 31 December 2016 and 30 June 2016 balances were presented in a comparable way the Cash and cash equivalents balance would have been $5,260m and $4,083m, respectively. Current Interest-bearing loans and borrowings would have been $2,549m and $1,228m, respectively.
 
Legal proceedings
The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2016.
 
Going concern
The Group has considerable financial resources available. As at 30 June 2017 the Group has $5.3bn in financial resources (cash balances of $5.2bn and undrawn committed bank facilities of $3bn which are available until April 2022, with only $2.9bn of debt due within one year). The Group's revenues are largely derived from sales of products which are covered by patents which provide a relatively high level of resilience and predictability to cash inflows, although our revenue is expected to continue to be significantly impacted by the expiry of patents over the medium term. In addition, government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues in many of our mature markets. However, we anticipate new revenue streams from both recently launched medicines and products in development, and the Group has a wide diversity of customers and suppliers across different geographic areas. Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully.
 
On the basis of the above paragraph and after making enquiries, the going concern basis has been adopted in these interim financial statements.
 
Financial information
This results announcement does not constitute statutory accounts of the Group within the meaning of sections 434(3) and 435(3) of the Companies Act 2006. The full group accounts for 2016 were published in the Annual Report 2016, which has been delivered to the registrar of companies. The report of the auditors, KPMG LLP, was (i) unqualified, (ii) did not include a reference to any matters to which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement under section 498(2) or (3) of the Companies Act 2006.
 
2   RESTRUCTURING COSTS
 
Profit before tax for the half year ended 30 June 2017 is stated after charging restructuring costs of $496m ($463m for the half year ended 30 June 2016). These have been charged to profit as follows:
 
 
 
 
H1 2017$m
 
H1 2016$m
 
Unreviewed*
Q2 2017$m
 
Q2 2016$m
Cost of sales
 
81
 
28
 
43
 
19
Research and development expense
 
142
 
107
 
38
 
69
Selling, general and administrative costs
 
197
 
328
 
103
 
220
Other operating income and expense
 
76
 
- 
 
- 
 
- 
Total
 
496
 
463
 
184
 
308
 
*The Q2 2017 information in respect of the three months ended 30 June 2017 included in the interim financial statements has not been reviewed by PricewaterhouseCoopers.
 
3   NET DEBT
 
The table below provides an analysis of net debt and a reconciliation of net cash flow to the movement in net debt.
 
The Group monitors net debt as part of its capital management policy as described in Note 26 of the Annual Report and Form 20-F Information 2016.
 
 
 
At 1 Jan 
2017 
$m 
 
Cash Flow
$m 
 
Non-cash
& Other
$m
 
Exchange Movements
$m
 
At 30 Jun 
2017 
$m 
Loans due after one year
 
(14,495)
 
 
(1,992)
 
 
(11)
 
 
(294)
 
 
(16,792)
 
Finance leases due after one year
 
(6)
 
 
- 
 
 
6 
 
 
- 
 
 
- 
 
Total long-term debt
 
(14,501)
 
 
(1,992)
 
 
(5) 
 
 
(294)
 
 
(16,792)
 
 
 
 
 
 
 
 
 
 
 
 
Current instalments of loans
 
(1,769)
 
 
- 
 
 
13 
 
 
- 
 
 
(1,756)
 
Current instalments of finance leases
 
(87)
 
 
10 
 
 
60 
 
 
(1) 
 
 
(18)
 
Total current debt
 
(1,856)
 
 
10 
 
 
73 
 
 
(1) 
 
 
(1,774)
 
 
 
 
 
 
 
 
 
 
 
 
Other investments - current
 
884 
 
 
112 
 
 
- 
 
 
2 
 
 
998 
 
Other investments - non-current
 
14 
 
 
109 
 
 
- 
 
 
- 
 
 
123 
 
Net derivative financial instruments
 
235 
 
 
32 
 
 
86 
 
 
- 
 
 
353 
 
Cash and cash equivalents
 
5,018 
 
 
298 
 
 
- 
 
 
(77)
 
 
5,239 
 
Overdrafts
 
(94)
 
 
(165)
 
 
- 
 
 
(2)
 
 
(261)
 
Short-term borrowings
 
(357)
 
 
(541)
 
 
- 
 
 
- 
 
 
(898)
 
 
 
5,700 
 
 
(155)
 
 
86 
 
 
(77)
 
 
5,554 
 
Net debt
 
(10,657)
 
 
(2,137)
 
 
154 
 
 
(372)
 
 
(13,012)
 
 
 
Non-cash movements in the period include fair value adjustments under IAS 39.
 
4   FINANCIAL INSTRUMENTS
 
As detailed in the Group's most recent annual financial statements, our principal financial instruments consist of derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and other payables, and interest-bearing loans and borrowings. As indicated in Note 1, there have been no changes to the accounting policies for financial instruments, including fair value measurement, from those disclosed on pages 144 and 145 of the Company's Annual Report and Form 20-F Information 2016. In addition, there have been no changes of significance to the categorisation or fair value hierarchy of our financial instruments. Financial instruments measured at fair value include $731m of other investments, $2,012m of loans, and $353m of derivatives as at 30 June 2017. The total fair value of interest-bearing loans and borrowings at 30 June 2017, which have a carrying value of $19,725m in the Condensed Consolidated Statement of Financial Position, was $19,536m. Contingent consideration liabilities arising on business combinations have been classified under Level 3 in the fair value hierarchy and movements in fair value are shown below:
 
 
 
 
 
Diabetes
Alliance
2017
 
Other
 
2017
 
Total
 
2017
 
Total
 
2016
 
 
$m
 
$m
 
$m
 
$m
 At 1 January
 
 
4,240 
 
 
1,217 
 
 
5,457 
 
 
6,411 
 
 Settlements
 
 
(185)
 
 
(75)
 
 
(260)
 
 
(141)
 
 Revaluations
 
 
(71)
 
 
- 
 
 
(71)
 
 
160 
 
 Discount unwind
 
 
164 
 
 
41 
 
 
205 
 
 
248 
 
 At 30 June
 
 
4,148 
 
 
1,183 
 
 
5,331 
 
 
6,678 
 
 
 
 
5   LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES
 
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2016 and the interim financial statements for the three months ended 31 March 2017 (the Disclosures). Unless noted otherwise below or in the Disclosures, no provisions have been established in respect of the claims discussed below.
 
