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 2017
 
 
 
Commission File Number: 001-11960
 
 
 
AstraZeneca PLC
 
 
 
1 Francis Crick Avenue
 
Cambridge Biomedical Campus
 
Cambridge CB2 0AA
 
United Kingdom
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F X Form 40-F __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______
 
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes __ No X
 
If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________
 
 
 
AstraZeneca PLC
9 November 2017 07:00
Year-To-Date and Q3 2017 Results
An improved sales performance as the pipeline-driven transformation gathered pace
 
Financial Summary
 
 
YTD 2017
Q3 2017
$m
% change
$m
% change
 
Actual
CER1
Actual
CER
Total Revenue
16,688
(4)
(3)
6,232
9
10
Product Sales
14,665
(9)
(8)
4,882
(3)
(2)
Externalisation Revenue
2,023
49
50
1,350
n/m
n/m
 
 
 
 
 
 
 
Reported Operating Profit
2,991
26
16
1,149
12
9
Core Operating Profit2
5,068
8
5
1,853
9
9
 
 
 
 
 
 
 
Reported Earnings Per Share (EPS)
$1.34
3
(4)
$0.54
(32)
(33)
Core EPS
$2.98
(4)
(7)
$1.12
(15)
(17)
The difference in growth rates between Operating Profit and EPS included the impact of a one-off tax benefit in Q3 2016.
 
Financial Highlights
●      Receding impact from losses of exclusivity: Product Sales declined by 3% (2% at CER) in the quarter
●      Externalisation Revenue: $2,023m, including $997m received in the quarter from the MSD3 collaboration
●      Cost discipline continued:
●        Reported R&D costs declined by 3% (1% at CER) to $4,206m; Core R&D costs declined by 5% (2% at CER) to $3,956m
●        Reported SG&A costs declined by 11% (9% at CER) to $7,155m; Core SG&A costs declined by 7% (5% at CER) to $5,678m
●    The Company now anticipates a 2017 Core EPS performance towards the favourable end of the guidance range of a low to mid teens percentage decline
 
Commercial Highlights
The Growth Platforms grew by 3% (4% at CER) and represented 66% of Total Revenue:
●        Emerging Markets: 5% growth (7% at CER). China sales in the quarter increased by 12% (14% at CER)
●        Respiratory: 5% decline (3% at CER). Symbicort faced continued pressures in the US
●        New CVMD4: 5% growth. Brilinta sales up by 29% (31% at CER); Farxiga sales up by 24%
●        Japan: 3% growth (5% at CER). Underpinned by the growth of Tagrisso, Symbicort and Nexium
●        New Oncology5: 96% growth (97% at CER). An encouraging performance by Tagrisso; Lynparza US sales up by 9% in the quarter
 
Achieving Scientific Leadership
The table below highlights the development of the late-stage pipeline since 27 July 2017:
 
Regulatory Approvals
Faslodex - breast cancer (1st line) (US)
Lynparza - ovarian cancer (2nd line, 4th line/tablets) (US)
Calquence (acalabrutinib) - blood cancer (mantle cell lymphoma (MCL), 2nd line) (US)
Brilinta - prior myocardial infarction (MI) (CN)
Farxiga + Bydureon - type-2 diabetes (US, EU)
Bydureon BCise (autoinjector) - type-2 diabetes (US)
Symbicort - chronic obstructive pulmonary disease (COPD) exacerbations (US)
Regulatory Submission Acceptances
Lynparza - breast cancer (US, JP) (Priority Reviews)
Imfinzi - locally-advanced, unresectable lung cancer (US/Priority Review, EU, JP)
Bydureon BCise - type-2 diabetes (EU)
Major
Phase III
Data Readouts
moxetumomab pasudotox - leukaemia (met primary endpoint)
Duaklir - COPD (met primary endpoint)
tralokinumab - severe, uncontrolled asthma (did not meet primary endpoints)
Other Major Developments
Tagrisso - lung cancer (1st line): Breakthrough Therapy Designation (US)
Imfinzi - locally-advanced, unresectable lung cancer: Breakthrough Therapy Designation (US)
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our financial performance in the quarter was in line with expectations, reflecting good commercial execution, including strong growth in Emerging Markets with standout sales in China.
 
It was, however, the raft of news flow and approvals that was most notable. In particular, the positive developments for Tagrisso and Imfinzi in lung cancer and benralizumab and tezepelumab in asthma offset the disappointment of the first readout from the MYSTIC trial. The Accelerated Approval for Calquence in the treatment of an aggressive form of blood cancer was an important milestone for a medicine that will be the cornerstone of our presence in blood cancers. Further, the new strategic collaboration with MSD offers significant opportunities to maximise the potential of Lynparza.
 
This impressive momentum is set to continue with regulatory and data milestones that have the potential to show how our science-led strategy and pipeline-driven transformation are delivering for patients and shareholders."
 
FY 2017 Guidance: Updated
The Company provides guidance on Total Revenue and Core EPS only and today refines the guidance for Core EPS. This refinement primarily reflects the impact of the aforementioned MSD collaboration, for which the accounting treatment was finalised in the quarter.
 
All commentary in this section is at CER.
 
 
Updated Guidance
Prior Guidance
Total Revenue
A low to mid single-digit percentage decline
A low to mid single-digit percentage decline
Core EPS
Towards the favourable end of a low to mid teens percentage decline*
A low to mid teens percentage decline
*The Core EPS guidance anticipates a normalised effective Core tax rate in FY 2017 of 17-19% (FY 2016: 11%).
 
Guidance is subject to base-case assumptions of the progression of the pipeline and the extensive level of news flow listed on the following page. Variations in performance between quarters can be expected, with year-on-year Product Sales comparisons easing in the second half of the year, following the entry of multiple Crestor generic medicines in the US market in July 2016.
 
The Company presents Core EPS guidance only at CER. It is unable to provide guidance on a Reported/GAAP6 basis because the Company cannot reliably forecast material elements of the Reported/GAAP result, including the fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the section 'Cautionary Statements Regarding Forward-Looking Statements' at the end of this announcement.
 
In addition to the unchanged guidance above, the Company also provides unchanged indications in other areas of the Income Statement. The sum of Externalisation Revenue and Other Operating Income and Expense in
FY 2017 is anticipated to be ahead of that in FY 2016. Sustainable and ongoing income7 is expected to increase further as a proportion of total Externalisation Revenue in FY 2017 (FY 2016: 21%). Core R&D costs are expected to be broadly in line with those in FY 2016 and the Company anticipates a further reduction in Core SG&A costs in FY 2017, reflecting the evolving shape of the business. A full explanation is listed in the Operating & Financial Review.
 
FY 2017 Currency Impact
Based only on average exchange rates in the first nine months of 2017 (year to date, YTD 2017) and the Company's published currency sensitivities, the Company continues to expect a low single-digit percentage adverse impact from currency movements on Total Revenue and a minimal impact on Core EPS. Further details on currency sensitivities are contained within the Operating and Financial Review.
 
Notes
 
1.   Constant exchange rates. These are non-GAAP measures because they remove the effects of currency movements from Reported results.
2.   Core financial measures. These are non-GAAP measures because, unlike Reported performance, they cannot be derived directly from the information in the Group Financial Statements. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
3.   Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada)
4.   New Cardiovascular and Metabolic Diseases, incorporating Brilinta and Diabetes.
5.   New Oncology, comprising Lynparza, Tagrisso, Iressa (US), Imfinzi and, in due course, Calquence.
6.   Generally Accepted Accounting Principles.
7.   Sustainable and ongoing income is defined as Externalisation Revenue, excluding initial revenue.
 
All growth rates are shown at actual exchange rates, unless stated otherwise. Only one rate of growth is shown if the actual and constant exchange rates of growth are identical. All commentary in this announcement refers to the performance in the year to date, unless stated otherwise.
 
Pipeline: Forthcoming Major News Flow
Innovation is critical to addressing unmet patient needs and is at the heart of the Company's growth strategy. The focus on research and development is designed to yield strong results from the pipeline.
 
 
Q4 2017
 
Tagrisso - lung cancer (1st line): Regulatory submission
 
benralizumab - severe, uncontrolled asthma: Regulatory decision (US)
 
H1 2018
 
Lynparza - ovarian cancer (2nd line): Regulatory decision (EU, JP)
Lynparza - ovarian cancer (1st line): Data readout
Lynparza - breast cancer: Regulatory decision (US), regulatory submission (EU)
 
Imfinzi - lung cancer (PACIFIC): Regulatory decision (US)
Imfinzi +/- treme - lung cancer (ARCTIC): Data readout, regulatory submission
Imfinzi +/- treme - lung cancer (MYSTIC): Data readout (final overall survival)
Imfinzi +/- treme - head & neck cancer (KESTREL): Data readout
Imfinzi +/- treme - head & neck cancer (EAGLE): Data readout
 
moxetumomab pasudotox - leukaemia: Regulatory submission
selumetinib - thyroid cancer: Data readout, regulatory submission
 
Bevespi - COPD: Regulatory submission (JP)
Duaklir - COPD: Regulatory submission (US)
benralizumab - severe, uncontrolled asthma: Regulatory decision (EU, JP)
PT010 - COPD: Data readout
 
H2 2018
 
Lynparza - breast cancer: Regulatory decision (JP)
Lynparza - ovarian cancer (1st line): Regulatory submission
 
Imfinzi - lung cancer (PACIFIC): Regulatory decision (EU, JP)
Imfinzi +/- treme - lung cancer (MYSTIC): Regulatory submission
Imfinzi + treme - lung cancer (NEPTUNE): Data readout, regulatory submission
Imfinzi +/- treme - head & neck cancer (KESTREL): Regulatory submission
Imfinzi +/- treme - head & neck cancer (EAGLE): Regulatory submission
 
Farxiga - type-2 diabetes (DECLARE): Data readout
Bydureon BCise - type-2 diabetes: Regulatory decision (EU)
roxadustat - anaemia: Regulatory submission (US)
 
Bevespi - COPD: Regulatory decision (EU)
benralizumab - COPD: Data readout, regulatory submission
PT010 - COPD: Regulatory submission (JP)
 
anifrolumab - lupus: Data readout
 
The term 'data readout' in this section refers to Phase III data readouts.
 
Conference Call
A conference call and webcast for investors and analysts, hosted by management, will begin at 12:00 UK time today. Details can be accessed via astrazeneca.com/investors.
 
Reporting Calendar
The Company intends to publish its full-year and fourth-quarter financial results on 2 February 2018.
 
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, CVMD and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
 
For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
 
 
Media Relations
 
 
Esra Erkal-Paler
UK/Global
+44 203 749 5638
Rob Skelding
UK/Global
+44 203 749 5821
Karen Birmingham
UK/Global
+44 203 749 5634
Matt Kent
UK/Global
+44 203 749 5906
Gonzalo Viña
UK/Global
+44 203 749 5916
Jacob Lund
Sweden
+46 8 553 260 20
Michele Meixell
US
+1 302 885 2677
 
 
 
Investor Relations
 
 
Thomas Kudsk Larsen
 
+44 203 749 5712
Craig Marks
Finance; Fixed Income; M&A
+44 7881 615 764
Henry Wheeler
Oncology
+44 203 749 5797
Mitchell Chan
Oncology; Other
+1 240 477 3771
Christer Gruvris
Brilinta; Diabetes
+44 203 749 5716
Nick Stone
Respiratory; Renal
+44 203 749 5711
US toll free
 
+1 866 381 7277
 
Operating and Financial Review
_______________________________________________________________________________________
 
All narrative on growth and results in this section is based on actual exchange rates, unless stated otherwise. Financial figures are in US$ millions ($m). The performance shown in this announcement covers the nine and three-month periods to 30 September 2017 (the year to date (YTD 2017) or the quarter (Q3 2017), respectively) compared to the nine and three-month periods to 30 September 2016 (YTD 2016 and Q3 2016, respectively). All commentary in the Operating and Financial Review relates to the year to date, unless stated otherwise. Core financial measures, EBITDA and Net Debt are non-GAAP financial measures because they cannot be derived directly from the Group Condensed Consolidated Financial Statements. Management believes that these non-GAAP financial measures, when provided in combination with Reported results, will provide investors with helpful supplementary information to better understand the financial performance and position of the Company on a comparable basis from period to period. These non-GAAP financial measures are not a substitute for, or superior to, financial measures prepared in accordance with GAAP. Core financial measures are adjusted to exclude certain significant items, such as:
 
●        Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges relating to IT assets
●        Charges and provisions related to global restructuring programmes (this will include such charges that relate to the impact of global restructuring programmes on capitalised IT assets)
●        Other specified items, principally comprising legal settlements and acquisition-related costs, which include fair value adjustments and the imputed finance charge relating to contingent consideration on business combinations
 
Details on the nature of Core financial measures are provided on page 64 of the Annual Report and Form 20-F Information 2016. Reference should be made to the reconciliation of Core to Reported financial information included therein and in the Reconciliation of Reported to Core Financial Measures table included in the Financial
Performance section of this announcement.
 
EBITDA is defined as Reported Profit Before Tax after adding back Net Finance Expense, Joint Ventures and Associates and charges for depreciation, amortisation and impairment. Reference should be made to the Reconciliation of Reported Profit Before Tax to EBITDA included in the Financial Performance section of this announcement.
 
Net Debt is defined as interest-bearing loans and borrowings net of cash and cash equivalents, other investments and net derivative financial instruments. Reference should be made to the Reconciliation of Interest-Bearing Loans and Borrowings to Net Debt included in the Cash Flow and Balance Sheet section of this announcement.
 
