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  November 2015

Commission File Number:  001-11960

AstraZeneca PLC

2 Kingdom Street, London W2 6BD

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-_____________
 
 
 
 

5 November 2015
Year-To-Date and Q3 2015 Results
 
Financial Summary
 
YTD 2015
 
Q3 2015
 
$m
% change
 
$m
% change
   
CER1
Actual
   
CER1
Actual
Total Revenue2
18,309
-
(8)
 
5,945
(2)
(10)
               
Core3 Op. Profit
5,346
-
(7)
 
1,728
7
(2)
Core EPS
$3.32
2
(6)
 
$1.03
8
(2)
               
Reported Op. Profit
3,026
31
22
 
1,170
137
116
Reported EPS
$1.60
40
30
 
$0.61
237
203
 
 
·      Core EPS in the year to date up by 2% with Q3 Core EPS growth of 8% 
 
·      Total Revenue stable in the year to date; Core Gross margin up by 1.0% points to 83.3%
 
·      Resilient top-line performance underpinned continued investment in R&D. Core R&D costs up by 18% in Q3,  reflecting the recent start of key Oncology trials
 
·      Core SG&A costs declined by 3% in the third quarter; increased by 2% in the year to date
 
·      Upgraded FY 2015 Total Revenue and Core EPS guidance at constant exchange rates
 
YTD Commercial Highlights
Growth platforms grew by 10%, representing 57% of Total Revenue:
 
1.   Respiratory: +8%, including 38% Q3 sales growth in Emerging Markets
 
2.   Brilinta/Brilique: +44%; Q3 US growth of 73%
 
3.   Diabetes: +26%, including 73% sales growth in Emerging Markets
 
4.   Emerging Markets: +12%. China sales growth of 17% (Q3 2015: +11%)
 
5.   Japan: +3%, with Q3 sales growth of 6%
 
Achieving Scientific Leadership: Progress since the prior results announcement
Regulatory Approvals
Brilinta - post-myocardial infarction (MI) (PEGASUS trial) (US)
Regulatory Submission Acceptances
PT003 - COPD (US)
Brilinta - acute coronary syndrome, post-MI (JP)
AZD9291 - lung cancer (JP)
Other Key Developments
saxagliptin/dapaglifozin - type-2 diabetes (US): Complete Response Letter
AZD9291: Granted Priority Review by FDA and Japanese MHLW
FDA Fast Track designation:                                                           anifrolumab - lupus, tremelimumab - mesothelioma, durvalumab - head & neck cancer
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"I'm pleased with our continued progress as we focus on executing our plans across our growth platforms and pipeline. While we have more work to do on the submission of saxagliptin/dapagliflozin combination in Diabetes, the significant label update for Brilinta was accompanied by submission acceptances and accelerated reviews in cancer, respiratory diseases and lupus. In particular, our exciting Oncology portfolio maintained its momentum with four Priority Review and Fast Track designations as well as supportive data at key congresses.
 
Our financial performance in the year to date, including an 8% increase in Core EPS in the third quarter, underpinned today's upgrade to full-year guidance. 2016 will be a pivotal year in our strategic journey as we face the impact of loss of exclusivity to Crestor in the US. Looking ahead however, the continued performance of our growth platforms and upcoming launches will combine with our increasing focus on costs and cash generation to help offset short-term headwinds and return AstraZeneca to sustainable growth."
 
FY 2015 Guidance
All guidance is shown at CER1.
 
New
Old
Total Revenue
In line with the prior year
A low single-digit percent decline versus the prior year
Core Earnings Per Share
A mid to high single-digit percent increase versus the prior year
A low single-digit percent increase versus the prior year
 
Non-guidance information is also provided:
Based on average daily spot rates in the nine months to the end of September 2015, Total Revenue in FY 2015 is expected to decline by high single-digit percent, with Core EPS expected to be broadly in line with FY 2014. In addition, the majority of FY 2015 Externalisation Revenue is anticipated to have been realised in the first half of the year. Core R&D costs are expected to grow at a lower rate in the final quarter versus the year to date and the Company is committed to reducing Core SG&A costs in FY 2015 versus the prior year, both in terms of absolute value and relative to Total Revenue.
 
Pipeline: Forthcoming Major Newsflow
Q4 2015
lesinurad - gout: Regulatory decision (US)
brodalumab - psoriasis: Regulatory submission (US, EU)
durvalumab - lung cancer: Data read-out
H1 2016
PT003 - COPD: Regulatory decision (US)
benralizumab - severe asthma: Data read-out
Brilinta/Brilique - stroke: Data read-out
AZD9291 - lung cancer: Regulatory decisions
tremelimumab - mesothelioma: Data read-out
Lynparza - breast cancer: Data read-out
H2 2016
Brilinta/Brilique - peripheral arterial disease: Data read-out
saxagliptin/dapaglifozin - type-2 diabetes (EU): Regulatory decision durvalumab - head & neck cancer: Data read-out
Lynparza - ovarian cancer: Data read-out
CAZ AVI - serious infections: Regulatory decision (EU)
 
Notes
 
1.   All growth rates and guidance are shown at constant exchange rates (CER) unless specified otherwise.
 
2.   Total Revenue defined as Product Sales and Externalisation Revenue. For further details on the presentation of Total Revenue, see the announcement published by the Company in March 2015.
 
3.   See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
 
4.   The performance shown in this announcement covers the nine and three month periods to 30 September 2015 (the year to date and the quarter respectively) compared to the nine and three month periods to 30 September 2014 (the prior year to date and the prior quarter respectively).
 
Results Presentation
A conference call for investors and analysts, hosted by management, will begin at midday GMT today. Details can be accessed via www.astrazeneca.com/investors.
 
Reporting Calendar
The Company intends to publish its full-year financial results on 4 February 2016.
 
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
 
Contacts at AstraZeneca
 
Media Enquiries
 
   
Esra Erkal-Paler
UK/Global
+44 20 7604 8030
Vanessa Rhodes
UK/Global
+44 20 7604 8037
Ayesha Bharmal
UK/Global
+44 20 7604 8034
Jacob Lund
Sweden
+46 8 553 260 20
Michele Meixell
US
+1 302 885 2677
 
 
Investor Enquiries
 
UK
 
Thomas Kudsk Larsen
Oncology
+44 7818 524185
Eugenia Litz
RIA
+44 7884 735627
Nick Stone
CVMD
+44 7717 618834
Craig Marks
Finance
+44 7881 615764
Christer Gruvris
Consensus Forecasts
+44 7827 836825
US
   
Lindsey Trickett
Oncology, ING
+1 240 543 7970
Mitchell Chan
Oncology
+1 240 477 3771
Toll-Free
 
+1 866 381 7277
 
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD - Cardiovascular & Metabolic Disease,
ING - Infection, Neuroscience & Gastrointestinal
 
 
Operating and Financial Review
_____________________________________________________________________________
 
All narrative on growth and results in this section relates to Core performance, based on constant exchange rates (CER) unless stated otherwise. Financial figures are in $ millions ($m). The performance shown in this announcement covers the nine and three-month periods to 30 September 2015 (the year to date and the third quarter respectively) compared to the nine and three months to 30 September 2014. 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 intangibles, including impairment reversals but excluding any charges relating to IT assets
− charges and provisions related to our global restructuring programmes (this will include such charges that relate to the impact of our global restructuring programmes on our 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
 
More detail on the nature of these measures is given on page 72 of the 2014 Annual Report and Form 20-F Information.
 
Total Revenue
Total Revenue was stable in the year to date at $18,309m. The decline of 2% in the third quarter, compared to recent increases, reflected a lower level of Externalisation Revenue. Based on actual exchange rates, Total Revenue declined by 8% in the nine-month period reflecting the particular weakness of key trading currencies against the US dollar.
 
Product Sales
Product Sales declined by 2% in the year to date (Q3 2015: down by 2%) reflecting the US market entry of Nexium generic products from February 2015 as well as an adverse impact from the change in accounting for the US Branded Pharmaceutical Fee following issuance of final regulations in Q3 2014.
 
Externalisation Revenue
Externalisation Revenue of $875m in the year to date (Q3 2015: $95m) primarily reflected income from completion of the collaboration agreement in haematology with Celgene Corporation (Celgene) ($450m), together with income from the co-commercialisation agreement with Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) for Movantik in the US ($200m) and the co-commercialisation of Nexium in Japan ($55m), also with Daiichi Sankyo.
 
 
Product Sales
________________________________________________________________________________
 
The performance of a selection of key medicines is shown below. A geographical split of the performance is shown in Notes 6 and 7.
 