As discussed in the Disclosures, for the majority of claims in which AstraZeneca is involved it is not possible to make a reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings. In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision is made.
 
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the loss absorbed or make a provision for our best estimate of the expected loss.
 
The position could change over time and the estimates that we have made and upon which we have relied in calculating these provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors causing this uncertainty are described more fully in the Disclosures and herein.
 
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.
 
Matters disclosed in respect of the second quarter of 2017 and to 27 July 2017.
 
Patent litigation
 
Tagrisso (osimertinib)
Patent proceedings outside the US
As previously disclosed, in Europe, in October 2016, Stada Arzneimittel AG filed an opposition to the grant of European Patent No. 2,736,895. The European Patent Office Opposition Hearing is scheduled for January 2018.
 
Faslodex (fulvestrant)
US patent proceedings
As previously disclosed, AstraZeneca has filed patent infringement lawsuits in the US District Court in New Jersey relating to patents listed in the FDA Orange Book with reference to Faslodex after AstraZeneca received notice of ANDAs seeking FDA approval to market generic versions of Faslodex prior to the expiration of AstraZeneca's patents. As previously disclosed, AstraZeneca has resolved the lawsuits with five of the ANDA filers. In July 2017, AstraZeneca resolved the lawsuit with a sixth ANDA filer.
 
Patent proceedings outside the US
As previously disclosed, in Germany, in January 2017, the Federal Patent Court declared European Patent No. EP 1,250,138 invalid at an oral hearing. AstraZeneca formally appealed the decision in June 2017.
 
In May 2017, at an oral hearing, the Opposition Division of the European Patent Office revoked a Faslodex divisional application for European Patent No. EP 2,266,573 for lack of inventive step. Oppositions against the grant of the patent had been filed by five opponents. AstraZeneca appealed in July 2017.
 
As previously disclosed, in Brazil, in February 2013, Eurofarma Laboratorios S.A. (Eurofarma) filed a nullity action against a formulation patent for Faslodex. In October 2015, the 31st Specialized Intellectual Property (IP) Federal Court of Rio de Janeiro invalidated AstraZeneca's patent. In July 2017, the 1st Specialized IP Panel of the Rio Federal Court of Appeals rejected AstraZeneca's appeal against this decision. AstraZeneca is considering further options for appeal.
 
Crestor (rosuvastatin calcium)
Patent proceedings outside the US
In Spain, in March 2017, AstraZeneca received an interim injunction from the Commercial Courts of Barcelona against the launch of ratiopharm España, S.A.'s rosuvastatin zinc product. In March 2017, AstraZeneca also initiated main infringement proceedings before the same court. On 14 July 2017, the Barcelona court lifted the interim injunction. AstraZeneca will appeal. The main infringement proceedings are ongoing.
 
Pulmicort Respules (budesonide inhalation suspension)
US patent proceedings
As previously disclosed, in the US, in February 2015, the US District Court for the District of New Jersey (the District Court) determined that the asserted claims of US Patent No. 7,524,834 were invalid and denied AstraZeneca's motion for an injunction against Apotex, Inc. and Apotex Corp., Breath Limited, Sandoz, Inc. and Watson Laboratories, Inc. (together, the Generic Challengers) pending an appeal of the District Court's decision. AstraZeneca appealed that decision to the US Court of Appeals for the Federal Circuit (the Court of Appeals) and filed an Emergency Motion for an Injunction Pending Appeal. The Court of Appeals granted AstraZeneca's motion and issued an injunction against the Generic Challengers pending appeal. In May 2015, the Court of Appeals affirmed the District Court's decision and lifted the injunction that was issued. Since 2009, various injunctions were issued in this matter. Damages claims based on those injunctions have been filed and a provision has been taken.
 
Nexium (esomeprazole magnesium)
Patent proceedings outside the US
As previously disclosed, in Canada, in July 2014, the Federal Court found the Nexium substance patent (Canadian Patent No. 2,139,653 (the '653 Patent)) invalid and not infringed by Apotex Inc. In July 2015, AstraZeneca's appeal was dismissed. AstraZeneca was granted leave to appeal to the Supreme Court of Canada (the Supreme Court) and a hearing was held in November 2016. In June 2017, the Supreme Court granted AstraZeneca's appeal and found the '653 Patent valid. AstraZeneca is considering its next steps.
 
Synagis (palivizumab)
US patent proceedings
As previously disclosed, in March 2017, MedImmune LLC was served with a complaint filed by UCB BioPharma SPRL in the US District Court for the District of Delaware (the District Court) alleging that Synagis infringed US Patent No. 7,566,771. In May 2017, the District Court granted the parties' joint stipulation to voluntarily terminate the litigation.
 
Product liability litigation
 
Bydureon/Byetta (exenatide)
As previously disclosed, Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are among multiple defendants in various lawsuits filed in federal and state courts in the US involving claims of physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege several types of injuries including pancreatitis, pancreatic cancer, thyroid cancer, and kidney cancer. A multi-district litigation has been established in the US District Court for the Southern District of California (the District Court) in regard to the alleged pancreatic cancer cases in federal courts. Further, a coordinated proceeding has been established in Los Angeles, California in regard to the various lawsuits in California state courts.
 
In November 2015, the District Court granted the defendants' motion for summary judgment and dismissed all claims alleging pancreatic cancer that accrued prior to 11 September 2015. A similar motion was granted in favour of the defendants in the California state coordinated proceeding, and judgment was entered in May 2016. The plaintiffs have appealed both rulings, and oral argument before the US Court of Appeals for the Ninth Circuit is scheduled for October 2017.
 
Nexium (esomeprazole) and Prilosec (omeprazole)
As previously disclosed, in the US, AstraZeneca is defending various lawsuits involving multiple plaintiffs claiming that they have been diagnosed with kidney injuries following treatment with proton pump inhibitors, including Nexium and Prilosec. In February 2017, the Judicial Panel on Multidistrict Litigation (JPML) denied a motion brought by counsel for some of these plaintiffs seeking to transfer any currently pending federal court cases as well as any similar, subsequently filed cases to a coordinated and consolidated pre-trial multidistrict litigation (MDL) proceeding. In May 2017, counsel for a different group of plaintiffs filed a new motion with the JPML seeking the transfer of any currently pending federal court cases as well as any similar, subsequently filed cases to a coordinated and consolidated pre-trial MDL proceeding.
 