The Company strongly encourages readers not to rely on any single financial measure, but to review AstraZeneca's financial statements, including the notes thereto, and other publicly-filed Company reports, carefully and in their entirety.
 
Total Revenue
 
 
YTD 2017
Q3 2017
$m
% change
$m
% change
Actual
CER
Actual
CER
Total Revenue
16,688
(4)
(3)
6,232
9
10
 
 
 
 
 
 
 
Product Sales
14,665
(9)
(8)
4,882
(3)
(2)
Externalisation Revenue
2,023
49
50
1,350
n/m
n/m
 
Product Sales
The receding effects of the Crestor and Seroquel XR losses of exclusivity in the US impacted Product Sales in the year to date. Global Product Sales declined by 9% (8% at CER) from $16,059m to $14,665m. Of the $1,394m difference, $999m was represented by a 36% decline (35% at CER) in Crestor sales; $393m was represented by a 64% decline in Seroquel XR sales.
 
Emerging Markets sales grew by 5% (7% at CER) to $4,519m; Emerging Markets represented AstraZeneca's largest sales region in the year to date. China sales increased by 6% (10% at CER) to $2,142m in the year to date. In the quarter, China sales increased by 12% (14% at CER) to $723m, reflecting a strong underlying performance. US sales declined by 23% to $4,399m and were, alongside the effects of the Crestor and Seroquel XR losses of exclusivity, also impacted by the sales of Symbicort, which declined by 15% to $811m. Product Sales in Europe declined by 7% (6% at CER) to $3,460m.
 
Representing 66% of Total Revenue, the Growth Platforms grew by 3% (4% at CER) to $11,055m:
 
 
YTD 2017
Q3 2017
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Emerging Markets
4,519
5
7
1,515
9
10
Respiratory
3,372
(5)
(3)
1,092
(2)
(2)
New CVMD
2,543
5
5
873
7
7
Japan
1,645
3
5
578
(3)
4
New Oncology
876
96
97
339
72
73
 
 
 
 
 
 
 
Total*
11,055
3
4
3,760
5
6
*Total Product Sales for Growth Platforms are adjusted to remove duplication on a medicine and regional basis.
 
Externalisation Revenue
Where AstraZeneca retains a significant ongoing interest in medicines or potential new medicines, income arising from externalisation agreements is reported as Externalisation Revenue in the Company's financial statements.
 
A breakdown of Externalisation Revenue in the year to date is shown below:
 
 
Medicine
Partner
Region
$m
Lynparza & selumetinib
MSD
- initial revenue
Global
997
Zoladex
TerSera Therapeutics LLC (TerSera)- initial revenue
US and Canada
250
anaesthetics
Aspen Global, Inc. (Aspen)
- milestone revenue
Global (excl.US)
150
Siliq
Valeant Pharmaceuticals International, Inc. (Valeant)
- milestone revenue
US
130
MEDI8897
Sanofi Pasteur, Inc. (Sanofi Pasteur)
- initial revenue
Global
127
Tudorza/Duaklir
Circassia Pharmaceuticals plc (Circassia)
- initial revenue
US
64
lanabecestat
Eli Lilly and Company (Lilly)
- milestone revenue
Global
50
MEDI1341
Takeda Pharmaceutical Company Limited (Takeda)
- initial revenue
Global
50
Other
 
 
205
 
 
 
 
Total
 
 
2,023
 
The following table illustrates the level of sustainable and ongoing income within the total of Externalisation Revenue. The Company anticipates that sustainable and ongoing income will grow as a proportion of Externalisation Revenue over time.
 
 
YTD 2017
Q3 2017
 
$m
% of total
% change
$m
% of total
% change
Actual
CER
Actual
CER
Royalties
100
5
22
25
31
2
14
57
 
 
 
 
 
 
 
 
 
Milestones/Other
431
21
104
109
272
20
n/m
n/m
 
 
 
 
 
 
 
 
 
Total Sustainable and Ongoing Externalisation Revenue
531
26
81
85
303
22
n/m
n/m
 
 
 
 
 
 
 
 
 
Initial Revenue
1,492
74
40
39
1,047
78
63
60
 
 
 
 
 
 
 
 
 
Total Externalisation Revenue
2,023
100
49
49
1,350
100
n/m
n/m
 
A number of AstraZeneca medicines were externalised or disposed after 30 September 2016, thus adversely impacting the overall year-on-year Product Sales performance in the year to date:
 
Medicine
Region
Completion
Product Sales in
Impacted Regions
YTD 2016
 
YTD 2017*
Difference
$m
 
$m
$m
Toprol-XL
US
October 2016
81
34
(47)
Bydureon/Byetta
China
October 2016
9
-
(9)
antibiotics
Global (excl. US)
December 2016
143
28
(115)
Zoladex
US and Canada
March 2017
50
24
(26)
Seloken
Europe
June 2017
67
48
(19)
Zomig
Global (excl. Japan)
June 2017
56
45
(11)
 
 
 
 
 
 
Total
 
 
406
179
(227)
Proportion of YTD 2017 Product Sales
 
 
 
 
-2%
*YTD 2017 Product Sales here comprise sales made to partners under manufacturing and supply agreements.
 
Examples of sustainable and ongoing income, as part of Externalisation Revenue, are shown below:
 
Announcement
Medicine
Partner
Region
Externalisation Revenue
July 2017
Lynparza
MSD
Global
●        Initial $1.0bn revenue
●        Up to $0.75bn for certain licence options
●        Up to $6.15bn in regulatory and sales milestones
March 2017
MEDI8897
Sanofi Pasteur
Global
●        Initial €120m revenue
●        Up to €495m in sales and development-related milestones
February 2017
Zoladex
TerSera
US and Canada
●        Initial $250m revenue
●        Up to $70m in sales-related milestones
●        Mid-teen percentage royalties on sales
October 2016
Toprol-XL
Aralez Pharmaceuticals Inc.
US
●        Initial $175m revenue
●        Up to $48m milestone and sales-related revenue
●        Mid-teen percentage royalties on sales
July 2016
tralokinumab - atopic dermatitis
LEO Pharma A/S
(LEO Pharma)
Global
●        Initial $115m revenue
●        Up to $1bn in commercially-related milestones
●        Up to mid-teen tiered percentage royalties on sales
September 2015
Siliq
Valeant
Global, later
amended to US
●        Initial $100m revenue
●        Pre-launch milestone of $130m
●        Sales-related royalties up to $175m
●        Profit sharing
March 2015
Movantik
Daiichi Sankyo Company, Ltd
(Daiichi Sankyo)
US
●        Initial $200m revenue
●        Up to $625m in sales-related revenue
 
 
Product Sales
_____________________________________________________________________________________
 
The performance of key medicines is shown below, with a geographical split shown in Note 6 and 7.
 
Therapy Area
 
Medicine
 
YTD 2017
 
Q3 2017
 
$m
 
% of total*
 
% change
 
$m
 
% of total
 
% change
 
Actual
 
CER
 
Actual
 
CER
 
Oncology
 
Tagrisso
 
651
 
4
 
136
 
138
 
248
 
5
 
86
 
89
 
Iressa
 
398
 
3
 
1
 
2
 
137
 
3
 
10
 
10
 
Lynparza
 
197
 
1
 
26
 
26
 
81
 
2
 
40
 
36
 
Imfinzi
 
1
 
-
 
n/m
 
n/m
 
-
 
-
 
-
 
-
 
Legacy:
 
 
 
 
 
 
 
 
 
Faslodex
 
703
 
5
 
16
 
16
 
241
 
5
 
16
 
16
 
Zoladex
 
548
 
4
 
(6)
 
(5)
 
185
 
4
 
(7)
 
(6)
 
Casodex
 
161
 
1
 
(14)
 
(12)
 
51
 
1
 
(18)
 
(16)
 
Arimidex
 
160
 
1
 
(9)
 
(6)
 
54
 
1
 
(4)
 
(2)
 
Others
 
85
 
1
 
13
 
16
 
29
 
1
 
7
 
15
 
Total Oncology
 
2,904
 
20
 
18
 
19
 
1,026
 
21
 
18
 
19
 
CVMD
 
 
Brilinta
 
780
 
5
 
29
 
31
 
284
 
6
 
37
 
36
 
Farxiga
 
742
 
5
 
24
 
24
 
285
 
6
 
30
 
29
 
Onglyza
 
431
 
3
 
(25)
 
(25)
 
127
 
3
 
(25)
 
(25)
 
Bydureon
 
427
 
3
 
(2)
 
(2)
 
128
 
3
 
(12)
 
(12)
 
Byetta
 
128
 
1
 
(36)
 
(35)
 
39
 
1
 
(36)
 
(36)
 
Symlin
 
35
 
-
 
30
 
30
 
10
 
-
 
(9)
 
(9)
 
Legacy:
 
 
 
 
 
 
 
 
 
Crestor
 
1,771
 
12
 
(36)
 
(35)
 
580
 
12
 
(16)
 
(14)
 
Seloken/Toprol-XL
 
527
 
4
 
(6)
 
(4)
 
160
 
3
 
(14)
 
(12)
 
Atacand
 
227
 
2
 
(3)
 
(1)
 
80
 
2
 
10
 
11
 
Others
 
259
 
2
 
(16)
 
(14)
 
80
 
2
 
(6)
 
(5)
 
Total CVMD
 
5,327
 
36
 
(16)
 
(14)
 
1,773
 
36
 
(4)
 
(4)
 
Respiratory
 
Symbicort
 
2,051
 
14
 
(9)
 
(8)
 
668
 
14
 
(4)
 
(4)
 
Pulmicort
 
805
 
5
 
4
 
7
 
242
 
5
 
8
 
9
 
Daliresp/Daxas
 
145
 
1
 
28
 
28
 
53
 
1
 
26
 
26
 
Tudorza/Eklira
 
108
 
1
 
(19)
 
(18)
 
37
 
1
 
(21)
 
(21)
 
Duaklir
 
56
 
-
 
27
 
30
 
21
 
-
 
50
 
43
 
Bevespi
 
8
 
-
 
n/m
 
n/m
 
4
 
-
 
n/m
 
n/m
 
Others
 
199
 
1
 
(13)
 
(12)
 
67
 
1
 
(22)
 
(22)
 
Total Respiratory
 
3,372
 
23
 
(5)
 
(3)
 
1,092
 
22
 
(2)
 
(2)
 
Other
 
Nexium
 
1,525
 
10
 
(1)
 
-
 
469
 
10
 
(9)
 
(7)
 
Synagis
 
453
 
3
 
21
 
21
 
153
 
3
 
47
 
47
 
Losec/Prilosec
 
202
 
1
 
(7)
 
(5)
 
66
 
1
 
(8)
 
(8)
 
Seroquel XR
 
224
 
2
 
(64)
 
(64)
 
62
 
1
 
(67)
 
(68)
 
Movantik/Moventig
 
92
 
1
 
42
 
42
 
30
 
1
 
20
 
20
 
FluMist/Fluenz
 
20
 
-
 
(46)
 
(46)
 
20
 
-
 
(23)
 
(23)
 
Others
 
546
 
4
 
(40)
 
(39)
 
191
 
4
 
(30)
 
(29)
 
Total Other
 
3,062
 
21
 
(19)
 
(18)
 
991
 
20
 
(18)
 
(17)
 
 
Total
Product Sales
 
14,665
 
100
 
(9)
 
(8)
 
4,882
 
100
 
(3)
 
(2)
 
*Due to rounding, the sum of individual brand percentages may not agree to totals.
 
 
Product Sales Summary
_______________________________________________________________________________________
 
 
ONCOLOGY
Product Sales of $2,904m; an increase of 18% (19% at CER). Oncology Product Sales represented 20% of total Product Sales, up from 15% in the first nine months of 2016.
 
 
Lung Cancer
 
 
Tagrisso
Product Sales of $651m; an increase of 136% (138% at CER).
 
Within Emerging Markets, Tagrisso was approved in China in March 2017 as the first AstraZeneca medicine under the China FDA's Priority Review pathway. Sales in the US and Europe were $277m and $124m, respectively. Sales grew by 54% year-on-year in the US, with progress in T790M-mutation testing rates accompanied by the launch of a new diagnostic-testing voucher programme for patients. In Europe, where Tagrisso was launched in 2016, sales of $124m were driven by a continued uptake and positive reimbursement decisions, most recently in Italy, Portugal and Sweden.
 
Testing rates in Japan, where Tagrisso was also launched in 2016, exceeded 90%, with year-to-date sales of $158m (FY 2016: $82m) reflecting a high penetration rate in the currently-approved 2nd-line T790M-mutation setting. Sequential quarterly sales declined in the quarter in Japan, reflecting the one-time impact of the ending of the Ryotanki restriction in Q2 2017. This regulation in Japan restricts prescriptions for medicines in their first year on the market to just two weeks of supply.
 
To date, Tagrisso has received regulatory approval in over 50 countries.
 
 
Iressa
Product Sales of $398m; an increase of 1% (2% at CER).
 
Emerging Markets sales increased by 7% (8% at CER) to $200m. China Product Sales increased by 17% (22% at CER) to $115m, reflecting an improvement in patient access following the National Negotiation process in 2016. Iressa was subsequently included on the National Reimbursement Drug List (NRDL). Other Emerging Markets sales were negatively impacted by competition from branded and generic medicines, including in South Korea.
 
Sales in the US increased by 69% to $27m and declined in Europe by 12% to $80m. Given the significant future potential of Tagrisso, the Company continues to prioritise the ongoing launch of Tagrisso in established markets over commercial support for Iressa.
 
Other Cancers
 
Lynparza
Product Sales of $197m; an increase of 26%.
 