 
YTD 2015
 
Q3 2015
   
% Change
   
% Change
 
$m
CER
Actual
 
$m
CER
Actual
               
Respiratory, Inflammation & Autoimmunity
             
Symbicort
2,535
(2)
(10)
 
848
(4)
(12)
Pulmicort
740
17
9
 
222
16
8
Tudorza/Eklira
Daliresp
143
72
n/m
n/m
n/m
n/m
 
58
33
n/m
n/m
n/m
n/m
Duaklir
15
n/m
n/m
 
8
n/m
n/m
               
Others
193
(5)
(15)
 
61
(6)
(15)
TOTAL
3,698
8
(1)
 
1,230
7
(1)
               
Cardiovascular & Metabolic Disease
             
Brilinta/Brilique
445
44
30
 
170
48
34
Onglyza
594
2
(4)
 
203
-
(8)
Bydureon
425
38
34
 
162
34
30
Farxiga/Forxiga
340
180
158
 
135
107
88
Byetta
244
(1)
(5)
 
72
(17)
(22)
               
Legacy:
             
Crestor
3,695
(4)
(10)
 
1,218
(3)
(9)
Seloken/Toprol-XL
550
4
(6)
 
172
(2)
(13)
Atacand
272
(15)
(29)
 
78
(24)
(37)
               
Others
464
(10)
(18)
 
137
(23)
(30)
TOTAL
7,029
3
(4)
 
2,347
2
(6)
               
Oncology
             
Iressa
414
(2)
(12)
 
141
1
(10)
Lynparza
58
n/m
n/m
 
28
n/m
n/m
               
Legacy:
             
Zoladex
618
8
(11)
 
209
8
(13)
Faslodex
519
7
(4)
 
186
11
(1)
Casodex
204
(6)
(17)
 
65
(6)
(19)
Arimidex
190
(7)
(17)
 
64
(1)
(14)
               
Others
106
18
3
 
35
11
(5)
TOTAL
2,109
6
(8)
 
728
9
(6)
Infection, Neuroscience & Gastrointestinal
             
Nexium
1,932
(26)
(32)
 
641
(24)
(30)
Seroquel XR
784
(9)
(14)
 
258
(14)
(18)
Synagis
387
(22)
(22)
 
117
(3)
(3)
Losec/Prilosec
263
(6)
(16)
 
82
(5)
(15)
FluMist/Fluenz
97
(39)
(40)
 
76
(48)
(49)
Movantik/Moventig
14
n/m
n/m
 
10
n/m
n/m
               
Others
1,121
(6)
(18)
 
361
(2)
(15)
TOTAL
4,598
(18)
(24)
 
1,545
(17)
(24)
               
TOTAL PRODUCT SALES
17,434
(2)
(10)
 
5,850
(2)
(11)
 
 
YTD Product Sales Summary
________________________________________________________________________________
 
During 2014, final regulations relating to the US Branded Pharmaceutical Fee were issued, affecting how the fee is recognised; AstraZeneca consequently accrues for the obligation as each sale occurs. As the fee is based on actual Product Sales in the current year, the fee is recognised as a deduction from Product Sales rather than a charge to SG&A, impacting individual medicine sales by an average of 2%.
 
Respiratory, Inflammation & Autoimmunity
 
Symbicort
Year-to-date Product Sales declined by 2% to $2,535m and the medicine continues to be competitive.
 
In the US, the year-to-date decline to $1,110m was limited to 1% with continued lower net prices reflecting additional access and co-pay assistance. Robust volume growth was driven by higher market share within a growing market.
 
In Europe, Product Sales declined by 13% to $825m with a modest volume decline and a significant price decline reflecting increased competition from recently-launched analogue medicines. In contrast, Emerging Markets' sales grew by 33% to $296m with China sales growing by 50% to $95m, primarily reflecting volume growth.
 
Pulmicort
Pulmicort sales in the year to date were $740m, an increase of 17%. Growth was driven primarily by the performance of Pulmicort Respules in Emerging Markets, which were up 40% at $443m. China Product Sales increased by 47% to $354m, reflecting sustained investment in supporting asthma and COPD patients, both in hospitals and more recently at home.
 
Tudorza/Eklira
Product Sales in the year to date were $143m, including $77m in the US, where the brand name is Tudorza. In March 2015 the Company completed the acquisition of the Actavis plc product rights to the brand.
 
Rights were also acquired at that time for Daliresp, for which sales amounted to $72m in the year to date.
 
Duaklir
In the third quarter Duaklir continued its successful launch, principally in Europe. Year-to-date total sales of $15m (Q3 2015: $8m, Q2 2015: $5m) reflected good progress of this leading LAMA/LABA medicine, with an encouraging formulary uptake in the UK and market-share increases in Germany. 
 
Cardiovascular & Metabolic Disease
 
Brilinta/Brilique
Sales in the year to date were $445m, an increase of 44%, with the third quarter exhibiting growth driven by strong marketing execution (Q3 2015: up by 48%, Q2 2015: up by 38%). AstraZeneca announced on 3 September 2015 that the FDA had approved Brilinta tablets at a new 60mg dose to be used by patients with a history of heart attack beyond the first year of treatment.
 
Sales in the US were $170m, increasing by 65% (Q3 2015: up by 73%, Q2 2015: up by 57%). This reflected higher total-prescription volumes driven by marketing and other initiatives, together with an element of stocking for the new 60mg dose.
 
In Europe, Brilique continued to perform well, with an increase in Product Sales of 19% to $170m, reflecting indication leadership across a number of European markets. Emerging Markets sales grew by 93% to $78m with China representing the largest single market for the medicine.
 
Onglyza
Sales were up 2% in the nine-month period to $594m despite an emphasis on the promotion of Farxiga in the US. Sales in the third quarter were stable year-on-year versus the 7% decline in Q2 2015.
 
US sales were down by 15% at $322m in the year to date, due to competitive pressures in the DPP-4 class driving a lower market share, as well as a decline in the net price.
 
Sales in Europe grew by 17% to $108m, while Emerging Markets sales grew by 47% to $116m.
 
Farxiga/Forxiga
Sales of Farxiga/Forxiga were up 180% in the year to date to $340m.
 
In the US, Product Sales of $184m represented growth of 167%. Promotional activity underpinned increasing total-prescription market-share growth in the year to date; this was accompanied by overall growth in the market.
 
Sales in Europe reached $89m, up by 159% in the year to date reflecting the launch phase of the medicine.
 
Bydureon/Byetta
Combined sales were $669m in the nine-month period, growing by 16%, with Bydureon representing 64% of total Bydureon/Byetta sales.
 
In the US, sales were $526m, up by 22%, with higher volumes driven by market growth and higher net prices. The majority of the remaining sales of Bydureon/Byetta resided in Europe, where year-to-date sales reached $101m, reflecting the ongoing successful Pen launch.
 
Legacy: Crestor
Sales of Crestor declined in the year to date by 4% to $3,695m, with volumes marginally falling. The performance reflected competition from generic statins and price pressures.
 
In the US, Crestor sales declined by 4% to $2,067m, driven by lower market share and destocking, which was partially offset by favourable price movements.
 
In Europe sales declined by 9% to $691m, reflecting prevailing competitive trends. Crestor consolidated its position as the leading statin in Japan, with sales growth of 6% to $337m in the nine-month period. Sales in China grew by 17% to $202m.
 
Oncology
 
Iressa
Sales of Iressa declined by 2% to $414m in the year to date, driven by the competitive environment in Europe where sales were down by 6% to $96m; Japan sales declined by 12% to $91m. Since the US launch in July 2015, Iressa has seen an encouraging increase in new-patient starts.
 
Emerging Markets sales grew by 6% to $214m, with China sales increasing by 8% to $119m and Latin America sales increasing by 11% to $8m.
 
Lynparza
Sales of Lynparza reached $58m in the nine-month period. US sales of $46m followed the launch of the medicine at the end of 2014. Growth was driven by the pool of eligible patients awaiting treatment as well as patients newly tested for BRCA mutation.
 
Legacy: Zoladex
Sales increased by 8% to $618m, with a notable performance in China where sales reached $91m, reflecting growth of 35%.
 
Legacy: Faslodex
Sales were up 7% to $519m in the year to date. A 4% rise in US sales to $261m was complemented by stable Europe sales of $154m. The notable performance was in Emerging Markets, where sales of $65m represented a growth rate of 46%. With the recent launch of 500mg Faslodex, China sales accelerated in the period to $7m (Q3 2015: up by 50%, H1 2015: up by 33%). AstraZeneca Russia also achieved federal reimbursement for the medicine.
 
Infection, Neuroscience & Gastrointestinal
 
Nexium
Sales of Nexium declined by 26% to $1,932m in the year to date.
 
US sales declined by 48% to $727m following the loss of exclusivity in February 2015, directly impacting both pricing and volumes. The estimate for pipeline inventory returns was increased in the third quarter. Sales in Europe declined by 10% to $209m.
 
Nexium sales in Emerging Markets were stable at $585m, with growth in Latin America of 19% to $98m, an exception to the overall performance. Japan sales increased by 16% in the period to $298m.
 
Seroquel XR
Sales declined by 9% to $784m in the nine-month period. In the US, sales were stable at $540m; the performance was mainly driven by favourable market growth and higher underlying net prices.
 
Product Sales in Europe declined by 28% to $160m, reflecting generic-product competition.
 
Synagis
Sales of Synagis declined by 22% to $387m in the year to date, with a 41% decline to $157m seen in the US reflecting lower demand related to the American Academy of Pediatrics Committee on Infectious Disease guidelines issued in mid-2014. These further restricted patients eligible for preventative therapy with Synagis. While these guidelines were inconsistent with the approved label, demand was significantly impacted; this is anticipated to continue in the remainder of the year. Product Sales in Europe to AbbVie were stable at $230m.
 
FluMist/Fluenz
Product Sales in the year to date declined by 39% to $97m, reflecting delays in supply. In the US, Product Sales fell by 38% to $88m, while in Europe, the decline of 38% resulted in sales of $9m.  
 
Movantik/Moventig
Product Sales of Movantik were $14m in the year to date (Q3 2015: $10m); the medicine was launched in March 2015. The majority of Product Sales have been in the US. On 19 March 2015 the Company announced a co-commercialisation agreement with Daiichi Sankyo for Movantik in the US.
 
Regional Product Sales
________________________________________________________________________________
 
   
YTD 2015
 
Q3 2015
   
     
% Change
   
% Change
   
   
$m
CER
Actual
 
$m
CER
Actual
   
 
US
6,902
(8)
(8)
 
2,377
(6)
(6)
   
                     
 
Europe
3,902
(6)
(20)
 
1,301
(8)
(21)
   
                     
 
Established ROW1
2,236
(2)
(16)
 
745
-
(17)
   
   
Japan
1,479
3
(12)
 
502
6
(12)
   
   
Canada
399
5
(8)
 
126
1
(14)
   
   
Other Established ROW
358
(22)
(34)
 
117
(20)
(36)
   
                     
 
Emerging Markets2
4,394
12
1
 
1,427
10
(3)
   
   
China
1,931
17
15
 
622
11
10
   
   
Ex.China
2,463
10
(9)
 
805
9
(11)
   
                     
 
Total
17,434
(2)
(10)
 
5,850
(2)
(11)
   
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 Product Sales declined by 8% to $6,902m in the year to date. Excluding the impact of the change in accounting related to the Branded Pharmaceutical Fee, Product Sales in the year to date and third quarter declined by 6% and 4% versus the comparative period.
 