Commercial litigation
 
Amplimmune
In the US, in June 2017, AstraZeneca was served with a lawsuit filed by the stockholders' agents for Amplimmune, Inc. (Amplimmune) in Delaware State Court that alleges, among other things, breaches of contractual obligations relating to a 2013 merger agreement between AstraZeneca and Amplimmune.
 
Government investigations/proceedings
 
Synagis (palivizumab)
Qui tam litigation in New York
In June 2017, AstraZeneca was served with a lawsuit in US Federal Court in New York by a Relator under the qui tam (whistleblower) provisions of the federal and certain state False Claims Acts. The lawsuit was originally filed under seal in April 2009 and alleges that MedImmune made false claims about Synagis. As previously disclosed, in March 2017, the Office of the Attorney General for the State of New York had filed a Complaint in Intervention in this matter.
 
Seroquel IR (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)
Texas Attorney General litigation
As previously disclosed, in the US, in October 2014, following a previously disclosed investigation by the State of Texas (the State) into AstraZeneca's sales and marketing activities involving Seroquel, the Texas Attorney General's Office intervened in a State whistleblower action pending in Travis County Court, Texas (the County Court). The lawsuit alleges that AstraZeneca engaged in inappropriate promotion of Seroquel and made improper payments intended to influence the formulary status of Seroquel. The relief that the State seeks to recover from AstraZeneca includes trebled civil remedies, penalties, interest, and attorneys' fees pursuant to the Texas Medicaid Fraud Prevention Act and damages pursuant to Texas common law. In June 2017, the Court entered an order denying all of the State's motions for summary judgment except for the State's motion on the defence of waiver, and denying AstraZeneca's motion for summary judgment. Trial is scheduled for October 2017.
 
 
6   SUBSEQUENT EVENTS
 
On 27 July 2017, the Company disclosed subsequent events separately. These disclosures should be read in conjunction with the Interim Financial Statements.
 
 
 
 
 
 
7 PRODUCT ANALYSIS - H1 2017
The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.
 
 
 
World
 
Emerging Markets
 
US
 
Europe
 
Established ROW
 
H1 2017
$m
 
Actual
%
CER
%
 
H1 2017
$m
 
Actual
%
CER%
 
H1 2017
$m
 
Actual
%
 
H1 2017
$m
 
Actual
%
CER
%
 
H1 2017
$m
 
Actual
%
CER
%
 Oncology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Tagrisso
403 
 
n/m 
n/m 
 
40 
 
n/m 
n/m 
 
180 
 
75 
 
76 
 
n/m 
n/m 
 
107 
 
n/m 
n/m 
 Iressa
261 
 
(3)
(3)
 
129 
 
(4)
(1)
 
17 
 
70 
 
54 
 
(11)
(11)
 
61 
 
(6)
(8)
 Lynparza
116 
 
18 
20 
 
5 
 
25 
75 
 
50 
 
(19)
 
58 
 
81 
81 
 
3 
 
n/m 
n/m 
 Imfinzi
1 
 
n/m 
n/m 
 
- 
 
- 
- 
 
1 
 
n/m 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
462 
 
15 
16 
 
54 
 
15 
9 
 
241 
 
14 
 
133 
 
18 
22 
 
34 
 
13 
13 
 Zoladex
363 
 
(5)
(4)
 
168 
 
10 
11 
 
14 
 
(26)
 
67 
 
(16)
(11)
 
114 
 
(12)
(14)
 Casodex
110 
 
(12)
(10)
 
56 
 
4 
9 
 
- 
 
n/m
 
11 
 
(15)
(15)
 
43 
 
(23)
(23)
 Arimidex
106 
 
(11)
(8)
 
57 
 
2 
7 
 
3 
 
(70)
 
17 
 
(6)
(6)
 
29 
 
(17)
(17)
 Others
56 
 
17 
17 
 
13 
 
- 
- 
 
- 
 
- 
 
3 
 
- 
- 
 
40 
 
25 
25 
 Total Oncology
1,878 
 
18 
20 
 
522 
 
13 
15 
 
506 
 
21 
 
419 
 
21 
25 
 
431 
 
19 
18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CVMD
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Brilinta
496 
 
26 
28 
 
121 
 
33 
36 
 
215 
 
35 
 
135 
 
8 
13 
 
25 
 
25 
25 
 Farxiga
457 
 
22 
22 
 
100 
 
89 
83 
 
206 
 
(1)
 
105 
 
18 
24 
 
46 
 
84 
84 
 Onglyza
304 
 
(24)
(24)
 
63 
 
(21)
(21)
 
159 
 
(25)
 
52 
 
(29)
(27)
 
30 
 
(19)
(19)
 Bydureon
299 
 
3 
3 
 
5 
 
n/m 
n/m 
 
243 
 
4 
 
42 
 
(16)
(14)
 
9 
 
80 
80 
 Byetta
89 
 
(36)
(35)
 
5 
 
(64)
(64)
 
58 
 
(35)
 
18 
 
(28)
(24)
 
8 
 
(20)
(20)
 Symlin
25 
 
56 
56 
 
- 
 
- 
- 
 
25 
 
56 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
1,191 
 
(43)
(42)
 
389 
 
10 
14 
 
153 
 
(85)
 
362 
 
(17)
(15)
 
287 
 
- 
(1)
 Seloken/Toprol-XL
367 
 
(2)
1 
 
289 
 
6 
10 
 
30 
 
(43)
 
42 
 
(5)
(2)
 
6 
 
20 
20 
 Atacand
147 
 
(9)
(7)
 
85 
 
5 
7 
 
12 
 
(43)
 
42 
 
(14)
(12)
 
8 
 
(20)
(20)
 Others
179 
 
(20)
(17)
 
110 
 
(19)
(13)
 
- 
 
- 
 
49 
 
(23)
(23)
 
20 
 
(20)
(20)
 Total CVMD
3,554 
 
(20)
(19)
 
1,167 
 
8 
11 
 
1,101 
 
(45)
 
847 
 
(11)
(9)
 
439 
 
4 
3 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Respiratory
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
1,383 
 
(11)
(10)
 
213 
 
2 
4 
 
554 
 
(19)
 
399 
 
(14)
(10)
 