Lynparza was available to patients in over 30 countries by the end of the period, with regulatory reviews underway in additional countries. On 17 August 2017, Lynparza received an additional, broad approval in the US, namely for patients regardless of BRCA-mutation status, for the treatment of 2nd-line ovarian cancer with a new tablet formulation. This was in addition to the full approval for the later-line treatment of patients with BRCA-mutant ovarian cancer. This was followed by an immediate encouraging uplift in new-patient starts.
 
US sales declined by 9% in the year to date to $87m, reflecting the introduction of competing poly ADP ribose polymerase (PARP)-inhibitor medicines in earlier lines of treatment that were approved in broader patient populations. Encouraging progress was made in the quarter, however, with sales growth of 9% reflecting the aforementioned approval for the treatment of 2nd-line ovarian cancer. Sales in Europe increased by 68% (70% at CER) to $94m, following a number of successful launches.
 
On 27 July 2017, AstraZeneca and MSD announced a global strategic oncology collaboration to co-develop Lynparza and potential medicine selumetinib for multiple cancer types. The companies intend to develop Lynparza and selumetinib jointly, both in monotherapy and in combination with other potential medicines. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines, Imfinzi and pembrolizumab, separately. MSD is planning to co-commercialise Lynparza and potential medicine selumetinib with the Company in due course.
 
Imfinzi
Product Sales of $1m; launched in the US on 1 May 2017.
 
Approved under the US FDA's Accelerated-Approval pathway and launched on the same day as a fast-to-market, limited commercial opportunity, Imfinzi is currently indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neo-adjuvant) or after (adjuvant) surgery. At present, there are five immunotherapy medicines approved for the treatment of bladder cancer in the US. The Company is actively preparing for the potential launch of Imfinzi in locally-advanced, unresectable non-small cell lung cancer (NSCLC) in H1 2018, given US FDA regulatory submission acceptance received in October 2017.
 
 
Legacy: Faslodex
Product Sales of $703m; an increase of 16%.
 
China sales grew by 29% (36% at CER) to $18m in the year to date, which followed the recent successful negotiation and subsequent inclusion on the NRDL; overall Faslodex Emerging Markets sales grew by 26% (23% at CER) to $88m. In May 2017, the Company received a label extension for Faslodex in Russia in the 1st-line monotherapy setting, based on data from the FALCON trial. Russia sales grew by 50% in the year to date (30% at CER) to $15m.
 
US sales increased by 15% to $368m, mainly reflecting a continued strong uptake of the combination with palbociclib, a medicine approved for the treatment of hormone-receptor-positive (HR+) breast cancer. Europe sales increased by 15% (16% at CER) to $194m.
 
In June 2017, a label extension based upon the FALCON trial in the 1st-line setting was approved in Japan; sales grew by 11% (13% at CER) in the year to date to $50m.
 
 
Legacy: Zoladex
Product Sales of $548m; a decline of 6% (5% at CER).
 
Emerging Markets sales growth of 9% (10% at CER) to $260m particularly reflected an increase in China sales of 21% (26% at CER) to $127m. Sales in Europe declined by 11% (8% at CER) to $104m. Sales in Established Rest Of World (ROW, comprising Japan, Canada, Australia and New Zealand) declined by 16% (15% at CER) to $168m, driven by lower levels of use. On 31 March 2017, the Company completed an agreement with TerSera for the commercial rights to Zoladex in the US and Canada.
 
 
CVMD
Product Sales of $5,327m; a decline of 16% (14% at CER). CVMD Product Sales represented 36% of total Product Sales, down from 39% in the first nine months of 2016.
 
 
Brilinta 
Product Sales of $780m; an increase of 29% (31% at CER).
 
Emerging Markets sales of Brilinta in the year to date grew by 29% (32% at CER) to $175m, with China Product Sales increasing by 32% (38% at CER) to $86m. This was followed by the recent successful negotiation and subsequent inclusion of Brilinta on the NRDL. Growth in Emerging Markets was reflected in a continued outperformance of the growth of the oral anti-platelet market. Strong sales growth was delivered in many markets, including other parts of Asia Pacific, as well as in Russia.
 
US sales of Brilinta, at $355m, represented an increase of 46% in the year to date, including growth of 67% in the quarter; Brilinta achieved record total-prescription market share of 6.8% at the end of the period. Days-of-therapy volume market-share data was particularly encouraging. The performance reflected the growth in demand, driven by updated preferred guidelines from the American College of Cardiology and the American Heart Association in 2016, as well as the narrowing of a competitor's label; Brilinta remained the branded oral anti-platelet market leader in the US. Sales of Brilique in Europe increased by 11% (13% at CER) to $213m, reflecting indication leadership across a number of markets.
 
 
Farxiga
Product Sales of $742m; an increase of 24%.
 
Emerging Markets sales increased by 74% (72% at CER) to $160m, reflecting ongoing launches and improved levels of patient access. In March 2017, Forxiga became the first sodium-glucose co-transporter 2 (SGLT2) inhibitor medicine to be approved in China.
 
US sales increased by 4% to $339m, with sales subdued by the impact of affordability programmes. Given recent changes to these programmes, the Company saw a diminished impact on sales in the quarter; importantly, Farxiga's market share in the SGLT2 class remained stable in the period. Overall, the SGLT2 class gained market share from other classes of type-2 diabetes medicines, supported by growing evidence around the cardiovascular (CV) benefits of the class.
 
Sales in Europe increased by 26% (27% at CER) to $171m as the medicine continued to lead the growing class. In Japan, where Ono Pharmaceutical Co., Ltd is a partner and records in-market sales, sales to the partner amounted to $31m.
 
 
Onglyza 
Product Sales of $431m; a decline of 25%.
 
The performance reflected adverse pressures on the dipeptidyl peptidase-4 (DPP-4) class and an acceleration of ongoing Diabetes market dynamics. Sales in Emerging Markets declined by 15% (16% at CER) to $93m as the Company focused on Farxiga. Onglyza, however, entered the NRDL in China in the period with year-to-date growth of 41% (47% at CER) to $24m.
 
US sales declined by 29% to $217m. Continued competitive pressures and a lower market share were only partially offset by the favourable impact of lower utilisation of patient-access programmes. Sales in Europe declined by 24% (23% at CER) to $78m. In Japan, in-market sales are recorded by Kyowa Hakko Kirin Co., Ltd, to whom sales totalled $10m.
 
 
Bydureon/Byetta
Product Sales of $555m; a decline of 13% (12% at CER).
 
Combined sales of Bydureon and Byetta in Emerging Markets were $5m and $9m, respectively. In 2016, AstraZeneca entered a strategic collaboration with 3SBio Inc. for the rights to commercialise Bydureon and Byetta in China. Combined US sales for Bydureon and Byetta were $424m, despite intense levels of competition. Bydureon US sales declined by 2% to $343m, representing 81% of total US Bydureon and Byetta sales. The fall in US Byetta sales continued in the year to date; the decline of 36% to $81m reflected the Company's promotional focus on once-weekly Bydureon over twice-daily Byetta. Combined sales in Europe declined by 19% (17% at CER) to $91m.
 
 
Legacy: Crestor
Product Sales of $1,771m; a decline of 36% (35% at CER).
 
Sales in China grew by 15% (19% at CER) to $273m. In the US, sales declined by 78% to $246m, reflecting the market entry in July 2016 of multiple Crestor generic medicines. In the quarter, the US performance was flattered by a managed-market adjustment. In Europe, sales declined by 22% (21% at CER) to $514m, reflecting the increasing presence of generic medicines. In Japan, where Shionogi Co. Ltd is a partner, Crestor maintained its position as the leading statin, with growth of 1% (2% at CER) to $394m despite the entry in the quarter of the first Crestor competitor. Multiple Crestor generics are expected to launch in Japan in due course.
 
 
RESPIRATORY
Product Sales of $3,372m; a decline of 5% (3% at CER). Respiratory Product Sales represented 23% of total Product Sales, up from 22% in the first nine months of 2016.
 
Symbicort
Product Sales of $2,051m; a decline of 9% (8% at CER).
 
Symbicort continued to lead the global market by volume within the inhaled corticosteroids (ICS) / Long-Acting Beta Agonist (LABA) class. Emerging Markets sales grew by 7% (8% at CER) to $322m, reflecting growth in China of 13% (18% at CER) to $136m and in Latin America (ex-Brazil), where sales grew by 27% (31% at CER) to $33m.
 
In contrast, US sales declined by 15% to $811m, in line with expectations of continued challenging conditions; these conditions were a result of the impact of managed-care access programmes on pricing within the class. Competition also remained intense from other classes, such as Long-Acting Muscarinic Antagonist (LAMA) / LABA combination medicines. In Europe, sales declined by 13% (11% at CER) to $590m, reflecting competition from other branded and Symbicort-analogue medicines.
 
In Japan, where Astellas Pharma Co. Ltd assists as a promotional partner, sales increased by 3% (5% at CER) to $151m.
 
Pulmicort
Product Sales of $805m; an increase of 4% (7% at CER).
 
Emerging Markets sales increased by 14% (19% at CER) to $571m, reflecting strong underlying volume growth, with sales in China, Middle East and North Africa particularly encouraging. Emerging Markets represented 71% of global sales. China sales increased by 13% (18% at CER) to $463m and represented 58% of global sales. Usage in China continued to increase, with the increasing prevalence of acute COPD and paediatric asthma accompanied by continued investment by the Company in new hospital nebulisation centres. Legacy sales in the US and Europe declined by 22% to $107m and by 10% to $66m, respectively.
 
Daliresp/Daxas
Product Sales of $145m; an increase of 28%.
 
US sales, representing 86% of global sales, increased by 23% to $124m, driven by favourable pricing and greater use of the medicine which is the only oral, selective, long-acting inhibitor of the enzyme phosphodiesterase-4, an inflammatory agent in COPD. Sales outside the US increased by 75% to $21m.
 
Tudorza/Eklira
Product Sales of $108m; a decline of 19% (18% at CER).
 
Sales in the US declined by 23% to $47m, reflecting lower use of inhaled monotherapy medicines for COPD and the Company's commercial focus on the launch of Bevespi Aerosphere. On 17 March 2017, AstraZeneca announced that it had entered a strategic collaboration with Circassia for the development and commercialisation of Tudorza in the US. Circassia began its promotion of Tudorza in the US in May 2017; AstraZeneca will continue to book Product Sales in the US. Sales in Europe declined by 15% (14% at CER) to $55m.
 
Duaklir
 
Product Sales of $56m; an increase of 27% (30% at CER).
 
Duaklir, the Company's first inhaled dual bronchodilator, is now available for patients in over 25 countries. The growth in sales in the year to date was favourably impacted by the performances in Germany and the UK and the recent launch in Italy. Duaklir is expected to be submitted for US regulatory review in H1 2018. Duaklir is a registered trademark in certain European countries. The US trademark is to be confirmed.
 
Bevespi
Product Sales of $8m; launched in 2017.
 
Bevespi Aerosphere was launched commercially in the US during the first quarter of 2017. Prescriptions in the period tracked in line with other LAMA/LABA launches. The overall LAMA/LABA class in the US, however, continued to grow more slowly than anticipated. Bevespi Aerosphere was the first product launched using the Company's Aerosphere co-suspension Delivery Technology delivered in a pressurised metered-dose inhaler (pMDI).
 
 
OTHER
Product Sales of $3,062m; a decline of 19% (18% at CER). Other Product Sales represented 21% of total Product Sales, down from 23% in the first nine months of 2016.
 
Nexium
Product Sales of $1,525m; 1% decline (stable at CER).
 
Emerging Markets sales declined by 5% (2% at CER) to $516m; however, sales increased by 6% to $442m in the US. The latter performance was flattered by returns adjustments related to the loss of exclusivity in 2015. Sales in Europe declined by 7% to $176m. In Japan, where Daiichi Sankyo is a partner, sales increased by 6% (8% at CER) to $330m.
 
Synagis
Product Sales of $453m; an increase of 21%.
 
US sales increased by 6% to $182m, despite restrictive guidelines from the American Academy of Pediatrics Committee on Infectious Diseases, which reduced the number of patients eligible for preventative therapy with Synagis. Product Sales to AbbVie Inc., which is responsible for the commercialisation of Synagis in over 80 countries outside the US, increased by 33% to $271m, flattered by an element of true-up adjustments.
 
Seroquel XR
Product Sales of $224m; a decline of 64%.
 
Sales of Seroquel XR in the US declined by 77% to $103m. Since November 2016, several competitors have launched generic Seroquel XR medicines in the US. Sales of Seroquel XR in Europe declined by 42% to $61m, also reflecting the impact of generic-medicine competition.
 
FluMist/Fluenz
Product Sales of $20m; a decrease of 46%.
 
FluMist is approved by the FDA for the 2017-2018 influenza season and will be available in the US. No US sales of FluMist were recorded in the quarter, however, due to the adverse US Advisory Committee on Immunization Practices (ACIP) recommendation for use during the 2017-2018 influenza season. FluMist continues to be recommended for use outside the US.
 
Sales in Europe declined by 14% to $18m primarily driven by lower usage rates in Germany that reflected the competitive environment and parity recommendations for injectable vaccines, which more than offset the favourable impact of the UK National Immunisation Programme. Fluenz is the vaccine of choice in the UK for children aged 2-17 years.
 