The declines reflected the loss of Nexium patent exclusivity, competition facing Crestor from therapeutic substitution by generic statins and the adverse impact of the Synagis guideline changes.
 
Favourable performances were delivered by Brilinta, Farxiga, Bydureon and Lynparza as well as the recently-acquired respiratory medicines Tudorza and Daliresp. Brilinta accelerated its strong quarterly growth, underpinned by total and new-to-brand prescription market share gains.
 
Continued growth in demand for Farxiga was supported by additional promotional activity. Bydureon continued to benefit from the launch of the Bydureon Pen as well as growth in demand in the overall GLP-1 class.
 
Europe
Sales in Europe declined by 6% to $3,902m in the year to date. Strong growth from the diabetes medicines Onglyza and Forxiga was more than offset by continued generic competition facing Crestor and Seroquel XR. A 13% decline in Symbicort sales to $825m reflected adverse pricing movements driven by competition from analogues in key markets. Duaklir more than doubled its first-half sales in Q3, bringing the year to date total to $14m.
 
Established ROW
Sales in the Established ROW fell by 2% to $2,236m in the year to date.
 
Japan sales increased by 6% in both the second and third quarters, reflecting the passing of the anniversary of the mandated April 2014 biennial price cut. Nexium and Crestor continued to grow in the nine-month period, increasing by 16% to $298m and 6% to $337m respectively. Crestor growth reflected a continued increase in the usage of the 5mg dosage. Symbicort sales in the year to date increased by 3% to $132m; a 3% decline in the third quarter to $47m however reflected the strong comparative period's performance. Market share of Symbicort was broadly stable in the third quarter and in the year to date.
 
Canada Product Sales grew by 5% to $399m in the year to date, driven by the performances of Onglyza and Symbicort.
 
Emerging Markets
The Company continues to focus on delivering innovative medicines by accelerating investment in its Emerging Markets capabilities, with a focus on China and other leading markets, such as Russia and Brazil. Sales increased by 12% to $4,394m in the nine-month period with growth delivered across the region. Emerging Markets sales in the third quarter increased by 10% to $1,427m, ahead of the Company's long-term forecast of mid-to-high single-digit growth in the region's Product Sales.
 
China sales increased by 17% to $1,931m and by 11% in the third quarter. In the year to date Brazil sales were up 20% to $304m and Russia sales were up 22% to $163m.
 
Financial Performance
________________________________________________________________________________       
 
YTD 2015
Reported
Restructuring
Intangible
Amortisation & Impairments
Diabetes Alliance
Other1
Core
% Change
YTD 2015
YTD 20142
CER
Actual
Product Sales
17,434
-
-
-
-
17,434
19,412
(2)
(10)
Externalisation Revenue
875
-
-
-
-
875
419
112
109
Total Revenue
18,309
-
-
-
-
18,309
19,831
-
(8)
                   
Cost of Sales
(3,377)
124
343
-
-
(2,910)
(3,529)
(8)
(18)
                   
Gross Profit
14,932
124
343
-
-
15,399
16,302
2
(6)
Gross Margin3
80.6%
       
83.3%
81.8%
+1.0
+1.5
                   
Distribution
(240)
-
-
-
-
(240)
(236)
15
2
% Total Revenue
1.3%
       
1.3%
1.2%
-0.2
-0.1
                   
R&D
(4,251)
180
35
-
-
(4,036)
(3,581)
22
13
% Total Revenue
23.2%
       
22.0%
18.1%
-3.8
-3.9
                   
SG&A
(8,444)
358
684
324
274
(6,804)
(7,263)
2
(6)
% Total Revenue
46.1%
       
37.2%
36.6%
-0.4
-0.6
                   
Other Operating Income
1,029
-
156
-
(158)
1,027
531
105
94
% Total Revenue
5.6%
       
5.6%
2.7%
+2.8
+2.9
                   
Operating Profit
3,026
662
1,218
324
116
5,346
5,753
-
(7)
% Total Revenue
16.5%
       
29.2%
29.0%
-0.2
+0.2
                   
Net Finance
Expense
(750)
-
-
305
90
(355)
(381)
   
Joint Ventures
(9)
-
-
-
-
(9)
(2)
   
                   
Profit Before Tax
2,267
662
1,218
629
206
4,982
5,370
-
(7)
Taxation
(249)
(139)
(247)
(141)
(14)
(790)
(921)
   
Tax Rate
11%
       
16%
17%
   
Profit After Tax
2,018
523
971
488
192
4,192
4,449
2
(6)
                   
Non-controlling Interests
(1)
-
-
-
-
(1)
(2)
   
Net Profit
2,017
523
971
488
192
4,191
4,447
2
(6)
                   
Weighted Average Shares
1,264
1,264
1,264
1,264
1,264
1,264
1,262
   
                   
Earnings Per Share
1.60
0.41
0.77
0.39
0.15
3.32
3.52
2
(6)
 
1Other adjustments include provision charges and settlement income related to certain legal matters (see Note 5) and fair value adjustments to contingent consideration liabilities arising on business combinations (see Note 4). 
22014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from Other Operating Income.
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
4All financial figures, except Earnings Per Share, are in $ millions ($m). Weighted Average Shares are in millions.
 
 
Q3 2015
Reported
Restructuring
Intangible
Amortisation & Impairments
Diabetes Alliance
Other1
Core
% Change
Q3 2015
Q3 20142
CER
Actual
Product Sales
5,850
-
-
-
-
5,850
6,542
(2)
(11)
Externalisation Revenue
95
-
-
-
-
95
67
50
41
Total Revenue
5,945
-
-
-
-
5,945
6,609
(2)
(10)
                   
Cost of Sales
(1,041)
23
26
-
-
(992)
(1,180)
(8)
(16)
                   
Gross Profit
4,904
23
26
-
-
4,953
5,429
-
(9)
Gross Margin3
82.2%
       
83.0%
82.0%
+1.1
+1.0
                   
Distribution
(79)
-
-
-
-
(79)
(87)
2
(9)
% Total Revenue
1.3%
       
1.3%
1.3%
-0.1
-
                   
R&D
(1,429)
56
(27)
-
-
(1,400)
(1,275)
18
10
% Total Revenue
24.0%
       
23.5%
19.3%
-3.8
-4.2
                   
SG&A
(2,679)
135
240
108
(24)
(2,220)
(2,486)
(3)
(11)
% Total Revenue
45.1%
       
37.3%
37.6%
+0.5
+0.3
                   
Other Operating Income
453
-
21
-
-
474
189
156
152
% Total Revenue
7.6%
       
8.0%
2.9%
+4.6
+5.1
                   
Operating Profit
1,170
214
260
108
(24)
1,728
1,770
7
(2)
% Total Revenue
19.7%
       
29.1%
26.8%
+2.4
+2.3
                   
Net Finance
Expense
(237)
-
-
101
31
(105)
(114)
   
Joint Ventures
(2)
-
-
-
-
(2)
(2)
   
                   
Profit Before Tax
931
214
260
209
7
1,621
1,654
8
(2)
Taxation
(161)
(45)
(54)
(46)
(12)
(318)
(321)
   
Tax Rate
17%
       
20%
19%
   
Profit After Tax
770
169
206
163
(5)
1,303
1,333
8
(2)
                   
Non-controlling Interests
-
-
-
-
-
-
1
   
Net Profit
770
169
206
163
(5)
1,303
1,334
8
(2)
                   
Weighted Average Shares
1,264
1,264
1,264
1,264
1,264
1,264
1,263
   
                   
Earnings Per Share
0.61
0.13
0.17
0.13
(0.01)
1.03
1.05
8
(2)
 
1Other adjustments include fair value adjustments to contingent consideration liabilities arising on business combinations (see Note 4). 
22014 comparatives have been restated to reflect the reclassification of Externalisation Revenue from Other Operating Income.
3 Gross Margin reflects Gross Profit derived from Product Sales, divided by Product Sales.
4All financial figures, except Earnings Per Share, are in $ millions ($m). Weighted Average Shares are in millions.
 
Profit and Loss
 
Gross Profit
Core Gross Profit increased by 2% in the nine-month period to $15,399m. Excluding the impact of externalisation, the Core Gross-Profit margin increased by 1% point. Drivers of the margin increase included the mix of Product Sales and manufacturing efficiencies.
 
Operating Expenses
Core R&D costs were up 22% in the year to date to $4,036m as the Company continued its focused investment in the pipeline. Oncology is anticipated to attract over 40% of total Core R&D costs over the full year, reflecting a number of key new and active trials.
 
After a 1% reduction of Core SG&A costs in Q2 2015, third-quarter costs declined by 3% to $2,220m. Core SG&A costs were up 2% to $6,804m in the nine-month period as the Company continued to invest in the product-launch programme and the growth platforms.
 
The Company is committed to reducing Core SG&A costs in FY 2015 versus the prior year, both in terms of absolute value and relative to Total Revenue. A number of programmes designed to meet this target are progressing. These initiatives are centred on:
 
 
-      Sales, marketing and medical-cost effectiveness
 
-      Centralisation of selected functions and process improvements
 
-      Reduced third-party spend
 
-      Additional efficiencies gained across support functions and IT
 
-      Continued footprint optimisation, including presence in the UK and US
 
Resources are being deployed more selectively to meet changing customer needs and the evolving portfolio, while driving top-line growth more efficiently.
 
Other Operating Income
Core Other Operating Income of $1,027m in the year to date included royalty income of $261m, together with gains on the disposals of Entocort ($215m), Myalept ($193m), Caprelsa ($165m) and other disposals, including the US rights to Tenormin.
 
Operating Profit
Core Operating Profit was stable at $5,346m in the year to date. The Core Operating Margin declined by 0.2% points to 29.2% of Total Revenue as the Company continued to invest in the pipeline and the growth platforms. The increase of 2.4% points in the Core Operating Margin in the third quarter to 29.1% reflected the 3% decline in Core SG&A costs and increases in Core Other Operating Income.
 