217 
 
11 
9 
 Pulmicort
563 
 
3 
7 
 
396 
 
13 
19 
 
78 
 
(26)
 
48 
 
(11)
(9)
 
41 
 
3 
3 
 Daliresp/Daxas
92 
 
30 
30 
 
3 
 
n/m 
n/m 
 
79 
 
20 
 
9 
 
n/m 
n/m 
 
1 
 
n/m 
n/m 
 Tudorza/Eklira
71 
 
(18)
(16)
 
- 
 
n/m 
n/m 
 
29 
 
(29)
 
38 
 
(7)
(5)
 
4 
 
- 
- 
 Duaklir
35 
 
17 
23 
 
- 
 
n/m 
n/m 
 
- 
 
- 
 
34 
 
21 
29 
 
1 
 
- 
- 
 Bevespi
4 
 
n/m 
n/m 
 
- 
 
- 
- 
 
4 
 
n/m 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Others
132 
 
(8)
(6)
 
47 
 
(34)
(30)
 
2 
 
(71)
 
61 
 
22 
24 
 
22 
 
38 
38 
 Total Respiratory
2,280 
 
(6)
(4)
 
659 
 
4 
9 
 
746 
 
(17)
 
589 
 
(8)
(5)
 
286 
 
11 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
1,056 
 
3 
4 
 
344 
 
(6)
(2)
 
339 
 
15 
 
120 
 
(6)
(3)
 
253 
 
7 
5
 Synagis
300 
 
11
11 
 
- 
 
- 
- 
 
167 
 
2 
 
133 
 
23 
23 
 
- 
 
- 
- 
 Losec/Prilosec
136 
 
(6)
(3)
 
70 
 
(3)
1 
 
8 
 
60 
 
38 
 
(7)
(5)
 
20 
 
(26)
(26)
 Seroquel XR
162 
 
(62)
(62)
 
32 
 
(9)
(6)
 
77 
 
(75)
 
43 
 
(43)
(43)
 
10 
 
- 
-
 Movantik/Moventig
62 
 
55 
55 
 
- 
 
- 
- 
 
62 
 
55 
 
- 
 
- 
- 
 
- 
 
- 
- 
 FluMist/Fluenz
- 
 
n/m
n/m
 
- 
 
- 
- 
 
- 
 
n/m
 
- 
 
- 
- 
 
- 
 
- 
- 
 Others
355 
 
(44)
(44)
 
210 
 
(20)
(24)
 
7 
 
(91) 
 
83 
 
(52)
(44)
 
55 
 
(57)
(60)
 Total Other
2,071 
 
(19)
(18)
 
656 
 
(11)
(10)
 
660 
 
(26)
 
417 
 
(20)
(17)
 
338 
 
(16)
(18)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TOTAL PRODUCT SALES
9,783 
 
(11)
(10)
 
3,004 
 
3 
6 
 
3,013 
 
(28)
 
2,272 
 
(8)
(5)
 
1,494 
 
3 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 PRODUCT ANALYSIS - Q2 2017 (Unreviewed*)
The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth.
 
 
 
World
 
Emerging Markets
 
US
 
Europe
 
Established ROW
 
Q2 2017
$m
 
Actual
%
CER
%
 
Q2 2017
$m
 
Actual
%
CER%
 
Q2 2017
$m
 
Actual
%
 
Q2 2017
$m
 
Actual
%
CER
%
 
Q2 2017
$m
 
Actual
%
CER
%
 Oncology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Tagrisso
232 
 
n/m 
n/m 
 
34 
 
n/m 
n/m 
 
90 
 
55 
 
41 
 
n/m 
n/m 
 
67 
 
n/m 
n/m 
 Iressa
137 
 
1 
2 
 
68 
 
1 
4 
 
9 
 
50 
 
28 
 
4 
4 
 
32 
 
(9)
(11)
 Lynparza
59 
 
9 
11 
 
1 
 
(50)
- 
 
23 
 
(32)
 
33 
 
83 
83 
 
2 
 
n/m 
n/m 
 Imfinzi
1 
 
n/m 
n/m 
 
- 
 
- 
- 
 
1 
 
n/m 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
248 
 
18 
18 
 
27 
 
4 
(4)
 
123 
 
10 
 
79 
 
39
46
 
19 
 
19 
19 
 Zoladex
178 
 
(13)
(12)
 
81 
 
(6)
(5)
 
6 
 
(33)
 
35 
 
(15)
(10)
 
56 
 
(18)
(19)
 Casodex
54 
 
(14)
(11)
 
26 
 
4 
12 
 
- 
 
n/m
 
5 
 
(17)
(17)
 
23 
 
(23)
(23)
 Arimidex
54 
 
(13)
(10)
 
28 
 
4 
11 
 
2 
 
(67)
 
9 
 
(10)
(10)
 
15 
 
(21)
(21)
 Others
30 
 
11 
11 
 
6 
 
- 
- 
 
- 
 
- 
 
2 
 
- 
- 
 
22 
 
16 
16 
 Total Oncology
993 
 
17 
19 
 
271 
 
13 
15 
 
254 
 
12 
 
232 
 
30 
35 
 
236 
 
17 
16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CVMD
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Brilinta
272 
 
27 
29 
 
61 
 
22 
22 
 
128 
 
44 
 
70 
 
8 
14 
 
13 
 
30 
30 
 Farxiga
250 
 
18 
20 
 
58 
 
81 
78 
 
110 
 
(4) 
 
55 
 
15 
23 
 
27 
 
69 
69 
 Onglyza
150 
 
(21)
(21)
 
33 
 
(25)
(25)
 
78 
 
(11)
 
25 
 
(38)
(35)
 
14 
 
(26)
(26)
 Bydureon
146 
 
(6)
(6)
 
4 
 
n/m 
n/m 
 
116 
 
(8)
 
20 
 
(26)
(22)
 
6 
 
n/m 
n/m 
 Byetta
43 
 
(43)
(43)
 
- 
 
n/m 
n/m 
 
28 
 
(40)
 
10 
 
(33)
(27)
 
5 
 
- 
- 
 Symlin
11 
 
- 
- 
 
- 
 
- 
- 
 
11 
 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
560 
 
(40)
(38)
 
187 
 
9 
13 
 
41 
 
(89)
 
167 
 
(26)
(24)
 