 
Regional Product Sales
_______________________________________________________________________________________
 
 
 
YTD 2017
Q3 2017
$m
% of total1
% change
$m
% of total
% change
Actual
CER
Actual
CER
Emerging Markets2
4,519
31
5
7
1,515
31
9
10
 
China
2,142
15
6
10
723
15
12
14
 
Ex. China
2,377
16
4
5
792
16
5
7
 
 
 
 
 
 
 
 
 
US
4,399
30
(23)
(23)
1,386
28
(10)
(10)
 
 
 
 
 
 
 
 
 
Europe
3,460
24
(7)
(6)
1,188
24
(6)
(8)
 
 
 
 
 
 
 
 
 
Established ROW
2,287
16
1
1
793
16
(4)
-
 
Japan
1,645
11
3
5
578
12
(3)
4
 
Canada
353
2
(5)
(6)
115
2
(9)
(10)
 
Other
Established ROW
289
2
(6)
(9)
100
2
(6)
(10)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total
14,665
100
(9)
(8)
4,882
100
(3)
(2)
1 Due to rounding, the sum of individual brand percentages may not agree to totals.
2 Emerging Markets comprises all remaining Rest of World markets, including Brazil, China, India, Mexico, Russia and Turkey.
 
 
Emerging Markets
Product Sales of $4,519m; an increase of 5% (7% at CER).
 
China sales grew by 6% (10% at CER) to $2,142m, representing 47% of total Emerging Markets sales. Onglyza and Iressa were included on the NRDL in China in the period, as were Brilinta, Faslodex and Seroquel XR, following price negotiation. Crestor also had its 2nd-line usage restriction removed and Zoladex was reclassified from the hormone and endocrine classification to oncology, which is expected to continue to support growth.
 
Sales in Latin America were impacted by ongoing economic conditions, with sales in Latin America (ex-Brazil) declining by 8% (6% at CER) to $335m. Brazil sales increased by 3% (but declined by 8% at CER) to $274m. Russia sales increased by 10% (but declined by 7% at CER) to $170m.
 
Despite this, the Growth Platforms in Emerging Markets grew by 17% (20% at CER) to $1,503m. Sales of Symbicort grew by 7% (8% at CER) to $322m, reflecting higher prescription demand. Tagrisso launches in Emerging Markets led to year-to-date sales of $85m. Tagrisso was launched in China in April 2017; China sales of Tagrisso totalled $53m in the year to date. Brilinta also received provincial reimbursement listing in China for the period across more than 15 provinces.
 
 
US
Product Sales of $4,399m; a decline of 23%.
 
The decline in sales reflected generic-medicine launches that impacted sales of Crestor and Seroquel XR. Unfavourable managed-care pricing and continued competitive intensity impacted sales of Symbicort, which declined by 15% to $811m. The New Oncology Growth Platform in the US, however, grew by 34% to $392m, primarily reflecting encouraging Tagrisso sales growth of 54% to $277m in the year to date (YTD 2016: $180m). Brilinta grew by 46% in the US to $355m. The New CVMD Growth Platform declined by 1% in the US to $1,370m, reflecting the competitive environment in Diabetes.
 
 
Europe
Product Sales of $3,460m; a decline of 7% (6% at CER).
 
The New Oncology Growth Platform in Europe grew by 108% (110% at CER) to $218m, partly driven by Tagrisso sales of $124m. Lynparza sales of $94m represented growth of 68% (70% at CER). Forxiga sales growth of 26% (27% at CER) to $171m was accompanied by Brilique growth of 11% (13% at CER) to $213m. These performances were more than offset by declines in other areas, including a 13% decline (11% at CER) in Symbicort sales to $590m. Symbicort maintained its position, however, as the number one ICS/LABA medicine, despite competition from branded and analogue medicines. Crestor sales declined by 22% (21% at CER) to $514m, reflecting the increasing presence of generic medicines.
 
 
Established ROW
Product Sales of $2,287m; an increase of 1%.
 
Japan sales increased by 3% (5% at CER) to $1,645m, partly reflecting sales of Symbicort and the launch of Tagrisso. Symbicort sales in Japan increased by 3% (5% at CER) to $151m and, following the launch in Japan in May 2016, Tagrisso sales in the year to date amounted to $158m. The first Crestor competitor medicine was launched in Q3 2017, with full generic competition anticipated from Q4 2017. Despite the magnitude of the impact of brand equity in the Japanese market, the Company anticipates an impact from generic competition on Crestor Japan sales. Nexium sales in Japan increased by 6% (8% at CER) to $330m and sales of Forxiga increased by 55% (60% at CER) to $31m.
 
 
Financial Performance
________________________________________________________________________________________
 
 
 
Reported      
YTD 2017
YTD 2016
Actual
CER
$m
$m
% change
 
Total Revenue
 
16,688
 
17,417
 
(4)
 
(3)
 
Product Sales
 
14,665
 
16,059
 
(9)
 
(8)
 
Externalisation Revenue
 
2,023
 
1,358
 
49
 
50
 
 
 
 
 
 
Cost of Sales
 
(3,093)
 
(2,966)
 
4
 
9
 
\
 
 
 
 
Gross Profit
 
13,595
 
14,451
 
(6)
 
(5)
 
Gross Margin*
 
80.3%
 
81.7%
 
-1
 
-2
 
 
 
 
 
 
Distribution Expense
 
(225)
 
(243)
 
(8)
 
(4)
 
% Total Revenue
 
1.3%
 
1.4%
 
-
 
-
 
R&D Expense
 
(4,206)
 
(4,347)
 
(3)
 
(1)
 
% Total Revenue
 
25.2%
 
25.0%
 
-
 
-1
 
SG&A Expense
 
(7,155)
 
(8,027)
 
(11)
 
(9)
 
% Total Revenue
 
42.9%
 
46.1%
 
+3
 
+3
 
Other Operating Income and Expense
 
982
 
535
 
83
 
86
 
% Total Revenue
 
5.9%
 
3.1%
 
+3
 
+3
 
 
 
 
 
 
Operating Profit
 
2,991
 
2,369
 
26
 
16
 
% Total Revenue
 
17.9%
 
13.6%
 
+4
 
+3
 
Net Finance Expense
 
(1,128)
 
(978)
 
15
 
4
 
Joint Ventures and Associates
 
(43)
 
(22)
 
89
 
89
 
Profit Before Tax
 
1,820
 
1,369
 
33
 
24
 
Taxation
 
(213)
 
220
 
 
 
Tax Rate
 
12%
 
(16)%
 
 
 
Profit After Tax
 
1,607
 
1,589
 
1
 
(6)
 
 
 
 
 
 
Earnings Per Share
$1.34
 
$1.31
 
3
 
(4)
 
* Gross Margin, as a percentage of Product Sales, reflects Gross Profit derived from Product Sales, divided by Product Sales. YTD 2017 Cost of Sales included $200m of costs relating to externalisation activities, which is excluded from the calculation of Gross Margin (YTD 2016: $32m).
 
 
 
Reported
Q3 2017
Q3 2016
Actual
CER
$m
$m
% change
Total Revenue
 
6,232
 
5,699
 
9
 
10
 
Product Sales
 
4,882
 
5,025
 
(3)
 
(2)
 
Externalisation Revenue
 
1,350
 
674
 
n/m
 
n/m
 
 
 
 
 
 
Cost of Sales
 
(1,249)
 
(900)
 
39
 
40
 
\
 
 
 
 
Gross Profit
 
4,983
 
4,799
 
4
 
4
 
Gross Margin*
 
77.7%
 
82.2%
 
-4
 
-4
 
 
 
 
 
 
Distribution Expense
 
(76)
 
(76)
 
(1)
 
1
 
% Total Revenue
 
1.2%
 
1.3%
 
-
 
-
 
R&D Expense
 
(1,404)
 
(1,402)
 
-
 
1
 
% Total Revenue
 
22.5%
 
24.6%
 
+2
 
+2
 
SG&A Expense
 
(2,497)
 
(2,403)
 
4
 
5
 
% Total Revenue
 
40.1%
 
42.2%
 
+2
 
+2
 
Other Operating Income and Expense
 
143
 
110
 
29
 
29
 
% Total Revenue
 
2.3%
 
1.9%
 
-
 
-
 
 
 
 
 
 
Operating Profit
 
1,149
 
1,028
 
12
 
9
 
% Total Revenue
 
18.4%
 
18.0%
 
-
 
-
 
Net Finance Expense
 
(386)
 
(342)
 
13
 
5
 
Joint Ventures and Associates
 
(17)
 
(10)
 
60
 
60
 
Profit Before Tax
 
746
 
676
 
10
 
11
 
Taxation
 
(97)
 
319
 
 
 
Tax Rate
 
13%
 
(47)%
 
 
 
Profit After Tax
 
649
 
995
 
(35)
 
(36)
 
 
 
 
 
 
Earnings Per Share
$0.54
 
$0.80
 
(32)
 
(33)
 
* Gross Margin, as a percentage of Product Sales, reflects Gross Profit derived from Product Sales, divided by Product Sales. Q3 2017 Cost of Sales included $159m of costs relating to externalisation activities (Q3 2016: $4m), which is excluded from the calculation of Gross Margin.
 
Reconciliation of Reported Profit Before Tax to EBITDA
 
 
   YTD 2017
   Q3 2017
 
 $m 
  % change 
 $m 
  % change 
 
 
 Actual
 CER 
 
 Actual
 CER 
 Reported Profit Before Tax
 1,820
 33
 24
 746
 10
 11
 Net Finance Expense
 1,128
 15
 4
 386
 13
 5
 Joint Ventures and Associates
 43
 89
 89
 17
 60
 60
 Depreciation, Amortisation and Impairment
 1,929
 9
 12
 655
 7
 7
 EBITDA*
 4,920
 19
 15
 1,804
 10
 9
 
* The Company uses EBITDA as a non-GAAP measure in addition to its Core Financial Measures.               
 
Reconciliation of Reported to Core Financial Measures
 
YTD 2017
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core2
Core
Actual
CER
$m
$m
$m
$m
$m
$m
% change
Gross Profit
 
13,595
 
128
 
103
 
-
 
-
 
13,826
 
(6)
 
(5)
 
Gross Margin3
 
80.3%
 
-
 
-
 
-
 
-
 
81.8%
 
-1
 
-1
 
 
 
 
 
 
 
 
 
 
Distribution Expense
 
(225)
 
-
 
-
 
-
 
-
 
(225)
 
(8)
 
(4)
 
R&D Expense
 
(4,206)
 
177
 
73
 
-
 
-
 
(3,956)
 
(5)
 
(2)
 
SG&A Expense
 
(7,155)
 
265
 
773
 
235
 
204
 
(5,678)
 
(7)
 
(5)
 
Other Operating Income and Expense
 
982
 
75
 
44
 
-
 
-
 
1,101
 
91
 
94
 
 
 
 
 
 
 
 
 
 
Operating Profit
 
2,991
 
645
 
993
 
235
 
204
 
5,068
 
8
 
5
 
% Total Revenue
 
17.9%
 
-
 
-
 
-
 
-
 
30.4%
 
+3
 
+2
 
 
 
 
 
 
 
 
 
 
Net Finance Expense
 
(1,128)
 
-
 
-
 
234
 
368
 
(526)
 
8
 
5
 
 
 
 
 
 
 
 
 
 
Taxation
 
(213)
 
(135)
 
(240)
 
(144)
 
(86)
 
(818)
 
n/m
 
n/m
 
 
 
 
 
 
 
 
 
 
Earnings Per Share
 
$1.34
 
$0.40
 
$0.59
 
$0.26
 
$0.39
 
$2.98
 
(4)
 
(7)
 
1 Other adjustments include discount unwind on acquisition-related liabilities (see Note 4), provision charges related to certain legal matters (see Note 5) and foreign-exchange gains and losses relating to the classification of certain non-structural intra-group loans.
2 Each of the measures in the Core column in the above table are non-GAAP measures.
3 Gross Margin as a percentage of Product Sales reflects gross profit derived from Product Sales, divided by Product Sales. YTD 2017 Cost of Sales includes $200m of costs relating to externalisation activities (YTD 2016: $32m), which is excluded from the calculation of Gross Margin. Movements in Gross Margin are expressed in percentage points. 
 
Q3 2017
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core2
Core
Actual
CER
$m
$m
$m
$m
$m
$m
% change
Gross Profit
 
4,983
 
47
 
45
 
-
 
-
 
5,075
 
4
 
4
 
Gross Margin3
 
77.7%
 
-
 
-
 
-
 
-
 
79.6%
 
-4
 
-4
 
 
 
 
 
 
 
 
 
 
Distribution Expense
 
(76)
 
-
 
-
 
-
 
-
 
(76)
 
(1)
 
1
 
R&D Expense
 
(1,404)
 
35
 
30
 
-
 
-
 
(1,339)
 
-
 
-
 
SG&A Expense
 
(2,497)
 
68
 
265
 
102
 
112
 
(1,950)
 
3
 
4
 
Other Operating Income and Expense
 
143
 
(1)
 
1
 
-
 
-
 
143
 
32
 
32
 
 
 
 
 
 
 
 
 
 
Operating Profit
 
1,149
 
149
 
341
 
102
 
112
 
1,853
 
9
 
9
 
% Total Revenue
 
18.4%
 
-
 
-
 
-
 
-
 
29.7%
 
-
 
-
 
 
 
 
 
 
 
 
 
 
Net Finance Expense
 
(386)
 
-
 
-
 
70
 
147
 
(169)
 
(2)
 
3
 
 
 
 
 
 
 
 
 
 
Taxation
 
(97)
 
(31)
 
(78)
 
(37)
 
(46)
 
(289)
 
n/m
 
n/m
 
 
 
 
 
 
 
 
 
 
Earnings Per Share
 
$0.54
 
$0.09
 
$0.21
 
$0.11
 
$0.17
 
$1.12
 
(15)
 
(17)
 
1 Other adjustments include discount unwind on acquisition-related liabilities (see Note 4), provision charges related to certain legal matters (see Note 5) and foreign-exchange gains and losses relating to the classification of certain non-structural intra-group loans.
2 Each of the measures in the Core column in the above table are non-GAAP measures.
3 Gross Margin as a percentage of Product Sales reflects gross profit derived from Product Sales, divided by Product Sales. Q3 2017 Cost of Sales included $159m of costs relating to externalisation activities (Q3 2016: $4m), which is excluded from the calculation of Gross Margin. Movements in Gross Margin are expressed in percentage points.
 