Reported Operating Profit of $3,026m was 31% higher than the first nine months of 2014.
 
Finance Expense
The Core Net Finance Expense was $355m versus $381m in the comparative period. Reported net finance expense of $750m included a charge of $395m relating to the discount unwind on contingent consideration liabilities recognised on business combinations, principally relating to the acquisition of BMS's share of the global diabetes alliance last year.
 
Taxation
Excluding the previously disclosed one-off tax benefit of $186m following agreement of US federal tax liabilities of open years up to 2008, other provision releases and the benefit of the UK patent box, the Core tax rate and Reported tax rates for the nine months were 22% and 24% respectively. Including the impact of these benefits, the Core and Reported tax rates for the nine months ended 30 September 2015 were 16% and 11% respectively. The cash tax paid for the nine-month period was $954m, which is 42% of Reported Profit Before Tax and 19% of Core Profit Before Tax.
 
The Core and Reported tax rates for the same period in 2014 were 19% and 21% respectively when excluding the impact of the one-off tax benefit of $117m in respect of prior periods following the inter-governmental agreement of a transfer pricing matter. Including the impact of this benefit, the Core and Reported tax rates for the nine months ended 30 September 2014 were 17% and 15% respectively.
 
Earnings Per Share (EPS)
Core EPS in the year to date increased by 2% to $3.32. Reported EPS was up by 40% at $1.60.
 
Productivity
The Company continued to make good progress in implementing the fourth wave of restructuring announced in the first quarter of 2013 that was subsequently expanded during 2014 and in the first half of 2015. Restructuring charges of $214m were taken in the third quarter, bringing the year to date total to $662m.
 
Cash Flow and Balance Sheet
 
Cash Flow
The Company generated a cash inflow from operating activities of $2,753m in the year to date, compared with an inflow of $5,216m in the comparative period, reflecting the operational performance of the business and an adverse movement in working capital.
 
Net cash outflows from investing activities were $1,654m compared with $5,516m in the first nine months of 2014, the difference primarily reflecting the acquisition of the BMS share of the global diabetes alliance in 2014 and the proceeds from disposals of intangible assets in 2015.
 
Net cash distributions to shareholders were $3,456m through dividends of $3,486m, offset by proceeds from the issue of shares of $30m due to the exercise of stock options.
 
The Company has embarked upon an initiative to further improve cash generation from the business including standardisation of global processes and payment terms.
 
Debt and Capital Structure
At 30 September 2015, outstanding gross debt (interest-bearing loans and borrowings) was $10,947m (30 September 2014: $9,926m). Of the gross debt outstanding at 30 September 2015, $2,671m is due within one year (30 September 2014: $2,399m).
 
The Company's net debt position at 30 September 2015 was $5,886m (30 September 2014: $3,596m).
                                     
Shares in Issue
During the year to date, 0.7 million shares were issued in respect of share option exercises for a consideration of $30m. The total number of shares in issue at 30 September 2015 was 1,264 million.
 
Capital Allocation
In setting the dividend distribution policy and the overall financial strategy, 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 business investment, funding the progressive dividend policy and meeting debt-service obligations, the Board will keep under review the opportunity to return cash in excess of these requirements to shareholders through periodic share repurchases. The Board has decided however that no share repurchases will take place in FY 2015 in order to maintain the strategic flexibility to invest in the business.
 
 
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
2014
 
YTD 20151
 
Change %
 
Total Revenue
 
Core Operating Profit
EUR
 
Product Sales
 
0.75
 
0.90
 
(16)
 
(225)
 
(138)
JPY
 
Product Sales
 
105.87
 
120.91
 
(12)
 
(119)
 
(84)
CNY
 
Product Sales
 
6.16
 
6.25
 
(1)
 
(115)
 
(49)
SEK
 
Costs
 
6.86
 
8.41
 
(18)
 
(6)
 
114
GBP
 
Costs
 
0.61
 
0.65
 
(7)
 
(37)
 
112
Other3
                 
(242)
 
(139)
                         
                                   
1Based on average daily spot rates YTD to the end of September 2015
2Based on 2014 actual average exchange rates and group currency exposures
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 September 2015 AstraZeneca had hedged over 90% of forecast short-term currency exposure that arises between the booking and settlement dates on non-local currency purchases and Product Sales.
 
Corporate and Business Development Update
___________________________________________________________________________
 
a) Purchase of US Biologics Manufacturing Facility
On 11 September 2015 AstraZeneca announced that it had added to its biologics manufacturing capability in the US with the purchase of a high-tech biologics bulk manufacturing facility from Amgen Inc., (Amgen). Over time, the LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the Company's extensive portfolio of biologics medicines.
 
b) Entocort Divestment
In the third quarter AstraZeneca completed an agreement with Tillotts, part of Zeria Pharmaceutical Co., Ltd, for the divestment of global rights, outside the US, to Entocort (budesonide), a gastroenterology medicine for patients with mild-moderate Crohn's disease and ulcerative colitis.
 
Entocort is currently available in over 40 countries, with total Product Sales of $53m outside the US in 2014. Under the terms of the agreement, Tillotts made an upfront payment to AstraZeneca of $215m upon completion of the transaction to acquire the rights to sell and develop Entocort capsules and enema formulations outside the US. The payment has been shown within Other Operating Income in the Company's financial statements in the third quarter.
 
c) Caprelsa Divestment
In the third quarter AstraZeneca completed an agreement with Genzyme Corporation (Genzyme), part of Sanofi S.A., for the divestment of Caprelsa (vandetanib), a rare-disease medicine. Caprelsa was granted Orphan Drug Designation by the US FDA in 2005 and is currently available in 28 countries for the treatment of aggressive and symptomatic medullary thyroid carcinoma.
 
Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300m, including an upfront payment of $165m to acquire the global rights to sell and develop Caprelsa. The upfront payment has been shown within Other Operating Income in the Company's financial statements in the third quarter; further development and sales milestone payments may reach up to $135m and will be reported in Other Operating Income. The transaction did not include the transfer of any AstraZeneca employees or facilities.
 
d) Agreement to Develop Novel Immuno-Oncology Treatments
On 6 August 2015 it was announced that AstraZeneca and Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation, had entered into a licensing agreement under which AstraZeneca will acquire exclusive global rights to develop, manufacture and commercialise the adenosine A2A receptor antagonist, HTL-1071, a small molecule immuno-oncology candidate, and potential additional A2A receptor-blocking compounds. AstraZeneca will explore the assets across a range of cancers, including in combination with its existing portfolio of immunotherapies.
 
e) Adding New Combination Clinical Trials to Existing Immuno-Oncology Research Collaboration
On 22 October 2015 AstraZeneca and Eli Lilly and Company (Lilly) announced an extension to their existing Immuno-Oncology collaboration exploring novel combination therapies for the treatment of patients with solid tumours. Under the terms of the expanded agreement, AstraZeneca and Lilly will evaluate the safety and efficacy of a range of additional combinations across the companies' complementary portfolios.
 
Durvalumab, AstraZeneca's investigational anti-PD-L1 immune-checkpoint inhibitor, will be combined with Lilly molecules including a TGF-beta kinase inhibitor, galunisertib; a CXCR4 peptide antagonist; and an anti-CSF-1R monoclonal antibody, which will be assessed additionally with AstraZeneca's anti-CTLA-4 monoclonal antibody, tremelimumab.
 
Management Update
___________________________________________________________________________
 
On 24 August 2015 AstraZeneca announced the appointment of Sean Bohen MD, PhD, as Executive Vice President of Global Medicines Development and Chief Medical Officer. He joined the Company on 15 September 2015.
 
Dr. Bohen is responsible for driving the progress of AstraZeneca's portfolio of small molecules and biologics investigational medicines through late-stage development to regulatory approval. As Chief Medical Officer, he is responsible for patient safety across the entire AstraZeneca and MedImmune portfolio.
 
Dr. Bohen joined AstraZeneca from Genentech where he was most recently Senior Vice President of Early Development. He oversaw preclinical and clinical development programmes across all therapy areas, including oncology, respiratory and autoimmune diseases, to deliver trial-ready drug candidates to late-stage development. Before this, he held a number of positions in early and late-stage development, playing a key role in the growth and progress of the Genentech/Roche portfolio. Dr. Bohen was instrumental in bringing a large number of new medicines to patients, in particular for cancer and led activities to incorporate diagnostics into clinical programmes.
 
Prior to joining Genentech, Dr. Bohen was a Clinical Instructor in Oncology at Stanford University School of Medicine, a research associate at the Howard Hughes Medical Institute and a postdoctoral fellow at the National Cancer Institute in the US.
 
Research and Development Update
________________________________________________________________________________
 
A comprehensive table with AstraZeneca's pipeline of medicines in human trials can be found later in this document.
 
Progress since the prior results announcement on 30 July 2015:
 
Regulatory Approvals
1
-     Brilinta - post-MI (PEGASUS trial) (US)
Regulatory Submission Acceptances
3
-     PT003 - COPD (US)
-     Brilinta - ACS, post-MI (JP)
-     AZD9291 - lung cancer (JP)
 
Other Key Developments
6
-     saxagliptin/dapaglifozin - type-2 diabetes (US):
Complete Response Letter
 
-      AZD9291: Granted Priority Review by FDA and Japanese MHLW
 
-       FDA Fast Track designation: 
anifrolumab - lupus (SLE), tremelimumab - mesothelioma, durvalumab - head & neck cancer
 
New Molecular Entities (NMEs) in Pivotal Trials or under Regulatory Review
15
RIA
-     lesinurad
-     PT003
-     brodalumab
-     benralizumab
-     tralokinumab - severe asthma
-     PT010 - COPD
-     anifrolumab
 
CVMD
-     roxadustat
 
Oncology
-     AZD9291
-     cediranib - ovarian cancer
-     tremelimumab
-     durvalumab
-     moxetumomab pasudotox - leukaemia
-     selumetinib - lung cancer
 
ING
-     CAZ AVI
 
Projects in clinical pipeline
113
 
 
 
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD - Cardiovascular & Metabolic Disease, 
 
ING - Infection, Neuroscience & Gastrointestinal
 
In the period 2015-2016 AstraZeneca anticipates 12-16 Phase II starts, 14-16 NME and major line-extension regulatory submissions and 8-10 NME and major line-extension approvals.
 