165 
 
2 
2 
 Seloken/Toprol-XL
181 
 
(4)
(1)
 
137 
 
4 
8 
 
19 
 
(41)
 
21 
 
(5)
- 
 
4 
 
33 
33 
 Atacand
72 
 
(19)
(18)
 
41 
 
(11)
(11)
 
6 
 
(50)
 
21 
 
(16)
(12)
 
4 
 
(33)
(33)
 Others
90 
 
(13)
(9)
 
52 
 
(4)
6 
 
- 
 
- 
 
26 
 
(24)
(24)
 
12 
 
(25)
(25)
 Total CVMD
1,775 
 
(18)
(17)
 
573 
 
7 
9 
 
537 
 
(40)
 
415 
 
(17)
(14)
 
250 
 
5 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Respiratory
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
706 
 
(12)
(11)
 
101 
 
(3)
(2) 
 
299 
 
(17)
 
199 
 
(15)
(11)
 
107 
 
2 
3 
 Pulmicort
226 
 
(5)
(3)
 
146 
 
3 
8 
 
37 
 
(26)
 
22 
 
(12)
(12)
 
21 
 
(5)
(5)
 Daliresp/Daxas
48 
 
20 
20 
 
2 
 
n/m 
n/m 
 
41 
 
17 
 
4 
 
- 
- 
 
1 
 
n/m 
n/m 
 Tudorza/Eklira
34 
 
(29)
(27)
 
- 
 
n/m 
n/m 
 
14 
 
(42)
 
18 
 
(10)
(10)
 
2 
 
(33)
(33)
 Duaklir
16 
 
(6)
- 
 
- 
 
n/m 
n/m 
 
- 
 
- 
 
15 
 
(6)
6 
 
1 
 
- 
- 
 Bevespi
3 
 
n/m 
n/m 
 
- 
 
- 
- 
 
3 
 
n/m 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Others
66 
 
(18)
(15)
 
20 
 
(42)
(39)
 
- 
 
n/m 
 
33 
 
10 
13 
 
13 
 
- 
- 
 Total Respiratory
1,099 
 
(10)
(9)
 
269 
 
(5)
(1)
 
394 
 
(16)
 
291 
 
(12)
(8)
 
145 
 
1 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
595 
 
6 
7 
 
169 
 
(11)
(8)
 
203 
 
25 
 
59 
 
(12)
(9)
 
164 
 
15 
15 
 Synagis
70 
 
n/m 
n/m 
 
- 
 
- 
- 
 
10 
 
n/m 
 
60 
 
n/m 
n/m 
 
- 
 
- 
- 
 Losec/Prilosec
68 
 
(3)
- 
 
35 
 
6 
9
 
3 
 
- 
 
20 
 
- 
5 
 
10 
 
(29)
(29)
 Seroquel XR
95 
 
(58)
(58)
 
17 
 
- 
-
 
53 
 
(67)
 
21
 
(49)
(49)
 
4 
 
(20) 
(20)
 Movantik/Moventig
32 
 
39 
39 
 
- 
 
- 
- 
 
32 
 
39 
 
- 
 
- 
- 
 
- 
 
- 
- 
 FluMist/Fluenz
- 
 
n/m
n/m
 
- 
 
- 
- 
 
- 
 
n/m
 
- 
 
- 
- 
 
- 
 
- 
- 
 Others
213 
 
(32)
(31)
 
108 
 
(27)
(24)
 
42 
 
n/m 
 
45 
 
(48)
(56)
 
18 
 
(71)
(65)
 Total Other
1,073 
 
(13)
(12)
 
329 
 
(15)
(12)
 
343 
 
(9)
 
205 
 
(14)
(16)
 
196 
 
(13)
(11)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TOTAL PRODUCT SALES
4,940 
 
(10)
(8)
 
1,442 
 
- 
2 
 
1,528 
 
(22)
 
1,143 
 
(8)
(6)
 
827 
 
2 
2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*The Q2 2017 information in respect of the three months ended 30 June 2017 included in the interim financial statements has not been reviewed by PricewaterhouseCoopers.
 
 
 
9 QUARTERLY PRODUCT SALES - 2017 (Unreviewed*)
The table below provides an analysis of sequential quarterly Product Sales with Actual and CER growth rates reflecting quarter-on-quarter growth.
 
 
 
Q1 2017
$m
 
Actual
%
CER
%
 
Q2 2017
$m
 
Actual
%
CER%
 
 Oncology
 
 
 
 
 
 
 
 
 
 
 Tagrisso
171 
 
16 
19 
 
232 
 
36 
34 
 
 Iressa
124 
 
5 
8 
 
137 
 
10 
9 
 
 Lynparza
57 
 
(8)
(6)
 
59 
 
4 
2 
 
 Imfinzi
- 
 
- 
- 
 
1 
 
n/m 
n/m 
 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 Faslodex
214 
 
(4)
(3)
 
248 
 
16 
15 
 
 Zoladex
185 
 
(21)
(12)
 
178 
 
(4)
(5)
 
 Casodex
56 
 
(7)
(2)
 
54 
 
(4)
(3)
 
 Arimidex
52 
 
(9)
(7)
 
54 
 
4 
4 
 
 Others
26 
 
(10)
(3)
 
30 
 
15 
7 
 
 Total Oncology
885 
 
(5)
- 
 
993 
 
12 
11 
 
 
 
 
 
 
 
 
 
 
 
 
 CVMD
 
 
 
 
 
 
 
 
 
 
 Brilinta
224 
 
(5)
(4)
 
272 
 
21 
20 
 
 Farxiga
207 
 
(13)
(13)
 
250 
 
21 
20 
 
 Onglyza
154 
 
3 
3 
 
150 
 
(3)
(3)
 
 Bydureon
153 
 
8 
8 
 
146 
 
(5)
(5)
 
 Byetta
46 
 
(16)
(16)
 
43 
 
(7)
(7)
 
 Symlin
14 
 
- 
- 
 
11 
 
(21)
(21)
 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 Crestor
631 
 
- 
3 
 
560 
 
(11)
(12)
 
 Seloken/Toprol-XL
186 
 
4 
6 
 
181 
 
(3)
(4)
 
 Atacand
75 
 
(7)
(6)
 
72 
 
(4)
(5)
 
 Others
89 
 
3 
12 
 
90 
 
1 
(3)
 