 
Profit and Loss Commentary for the Year To Date
 
Gross Profit
Reported Gross Profit declined by 6% (5% at CER) to $13,595m; Core Gross Profit declined by 6% (5% at CER) to $13,826m. The $997m of Externalisation Revenue received as part of the Lynparza and selumetinib collaboration with MSD was outweighed by the receding effects of the Crestor and Seroquel XR loss of exclusivity in the US.
 
The calculation of the Reported Gross and Core Gross Margins excludes the impact of Externalisation Revenue, thereby reflecting the underlying performance of Product Sales. The Reported Gross Profit Margin declined by one percentage point (two percentage points at CER) to 80.3%. The Core Gross Profit margin declined by one percentage point to 81.8%. The declines primarily reflected the effect of losses of exclusivity, as well as the impact of supply agreements on externalised or divested medicines.
 
In the quarter, the Reported Gross Profit Margin declined by four percentage points to 77.7%; the Core Gross Profit margin declined by four percentage points to 79.6%. These declines partly reflected the magnitude of the Gross Margins in the comparative period, as well as manufacturing costs. The profit-share element of the aforementioned MSD collaboration was and will continue to be reflected in the Cost of Sales and the calculation of the Reported and Core Gross Margin; this also adversely impacted the Gross Margin performance in the quarter.
 
 
Operating Expenses: R&D
Reported R&D costs declined by 3% (1% at CER) to $4,206m, with the Company continuing to focus on resource prioritisation and cost discipline. Core R&D costs declined by 5% (2% at CER) to $3,956m. Core R&D costs over the full year are expected to be broadly in line with those in FY 2016 at CER.
 
 
Operating Expenses: SG&A
Reported SG&A costs declined by 11% (9% at CER) to $7,155m, reflecting the evolving shape of the business. Core SG&A costs declined by 7% (5% at CER) to $5,678m.
 
In the quarter, Reported SG&A costs increased by 4% (5% at CER) to $2,497m, reflecting the magnitude of the reduction in Reported SG&A costs in the comparative period, early investment in forthcoming launches and commercial support in Emerging Markets, particularly in China. Core SG&A costs in the quarter increased by 3% (4% at CER) to $1,950m.
 
The Company has continued to consolidate its operations used by multiple parts of the business. It is committed to driving simplification and standardisation through centralisation in shared services of back-office and some middle-office activities that are currently performed in various enabling units, including Finance, HR, Procurement and IT. Instead of operating numerous shared-service centres and managing outsourced vendors independently, the recently-launched Global Business Services organisation will, over time, provide integration of governance, locations and business practices to all shared services and outsourcing activities across AstraZeneca.
 
 
Other Operating Income and Expense
Where AstraZeneca does not retain a significant ongoing interest in medicines or potential new medicines, income from disposal transactions is reported within Other Operating Income and Expense in the Company's financial statements.
 
Reported Other Operating Income and Expense increased by 83% (86% at CER) to $982m and included:
●        $301m resulting from the sale of rights to Seloken in Europe to Recordati S.p.A (Recordati)
●        $165m resulting from the sale of the global rights to Zomig outside Japan to the Grünenthal Group (Grünenthal)
●        $161m of gains recognised on the sale of short-term investments
●        $73m from the sale of Prilosec royalty streams
●        A milestone receipt of $50m in relation to the disposal of Zavicefta to Pfizer Inc.
●        Other gains on disposal of intangible assets
 
Core Other Operating Income and Expense increased by 91% (94% at CER) to $1,101m, with the difference to Reported Other Operating Income and Expense primarily driven by a restructuring charge taken against land and buildings.
 
 
Operating Profit
Reported Operating Profit increased by 26% (16% at CER) to $2,991m. The Reported Operating Margin increased by four percentage points (three percentage points at CER) at 18% of Total Revenue. Core Operating Profit increased by 8% (5% at CER) to $5,068m. The Core Operating Margin increased by three percentage points (two percentage points at CER) to 30% of Total Revenue.
 
 
Net Finance Expense
Reported Net Finance Expense increased by 15% to $1,128m, primarily reflecting an adverse foreign-exchange impact relating to the classification of certain non-structural intra-group loans. Reported Net Finance Expense increased by 4% at CER, reflecting the impact of bond issuances in May 2016 and June 2017. Excluding the discount unwind on acquisition-related liabilities and the adverse foreign-exchange impact, Core Net Finance Expense increased by 8% (5% at CER) to $526m.
 
Profit Before Tax
Reported Profit Before Tax increased by 33% (24% at CER) to $1,820m, reflecting the higher Operating Profit partly offset by increased interest charges. EBITDA increased by 19% (15% at CER) to $4,920m.
 
Taxation
The Reported and Core Tax Rates for the year to date were 12% and 18% respectively. The Reported Tax Rate was lower than the 2017 UK Corporation Tax Rate of 19.25% mainly due to the impact of tax settlements and non-taxable fair value adjustments relating to contingent consideration on business combinations. The Core Tax Rate was lower than the 2017 UK Corporation Tax Rate of 19.25% mainly due to the impact of tax settlements. The net cash tax paid for the year to date was $473m, representing 26% of Reported Profit Before Tax and 11% of Core Profit Before Tax.
 
The Reported and Core Tax Rates for the comparative period were (16%) and 8% respectively. These rates included a one-off benefit of $453m following agreements between the Canadian tax authority and the UK and Swedish tax authorities in respect of transfer pricing arrangements for the 13-year period from 2004-2016. Excluding this effect, the Reported and Core Tax Rates for the comparative period were 17% and 19% respectively.
 
 
Earnings Per Share (EPS)
Reported EPS of $1.34 represented an increase of 3% (a decline of 4% at CER). Core EPS declined by 4% (7% at CER) to $2.98. The performance was driven by a decline in Total Revenue, partly offset by continued progress on cost control and an increase in Other Operating Income and Expense. The difference in growth rates between Operating Profit and EPS included the impact of a one-off tax benefit in Q3 2016.
 
 
Cash Flow and Balance Sheet
 
 
Cash Flow
The Company generated a net cash inflow from operating activities of $2,581m in the year to date, compared with $2,185m in the comparative period. In Q3 2017, the Company received an upfront cash receipt of $1.6bn from the global strategic oncology collaboration with MSD, $997m of which was recorded in Operating Profit, with the remainder deferred to the balance sheet.
 
 
 
YTD 2017
 
YTD 2016
 
Difference
 
$m
 
$m
 
$m
 
Reported operating profit
 
2,991
 
2,369
 
622
 
Depreciation, amortisation and impairment
 
1,929
 
1,767
 
162
 
 
 
 
 
(Increase)/decrease in working capital and short-term provisions
 
(228)
 
(472)
 
244
 
(Gains)/losses on disposal of intangible assets
 
(735)
 
(198)
 
(537)
 
Fair value movement on contingent consideration arising from business combinations
 
(62)
 
132
 
(194)
 
Non-cash and other movements
 
(322)
 
(479)
 
157
 
Interest paid
 
(519)
 
(489)
 
(30)
 
Tax paid
 
(473)
 
(445)
 
(28)
 
 
 
 
 
Net cash inflow from operating activities
2,581
2,185
396
 
Net cash outflows from investing activities were $686m in the year to date compared with $4,572m in the comparative period. The prior-period outflow included an upfront payment as part of the majority investment in Acerta Pharma.
 
The cash payment of contingent consideration in respect of the Bristol-Myers Squibb Company share of the global Diabetes alliance amounted to $235m in the year to date, which included a $100m milestone payment in respect of Qtern and royalty payments.
 
Net cash outflows from financing activities were $2,924m in the year to date compared to outflows of $1,020m in the comparative period, which included cash inflows on the issuance of new long-term loans of $2,483m.
 
 
Capital Expenditure
Capital expenditure amounted to $849m in the year to date, which included investment in the new global headquarters in Cambridge, UK, as well as strategic manufacturing capacity in the UK, the US, Sweden and China.
 
 
Debt and Capital Structure
At 30 September 2017, outstanding gross debt (interest-bearing loans and borrowings) was $17,852m. Of the gross debt outstanding at 30 September 2017, $941m was due within one year. The Company's Net Debt position at 30 September 2017 was $12,134m.
 
Reconciliation of Interest-Bearing Loans and Borrowings to Net Debt
 
 
At 30 Sep 2017
 
At 31 Dec 2016
 
At 30 Sep 2016
 
$m
 
$m
 
$m
 
Cash and cash equivalents
 
4,036
 
5,018
 
3,090
 
Other investments
 
1,255
 
898
 
927
 
Net derivatives
 
427
 
235
 
267
 
 
 
 
 
Cash, short-term investments and derivatives
 
5,718
 
6,151
 
4,284
 
 
 
 
 
Overdrafts and short-term borrowings
 
(930)
 
(451)
 
(1,075)
 
Finance leases
 
(12)
 
(93)
 
(97)
 
Current instalments of loans
 
-
 
(1,769)
 
(1,775)
 
Loans due after one year
 
(16,910)
 
(14,495)
 
(14,736)
 
 
 
 
 
Interest-bearing loans and borrowings (gross debt)
 
(17,852)
 
(16,808)
 
(17,683)
 
 
 
 
 
Net Debt
(12,134)
 
(10,657)
 
(13,399)
 
 
 
Capital Allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and the Company's shareholders. After providing for investment in the business, supporting the progressive dividend policy and maintaining a strong, investment-grade credit rating, the Board will keep under review potential investment in immediately earnings-accretive, value-enhancing opportunities.
 
 
Foreign-Exchange Rates
 
 
Sensitivity
The Company provides the following currency sensitivity information:
 
 
Average Exchange Rates Versus USD
 
Impact Of 5% Strengthening in Exchange Rate Versus USD ($m)1
Currency
Primary Relevance
FY 2016
YTD 20172
% change
Total Revenue
Core Operating Profit
EUR
Product Sales
0.90
0.90
+1
+179
+123
JPY
Product Sales
108.84
111.93
-3
+104
+71
CNY
Product Sales
6.65
6.80
-2
+131
+74
SEK
Costs
8.56
8.62
-1
+7
-98
GBP
Costs
0.74
0.78
-6
+29
-131
Other3
 
 
 
 
+194
+124
1Based on 2016 results at 2016 actual exchange rates.
2Based on average daily spot rates between 1 January and 30 September 2017.
3Other important currencies include AUD, BRL, CAD, KRW and RUB.
 
Foreign-Exchange Hedging
AstraZeneca monitors the impact of adverse currency movements on a portfolio basis, recognising correlation effects. The Company may hedge to protect against adverse impacts on cash flow over the short to medium term. As at 30 September 2017, AstraZeneca had hedged 95% of forecast short-term currency exposure that arises between the booking and settlement dates on Product Sales and non-local currency purchases.
 
 
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) AstraZeneca and MSD Establish Strategic Oncology Collaboration
On 27 July 2017, AstraZeneca and MSD announced that they had entered a global strategic oncology collaboration to co-develop and co-commercialise Lynparza for multiple cancer types. The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi and pembrolizumab.
 
The companies will also jointly develop and commercialise AstraZeneca's selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase pathway, currently being developed for multiple indications including thyroid cancer.
 
As part of the agreement, MSD will pay AstraZeneca up to $8.5bn in total consideration, including $1.6bn upfront, $750m for certain licence options and up to $6.15bn contingent upon successful achievement of future regulatory and sales milestones. The collaboration agreement was completed upon signing. Under the terms of the agreement, AstraZeneca subsequently recorded $997m under Externalisation Revenue. AstraZeneca books all Product Sales of Lynparza and selumetinib; gross profits due to MSD under the collaboration are recorded under Cost of Sales. The initial, regulatory and commercial milestone payments have been and will be recorded as Externalisation Revenue in the Company's financial statements.
 
b) AstraZeneca and Aspen Enter Agreement for Remaining Rights to Anaesthetics Medicines
On 14 September 2017, AstraZeneca announced that it had entered into an agreement with Aspen, under which Aspen will acquire the residual rights to the established anaesthetic medicines comprising Diprivan, EMLA, Xylocaine/Xylocard/Xyloproct, Marcaine, Naropin, Carbocaine and Citanest.
 
AstraZeneca entered into an agreement with Aspen in June 2016, under which Aspen gained the exclusive commercialisation rights to the medicines in markets outside the US. Under the terms of the new agreement, Aspen will pay an upfront consideration of $555m and up to $211m in performance-related milestones based on sales and gross margin during the period from 1 September 2017 to 30 November 2019. AstraZeneca will continue to manufacture and supply the medicines to Aspen during a transition period of up to five years.
 
Under the terms of the original agreement, Aspen made an upfront payment to AstraZeneca of $520m and agreed to make future Product Sales-related payments of up to $250m, as well as paying double-digit percentage royalties on Product Sales. AstraZeneca agreed to continue to manufacture and supply the medicines to Aspen on a cost-plus basis for an initial period of 10 years.
 