 
1.   Respiratory, Inflammation & Autoimmunity (RIA)
 
Steady progress continues to be made in the RIA pipeline, which now includes seven programmes in pivotal trials or under registration. AstraZeneca's respiratory portfolio includes a range of differentiated potential medicines such as novel combinations, biologics and devices for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The pipeline also includes a number of assets in inflammatory and autoimmune diseases within areas such as gout, psoriasis, systemic lupus and rheumatoid arthritis.
 
At the European Respiratory Society (ERS) meeting in Amsterdam, Netherlands in September 2015, positive Phase III results were presented for PT003 for COPD. PT003 could be the first LAMA/LABA combination to be delivered in a pressurised metered-dose inhaler using a unique co-suspension technology. Overall 33 abstracts were presented from across the Respiratory disease portfolio, including findings from the Company's biologics pipeline and early-science programmes.
 
a) Lesinurad (gout)
On 23 October 2015 the FDA's Arthritis Advisory Committee (AAC) voted 10 to 4 to recommend the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine-oxidase inhibitor. The AAC reviewed safety and efficacy data from the pivotal Phase III combination-therapy programme trials, representing the largest clinical-trial data set of gout patients treated with combination urate-lowering therapy.
 
The FDA is not bound by the AAC's recommendation but takes its advice into consideration when reviewing the application for a potential medicine. The Prescription Drug User Fee Act (PDUFA) target goal date for lesinurad is 29 December 2015. If approved, lesinurad will be the first selective uric acid reabsorption inhibitor, or SURI, in the US.
 
b) PT003 (COPD)
Among key abstracts presented at the ERS meeting were the positive Phase III efficacy and safety data from the PINNACLE programme of the novel LAMA (glycopyrronium) and LABA (formoterol fumarate) combination.
 
The two pivotal 24-week trials, PINNACLE-1 and PINNACLE-2, tested the potential to improve lung function in patients with COPD and showed that PT003 had positive effects on both co-primary and secondary endpoints. There were no unexpected safety findings, with adverse events being consistent with previous results from the development programme.
 
During the period the FDA accepted the PT003 New Drug Application for standard full review with an expected PDUFA action date in Q2 2016, as anticipated.
 
c) Brodalumub (psoriasis)
Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis.
 
On 1 September 2015 AstraZeneca announced that it had entered into a collaboration agreement with Valeant Pharmaceuticals International, Inc. (Valeant) under which it will grant an exclusive license for Valeant to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen, the originator of brodalumab. Completion of the transaction occurred on 1 October 2015.
 
Brodalumab is supported by data from the three AMAGINE Phase III pivotal trials. The results highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials, involving over 3,500 patients.
 
On 1 October 2015 The New England Journal of Medicine published positive results from the AMAGINE-2 and AMAGINE-3 Phase III trials.
 
d) Anifrolumab (lupus)
Anifrolumab is an investigational, monoclonal antibody that binds to the type I interferon (IFN)-α receptor and blocks the biological effects of all type I IFNs. It is currently in Phase III development for systemic lupus erythematosus; the first patient was dosed in July 2015. The Company anticipates the publication of Phase IIb data next week in an oral presentation at the American College of Rheumatology annual meeting in San Francisco, California.
 
In August 2015 the FDA granted Fast Track designation to anifrolumab, designed to expedite the development and review of drugs that treat serious conditions and meet an unmet medical need.
 
 
 
2.   Cardiovascular & Metabolic Disease (CVMD)
 
AstraZeneca's strategy in CVMD focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across CV disease, diabetes and chronic kidney-disease indications. The patient-centric approach is reinforced by science-led life-cycle management programmes and technologies, including early research into regenerative methods.
 
In the third quarter, AstraZeneca presented 54 abstracts from the Company's research and development in diabetes at the 51st Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.
 
The presentations included data on a number of approved products for the treatment of type-2 diabetes, including Onglyza, Farxiga/Forxiga, Bydureon and Byetta. Additionally several abstracts representing AstraZeneca's early-stage and pre-clinical research explored novel pathways and modalities to address the underlying pathophysiology of diabetes.
 
a) Brilinta/Brilique (CV disease)
Brilinta/Brilique is an oral anti-platelet treatment that works by inhibiting platelet activation and was first approved by the FDA in July 2011 on the basis of data from the PLATO study. For at least the first 12 months following a myocardial infarction, it is superior to clopidogrel and is the first and only oral anti-platelet medicine to demonstrate superior reductions in cardiovascular death.
 
On 29 August 2015, the European Society of Cardiology updated NSTE-acute coronary syndrome (ACS) guidelines, continuing to recommend ticagrelor over clopidogrel in ACS for all patients at moderate to high risk of ischaemic events, regardless of initial treatment strategy and including those pre-treated with clopidogrel. The society also guided that dual anti-platelet therapy (P2Y12-inhibitor plus aspirin) beyond one year may be considered after careful assessment of the ischaemic and bleeding risks of patients.
 
AstraZeneca announced on 3 September 2015 that the FDA had approved Brilinta tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year.
 
The SOCRATES trial evaluating the efficacy of Brilinta/Brilique compared to aspirin in reducing thrombotic events in patients with acute ischaemic stroke and high-risk transient ischaemic attack saw its last patient randomised in November 2015. This trial is scheduled to report data in the first half of 2016. SOCRATES is an event-driven global clinical trial involving 13,200 patients in 33 countries and is part of the broader PARTHENON lifecycle programme for Brilinta/Brilique.
 
b) Saxagliptin/dapagliflozin (type-2 diabetes)
On 15 October 2015 AstraZeneca announced that the FDA had issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type-2 diabetes. The CRL stated that more clinical data are required to support the application. This includes clinical-trial data from ongoing or completed trials and may require information from new trials.
 
AstraZeneca will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/dapagliflozin fixed-dose combination. This announcement did not affect ongoing interactions with other health authorities as part of individual-application procedures. Based on the information available, the CRL is not expected to affect the individual components of saxagliptin or dapagliflozin, which are approved for the treatment of adult patients with type-2 diabetes.
 
c) Onglyza (type-2 diabetes)
AstraZeneca is working closely with regulators as part of the ongoing review of the full Phase III SAVOR cardiovascular outcomes trial data-set. The Company is currently awaiting a forthcoming decision from the FDA on a possible label update for Onglyza and Kombiglyze XR respectively.
 
 
3.   Oncology
 
AstraZeneca continues to make progress in both early and late-stage programmes toward the goal of eliminating cancer as a major cause of death. In the third quarter, partnerships and collaborations were established with Inovio Pharmaceuticals, Peregrine Pharmaceuticals, Heptares Therapeutics and Mirati Therapeutics, all operating in the Immuno-Oncology sector. In parallel, the early portfolio is advancing molecules into human trials. In the quarter, the first patient was dosed with MEDI9447, a CD73 monoclonal antibody. Other targets, including GITR and TLR7/8 are planned to start shortly and will bolster the Company's ongoing Oncology efforts.
 
During the third quarter, the Company presented new data for its Oncology portfolio at the World Conference on Lung Cancer (WCLC) and the European Cancer Congress (ECC) to share ongoing progress.
 
 
a)   AZD9291 (lung cancer)
At the WCLC data on AZD9291 was a major focus. In the 1st-line EGFR-mutation positive non-small cell lung cancer (NSCLC) setting, AZD9291 showed an overall response rate of 75%; 72% of patients were progression-free at 12 months and the longest duration of response was ongoing at 18 months.
 
At ECC, data were presented from a pooled analysis of the AURA Phase II trials (AURA extension and AURA2) in patients with EGFR-mutated NSCLC who had progressed on an EGFR-targeted treatment and whose tumours had the T790M resistance mutation. The data confirmed findings already reported at previous meetings for AZD9291; data from over 400 pre-treated patients with EGFRm T790M showed an objective response rate of 66% (95% confidence interval (CI); 61% to 71%). Preliminary median progression-free survival (PFS) was 9.7 months (95% CI; 8.3 months to non-calculable) and median duration of response was non-calculable (95% CI; 8.3 months to NC).
 
Furthermore, clinical anecdotes and pre-clinical data recently presented at the WCLC and the ECC suggest that AZD9291 penetrates the blood-brain barrier and may have activity on brain metastases. New data from the BLOOM (NCT02228369) study on the activity of AZD9291 in the brain is anticipated to be presented at the forthcoming American Association for Cancer Research NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, Massachusetts.
 
b) Durvalumab (solid and haematological tumours)
Durvalumab, AstraZeneca's cornerstone Immuno-Oncology medicine, is currently being tested in a number of clinical trials in monotherapy and in combination with other potential AstraZeneca medicines such as tremelimumab, with the potential to be part of the first chemotherapy-free treatment option for first-line patients across several tumour types.
 
Anti-PD1/PD-L1 monotherapy is transforming cancer medicine, but the benefit is largely limited to patients with PD-L1 positive tumours. Data from the combination of durvalumab and tremelimumab have demonstrated anti-tumour activity in patients with heavily pre-treated NSCLC regardless of PD-L1 status, including in patients with no tumour-cell-membrane PD-L1 staining. A comprehensive registration programme with durvalumab monotherapy and in combination with tremelimumab is underway across multiple tumour types, stages of disease, and lines of therapy. Additional combination trials of durvalumab with other immunotherapies, targeted therapies and chemotherapies are also underway.
 
A development programme for durvalumab in haematological malignancies in combination with effective therapies through the alliance with Celgene has also been accelerated.
 
