Annual Reports

 
Other

  • 6-K (Mar 12, 2018)
  • 6-K (Mar 7, 2018)
  • IRANNOTICE (Mar 6, 2018)
  • 6-K (Mar 1, 2018)
  • 6-K (Feb 23, 2018)
  • 6-K (Feb 20, 2018)
AstraZeneca 6-K 2018

Documents found in this filing:

  1. 6-K
  2. 6-K
     
 

 
 
 
 
 
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 February 2018
 
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
 
INDEX TO EXHIBITS
 
 
 
AstraZeneca PLC
2 February 2018 07:00
 
Full-Year 2017 Results
Encouraging progress made on commercial execution and cost discipline; Product Sales growth in the quarter.
AstraZeneca positioned for Product Sales growth from FY 2018
 
Financial Summary
 
 
FY 2017
Q4 2017
$m
% change
$m
% change
 
Actual
CER1
Actual
CER
Total Revenue
22,465
(2)
(2)
5,777
3
2
Product Sales
20,152
(5)
(5)
5,487
4
3
Externalisation Revenue
2,313
37
38
290
(11)
(12)







Reported Operating Profit2
3,677
(25)
(28)
686
(73)
(71)
Core Operating Profit3
6,855
2
-
1,787
(12)
(11)







Reported Earnings Per Share (EPS)
$2.37
(14)
(15)
$1.03
(29)
(24)
Core EPS
$4.28
(1)
(2)
$1.30
7
13
 
Financial Highlights
 
        ● Total Revenue declined by 2% in the year, in line with guidance. Externalisation Revenue increased by 37% (38% at CER) in the year to $2,313m. Ongoing Externalisation Revenue4 of $821m in the year represented 35% of total Externalisation Revenue (FY 2016: $356m, 21%)
        ● Cost discipline in the year continued:
            -     Reported R&D costs declined by 2% (1% at CER) to $5,757m; Core R&D costs declined by 4% (3% at CER) to $5,412m
            -     Reported SG&A costs increased by 9% (10% at CER) to $10,233m; Core SG&A costs declined by 4% (3% at CER) to $7,853m
        ● Reported EPS of $2.37 and Core EPS of $4.28 for the year, including:
            -     A $617m net benefit in Q4 2017 to Reported Profit After Tax, reflecting adjustments to deferred taxes in line with the recently reduced US federal income tax rate from 35% to 21%
            -     A $321m benefit to Reported and Core Taxation in Q4 2017; the Reported Tax Rate in FY 2017 was (29)% and the Core Tax Rate in FY 2017 was 14%, driven by reductions in tax provisions
        ● The Board reaffirms its commitment to the progressive dividend policy; a second interim dividend of $1.90 per share has been declared, taking the full-year dividend per share to $2.80 (unchanged)  
        ● FY 2018 guidance (CER): Product Sales - a low single-digit percentage increase; Core EPS - $3.30 to $3.50
 
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"AstraZeneca's revenues improved over the course of the year, a sign of how our company is steadily turning a corner. Strong commercial execution helped us bring our science to more patients, making the most of our exciting pipeline. We made encouraging progress across the main therapy areas and delivered strong growth in China.
Alongside our CVMD medicines Brilinta and Farxiga reaching blockbuster status, we launched our first Respiratory biologic medicine, Fasenra and new cancer medicines, Imfinzi and Calquence. As well as bringing five new medicines to patients last year, we continued to find more potential uses for existing treatments, including Lynparza and Tagrisso.
We remain committed to our progressive dividend policy. Our strategy is working, propelled by a strong pipeline, good sales performance and continued cost discipline."
 
Commercial Highlights
Product Sales growth of 4% (3% at CER) in Q4 2017 to $5,487m, which included favourable true-up adjustments relating to the first nine months of 2017; the great majority of these true-up adjustments concerned legacy medicines. The Growth Platforms gathered momentum in the year and represented 68% of Total Revenue. They grew by 5% (6% at CER) in the year and by 12% in the quarter:
        ● Emerging Markets: Full-year growth of 6% (8% at CER), in line with long-term ambitions. China sales in the year grew by 12% (15% at CER) and in the quarter by 33% (30% at CER), supported by the launches of new medicines
        ● Respiratory: Full-year sales declined by 1%; Q4 2017 sales up by 10% (8% at CER), reflecting improved performances by Symbicort and Pulmicort
        ● New CVMD5: Full-year growth of 9%. Growth of 23% in the quarter (21% at CER), with strong performances from Farxiga and Brilinta, each becoming blockbusters by exceeding $1bn in sales in the year
        ● Japan: 1% full-year growth (4% at CER), underpinned by the growth of Tagrisso and Forxiga, partly mitigated by the impact of the entry of generic competition to Crestor in the second half of the year
        ● New Oncology6: 98% full-year growth. Tagrisso reached $955m to become AstraZeneca's largest-selling Oncology medicine. Imfinzi sales of $18m in the quarter vs. $19m in the full year
 
 
FY 2018 Guidance
 
All measures in this section are at CER. Company guidance is on Product Sales and Core EPS only.
 
