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 2016
 
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
28 July 2016 07:00
This announcement contains inside information.
 
H1 2016 Results
Financial Summary
 
 
 
 
 
 
 
 
 
H1 2016
 
Q2 2016
 
$m
% change
$m 
% change
 
CER1
Actual
CER1
Actual
Total Revenue
11,718
(3)
(5)
5,603
(10)
(11)
Product Sales
11,034
(2)
(5)
5,469
(5)
(6)
Externalisation Revenue
684
(12)
(12)
134
(72)
(72)
 
 
 
 
 
 
 
Reported Operating Profit
1,341
(24)
(28)
303
(64)
(67)
Core Operating Profit2
2,999
(14)
(17)
1,406
(21)
(22)
 
 
 
 
 
 
 
Reported Earnings Per Share (EPS)
$0.51
(45)
(48)
$0.00
(99)
(100)
Core EPS
$1.78
(20)
(22)
$0.83
(31)
(31)
 
 
 
 
●       Total Revenue down by 3% as expected, reflecting a 2% decline in Product Sales that was driven by patent expiries, in particular Crestor in the US. The phasing of Externalisation Revenue is towards H2 2016
●       Reported and Core R&D costs increased by 6% and 9% respectively;   Reported SG&A costs were stable, with Core SG&A costs declining by 5%, supporting full-year commitments
●       Reported EPS declined 45%, negatively impacted by restructuring charges related to the recently-announced cost reduction programme. Core EPS declined 20%, reflecting the phasing of Externalisation Revenue to the second half of the year
●       An unchanged first interim dividend per share of $0.90
●       FY 2016 guidance unchanged
 
Commercial Highlights
 
The Growth Platforms grew by 7% in the half. Of the six platforms, the performance included:
●    Emerging Markets: +7%. Encouraging China growth of 11%
●    Diabetes: +18%. A good performance underpinned by the success of Farxiga 
●    Respiratory: +1%. Strong Emerging Markets sales of Symbicort, pricing compression in the US and Europe
●    New Oncology: Sales of $251m reflected the successful ongoing launch of Tagrisso 
 
Achieving Scientific Leadership: Progress since the last results announcement
 
Regulatory Approvals / Conditional Marketing Authorisation*
- Qtern (saxagliptin/dapagliflozin) - type-2 diabetes (EU)
- Zavicefta (previously CAZ AVI) - serious infections (EU)
- Pandemic Live Attenuated Influenza Vaccine - pandemic influenza (EU)*
Regulatory Submission Acceptances
- saxagliptin/dapagliflozin, resubmission (US)
 
Positive Phase III Data Readouts
- benralizumab - severe asthma
- Faslodex - breast cancer (1st line)
- Tagrisso - lung cancer (2nd line)
Other Key Developments
- Orphan Drug Designation: selumetinib - thyroid cancer (US)
- Fast Track Designation: Lynparza - ovarian cancer (2nd line) (US)
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our performance in the first half was in line with expectations, reflecting the anticipated near-term patent expiry challenges and the phasing of Externalisation Revenue in 2016. Our Growth Platforms continued to advance and made up over 60% of Total Revenue. Importantly, our transformed pipeline is advancing quickly and delivering a rich flow of differentiated medicines, boding well for our return to growth.
 
Alongside positive results for our first potential Respiratory biologic medicine, benralizumab, and for Tagrisso in second-line lung cancer, we are encouraged by the rapid patient recruitment in our Immuno-Oncology durva/treme combination programmes. This strong scientific momentum is set to continue, in particular where we anticipate key Immuno-Oncology data."
 
 
FY 2016 Guidance
Guidance for FY 2016 is unchanged and is shown at CER1.
 
Total Revenue
A low to mid single-digit percentage decline
Core EPS
A low to mid single-digit percentage decline
 
The above guidance incorporates the dilutive effects arising from the Acerta Pharma B.V. (Acerta Pharma) and ZS Pharma, Inc. (ZS Pharma) transactions announced in FY 2015.
 
Externalisation Revenue is expected to be ahead of that in FY 2015, including an element of recurring income arising from prior agreements. This is in line with the Company's long-term business model, which includes externalisation as part of the portfolio-management strategy.
 
Externalisation activities, a result of increasing R&D productivity and the focus on three therapy areas, relate to specific risk and reward-sharing strategic collaborations. They broaden, accelerate and maximise the development and commercialisation potential for a number of the Company's medicines. Initial and milestone revenue, together with sales-related revenue, is included in the Company's financial statements as Externalisation Revenue. Receipts will be defined as Externalisation Revenue where AstraZeneca retains a significant ongoing interest in the potential or on-market medicine.
 
Core R&D costs are expected to be at a similar level to FY 2015. The Company is committed to materially reducing Core SG&A costs in FY 2016 versus the prior year. These measures are based on constant exchange rates.
 
The Company presents Core EPS guidance. 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.
 
FY 2016 Currency Impact
Based on average exchange rates in the first half and the Company's published currency sensitivities, there is now expected to be only a minimal adverse impact from currency movements on Total Revenue in FY 2016. Core EPS is now expected to benefit from currency movements by a low to mid single-digit percentage versus the prior year. Further details on currency sensitivities are contained within the Operating and Financial Review.
 
Pipeline: Forthcoming Major Newsflow
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 for the pipeline.
 
H2 2016
 
benralizumab - severe asthma: Regulatory submission (US, EU)
brodalumab - psoriasis: Regulatory decision (US)
 
Brilinta - peripheral arterial disease (PAD): Data readout
ZS-9 - hyperkalaemia: Regulatory re-submission (US)
roxadustat - anaemia: Rolling regulatory submission (CN)
 
Lynparza - breast cancer: Data readout
Lynparza - ovarian cancer (2nd line): Data readout
Tagrisso - lung cancer: Regulatory submission (CN)
cediranib - ovarian cancer: Regulatory decision (EU)selumetinib - lung cancer: Data readout
durvalumab - head and neck cancer (HAWK): Data readout (Phase II)*
acalabrutinib - blood cancer: Data readout, regulatory submission (US) (Phase II)*
 
H1 2017
 
brodalumab: Regulatory decision (EU)
 
Brilinta - PAD: Regulatory submission
saxagliptin/dapagliflozin - type-2 diabetes: Regulatory decision (US)
ZS-9 - hyperkalaemia: Regulatory decision (EU)
 
Lynparza - breast cancer: Regulatory submission
Lynparza - ovarian cancer (2nd line): Regulatory submission
selumetinib - lung cancer: Regulatory submission
durvalumab - head and neck cancer (HAWK): Regulatory submission (US) (Phase II)*
durva + treme - head and neck cancer (CONDOR): Data readout, regulatory submission (US) (Phase II)*
durva + treme - lung cancer (MYSTIC): Data readout
durva + treme - lung cancer (ARCTIC): Data readout
 
H2 2017
 
tralokinumab - severe asthma: Data readout
 
roxadustat - anaemia: Data readout (AstraZeneca-sponsored trial)
 
Lynparza - ovarian cancer (1st line): Data readout, regulatory submission
Tagrisso - lung cancer (1st line): Data readout
durvalumab - lung cancer (PACIFIC): Data readout, regulatory submission (US)
durva + treme - lung cancer (MYSTIC): Regulatory submission
durva + treme - lung cancer (ARCTIC): Regulatory submission
durva + treme - head and neck cancer (KESTREL): Data readout
moxetumumab - leukaemia: Data readout
 
The term 'data readout' in this section refers to Phase III data readouts, unless specified otherwise.
*Potential fast-to-market opportunity ahead of randomised, controlled trials.
Notes
1.   All growth rates and guidance are shown at constant exchange rates (CER) unless otherwise specified.
2.   See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
 
 
Results Presentation
A conference call for investors and analysts, hosted by management, will begin at midday UK time today. Details can be accessed via www.astrazeneca.com/investors.
 
Reporting Calendar
The Company intends to publish its nine-month financial results on 10 November 2016. 
 
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 therapy areas - Respiratory & Autoimmunity, Cardiovascular & Metabolic Diseases and Oncology. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. 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.
 
Media Enquiries
Neil Burrows
 
UK/Global
 
+44 203 749 5637
 
Vanessa Rhodes
 
UK/Global
 
+44 203 749 5736
 
Karen Birmingham
 
UK/Global
 
+44 203 749 5634
 
Rob Skelding
 
UK/Global
 
+44 203 749 5821
 
Jacob Lund
 
Sweden
 
+46 8 553 260 20
 
Michele Meixell
 
US
 
+1 302 885 2677
 
 
Investor Relations
UK
Thomas Kudsk Larsen
 
 
+44 203 749 5712
 
Craig Marks
 
Finance, Fixed Income, M&A
 
+44 7881 615 764
 
Nick Stone
 
Respiratory & Autoimmunity
 
+44 203 749 5716
 
Henry Wheeler
 
Oncology
 
+44 203 749 5797
 
Christer Gruvris
Infection & Neuroscience
+44 203 749 5711
US
 
 
Lindsey Trickett
 
Cardiovascular & Metabolic Diseases
 
+1 240 543 7970
 
Mitchell Chan
 
Oncology
 
+1 240 477 3771
 
Toll free
 
+1 866 381 7277
 
Adrian Kemp
Company Secretary
AstraZeneca PLC
 
 
Operating and Financial Review
_______________________________________________________________________________________
All narrative on growth and results in this section is based on CER 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 2016 (the half and the quarter, respectively) compared to the six and three-month periods to 30 June 2015.
 
Core measures, which are presented in addition to Reported financial information, are non-GAAP measures provided to enhance understanding of the Company's underlying financial performance. 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 2015.
 
Total Revenue
 
 
H1 2016
Q2 2016
 
$m
% CER change
$m
% CER change
Product Sales
11,034
(2)
5,469
(5)
Externalisation Revenue
684
(12)
134
(72)
 
 
 
 
 
Total Revenue
11,718
(3)
5,603
(10)
 
Based on actual exchange rates, Total Revenue fell by 5% in the half, reflecting the strength of the US dollar.
 
Product Sales
The level of decline in Product Sales was driven by the US market entry of a Crestor generic medicine in the second quarter, as well as the ongoing impact of Nexium generic medicines in the US. Overall US Product Sales declined by 7% in the half, with Product Sales in Europe down by 3%.
 
Within Product Sales, Growth Platform sales grew by 7% in the half and represented 61% of Total Revenue:
 
 
 
 
H1 2016
Q2 2016
Growth Platforms
Product Sales ($m)
% CER change
Product Sales ($m)
% CER change
Emerging Markets
2,913
7
 1,448
9
Respiratory
2,433
1
1,226
1
Diabetes
1,223
18
645
13
Japan
998
(3)
569
1
Brilinta
395
48
214
51
New Oncology1
251
n/m
152
n/m
 
 
 
 
 
Total2
7,179
7
3,744
8
 
 
 
  
 
 
 
1New Oncology comprises Lynparza, Iressa (US) and Tagrisso 
2Total Product Sales for Growth Platforms adjusted to remove duplication on a medicine and regional basis 
 
Externalisation Revenue
Externalisation Revenue recognised in the half amounted to $684m. Highlights included:
 
Medicine
Partner
Region
$m
Plendil
China Medical System Holdings Ltd (CMS) -commercialisation rights - initial revenue
China
298
AZD3293
Eli Lilly and Company (Lilly) - milestone revenue
Global
100
Nexium OTC 20mg
Pfizer Inc. - milestone revenue
Global
93
Moventig
ProStrakan Group plc (ProStrakan) - commercialisation rights - initial revenue
EU
70
 
Examples of sustainable future Externalisation Revenue are shown below:
 
Announcement Date
Medicine
Partner
Region
Externalisation Revenue
1 July 2016
Tralokinumab - atopic dermatitis
LEO Pharma*
Global
●        Initial $115m milestone
●        $1bn in commercially-related milestones
●        Up to mid-teen tiered percentage royalties on Product Sales
9 June 2016
Anaesthetics
Aspen*
Global (excl. US)
●        Initial $520m milestone
●        $250m in sales-related revenue
●        Double-digit percentage trademark royalties on Product Sales
2 September 2015
FluMist
Daiichi Sankyo
Japan
●        Initial (undisclosed) milestone
●        Sales-related revenue (undisclosed)
19 March 2015
Movantik
Daiichi Sankyo
US
●        Initial $200m milestone
●        Up to $625m in sales-related payments
29 October 2010
Nexium
Daiichi Sankyo
Japan
●        Initial $100m milestone
●      Sales-related revenue (undisclosed)
*For further details, please see the Corporate & Business Development section
 
 
Product Sales
_______________________________________________________________________________________
The performance of key medicines is shown below, with a geographical split shown in Notes 8 and 9.
 
 
H1 2016
 
 
        
 
        
 
        
Q2 2016
                                                                           
        
 
$m
 
% Change
 

 Actual
$m
% Change  
 
CER
 
CER
 

 Actual             

  
Respiratory & Autoimmunity
 
 
 
 
 
 
 
Symbicort
 
1,552
 
(6)
 
(8)
 
803
 
(4)
 
(5)
 
Pulmicort
 
549
 
10
 
6
 
239
 
6
 
3
 
Tudorza/Eklira
 
87
 
4
 
2
 
48
 
(13)
 
(13)
 
Daliresp/Daxas
 
71
 
n/m
 
n/m
 
40
 
25
 
25
 
Duaklir
 
30
 
n/m
 
n/m
 
17
 
n/m
 
n/m
 
Others
 
144
 
13
 
9
 
79
 
34
 
34
 
Total
 
2,433
 
1
 
(1)
 
1,226
 
1
 
-
 
 
 
 
 
 
H1 2016
 
Q2 2016
 
 
$m
 
% Change
 
$m
 
% Change
 
 
CER
 
Actual
 
CER
 
Actual
 
Cardiovascular & Metabolic Diseases
 
 
 
 
 
 
 
Onglyza
 
402
 
6
 
3
 
191
 
(7)
 
(8)
 
Brilinta
 
395
 
48
 
44
 
214
 
51
 
49
 
Farxiga
 
376
 
88
 
83
 
211
 
65
 
64
 
Bydureon
 
291
 
11
 
11
 
156
 
11
 
11
 
Byetta
 
138
 
(19)
 
(20)
 
76
 
(6)
 
(7)
 
 
 
 
 
 
 
 
Legacy:
 
 
 
 
 
 
 
Crestor
 
2,082
 
(15)
 
(16)
 
926
 
(29)
 
(29)
 
Seloken/Toprol-XL
 
374
 
7
 
(3)
 
189
 
8
 
2
 
Atacand
 
160
 
(11)
 
(18)
 
89
 
(5)
 
(10)
 
Others
 
242
 
(23)
 
(23)
 
116
 
(25)
 
(26)
 
Total
 
4,460
 
(2)
 
(5)
 
2,168
 
(11)
 
(12)
 
Oncology
 
 
 
 
 
 
 
Iressa
 
270
 
2
 
(1)
 
135
 
5
 
5
 
Tagrisso
 
143
 
n/m
 
n/m
 
92
 
n/m
 
n/m
 
Lynparza
 
98
 
n/m
 
n/m
 
54
 
n/m
 
n/m
 
 
 
 
 
 
 
 
Legacy:
 
 
 
 
 
 
 
Faslodex
 
401
 
23
 
20
 
211
 
23
 
23
 
Zoladex
 
382
 
(3)
 
(7)
 
204
 
(4)
 
(5)
 
Casodex
 
125
 
(9)
 
(10)
 
63
 
(10)
 
(9)
 
Arimidex
 
119
 
(2)
 
(6)
 
62
 
(2)
 
(3)
 
Others
 
48
 
(33)
 
(33)
 
27
 
(30)
 
(27)
 
Total
 
1,586
 
18
 
15
 
848
 
20
 
20
 
Infection & Neuroscience
 
 
 
 
 
 
 
Nexium
1,025
(18)
(21)
562
(13)
(13)
Seroquel XR
 
427
 
(17)
 
(19)
 
225
 
(14)
 
(15)
 
Synagis
 
271
 
-
 
-
 
27
 
(59)
 
(59)
 
Losec/Prilosec
 
145
 
(17)
 
(20)
 
70
 
(16)
 
(18)
 
Movantik/Moventig
 
40
 
n/m
 
n/m
 
23
 
n/m
 
n/m
 
FluMist/Fluenz
 
11
 
(48)
 
(48)
 
6
 
(57)
 
(57)
 
Others
 
636
 
(11)
 
(16)
 
314
 
(12)
 
(17)
 
Total
 
2,555
 
(13)
 
(16)
 
1,227
 
(14)
 
(16)
 
 
 
 
 
 
 
 
Total Product Sales
 
11,034
 
(2)
 
(5)
 
5,469
 
(5)
 
(6)
 
 
 
Product Sales Summary
_______________________________________________________________________________________
 
Respiratory & Autoimmunity
 
Symbicort
Symbicort sales declined by 6% to $1,552m in the half. The decline was driven primarily by continuing price erosion, partially offset by volume growth. Symbicort became, however, the global market leader by volume in the period.
 
In the US, sales of $681m represented a decline of 5%. This reflected the impact of competitive intensity in the half that was partly offset by encouraging volume growth and market-share gains.
 
In Europe, sales declined by 18% to $466m, a result of declining market demand in the class, as well as increased competition from analogue medicines. In contrast, Emerging Markets sales grew by 25% to $209m; China sales grew by 33% to $80m.
 
Pulmicort
Pulmicort sales were $549m in the half, an increase of 10%. Growth reflected the performance of Pulmicort Respules in Emerging Markets, where Pulmicort sales grew by 23% to $349m. China sales increased by 26% to $288m, partly reflecting the increasing prevalence of acute chronic obstructive pulmonary disease (COPD) and paediatric asthma. To address this growing prevalence, AstraZeneca continued its expansion of treatment centres, as well as provided increased access to home-based patient care systems.
 
Tudorza/Eklira
Sales in the half were up by 4% to $87m, driven by Europe sales growth of 17% to $41m. US sales declined by 9% to $41m, partly reflecting lower market demand and a loss of Medicare Part D access, which was partially mitigated by the effect of inventory stocking.
 
Daliresp/Daxas
Rights were acquired in March 2015 from Actavis plc (Actavis) for Daliresp in the US and Canada. Sales in the half were $71m, driven by higher volume demand and inventory stocking. In the US, sales grew to $66m and represented 93% of global sales.
 
On 3 May 2016, AstraZeneca announced that it had completed the acquisition of the core respiratory business of Takeda Pharmaceutical Company Limited (Takeda). The agreement, initially announced in December 2015, included the expansion of rights to Daliresp in the US (marketed as Daxas in other countries). Since completion, Daxas sales in Europe amounted to $4m.
 
Duaklir
Duaklir has been launched successfully in more than 25 countries, with sales of $30m during the half reflecting encouraging levels of market share achieved in major European markets. Further launches are anticipated in due course.
 
 
Cardiovascular & Metabolic Diseases
 
Onglyza
Sales increased by 6% to $402m as DPP-4 class volumes continued to grow.
 
Sales in the US were stable at $212m. A higher net price, restocking levels and good federal-business sales offset the continued competitive pressures in the DPP-4 class.
 
Sales in Europe increased by 4% to $73m, a comparable rate to the overall DPP-4 class. Emerging Markets sales increased by 16% to $80m, with strong perfomance in Brazil (up by 67% to $8m) and Latin America ex-Brazil (up by 27% to $11m).
 
Brilinta
Sales in the half increased by 48% to $395m. 
 
US sales of Brilinta were $159m, an increase of 57%. Updated preferred guidelines regarding acute coronary syndrome treatment from the American College of Cardiology and the American Heart Association in March 2016 helped to expand the use of Brilinta, illustrated by a new-to-brand prescription market share of 12%. Brilinta became the branded oral anti-platelet market leader in the US in the half. 
 