The new agreement did not impact the first Product Sales-related payment of $150m due to AstraZeneca, which was recorded as Externalisation Revenue in the Company's financial statements in the quarter. Under the new agreement, Aspen will no longer pay royalties to AstraZeneca. The remaining $100m Product Sales-related payment from the original agreement will be made to AstraZeneca in 2018, if the contingent terms are met and will be recorded as Other Operating Income and Expense to reflect the reduced ongoing interest in the medicines as a result of the new agreement. Furthermore, as AstraZeneca will transition the manufacture and supply of the medicines to Aspen and therefore will have a reduced ongoing interest, the $555m initial and up to $211m sales and gross margin-related payments from the new agreement will also be recorded as Other Operating Income and Expense in the Company's financial statements. The Company announced completion of the agreement on 1 November 2017.
 
c) Agreement for Rights to Zomig in Japan
On 30 September 2017, AstraZeneca entered into an agreement with Sawai Pharmaceuticals Company Ltd (Sawai) for the rights to Zomig in Japan. Zomig is a legacy medicine indicated for the acute treatment of migraines and cluster headaches, an area of medicine outside AstraZeneca's strategic focus. The divestment of the rights to Zomig in Japan follows an agreement entered into in June 2017, under which Grünenthal acquired the rights to the medicine in all other markets. AstraZeneca received initial revenue from Sawai which was recorded as Other Operating Income and Expense in the Company's financial statements.
 
d) AstraZeneca and Takeda Establish Collaboration to Develop and Commercialise MEDI1341
On 29 August 2017, AstraZeneca and Takeda announced that they had entered an agreement to jointly develop and commercialise MEDI1341, an antibody currently in development as a potential treatment for Parkinson's disease.
 
Under the terms of the agreement, AstraZeneca will lead Phase I development, while Takeda will lead future clinical-development activities. The companies will share equally future development and commercialisation costs for MEDI1341, as well as any future revenues. Takeda will pay AstraZeneca up to $400m, including initial income of $50m in Q3 2017 and development and sales milestones thereafter, all recorded as Externalisation Revenue in the Company's financial statements. Additional terms of the agreement were not disclosed.
 
e) MedImmune and NewLink Announce Collaboration on Immuno-Oncology Combination Clinical Trial
During the period, it was announced that MedImmune, the Company's global biologics research and development arm and NewLink Genetics Corporation (NewLink Genetics) had entered into a clinical collaboration agreement to evaluate the combination of Imfinzi, AstraZeneca's PD-L1 monoclonal antibody and indoximod, NewLink Genetics' small molecule IDO pathway inhibitor, along with standard-of-care chemotherapy for patients with metastatic pancreatic cancer. The primary objective for this randomised, placebo-controlled, Phase II trial is to evaluate the immuno-oncology-based combination compared to gemcitabine alone.
 
f) AstraZeneca and Incyte Enter Clinical-Trial Collaboration in Early Lung Cancer
On 31 October 2017, the Company announced the expansion of its clinical collaboration with Incyte Corporation (Incyte). As part of the agreement, the companies will evaluate the efficacy and safety of epacadostat, Incyte's investigational selective IDO1 enzyme inhibitor, in combination with Imfinzi, compared to Imfinzi alone. The exclusive collaboration for the trial population allows for the two companies to conduct a Phase III trial in patients with locally-advanced (Stage III), unresectable NSCLC whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). This agreement builds on the positive clinical data readout from the PACIFIC trial, published in September 2017.
 
g) Senior Executive Team Changes
On 10 October 2017, David Fredrickson was appointed Executive Vice-President, Global Head Oncology Business Unit (OBU), with responsibility for sales, marketing, medical affairs and diagnostics for Oncology medicines globally, as well as Oncology commercial operations in the US, UK, Spain, Italy, Germany and France. Prior to this appointment, Mr. Fredrickson was President and Country Representative, Japan, where he was responsible for, inter alia, the launch of Tagrisso. Before that, as Vice President, US for Oncology, Infectious Diseases and Neuroscience, he was responsible for the US launches of Tagrisso, Lynparza and Iressa. Mr. Fredrickson also spent a number of years at Roche Holding Ltd.
 
He became a member of the Senior Executive Team, reporting to the Chief Executive Officer on 10 October 2017. Mr Fredrickson took over leadership of the OBU from Jamie Freedman, who was appointed President, AstraZeneca Canada, effective on the same day.
 
 
Research and Development Update
________________________________________________________________________________________
 
A comprehensive table with AstraZeneca's pipeline of medicines in human trials can be found later in this document. Since the results announcement on 27 July 2017 (the period):
 
 
Regulatory
Approvals
9
-     Faslodex - breast cancer (1st line) (US)
-     Lynparza - ovarian cancer (2nd line, 4th line/tablets) (US)
-     Calquence (acalabrutinib) - MCL (2nd line) (US)
-     Brilinta - prior MI (CN)
-     Farxiga + Bydureon - type-2 diabetes (US, EU)
-     Bydureon BCise - type-2 diabetes (US)
-     Symbicort - COPD exacerbations (US)
 
Regulatory
Submission
Acceptances
6
-     Lynparza - breast cancer (US, JP) (Priority Reviews)
-     Imfinzi - locally-advanced, unresectable NSCLC ((US/Priority Review), EU, JP)
-     Bydureon BCise - type-2 diabetes (EU)
 
Major
Phase III
Data Readouts
5
-     Tagrisso - lung cancer (1st line) (FLAURA) (met primary endpoint)
-     Imfinzi - lung cancer (MYSTIC) (did not meet PFS primary endpoint)
-     moxetumomab pasudotox - leukaemia (met primary endpoint)
-     Duaklir - COPD (met primary endpoint)
-     tralokinumab - severe, uncontrolled asthma (did not meet primary endpoints)
 
Other Major Developments
3
-     Tagrisso - lung cancer (1st line)
(Breakthrough Therapy Designation, US)
-     Imfinzi - locally-advanced, unresectable lung cancer
(Breakthrough Therapy Designation, US)
-     Calquence - MCL (2nd line)
(Breakthrough Therapy Designation, US)
 
New Molecular Entities(NMEs) in Phase III Trials or Under Regulatory Review
11
Oncology
-     Imfinzi + treme - multiple cancers
-     moxetumomab pasudotox - leukaemia
-     selumetinib - thyroid cancer
-     savolitinib - kidney cancer
 
CVMD
-     ZS-9 (sodium zirconium cyclosilicate) - hyperkalaemia*
-     roxadustat - anaemia*
 
Respiratory
-     benralizumab - severe, uncontrolled asthma*, COPD
-     tralokinumab - severe, uncontrolled asthma
-     PT010 - COPD
 
Other
-     anifrolumab - lupus
-     lanabecestat - Alzheimer's disease
 
Projects in Clinical Pipeline
129
 
*Under Regulatory Review. The table shown above as at 9 November 2017.
 
 
ONCOLOGY
AstraZeneca has a deep-rooted heritage in Oncology and offers a growing line of new medicines that has the potential to transform patients' lives and the Company's future. At least six Oncology medicines are expected to be launched between 2014 and 2020, of which Lynparza, Tagrisso, Imfinzi and Calquence are already benefitting patients. An extensive pipeline of small-molecule and biologic medicines is in development and the Company is committed to advancing New Oncology, primarily focused on lung, ovarian, breast and blood cancers, as one of AstraZeneca's five Growth Platforms.
 
At the recent 2017 European Society of Medical Oncology (ESMO) annual meeting, AstraZeneca presented data from more than 40 abstracts, including two pivotal clinical-trial readouts selected for late-breaking presentation at the Presidential Symposium. Highlights included new data on approved and potential new medicines from the Company's pipeline across multiple scientific platforms and tumour types.
 
a) Faslodex (breast cancer)
On 28 August 2017, the Company announced approval in the US for the expansion of Faslodex use into advanced breast-cancer patients not previously treated with endocrine (hormonal) medicines. The US FDA approval was based on data from the Phase III FALCON trial, where Faslodex 500mg demonstrated superiority over anastrozole 1mg in the treatment of locally-advanced or metastatic breast cancer in post-menopausal patients who had not received prior hormonal-based medicine for hormone receptor-positive breast cancer. The FALCON trial data showed that Faslodex significantly reduced the risk of disease worsening or death by 20%.
During the period, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had adopted a positive opinion recommending a new indication for Faslodex that will expand its use to include combination therapy with palbociclib. The combination use was designed for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally-advanced or metastatic breast cancer or who have received prior endocrine therapy. The CHMP opinion was based on data from the Phase III PALOMA-3 trial which demonstrated that the combination of Faslodex 500mg and palbociclib 125mg resulted in a 4.9 month progression-free survival (PFS) improvement over Faslodex and placebo.
 
The Company also announced during the period that the US FDA had approved a new indication for Faslodex, expanding the indication to include use with abemaciclib for the treatment of HR+, HER2- advanced or metastatic breast cancer in patients with disease progression after endocrine therapy. The US FDA approval was based on data from the Phase III MONARCH 2 trial, which met the primary endpoint of PFS.
 
Finally, the Company announced during the period the approval of the supplemental New Drug Application (NDA) of Faslodex in combination with palbociclib in Japan, based on data from the PALOMA-3 trial; the approval was for the treatment of pre-menopausal breast cancer patients taking a luteinising hormone-releasing hormone medication.
 
b) Lynparza (multiple cancers)
On 17 August 2017, the Company announced approval in the US for Lynparza tablets as a maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer, regardless of BRCA-mutation status. Lynparza tablets were also indicated for patients with BRCA-mutated ovarian cancer beyond the 3rd-line setting, with the Accelerated Approval converted to full approval. Data from two randomised trials supported the new approval and the conversion of the prior approval to full approval, originally based on a single-arm trial.
 
Data from the Phase III SOLO-2 trial confirmed the benefit of Lynparza in germline BRCA-mutated (gBRCAm) patients, demonstrating a 70% reduced risk of disease progression or death (HR, hazard ratio, 0.30) and improved PFS to 19.1 vs 5.5 months for placebo by investigator-assessed analysis. Data from the Phase II Study-19 trial showed that Lynparza reduced the risk of disease progression or death by 65% and improved PFS compared to placebo in patients of any BRCA status (HR 0.35; median PFS of 8.4 months vs 4.8 months for placebo). Additionally, patients in Study 19, treated with Lynparza as a maintenance therapy, had a median overall survival (OS) of 29.8 months vs 27.8 months for placebo (HR 0.73).
 
During the period, the Company received regulatory submission acceptance in the US for Lynparza tablet's supplementary NDA based on the OlympiAD trial data in breast cancer. In the period, the Company also announced the submission of an NDA to Japan's Pharmaceuticals and Medical Devices Agency for the use of Lynparza tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018. The OlympiAD trial focused on patients with germline BRCA-mutated, HER2- metastatic breast cancer who had been treated previously with chemotherapy either in the neo-adjuvant, adjuvant or metastatic settings. This followed the Phase III OlympiAD data presented at the 2017 American Society of Clinical Oncology annual meeting. Lynparza is the first PARP inhibitor with a regulatory submission outside ovarian cancer.
 
c) Tagrisso (lung cancer)
At the recent ESMO Congress's Presidential Symposium, the Company presented positive results from the Phase III FLAURA trial for patients with 1st-line epidermal growth factor receptor (EGFR)-mutated NSCLC. Patients treated with Tagrisso had less than half the risk of progression or death compared with patients on erlotinib or gefitinib (HR 0.46). The median PFS was 18.9 months for patients on Tagrisso vs. 10.2 months for patients in the comparator arm. FLAURA demonstrated clinically-meaningful preliminary OS data favouring Tagrisso, namely a 37% reduction in the risk of death. OS data were 25% mature at the time of the interim analysis and a final OS analysis is planned for a later stage.
 
Improvements in PFS with Tagrisso were consistent across all pre-specified patient subgroups, with at least a 40% reduction in the risk of progression or death, including in patients with or without central nervous system metastases at trial entry, Asian/non-Asian patients, patients with or without prior smoking history and patients with exon 19 deletion/L858R. Patients treated with Tagrisso had more than double the median duration of response than those on the comparator arm (17.2 months vs. 8.5 months), while the objective response rates (ORR) were similar.
 
The US National Comprehensive Cancer Network (NCCN) guidelines were updated on 28 September 2017 to include Tagrisso as a category-2A treatment option in NSCLC patients with an EGFR mutation discovered prior to 1st-line treatment. The medicine is not currently approved for treatment in the 1st-line setting.
 
During the period, the Company and its partner Hutchison China MediTech Limited presented preliminary safety and clinical activity of savolitinib when given in combination with Tagrisso in a Phase Ib trial at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Japan. The trial was conducted in patients with EGFR-mutation-positive NSCLC with mesenchymal epithelial transition (MET)-amplification, who had progressed following 1st-line treatment with a tyrosine kinase inhibitor (TKI). Early data on safety and anti-tumour activity for savolitinib plus Tagrisso demonstrated a response according to RECIST 1.1 criteria in 28% of patients previously treated with third-generation T790M-directed EGFR TKIs, including Tagrisso. In patients who had progressed after prior treatment with a first- or second-generation EGFR inhibitor, 53% of T790M-negative patients had a partial response, while 57% of T790M-positive patients had a partial response. In the 66 patients treated with savolitinib plus Tagrisso, the most common all-causality adverse events of any grade were consistent with the known safety profiles of both therapies, including nausea (44%), vomiting (35%), fatigue (30%), and decreased appetite (30%).
 
d) Imfinzi (lung and other cancers) 
The Company continues to advance multiple monotherapy trials of Imfinzi and combination trials of Imfinzi with tremelimumab and other potential new medicines:
 
Lung Cancer
During the period, the Company maintained strong momentum in its early immunotherapy efforts in lung cancer. On 31 July 2017, Imfinzi was granted Breakthrough Therapy Designation by the US FDA for patients with locally-advanced, unresectable NSCLC. PACIFIC is a Phase III, randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in patients with locally-advanced (Stage III) unresectable NSCLC, who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy. PACIFIC trial results presented at the 2017 ESMO annual meeting showed a statistically-significant and clinically-meaningful PFS benefit with Imfinzi and also demonstrated a favourable risk/benefit profile. The trial will continue in order to evaluate OS, the other primary endpoint, which is anticipated to be assessed in 2019.
 