Product Sales
A low single-digit percentage increase
Core EPS
$3.30 to $3.50
 
The aforementioned growth in Product Sales is anticipated to be weighted towards the second half of the year. This reflects the remaining impact of generic competition, in particular Crestor in Europe and Japan.
 
Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance and indications on a Reported basis because the Company cannot reliably forecast material elements of the Reported 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.
 
FY 2018 Currency Impact
Based only on average exchange rates in January 2018 and the Company's published currency sensitivities, there would be a low single-digit percentage favourable impact from currency movements on Product Sales and a minimal impact on Core EPS in the year. Further details on currency sensitivities are contained within the Operating and Financial Review.
 
FY 2018: Additional Commentary
Outside of guidance, the Company today provides additional indications for FY 2018 vs. the prior year:
        ● The sum of Externalisation Revenue and Other Operating Income and Expense is anticipated to reduce vs. FY 2017. As part of its long-term growth strategy, the Company remains committed to focusing on appropriate cash-generating and value-accretive externalisation activities that reflect the ongoing productivity of the pipeline. It is also committed to the continued management of its portfolio disposals and to increasing the focus on the three main therapy areas over time
        ● Core R&D costs in FY 2018 are anticipated to be in the range of a low single-digit percentage decline to stable. This expectation includes the favourable impact on development costs from the MSD collaboration (Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada))
       ● The Company maintains its focus on reducing operational and infrastructure costs. Total Core SG&A costs, however, are expected to increase by a low to mid single-digit percentage in FY 2018, wholly reflecting targeted support for launches and potential launches, including Fasenra in severe, uncontrolled asthma and Imfinzi in locally-advanced, unresectable lung cancer. The Company also anticipates a reduction in restructuring costs in 2018 vs. the prior year
        ● A Core Tax Rate of 16-20% (FY 2017: 14%)
 
Achieving Scientific Leadership
The table below highlights the development of the late-stage pipeline since the prior results announcement:
 
Regulatory Approvals
Faslodex - breast cancer (combinations) (US, EU)
Lynparza - ovarian cancer (JP)
Lynparza - breast cancer (US)
Fasenra (benralizumab) - severe, uncontrolled asthma (US, EU, JP)
Regulatory Submissions and/or Acceptances
Tagrisso - lung cancer (1st line) (US - Priority Review, EU, JP)
ZS-9 - hyperkalaemia (US)
Major Phase III Data Readouts and Developments
Lynparza - ovarian cancer: Priority review (CN)
roxadustat - anaemia: Priority review (CN)
PT010 - COPD1 (KRONOS trial) (most2 primary endpoints met)
tezepelumab - severe, uncontrolled asthma: First patient commenced dosing
                1Chronic Obstructive Pulmonary Disease.
                2Eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators.
 
Notes
 
        1.   Constant exchange rates. These are non-GAAP financial measures because they remove the effects of currency movements from Reported results.
        2.   Reported financial measures are our financial results presented in accordance with IFRS, the Generally Accepted Accounting Principles (GAAP) on the basis of which we prepare our financial results.
        3.   Core financial measures. These are non-GAAP financial measures because, unlike Reported performance, they cannot be derived directly from the information in the Group Financial Statements. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
       4.   Ongoing Externalisation Revenue is defined as Externalisation Revenue excluding Initial Externalisation Revenue (which is defined as Externalisation Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Externalisation Revenue comprises, among other items, royalties, milestones and profit sharing income. Ongoing Externalisation Revenue and Initial Externalisation Revenue are non-GAAP financial measures because they cannot be derived directly from the information included in the Group Financial Statements.
        5.   New Cardiovascular and Metabolic Diseases, incorporating Brilinta and Diabetes.
        6.   New Oncology, comprising Lynparza, Tagrisso, Iressa (US), Imfinzi and Calquence.
All growth rates in this announcement 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 and are vs. the prior year, 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.
 