Sales of Brilique in Europe grew by 17% to $125m, reflecting indication leadership across a number of markets. In the second quarter, the German Institute for Quality and Efficiency in Healthcare gave its assessment of the additional benefit from Brilique at the 60mg dose. This assessment referred to the new indication (high-risk, post- myocardial infarction) which emanated from the PEGASUS trial.
 
Emerging Markets sales grew by 106% to $91m, with China representing 47% of Emerging Markets sales at $43m, despite the medicine not being included on the National Drug Reimbursement List.
 
Farxiga
During the half, sales increased by 88% to $376m.
 
Sales of Farxiga in the US increased by 82% to $209m, reflecting higher market volumes, extended market share and net pricing. Encouraging levels of patient access and greater promotional activity drove volumes and total prescription share growth during the period. 
 
Sales of Forxiga in Europe were up 72% to $89m in the half as the medicine continued to lead the SGLT2 class. Emerging Markets sales increased by 135% to $53m, with strong performances in Asia Pacific (up by 167% to $22m), Brazil (up by 78% to $12m), and Latin America ex-Brazil (up by 80% to $8m).
 
Bydureon/Byetta
Combined sales for Bydureon/Byetta were $429m with Bydureon sales up by 11%, representing around 68% of total Bydureon/Byetta sales. With the Company's focus on Bydureon, Byetta sales declined by 19% to $138m.
 
In the US, Bydureon sales were $234m, an increase of 5%, despite increased competition from new market entrants. Sales in Europe increased by 43% to $50m, reflecting the Company's ongoing effort to expand its Diabetes presence.
 
Legacy: Crestor
Sales of Crestor declined in the half by 15% to $2,082m.
 
In the US, Crestor sales declined by 27% to $1,004m as the first Crestor generic competitor entered the market on 2 May 2016. The impact of destocking offset the favourable effects from a higher net price. Crestor continued to maintain both total and new-to-brand prescription levels of market share; multiple generic Crestor medicines, however, entered the US market in July 2016.
 
In Europe, sales declined by 4% to $438m, reflecting the increasing prevalence of generic-medicine competition. Crestor consolidated its position as the leading statin in Japan, with sales growth in the half of 5% to $250m. Sales in China grew by 16% to $156m.
 
 
Oncology
 
Iressa
Sales of Iressa in the half increased by 2% to $270m.
 
Following the US launch in July 2015, first-half sales were $10m as the Company prioritised the launch of Tagrisso.
 
In Europe, sales declined by 8% to $61m, reflected in falling market-volume share in France and Italy. Emerging Markets sales increased by 3% to $134m. The growth was limited by a decline in China sales of 3% to $71m, reflecting the competitive environment. In June 2016, however, Iressa received national reimbursement listing in China.
 
Tagrisso
Sales of Tagrisso were $143m, with the US representing 72% of global sales; the first regulatory approval for Tagrisso was in the US in November 2015.
 
After regulatory approval in the EU and Japan in the first quarter, Tagrisso sales amounted to $25m in Europe and $15m in Japan. Regulatory approvals have been granted in a number of further markets, including Korea, Switzerland and Canada; the Company anticipates additional regulatory approvals in due course.
 
Lynparza
Sales of Lynparza reached $98m in the half. Sales in the US increased to $62m, primarily driven by higher demand, an increased net price and changes in inventory-stocking levels. Sales in Europe were $32m following several successful launches. Lynparza is now available for patients in 29 countries, with regulatory reviews underway in nine additional countries including Singapore, Brazil, and Russia.
 
Legacy: Faslodex
Faslodex sales increased by 23% to $401m. US sales grew by 28% to $211m, driven by higher levels of demand following an expanded label for 2nd-line treatment for advanced or metastatic breast cancer.
 
Europe sales increased by 13% to $113m. Emerging Markets sales were up in the half by 36% to $47m, with China sales growth of 125% to $9m.
 
Legacy: Zoladex
Sales declined by 3% to $382m, primarily driven by a decline in Europe sales of 3% to $80m and an Emerging Market sales decline of 5% to $153m. China sales grew by 5% to $60m. US sales increased by 36% to $19m, reflecting higher volume demand and a higher net price.
 
 
Infection & Neuroscience
 
Nexium
Sales of Nexium declined by 18% to $1,025m in the half, due primarily to the impact of generic-medicine competition in the US and Europe.
 
Sales in the US declined by 39% to $294m following the loss of exclusivity in 2015 and changes in managed-care contracts. Sales in Europe declined by 10% to $127m, with Emerging Markets sales increasing by 1% to $367m. Japan sales decreased by 11% to $184m, reflecting the competitive environment.
 
Seroquel XR
Sales declined by 17% to $427m. Sales in the US were $306m, representing a decline of 13%. Sales in Europe declined by 32% to $76m, due primarily to the impact of generic-medicine competition.
 
Synagis
Sales of Synagis remained stable at $271m. Sales in US increased by 2% to $163m, driven primarily by higher net pricing, which was partly mitigated by lower demand. This was a consequence of the more-restrictive guidelines from the American Academy of Pediatrics Committee on Infectious Disease, which reduced the number of patients eligible for preventative therapy with Synagis.
 
FluMist/Fluenz
Sales in the half declined by 48% to $11m, reflecting lower volumes. The Company confirmed on 23 June 2016 that the Advisory Committee on Immunization Practices (ACIP) of the 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. The ACIP's updated recommendation is expected to result in very limited US demand in the second half of the year. The Company consequently wrote down the value of its inventory of FluMist by $47m in the second quarter, which was reflected within the Cost of Sales.
 
 
Regional Product Sales
_______________________________________________________________________________________
 
 
H1 2016
Q2 2016
 
$m
% Change
$m
% Change
 
CER
Actual
CER
Actual
US
4,209
(7)
(7)
1,963
(17)
(17)
 
 
 
 
 
 
 
Europe
2,467
(3)
(5)
1,249
(2)
(1)
 
 
 
 
 
 
 
Established ROW1
1,445
(4)
(3)
809
(1)
3
 
Japan
998
(3)
2
569
1
9
 
Canada
245
(1)
(10)
129
(1)
(7)
 
Other Established ROW
202
(9)
(16)
111
(6)
(10)
 
 
 
 
 
 
 
Emerging Markets2
2,913
7
(2)
1,448
9
1
 
China
1,384
11
6
610
10
5
 
Ex. China
1,529
4
(8)
838
8
(2)
 
 
 
 
 
 
 
Total
11,034
(2)
(5)
5,469
(5)
(6)
 
1 Established ROW comprises Japan, Canada, Australia and New Zealand.
2 Emerging Markets comprises all remaining Rest of World markets, including Brazil, China, India, Mexico, Russia and Turkey.
 
US
US sales declined by 7% in the half to $4,209m, driven primarily by the loss of exclusivity of Crestor on 2 May 2016. Crestor sales were $1,004m, a 27% decrease versus the comparative period. The decline was partially offset by favourable performances from Growth-Platform medicines Farxiga (up by 82% to $209m), Brilinta (up by 57% to $159m) and Lynparza (up to $62m).
 
Europe
Sales in Europe declined by 3% to $2,467m, driven primarily by ongoing price pressures. The strong growth of Forxiga sales (up by 72% to $89m) and Brilique sales (increasing by 17% to $125m) was more than offset by an 18% decline in Symbicort sales to $466m, which reflected adverse pricing and lower volumes, driven by competition from analogue medicines. Lynparza sales increased to $32m following its launch in 2015, reflecting a strong performance in Germany.
 
Established ROW
Sales in the Established Rest Of World (ROW) declined by 4% to $1,445m. Japan sales for the half declined by 3% to $998m, reflecting the biennual price cut in April 2016. Sales of Forxiga increased by 127% to $25m. Nexium sales declined by 15% to $237m, despite retaining position as the number one medicine in the class by market-share volume and new-to-brand prescription share.
 
Emerging Markets
Emerging Markets sales increased by 7% to $2,913m, despite continued downward pressure from macro-economic conditions in Latin America. China sales grew by 11% to $1,384m; China represented 48% of Emerging Markets sales in the half.
 
Sales in Brazil grew by 13% to $177m due to the strong performances of Forxiga (up by 78% to $12m), Oncology (up by 13% to $40m) and Seloken (up by 16% to $32m). Russia sales were up by 12% to $104m, led by strong performances in Cardiovascular & Metabolic Diseases medicine sales (up by 32% to $32m).
 
 
Financial Performance
______________________________________________________________________________________
 
H1 2016
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core
% Change
H1 2016
H1 2015
CER
Actual
 
 
Product Sales
 
 
 
11,034
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
11,034
 
 
 
11,584
 
 
 
(2)
 
 
 
(5)
 
 
 
Externalisation Revenue
 
 
 
684
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
684
 
 
 
780
 
 
 
(12)
 
 
 
(12)
 
 
 
Total Revenue
 
 
 
11,718
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
11,718
 
 
 
12,364
 
 
 
(3)
 
 
 
(5)
 
 
 
 
 
 
 
 
 
 
 
 
 
Cost of Sales
 
 
 
(2,066)
 
 
 
28
 
 
 
58
 
 
 
-
 
 
 
-
 
 
 
(1,980)
 
 
 
(1,918)
 
 
 
5
 
 
 
3
 
 
 
 
 
 
 
 
 
 
 
 
 
Gross Profit
 
 
 
9,652
 
 
 
28
 
 
 
58
 
 
 
-
 
 
 
-
 
 
 
9,738
 
 
 
10,446
 
 
 
(4)
 
 
 
(7)
 
 
 
Gross Margin2
 
 
 
81.5%
 
 
 
 
 
 
 
82.3%
 
 
 
83.4%
 
 
 
-1.1
 
 
 
-1.1
 
 
 
 
 
 
 
 
 
 
 
 
 
Distribution Expense
 
 
 
(167)
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
(167)
 
 
 
(161)
 
 
 
9
 
 
 
4
 
 
 
% Total Revenue
 
 
 
1.4%
 
 
 
 
 
 
 
1.4%
 
 
 
1.3%
 
 
 
-0.2
 
 
 
-0.1
 
 
 
 
 
 
 
 
 
 
 
 
 
R&D Expense
 
 
 
(2,945)
 
 
 
107
 
 
 
25
 
 
 
-
 
 
 
-
 
 
 
(2,813)
 
 
 
(2,636)
 
 
 
9
 
 
 
7
 
 
 
% Total Revenue
 
 
 
25.1%
 
 
 
 
 
 
 
24.0%
 
 
 
21.3%
 
 
 
-2.5
 
 
 
-2.7
 
 
 
 
 
 
 
 
 
 
 
 
 
SG&A Expense
 
 
 
(5,624)
 
 
 
328
 
 
 
504
 
 
 
218
 
 
 
347
 
 
 
(4,227)
 
 
 
(4,584)
 
(5)
 
 
 
(8)
 
 
 
% Total Revenue
 
 
 
48.0%
 
 
 
 
 
 
 
36.1%
 
 
 
37.1%
 
 
 
+0.8
 
 
 
+1.0
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Operating Income
 
 
 
425
 
 
 
-
 
 
 
43
 
 
 
-
 
 
 
-
 
 
 
468
 
 
 
553
 
 
 
(14)
 
 
 
(15)
 
 
 
% Total Revenue
 
 
 
3.6%
 
 
 
 
 
 
 
4.0%
 
 
 
4.5%
 
 
 
-0.5
 
 
 
-0.5
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating Profit
 
 
 
1,341
 
 
 
463
 
 
 
630
 
 
 
218
 
 
 
347
 
 
 
2,999
 
 
 
3,618
 
 
 
(14)
 
 
 
(17)
 
 
 
% Total Revenue
 
 
 
11.4%
 
 
 
 
 
 
 
25.6%
 
 
 
29.3%
 
 
 
-3.5
 
 
 
-3.7
 
 
 
 
 
 
 
 
 
 
 
 
 
Net Finance
Expense
 
 
 
(636)
 
 
 
-
 
 
 
-
 
 
 
195
 
 
 
126
 
 
 
(315)
 
 
 
(250)
 
 
 
 
 
Joint Ventures
 
 
 
(12)
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
(12)
 
 
 
(7)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Profit Before Tax
 
 
 
693
 
 
 
463
 
 
 
630
 
 
 
413
 
 
 
473
 
 
 
2,672
 
 
 
3,361
 
 
 
(18)
 
 
 
(21)
 
 
 
Taxation
 
 
 
(99)
 
 
 
(97)
 
 
 
(140)
 
 
 
(95)
 
 
 
(30)
 
 
 
(461)
 
 
 
(472)
 
 
 
 
 
Tax Rate
 
 
 
14%
 
 
 
 
 
 
 
17%
 
 
 
14%
 
 
 
 
 
Profit After Tax
 
 
 
594
 
 
 
366
 
 
 
490
 
 
 
318
 
 
 
443
 
 
 
2,211
 
 
 
2,889
 
 
 
(21)
 
 
 
(23)
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-controlling Interests
 
 
 
49
 
 
 
(5)
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
44
 
 
 
(1)
 
 
 
 
 
Net Profit
 
 
 
643
 
 
 
361
 
 
 
490
 
 
 
318
 
 
 
443
 
 
 
2,255
 
 
 
2,888
 
 
 
(20)
 
 
 
(22)
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted Average Shares
 
 
 
1,264
 
 
 
1,264
 
 
 
1,264
 
 
 
1,264
 
 
 
1,264
 
 
 
1,264
 
 
 
1,263
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Earnings Per Share ($)
 
 
 
0.51
 
 
 
0.29
 
 
 
0.39
 
 
 
0.25
 
 
 
0.34
 
 
 
1.78
 
 
 
2.29
 
 
 
(20)
 
 
 
(22)
 
1 Other adjustments include provision charges related to certain legal matters (see Note 7) and fair value adjustments arising on acquisition-related liabilities (see Note 6).
2 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales
3 All financial figures, except Earnings Per Share, are in $ millions ($m). Weighted Average Shares are in millions.
 
Q2 2016
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core
% Change
Q2 2016
Q2 2015
CER
Actual
 
 
Product Sales
 
 
 
5,469
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
5,469
 
 
 
5,836
 
 
 
(5)
 
 
 
(6)
 
 
 
Externalisation Revenue
 
 
 
134
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
134
 
 
 
471
 
 
 
(72)
 
 
 
(72)
 
 
 
Total Revenue
 
 
 
5,603
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
5,603
 
 
 
6,307
 
 
 
(10)
 
 
 
(11)
 
 
 
 
 
 
 
 
 
 
 
 
 
Cost of Sales
 
 
 
(1,062)
 
 
 
19
 
 
 
29
 
 
 
-
 
 
 
-
 
 
 
(1,014)
 
 
 
(965)
 
 
 
3
 
 
 
5
 
 
 
 
 
 
 
 
 
 
 
 
 
Gross Profit
 
 
 
4,541
 
 
 
19
 
 
 
29
 
 
 
-
 
 
 
-
 
 
 
4,589
 
 
 
5,342
 
 
 
(13)
 
 
 
(14)
 
 
 
Gross Margin2
 
 
 
80.6%
 
 
 
 
 
 
 
81.5%
 
 
 
83.5%
 
 
 
-1.5
 
 
 
-2.0
 
 
 
 
 
 
 
 
 
 
 
 
 
Distribution Expense
 
 
 
(91)
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
(91)
 
 
 
(84)
 
 
 
11
 
 
 
8
 
 
 
% Total Revenue
 
 
 
1.6%
 
 
 
 
 
 
 
1.6%
 
 
 
1.3%
 
 
 
-0.3
 
 
 
-0.3
 
 
 
 
 
 
 
 
 
 
 
 
 
R&D Expense
 
 
 
(1,465)
 
 
 
69
 
 
 
12
 
 
 
-
 
 
 
-
 
 
 
(1,384)
 
 
 
(1,356)
 
 
 
3
 
 
 
2
 
 
 
% Total Revenue
 
 
 
26.1%
 
 
 
 
 
 
 
24.7%
 
 
 
21.5%
 
 
 
-3.2
 
 
 
-3.2
 
 
 
 
 
 
 
 
 
 
 
 
 
SG&A Expense
 
 
 
(3,052)
 
 
 
220
 
 
 
275
 
 
 
110
 
 
 
347
 
 
 
(2,100)
 
 
 
(2,216)
 
(3)
 
 
 
(5)
 
 
 
% Total Revenue
 
 
 
54.5%
 
 
 
 
 
 
 
37.5%
 
 
 
35.1%
 
 
 
-2.7
 
 
 
-2.4
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Operating Income
 
 
 
370
 
 
 
-
 
 
 
22
 
 
 
-
 
 
 
-
 
 
 
392
 
 
 
127
 
 
 
n/m
 
 
 
n/m
 
 
 
% Total Revenue
 
 
 
6.6%
 
 
 
 
 
 
 
7.0%
 
 
 
2.0%
 
 
 
+4.9
 
 
 
+5.0
 
 
 
 
 
 
 
 
 
 
 
 
 
Operating Profit
 
 
 
303
 
 
 
308
 
 
 
338
 
 
 
110
 
 
 
347
 
 
 
1,406
 
 
 
1,813
 
 
 
(21)
 
 
 
(22)
 
 
 
% Total Revenue
 
 
 
5.4%
 
 
 
 
 
 
 
25.1%
 
 
 
28.7%
 
 
 
-3.5
 
 
 
-3.6
 
 
 
 
 
 
 
 
 
 
 
 
 
Net Finance
Expense
 
 
 
(325)
 
 
 
-
 
 
 
-
 
 
 
98
 
 
 
69
 
 
 
(158)
 
 
 
(132)
 
 
 
 
 
Joint Ventures
 
 
 
(8)
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
(8)
 
 
 
(2)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(Loss)/Profit Before Tax
 
 
 
(30)
 
 
 
308
 
 
 
338
 
 
 
208
 
 
 
416
 
 
 
1,240
 
 
 
1,679
 
 
 
(27)
 
 
 
(26)
 
 
 
Taxation
 
 
 
(1)
 
 
 
(64)
 
 
 
(74)
 
 
 
(48)
 
 
 
(25)
 
 
 
(212)
 
 
 
(160)
 
 
 
 
 
Tax Rate
 
 
 
(3)%
 
 
 
 
 
 
 
17%
 
 
 
10%
 
 
 
 
 
(Loss)/Profit After Tax
 
 
 
(31)
 
 
 
244
 
 
 
264
 
 
 
160
 
 
 
391
 
 
 
1,028
 
 
 
1,519
 
 
 
(33)
 
 
 
(32)
 
 
 
 
 
 
 
 
 
 
 
 
 
Non-controlling Interests
 
 
 
28
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
-
 
 
 
28
 
 
 
1
 
 
 
 
 
Net (Loss)/ Profit
 
 
 
(3)
 
 
 
244
 
 
 
264
 
 
 
160
 
 
 
391
 
 
 
1,056
 
 
 
1,520
 
 
 
(31)
 
 
 
(31)
 
 
 
 
 
 
 
 
 
 
 
 
 
Weighted Average Shares
 
 
 
1,265
 
 
 
1,265
 
 
 
1,265
 
 
 
1,265
 
 
 
1,265
 
 
 
1,265
 
 
 
1,264
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Earnings Per Share ($)
 
 
 
0.00
 
 
 
0.20
 
 
 
0.21
 
 
 
0.12
 
 
 
0.30
 
 
 
0.83
 
 
 
1.21
 
 
 
(31)
 
 
 
(31)
 
1 Other adjustments include provision charges related to certain legal matters (see Note 7) and fair value adjustments arising on acquisition-related liabilities (see Note 6).
2 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales
3 All financial figures, except Earnings Per Share, are in $ millions ($m). Weighted Average Shares are in millions.
 
Profit and Loss
Gross Profit
Reported Gross Profit declined by 1% in the half to $9,652m and, excluding the impact of externalisation, the Reported Gross Profit Margin was 81.5%, an increase of two percentage points. An adverse impact from the mix of sales, the market entry of a Crestor generic medicine in the US, as well as a write-down of inventory levels of FluMist in the US were more than offset by lower restructuring and amortisation charges. Excluding these charges, Core Gross Profit declined by 4% to $9,738m and, excluding the impact of externalisation, the Core Gross Profit margin declined by one percentage point to 82.3%.
 