 Total CVMD
1,779 
 
(2)
- 
 
1,775 
 
- 
(1)
 
 
 
 
 
 
 
 
 
 
 
 
 Respiratory
 
 
 
 
 
 
 
 
 
 
 Symbicort
677 
 
(9)
(7)
 
706 
 
4 
3 
 
 Pulmicort
337 
 
17 
19 
 
226 
 
(33)
(33)
 
 Daliresp/Daxas
44 
 
7 
10 
 
48 
 
9 
9 
 
 Tudorza/Eklira
37 
 
3 
6 
 
34 
 
(8)
(8)
 
 Duaklir
19 
 
- 
- 
 
16 
 
(16)
(15)
 
 Bevespi
1 
 
(67)
(50)
 
3 
 
n/m 
n/m 
 
 Others
66 
 
(20)
(19)
 
66 
 
- 
(4)
 
 Total Respiratory
1,181 
 
(2)
(1)
 
1,099 
 
(7)
(8)
 
 
 
 
 
 
 
 
 
 
 
 
 Other
 
 
 
 
 
 
 
 
 
 
 Nexium
461 
 
(6)
(4)
 
595 
 
29 
28 
 
 Synagis
230 
 
(24)
(24)
 
70 
 
(70)
(70) 
 
 Losec/Prilosec
68 
 
15 
18 
 
68 
 
- 
(3)
 
 Seroquel XR
67 
 
(43)
(42)
 
95 
 
42 
38 
 
 Movantik/Moventig
30 
 
15 
15 
 
32 
 
7 
7 
 
 FluMist/Fluenz
- 
 
n/m
n/m
 
- 
 
- 
- 
 
 Others
142 
 
(42)
(41)
 
213 
 
50 
51 
 
 Total Other
998 
 
(24)
(22)
 
1,073 
 
8 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 TOTAL PRODUCT SALES
4,843 
 
(8)
(6)
 
4,940 
 
2 
1 
 
The Q2 2017 information in respect of the three months ended 30 June 2017 included in the interim financial statements has not been reviewed by PricewaterhouseCoopers.
 
10 QUARTERLY PRODUCT SALES - 2016
The table below provides an analysis of sequential quarterly Product Sales, with Actual and CER growth rates reflecting quarter-on-quarter growth.
 
 
Q1 2016
$m
 
Actual
%
CER
%
 
Q2 2016
$m
 
Actual
%
CER%
 
Q3 2016
$m
 
Actual
%
CER
%
 
Q4 2016
$m
 
Actual
%
CER
%
 Oncology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Tagrisso
51 
 
183 
200 
 
92 
 
80 
82 
 
133 
 
45 
44 
 
147 
 
11 
11 
 Iressa
135 
 
5 
5 
 
135 
 
- 
(2)
 
125 
 
(7)
(8)
 
118 
 
(6)
(4)
 Lynparza
44 
 
22 
22 
 
54 
 
23 
23 
 
58 
 
7 
7 
 
62 
 
7 
9 
 Imfinzi
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
190 
 
3 
3 
 
211 
 
11 
9 
 
207 
 
(2)
(2)
 
222 
 
7 
9 
 Zoladex
178 
 
(10)
(8)
 
204 
 
15 
8 
 
199 
 
(2)
(2)
 
235 
 
18 
11 
 Casodex
62 
 
(2)
(6)
 
63 
 
2 
- 
 
62 
 
(2)
(5)
 
60 
 
(3)
(2)
 Arimidex
57 
 
(5)
(5)
 
62 
 
9 
7 
 
56 
 
(10)
(13)
 
57 
 
2 
5 
 Others
21 
 
(22)
(22)
 
27 
 
29 
12 
 
27 
 
- 
4 
 
29 
 
7 
- 
 Total Oncology
738 
 
3 
3 
 
848 
 
15 
12 
 
867 
 
2 
2 
 
930 
 
7 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CVMD
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Brilinta
181 
 
4 
5 
 
214 
 
18 
16 
 
208 
 
(3)
(2)
 
236 
 
13 
15 
 Farxiga
165 
 
9 
10 
 
211 
 
28 
26 
 
220 
 
4 
4 
 
239 
 
9 
9 
 Onglyza
211 
 
10 
12 
 
191 
 
(9)
(11)
 
169 
 
(12)
(11)
 
149 
 
(12)
(11)
 Bydureon
135 
 
(13)
(16)
 
156 
 
16 
14 
 
145 
 
(7)
(6)
 
142 
 
(2)
(1)
 Byetta
62 
 
(14)
(14)
 
76 
 
23 
21 
 
61 
 
(20)
(19)
 
55 
 
(10)
(10)
 Symlin
5 
 
(64)
(64)
 
10 
 
n/m 
n/m 
 
11 
 
10 
10 
 
14 
 
27 
27 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
1,156 
 
(13)
(13)
 
926 
 
(20)
(21)
 
688 
 
(26)
(26)
 
631 
 
(8)
(7)
 Seloken/Toprol-XL
185 
 
16 
11 
 
189 
 
2 
- 
 
185 
 
(2)
(2)
 
178 
 
(4)
(2) 
 Atacand
71 
 
(17)
(15)
 
89 
 
25 
22 
 
74 
 
(17)
(19)
 
81 
 
9 
14 
 Others
121 
 
(9)
(16)
 
106 
 
(12)
(11)
 
84 
 
(21)
(19)
 
86 
 
2 
- 
 Total CVMD
2,292 
 
(7)
(7)
 
2,168 
 
(5)
(7)
 
1,845 
 
(15)
(15)
 
1,811 
 
(2)
(1)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Respiratory
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
749 
 
(13)
(12)
 
803 
 
7 
6 
 
697 
 
(13)
(13)
 
740 
 
6 
8 
 Pulmicort
310 
 
13 
14 
 
239 
 
(23)
(23)
 
224 
 
(6)
(6)
 
288 
 
29 
31 
 Daliresp/Daxas
31 
 
(3)
(3)
 
40 
 
29 
29 
 
42 
 
5 
5 
 
41 
 
(2)
(2)
 Tudorza/Eklira
39 
 
(17)
(17)
 
48 
 
23 
21 
 
47 
 
(2)
- 
 
36 
 
(23)
(23)
 Duaklir
13 
 
8 
8 
 
17 
 
31 
31 
 
14 
 
(18)
(18)
 