H1 2018
Lynparza - ovarian cancer (2nd line): Regulatory decision (EU)
Lynparza - ovarian cancer (1st line): Data readout
Lynparza - breast cancer: Regulatory submission (EU)
Tagrisso - lung cancer: Regulatory decision (US)
 
Imfinzi - lung cancer (PACIFIC): Regulatory decision (US)
Imfinzi +/- treme - lung cancer (ARCTIC) (3rd line): Data readout, regulatory submission
Imfinzi +/- treme - lung cancer (MYSTIC) (1st line): Data readout (final overall-survival (OS))
Imfinzi +/- treme - head & neck cancer (KESTREL) (1st line): Data readout
Imfinzi +/- treme - head & neck cancer (EAGLE) (2nd line): Data readout
 
selumetinib - thyroid cancer: Data readout
 
ZS-9 - hyperkalaemia: Regulatory decision (US, EU)
 
Bevespi - COPD: Regulatory submission (JP)
Duaklir - COPD: Regulatory submission (US)
 
H2 2018
Lynparza - breast cancer: Regulatory decision (JP)
Lynparza - ovarian cancer (1st line): Regulatory submission
Lynparza - pancreatic cancer: Data readout
Tagrisso - lung cancer: Regulatory decision (EU, JP)
 
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

selumetinib - thyroid cancer: Regulatory submission

Farxiga - type-2 diabetes (DECLARE): Data readout
Bydureon autoinjector - type-2 diabetes: Regulatory decision (EU)
roxadustat - anaemia: Regulatory submission (US)
 
Bevespi - COPD: Regulatory decision (EU)
Fasenra - COPD: Data readout
PT010 - COPD: Regulatory submission
 
anifrolumab - lupus: Data readout
2019
Lynparza - pancreatic cancer: Regulatory submission
Lynparza - ovarian cancer (3rd line): Data readout, regulatory submission
 
Imfinzi - lung cancer (PACIFIC): Data readout (final OS)
Imfinzi +/- treme - lung cancer (POSEIDON): Data readout, regulatory submission
Imfinzi +/- treme - small-cell lung cancer (CASPIAN): Data readout, regulatory submission
Imfinzi
+/- treme - bladder cancer (DANUBE): Data readout, regulatory submission
 
Calquence - chronic lymphocytic leukaemia: Data readout

Brilinta - coronary artery disease / type-2 diabetes: Data readout, regulatory submission
Farxiga - type-2 diabetes (DECLARE): Regulatory submission
Farxiga - heart failure: Data readout
Fasenra - COPD: Regulatory submission

anifrolumab - lupus: Regulatory submission
lanabecestat - Alzheimer's disease: Data readout
The term 'data readout' in this section refers to Phase III data readouts.
Conference Call
A live presentation and webcast for investors and analysts, hosted by management, will begin at 12:30pm UK time today. Details can be accessed via astrazeneca.com.
Reporting Calendar
The Company intends to publish its first-quarter financial results on 18 May 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 astrazeneca.com and follow us on Twitter @AstraZeneca.
 
Media Relations
 
 
Esra Erkal-Paler
UK/Global
+44 203 749 5638
Gonzalo Viña
UK/Global
+44 203 749 5916
Rob Skelding
UK/Global
+44 203 749 5821
Karen Birmingham
UK/Global
+44 203 749 5634
Matt Kent
UK/Global
+44 203 749 5906
Jacob Lund
Sweden
+46 8 553 260 20
Michele Meixell
US
+1 302 885 2677
 
 
 
Investor Relations
 
 
Thomas Kudsk Larsen
 
 
+44 203 749 5712
Craig Marks
Finance; Fixed Income; M&A
+44 7881 615 764
Henry Wheeler
Oncology
+44 203 749 5797
Mitchell Chan
Oncology; Other
+1 240 477 3771
Christer Gruvris
Brilinta; Diabetes
+44 203 749 5711
Nick Stone
Respiratory; Renal
+44 203 749 5716
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 twelve and three-month periods to 31 December 2017 (the year (FY 2017), or the quarter (Q4 2017), respectively) compared to the twelve and three-month periods to 31 December 2016 (FY 2016 and Q4 2016, respectively). All commentary in the Operating and Financial Review relates to the full year, unless stated otherwise.
Core financial measures, EBITDA, Net Debt, Initial Externalisation Revenue and Ongoing Externalisation Revenue 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 readers 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, which includes charges that relate to the impact of global restructuring programmes on capitalised IT assets
            ● Other specified items, principally comprising acquisition-related costs, which include fair value adjustments and the imputed finance charge relating to contingent consideration on business combinations, legal settlements and foreign-exchange gains and losses on certain non-structural intra-group loans*
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.
*This element has been added to the definition of Core financial measures during 2017. There were no such gains and losses in the income statement in prior periods.
EBITDA is defined as Reported Profit Before Tax after adding back Net Finance Expense, results from 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.
Ongoing Externalisation Revenue is defined as Externalisation Revenue excluding Initial Externalisation Revenue (which is defined as Externalisation Revenue that is recognised at the date of completion of an agreement or transaction, in respect of upfront consideration). Ongoing Externalisation Revenue comprises, among other items, royalties, milestones and profit sharing income.
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
 
FY 2017
Q4 2017
$m
% change
$m
% change
Actual
CER
Actual
CER
Total Revenue
22,465
(2)
(2)
5,777
3
2