Operating Expenses: R&D
Reported R&D costs increased by 6% in the half to $2,945m. This reflected the number of potential medicines in pivotal trials as well as the absorption of the R&D costs of ZS Pharma and Acerta Pharma. These costs were partially offset by lower restructuring costs and impairment charges. Without the impact of ZS Pharma and Acerta Pharma, Reported R&D costs would have increased by 1%.
 
Excluding the impact of lower restructuring and impairment charges, Core R&D costs increased by 9% to $2,813m (Q2 2016: Growth of 3%). Without the impact of the aforementioned investments in ZS Pharma and Acerta Pharma, Core R&D costs in the half would have increased by 3%.
 
Operating Expenses: SG&A
Reported SG&A costs were stable in the half at $5,624m, with efficiency savings in sales and marketing operations and further reductions in IT costs offset by higher restructuring costs, amortisation charges and fair value adjustments, which are excluded from the Core measurement. Core SG&A costs declined by 5% in the half to $4,227m, in line with full-year expectations of a material reduction.
 
Other Operating Income
Reported Other Operating Income of $425m included:
●              $183m of income related to the disposal of the ex-US rights to Imdur
●            $89m of royalty income related to the entry of the first US Crestor generic medicine from the period between 2 May 2016 and 8 July 2016
●            Other royalty income of $117m, including that related to HPV and the antibiotic medicine, ertapenem
 
Operating Profit
Reported Operating Profit declined by 24% to $1,341m. The Reported Operating Margin declined by three percentage points to 11% of Total Revenue.
 
Core Operating Profit declined by 14% to $2,999m in the half. The Core Operating Margin declined by three percentage points to 26% of Total Revenue.
 
Net Finance Expense
Reported Net Finance Expense of $636m compared to $513m in the prior half, and included $321m for the discount unwind on acquisition-related liabilities. The Core Net Finance Expense, which excludes the aforementioned discount unwind, was $315m in the half, compared to $250m in the comparative period. The increase reflected higher loan interest arising from an increase in net debt, driven by the acquisition of ZS Pharma and the investment in Acerta Pharma.
 
Taxation
The Reported and Core tax rates for the half were 14% and 17% respectively. These tax rates were lower than the UK Corporation Tax Rate of 20%, mainly due to the impact of the geographical mix of profits, tax settlements and the UK patent box. The cash tax paid for the half was $262m, which was 38% of Reported Profit Before Tax and 10% of Core Profit Before Tax. The Reported and Core tax rates for H1 2015 were 7% and 14% respectively.
 
Earnings Per Share (EPS)
Reported EPS of $0.51 in the half represented a 45% decline, with Core EPS in the half declining by 20% to $1.78. The declines were driven by the first market entry of a Crestor generic medicine in the US, as well as the ongoing impact of US Nexium generic medicines. The reduction also reflected the phasing of Externalisation Revenue over the year.
 
 
Productivity
AstraZeneca continues to enhance productivity through the implementation of its restructuring initiatives, including those announced on 29 April 2016. Restructuring charges of $463m were incurred in the half. The Company remains on track to realise savings and incur expenses in line with prior announcements.
 
 
Cash Flow and Balance Sheet
 
Cash Flow
The Company generated a net cash inflow from operations of $1,374m, compared with $1,008m in the comparative period. Improved working capital and lower net tax payments more than offset the lower profit.
 
Net cash outflows from investing activities were $3,948m compared with $1,234m in the comparative period. The increase primarily reflected the net cash outflow of $2,383m on the investment in Acerta Pharma.
 
Net cash outflows from financing activities were $6m, incorporating $2,483m of new long-term loans, net of a dividend payment in the period of $2,409m. This compared to an outflow of $2,388m in the comparative period.
 
The cash payment of contingent consideration in respect of the Bristol-Myers Squibb Company share of the global Diabetes alliance amounted to $141m in the half. The consideration is based on a tiered structure, whereby a higher royalty rate is applied until a specified level of sales is achieved in the year; thereafter a lower rate is applied to the remaining sales in the year and settled in the quarter following the application of the charge.
 
Debt and Capital Structure
At 30 June 2016, outstanding gross debt (interest-bearing loans and borrowings) was $17,579m (30 June 2015: $11,008m). Of the gross debt outstanding at 30 June 2016, $1,060m was due within one year (30 June 2015: $2,705m). The Company's net debt position at 30 June 2016 was $12,734m (30 June 2015: $5,994m).
 
On 9 May 2016, the Company announced the successful pricing of euro medium-term notes in an aggregate principal amount of €2.2bn, consisting of three tranches:
 
€500m of five-year, fixed-rate notes with a coupon of 0.25%
€900m of eight-year, fixed-rate notes with a coupon of 0.75%
€800m of 12-year, fixed-rate notes with a coupon of 1.25%
 
Shares in Issue
During the half, 0.5 million shares were issued in respect of share option exercises for a consideration of $22m. The total number of shares in issue as at 30 June 2016 was 1,265 million.
 
Dividends
The Board has recommended an unchanged first interim dividend of $0.90 (68.7 pence, 7.81 SEK) per Ordinary Share.
 
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.
 
Sensitivity: Foreign-Exchange Rates
The Company provides the following currency sensitivity information:
 
 
 
 
 
Average Exchange Rates Versus USD
 
 
 
Impact Of 5% Weakening In Exchange Rate Versus USD ($m)2
 
Currency
 
Primary Relevance
 
FY 2015
 
H1 20161
 
Change %
 
Total Revenue
 
Core Operating Profit
 
EUR
 
Product Sales
 
0.90
 
0.90
 
1
 
(178)
 
(103)
 
JPY
 
Product Sales
 
121.04
 
111.74
 
8
 
(102)
 
(66)
 
CNY
 
Product Sales
 
6.28
 
6.54
 
(4)
 
(133)
 
(62)
 
SEK
 
Costs
 
8.43
 
8.33
 
1
 
(8)
 
71
 
GBP
 
Costs
 
0.65
 
0.70
 
(6)
 
(34)
 
96
 
Other3
 
 
 
 
 
 
 
 
 
(201)
 
(122)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1Based on average daily spot rates in the six months to the end of June 2016
2Based on 2015 actual results at 2015 actual exchange rates
3Other important currencies include AUD, BRL, CAD, KRW and RUB
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Currency 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 2016, AstraZeneca had hedged 90% of forecast short-term currency exposure that arises between the booking and settlement dates on non-local currency purchases and Product Sales.
 
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 212 to 226 of the Annual Report and Form 20-F Information 2015, will change in respect of the second six months of the financial year.
 
In summary, the principal risks and uncertainties listed in the Annual Report and 20-F Information 2015 are:
 
a) Medicine pipeline and intellectual property risks
Failure to meet development targets; delay to new product launches; acquisitions and strategic alliances, including licensing and collaborations, may be unsuccessful; difficulties obtaining and maintaining regulatory approvals for new products; failure to obtain and enforce effective intellectual property (IP) protection.
 
b) Commercialisation risks
Expiry or loss of, or limitations to, IP rights and consequential pressure from generic competition; abbreviated approval processes for biosimilars; political and socio-economic conditions; developing our business in Emerging Markets; challenges to achieving commercial success of new products; effects of patent litigation in respect of IP rights; price controls and reductions; economic, regulatory and political pressures; illegal trade in medicines; increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; failure to adhere to applicable laws, rules and regulations; failure of information technology and cybercrime; any expected gains from productivity initiatives are uncertain; failure of outsourcing; failure to attract and retain key personnel and failure to successfully engage with employees.
 
c) Supply chain and business execution risks
Difficulties and delays in the manufacturing, distribution and sale of products; reliance on third-party goods and services; manufacturing biologic products.
 
d) Legal, regulatory and compliance risks
Adverse outcome of litigation and/or governmental investigations; failure to adhere to applicable laws, rules and regulations relating to anti-competitive behaviour; substantial product-liability claims; failure to adhere to applicable laws, rules and regulations relating to environment, health and safety; environmental and occupational health and safety liabilities; misuse of social media platforms and new technology.
 
e) Economic and financial risks
Failure to achieve strategic priorities or to meet targets or expectations; adverse impact from sustained economic downturn; fluctuations in exchange rates; limited third-party insurance coverage; taxation; pensions.
 
 
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) Licensing Agreements In Skin Diseases
On 1 July 2016, the Company announced that it had entered into an agreement with LEO Pharma A/S (LEO Pharma), a specialist in dermatological care, for the global licence to tralokinumab in skin diseases. Tralokinumab is a potential new medicine (an IL-13 monoclonal antibody) that has completed a Phase IIb trial for the treatment of patients with atopic dermatitis, an inflammatory skin disease resulting in itchy, red, swollen and cracked skin.
 
Under the terms of the agreement, LEO Pharma will make an upfront payment to AstraZeneca of $115m, up to $1bn in commercially-related milestones and up to mid-teen tiered percentage royalties on Product Sales. AstraZeneca will manufacture and supply tralokinumab to LEO Pharma. AstraZeneca will retain all rights to tralokinumab in respiratory disease and any other indications outside of dermatology. The Company anticipates completion of the transaction in the third quarter.
 
On the same date, AstraZeneca and an affiliate of Valeant Pharmaceuticals International, Inc. (Valeant) agreed to terminate the licence for Valeant's right to develop and commercialise brodalumab in Europe. Simultaneously, AstraZeneca has entered into an agreement with LEO Pharma for the exclusive licence to brodalumab in Europe. Brodalumab is an IL-17 receptor monoclonal antibody under regulatory review for patients with moderate-to-severe plaque psoriasis (a skin disease that causes red patches of skin covered with silvery scales) and in development for psoriatic arthritis (inflammation of the joints associated with psoriasis).
 
In September 2015, AstraZeneca and Valeant entered an agreement granting Valeant an exclusive licence to develop and commercialise brodalumab globally, outside Japan and certain other Asian countries where the rights are held by Kyowa Hakko Kirin Co., Ltd. Valeant will continue to lead development and commercialisation of brodalumab in the US and all other markets included in the original agreement.
 
LEO Pharma will gain the European rights to brodalumab under similar terms to those agreed with Valeant. Additionally, Amgen Inc. will continue to receive a low single-digit percentage inventor royalty.
 
b) Rights To Global Anaesthetics Portfolio
On 9 June 2016, the Company announced that it had entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of Aspen Pharmacare Holdings Limited, for rights to its global anaesthetics portfolio outside the US.
 
Under the terms of the agreement, AGI will acquire the commercialisation rights for an upfront consideration of $520m. Additionally, AGI will pay AstraZeneca up to $250m in a Product Sales-related payment, as well as double-digit percentage trademark royalties on Product Sales. AstraZeneca will manufacture and supply the medicines on a cost-plus basis to AGI for an initial period of 10 years. Upon completion, anticipated in the third quarter of 2016, AGI will assume responsibility for all activities relating to the sale of the portfolio in all relevant markets.
 
AstraZeneca will retain a significant ongoing interest in the anaesthetics portfolio, including a long-term manufacturing and supply agreement and participation in commercial strategy. The upfront and milestone payments, as well as royalty receipts, which are open-ended, will therefore be reported as Externalisation Revenue in the Company's financial statements.
 
c) Zurampic In Europe And Latin America
On 2 June 2016, AstraZeneca announced that it had entered into a licensing agreement with Grünenthal GmbH (Grünenthal) for the exclusive rights to Zurampic (lesinurad) in Europe and Latin America. Zurampic was approved by the European Medicines Agency (EMA) in February 2016, in combination with a xanthine oxidase inhibitor, for the adjunctive treatment of hyperuricemia (excess of uric acid in the blood) in adult patients with uncontrolled gout.
 
Under the terms of the agreement, Grünenthal will submit a fixed-dose combination programme for regulatory review and will pay AstraZeneca up to $230m in sales and other related milestones over the lifetime of the contract. Grünenthal will also pay tiered, low double-digit percentage royalties on annual Product Sales. Revenue from the licensing agreement will provide AstraZeneca with future recurring Externalisation Revenue from expected milestone payments and tiered, low double-digit percent royalty payments on Product Sales. The Company anticipates completion of the transaction in the third quarter.
 
d) Acquisition Of Takeda's Respiratory Business
On 3 May 2016 AstraZeneca announced that it had completed the acquisition of the main respiratory business of Takeda. The agreement, announced in December 2015, included the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral phosphodiesterase 4 (PDE4) inhibitor for the treatment of COPD. PDE4 is an enzyme involved in modulating production of inflammatory mediators by immune cells. AstraZeneca has marketed Daliresp in the US since the acquisition of the rights from Actavis in the first quarter of 2015.
 
e) Agreement with China Medical System Holdings (CMS) - Imdur outside the US
On 29 February 2016, AstraZeneca announced that it had entered into an agreement with CMS and its associated company, Tibet Rhodiola Pharmaceutical Holding Co., for the divestment of the global rights to Imdur outside the US. Imdur is a mature medicine for the prevention of angina in patients with heart disease; its global sales outside the US were $57m in FY 2015. The transaction completed in the second quarter.
 
Under the terms of this agreement, AstraZeneca recognised income of $183m for the rights to Imdur in all markets outside the US. Income from the agreement was reported within Other Operating Income.
 
 
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 28 April 2016 (the period): 
 
Regulatory Approvals
3
 
-     Qtern (saxagliptin/dapagliflozin) - type-2 diabetes (EU)
-     Zavicefta (previously CAZ AVI) - serious infections (EU)
-     Pandemic Live Attenuated Influenza Vaccine - pandemic influenza (EU)1
 
Regulatory Submission Acceptances
1
 
 
-     saxagliptin/dapagliflozin, resubmission (US)
 
Positive Phase III Data Readouts
3
-     benralizumab - severe asthma
 
-     Faslodex - breast cancer (1st line)
-     Tagrisso - lung cancer (2nd line)
 
Other Key Developments
2
 
 
-     Orphan Drug Designation: selumetinib - thyroid cancer (US)
-     Fast Track Designation: Lynparza - ovarian cancer (2nd line) (US)
 
New Molecular Entities (NMEs) in Pivotal Trials or under Regulatory Review*
14
Respiratory & Autoimmunity
-     brodalumab - psoriasis*
-     benralizumab - severe asthma
-     tralokinumab - severe asthma
-     PT010 - COPD
-     anifrolumab - lupus
 
Cardiovascular & Metabolic Diseases
-     ZS-9* - hyperkalaemia
-     roxadustat - anaemia
 
Oncology
-     cediranib* - ovarian cancer
-     selumetinib - lung cancer
-     durvalumab - multiple cancers
-     durva + treme - multiple cancers
-     acalabrutinib - blood cancers
-     moxetumomab pasudotox - leukaemia
 
Neuroscience
-     AZD3293 - early Alzheimers' disease
 
Projects in clinical pipeline
145
 
1Conditional Marketing Authorisation
 
1.   Respiratory & Autoimmunity
 
AstraZeneca's Respiratory portfolio includes a range of differentiated potential medicines such as novel combinations, biologics and devices for the treatment of asthma and COPD. The pipeline also includes a number of potential medicines designed to treat autoimmune diseases, with a lead programme in systemic lupus erythematosus.
 
AstraZeneca highlighted the breadth of its Respiratory portfolio at the American Thoracic Society international conference in May 2016, involving more than 60 posters and abstracts that illustrated progress in asthma and COPD medicines.
 
The following shows the progress in the Respiratory & Autoimmunity portfolio since the last results announcement:
 
a) Benralizumab (severe asthma)
On 17 May 2016, the Company announced positive top-line results from the benralizumab Phase III programme, an encouraging milestone for AstraZeneca and for millions of patients suffering from severe asthma. Two pivotal Phase III trials (SIROCCO and CALIMA) achieved statistical significance in reducing exacerbations among patients with severe uncontrolled asthma with eosinophilic inflammation. These trials evaluated treatment with benralizumab versus placebo added to high-dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA) for the prevention of asthma exacerbations in patients with uncontrolled severe asthma.
Benralizumab is an eosinophil-depleting monoclonal antibody and AstraZeneca's first respiratory biologic medicine. Upon anticipated regulatory approval, benralizumab will potentially be used in addition to inhaled combination medicines. Benralizumab has the potential to deliver rapid and sustained improvement in lung function, symptoms and quality of life, together with significant reductions in exacerbations, hospitalisations and oral corticosteroids use; and simple, convenient dosing and administration.
b) Brodalumab (psoriasis)
On 19 July 2016, the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the US FDA voted unanimously to recommend approval for brodalumab for adult patients with moderate-to-severe plaque psoriasis. 14 of the panelists voted for approval with conditions related to product labelling and post-marketing obligations based on observations related to suicidal ideation and behaviour. Patient safety is the highest priority and as such the Company is committed to supporting the partner Valeant in addressing any concerns raised by the Committee as the FDA continues its review of brodalumab. Valeant is the Biologics License Application (BLA) holder for brodalumab and is responsible for all development and commercialisation activities in the US. Valeant has communicated that the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of 16 November 2016 for the BLA.
 
2.   Cardiovascular & Metabolic Diseases
 
This therapy area includes a broad type-2 diabetes portfolio, differentiated devices and unique small and large-molecule programmes to reduce morbidity, mortality and organ damage across cardiovascular (CV) disease, diabetes and chronic kidney disease (CKD) indications.
 
a) Brilinta (CV disease)
In May 2016, the Brilinta THEMIS trial completed its recruitment, with more than 19,000 patients now randomised within the trial. THEMIS is part of PARTHENON, AstraZeneca's largest clinical-trial programme, evaluating Brilinta in more than 80,000 high-risk CV patients. THEMIS is an event-driven, randomised, double-blind, placebo-controlled trial, designed to evaluate the effect of Brilinta versus placebo for prevention of major CV events in patients with established coronary artery disease and type-2 diabetes, but without a previous myocardial infarction (MI) or stroke. Results are expected in 2018.
 
The Ministry of Health, Labour and Welfare Drug Committee assessment of Brilinta's application for approval is ongoing in Japan and a regulatory decision is now anticipated in the second half of 2016.
 
There were three new treatment guidelines updated in China in the first half of the year. The ACS Emergency Room Rapid Guideline, Chinese PCI Guideline and the Coronary Artery Bypass Graft Consensus (2016) guideline. These recommended Brilinta as 'first-choice treatment' over any other platelet inhibitor.
 
b) Qtern (saxagliptin/dapagliflozin) (type-2 diabetes)
On 19 July 2016 AstraZeneca announced that the European Commission had approved Qtern tablets for the treatment of type-2 diabetes in the European Union (EU) plus Iceland, Liechtenstein and Norway. The fixed-dose combination of saxagliptin and dapagliflozin was the first DPP-4/SGLT2 combination medicine to be approved.
 
After receiving a Complete Response Letter (CRL) from the US FDA in October 2015, the Company submitted a regulatory filing with new clinical data, which was accepted by the FDA. The submission was based on discussions with regulators and was a first step towards regulatory approval in the US. The PDUFA date is scheduled for the first quarter of 2017.
 
c) Type-2 diabetes CV outcomes trials
As the field of type-2 diabetes medicines continues to evolve, with multiple outcomes trials producing data, AstraZeneca continues to assess both the SGLT2 and GLP-1 classes for potential long-term benefits. Two significant type-2 diabetes outcomes trials are underway and are fully recruited. Details and updates on those two trials are listed below:
 
Medicine
Trial
Mode of Action
Number of Patients
Primary Endpoint
Timeline
Bydureon
 
EXSCEL
 
GLP-1 agonist
 
~15,000
 
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
2018
(final analysis)
Farxiga
DECLARE
SGLT2 inhibitor
~17,000*
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
2019
(final analysis)
2017
(anticipated interim analysis)
*Includes ~10,000 patients who have had no prior index event (primary prevention) and ~7,000 patients who have suffered an index event (secondary prevention).
 
d) ZS-9 (hyperkalaemia)
On 27 May 2016, AstraZeneca announced that the US FDA had issued a CRL regarding the new drug application (NDA) for ZS-9 (sodium zirconium cyclosilicate), the potential new medicine being developed for the treatment of hyperkalaemia (a high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. The CRL referred to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it had yet to review. The CRL did not require the generation of new clinical data. AstraZeneca and ZS Pharma have made important progress in addressing the findings of the CRL and are in dialogue with the FDA regarding the timing of the resubmission of the NDA. From the time of the resubmission, anticipated to be in the second half of the year, the Company assumes a maximum of a six-month period for the FDA review.
 