19 
 
36 
43 
 Bevespi
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 
3 
 
n/m 
n/m 
 Others
65 
 
- 
(3)
 
79 
 
22 
18 
 
86 
 
9 
12 
 
83 
 
(3) 
1 
 Total Respiratory
1,207 
 
(6)
(6)
 
1,226 
 
2 
1 
 
1,110 
 
(9)
(9)
 
1,210 
 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
463 
 
(18)
(18)
 
562 
 
21
20 
 
516 
 
(8)
(9)
 
491 
 
(5)
(4)
 Synagis
244 
 
(11)
(11)
 
27 
 
(89)
(89)
 
104 
 
n/m 
n/m 
 
302 
 
n/m 
n/m 
 Losec/Prilosec
75 
 
(3)
(4)
 
70 
 
(7)
(9)
 
72 
 
3 
4 
 
59 
 
(18)
(17)
 Seroquel XR
202 
 
(16)
(16)
 
225 
 
11 
11 
 
190 
 
(16)
(16)
 
118 
 
(38)
(37)
 Movantik/Moventig
17 
 
13 
13 
 
23 
 
35 
35 
 
25 
 
9 
9 
 
26 
 
4 
4 
 FluMist/Fluenz
5 
 
(97)
(97)
 
6 
 
20 
20 
 
26 
 
n/m 
n/m 
 
67 
 
n/m 
n/m 
 Others
322 
 
(15)
(7)
 
314 
 
(2)
(4)
 
270 
 
(14)
(16)
 
246 
 
(9)
(8)
 Total Other
1,328 
 
(24)
(22)
 
1,227 
 
(8)
(9)
 
1,203 
 
(2)
(3)
 
1,309 
 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TOTAL PRODUCT SALES
5,565 
 
(10)
(10)
 
5,469 
 
(2)
(3)
 
5,025 
 
(8)
(8)
 
5,260 
 
5 
6 
 
11 QUARTERLY PRODUCT SALES - 2015
The table below provides an analysis of sequential quarterly Product Sales, with Actual and CER growth rates reflecting quarter-on-quarter growth.
 
 
 
Q1 2015
$m
 
Actual
%
CER
%
 
Q2 2015
$m
 
Actual
%
CER%
 
Q3 2015
$m
 
Actual
%
CER
%
 
Q4 2015
$m
 
Actual
%
CER
%
 Oncology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Tagrisso
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 
18 
 
n/m 
n/m 
 Iressa
144 
 
(4) 
- 
 
129 
 
(10)
(8)
 
141 
 
9 
10 
 
129 
 
(9)
(7)
 Lynparza
9 
 
n/m 
n/m 
 
21 
 
133 
133 
 
28 
 
33 
33 
 
36 
 
29 
29 
 Imfinzi
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
161 
 
(12)
(6)
 
172 
 
7 
8 
 
186 
 
8 
8 
 
185 
 
(1)
1 
 Zoladex
194 
 
(15)
(9)
 
215 
 
11 
11 
 
209 
 
(3)
- 
 
198 
 
(5)
(2)
 Casodex
70 
 
(5)
1 
 
69 
 
(1)
- 
 
65 
 
(6)
(4)
 
63 
 
(3)
(1)
 Arimidex
62 
 
(9)
(5)
 
64 
 
3 
7 
 
64 
 
- 
- 
 
60 
 
(6)
(5)
 Others
34 
 
(13)
(10)
 
37 
 
9 
9 
 
35 
 
(5)
- 
 
27 
 
(23)
(16)
 Total Oncology
674 
 
(9)
(4)
 
707 
 
5 
6 
 
728 
 
3 
5 
 
716 
 
(2)
- 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CVMD
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Brilinta
131 
 
(2)
3 
 
144 
 
10 
13 
 
170 
 
18 
19 
 
174 
 
2 
4 
 Farxiga
76 
 
(19)
(18)
 
129 
 
70 
75 
 
135 
 
5 
5 
 
152 
 
13 
14 
 Onglyza
183 
 
(9)
(5)
 
208 
 
14 
15 
 
203 
 
(2)
(2)
 
192 
 
(5)
(5)
 Bydureon
123 
 
- 
8 
 
140 
 
14 
11 
 
162 
 
16 
13 
 
155 
 
(4)
(1)
 Byetta
90 
 
30 
35 
 
82 
 
(9)
(9)
 
72 
 
(12)
(12)
 
72 
 
- 
1 
 Symlin
16 
 
60 
60 
 
13 
 
(19)
(19)
 
5 
 
(62)
(62)
 
14 
 
n/m 
n/m 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
1,167 
 
(16)
(13)
 
1,310 
 
12 
14 
 
1,218 
 
(7)
(7)
 
1,322 
 
9 
9 
 Seloken/Toprol-XL
194 
 
11 
22 
 
184 
 
(5)
(4)
 
172 
 
(7)
(3)
 
160 
 
(7)
- 
 Atacand
95 
 
(19)
(11)
 
99 
 
4 
9 
 
78 
 
(21)
(19)
 
86 
 
10 
13 
 Others
155 
 
(7)
7 
 
143 
 
(8)
(7)
 
132 
 
(8)
(7)
 
133 
 
1 
4 
 Total CVMD
2,230 
 
(10)
(6)
 
2,452 
 
10 
12 
 
2,347 
 
(4)
(4)
 
2,460 
 
5 
7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Respiratory
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
845 
 
(14)
(9)
 
842 
 
- 
2 
 
848 
 
1 
1 
 
859 
 
1 
3 
 Pulmicort
286 
 
6 
11 
 
232 
 
(19)
(17)
 
222 
 
(4)
(6)
 
274 
 
23 
26 
 Daliresp/Daxas
7 
 
n/m 
n/m 
 
32 
 
n/m 
n/m 
 
33 
 
3 
3 
 
32 
 
(3)
(3)
 Tudorza/Eklira
30 
 
n/m 
n/m 
 
55 
 
83 
90 
 
58 
 
5 
5 
 
47 
 
(19)
(19)
 Duaklir
2 
 
n/m 
n/m 
 
5 
 
n/m 
n/m 
 
8 
 
60 
60 
 
12 
 
50 
50 
 Bevespi
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 
- 
 
- 
- 
 Others
73 
 
(4)
12 
 
59 
 
(19)
(20)
 