During the period, the US FDA accepted a supplemental Biologics License Application for Imfinzi for the treatment of patients with locally-advanced, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The agency granted Imfinzi Priority Review status in this potential indication. The Company also recently submitted the data from the PACIFIC trial to the EMA for the same indication and received acceptance of the submission. Additional regulatory submissions for the PACIFIC trial were made and/or accepted in the period in Australia, Brazil, Canada, Japan and Switzerland.
 
On 28 September 2017, the US NCCN Clinical Practice Guidelines in Oncology were updated to include Imfinzi for the treatment of patients with locally-advanced, unresectable NSCLC with no disease progression after two or more cycles of definitive chemoradiation, based on the data from the aforementioned PACIFIC trial. The medicine is not currently approved for treatment in the locally-advanced, unresectable NSCLC setting.
 
The Company now expects the first data from the Phase III ARCTIC trial in 3rd-line, PDL1-low/negative NSCLC to be available in H1 2018. The timeline reflects the event-driven nature of the trial as the Company awaits greater maturity of OS data.
 
Ongoing key lung-cancer trials include:
 
 
Name
Phase
Line of Treatment
Population
Design
Timelines
Status
Monotherapy
ADJUVANT*
III
N/A
Stage Ib-IIIa NSCLC
Imfinzi vs placebo
FPCD1 Q1 2015
 
First data anticipated 2020
 
Recruitment ongoing
PACIFIC
III
N/A
Locally-advanced (Stage III), unresectable NSCLC
Imfinzi vs placebo
FPCD Q2 2014
 
LPCD2 Q2 2016
 
Final OS data anticipated 2019
 
Recruitment completed
 
PFS primary endpoint met
PEARL
III
1st line
NSCLC (Asia)
Imfinzi vs SoC chemotherapy
FPCD Q1 2017
 
First data anticipated 2020
 
Recruitment ongoing
Combination therapy
MYSTIC
III
1st line
NSCLC
Imfinzi, Imfinzi + treme vs SoC chemotherapy
FPCD Q3 2015
 
LPCD Q3 2016
 
Final OS data anticipated H1 2018
 
Recruitment completed
 
PFS primary endpoint not met
NEPTUNE
III
1st line
NSCLC
Imfinzi + treme vs SoC chemotherapy
FPCD Q4 2015
 
LPCD Q2 2017
 
First data anticipated H2 2018
 
Recruitment completed
POSEIDON
III
1st line
NSCLC
Imfinzi + SoC, Imfinzi + treme + SoC vs SoC chemotherapy
FPCD Q2 2017
 
First data anticipated 2019
 
Recruitment ongoing
ARCTIC
III
3rd line
PDL1- low/neg. NSCLC
Imfinzi, tremelimumab, Imfinzi + treme vs SoC chemotherapy
FPCD Q2 2015
 
LPCD Q3 2016
 
First data anticipated H1 2018
 
Recruitment completed
CASPIAN
III
1st line
Small-cell lung cancer (SCLC)
Imfinzi + SoC, Imfinzi + treme + SoC vs SoC chemotherapy
FPCD Q1 2017
 
First data anticipated 2020
 
Recruitment ongoing
*Conducted by the National Cancer Institute of Canada
1First Patient Commenced Dosing
2Last Patient Commenced Dosing
 
Other Cancers
In November 2017, Imfinzi received approval in Canada, under the Health Canada's accelerated-approval framework (Notice of Compliance with Conditions (NOC/c) policy), for the treatment of patients with locally-advanced or mUC who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. Approval was granted in an 'all-comer' population based on both tumour response rate and duration of response. Data from Study 1108, which supported this approval, was shared at the recent 2017 ASCO annual meeting and showed a 17.0% objective response rate (ORR) by BICR in all-comers and a 26.3% ORR in patients with PDL1-positive tumours.
 
During the period, the Company amended its late-stage clinical development programme in 1st-line locally-advanced or metastatic urothelial carcinoma (bladder cancer). A refinement of the Phase III DANUBE trial meant that OS became the only primary endpoint, with the first data now anticipated in 2019. Patient enrolment was also increased from 1,005 to 1,200 patients, reflecting the inclusion of an expansion cohort in China.
 
The STRONG trial, a Phase IIIb, modular, five-year safety, open-label trial commenced dosing in the period and will evaluate the safety of a fixed-dose regimen equivalent to the current weight-based dose regimen of Imfinzi + tremelimumab combination therapy or Imfinzi monotherapy in patients with advanced solid tumours (via tumour-specific modules). The first tumour module dosed was metastatic urothelial carcinoma.
 
During the period, the Company launched a new Phase III trial to assess the safety and efficacy of Imfinzi monotherapy or Imfinzi plus tremelimumab combination therapy versus standard of care in patients with unresectable hepatocellular carcinoma (HCC, liver cancer). The HIMALAYA trial will include a fixed dose of Imfinzi (1,500mg, monthly) and tremelimumab (300mg).
 
Ongoing key trials are listed below:
 
Name
Phase
Line of Treatment
Population
Design
Timelines
Status
DANUBE
III
1st line
Cisplatin chemotherapy- eligible/
ineligible bladder cancer
 
Imfinzi, Imfinzi + treme vs SoC chemotherapy
FPCD Q4 2015
 
LPCD Q1 2017
 
First data anticipated 2019
 
Recruitment completed
KESTREL
 
III
1st line
Head and neck squamous cell carcinoma (HNSCC, head and neck cancer)
Imfinzi, Imfinzi + treme vs SoC
FPCD Q4 2015
 
LPCD Q1 2017
 
First data anticipated H1 2018
 
Recruitment completed
EAGLE
III
2nd line
HNSCC
Imfinzi, Imfinzi + treme vs SoC
FPCD Q4 2015
 
LPCD Q3 2017
 
First data anticipated H1 2018
 
Recruitment completed
HIMALAYA
 
III
1st line
HCC
Imfinzi, Imfinzi + treme vs sorafenib
First data anticipated 2019
 
Recruitment ongoing
 
On 7 September 2017, the Company announced that its partner, Celgene Corporation (Celgene) was informed by the US FDA that the agency had placed a partial clinical hold on five trials and a full clinical hold on one trial in the Celgene FUSION programme. The trials are testing Imfinzi in combination with immunomodulatory agents such as lenalidomide, with or without chemotherapy, in blood cancers such as multiple myeloma, chronic lymphocytic leukaemia and lymphoma.
 
e) Calquence (acalabrutinib) (blood cancer)
On 31 October 2017, the Company announced that the US FDA had granted Accelerated Approval to Calquence, a kinase inhibitor indicated for the treatment of adult patients with MCL who have received at least one prior therapy. Calquence was approved under the FDA's Accelerated Approval Program, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and fill an unmet medical need based on a surrogate endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
 
The Accelerated Approval was based on results from the ACE-LY-004 trial, where Calquence demonstrated an 80% ORR, with a 40% complete response and 40% partial-response rate. Full results from the ACE-LY-004 clinical trial will be presented in December 2017 at the 59th American Society of Hematology annual meeting in Atlanta, US. The approval followed acceptance of the submission and the granting of Priority Review and Breakthrough Therapy Designation earlier in the period, based on the totality of clinical data from the Calquence development programme, including data from the Phase II ACE-LY-004 clinical trial.
 
f) Moxetumomab pasudotox (leukaemia)
During the period, the Company maintained momentum in its efforts in blood cancers, with high-level results from a pivotal Phase III single-arm trial of moxetumomab pasudotox, an anti-CD22 recombinant immunotoxin, as treatment for adult patients with relapsed/refractory hairy cell leukaemia (HCL) who have had at least two prior lines of therapy. The clinical trial met its primary endpoint of durable complete response. HCL is an orphan disease with no cure and no established standard of care for patients in late-line therapy who relapse or refractory to prior therapies. AstraZeneca plans to submit the complete results from the Phase III trial for presentation at a forthcoming medical meeting.
 
 
 
CVMD
CV, renal and metabolic diseases are key areas of focus for AstraZeneca as the Company sets the challenge to better understand how its portfolio of medicines might be used to help address multiple risk factors or co-morbidities across CVMD. Today, AstraZeneca is delivering life-changing results in the main CV-disease areas and their complications. AstraZeneca is investing in the science to demonstrate CV and mortality benefits by slowing the underlying progression of CV-related disease and protecting the organs of the CV system. Ultimately, AstraZeneca is looking to do more than just slow CV-related disease, but to modify or even halt the natural course of the disease itself and regenerate organs.
 
The net result is a strong, continued commitment to new CVMD treatment options that have the potential to deliver improved outcomes to hundreds of millions of patients across the globe.
 
a) Brilique (CV disease)
During the period, the China FDA approved Brilique 60mg tablets for patients with a history of MI, following an MI event. The approval was based on data from the PEGASUS trial and expanded the use of Brilique in combination with aspirin, to reduce the rate of CV death, MI and stroke in patients with a history of MI and at least one additional high-risk factor for developing an atherothrombotic event.
 
During the 2017 European Society of Cardiology congress in Barcelona, AstraZeneca presented results from a new sub-analysis of data from the Phase III PEGASUS trial. The trial showed that treatment with Brilique 60mg twice daily reduced the risk in CV-caused death (versus placebo) by 29% in patients taking low-dose aspirin but still at high risk of an atherothrombotic event.
 
b) Farxiga (diabetes)
24-week data from the DEPICT-1 trial was published in The Lancet Diabetes and Endocrinology and presented at the 2017 European Association for the Study of Diabetes (EASD) 53rd annual meeting in September 2017. The trial showed that Farxiga, when given as an oral adjunct to injectable insulin in patients with inadequately-controlled type-1 diabetes, demonstrated significant and clinically-relevant reductions from baseline in HbA1c, weight reductions and lowered total daily insulin dosing at 24 weeks compared to placebo at both the 5mg and 10mg dose. Furthermore, as assessed by continuous glucose monitoring, treatment with Farxiga at both doses reduced mean glucose and glucose fluctuations (assessed by mean amplitude of glycaemic excursions) and increased the percentage of glucose readings in the target range (70-180mg/dL). Specifically, patients treated with Farxiga 5mg and 10mg spent more than two hours and more than 2.5 hours longer in the target glucose range each day, respectively.
 
The overall adverse event profile was in line with the known clinical profile of Farxiga, with no imbalance in adverse events reported. The occurrence of hypoglycaemia overall, as well as severe hypoglycaemia, was not increased in the Farxiga treatment groups compared with placebo. Similarly, in this trial, Farxiga was not associated with an increase in the occurrence of definite diabetic ketoacidosis (DKA) compared with placebo. Four (1%) events occurred in the Farxiga 5mg group, five (2%) occurred in the Farxiga 10mg group and three (1%) occurred in the placebo group, respectively. Insulin pump failure and missed insulin doses were the most frequent risk factors for definite DKA in the placebo and Farxiga groups.
 
The DEPICT clinical programme for Farxiga is ongoing; final results are required to evaluate the next regulatory steps. Farxiga is not currently approved for the treatment of type-1 diabetes.
 
c) Bydureon (type-2 diabetes)
AstraZeneca presented the full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial at the aforementioned EASD meeting. The trial demonstrated CV safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes across a range of CV outcomes.
 
Bydureon did not increase the incidence of major adverse CV events (MACE), a composite endpoint of CV death, non-fatal heart attack or non-fatal stroke, compared to placebo (HR 0.91; 95% confidence interval (CI): 0.83-1.00; p<0.001 for non-inferiority). There were also fewer CV events observed in the Bydureon arm of the trial (839 (11.4%) versus 905 (12.2%)), although the primary efficacy objective of a superior reduction in MACE did not meet statistical significance (p=0.061). Additionally, in a pre-specified secondary analysis, patients treated with exenatide had a 14% lower incidence of death from all causes (HR: 0.86; 95% CI: 0.77-0.97).
 
During the period, the US FDA approved the inclusion of data from the DURATION-8 clinical trial into the Farxiga and Bydureon labels. DURATION-8 evaluated the simultaneous combination of a GLP-1 receptor agonist with an SGLT2 inhibitor on a background of metformin therapy, in high baseline HbA1c patients with inadequate glycemic control. The results demonstrated that combining agents that work in different ways can significantly reduce HbA1c, as well as weight and systolic blood pressure.
 
In August 2017, the EMA approved the incorporation of DURATION-8 data into the Bydureon label. The label included updates to both the indication statement and the clinical-trial section. DURATION-8 data is now represented in both the Bydureon and Forxiga European summary of product characteristics.
 
In October 2017, the Company announced that the US FDA had approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose BCise device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control. AstraZeneca anticipates that Bydureon BCise will be available for patients in the US in the first quarter of 2018. A regulatory application for the new BCise device was also accepted by the EMA in the period.
 