In the EU, the EMA has accepted a request to extend the submission timeline in order for the Company to provide a comprehensive and complete package. The Company continues to anticipate EU approval in the first half of 2017.
 
e) Roxadustat (anaemia)
In the period, the Company approved Phase III investment for roxadustat in an additional type of anaemia, Myelodysplastic Syndrome (MDS), with AstraZeneca's partner, Fibrogen, Inc. MDS is a condition in which the bone marrow produces insufficient levels of healthy blood cells and there are abnormal (blast) cells in the blood and/or bone marrow. Anaemia is observed in approximately 60-80% of MDS patients, producing symptoms of fatigue, angina, dizziness, cognitive impairment or altered sense of well-being and all too often requiring transfusions. Transfused patients with MDS experience higher rates of cardiac events, diabetes, infections, and transformation to acute myeloid leukaemia and have a decreased overall survival rate when compared with non-transfused patients. 
 
The Phase III trial will seek to demonstrate the efficacy and safety of roxadustat, which acts on both the production of red blood cells and management of iron, in achieving transfusion independence in patients with lower-risk MDS and a low transfusion burden.
 
Roxadustat is already in late Phase III development against anaemia arising from CKD, with a rolling regulatory submission expected to initiate in China before the end of the year. The first Phase III data from an AstraZeneca-sponsored registrational trial are expected to be available during the second half of 2017, with a potential regulatory submission in the US anticipated in 2018.
 
 
3.   Oncology
 
AstraZeneca has a deep-rooted heritage in Oncology and offers a rapidly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, the Company is committed to advancing New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers.
 
In addition to core capabilities, the Company is actively pursuing innovative collaborations and investments that accelerate the delivery of AstraZeneca's strategy, as illustrated by the Company's investment in Acerta Pharma in haematology.
 
AstraZeneca highlighted its pipeline of Oncology medicines at the American Society of Clinical Oncology meeting on 6 June 2016. At the meeting, AstraZeneca's Oncology management team presented both pipeline programmes and lifecycle management trials in Immuno-Oncology (IO), DNA Damage Response (DDR), tumour drivers & resistance and haematology. The Company presented 73 abstracts and oral presentations, including updates on the Lynparza Study 19, Tagrisso in leptomeningeal disease and durvalumab in 2nd-line, PDL1-positive urothelial bladder cancer. In addition to the breadth and depth of the data shared at the meeting, AstraZeneca announced a number of encouraging updates in the period.
 
a) Faslodex (breast cancer)
On 27 May 2016, the Company announced that Faslodex had met its primary endpoint in the FALCON trial. Top-line data showed that 1st-line treatment with Faslodex extends progression-free survival (PFS) in postmenopausal women with locally-advanced or metastatic hormone receptor-positive breast cancer, compared to the current standard of care. Full evaluation of the data is ongoing and results are expected to be presented at a forthcoming medical meeting.
 
b) Lynparza (ovarian and other cancers)
The Phase III SOLO-2 trial for Lynparza was granted Fast Track Designation by the FDA in the period. SOLO-2 is designed to evaluate Lynparza as a potential maintenance treatment for platinum-sensitive, relapsed germline BRCA-mutated, ovarian-cancer patients who are in complete or partial response following platinum-based chemotherapy. The FDA's Fast Track programme is designed to expedite the development and review of medicines to treat serious conditions and fill an unmet medical need. SOLO-2 high-level results are expected to be available later this year.
 
On 18 May 2016, the top-line results from the Phase III Lynparza GOLD trial in advanced gastric-cancer patients were announced. Lynparza, in combination with paclitaxel chemotherapy and compared with paclitaxel chemotherapy alone, did not meet the primary endpoint of overall survival (OS) in either the overall population or patients whose tumour tested negative for Ataxia-Telangectasia Mutated (ATM) protein. While there was a numerical survival trend in the Lynparza plus paclitaxel arm, it did not meet statistical significance. The particular regimen in the GOLD trial, at a low dose and in combination with chemotherapy, differed from other Phase III trials in the Lynparza programme. The Lynparza GOLD data will be analysed and submitted for presentation at a forthcoming medical meeting.
 
c) Tagrisso (lung cancer)
On 18 July 2016 the Company announced that Tagrisso's confirmatory Phase III AURA3 trial had met its primary endpoint, demonstrating superior PFS data compared to standard platinum-based doublet chemotherapy in 2nd-line patients with EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor therapy.
 
Tagrisso also demonstrated a safety profile consistent with previous trials and, in addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically-meaningful improvements versus chemotherapy. A full evaluation of the AURA3 data, including an analysis of OS data is ongoing and the results will be presented at a forthcoming medical meeting.
 
d) Selumetinib (lung and other cancers)
On 12 May 2016, selumetinib was granted Orphan Drug Designation by the FDA for the treatment of patients with differentiated thyroid cancer (DTC). DTC, diagnosed in approximately 60,000 patients in the US each year, is usually treated with surgery. High-risk patients, however, need additional radioactive iodine (RAI) to kill cancer cells. Up to one in seven patients do not respond to RAI because they lack a key substance, sodium/iodine importer, that is needed to move RAI into cancer cells.
 
Selumetinib is a MEK 1/2 inhibitor that has already demonstrated clinically-meaningful increases in iodine uptake and retention in patients with thyroid cancer who did not previously respond to RAI. A MEK inhibitor inhibits the mitogen-activated protein kinase enzymes (MEK1 and/or MEK2).
 
e) Durvalumab (multiple cancers)
The Company continues to advance multiple monotherapy trials of durvalumab and combination trials of durvalumab with tremelimumab in IO. An update on key AstraZeneca-sponsored ongoing trials with durvalumab is provided over the page:
 
LUNG CANCER NamePhaseLine of treatmentPopulationDesignTimelinesStatusEarly disease MonotherapyADJUVANT1IIIN/AStage Ib-IIIa NSCLCdurvalumab vs placeboFPD2 Q1 2015 Data expected 2020RecruitingPACIFICIIIN/AStage III unresectable NSCLCdurvalumab vs placeboFPD Q2 2014 LPCD3 Q2 2016 Data expected H2 2017Recruitment completedAdvanced/metastatic disease Combination therapyMYSTICIII1st lineNSCLCdurvalumab vs durva + treme vs SoC4FPD Q3 2015LPCD Q3 2016 Data expected H1 2017Recruitment completedNEPTUNEIII1st lineNSCLCdurva + treme vs SoCFPD Q4 2015 Data expected 2018Recruiting -III1st lineNSCLCdurvalumab + chemotherapy +/- tremelimumab-Recruiting in safety lead-in Phase I/II trialARCTICIII3rd linePD-L1 neg.5 NSCLCdurvalumab vs tremelimumab vs durva + treme vs SoCFPD Q2 2015 LPCD Q3 2016 Data expected H1 2017Recruitment completed-III1st lineSCLC6durva + treme + chemotherapy vs SoC-Awaiting first patient dosed1 Conducted by the National Cancer Institute of Canada   2 FPD = First Patient Dosed   3LPCD = Last Patient Commenced Dosing4 SoC = Standard of Care  5 PD-L1 negativity cut-off measured at <25% of tumour-cell staining   6 SCLC = Small Cell Lung Cancer METASTATIC OR RECURRENT HEAD AND NECK CANCER NamePhaseLine of treatmentPopulationDesignTimelinesStatusMonotherapyHAWKII2nd linePD-L1 pos. SCCHN1durvalumab (single arm)FPD Q1 2015 LPCD Q2 2016 Data expectedH2 2016Recruitment completed  Combination therapyCONDORII2nd linePD-L1 neg. SCCHNdurvalumab vs tremelimumab vs durva + tremeFPD Q2 2015 LPCD Q2 2016 Data expected H1 2017Recruitment completed KESTREL III1st lineSCCHNdurvalumab vs durva + treme vs SoCFPD Q4 2015 Data expected H2 2017RecruitingEAGLEIII2nd lineSCCHNdurvalumab vs durva + treme vs SoCFPD Q4 2015 Data expected 2018Recruiting
1SCCHN = Squamous Cell Carcinoma of the Head and Neck
 
METASTATIC UROTHELIAL BLADDER CANCER
Name
Phase
Line of treatment
Population
Design
Timelines
Status
Combination therapy
DANUBE
III
1st line
Cisplatin chemo-
therapy- eligible/
ineligible bladder cancer
durvalumab vs durva + treme vs SoC
FPD Q4 2015
 
 
Data expected 2018
Recruiting
 
 
 
 
OTHER METASTATIC CANCERS/EARLY TRIALS
Name
Phase
Line of treatment
Population
Design
Timelines
Status
Combination therapy
ALPS
II
2nd line
Pancreatic ductal carcinoma
durva + treme (single arm)
FPD Q4 2015
 
Data expected H2 2017
Recruiting
 
 
-
II
2nd line
Unresectable liver cancer
durvalumab vs tremelimumab vs durva + treme
FPD Q1 2016Data expected 2017
Recruiting
-
II
2nd/3rd line
Metastatic gastric cancer
durvalumab vs tremelimumab vs durva + treme
FPD Q2 2016Data expected 2017
Recruiting
 
 
f) MEDI0562 (cancer)
During the period, AstraZeneca made a final selection of the OX40 agonist to take forward to mid- and late-stage development. The fully-humanised OX40 monoclonal antibody, MEDI562 is advancing in Phase I as a monotherapy and in combination with durvalumab or tremelimumab. Data compiled from the murine OX40 (MEDI6469) and fusion-protein OX40 (MEDI6383) programmes have informed and directed the ongoing development of MEDI0562.
 
 
Infection & Neuroscience
 
a) Zavicefta (serious infections)
On 28 June 2016, the EMA granted marketing authorisation to Zavicefta (ceftazidime and avibactam, previously known as CAZ AVI) for a broad label of indications covering complicated intra-abdominal infections, complicated urinary tract infections including pyelonephritis (infection of the kidney), and hospital-acquired pneumonia, including ventilator-associated pneumonia. The approval also included using Zavicefta to treat infections caused by aerobic Gram-negative organisms in adult patients who have limited treatment options, an indication which, to date, has not been awarded to any other novel antibiotic medicine.
 
On 21 July 2016, the Company announced positive results from the Phase III REPROVE trial, which assessed the efficacy of Zavicefta compared with meropenem in the treatment of adult patients with hospital-acquired pneumonia, including ventilator-associated pneumonia. Zavicefta met the primary objective of statistical non-inferiority compared to meropenem at the test of cure visit (day 21 from randomisation). The trial showed an adverse event profile consistent with current knowledge of the safety profile of the medicines.
 
b) Pandemic Live Attenuated Influenza Vaccine (P/LAIV) (pandemic influenza)
On 1 April 2016, the Committee for Medicinal Products for Human Use of the EMA issued a positive opinion recommending the conditional approval of P/LAIV. P/LAIV is indicated for the prevention of influenza in a pandemic setting in children and adolescents. In the event that the World Health Organization declares a pandemic, a dossier can be submitted for conversion to full approval, providing an expedient public-health tool to protect European children.
 
 
ASTRAZENECA DEVELOPMENT PIPELINE 30 JUNE 2016
 
AstraZeneca-sponsored or -directed studies
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.
†    US and EU dates correspond to anticipated acceptance of the regulatory submission.
#    Collaboration.
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Submission / Submission Acceptance†
 
 
 
US
EU
Japan
China
 
 
Respiratory & Autoimmunity
 
 
 
 
 
 
 
Zurampic#1 (lesinurad)CLEAR 1,2CRYSTAL
 
 
selective uric acid reabsorption inhibitor (URAT-1)
 
 
chronic treatment of hyperuricemia in patients with gout
 
 
Q4 2011
 
 
Approved
 
 
Approved
 
 
 
 
N/A
 
 
N/A
 
 
Bevespi Aerosphere (PT003)
 
 
LABA/LAMA
 
 
COPD
 
 
Q2 2013
 
 
Approved
 
 
 2017
 
 
2017
 
 
2017
 
 
brodalumab#2AMAGINE-1,2,3
 
 
IL-17R mAb
 
 
psoriasis
 
 
Q3 2012
 
 
Accepted
 
 
Accepted
 
 
N/A
 
 
N/A
benralizumab#
CALIMA SIROCCO ZONDA BISE BORA
 
GREGALE
 
 
IL-5R mAb
 
 
severe asthma
 
 
Q4 2013
 
 
H2 2016
 
 
H2 2016
 
 
N/A
 
 
N/A
 
 
benralizumab#
TERRANOVA GALATHEA
 
 
IL-5R mAb
 
 
COPD
 
 
Q3 2014
 
 
2018
 
 
2018
 
 
N/A
 
 
N/A
 
 
PT010
 
 
LABA/LAMA/ICS
 
 
COPD
 
 
Q3 2015
 
 
2018
 
 
2018
 
 
2018
 
 
2019
 
 
tralokinumab
STRATOS 1,2
TROPOS
MESOS
 
 
IL-13 mAb
 
 
severe asthma
 
 
Q3 2014
 
 
2018
 
 
2018
 
 
2018
 
 
 
anifrolumab# TULIP
 
 
IFN-alphaR mAb
 
 
systemic lupus erythematosus
 
 
Q3 2015
 
 
2019
(Fast Track)
 
 
2019
 
 
2019
 
 
 
Cardiovascular & Metabolic Diseases
 
 
 
 
 
 
 
Brilinta3
 
 
P2Y12 receptor antagonist
 
 
arterial thrombosis
 
 
 
Launched
 
 
Launched
 
 
Accepted
 
 
Launched
 
 
Farxiga4
 
 
SGLT2 inhibitor
 
 
type-2 diabetes
 
 
 
Launched
 
 
Launched
 
 
Launched
 
 
Accepted
 
 
Epanova#
 
 
omega-3 carboxylic acids
 
 
severe hypertrigly-ceridemia
 
 
 
Approved
 
 
 
2018
 
 
 
ZS-9 (sodium zirconium cyclosilicate)
 
 
potassium binder
 
 
hyperkalaemia
 
 
 
H2 2016
 
 
Accepted
 
 
 
 
roxadustat# OLYMPUS (US) ROCKIES (US)
 
 
hypoxia-inducible factor prolyl hydroxylase inhibitor
 
 
anaemia in CKD/ESRD
 
 
Q3 2014
 
 
2018
 
 
N/A
 
 
N/A
 
 
H2 20165
 
 
Oncology
 
 
 
 
 
 
 
Tagrisso
AURA, AURA 2, (AURA17 Asia regional)
 
 
EGFR tyrosine kinase inhibitor
 
 
≥2nd-line advanced EGFRm T790M NSCLC
 
 
 
Q2 2014
 
 
Launched
(Breakthrough Therapy, Priority Review, Orphan drug)
 
 
Launched (Accelerated assessment)
 
 
Approved
 
 
H2 2016
 
 
Tagrisso
AURA 3
 
 
EGFR tyrosine kinase inhibitor
 
 
≥2nd-line advanced EGFRm T790M NSCLC
 
 
Q3 2014
 
 
2017
 
 
 
 
2017
 
 
2017
 
 
2018
 
 
cediranib
ICON 6
 
 
VEGFR tyrosine kinase inhibitor
 
 
PSR ovarian cancer
 
 
Q2 2007
 
 
 
Accepted (Orphan drug)
 
 
 
 
acalabrutinib# (ACP-196)
 
 
Bruton's tyrosine kinase (BTK) inhibitor
 
 
B-cell blood cancers
 
 
Q1 2015
 
 
H2 2016
(Orphan drug)
 
 
 
 
 
selumetinib#SELECT-1
 
 
MEK inhibitor
 
 
2nd-line KRASm NSCLC
 
 
Q4 2013
 
 
2017
 
 
2017
 
 
 
 
selumetinib#ASTRA
 
 
MEK inhibitor
 
 
differentiated thyroid cancer
 
 
Q3 2013
 
 
2018
(Orphan drug)6
 
 
2018
 
 
 
 
moxetumomab pasudotox#
PLAIT
 
 
anti-CD22 recombinantimmunotoxin
 
 
hairy cell leukaemia
 
 
Q2 2013
 
 
2017
(Orphan drug)
 
 
2018
 
 
 
 
durvalumab#PACIFIC
 
 
PD-L1 mAb
 
 
stage III NSCLC
 
 
Q2 2014
 
 
2017
 
 
 
2020
 
 
2020
 
 
 
durvalumab# +
tremelimumabARCTIC
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
3rd-line NSCLC
 
 
Q2 2015
 
 
2017
 
 
2017
 
 
2017
 
durvalumab# + tremelimumab
MYSTIC
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
 
1st-line NSCLC
 
 
Q3 2015
 
 
 
2017
 
 
 
2017
 
 
 
2017
 
 
 
2020
durvalumab# + tremelimumab
 
NEPTUNE
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
1st-line NSCLC
 
 
Q4 2015
 
 
2019
 
 
2019
 
 
2019
 
 
 
durvalumab#HAWK
 
 
PD-L1 mAb
 
 
2nd-line SCCHN (PD-L1 positive)
 
 
Q1 2015
 
 
 
2017
(Fast Track)
 
 
2019
 
 
2019
 
 
 
durvalumab# + tremelimumabCONDOR
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
2nd-line SCCHN (PD-L1 negative)
 
 
Q2 2015
 
 
2017
 
 
2019
 
 
2019
 
durvalumab# + tremelimumabKESTREL
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
 
1st-line SCCHN
 
 
Q4 2015
 
 
 
2018
 
 
 
2018
 
 
 
2018
 
 
durvalumab# + tremelimumabEAGLE
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
 
2nd-line SCCHN
 
 
Q4 2015
 
 
 
2019
 
 
 
2019
 
 
 
2019
 
 
durvalumab# + tremelimumab
ALPS
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
 
metastatic pancreatic ductal carcinoma
 
 
Q4 2015
 
 
 
2017
 
 
2017
 
 
 
2017
 
 
durvalumab# + tremelimumab
DANUBE
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
 
1st-line bladder cancer
 
 
Q4 2015
 
 
 
2018
 
 
 
 
 
2018
 
 
 
2018
 
 
 
 
Infection & Neuroscience
 
 
 
 
 
 
 
Zinforo#
 
 
extended spectrum cephalosporin with affinity to penicillin-binding proteins
 
 
pneumonia/skin infections
 
 
 
N/A
 
 
Launched
 
 
N/A
 
 
Submitted
 
 
Zavicefta#
(CAZ AVI#)
 
 
cephalosporin/ beta lactamase inhibitor
 
 
hospital-acquired pneumonia/ ventilator-associated pneumonia
 
 
Q2 2013
 
 
N/A
 
 
 Approved7
 
 
N/A
 
 
2017
 
 
Zavicefta#
 
 
cephalosporin/
beta lactamase inhibitor
 
 
serious infections, complicated intra-abdominal infection, complicated urinary tract infection
 
 
Q1 2012
 
 
N/A
 
 
 Approved7
 
 
N/A
 
 
2017
 
 
MEDI-550
 
 
pandemic influenza virus vaccine
 
 
pandemic influenza prophylaxis
 
 
 