Finally a new potential biomarker for use with durvalumab was presented at the ECC, showing that gamma interferon, along with PD-L1, was shown to be associated with responses to durvalumab monotherapy in lung-cancer patients.
 
The table overleaf illustrates ongoing trials with durvalumab:
 
LUNG CANCER
Name
Phase
Line of treatment
Population
Design
Timelines
Status
Early disease
Monotherapy
ADJUVANT
III
N/A
Stage Ib-IIIa NSCLC
durvalumab vs placebo
FPD Q1 2015
 
Data expected 2020
Recruiting
PACIFIC
III
N/A
Stage III unresectable NSCLC
durvalumab vs placebo
FPD Q2 2014
 
Data expected 2017
Recruiting
Advanced/metastatic disease
Monotherapy
ATLANTIC
II
3rd line
PD-L1+ NSCLC
durvalumab (single arm)
FPD Q1 2014
 
LPD Q2 2015 (certain cohorts)
First data by year-end 2015
Combination therapy
ARCTIC
III
3rd line
NSCLC
durvalumab vs SoC (PD-L1+) or durvalumab vs tremelimumab vs durva + treme vs SoC (PD-L1-)
FPD Q2 2015
 
Data expected 2017
Recruiting
CAURAL
III
2nd line
T790M+ NSCLC
AZD9291 vs AZD9291 + durvalumab
FPD Q3 2015
 
Data expected 2017
Initiated enrolment; currently on partial hold to characterise incidence of interstitial lung disease
MYSTIC
III
1st line
NSCLC (PFS endpoint)
durvalumab vs durva + treme vs SoC
FPD Q3 2015
 
Data expected 2017
First patient dosed
NEPTUNE
III
1st line
NSCLC
(OS endpoint)
durva + treme vs SoC
Data expected 2018
Awaiting first patient dosed
-
III
1st line
NSCLC
durvalumab + chemotherapy +/- tremelimumab
 
In preparation
 
 
METASTATIC HEAD AND NECK CANCER
Name
Phase
Line of treatment
Population
Design
Timelines
Status
Monotherapy
HAWK
II
2nd line
PD-L1+ SCCHN
durvalumab (single arm)
FPD Q1 2015
 
Data expected
H2 2016
Recruiting
 
Indication granted FDA Fast Track designation
Combination therapy
CONDOR
II
2nd line
PD-L1-SCCHN
durvalumab vs tremelimumab vs durva + treme
FPD Q2 2015
 
Data expected 2017
Recruiting
EAGLE
III
2nd line
SCCHN
durvalumab vs durva + treme vs SoC
Data expected 2018
In preparation
KESTREL
 
III
1st line
SCCHN
durvalumab vs durva + treme vs SoC
FPD Q4 2015
 
Data expected 2018
In preparation
 
 
 
METASTATIC BLADDER CANCER
Name
Phase
Line of treatment
Population
Design
Timelines
Status
DANUBE
III
1st line
Cisplatin chemo-
therapy- eligible/
ineligible
durvalumab vs durva + treme vs SoC
FPD Q4 2015
 
Data expected 2018
First patient dosed
 
 
 
OTHER TUMOUR TYPES
Name
Phase
Line of treatment
Indication
Design
Timelines
Status
-
II
2nd/
3rd line
Metastatic gastric cancer
durvalumab vs tremelimumab vs durva + treme
 
In preparation
-
II
2nd line
Unresectable liver cancer
durvalumab vs tremelimumab vs durva + treme
 
In preparation
ALPS
II
2nd line
Metastatic pancreatic cancer
durva + treme (single arm)
 
In preparation
 
FPD=First Patient Dosed, LPD=Last Patient Dosed, SoC=Standard of Care
 
c) Lynparza (ovarian cancer)
Exploratory biomarker data presented at the ECC from a Phase II study of Lynparza are contributing to an enhanced scientific understanding of why some women with ovarian cancer without a BRCA1/2 mutation demonstrate anti-tumour activity with poly ADP-ribose polymerase (PARP) inhibitor treatment.
 
The data suggest that these women have tumours with mutations in other homologous recombination repair (HRR) genes that behave in a similar way to BRCA mutations. The potential of Lynparza to target tumours with HRR mutations beyond those in BRCA genes is under investigation in ongoing clinical trials.
 
4.   Infection, Neuroscience & Gastrointestinal
 
a) CAZ AVI (serious infections)
On 2 September 2015 the Company announced that the CAZ AVI pivotal trials RECAPTURE 1 and RECAPTURE 2 had met the objective of statistical non-inferiority compared to doripenem for both the EMA primary and FDA co-primary endpoints. In addition and for the EMA primary endpoint, CAZ AVI was statistically superior (at the 5% level) to doripenem. CAZ AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming increasingly resistant to antibiotics and pose a threat to public health. CAZ AVI is currently under regulatory review by the EU.
 
b) FluMist/Fluenz (influenza vaccine)
The Company completed a strategic agreement in the third quarter with Daiichi Sankyo for the development and commercialisation of FluMist in the Japanese market.
 
c) Strategic Alliance to Accelerate New Antibiotic Development
On 16 September 2015 it was announced that multiple drugs to combat bioterrorism threats and other life-threatening bacterial infections will be developed under a public-private partnership agreement between the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) and AstraZeneca.
 
ASPR's Biomedical Advanced Research and Development Authority (BARDA) and AstraZeneca will manage and fund the portfolio over the next five years. In the arrangement, BARDA initially will provide $50m toward product development and could provide up to a total of $170m for development of additional products in the portfolio during the five-year period. The first candidate medicine in the portfolio combines two antibiotics, Aztreonam and Avibactam, known together as ATM AVI. The Phase I trial for ATM AVI was commenced by the Company in 2012.
 
 
 
ASTRAZENECA DEVELOPMENT PIPELINE 30 SEPTEMBER 2015
Phase III / Pivotal Phase II / Registration
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.
#    Partnered product.
 
Compound
Mechanism
Area Under Investigation
Date Commenced
Estimated Regulatory Submission / Submission Acceptance†
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
anifrolumab# TULIP
IFN-alphaR mAb
systemic lupus erythematosus
Q3 2015
2019
(Fast Track)
2019
2019
 
benralizumab#
CALIMA SIROCCO ZONDA BISE BORA
GREGALE
IL-5R mAb
severe asthma
Q4 2013
H2 2016
H2 2016
N/A
N/A
benralizumab#
TERRANOVA GALATHEA
IL-5R mAb
COPD
Q3 2014
2018
2018
N/A
N/A
brodalumab#
AMAGINE-1,2,3
IL-17R mAb
psoriasis
Q3 2012
Q4 2015
Q4 2015
N/A
N/A
lesinurad
CLEAR 1,2
CRYSTAL
selective uric acid reabsorption inhibitor (URAT-1)
chronic treatment of hyperuricemia in patients with gout
Q4 2011
Accepted
Accepted
   
PT003 GFF PINNACLE
LABA / LAMA
COPD
Q2 2013
Accepted
H2 2016
2017
2017
PT010
LABA / LAMA / ICS
COPD
Q3 2015
2018
2018
2018
2019
tralokinumab
STRATOS 1,2
TROPOS
IL-13 mAb
severe asthma
Q3 2014
2018
2018
2018
 
Cardiovascular and Metabolic Disease
Brilinta/Brilique1
P2Y12 receptor antagonist
arterial thrombosis
 
Launched
Launched
Submitted
Launched
Epanova#
omega-3 carboxylic acids
severe hypertrigly-ceridemia
 
Approved
 
2018
2019
Farxiga/Forxiga2
SGLT2 inhibitor
type-2 diabetes
 
Launched
Launched
Launched
Submitted
roxadustat# OLYMPUS ROCKIES
hypoxia-inducible factor prolyl hydroxylase inhibitor
anaemia in CKD/ESRD
Q3 2014
2018
N/A
N/A
H2 2016
Oncology
AZD9291
AURA, AURA 2
EGFR tyrosine kinase inhibitor
≥2nd-line advanced EGFRm T790M NSCLC
 
Q2 2014
Accepted (Breakthrough designation, Priority Review)
Accepted (Accelerated assessment)
Accepted (Priority Review)
2017
AZD9291
FLAURA
EGFR tyrosine kinase inhibitor
1st-line advanced EGFRm NSCLC
Q1 2015
2017
2017
2017
2020
AZD9291+dur-valumab#
CAURAL3
EGFR tyrosine kinase inhibitor + PD-L1 mAb
≥2nd-line advanced EGFRm T790M NSCLC
Q3 2015
       
cediranib
ICON 6
VEGFR tyrosine kinase inhibitor
PSR ovarian cancer
Q2 2007
 
Accepted (Orphan Drug)
   
durvalumab#
ATLANTIC
PD-L1 mAb
3rd-line NSCLC (PD-L1 positive)
Q1 2014
H1 2016
(Fast Track)
2017
2017
 
durvalumab#
PACIFIC
PD-L1 mAb
stage III NSCLC
Q2 2014
2017
2020
2020
 
durvalumab#
HAWK
PD-L1 mAb
2nd-line SCCHN (PD-L1 positive)
Q1 2015
 
2017
(Fast Track)
2017
2017
 
durvalumab# +
tremelimumab
ARCTIC
PD-L1 mAb + CTLA-4 mAb
3rd-line NSCLC
Q2 2015
2017
2017
2017
 
durvalumab# + tremelimumab
CONDOR
PD-L1 mAb + CTLA-4 mAb
2nd-line SCCHN (PD-L1 negative)
Q2 2015
2017
2017
2017
 
durvalumab# + tremelimumab
MYSTIC
PD-L1 mAb + CTLA-4 mAb
1st-line NSCLC
Q3 2015
2017
2017
2017
 
moxetumomab pasudotox#
anti-CD22 recombinant
immunotoxin
hairy cell leukaemia
Q2 2013
2018
2018
   
selumetinib#
ASTRA
MEK inhibitor
differentiated thyroid cancer
Q3 2013
2018
2018
   
selumetinib#
SELECT-1
MEK inhibitor
2nd-line KRASm NSCLC
Q4 2013
2017
2017
   
tremelimumab DETERMINE
CTLA-4 mAb
mesothelioma
Q2 2014
H1 2016
(Orphan Drug, Fast Track)
H2 2016
H2 2016
 
Infection, Neuroscience and Gastrointestinal
CAZ AVI#
 
cephalosporin/
beta lactamase inhibitor
serious infections, complicated intra-abdominal infection, complicated urinary tract infection
Q1 2012
N/A
Accepted
 
2017
CAZ AVI#
cephalos-porin/ beta lactamase inhibitor
hospital-acquired pneumonia/ ventilator-associated pneumonia
Q2 2013
N/A
Accepted
 
2017
Zinforo#
extended spectrum cephalosporin with affinity to penicillin-binding proteins
pneumonia/skin infections
 
N/A
Launched
N/A
Submitted
 
¶    Registrational Phase II/III study.
1    Brilinta in the US; Brilique in rest of world.
2    Farxiga in the US; Forxiga in rest of world.
3    Temporarily closed to enrolment.
 