61 
 
3 
3 
 
65 
 
7 
11 
 Total Respiratory
1,243 
 
(7)
(2)
 
1,225 
 
(1)
1 
 
1,230 
 
- 
- 
 
1,289 
 
5 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Other
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
644 
 
(23)
(20)
 
647 
 
- 
3 
 
641 
 
(1)
(2)
 
564 
 
(12)
(10)
 Synagis
204 
 
(50)
(50)
 
66 
 
(68)
(68)
 
117 
 
77 
77 
 
275 
 
135 
135 
 Losec/Prilosec
96 
 
(13)
(8)
 
85 
 
(11)
(9)
 
82 
 
(4)
(5)
 
77 
 
(6)
(2)
 Seroquel XR
262 
 
(15)
(13)
 
264 
 
1 
4 
 
258 
 
(2)
(2)
 
241 
 
(7)
(6)
 Movantik/Moventig
3 
 
n/m 
n/m 
 
1 
 
(67)
(67)
 
10 
 
n/m 
n/m 
 
15 
 
50 
50 
 FluMist/Fluenz
7 
 
(95)
(94)
 
14 
 
n/m
n/m 
 
76 
 
n/m 
n/m 
 
191 
 
n/m 
n/m 
 Others
385 
 
12 
16 
 
375 
 
(3)
1 
 
361 
 
(4)
2 
 
379 
 
5 
2 
 Total Other
1,601 
 
(25)
(24)
 
1,452 
 
(9)
(7)
 
1,545 
 
6 
8 
 
1,742 
 
13 
13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 TOTAL PRODUCT SALES
5,748 
 
(14)
(10)
 
5,836 
 
2 
3 
 
5,850 
 
- 
1 
 
6,207 
 
6 
7 
 
Shareholder Information
 
 
Announcement of nine months and third quarter 2017 results
9 November 2017
 
 
 
Future dividends will normally be paid as follows:
 
First interim
Announced with half-year and second-quarter results and paid in September
Second interim
Announced with full-year and fourth-quarter results and paid in March
 
 
 
 
 
The record date for the first interim dividend for 2017, payable on 11 September 2017, will be 11 August 2017. Ordinary Shares listed in London and Stockholm will trade ex-dividend from 10 August 2017. American Depositary Shares listed in New York will trade ex-dividend from 9 August 2017.
 
 
 
 
Trademarks of the AstraZeneca group of companies and of companies other than AstraZeneca appear throughout this document in italics. AstraZeneca, the AstraZeneca logotype and the AstraZeneca symbol are all trademarks of the AstraZeneca group of companies. Trademarks of companies other than AstraZeneca that appear in this document include Anticalin, a trademark of Pieris AG; Duaklir Genuair, Duaklir, Eklira, and Tudorza, trademarks of Almirall, S.A.; Toprol-XL, a trademark of Aralez Pharmaceuticals Inc. or AstraZeneca (depending on geography); Epanova, a trademark of Chrysalis Pharma AG.; Synagis, owned by AstraZeneca or AbbVie Inc. (depending on geography); Kyntheum and Siliq, owned by Leo Pharma A/S or Valeant Pharmaceuticals Luxembourg S.á.r.l. (depending on geography); and Zavicefta, a trademark of Pfizer Inc.; and Zomig, a trademark of Grünenthal GmbH.
 
 
Addresses for Correspondence
Registered Office
1 Francis Crick Avenue
Cambridge Biomedical Campus, Cambridge
CB2 0AA
UK
 
 
Registrar and
Transfer Office
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
Swedish Central Securities Depository
Euroclear Sweden AB
PO Box 191
SE-101 23 Stockholm
Sweden
 
 
US Depositary
Citibank Shareholder Services
PO Box 43077
Providence
RI 02940-3077
USA
 
Tel: +44 (0)20 3749 5000
Tel (freephone in UK):
0800 389 1580
 
Tel (outside UK):+44 (0)121 415 7033
Tel: +46 (0)8 402 9000
Tel: (toll free in the US)
+1 (888) 697 8018
 
Tel: (outside the US)
+1 (781) 575 4555
 
citibank@shareholders-online.com
 
Cautionary Statements Regarding Forward-Looking Statements
_______________________________________________________________________________________
 
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement:
 
This document contains certain forward-looking statements with respect to the operations, performance and financial condition of the Group, including, among other things, statements about expected revenues, margins, earnings per share or other financial or other measures. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of preparation of this document and AstraZeneca undertakes no obligation to update these forward-looking statements. We identify the forward-looking statements by using the words 'anticipates', 'believes', 'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things: the loss or expiration of, or limitations to, patents, marketing exclusivity or trademarks, or the risk of failure to obtain and enforce patent protection; effects of patent litigation in respect of IP rights; the impact of any delays in the manufacturing, distribution and sale of any of our products; the impact of any failure by third parties to supply materials or services; the risk of failure of outsourcing; the risks associated with manufacturing biologics; the risk that R&D will not yield new products that achieve commercial success; the risk of delay to new product launches; the risk that new products do not perform as we expect; the risk that strategic alliances and acquisitions, including licensing and collaborations, will be unsuccessful; the risks from pressures resulting from generic competition; the impact of competition, price controls and price reductions; the risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the difficulties of obtaining and maintaining regulatory approvals for products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; the risk of failure of critical processes affecting business continuity; economic, regulatory and political pressures to limit or reduce the cost of our products; failure to achieve strategic priorities or to meet targets or expectations; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; the risk of substantial product liability claims; the risk of failure to adhere to applicable laws, rules and regulations; the risk of failure to adhere to applicable laws, rules and regulations relating to anti-competitive behaviour; the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; taxation risks; exchange rate fluctuations; the risk of an adverse impact of a sustained economic downturn; political and socio-economic conditions; the risk of environmental liabilities; the risk of occupational health and safety liabilities; the risk associated with pensions liabilities; the impact of failing to attract and retain key personnel and to successfully engage with our employees; the risk of misuse of social medial platforms and new technology; and the risk of failure of information technology and cybercrime. Nothing in this presentation / webcast should be construed as a profit forecast.
 
 
SIGNATURES
 
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
 
AstraZeneca PLC
 
Date: 27 July 2017
By:  /s/ Adrian Kemp
 
Name: Adrian Kemp
 
Title: Company Secretary