N/A
 
 
Approved8
 
 
N/A
 
 
N/A
 
 
AZD3293#
AMARANTH
 
 
beta-secretase inhibitor
 
 
Early Alzheimer's disease
 
 
Q2 2016
 
 
2020
 
 
2020
 
 
2020
 
¶    Registrational Phase II trial
1    AstraZeneca announced it has granted Ironwood exclusive US rights (26 April 2016) and Grünenthal exclusive rights in Europe and Latin America (2 June 2016)
2    AstraZeneca and Valeant agreed to terminate the licence for Valeant's right to develop and commercialise brodalumab in Europe.    AstraZeneca entered into an agreement with LEO Pharma for the exclusive licence to brodalumab in Europe (1 July 2016)
3    Brilinta in the US; Brilique in rest of world
4    Farxiga in the US; Forxiga in rest of world
5    Rolling NDA submission to be initiated in H2 2016
6    FDA granted Orphan Drug Designation 10 May 2016
7    EU approval received 24 June 2016
8    EU approval received 20 May 2016
 
Phases I and II
 
NMEs and significant additional indications
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
Respiratory & Autoimmunity
 
 
PT010
 
 
LABA/LAMA/ICS
 
 
asthma
 
 
II
 
 
Q2 2014
 
 
tralokinumab#1
 
 
IL-13 mAb
 
 
atopic dermatitis
 
 
II
 
 
Q1 2015
 
 
anifrolumab#
 
 
IFN-alphaR mAb
 
 
lupus nephritis
 
 
II
 
 
Q4 2015
 
 
anifrolumab#
 
 
IFN-alphaR mAb
 
 
systemic lupus erythematosus (subcutaneous)
 
 
I
 
 
Q4 2015
 
 
verinurad
 
 
selective uric acid reabsorption inhibitor (URAT-1)
 
 
chronic treatment of hyperuricemia in patients with gout
 
 
II
 
 
Q3 2013
 
 
abediterol
 
 
LABA
 
 
asthma/COPD
 
 
II
 
 
Q4 2007
 
 
AZD7594
 
 
inhaled SGRM
 
 
asthma/COPD
 
 
II
 
 
Q3 2015
 
 
AZD7624
 
 
inhaled P38 inhibitor
 
 
COPD
 
 
II
 
 
Q4 2014
 
 
AZD9412#
 
 
inhaled interferon beta
 
 
asthma/COPD
 
 
II
 
 
Q3 2015
 
 
mavrilimumab#
 
 
GM-CSFR mAb
 
 
rheumatoid arthritis
 
 
II
 
 
Q1 2010
 
 
inebilizumab#
 
 
CD19 mAb
 
 
neuromyelitis optica
 
 
II
 
 
Q1 2015
(Orphan drug)
 
 
MEDI2070#
 
 
IL-23 mAb
 
 
Crohn's disease
 
 
II
 
 
Q1 2013
 
 
tezepelumab#
 
 
TSLP mAb
 
 
asthma / atopic dermatitis
 
 
II
 
 
Q2 2014
 
 
lesinurad + allopurinol FDC#2
 
 
selective uric acid reabsorption inhibitor (URAT-1)+xanthine oxidase inhibitor FDC
 
 
chronic treatment of hyperuricemia in patients with gout
 
 
I
 
 
Q4 2015
 
 
AZD1419#
 
 
TLR9 agonist
 
 
Asthma
 
 
I
 
 
Q3 2013
 
 
AZD5634
 
 
inhaled ENaC
 
 
cystic fibrosis
 
 
I
 
 
Q1 2016
 
 
AZD7986
 
 
DPP1
 
 
COPD
 
 
I
 
 
Q4 2014
 
 
AZD8871
 
 
MABA
 
 
COPD
 
 
I
 
 
Q4 2015
 
 
AZD9567
 
 
oral SGRM
 
 
rheumatoid arthritis
 
 
I
 
 
Q4 2015
 
 
MEDI0700#
 
 
BAFF/B7RP1 bispecific mAb
 
 
systemic lupus erythematosus
 
 
I
 
 
Q1 2016
 
 
MEDI4920
 
 
anti-CD40L-Tn3 fusion protein
 
 
primary Sjögren's syndrome
 
 
I
 
 
Q2 2014
 
 
MEDI5872#
 
 
B7RP1 mAb
 
 
systemic lupus erythematosus
 
 
I
 
 
Q4 2008
 
 
MEDI9314
 
 
IL-4R mAb
 
 
atopic dermatitis
 
 
I
 
 
Q1 2016
 
 
Cardiovascular & Metabolic Diseases
 
 
MEDI4166
 
 
PCSK9/GLP-1 mAb + peptide fusion
 
 
diabetes / cardiovascular
 
 
II
 
 
Q1 2016
 
 
MEDI6012
 
 
LCAT
 
 
ACS
 
 
II
 
 
Q4 2015
 
 
AZD4076
 
 
anti-miR103/107 oligonucleotide
 
 
non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
 
 
I
 
 
Q4 2015
 
 
AZD5718
 
 
FLAP
 
 
CAD
 
 
I
 
 
Q1 2016
 
 
MEDI0382
 
 
GLP-1/
glucagon dual agonist
 
 
diabetes / obesity
 
 
I
 
 
Q1 2015
 
 
MEDI8111
 
 
Rh-factor II
 
 
trauma / bleeding
 
 
I
 
 
Q1 2014
 
 
Oncology
 
 
durvalumab#
 
 
PD-L1 mAb
 
 
bladder cancer
 
 
II
 
 
Q1 2016
(Breakthrough Therapy)
durvalumab#
PD-L1 mAb
solid tumours
II
Q3 2014
durvalumab# + tremelimumab
PD-L1 mAb + CTLA-4 mAb
gastric cancer
II
Q2 2015
durvalumab# + AZD5069
PD-L1 mAb + CXCR2
SCCHN
II
Q3 2015
durvalumab# + AZD9150#
 
 
PD-L1 mAb + STAT3 inhibitor
 
 
durvalumab#
 
 
PD-L1 mAb
 
 
solid tumours
 
 
I
 
 
Q3 2014
 
 
durvalumab# + monalizumab
 
 
PD-L1 mAb + NKG2a mAb
 
 
solid tumours
 
 
I
 
 
Q1 2016
 
 
durvalumab# + MEDI9447
 
 
PD-L1 mAb + CD73 mAb
 
 
solid tumours
 
 
I
 
 
Q1 2016
 
 
durvalumab# + Iressa
 
 
PD-L1 mAb+ EGFR tyrosine kinase inhibitor
 
 
NSCLC
 
 
I
 
 
Q2 2014
 
 
durvalumab# + MEDI0680
 
 
PD-L1 mAb + PD-1 mAb
 
 
solid tumours
 
 
I
 
 
Q2 2014
 
 
durvalumab# + dabrafenib + trametinib
 
 
PD-L1 mAb+ BRAF inhibitor + MEK inhibitor
 
 
melanoma
 
 
I
 
 
Q1 2014
 
 
durvalumab# + tremelimumab
 
 
PD-L1 mAb + CTLA-4 mAb
 
 
solid tumours
 
 
I
 
 
Q4 2013
 
 
Tagrisso + (durvalumab# or selumetinib# or savolitinib#)
TATTON
 
 
EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor)
 
 
advanced EGFRm NSCLC
 
 
II
 
 
Q2 2016
 
 
selumetinib + durvalumab#
 
 
MEK inhibitor + PD-L1 mAb
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
savolitinib/volitinib#
 
 
MET tyrosine kinase inhibitor
 
 
papillary renal cell carcinoma
 
 
II
 
 
Q2 2014
 
 
AZD1775# + chemotherapy
 
 
Wee1 inhibitor + chemotherapy
 
 
ovarian cancer
 
 
II
 
 
Q4 2012
 
 
AZD1775#
 
 
Wee1 inhibitor
 
 
solid tumours
 
 
I
 
 
Q3 2015
 
 
AZD1775# + Lynparza
 
 
Wee1 inhibitor + PARP inhibitor
 
 
solid tumours
 
 
I
 
 
Q3 2015
 
 
AZD1775# + durvalumab#
 
 
Wee1 inhibitor +
PD-L1 mAb
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
vistusertib (AZD2014)
 
 
mTOR serine/ threonine kinase inhibitor
 
 
solid tumours
 
 
II
 
 
Q1 2013
 
 
AZD3759 BLOOM
 
 
EGFR tyrosine kinase inhibitor
 
 
brain metastases in advanced EGFRm NSCLC
 
 
 
II
 
 
Q4 2015
 
 
Tagrisso BLOOM
 
 
EGFR tyrosine kinase inhibitor
 
 
AZD5363#
 
 
AKT kinase inhibitor
 
 
breast cancer
 
 
II
 
 
Q1 2014
 
 
AZD4547
 
 
FGFR tyrosine kinase inhibitor
 
 
solid tumours
 
 
II
 
 
Q4 2011
 
 
inebilizumab#
 
 
CD19 mAb
 
 
diffuse B-cell lymphoma
 
 
II
 
 
Q1 2012
 
 
MEDI-573#
 
 
IGF mAb
 
 
metastatic breast cancer
 
 
II
 
 
Q2 2012
 
 
AZD0156
 
 
ATM serine/threonine kinase inhibitor
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
AZD2811#
 
 
Aurora B kinase inhibitor
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
AZD6738
 
 
ATR serine/threonine kinase inhibitor
 
 
solid tumours
 
 
I
 
 
Q4 2013
 
 
AZD8186
 
 
PI3 kinase beta 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
 
 
AZD4635
 
 
A2aR inhibitor
 
 
solid tumours
 
 
I
 
 
Q2 2016
 
 
MEDI0562#
 
 
humanised OX40 agonist
 
 
solid tumours
 
 
I
 
 
Q1 2015
 
 
MEDI0562# + tremelimumab
 
 
humanised OX40 agonist + CTLA-4 mAb
 
 
solid tumours
 
 
I
 
 
Q2 2016
 
 
MEDI0562# + durvalumab#
 
 
humanised OX40 agonist + PD-L1 mAb
 
 
solid tumours
 
 
I
 
 
Q2 2016
 
 
MEDI-565#
 
 
CEA BiTE mAb
 
 
solid tumours
 
 
I
 
 
Q1 2011
 
 
MEDI0680
 
 
PD-1 mAb
 
 
solid tumours
 
 
I
 
 
Q4 2013
 
 
MEDI1873
 
 
GITR agonist fusion protein
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
MEDI3617#
 
 
ANG-2 mAb
 
 
solid tumours
 
 
I
 
 
Q4 2010
 
 
MEDI4276
 
 
HER2 bispecific ADC mAb
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
MEDI9197#
 
 
TLR 7/8 agonist
 
 
solid tumours
 
 
I
 
 
Q4 2015
 
 
MEDI9447
 
 
CD73 mAb
 
 
solid tumours
 
 
I
 
 
Q3 2015
 
 
Infection & Neuroscience
 
 
CXL#
 
 
beta lactamase inhibitor / cephalosporin
 
 
methicillin-resistant S. aureus
 
 
II
 
 
Q4 2010
 
 
AZD3241
 
 
myeloperoxidase inhibitor
 
 
multiple system atrophy
 
 
II
 
 
Q2 2015
(Orphan drug)
 
 
MEDI3902
 
 
Psl/PcrV bispecific mAb
 
 
prevention of nosocomial pseudomonas pneumonia
 
 
II
 
 
Q2 2016
(Fast Track, US)
 
 
MEDI4893
 
 
mAb binding to S. aureus toxin
 
 
hospital-acquired pneumonia / serious S. aureus infection
 
 
II
 
 
Q4 2014
(Fast Track, US)
 
 
MEDI7510
 
 
RSV sF+GLA-SE
 
 
prevention of RSV disease in older adults
 
 
II
 
 
Q3 2015
 
 
MEDI8852
 
 
influenza A mAb
 
 
influenza A treatment
 
 
II
 
 
Q4 2015
(Fast Track, US)
 
 
MEDI8897#
 
 
RSV mAb-YTE
 
 
passive RSV prophylaxis
 
 
II
 
 
Q1 2015
(Fast Track, US
 
 
ATM AVI#
 
 
monobactam/ beta lactamase inhibitor
 
 
targeted serious bacterial infections
 
 
II
 
 
Q2 2016
 
 
AZD8108
 
 
NMDA antagonist
 
 
suicidal ideation
 
 
I
 
 
Q4 2014
 
 
MEDI1814
 
 
amyloid beta mAb
 
 
Alzheimer's disease
 
 
I
 
 
Q2 2014
 
 
MEDI7352
 
 
NGF/TNF bispecific mAb
 
 
osteoarthritis pain
 
 
I
 
 
Q1 2016
1    AstraZeneca entered licensing agreement with LEO Pharma (1 July 2016)
2    AstraZeneca announced it granted Ironwood exclusive US rights (26 April 2016) and Grünenthal exclusive rights in Europe and Latin America (2 June 2016)
 
Significant Lifecycle Management (LCM)
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Submission Acceptance†
 
 
 
US
EU
Japan
China
 
 
Respiratory & Autoimmunity
 
 
 
 
 
 
 
Symbicort
SYGMA
 
 
ICS/LABA
 
 
as-needed use in mild asthma
 
 
Q4 2014
 
 
N/A
 
 
2018
 
 
 
2019
 
 
Symbicort
 
 
ICS/LABA
 
 
breath actuated Inhaler asthma/COPD
 
 
 
2018
 
 
 
 
 
Duaklir Genuair#
 
 
LAMA/LABA
 
 
COPD
 
 
 
2018
 
 
Launched
 
 
2018
 
 
2018
 
 
Cardiovascular & Metabolic Diseases
 
 
 
 
 
 
 
Brilinta1PEGASUS-TIMI 54
 
 
P2Y12 receptor antagonist
 
 
outcomes trial in patients with prior myocardial infarction
 
 
Q4 2010
 
 
Launched
(Priority Review)
 
 
Launched
 
 
Accepted
 
 
Accepted
 
 
Brilinta1
EUCLID
 
 
P2Y12 receptor antagonist
 
 
outcomes trial in patients with peripheral artery disease
 
 
Q4 2012
 
 
2017
 
 
2017
 
 
2017
 
 
2018
 
 
Brilinta1
THEMIS
 
 
P2Y12 receptor antagonist
 
 
outcomes trial in patients with type-2 diabetes and CAD, but without a previous history of MI or stroke
 
 
Q1 2014
 
 
2018
 
 
2018
 
 
2018
 
 
2019
 
 
Brilinta1
HESTIA
 
 
P2Y12 receptor antagonist
 
 
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
 
 
Q1 2014
 
 
2020
 
 
2020
 
 
 
 
Onglyza
SAVOR-TIMI 53
 
 
DPP-4 inhibitor
 
 
type-2 diabetes outcomes trial
 
 
Q2 2010
 
 
Launched
 
 
Launched
 
 
 
Accepted2
 
 
Kombiglyze XR/Komboglyze3
 
 
DPP-4 inhibitor/ metformin FDC
 
 
type-2 diabetes
 
 
 
Launched
 
 
Launched
 
 
 
Submitted
 
 
Farxiga4 DECLARE-TIMI 58
 
 
SGLT2 inhibitor
 
 
type-2 diabetes outcomes trial
 
 
Q2 2013
 
 
2020
 
 
2020
 
 
 
 
Farxiga4
 
 
SGLT2 inhibitor
 
 
type-1 diabetes
 
 
Q4 2014
 
 
2018
 
 
2017
 
 
2018
 
 
 
Xigduo XR/
Xigduo5
 
 
SGLT2 inhibitor/ metformin FDC
 
 
type-2 diabetes
 
 
 
Launched
 
 
Launched
 
 
Qtern (saxagliptin/
dapagliflozin FDC)
DPP-4 inhibitor/ SGLT2 inhibitor FDC
type-2 diabetes
Q2 2012
Accepted
Approved6
 
 
 
 
Bydureon weeklysuspension
 
 
GLP-1 receptor agonist
 
 
type-2 diabetes
 
 
Q1 2013
 
 
2017
 
 
2017
 
 
 
 
Bydureon EXSCEL
 
 
GLP-1 receptor agonist
 
 
type-2 diabetes outcomes trial
 
 
Q2 2010
 
 
2018
 
 
2018
 
 
2018
 
 
 
Epanova
STRENGTH
 
 
omega-3 carboxylic acids
 
 
outcomes trial in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol
 
 
Q4 2014
 
 
2020
 
 
2020
 
 
2020
 
 
2020
 
 
Oncology
 
 
 
 
 
 
 
Faslodex
FALCON
 
 
oestrogen receptor antagonist
 
 
1st-line hormone receptor +ve advanced breast cancer
 
 
Q4 2012
 
 
H2 2016
 
 
H2 2016
 
 
H2 2016
 
 
2020
 
 
Lynparza OlympiAD
 
 
PARP inhibitor
 
 
gBRCA metastatic breast cancer
 
 
Q2 2014
 
 
2017
 
 
2017
 
 
2017
 
 
 
Lynparza      SOLO-2
 
 
PARP inhibitor
 
 
2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
 
 
Q3 2013
 
 
2017
(Fast Track)
 
 
2017
 
 
2017
 
 
 
Lynparza      SOLO-1
 
 
PARP inhibitor
 
 
1st-line BRCAm ovarian cancer
 
 
Q3 2013
 
 
2018
 
 
2018
 
 
2018
 
 
 
Lynparza      SOLO-3
 
 
PARP inhibitor
 
 
gBRCA PSR ovarian cancer
 
 
Q1 2015
 
 
2018
 
 
 
 
 
Lynparza       POLO
 
 
PARP inhibitor
 
 
pancreatic cancer
 
 
Q1 2015
 
 
2018
 
 
2018
 
 
2018
 
 
 
Lynparza
 
 
PARP inhibitor
 
 
prostate cancer
 
 
Q3 2014
 
 
 
(Breakthrough Therapy)
 
 
 
 
 
Lynparza
OlympiA
 
 
PARP inhibitor
 
 
gBRCA adjuvant breast cancer
 
 
Q2 2014
 
 
2020
 
 
2020
 
 
2020
 
 
 
Tagrisso
FLAURA
 
 
EGFR tyrosine kinase inhibitor
 
 
1st-line advanced EGFRm NSCLC
 
 
Q1 2015
 
 
2017
 
 
2017
 
 
2017
 
 
2017
Tagrisso
 
ADAURA
 
 
EGFR tyrosine kinase inhibitor
 
 
adjuvant EGFRm NSCLC
 
 
Q4 2015
 
 
2022
 
 
2022
 
 
2022
 
 
2022
 
 
Infection & Neuroscience
 
 
 
 
 
 
 
Nexium
 
 
proton pump inhibitor
 
 
stress ulcer prophylaxis
 
 
 
 
 
 
H2 2016
 
 
Nexium
 
 
proton pump inhibitor
 
 
paediatrics
 
 
 
Launched
 
 
Launched
 
 
H2 2016
 
 
Accepted
 
 
linaclotide#
 
 
GC-C receptor peptide agonist
 
 
irritable bowel syndrome with constipation(IBS-C)
 
 
 
N/A
 
 
N/A
 
 
N/A
 
 
Accepted
1    Brilinta in the US; Brilique in rest of world
2    Submission filed and accepted July 2016
3    Kombiglyze XR in the US; Komboglyze in the EU
4    Farxiga in the US; Forxiga in rest of world
5    Xigduo XR in the US; Xigduo in the EU
6    EU approval 19 July 2016
 
Terminations (discontinued projects between 1 April and 30 June 2016)
 
 
 
NME / Line Extension
 
 
Compound
 
 
Reason for Discontinuation
 
 
Area Under Investigation
 
 
NME
 
 
MEDI7836
 
 
Safety/Efficacy
 
 
asthma
 
 
NME
 
 
MEDI6383#
 
 
Strategic
 
 
solid tumours
 
 
NME
 
 
durvalumab# + MEDI6383#
 
 
Strategic
 
 
solid tumours
 
 
NME
 
 
MEDI0639
 
 
Safety/Efficacy
 
 
solid tumours
 
 
LCM
 
 
Epanova/Farxiga
 
 
Safety/Efficacy
 
 
non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
 
 
LCM
 
 
Lynparza GOLD
 
 
Safety/Efficacy
 
 
2nd-line gastric cancer
 
Completed Projects / Divestitures
 
Compound
Mechanism
Area Under Investigation
Completed/
Divested
Estimated Regulatory Submission Acceptance†
 
 
 
US
EU
Japan
China
 
 
Diprivan#1
 
 
sedative and anaesthetic
 
 
conscious sedation
 
 
Divested
 
 
N/A
 
 
Launched
 
 
Accepted
 
 
Launched
1    AstraZeneca announced it entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the Aspen Group, for its global anaethetics portfolio outside of the US on 9 June 2016.
 