Major ongoing outcomes trials for patients are highlighted in the following table:
 
Medicine
Trial
Mechanism
Population
Primary Endpoint
Timeline
Farxiga
DECLARE
SGLT2 inhibitor
~17,0001 patients with type-2 diabetes
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
 
H2 2018 (final analysis)
Farxiga
DAPA-HF
SGLT2 inhibitor
~4,500 patients with heart failure (HF)
Time to first occurrence of CV death or hospitalisation for HF or an urgent HF visit
 
FPCD Q1 2017
Farxiga
DAPA-CKD
SGLT2 inhibitor
~4,000 patients with chronic kidney disease (CKD)
Time to first occurrence of ≥50% sustained decline in eGFR2 or reaching ESRD3 or CV death or renal death
 
FPCD Q1 2017
Brilinta
THEMIS
P2Y12 receptor antagonist
~19,000 patients with type-2 diabetes
and coronary artery disease
without a history of
MI or stroke
 
Composite of
CV death, non-fatal MI
and non-fatal stroke
2019
Epanova
STRENGTH
Omega-3 carboxylic acids
~13,000 patients with mixed dyslipidaemia
 
Time to first occurrence of CV death, non-fatal MI or non-fatal stroke
2019
1Includes ~10,000 patients who have had no prior index event (primary prevention) and ~7,000 patients who have suffered an index event (secondary prevention)
2Estimated Glomerular Filtration Rate
3End-Stage Renal Disease
 
d) ZS-9 (sodium zirconium cyclosilicate) (hyperkalaemia)
In April 2017, the EMA informed AstraZeneca that the Marketing Authorisation Application decision process for ZS-9 was put on hold until the agency had performed an inspection of the dedicated substance-manufacturing facility in Texas, US. This followed receipt of a second Complete Response Letter from the US FDA, as announced on 17 March 2017. During the period, the Company made further progress in addressing the manufacturing deficiencies identified by the FDA inspection and expects to be able to accommodate a new manufacturing inspection in due course.
 
e) Roxadustat (anaemia)
During the period, the Company and its partner FibroGen Inc. (Fibrogen) announced the regulatory submission of an NDA for roxadustat with the China FDA, concluding the rolling submission initiated in Q4 2016. The NDA was based on two Fibrogen-led Phase III trials, conducted in China, that met their primary efficacy endpoints in January 2017 respectively. If approved, roxadustat will be a first-in-class medicine, with China being the first approval country, ahead of other major markets.
 
 
 
RESPIRATORY
AstraZeneca's Respiratory portfolio is aimed at transforming the treatment of asthma and COPD through combination inhaled therapies, biologics for the unmet medical needs of specific patient populations and an early pipeline focused on disease modification.
 
The growing range of medicines includes up to four anticipated launches between 2017 and 2020. The capability in inhalation technology spans both pressurised, metered-dose inhalers and dry-powder inhalers to serve patient needs, as well as the innovative Aerosphere co-suspension Delivery Technology, a focus of AstraZeneca's future-platform development for respiratory-disease combination therapies.
 
a) Symbicort (COPD)
On 11 September 2017, the US FDA approved Symbicort for the reduction of exacerbations in patients with COPD. The approval was based on data that evaluated COPD exacerbations as the primary endpoint in two Phase IIIb trials (RISE and Study 003), supported by data from two legacy Phase IIIa trials (SUN and SHINE). The approval meant Symbicort was indicated to reduce exacerbations; the medicine is also used as a maintenance treatment for airflow obstruction in patients with COPD. The RISE data was published in Respiratory Medicine.
 
Following clinical data from the Phase III SYGMA trials, examining Symbicort Turbuhaler prescribed as an anti-inflammatory reliever as needed in patients with mild asthma, the primary objectives in severe-asthma exacerbation rates and asthma control were met. A full evaluation of the SYGMA primary and secondary objectives is ongoing and the results will be presented at a forthcoming medical meeting.
 
b) Duaklir (COPD)
On 7 September 2017, AstraZeneca announced positive top-line results from the Phase III AMPLIFY trial for Duaklir, which met its primary endpoints and demonstrated a statistically-significant improvement in lung function in patients with moderate to very-severe stable COPD, compared to each individual component (either aclidinium bromide or formoterol). A full evaluation of the AMPLIFY data is ongoing and further results will be presented at a forthcoming medical meeting.
 
c) Bevespi (COPD)
On 25 September 2017, the Company announced positive top-line results of the Phase III PINNACLE 4 trial. The trial demonstrated a statistically-significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components and placebo, all administered twice daily via pMDI to patients with moderate to very severe COPD. AstraZeneca will make regulatory submissions for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously-reported trials.
 
During the period, the first patient was randomised into AERISTO, a head-to-head trial that is assessing the efficacy and safety of Bevespi Aerosphere relative to the competing dual bronchodilator, a fixed-dose combination of umeclidinium and vilanterol, for patients with moderate to very severe COPD.
 
d) Benralizumab (severe, uncontrolled asthma)
On 11 September 2017, results from a sub-group analysis of the SIROCCO and CALIMA Phase III trials were presented at the aforementioned ERS Congress. The results confirmed benralizumab's efficacy and identified key predictive factors of those patients suffering from severe, uncontrolled asthma that would respond best to treatment with benralizumab. The results were published simultaneously in The Lancet Respiratory Medicine.
 
Benralizumab is under regulatory review in the US, EU, Japan and several other countries, with a US PDUFA date during the final quarter of 2017. Regulatory decisions are anticipated elsewhere during H1 2018.
 
e) Tralokinumab (severe, uncontrolled asthma)
On 1 November 2017, AstraZeneca announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 human monoclonal antibody, in severe, uncontrolled asthma.
 
STRATOS 1 and 2 were Phase III multi-centre, randomised, double-blinded, parallel-group, placebo-controlled trials designed to evaluate the efficacy and safety of a regular, subcutaneous administration of tralokinumab for 52 weeks in adult and adolescent patients with severe, inadequately-controlled asthma, despite treatment with inhaled corticosteroids plus LABA.
 
In the STRATOS 2 trial, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate, the primary endpoint, in patients with severe, uncontrolled asthma and elevated levels of a biomarker, Fractional exhaled Nitric Oxide, compared to placebo. In TROPOS, tralokinumab did not achieve a statistically-significant reduction in oral corticosteroid (OCS) use, the primary endpoint, when added to the standard of care, in patients dependent on OCS. Full data from STRATOS 1, STRATOS 2 and TROPOS will be presented at a forthcoming medical meeting.
 
f) Tezepelumab (asthma)
At the aforementioned ERS Congress, AstraZeneca and Amgen Inc. presented results from the PATHWAY Phase IIb trial of tezepelumab, a first-in-class treatment that blocks thymic stromal lymphopoietin (TSLP), an upstream driver of inflammation in asthma. The trial met its primary efficacy endpoint and the data demonstrated significant and clinically-meaningful annual asthma exacerbation-rate reductions of 61%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks, respectively, independent of baseline blood eosinophil count or other type-2 inflammatory biomarkers. Tezepelumab also demonstrated improvements in lung function at all doses and in asthma control at the two higher doses. The trial results were simultaneously published in the New England Journal of Medicine.
 
 
OTHER
a) Tezepelumab (atopic dermatitis)
During the period, the ALLEVIAD Phase IIa trial data showed that tezepelumab did not meet statistical significance on the primary endpoint (EASI 50) of the 12-week exploratory trial that evaluated tezepelumab in moderate to severe atopic dermatitis (AD) as add-on treatment to regular medium-to-high strength topical glucocorticosteroids. Numeric differences in favour of tezepelumab, however, were observed across a number of disease activity endpoints (EASI, IGA and SCORAD response) compared to placebo.
 
b) Anifrolumab (lupus)
 
 
During the period, the Company completed the enrolment of the second Phase III trial (TULIP 2) of anifrolumab in patients with moderate-to-severe systemic lupus erythematosus (SLE, or lupus). Data readouts from both the TULIP 1 and TULIP 2 trials are expected in H2 2018, with anticipated regulatory submissions in 2019.
 
In addition, the Company also completed enrolment during the period of the Phase II SLE trial of a sub-cutaneous route of administration of anifrolumab. 
c) Lanabecestat (Alzheimer's disease)
During the period, the Company and Lilly completed enrolment of the Phase II/III AMARANTH trial investigating the safety and efficacy of lanabecestat compared with placebo in the treatment of early Alzheimer's disease. A data readout from the lanabecestat clinical programme is anticipated in 2019.
 
 
Development Pipeline 30 September 2017
________________________________________________________________________________________
 
AstraZeneca-sponsored or -directed trials
 
Phase III / Pivotal Phase II / Registration
 
New Molecular Entities (NMEs) and significant additional indications
 
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed at this time.
 
 
 
 
 
 
 
       Estimated Regulatory Acceptance Date /Submission Status
Compound
 Mechanism
 Area Under Investigation
 Date Commenced Phase
 US
 EU
 Japan
 China
Oncology
 
 
 
 
 
 
 
Calquence# (acalabrutinib)
BTK inhibitor
B-cell malignancy
Q1 2015
Approved
 
 
 
Calquence# (acalabrutinib)
BTK inhibitor
1st-line chronic lymphocytic leukaemia
Q3 2015
2020
(Orphan Drug Designation)
2020
(Orphan designation)
 
 
Calquence# (acalabrutinib)
BTK inhibitor
relapsed/refractory chronic lymphocytic leukaemia, high risk
Q4 2015
2020
(Orphan Drug Designation)
2020
(Orphan designation)
 
 
Calquence# (acalabrutinib)
BTK inhibitor
1st-line mantle cell lymphoma
Q1 2017
2023
 
 
 
savolitinib#
SAVOIR
MET inhibitor
papillary renal cell carcinoma
Q3 2017
2020
2020
 
 
selumetinibASTRA
MEK inhibitor
differentiated thyroid cancer
Q3 2013
H2 2018
(Orphan Drug Designation)
H2 2018
 
 
moxetumomab pasudotox#
PLAIT
anti-CD22 recombinantimmunotoxin
hairy cell leukaemia
Q2 2013
H1 2018
(Orphan Drug Designation)
 
 
 
Imfinzi# +
tremelimumabARCTIC
PD-L1 mAb + CTLA-4 mAb
3rd-line NSCLC
Q2 2015
H1 2018
H1 2018
H1 2018
 
Imfinzi# + tremelimumab
MYSTIC
PD-L1 mAb + CTLA-4 mAb
 
1st-line NSCLC
Q3 2015
H2 2018
H2 2018
H2 2018
 
Imfinzi# + tremelimumab
NEPTUNE
PD-L1 mAb + CTLA-4 mAb
1st-line NSCLC
Q4 2015
2019
2019
2019
2020
Imfinzi#PACIFIC
PD-L1 mAb
locally-advanced (Stage III), NSCLC
Q2 2014
Accepted
(Breakthrough Therapy Designation & Priority Review)
Accepted
Accepted
 
Imfinzi# + tremelimumab + chemotherapy
POSEIDON
PD-L1 mAb + CTLA-4 mAb
1st-line NSCLC
Q2 2017
2019
2019
2019
2020
Imfinzi# + tremelimumab + SoC
CASPIAN
PD-L1 mAb + CTLA-4 mAb + SoC
 
1st-line small cell lung cancer
Q1 2017
2020
2020
2020
 
Imfinzi# + tremelimumabKESTREL
PD-L1 mAb + CTLA-4 mAb
 
1st-line HNSCC
Q4 2015
H2 2018
H2 2018
H2 2018
 
Imfinzi# + tremelimumabEAGLE
PD-L1 mAb + CTLA-4 mAb
 
2nd-line HNSCC
Q4 2015
H2 2018
H2 2018
H2 2018
 
Imfinzi# + tremelimumab
DANUBE
PD-L1 mAb + CTLA-4 mAb
 
1st-line bladder cancer
Q4 2015
 
2019
2019
 
2019
 
 
Lynparza#+ cediranib
CONCERTO
PARP inhibitor + VEGF inhibitor
 
recurrent platinum-resistant ovarian cancer
Q1 2017
 
2019
 
 
 
CVMD
 
 
 
 
 
Epanova
omega-3 carboxylic acids
severe hypertriglycerid-aemia
 
Approved
 
2020
 
ZS-9 (sodium zirconium cyclosilicate)
potassium binder
hyperkalaemia
 
-
Accepted1
2019
 
roxadustat# OLYMPUS (US) ROCKIES (US)
hypoxia-inducible factor prolyl hydroxylase inhibitor
anaemia in CKD / end-stage renal disease
Q3 2014
H2 2018
 
 
Accepted2
Respiratory
 
Bevespi Aerosphere (PT003)
LABA/LAMA
COPD
 
Launched
 Accepted
H2 2018
H2 2018
benralizumab#
CALIMA SIROCCO ZONDA
BISE
BORA
GREGALE
IL-5R mAb
severe, uncontrolled asthma
 
Accepted
Accepted
Accepted
2021
benralizumab#
TERRANOVA GALATHEA
IL-5R mAb
COPD
Q3 2014
H2 2018
H2 2018
2019
 
PT010
LABA/LAMA/ ICS
COPD
Q3 2015
2019
2019
H2 2018
H2 2018
tralokinumab
STRATOS 1,2
TROPOS
MESOS
IL-13 mAb
severe, uncontrolled asthma
Q3 2014
-
-
-
 
Other
 
 
 
 
 
 
 
anifrolumab# TULIP
IFN-alphaR mAb
systemic lupus erythematosus
Q3 2015
2019
(Fast Track)
2019
2019
 
lanabecestat#
AMARANTH + extension, DAYBREAK-ALZ
beta-secretase inhibitor
Alzheimer's disease
Q2 2016