Phases I and II
 
NMEs and significant additional indications
 
Compound
Mechanism
Area Under Investigation
Phase
Date Commenced Phase
 
 
Respiratory, Inflammation and Autoimmunity
 
abediterol (AZD0548)
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
Q1 2010
 
mavrilimumab#
GM-CSFR mAb
rheumatoid arthritis
II
Q1 2010
 
MEDI-551#
CD19 mAb
neuromyelitis optica2
II
Q1 2015
 
MEDI2070#
IL-23 mAb
Crohn's disease
II
Q1 2013
 
abrilumab#
alpha(4)beta(7) mAb
Crohn's disease / ulcerative colitis
II
Q4 2012
 
MEDI9929#
TSLP mAb
asthma / atopic dermatitis
II
Q2 2014
 
PT010
LABA/LAMA/ICS
asthma
II
Q2 2014
 
RDEA3170
selective uric acid reabsorption inhibitor (URAT-1)
chronic treatment of hyperuricemia in patients with gout
II
Q3 2013
 
tralokinumab
IL-13 mAb
idiopathic pulmonary fibrosis
II
Q4 2012
 
tralokinumab
IL-13 mAb
atopic dermatitis
II
Q1 2015
 
AZD1419#
TLR9 agonist
asthma
I
Q3 2013
 
AZD7986
DPP1
COPD
I
Q4 2014
 
AZD8999
MABA
COPD
I
Q4 2013
 
MEDI4920
anti-CD40L-Tn3 fusion protein
primary Sjögren's syndrome
I
Q2 2014
 
MEDI5872#
B7RP1 mAb
systemic lupus erythematosus
I
Q4 2008
 
MEDI7836
IL-13 mAb-YTE
asthma
I
Q1 2015
 
Cardiovascular and Metabolic Disease
 
AZD4901
NK3 receptor antagonist
polycystic ovarian syndrome
II
Q2 2013
 
AZD9977
selective mineralocorticoid receptor modulator
diabetic kidney disease
I
Q3 2015
 
MEDI0382
GLP-1/
glucagon dual agonist
diabetes / obesity
I
Q1 2015
 
MEDI6012
LCAT
ACS
I
Q1 2012
 
MEDI8111
Rh-factor II
trauma / bleeding
I
Q1 2014
 
Oncology
 
AZD1775#
WEE-1 inhibitor
ovarian cancer
II
Q4 2012
 
AZD2014
mTOR serine/ threonine kinase inhibitor
solid tumours
II
Q1 2013
 
AZD4547
FGFR tyrosine kinase inhibitor
solid tumours
II
Q4 2011
 
AZD5069+durvalumab#
CXCR2 + PD-L1 mAb
SCCHN
II
Q3 2015
 
AZD9150#+durvalumab#
STAT3 inhibitor + PD-L1 mAb
 
AZD5363#
AKT kinase inhibitor
breast cancer
II
Q1 2014
 
durvalumab#
PD-L1 mAb
solid tumours
II
Q3 2014
 
durvalumab# + tremelimumab
PD-L1 mAb + CTLA-4 mAb
gastric cancer
II
Q2 2015
 
MEDI-551#
CD19 mAb
diffuse B-cell lymphoma
II
Q1 2012
 
MEDI-573#
IGF mAb
metastatic breast cancer
II
Q2 2012
 
savolitinib/
volitinib#
MET tyrosine kinase inhibitor
papillary renal cell carcinoma
II
Q2 2014
 
selumetinib#
MEK inhibitor
2nd-line KRAS wt NSCLC
II
Q1 2013
 
AZD3759 BLOOM
EGFR tyrosine kinase inhibitor
brain metastases in advanced EGFRm NSCLC
I
Q4 2014
 
AZD9291
BLOOM
EGFR tyrosine kinase inhibitor
 
AZD5312#
androgen receptor inhibitor
solid tumours
I
Q2 2014
 
AZD6738
ATR serine / threonine kinase inhibitor
solid tumours
I
Q4 2013
 
AZD8186
PI3 kinase beta inhibitor
solid tumours
I
Q2 2013
 
AZD8835
PI3 kinase alpha inhibitor
solid tumours
I
Q4 2014
 
AZD9150#
STAT3 inhibitor
haematological malignancies
I
Q1 2012
 
AZD9291 + (durvalumab# or selumetinib# or savolitinib#)
TATTON
EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor)
advanced EGFRm NSCLC
I
Q3 2014
 
AZD9496
selective oestrogen receptor downregulator (SERD)
ER+ breast cancer
I
Q4 2014
 
durvalumab# after (AZD9291 or Iressa or (selumetinib# +docetaxel) or tremelimumab)
PD-L1 mAb
+ (EGFR tyrosine kinase inhibitor or MEK inhibitor or CTLA-4 mAb)
NSCLC
I
Q3 2014
 
durvalumab#
PD-L1 mAb
solid tumours
I
Q3 2014
 
durvalumab# + MEDI0680
PD-L1 mAb + PD-1 mAb
solid tumours
I
Q2 2014
 
durvalumab# + MEDI6383#
OX40 agonist + PD-L1 mAb
solid tumours
I
Q2 2015
 
durvalumab# + dabrafenib + trametinib1
PD-L1 mAb+ BRAF inhibitor + MEK inhibitor
melanoma
I
Q1 2014
 
durvalumab# + tremelimumab
PD-L1 mAb + CTLA-4 mAb
solid tumours
I
Q4 2013
 
Iressa + durvalumab#
PD-L1 mAb+ EGFR tyrosine kinase inhibitor
NSCLC
I
Q2 2014
 
MEDI0562#
humanised OX40 agonist
solid tumours
I
Q1 2015
 
MEDI-551# + rituximab
CD19 mAb + CD20 mAb
haematological malignancies
I
Q2 2014
 
MEDI-565#
CEA BiTE mAb
solid tumours
I
Q1 2011
 
MEDI0639#
DLL-4 mAb
solid tumours
I
Q2 2012
 
MEDI0680
PD-1 mAb
solid tumours
I
Q4 2013
 
MEDI3617#
ANG-2 mAb
solid tumours
I
Q4 2010
 
MEDI6383#
OX40 agonist
solid tumours
I
Q3 2014
 
MEDI9447
CD73 mAb
solid tumours
I
Q3 2015
 
Infection, Neuroscience and Gastrointestinal
 
AZD3241
myeloperoxidase inhibitor
multiple system atrophy
II
Q2 2012
 
AZD3293#
beta-secretase inhibitor
Alzheimer's disease
II
Q4 2014
 
AZD5847
oxazolidinone anti-bacterial inhibitor
tuberculosis
II
Q4 2012
 
CXL#
beta lactamase inhibitor / cephalosporin
methicillin-resistant S. aureus
II
Q4 2010
 
MEDI7510
RSV sF+GLA-SE
prevention of RSV disease in older adults
II
Q3 2015
 
MEDI8897#
RSV mAb-YTE
passive RSV prophylaxis
II
Q1 2015
(FDA Fast Track)
 
susatoxumab (MEDI4893)
MAb binding to S. aureus toxin
hospital-acquired pneumonia / serious S. aureus infection
II
Q4 2014
(FDA Fast Track)
 
ATM AVI#
monobactam/ beta lactamase inhibitor
targeted serious bacterial infections
I
Q4 2012
 
AZD8108
NMDA antagonist
suicidal ideation
I
Q4 2014
 
MEDI-550
pandemic influenza virus vaccine
pandemic influenza prophylaxis
I
Q2 2006
 
MEDI1814
amyloid beta mAb
Alzheimer's disease
I
Q2 2014
 
MEDI3902
anti-Psl/PcrV
prevention of nosocomial pseudomonas pneumonia
I
Q3 2014
(FDA Fast Track)
 
MEDI8852
influenza A mAb
influenza A treatment
I
Q1 2015
 
 
1    MedImmune-sponsored study in collaboration with Novartis AG.
2    Neuromyelitis optica: Now lead indication. Multiple sclerosis Phase I study continuing.
Significant Life-Cycle Management
 
Compound
Mechanism
Area Under Investigation
Date Commenced Phase
Estimated Regulatory Submission Acceptance
US
EU
Japan
China
Respiratory, Inflammation and Autoimmunity
Duaklir Genuair#
LAMA/LABA
COPD
 
2018
Launched
2018
2018
Symbicort
SYGMA
ICS/LABA
as-needed use in mild asthma
Q4 2014
N/A
2018
 
2019
Symbicort1
ICS/LABA
breath actuated Inhaler asthma/COPD
 
2018
     
Cardiovascular and Metabolism
Brilinta/Brilique2 EUCLID
P2Y12 receptor antagonist
outcomes study in patients with peripheral artery disease
Q4 2012
2017
2017
2017
2018
Brilinta/Brilique2 HESTIA
P2Y12 receptor antagonist
prevention of vaso-occlusive crises in paediatric patients with sickle cell disease
Q4 2014
2020
2020
   