Condensed Consolidated Statement of Comprehensive Income
For the half year ended 30 June
 
2016 
$m 
 
2015 
$m 
Product sales
 
11,034 
 
11,584 
Externalisation revenue
 
684 
 
780 
Total revenue
 
11,718 
 
12,364 
Cost of sales
 
(2,066)
 
(2,336)
Gross profit
 
9,652 
 
10,028 
Distribution costs
 
(167)
 
(161)
Research and development expense
 
(2,945)
 
(2,822)
Selling, general and administrative costs
 
(5,624)
 
(5,765)
Other operating income and expense
 
425 
 
576 
Operating profit
 
1,341 
 
1,856 
Finance income
 
31 
 
24 
Finance expense
 
(667)
 
(537)
Share of after tax losses in associates and joint ventures
 
(12)
 
(7)
Profit before tax
 
693 
 
1,336 
Taxation
 
(99)
 
(88)
Profit for the period
 
594 
 
1,248 
 
 
 
 
 
Other comprehensive income
 
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
 
Remeasurement of the defined benefit pension liability
 
(842)
 
242 
Tax on items that will not be reclassified to profit or loss
 
235 
 
(57)
 
 
(607)
 
185 
Items that may be reclassified subsequently to profit or loss
 
 
 
 
Foreign exchange arising on consolidation
 
(523)
 
(11)
Foreign exchange arising on designating borrowings in net investment hedges
 
(67)
 
(217)
Cash flow hedge losses
 
(103)
 
- 
Cash flow hedge gains transferred to the income statement
 
60 
 
- 
Fair value movements on derivatives designated in net investment hedges
 
(79)
 
20 
Amortisation of loss on cash flow hedge
 
1 
 
1 
Net available for sale losses taken to equity
 
(36)
 
(29)
Tax on items that may be reclassified subsequently to profit or loss
 
75 
 
43 
 
 
(672)
 
(193)
Other comprehensive income for the period, net of tax
 
(1,279)
 
(8)
Total comprehensive income for the period
 
(685)
 
1,240 
 
 
 
 
 
Profit attributable to:
 
 
 
 
Owners of the Parent
 
643 
 
1,247 
Non-controlling interests
 
(49)
 
1 
 
 
594 
 
1,248 
 
 
 
 
 
Total comprehensive income attributable to:
 
 
 
 
Owners of the Parent
 
(636)
 
1,239 
Non-controlling interests
 
(49)
 
1 
 
 
(685)
 
1,240 
 
 
 
 
 
Basic earnings per $0.25 Ordinary Share
 
$0.51 
 
$0.99 
Diluted earnings per $0.25 Ordinary Share
 
$0.51 
 
$0.99 
Weighted average number of Ordinary Shares in issue (millions)
 
1,264 
 
1,263 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,265 
 
1,265 
 
Condensed Consolidated Statement of Comprehensive Income
For the quarter ended 30 June
 
2016 
$m 
 
2015 
$m 
Product sales
 
5,469 
 
5,836 
Externalisation revenue
 
134 
 
471 
Total revenue
 
5,603 
 
6,307 
Cost of sales
 
(1,062)
 
(1,067)
Gross profit
 
4,541 
 
5,240 
Distribution costs
 
(91)
 
(84)
Research and development expense
 
(1,465)
 
(1,466)
Selling, general and administrative costs
 
(3,052)
 
(2,966)
Other operating income and expense
 
370 
 
199 
Operating profit
 
303 
 
923 
Finance income
 
17 
 
13 
Finance expense
 
(342)
 
(276)
Share of after tax losses in associates and joint ventures
 
(8)
 
(2)
(Loss)/Profit before tax
 
(30)
 
658 
Taxation
 
(1)
 
38 
(Loss)/Profit for the period
 
(31)
 
696 
 
 
 
 
 
Other comprehensive income
 
 
 
 
Items that will not be reclassified to profit or loss
 
 
 
 
Remeasurement of the defined benefit pension liability
 
(651)
 
259 
Tax on items that will not be reclassified to profit or loss
 
194 
 
(61)
 
 
(457)
 
198 
Items that may be reclassified subsequently to profit or loss
 
 
 
 
Foreign exchange arising on consolidation
 
(356)
 
438 
Foreign exchange arising on designating borrowings in net investment hedges
 
(274)
 
191 
Cash flow hedge losses
 
(103)
 
- 
Cash flow hedge gains transferred to the income statement
 
60 
 
- 
Fair value movements on derivatives designated in net investment hedges
 
(47)
 
(1)
Amortisation of loss on cash flow hedge
 
1 
 
1 
Net available for sale losses taken to equity
 
(7)
 
(48)
Tax on items that may be reclassified subsequently to profit or loss
 
65 
 
(57)
 
 
(661)
 
524 
Other comprehensive income for the period, net of tax
 
(1,118)
 
722 
Total comprehensive income for the period
 
(1,149)
 
1,418 
 
 
 
 
 
(Loss)/Profit attributable to:
 
 
 
 
Owners of the Parent
 
(3)
 
697 
Non-controlling interests
 
(28)
 
(1)
 
 
(31)
 
696 
 
 
 
 
 
Total comprehensive income attributable to:
 
 
 
 
Owners of the Parent
 
(1,121)
 
1,418 
Non-controlling interests
 
(28)
 
- 
 
 
(1,149)
 
1,418 
 
 
 
 
 
Basic earnings per $0.25 Ordinary Share
 
$0.00 
 
$0.55 
Diluted earnings per $0.25 Ordinary Share
 
$0.00 
 
$0.55 
Weighted average number of Ordinary Shares in issue (millions)
 
1,265 
 
1,264 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,265 
 
1,265 
 
Condensed Consolidated Statement of Financial Position
 
 
At 30 Jun 2016
$m
 
At 31 Dec 2015
$m
 
At 30 Jun 2015
$m
ASSETS
Non-current assets
 
 
 
 
 
 
Property, plant and equipment
 
6,613 
 
6,413 
 
 
 
6,134 
 
Goodwill
 
11,848 
 
11,868 
 
 
 
11,467 
 
Intangible assets
 
29,438 
 
22,646 
 
 
 
20,486 
 
Derivative financial instruments
 
337 
 
446 
 
 
 
471 
 
Investments in associates and joint ventures
 
105 
 
85 
 
 
 
52 
 
Other investments
 
470 
 
458 
 
 
 
448 
 
Other receivables
 
764 
 
907 
 
 
 
957 
 
Deferred tax assets
 
1,524 
 
1,294 
 
 
 
1,342 
 
 
 
51,099 
 
44,117 
 
 
 
41,357 
 
Current assets
 
 
 
 
 
 
Inventories
 
2,422 
 
2,143 
 
 
 
2,198 
 
Trade and other receivables
 
5,619 
 
6,622 
 
 
 
6,615 
 
Other investments
 
731 
 
613 
 
 
 
531 
 
Derivative financial instruments
 
5 
 
2 
 
 
 
51 
 
Income tax receivable
 
628 
 
387 
 
 
 
450 
 
Cash and cash equivalents
 
3,915 
 
6,240 
 
 
 
3,967 
 
 
 
13,320 
 
16,007 
 
 
 
13,812 
 
Total assets
 
64,419 
 
60,124 
 
 
 
55,169 
 
LIABILITIES
Current liabilities
 
 
 
 
 
 
Interest-bearing loans and borrowings
 
(1,060)
 
(916)
 
 
 
(2,705)
 
Trade and other payables
 
(10,259)
 
(11,663)
 
 
 
(10,659)
 
Derivative financial instruments
 
(57)
 
(9)
 
 
 
(6)
 
Provisions
 
(999)
 
(798)
 
 
 
(731)
 
Income tax payable
 
(1,960)
 
(1,483)
 
 
 
(2,049)
 
 
 
(14,335)
 
(14,869)
 
 
 
(16,150)
 
Non-current liabilities
 
 
 
 
 
 
Interest-bearing loans and borrowings
 
(16,519)
 
(14,137)
 
 
 
(8,303)
 
Derivative financial instruments
 
(103)
 
(1)
 
 
 
- 
 
Deferred tax liabilities
 
(4,076)
 
(2,733)
 
 
 
(1,582)
 
Retirement benefit obligations
 
(2,628)
 
(1,974)
 
 
 
(2,377)
 
Provisions
 
(426)
 
(444)
 
 
 
(479)
 
Other payables
 
(10,942)
 
(7,457)
 
 
 
(7,979)
 
 
 
(34,694)
 
(26,746)
 
 
 
(20,720)
 
Total liabilities
 
(49,029)
 
(41,615)
 
 
 
(36,870)
 
Net assets
 
15,390 
 
18,509 
 
 
 
18,299 
 
EQUITY
 
 
 
 
 
 
Capital and reserves attributable to equity holders of the Company
 
 
 
 
 
 
Share capital
 
316 
 
316 
 
 
 
316 
 
Share premium account
 
4,326 
 
4,304 
 
 
 
4,281 
 
Other reserves
 
2,030 
 
2,036 
 
 
 
2,033 
 
Retained earnings
 
6,858 
 
11,834 
 
 
 
11,649 
 
 
 
13,530 
 
18,490 
 
 
 
18,279 
 
Non-controlling interests
 
1,860 
 
19 
 
 
 
20 
 
Total equity
 
15,390 
 
18,509 
 
 
 
18,299 
 
 
 
 
 
 
 
 
 
 
Condensed Consolidated Statement of Cash Flows
 
For the half year ended 30 June
 
2016
$m 
 
2015 
$m 
Cash flows from operating activities
 
 
 
 
Profit before tax
 
693 
 
1,336 
Finance income and expense
 
636 
 
513 
Share of after tax losses in associates and joint ventures
 
12 
 
7 
Depreciation, amortisation and impairment
 
1,156 
 
1,565 
Increase in working capital and short-term provisions
 
(183)
 
(767)
Non-cash and other movements
 
(380)
 
(612)
Cash generated from operations
 
1,934 
 
2,042 
Interest paid
 
(298)
 
(252)
Tax paid
 
(262)
 
(782)
Net cash inflow from operating activities
 
1,374 
 
1,008 
Cash flows from investing activities
 
 
 
 
Movement in short-term investments and fixed deposits
 
(15)
 
273 
Purchase of property, plant and equipment
 
(584)
 
(497)
Disposal of property, plant and equipment
 
8 
 
16 
Purchase of intangible assets
 
(723)
 
(1,222)
Disposal of intangible assets
 
102 
 
350 
Purchase of non-current asset investments
 
(66)
 
(30)
Disposal of non-current asset investments
 
- 
 
56 
Payments to joint ventures
 
(15)
 
- 
Upfront payments on business acquisitions
 
(2,564)
 
- 
Payment of contingent consideration on business acquisitions
 
(141)
 
(239)
Interest received
 
63 
 
59 
Payments made by subsidiaries to non-controlling interests
 
(13)
 
- 
Net cash outflow from investing activities
 
(3,948)
 
(1,234)
Net cash outflow before financing activities
 
(2,574)
 
(226)
Cash flows from financing activities
 
 
 
 
Proceeds from issue of share capital
 
22 
 
20 
New long-term loans
 
2,483 
 
- 
Repayment of loans
 
- 
 
(884)
Dividends paid
 
(2,409)
 
(2,357)
Hedge contracts relating to dividend payments
 
5 
 
(43)
Repayment of obligations under finance leases
 
(8)
 
(34)
Movement in short-term borrowings
 
(99)
 
910 
Net cash outflow from financing activities
 
(6)
 
(2,388)
Net decrease in cash and cash equivalents in the period
 
(2,580)
 
(2,614)
Cash and cash equivalents at the beginning of the period
 
6,051 
 
6,164 
Exchange rate effects
 
34 
 
(29)
Cash and cash equivalents at the end of the period
 
3,505 
 
3,521 
Cash and cash equivalents consists of:
 
 
 
 
Cash and cash equivalents
 
3,915 
 
3,967 
Overdrafts
 
(410)
 
(446)
 
 
3,505 
 
3,521 
 
 
 
 
 
 
 
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 2015
 
 
 
316
 
 
 
 
4,261
 
 
 
 
2,021
 
 
 
 
13,029 
 
 
 
 
19,627 
 
 
 
 
19 
 
 
 
 
19,646 
 
 
 
Profit for the period
 
 
 
-
 
 
 
 
-
 
 
 
 
-
 
 
 
 
1,247 
 
 
 
 
1,247 
 
 
 
 
1 
 
 
 
 
1,248 
 
 
 
Other comprehensive income
 
 
 
-
 
 
 
 
-
 
 
 
 
-
 
 
 
 
(8)
 
 
 
 
(8)
 
 
 
 
- 
 
 
 
 
(8)
 
 
 
Transfer to other reserves
 
 
 
-
 
 
 
 
-
 
 
 
 
12
 
 
 
 
(12)
 
 
 
 
- 
 
 
 
 
- 
 
 
 
 
- 
 
 
 
Transactions with owners:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dividends
 
 
 
-
 
 
 
 
-
 
 
 
 
-
 
 
 
 
(2,400)
 
 
 
 
(2,400)
 
 
 
 
- 
 
 
 
 
(2,400)
 
 
 
Issue of Ordinary Shares
 
 
 
-
 
 
 
 
20
 
 
 
 
-
 
 
 
 
- 
 
 
 
 
20 
 
 
 
 
- 
 
 
 
 
20 
 
 
 
Share-based payments
 
 
 
-
 
 
 
 
-
 
 
 
 
-
 
 
 
 
(207)
 
 
 
 
(207)
 
 
 
 
- 
 
 
 
 
(207)
 
Net movement
 
 
 
-
 
 
 
 
20
 
 
 
 
12
 
 
 
 
(1,380)
 
 
 
 
(1,348)
 
 
 
 
1 
 
 
 
 
(1,347)
 
At 30 Jun 2015
 
 
 
316
 
 
 
 
4,281
 
 
 
 
2,033
 
 
 
 
11,649 
 
 
 
 
18,279 
 
 
 
 
20 
 
 
 
 
18,299 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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)
 
 
 
Dividend 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 
 
 
 
* 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 2016 and their respective responsibilities can be found on pages 86 and 87 of the AstraZeneca Annual Report and Form 20-F Information 2015.
 
Approved by the Board and signed on its behalf by
 
Pascal Soriot
Chief Executive Officer
 
28 July 2016
 
Independent Review Report to AstraZeneca PLC
 
Introduction
 
We have been engaged by the Company to review the condensed set of Financial Statements in the half-yearly financial report for the six months ended 30 June 2016 (but not for the quarter ended 30 June 2016 as presented in the Condensed Consolidated Statement of Comprehensive Income for the quarter ended 30 June 2016) which comprises Condensed Consolidated Statement of Comprehensive Income, Condensed Consolidated Statement of Financial Position, Condensed Consolidated Statement of Cash Flows, Condensed Consolidated Statement of Changes in Equity and Notes 1 to 8. 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 condensed set of financial statements.
 
This report is made solely to the Company in accordance with the terms of our engagement to assist the Company in meeting the requirements of the Disclosure and Transparency Rules (the DTR) of the UK's Financial Conduct Authority (the UK FCA). Our review has been undertaken so that we might state to the Company those matters we are required to state to it in this report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone other than the Company for our review work, for this report, or for the conclusions we have reached.
 
Directors' responsibilities
 
The half-yearly financial report 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 DTR of the UK FCA.
 
As disclosed in Note 1, the annual financial statements of the Group are prepared in accordance with IFRSs as adopted by the EU. The condensed set of financial statements included in this half-yearly financial report has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU.
 
Our responsibility
 
Our responsibility is to express to the Company a conclusion on the condensed set of financial statements in the half-yearly financial report based on our review.
 
Scope of review
 
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 UK. 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.
 
Conclusion
 
Based on our review, nothing has come to our attention that causes us to believe that the condensed set of financial statements in the half-yearly financial report for the six months ended 30 June 2016 is not prepared, in all material respects, in accordance with IAS 34 as adopted by the EU and the DTR of the UK FCA.
 
 
Antony Cates
 
for and on behalf of KPMG LLP
Chartered Accountants
15 Canada Square
London E14 5GL
 
28 July 2016
 
 
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 2016 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 2015. There have been no significant new or revised accounting standards applied in the six months ended 30 June 2016.
 
Legal proceedings
The information contained in Note 7 updates the disclosures concerning legal proceedings and contingent liabilities in the Group's Annual Report and Form 20-F Information 2015.
 
Going concern
The Group has considerable financial resources available. As at 30 June 2016 the Group has $5.8bn in financial resources (cash balances of $3.9bn and undrawn committed bank facilities of $3bn which are available until April 2021, with only $1.1bn 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 Directors have a reasonable expectation that the Company and the Group have adequate resources to continue in operational existence for the foreseeable future. Accordingly, the interim financial statements have been prepared on a going concern basis.
 
Financial information
The comparative figures for the financial year ended 31 December 2015 are not the Company's statutory accounts for that financial year. Those accounts have been reported on by the Group's auditors and have been delivered to the registrar of companies. The report of the auditors 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 quarter ended 30 June 2016 is stated after charging restructuring costs of $463m ($308m for the second quarter of 2016). These have been charged to profit as follows:
 
 
 
H1 2016$m
 
H1 2015$m
 
Q2 2016$m
 
Q2 2015$m
Cost of sales
 
28
 
101
 
19
 
58
Research and development expense
 
107
 
124
 
69
 
62
Selling, general and administrative costs
 
328
 
223
 
220
 
115
Total
 
463
 
448
 
308
 
235
 
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.
 
 
At 1 Jan 
2016 
$m 
 
Cash Flow
$m 
 
Acquisitions
 
$m
 
Non-cash
& Other
$m
 
Exchange Movements
$m
 
At 30 Jun 
2016 
$m 
 
 
Loans due after one year
 
 
 
 
(14,109)
 
 
 
 
(2,483)
 
 
 
 
- 
 
 
 
 
(12)
 
 
 
 
94 
 
 
 
 
(16,510)
 
 
 
Finance leases due after one year
 
 
 
 
(28)
 
 
 
 
- 
 
 
 
 
- 
 
 
 
 
19 
 
 
 
 
- 
 
 
 
 
(9)
 
 
 
Total long-term debt
 
 
 
 
(14,137)
 
 
 
 
(2,483)
 
 
 
 
- 
 
 
 
 
7 
 
 
 
 
94 
 
 
 
 
(16,519)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Current instalments of finance leases
 
 
 
 
(67)
 
 
 
 
8 
 
 
 
 
- 
 
 
 
 
(31)
 
 
 
 
- 
 
 
 
 
(90)
 
 
 
Total current debt
 
 
 
 
(67)
 
 
 
 
8 
 
 
 
 
- 
 
 
 
 
(31)
 
 
 
 
- 
 
 
 
 
(90)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Investments
 
 
 
 
613 
 
 
 
 
17 
 
 
 
 
140 
 
 
 
 
15 
 
 
 
 
(37)
 
 
 
 
748 
 
 
 
Net derivative financial instruments
 
 
 
 
438 
 
 
 
 
10 
 
 
 
 
- 
 
 
 
 
(266)
 
 
 
 
- 
 
 
 
 
182 
 
 
 
Cash and cash equivalents
 
 
 
 
6,240 
 
 
 
 
(2,355)
 
 
 
 
- 
 
 
 
 
- 
 
 
 
 
30 
 
 
 
 
3,915 
 
 
 
Overdrafts
 
 
 
 
(189)
 
 
 
 
(225)
 
 
 
 
- 
 
 
 
 
- 
 
 
 
 
4 
 
 
 
 
(410)
 
 
 
Short-term borrowings
 
 
 
 
(660)
 
 
 
 
99 
 
 
 
 
- 
 
 
 
 
1 
 
 
 
 
- 
 
 
 
 
(560)
 
 
 
 
 
6,442 
 
 
 
 
(2,454)
 
 
 
 
140 
 
 
 
 
(250)
 
 
 
 
(3)
 
 
 
 
3,875 
 
 
 
Net debt
 
 
 
 
(7,762)
 
 
 
 
(4,929)
 
 
 
 
140 
 
 
 
 
(274)
 
 
 
 
91 
 
 
 
 
(12,734)
 
 
Non-cash movements in the period include fair value adjustments under IAS 39.
 
4      MAJORITY EQUITY INVESTMENT IN ACERTA PHARMA
On 2 February 2016, AstraZeneca completed an agreement to invest in a majority equity stake in Acerta Pharma, a privately-owned biopharmaceutical company based in the Netherlands and US. The transaction provides AstraZeneca with a potential best-in-class irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), currently in Phase III development for B-cell blood cancers and in Phase I/II clinical trials in multiple solid tumours.
 
Under the terms of the agreement, AstraZeneca has acquired 55% of the issued share capital of Acerta for an upfront payment of $2.5bn. A further payment of $1.5bn will be paid either on receipt of the first regulatory approval for acalabrutinib for any indication in the US, or the end of 2018, depending on which is first. The agreement also includes options which, if exercised, provide the opportunity for Acerta shareholders to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta. The options can be exercised at various points in time, conditional on the first approval of acalabrutinib in both the US and Europe and when the extent of the commercial opportunity has been fully established, at a price of approximately $3bn net of certain costs and payments incurred by AstraZeneca and net of agreed future adjusting items, using a pre-agreed pricing mechanism. Acerta has approximately 150 employees.
 
AstraZeneca's 55% holding is a controlling interest and Acerta's combination of intangible product rights with an established workforce and their operating processes requires that the transaction is accounted for as a business combination in accordance with IFRS 3.
 
Goodwill is principally attributable to the value of the specialist knowhow inherent in the acquired workforce and the accounting for deferred taxes. Goodwill is not expected to be deductible for tax purposes. Acerta Pharma's results have been consolidated into the Group's results from 2 February 2016. From the period from acquisition to 30 June 2016, Acerta Pharma had no revenues and its loss after tax was $112 million.
 
 
 
 
 
 
 
Fair value
$m
 
 
 
Intangible assets
 
 
 
 
 
7,307 
 
 
 
Other assets including cash and cash equivalents
 
 
 
 
 
238 
 
 
 
Deferred tax liabilities
 
 
 
 
 
(1,827)
 
 
 
Other liabilities
 
 
 
 
 
(90)
 
 
 
Total net assets acquired
 
 
 
 
 
5,628 
 
 
 
Non-controlling interests
 
 
 
 
 
(1,903)
 
 
 
Goodwill
 
 
 
 
 
84 
 
 
 
Fair value of total consideration
 
 
 
 
 
3,809 
 
 
 
Less: fair value of deferred consideration
 
 
 
 
 
(1,332)
 
 
 
Total upfront consideration
 
 
 
 
 
2,477 
 
 
 
Less: cash and cash equivalents acquired
 
 
 
 
 
(94)
 
 
 
Net cash outflow
 
 
 
 
 
2,383 
 
 
5      ACQUISITION OF ZS PHARMA
On 17 December 2015, AstraZeneca completed the acquisition of ZS Pharma, a biopharmaceutical company based in San Mateo, California. ZS Pharma uses its proprietary ion-trap technology to develop novel treatments for hyperkalaemia, a serious condition of elevated potassium in the bloodstream, typically associated with CKD and Chronic Heart Failure.
 
During 2016, we have revised our assessment of the fair values of the assets and liabilities acquired as a result of new information obtained about facts and circumstances that existed at the date of acquisition that impact the value of deferred tax. This has resulted in a reduction to both deferred tax liabilities and goodwill of $68m.
 
 
 
 
 
 
Fair value
$m
 
 
 
Non-current assets
 
 
 
 
 
 
Intangible assets
 
 
 
3,162 
 
 
Property, plant and equipment
 
 
 
21 
 
 
 
3,183 
 
 
Current assets
 
 
 
169 
 
 
Current liabilities
 
 
 
(50)
 
 
Non-current liabilities
 
 
 
 
 
 
Deferred tax liabilities
 
 
 
(977)
 
 
Other liabilities
 
 
 
(13)
 
 
 
(990)
 
 
Total net assets acquired
 
 
 
2,312 
 
 
Goodwill
 
 
 
388 
 
 
Total upfront consideration
 
 
 
2,700 
 
 
Less: cash and cash equivalents acquired
 
 
 
(73)
 
 
Less: deferred upfront consideration
 
 
 
(181)
 
 
Net cash outflow
 
 
 
2,446 
 
6      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 146 and 147 of the Company's Annual Report and Form 20-F Information 2015. 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 $1,201m of other investments, $1,760m of loans, and $182m of derivatives as at 30 June 2016. The total fair value of interest-bearing loans and borrowings at 30 June 2016, which have a carrying value of $17,579m in the Condensed Consolidated Statement of Financial Position, was $19,385m. 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
2016
 
Other
 
2016
 
Total
 
2016
 
Total
 
2015
 
 
$m
 
$m
 
$m
 
$m
 
 
 At 1 January
 
 
 
 
5,092 
 
 
 
 
1,319
 
 
 
 
6,411 
 
 
 
 
6,899 
 
 
 
 Settlements
 
 
 
 
(141)
 
 
 
 
-
 
 
 
 
(141)
 
 
 
 
(239)
 
 
 
 Revaluations
 
 
 
 
32 
 
 
 
 
128
 
 
 
 
160 
 
 
 
 
82 
 
 
 
 Discount unwind
 
 
 
 
195 
 
 
 
 
53
 
 
 
 
248 
 
 
 
 
263 
 
 
 
 At 30 June
 
 
 
 
5,178 
 
 
 
 
1,500
 
 
 
 
6,678 
 
 
 
 
7,005 
 
 
7      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 2015 (the 2015 Disclosures). Unless noted otherwise below or in the 2015 Disclosures, no provisions have been established in respect of the claims discussed below.
 
As discussed in the 2015 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 2015 Disclosures and herein.
 
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property.
 
Matters disclosed in respect of the first quarter of 2016 and to 29 April 2016.
 
Patent litigation
 
Crestor (rosuvastatin) 
US patent proceedings
As previously disclosed, AstraZeneca is defending three patent infringement lawsuits in the US District Court for the District of South Carolina (the District Court) which, among other things, claim that AstraZeneca's Crestor sales induce infringement of the plaintiffs' patents. In December 2015, the District Court issued an order dismissing the first of these cases, filed by Palmetto Pharmaceuticals, LLC (Palmetto), and entered judgment in AstraZeneca's favour, which Palmetto is appealing. In February 2016, the District Court granted AstraZeneca's motions for summary judgment and dismissed the remaining two, consolidated cases filed by co-plaintiffs Medical University of South Carolina Foundation for Research Development and Charleston Medical Therapeutics (together CMT) and entered judgment in AstraZeneca's favour, which CMT has appealed.
 
Patent proceedings outside the US
As previously disclosed, in Australia, AstraZeneca was unsuccessful in defending the validity of certain Crestor patents, at trial and on appeal. This patent litigation concluded in September 2015. A provision has been taken in respect of claims from generic entities which were prevented by court order from launching their products in Australia before AstraZeneca's patents were subsequently found invalid. In April 2016, AstraZeneca was notified that the Commonwealth of Australia also intends to pursue a claim against AstraZeneca in relation to alleged losses it suffered in connection with this patent litigation. AstraZeneca will respond appropriately in due course.
 
As previously disclosed, in the Netherlands, in April 2014, AstraZeneca received a writ of summons from Resolution Chemicals Ltd. (Resolution) alleging partial invalidity and non-infringement of the supplementary protection certificate (SPC) related to the Crestor substance patent. In July 2015, the District Court of the Hague determined that the SPC does not extend to zinc salts of rosuvastatin and that Resolution's rosuvastatin zinc product does not infringe the SPC. AstraZeneca appealed. In February 2016, the Court of Appeal of the Hague overturned the decision and found that Resolution's product does infringe the SPC. Resolution may seek to appeal.
 
Faslodex (fulvestrant)
US patent proceedings
As previously disclosed, AstraZeneca has filed patent infringement lawsuits in the US District Court in New Jersey relating to four patents listed in the FDA Orange Book with reference to Faslodex, after AstraZeneca received seven Paragraph IV notices relating to six Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Faslodex prior to the expiration of AstraZeneca's patents. The first trial, against the first three ANDA filers, is scheduled to commence on 27 June 2016.
 
Patent proceedings outside the US
As previously disclosed, in September 2015, AstraZeneca filed a request for a provisional injunction against Hexal AG (Hexal) in the Regional Court of Düsseldorf after Hexal threatened to launch a generic Faslodex product in Germany. The request was denied in November 2015 and AstraZeneca appealed. In February 2016, the Higher Regional Court of Düsseldorf ruled in AstraZeneca's favour and ordered the provisional injunction against Hexal.
 
Movantik/Moventig (naloxegol)
US patent proceedings
As previously disclosed, in 2015, Neptune Generics LLC, filed a petition seeking inter partes review (IPR) with the US Patent Office challenging the validity of an FDA Orange Book listed patent relating to Movantik (US Patent No. 7,786,133). In April 2016, the US Patent Trial and Appeal Board denied the petition.
 
Patent proceedings outside the US
As previously disclosed, in Europe, Generics UK Ltd. (trading as Mylan) filed an opposition to the grant of European Patent No. 1,694,363 with the European Patent Office (EPO). In February 2016, the Opposition Division of the EPO upheld the patent as granted and dismissed the opposition.
 
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin)
US patent proceedings
As previously disclosed, following the denial of Mylan Pharmaceuticals, Inc.'s (Mylan) motion to dismiss for lack of jurisdiction by the US District Court for the District of Delaware (the District Court), Mylan appealed that decision. In March 2016, the US Court of Appeals for the Federal Circuit affirmed the District Court's decision (the March Decision). In April 2016, Mylan filed a petition for rehearing en banc of the March Decision.
 
Nexium (esomeprazole magnesium)
US patent proceedings
In February 2016, AstraZeneca received a Paragraph IV notice from MacLeods Pharmaceuticals Ltd. (MacLeods) challenging certain patents listed in the FDA Orange Book with reference to Nexium. MacLeods submitted an ANDA seeking to market esomeprazole magnesium. In March 2016, in response to MacLeods' notice, AstraZeneca filed a patent infringement lawsuit against MacLeods in the US District Court for the District of New Jersey. The litigation is at an early stage and no trial date has been set.
 
In March 2016, AstraZeneca received a Paragraph IV notice from Hetero USA Inc. (Hetero) challenging certain patents listed in the FDA Orange Book with reference to Nexium 24HR (OTC). Hetero submitted an ANDA seeking to market OTC esomeprazole magnesium. AstraZeneca is reviewing Hetero's notice.
 
Patent Proceedings outside the US
As previously disclosed, in Canada, in July 2014, the Federal Court found Canadian Patent No. 2,139,653 invalid and not infringed by Apotex Inc. In July 2015, AstraZeneca's appeal was dismissed. On 10 March 2016, the Supreme Court of Canada granted AstraZeneca leave to appeal. A tentative hearing date is set for 8 November 2016.
 
Product liability litigation
 
Onglyza (saxagliptin)
As previously disclosed, Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca, and/or AstraZeneca are among multiple defendants in various lawsuits filed in state and federal courts in the US involving multiple plaintiffs claiming physical injury from treatment with Onglyza. The lawsuits allege injuries including pancreatic cancer. AstraZeneca has been served with lawsuits filed in California state court on behalf of approximately 35 plaintiffs alleging heart failure, congestive heart failure, cardiac failure and/or death resulting from treatment with Onglyza/Kombiglyze.
 
Commercial litigation
 
Nexium/Prilosec trademark litigation
As previously disclosed, AstraZeneca filed separate complaints in the US District Court for the District of Delaware against Camber Pharmaceuticals, Inc. (Camber) and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) to enforce certain AstraZeneca trademark rights related to Nexium and Prilosec. The Delaware District Court issued preliminary injunctions against Camber's and Dr. Reddy's sales of generic esomeprazole magnesium in purple capsules. The Camber action has been settled through negotiation and as part of the settlement, the Delaware District Court entered a Consented Judgment of Permanent Injunction and Other Relief on 31 March 2016 in favour of AstraZeneca. Dr. Reddy's filed its own separate claims against AstraZeneca in both the Delaware District Court and the US District Court for the District of New Jersey. Dr. Reddy's also appealed the preliminary injunction decision of the Delaware District Court to the US Court of Appeals for the Third Circuit and in April 2016, voluntarily withdrew its appeal. All District Court cases involving Dr. Reddy's related to this matter had been stayed pending the appeal, and have now resumed.
 
Nexium Consumer litigation
As previously disclosed, in July 2015, the Delaware Superior Court granted AstraZeneca's motion to dismiss and entered judgment in a putative class action alleging that AstraZeneca's promotion, advertising and pricing of Nexium to physicians, consumers and third party payers was unfair, unlawful and deceptive. In April 2016, the Delaware Supreme Court affirmed the dismissal.
 
Toprol-XL (metoprolol succinate)
As previously disclosed, in March 2015, AstraZeneca was served with a state court complaint filed by the Attorney General for the State of Louisiana alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in unlawful monopolisation and unfair trade practices, causing the state government to pay increased prices for Toprol-XL. In February 2016, the Louisiana state court heard oral argument on AstraZeneca's motion to dismiss and ordered the dismissal of the complaint with prejudice and judgment in AstraZeneca's favour.
 
Matters disclosed in respect of the second quarter of 2016 and to 28 July 2016.
 
Patent litigation
 
Byetta (exenatide)
US patent proceedings
As previously disclosed, AstraZeneca filed a patent infringement lawsuit against Teva Pharmaceuticals USA, Inc. (Teva) in the US District Court for the District of Delaware (the District Court) relating to patents listed in the FDA Orange Book with reference to Byetta. In June 2016, AstraZeneca settled the patent litigation against Teva. The District Court entered a consent judgment which will enjoin Teva from launching its proposed exenatide product until 15 October 2017, subject to regulatory approval. Patent infringement proceedings against Amneal Pharmaceuticals LLC are ongoing, with trial scheduled for December 2017.
 
Crestor (rosuvastatin) 
US patent proceedings
As previously disclosed, in February 2016, the US District Court for the District of South Carolina granted AstraZeneca's motions for summary judgment and dismissed two consolidated patent infringement lawsuits filed by co-plaintiffs Medical University of South Carolina Foundation for Research Development and Charleston Medical Therapeutics (together, CMT) relating to the sale of Crestor, which CMT appealed. In July 2016, AstraZeneca and CMT jointly filed a stipulation requesting the appellate court to dismiss CMT's appeal.
 
Patent proceedings outside the US
As previously disclosed, in Australia, AstraZeneca was unsuccessful in defending the validity of certain Crestor patents, at trial and on appeal. The patent litigation concluded in September 2015. A provision was taken in Q4 2015 in respect of claims from generic entities which were prevented by court order from launching their products in Australia before AstraZeneca's patents were subsequently found to be invalid. In April 2016, AstraZeneca was notified that the Commonwealth of Australia also intends to pursue a claim against AstraZeneca in relation to alleged losses it suffered in connection with the same patent litigation and AstraZeneca has updated its provisions accordingly.
 
As previously disclosed, in the Netherlands, in April 2014, AstraZeneca received a writ of summons from Resolution Chemicals Ltd. (Resolution) alleging partial invalidity and non-infringement of the supplementary protection certificate (SPC) related to the Crestor substance patent. In July 2015, the District Court of the Hague determined that the SPC does not extend to zinc salts of rosuvastatin and that Resolution's rosuvastatin zinc product does not infringe the SPC. In February 2016, the Court of Appeal of the Hague overturned the decision and found that Resolution's product does infringe the SPC. Resolution has appealed. The hearing has been scheduled for 16 December 2016.
 
In France, in February 2016, Biogaran S.A.S. (Biogaran) obtained a marketing authorisation for its rosuvastatin zinc product. In April 2016, AstraZeneca and Shionogi Seiyaku Kabushiki Kaisha (Shionogi) sought a preliminary injunction to prevent Biogaran from launching its product. On 4 July 2016, the Paris Court of First Instance declined to issue a preliminary injunction. AstraZeneca and Shionogi have appealed.
 
As previously disclosed, in Japan, in March 2015, an individual filed a patent invalidation request with the Japanese Patent Office (JPO) in relation to the Crestor substance patent. On 13 July 2016, the JPO dismissed the request.
 
Faslodex (fulvestrant)
US patent proceedings
As previously disclosed, AstraZeneca has filed patent infringement lawsuits in the US District Court in New Jersey (the District Court) relating to four patents listed in the FDA Orange Book with reference to Faslodex after AstraZeneca received seven Paragraph IV notices relating to six ANDAs seeking FDA approval to market generic versions of Faslodex prior to the expiration of AstraZeneca's patents. In July 2016, AstraZeneca settled one of these, the lawsuit brought against Sandoz, Inc (Sandoz), and the District Court entered a consent judgment, which includes an injunction preventing Sandoz from launching a generic fulvestrant product until 25 March 2019, or earlier in some circumstances. Trial against two other defendants commenced on 11 July 2016 and is scheduled to reconvene on 1 August 2016.
 
In July 2016, AstraZeneca was served with four petitions for inter parties review by the Patent Trial and Appeal Board relating to each of the four Orange Book-listed patents.
 
Onglyza (saxagliptin) and Kombiglyze (saxagliptin and metformin)
US patent proceedings
In May 2016, Apotex Inc. and Apotex Corp. (collectively Apotex) sent a notice that it had submitted an ANDA for saxagliptin hydrochloride 2.5mg and 5mg tablets containing a Paragraph IV Certification alleging that US Patent No. RE44,186 (the '186 Patent), listed in the FDA Orange Book with reference to Onglyza and Kombiglyze XR, is invalid and/or will not be infringed by the products as described in its ANDA. In July 2016, AstraZeneca initiated patent infringement proceedings asserting the '186 Patent in the US District Court for the District of Delaware against Apotex.
 
In June 2016, Teva Pharmaceuticals USA, Inc., Amneal Pharmaceuticals, LLC, Actavis Laboratories FL, Inc., and Sun Pharma Global FZE each sent notices that they had submitted ANDAs for saxagliptin hydrochloride and metformin hydrochloride 2.5mg/1000mg, 5mg/1000mg, and 5mg/500mg tablets containing a Paragraph IV Certification alleging that US Patent No. 9,339,472 (the '472 Patent) listed in the FDA Orange Book with reference to Kombiglyze XR, is invalid, unenforceable and/or will not be infringed by the products as described in their ANDAs.
 
As previously disclosed, in April 2016, Mylan Pharmaceuticals, Inc. (Mylan) filed a petition for rehearing en banc (the Petition) of a March 2016 decision by the US Court of Appeals for the Federal Circuit (the Federal Circuit) affirming a decision by the US District Court for the District of Delaware that denied Mylan's motion to dismiss for lack of jurisdiction. In June 2016, the Federal Circuit denied the Petition.
 
As previously disclosed, in January 2016, Mylan filed a Request for Rehearing with the US Patent and Trademark Office (USPTO) seeking reconsideration of a December 2015 decision by the USPTO denying institution of an inter partes review challenging the validity of the '186 Patent (the Mylan IPR). In May 2016, the USPTO instituted the Mylan IPR. Following institution of the Mylan IPR, Wockhardt Bio AG, Amneal Pharmaceuticals LLC, Sun Pharmaceuticals Industries Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, Inc., and Aurobindo Pharma Ltd. also filed petitions for inter partes review challenging the validity of the '186 Patent and have sought to join the Mylan IPR.
 