Brilinta/Brilique2
PEGASUS-
TIMI 54
P2Y12 receptor antagonist
outcomes study in patients with prior myocardial infarction
Q4 2010
Launched
(Priority Review)
Accepted
Accepted
H2 2016
Brilinta/Brilique2 SOCRATES
P2Y12 receptor antagonist
outcomes study in patients with stroke or TIA
Q1 2014
H1 2016
H1 2016
H2 2016
2017
Brilinta/Brilique2 THEMIS
P2Y12 receptor antagonist
outcomes study in patients with type-2 diabetes and CAD, but without a previous history of MI or stroke
Q1 2014
2018
2018
2018
2019
Bydureon EXSCEL
GLP-1 receptor agonist
type-2 diabetes outcomes study
Q2 2010
2018
2018
2018
 
Bydureon weekly
suspension
GLP-1 receptor agonist
type-2 diabetes
Q1 2013
Q4 2015
Q4 2015
   
Epanova
STRENGTH
omega-3 carboxylic acids
outcomes study in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol
Q4 2014
2020
2020
2020
2020
Epanova/
Farxiga/Forxiga3
 
omega-3 carboxylic acids/ SGLT2 inhibitor
Non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
Q1 2015
       
Farxiga/Forxiga3
DECLARE-
TIMI 58
SGLT2 inhibitor
type-2 diabetes outcomes study
Q2 2013
2020
2020
   
Farxiga/Forxiga3
SGLT2 inhibitor
type-1 diabetes
Q4 2014
2018
2017
2018
 
Kombiglyze XR/Komboglyze4
DPP-4 inhibitor/ metformin FDC
type-2 diabetes
 
Launched
Launched
 
Submitted
Onglyza SAVOR-TIMI 53
DPP-4 inhibitor
type-2 diabetes outcomes study
Q2 2010
Accepted
Launched
 
Q4 2015
saxagliptin/
dapagliflozin FDC
DPP-4 inhibitor/ SGLT2 inhibitor FDC
type-2 diabetes
Q2 2012
Accepted 5
Accepted
   
Xigduo XR/
Xigduo6
SGLT2 inhibitor/ metformin FDC
type-2 diabetes
 
Launched
Launched
   
Oncology
Faslodex
FALCON
oestrogen receptor antagonist
1st-line hormone receptor +ve advanced breast cancer
Q4 2012
H2 2016
H2 2016
H1 2016
2020
Lynparza (olaparib) SOLO-1
PARP inhibitor
1st-line BRCAm ovarian cancer
Q3 2013
2017
2017
2017
 
Lynparza (olaparib) SOLO-2
PARP inhibitor
2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy
Q3 2013
H2 2016
H2 2016
H2 2016
 
Lynparza (olaparib) SOLO-3
PARP inhibitor
gBRCA PSR ovarian cancer
Q1 2015
2018
     
Lynparza (olaparib) GOLD
PARP inhibitor
2nd-line gastric cancer
Q3 2013
   
2017
 
Lynparza (olaparib)
OlympiA
PARP inhibitor
gBRCA adjuvant triple negative breast cancer
Q2 2014
2020
2020
2020
 
Lynparza (olaparib) OlympiAD
PARP inhibitor
gBRCA metastatic breast cancer
Q2 2014
H2 2016
H2 2016
H2 2016
 
Lynparza (olaparib) POLO
PARP inhibitor
pancreatic cancer
Q1 2015
2018
2018
2018
 
Lynparza (olaparib)
PARP inhibitor
prostate cancer
Q3 2014
       
Infection, Neuroscience and Gastrointestinal
Diprivan#
sedative and anaesthetic
conscious sedation
 
N/A
Launched
Accepted
Launched
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)
 
N/A
N/A
N/A
Q4 2015
Nexium
proton pump inhibitor
stress ulcer prophylaxis
       
H2 2016
Nexium
proton pump inhibitor
paediatrics
 
Launched
Launched
H2 2016
Accepted
                 
 
 
1    Development of a new breath-actuated pressurised metered dose inhaler is ongoing.
2    Brilinta in the US; Brilique in rest of world.
3    Farxiga in the US; Forxiga in rest of world.
4    Kombiglyze XR in the US; Komboglyze in the EU.
5    Complete Response Letter received October 2015.
6    Xigduo XR in the US; Xigduo in the EU.
 
Terminations (discontinued projects between 1 July and 30 September 2015)
 
NME / Line Extension
Compound
Reason for Discontinuation
Area Under Investigation
NME
AZD5213
Safety / efficacy
Tourette's syndrome / neuropathic pain
NME
MEDI-551# + MEDI0680
Safety / efficacy
diffuse large B-cell lymphoma
NME
MEDI6469#
Strategic
solid tumours
NME
durvalumab# + MEDI6469#
Strategic
solid tumours
NME
MEDI6469# + rituximab
Strategic
solid tumours
NME
MEDI6469# + tremelimumab
Strategic
solid tumours
NME
sifalimumab#
Strategic
systemic lupus erythematosus1
LCM
MEDI-551#
Safety / efficacy
chronic lymphocytic leukaemia
LCM
moxetumomab pasudotox#
Safety / efficacy
paediatric acute lymphoblastic leukemia
 
1    SLE project stopped but molecule under evaluation for alternative indications.
 
Completed Projects / Divestitures
 
Compound
Mechanism
Area Under Investigation
Completed/
Divested
Estimated Regulatory Submission Acceptance
US
EU
Japan
China
Bydureon Dual
Chamber Pen
GLP-1 receptor agonist
type-2 diabetes
Completed
Launched
Launched
Launched
 
brodalumab
AMVISION-1,21
IL-17R mAb
psoriatic arthritis
Partnered
       
Caprelsa2
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
medullary thyroid cancer
Divested
Launched
Launched
Approved3
Accepted
Caprelsa2
VEGFR / EGFR tyrosine kinase inhibitor with RET kinase activity
differentiated thyroid cancer
Divested
       
Entocort4
glucocorticoid steroid
Crohn's disease / ulcerative colitis
Completed/Divested
Launched
Launched
Q4 2015
N/A
Iressa
EGFR tyrosine kinase inhibitor
EGFRm NSCLC
Completed
Launched5
Launched
Launched
Launched
 
1    AstraZeneca has granted Valeant Pharmaceuticals an exclusive license to develop and commercialise brodalumab.
2    Divested to Genzyme (deal completed October 2015).
3    Approved in Japan in September 2015.
 
4    Global rights, outside the US, divested to Tillotts Pharma AG in July 2015. AstraZeneca continues to support the Japanese regulatory submission.
5    Launched in US Q3 2015.
 
 
Condensed Consolidated Statement of Comprehensive Income
 
For the nine months ended 30 September
 
2015 
$m 
 
Restated  2014*
$m 
Product sales
 
17,434 
 
19,412 
Externalisation revenue
 
875 
 
419 
Total revenue
 
18,309 
 
19,831 
Cost of sales
 
(3,377)
 
(4,175)
Gross profit
 
14,932 
 
15,656 
Distribution costs
 
(240)
 
(236)
Research and development expense
 
(4,251)
 
(4,080)
Selling, general and administrative costs
 
(8,444)
 
(8,916)
Other operating income and expense
 
1,029 
 
62 
Operating profit
 
3,026 
 
2,486 
Finance income
 
33 
 
45 
Finance expense
 
(783)
 
(703)
Share of after tax losses in joint ventures
 
(9)
 
(2)
Profit before tax
 
2,267 
 
1,826 
Taxation
 
(249)
 
(270)
Profit for the period
 
2,018 
 
1,556 
         
Other comprehensive income
       
Items that will not be reclassified to profit or loss
       
Remeasurement of the defined benefit pension liability
 
34 
 
(498)
Tax on items that will not be reclassified to profit or loss
 
(12)
 
127 
   
22 
 
(371)
Items that may be reclassified subsequently to profit or loss
       
Foreign exchange arising on consolidation
 
(359)
 
(412)
Foreign exchange arising on designating borrowings in net investment hedges
 
(322)
 
(292)
Fair value movements on derivatives designated in net investment hedges
 
24 
 
36 
Amortisation of loss on cash flow hedge
 
 
Net available for sale (losses)/gains taken to equity
 
(63)
 
73 
Tax on items that may be reclassified subsequently to profit or loss
 
84 
 
30 
   
(635)
 
(564)
Other comprehensive income for the period, net of tax
 
(613)
 
(935)
Total comprehensive income for the period
 
1,405 
 
621 
         
Profit attributable to:
       
Owners of the Parent
 
2,017 
 
1,554 
Non-controlling interests
 
 
   
2,018 
 
1,556 
         
Total comprehensive income attributable to:
       
Owners of the Parent
 
1,405 
 
626 
Non-controlling interests
 
 
(5)
   
1,405 
 
621 
         
Basic earnings per $0.25 Ordinary Share
 
$1.60 
 
$1.23 
Diluted earnings per $0.25 Ordinary Share
 
$1.59 
 
$1.23 
Weighted average number of Ordinary Shares in issue (millions)
 
1,264 
 
1,262 
Diluted weighted average number of Ordinary Shares in issue (millions)
 
1,265 
 
1,264 
 
* 2014 comparatives restated for reclassification of Externalisation revenue (see Note 1)
 
 
 
Condensed Consolidated Statement of Comprehensive Income
 
 
For the quarter ended 30 September
 
2015 
$m 
 
Restated 
2014*
$m 
Product sales
 
5,850 
 
6,542 
Externalisation revenue
 
95 
 
67 
Total revenue
 
5,945 
 
6,609 
Cost of sales
 
(1,041)
 
(1,415)
Gross profit
 
4,904 
 
5,194 
Distribution costs
 
(79)
 
(87)
Research and development expense
 
(1,429)
 
(1,552)
Selling, general and administrative costs
 
(2,679)
 
(3,132)
Other operating income and expense
 
453