Seroquel XR (quetiapine fumarate) 
Patent proceedings outside the US
In Spain, in May 2016, the Supreme Court affirmed a decision from October 2013 which found the Seroquel XR formulation patent invalid. The generic challengers were Accord Healthcare S.L.U. and Sandoz Farmaceutica S.A.
 
In Sweden, in May 2016, following a challenge to the validity of the formulation patent covering Seroquel XR by Sandoz A/S, the Stockholm District Court found the Seroquel XR formulation patent invalid.
 
In Denmark, in June 2016, following a challenge to the validity of the formulation patent covering Seroquel XR by Teva Denmark A/S and Accord Healthcare Ltd., the Danish Maritime and Commercial High Court found the Seroquel XR formulation patent invalid.
 
As previously disclosed, in France, in April 2015, Mylan SAS (Mylan) brought a patent invalidation action against AstraZeneca's French designation of the Seroquel XR formulation patent. In July 2016, the tribunal de grande instance de Paris found the Seroquel XR formulation patent invalid.
 
In various countries in Europe generic entities have claimed, or could claim, damages relating to preliminary injunctions issued in those countries that prevented generic Seroquel XR sales by those entities.  A provision has been taken.
 
Product liability litigation
 
Byetta/Bydureon (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 co-ordinated 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 co-ordinated proceeding, and judgment was entered in May 2016. The plaintiffs have appealed both rulings.
 
As previously disclosed, a single case was pending in Alabama state court and is now resolved.
 
Crestor (rosuvastatin calcium)
AstraZeneca is defending a number of lawsuits alleging multiple types of injuries caused by the use of Crestor, including diabetes mellitus, various cardiac injuries, rhabdomyolysis, and/or liver and kidney injuries. The claims of approximately 600 plaintiffs, comprising approximately 100 California residents and approximately 500 non-California residents, were aggregated in one co-ordinated proceeding in Los Angeles, California. The claims of approximately 600 additional non-California plaintiffs were also pending in California state court. In October 2014, the co-ordination judge dismissed the claims of the non-California plaintiffs whose claims were in the co-ordinated proceeding. The plaintiffs appealed the October 2014 order dismissing the non-California plaintiffs from the proceeding. In July 2016, the Court of Appeal in California dismissed the plaintiffs' appeal, effectively dismissing the claims of all of the non-California residents from California state court, leaving the option of re-filing in the plaintiffs' home states. The claims of approximately 80 plaintiffs remain pending in California state court.
 
Farxiga (dapagliflozin)
As previously disclosed, AstraZeneca has been named as one of multiple defendants in a lawsuit filed in the US District Court for the Western District of Kentucky involving one plaintiff claiming physical injury, including diabetic ketoacidosis and kidney failure, from treatment with Farxiga. Since then, cases with similar allegations have been filed in three additional jurisdictions. Motions to dismiss are pending in the Western District of Kentucky and one other jurisdiction.
 
Onglyza/Kombiglyze (saxagliptin)
AstraZeneca is defending various lawsuits filed in state and federal courts in the US involving multiple plaintiffs claiming injury from the treatment with either Onglyza or Kombiglyze. In May 2016, a federal judge in California granted AstraZeneca's motion for summary judgment and dismissed the claims of 14 of these plaintiffs who alleged injuries including pancreatic cancer. The previously disclosed lawsuit, filed on behalf of approximately 50 plaintiffs alleging heart failure, cardiac failure and/or death resulting from treatment with Onglyza/Kombiglyze remains pending.
 
Synagis (palivizumab)
AstraZeneca and MedImmune have been named as defendants in a lawsuit filed in the US District Court for the Middle District of Louisiana involving two plaintiffs alleging wrongful death from treatment with Synagis. A motion to dismiss is pending.
 
Commercial litigation
 
Nexium/Prilosec trademark litigation
As previously disclosed, AstraZeneca filed separate complaints in the US District Court for the District of Delaware against Camber Pharmaceuticals, Inc. (Camber) and Dr. Reddy's Laboratories, Inc. (Dr. Reddy's) to enforce certain AstraZeneca trademark rights related to Nexium and Prilosec. The Delaware District Court issued preliminary injunctions against Camber's and Dr. Reddy's sales of generic esomeprazole magnesium in purple capsules. The Camber action has been settled through negotiation and, as part of the settlement, the Delaware District Court entered a Consented Judgment of Permanent Injunction and Other Relief on 31 March 2016 in favour of AstraZeneca. Dr. Reddy's filed its own separate claims against AstraZeneca in both the Delaware District Court and the US District Court for the District of New Jersey. The New Jersey District Court has determined that the Delaware action should proceed first.
 
Toprol-XL (metoprolol succinate)
As previously disclosed, in March 2015, AstraZeneca was served with a state court complaint filed by the Attorney General for the State of Louisiana alleging that, in connection with enforcement of its patents for Toprol-XL, it had engaged in unlawful monopolisation and unfair trade practices, causing the state government to pay increased prices for Toprol-XL. In February 2016, the Louisiana state court granted AstraZeneca's motion to dismiss the complaint with prejudice and judgment in AstraZeneca's favour. The State of Louisiana has appealed this decision.
 
Pearl Therapeutics
AstraZeneca has been served with a complaint filed in Delaware State court by the former shareholders of Pearl Therapeutics, Inc. (Pearl) that alleges, among other things, breaches of contractual obligations relating to a 2013 merger agreement between AstraZeneca and Pearl.
 
Crestor Citizen's Petition
On 31 May 2016, AstraZeneca filed a Citizen's Petition with the FDA requesting that the Agency not approve any pending generic ANDAs for rosuvastatin until the expiration of paediatric orphan exclusivity for Crestor. On 27 June 2016, AstraZeneca filed its Complaint for Declaratory and Injunctive Relief and an Application for a Temporary Restraining Order (TRO) with the US District Court for the District of Columbia requesting that the Court prohibit the FDA from granting final approval to any pending ANDAs for generic versions of Crestor until the expiration of paediatric orphan exclusivity. On 19 July 2016, the Court denied AstraZeneca's application for a TRO, but provided for FDA to produce to AstraZeneca a copy of the administrative record.
 
 
 
 
8 PRODUCT ANALYSIS - H1 2016 
 
 
 
World
 
US
 
Europe
 
Established ROW
 
Emerging Markets
 
 
H1 2016
$m
 
CER
%
 
H1 2016
$m
 
CER%
 
H1 2016
$m
 
CER
%
 
H1 2016
$m
 
CER
%
 
H1 2016
$m
 
CER
%
 Respiratory & Autoimmunity:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
 
1,552
 
(6)
 
681
 
(5)
 
466
 
(18)
 
196
 
- 
 
209
 
25 
 Pulmicort
 
549
 
10 
 
106
 
(2)
 
54
 
(18)
 
40
 
(2)
 
349
 
23 
 Tudorza/Eklira
 
87
 
4 
 
41
 
(9)
 
41
 
17 
 
4
 
n/m 
 
1
 
n/m 
 Daliresp/Daxas
 
71
 
n/m 
 
66
 
n/m 
 
4
 
n/m 
 
-
 
- 
 
1
 
n/m 
 Duaklir
 
30
 
n/m 
 
-
 
- 
 
28
 
n/m 
 
1
 
n/m 
 
1
 
n/m 
 Others
 
144
 
13 
 
7
 
(30)
 
51
 
13 
 
17
 
55 
 
69
 
12 
 Total Respiratory & Autoimmunity
 
2,433
 
1 
 
901
 
(2)
 
644
 
(11)
 
258
 
2 
 
630
 
23 
 Cardiovascular & Metabolic Diseases:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Onglyza
 
402
 
6 
 
212
 
- 
 
73
 
4 
 
37
 
22 
 
80
 
16 
 Brilinta
 
395
 
48 
 
159
 
57 
 
125
 
17 
 
20
 
29 
 
91
 
106 
 Farxiga
 
376
 
88 
 
209
 
82 
 
89
 
72 
 
25
 
127 
 
53
 
135 
 Bydureon
 
291
 
11 
 
234
 
5 
 
50
 
43 
 
5
 
67 
 
2
 
- 
 Byetta
 
138
 
(19)
 
89
 
(26)
 
25
 
(17)
 
10
 
- 
 
14
 
45 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
 
2,082
 
(15)
 
1,004
 
(27)
 
438
 
(4)
 
286
 
(2)
 
354
 
9 
 Seloken/Toprol-XL
 
374
 
7 
 
53
 
10 
 
44
 
(6)
 
5
 
(29)
 
272
 
9 
 Atacand
 
160
 
(11)
 
21
 
17 
 
49
 
(6)
 
10
 
(29)
 
80
 
(16)
 Others
 
242
 
(23)
 
16
 
(54)
 
64
 
(11)
 
25
 
(20)
 
137
 
(22)
 Total Cardiovascular & Metabolic Diseases
 
4,460
 
(2)
 
1,997
 
(11)
 
957
 
4 
 
423
 
2 
 
1,083
 
9 
 Oncology:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Iressa
 
270
 
2 
 
10
 
n/m 
 
61
 
(8)
 
65
 
(6)
 
134
 
3 
 Tagrisso
 
143
 
n/m 
 
103
 
n/m 
 
25
 
n/m 
 
15
 
n/m 
 
-
 
- 
 Lynparza
 
98
 
n/m 
 
62
 
n/m 
 
32
 
n/m 
 
-
 
-
 
4
 
n/m 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
 
401
 
23 
 
211
 
28 
 
113
 
13 
 
30
 
16 
 
47
 
36 
 Zoladex
 
382
 
(3)
 
19
 
36 
 
80
 
(3)
 
130
 
(3)
 
153
 
(5)
 Casodex
 
125
 
(9)
 
2
 
n/m 
 
13
 
(13)
 
56
 
(20)
 
54
 
2 
 Arimidex
 
119
 
(2)
 
10
 
43 
 
18
 
(28)
 
35
 
(18)
 
56
 
15 
 Others
 
48
 
(33)
 
-
 
- 
 
3
 
(77)
 
32
 
3 
 
13
 
(12)
 Total Oncology
 
1,586
 
18 
 
417
 
85 
 
345
 
12 
 
363
 
(3)
 
461
 
5 
 Infection & Neuroscience:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
 
1,025
 
(18)
 
294
 
(39)
 
127
 
(10)
 
237
 
(15)
 
367
 
1 
 Seroquel XR
 
427
 
(17)
 
306
 
(13)
 
76
 
(32)
 
10
 
(29)
 
35
 
(9)
 Synagis
 
271
 
- 
 
163
 
2 
 
108
 
(2)
 
-
 
- 
 
-
 
- 
 Losec/Prilosec
 
145
 
(17)
 
5
 
(58)
 
41
 
(16)
 
27
 
(32)
 
72
 
(5)
 Movantik/Moventig
 
40
 
n/m 
 
40
 
n/m 
 
-
 
- 
 
-
 
- 
 
-
 
- 
 FluMist/Fluenz
 
11
 
(48)
 
11
 
(48)
 
-
 
- 
 
-
 
- 
 
-
 
- 
 Others
 
636
 
(11)
 
75
 
(29)
 
169
 
(6)
 
127
 
(3)
 
265
 
(11)
 Total Infection & Neuroscience
 
2,555
 
(13)
 
894
 
(21)
 
521
 
(12)
 
401
 
(13)
 
739
 
(5)
 Total Product Sales
 
11,034
 
(2)
 
4,209
 
(7)
 
2,467
 
(3)
 
1,445
 
(4)
 
2,913
 
7 
 
9 PRODUCT ANALYSIS - Q2 2016
 
 
 
World
 
US
 
Europe
 
Established ROW
 
Emerging Markets
 
 
Q2 2016
$m
 
CER
%
 
Q2 2016
$m
 
CER%
 
Q2 2016
$m
 
CER
%
 
Q2 2016
$m
 
CER
%
 
Q2 2016
$m
 
CER
%
 Respiratory & Autoimmunity:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Symbicort
 
803
 
(4)
 
359
 
(4)
 
235
 
(17)
 
105
 
2 
 
104
 
33 
 Pulmicort
 
239
 
6 
 
50
 
(11)
 
25
 
(17)
 
22
 
- 
 
142
 
21 
 Tudorza/Eklira
 
48
 
(13)
 
24
 
(33)
 
20
 
18 
 
3
 
50 
 
1
 
n/m 
 Daliresp/Daxas
 
40
 
25 
 
35
 
9 
 
4
 
n/m 
 
-
 
- 
 
1
 
n/m 
 Duaklir
 
17
 
n/m 
 
-
 
- 
 
16
 
n/m 
 
1
 
- 
 
-
 
- 
 Others
 
79
 
34 
 
3
 
40 
 
32
 
33 
 
14
 
n/m 
 
30
 
25 
 Total Respiratory & Autoimmunity
 
1,226
 
1 
 
471
 
(7)
 
332
 
(7)
 
145
 
8 
 
278
 
26 
 Cardiovascular & Metabolic Diseases:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Onglyza
 
191
 
(7)
 
88
 
(22)
 
40
 
14 
 
19
 
6 
 
44
 
12 
 Brilinta
 
214
 
51 
 
89
 
62 
 
65
 
16 
 
10
 
38 
 
50
 
104 
 Farxiga
 
211
 
65 
 
115
 
47 
 
48
 
71 
 
16
 
100 
 
32
 
127 
 Bydureon
 
156
 
11 
 
126
 
9 
 
27
 
42 
 
3
 
50 
 
-
 
(133)
 Byetta
 
76
 
(6)
 
47
 
(11)
 
15
 
7 
 
5
 
(17)
 
9
 
11 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Crestor
 
926
 
(29)
 
368
 
(52)
 
226
 
(1)
 
161
 
1 
 
171
 
5 
 Seloken/Toprol-XL
 
189
 
8 
 
32
 
52 
 
22
 
(4)
 
3
 
(25)
 
132
 
4 
 Atacand
 
89
 
(5)
 
12
 
71 
 
25
 
9 
 
6
 
(14)
 
46
 
(18)
 Others
 
116
 
(25)
 
11
 
(27)
 
34
 
- 
 
16
 
- 
 
55
 
(38)
 Total Cardiovascular & Metabolic Disease
 
2,168
 
(11)
 
888
 
(27)
 
502
 
9 
 
239
 
5 
 
539
 
3 
 Oncology:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Iressa
 
135
 
5 
 
6
 
n/m 
 
27
 
(19)
 
35
 
(6)
 
67
 
15 
 Tagrisso
 
92
 
n/m 
 
58
 
n/m 
 
19
 
n/m 
 
15
 
n/m 
 
-
 
- 
 Lynparza
 
54
 
n/m 
 
34
 
89 
 
18
 
n/m 
 
-
 
- 
 
2
 
n/m 
 Legacy:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Faslodex
 
211
 
23 
 
112
 
37 
 
57
 
8 
 
16
 
15 
 
26
 
15 
 Zoladex
 
204
 
(4)
 
9
 
13 
 
41
 
2 
 
68
 
(6)
 
86
 
(7)
 Casodex
 
63
 
(10)
 
2
 
100 
 
6
 
(14)
 
30
 
(18)
 
25
 
(4)
 Arimidex
 
62
 
(2)
 
6
 
50 
 
10
 
(17)
 
19
 
(19)
 
27
 
11
 Others
 
27
 
(30)
 
-
 
n/m 
 
1
 
(60)
 
19
 
6 
 
7
 
(22)
 Total Oncology
 
848
 
20 
 
227
 
89 
 
179
 
16 
 
202
 
1 
 
240
 
4 
 Infection & Neuroscience:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Nexium
 
562
 
(13)
 
163
 
(36)
 
67
 
(3)
 
142
 
(8)
 
190
 
13 
 Seroquel XR
 
225
 
(14)
 
162
 
(12)
 
41
 
(20)
 
5
 
(29)
 
17
 
(13)
 Synagis
 
27
 
(59)
 
3
 
n/m 
 
24
 
(66)
 
-
 
- 
 
-
 
- 
 Losec/Prilosec
 
70
 
(16)
 
3
 
(40)
 
20
 
(17)
 
14
 
(32)
 
33
 
(5)
 Movantik/Moventig
 
23
 
n/m 
 
23
 
n/m 
 
-
 
- 
 
-
 
- 
 
-
 
- 
 FluMist/Fluenz
 
6
 
(57)
 
6
 
(57)
 
-
 
- 
 
-
 
- 
 
-
 
- 
 Others
 
314
 
(12)
 
17
 
(71)
 
84
 
(13)
 
62
 
(13)
 
151
 
12 
 Total Infection & Neuroscience
 
1,227
 
(14)
 
377
 
(27)
 
236
 
(24)
 
223
 
(12)
 
391
 
9 
 Total Product Sales
 
5,469
 
(5)
 
1,963
 
(17)
 
1,249
 
(2)
 
809
 
(1)
 
1,448
 
9 
 
 
Shareholder Information
 
 
Announcements
 
Announcement of nine months and third quarter 2016 results
10 November 2016
Announcement of full year and fourth quarter 2016 results
2 February 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 2016, payable on 12 September 2016, will be 12 August 2016. Ordinary Shares listed in London and Stockholm will trade ex-dividend from 11 August 2016. American Depositary Shares listed in New York will trade ex-dividend from 10 August 2016.
 
Trademarks
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 Duaklir Genuair, Duaklir, Eklira, and Tudorza, trademarks of Almirall, S.A.; Epanova, a trademark of Chrysalis Pharma AG; and Zinforo, a trademark of Forest Laboratories.
 
Addresses for Correspondence
Registrar and
Transfer Office
Equiniti Limited
Aspect House
Spencer Road
Lancing
West Sussex
BN99 6DA
UK
US Depositary
Citibank Shareholder Services
PO Box 43077
Providence
RI 02940-3077
USA
 
Registered Office
1 Francis Crick Avenue
Cambridge Biomedical Campus, Cambridge
CB2 0AA
UK
 
 
Swedish Central Securities Depository
Euroclear Sweden AB
PO Box 191
SE-101 23 Stockholm
Sweden
 
 
 
Tel (freephone in UK):
0800 389 1580
 
Tel (outside UK):+44 (0)121 415 7033
Tel: (toll free in the US)
+1 (888) 697 8018
 
Tel: (outside the US)
+1 (781) 575 4555
 
citibank@shareholders-online.com
Tel: +44 (0)20 3749 5000
Tel: +46 (0)8 402 9000
 
 
 
 
 
 
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; the risk of substantial adverse litigation/government investigation claims and insufficient insurance coverage; effects of patent litigation in respect of IP rights; exchange rate fluctuations; the risk that R&D will not yield new products that achieve commercial success; the risk that strategic alliances and acquisitions, including licensing and collaborations, will be unsuccessful; the impact of competition, price controls and price reductions; taxation risks; the risk of substantial product liability claims; 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 of delay to new product launches; the difficulties of obtaining and maintaining regulatory approvals for products; 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 risk that new products do not perform as we expect; failure to achieve strategic priorities or to meet targets or expectations; 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 risk of misuse of social medial platforms and new technology; the risks associated with developing our business in emerging markets; the risk of illegal trade in our products; the risks from pressures resulting from generic competition; the risk of failure to successfully implement planned cost reduction measures through productivity initiatives and restructuring programmes; economic, regulatory and political pressures to limit or reduce the cost of our products; the risk that regulatory approval processes for biosimilars could have an adverse effect on future commercial prospects; the impact of failing to attract and retain key personnel and to successfully engage with our employees; the impact of increasing implementation and enforcement of more stringent anti-bribery and anti-corruption legislation; and the risk of failure of information technology and cybercrime. Nothing in this document/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: 28 July 2016
 
 By:  /s/ Adrian Kemp
Name: Adrian Kemp
Title: Company Secretary