Product Sales
20,152
(5)
(5)
5,487
4
3
Externalisation Revenue
2,313
37
38
290
(11)
(12)
 
Product Sales
Growth in Product Sales was reached in the final quarter of the year after a number of years of decline. Quarterly growth rates in FY 2017 Product Sales are shown below:
 
 
% change
Actual
CER
Q1 2017
(13)
(12)
Q2 2017
(10)
(8)
Q3 2017
(3)
(2)
Q4 2017
4
3
 
The growth in the fourth quarter included the favourable impact from true-up adjustments in the US relating to the first nine months of 2017, resulting from improved data insight and methodology in the estimation of payer rebates, product returns and discounts; AstraZeneca does not anticipate a similar magnitude of adjustments in future periods.
Over the full year, Product Sales declined by 5% from $21,319m to $20,152m, a difference of $1,167m; Crestor sales declined by $1,036m and Seroquel XR sales declined by $403m. Both medicines lost exclusivity in the US in the second half of 2016.
Emerging Markets sales grew by 6% (8% at CER) to $6,149m, in line with an unchanged average-growth ambition of a mid to high single-digit percentage. In the quarter, Emerging Markets sales grew by 10% (9% at CER) to $1,630m. China sales increased by 12% (15% at CER) to $2,955m in the year and, in the quarter, by 33% (30% at CER) to $813m. These results reflected strong performances across all three main therapy areas, including the impact of the launches of new medicines.
US sales declined by 16% to $6,169m and were, alongside the effects of the Crestor and Seroquel XR losses of exclusivity, impacted by the adverse sales performance of Symbicort, which declined by 12% to $1,099m. US sales, however, grew by 9% to $1,770m in the quarter as the effects of the Crestor and Seroquel XR losses of exclusivity dissipated. Sales in the quarter also benefitted from favourable true-up adjustments in the US relating to the first nine months of 2017.
Product Sales in Europe declined by 6% (7% at CER) to $4,753m in the year, partly driven by pricing pressures on Symbicort and the initial impact from generic competition to Crestor.
The Growth Platforms grew by 5% (6% at CER) to $15,231m, representing 68% of Total Revenue and, in the quarter, by 12% to $4,180m:
 
 
FY 2017
Q4 2017
$m
% change
$m
% change
 
Actual
CER
Actual
CER
Emerging Markets
6,149
6
8
1,630
10
9
Respiratory
4,706
(1)
(1)
1,334
10
8
New CVMD
3,567
9
9
1,024
23
21
Japan
2,208
1
4
563
(5)
2
New Oncology
1,313
98
98
437
102
100
 
 
 
 
 
 
 
Total*
15,231
5
6
4,180
12
12
*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, revenue arising from externalisation agreements is reported as Externalisation Revenue in the Company's financial statements. A breakdown of Initial Externalisation Revenue in the year is shown below:
Medicine
Partner
Region
$m
Lynparza
MSD
Global
997
Zoladex
TerSera Therapeutics LLC (TerSera)
US and Canada
250
MEDI8897
Sanofi Pasteur, Inc. (Sanofi Pasteur)
Global
127
Tudorza/Duaklir
Circassia Pharmaceuticals plc (Circassia)
US
64
MEDI1341
Takeda Pharmaceutical Company Limited
Global
50
Other
 
 
4
 
 
 
 
Total
 
 
1,492
 
A breakdown of Ongoing Externalisation Revenue in the year is shown below:
Medicine
Partner
Region
$m
Lynparza
MSD
- option payment
Global
250
Anaesthetics
Aspen Global, Inc. (Aspen)1
- milestone revenue
Global (excl.US)
150
Siliq
Valeant Pharmaceuticals International, Inc. (Valeant)
- milestone revenue
US
130
Lanabecestat
Eli Lilly and Company
- milestone revenue
Global
50
Crestor AG2
Daiichi Sankyo Company, Ltd
(Daiichi Sankyo)
- milestone revenue
Japan
45
Bydureon
3SBio Inc. (3SBio)
- milestone revenue
China
25
Other
 
 
171




Total
 
 
821
            1Following the sale of the remaining rights to the anaesthetics portfolio to Aspen in Q4 2017, any future income relating to these medicines will be recorded as Other Operating Income and Expense.
           2Authorised Generic.
 
Ongoing Externalisation Revenue of $821m represented 35% of total Externalisation Revenue (FY 2016: $356m, 21%). The Company anticipates that Ongoing Externalisation Revenue will grow as a proportion of Externalisation Revenue over time.
 
FY 2017
Q4 2017
 
$m
% of total1
% change
$m
% of total
% change
Actual
CER
Actual
CER
Royalties
108
5
(9)
(6)
8
3
(82)
(72)
Milestones/Other2
713
31
n/m
n/m
282
97
n/m
n/m









Ongoing Externalisation Revenue
 
821
 
35
n/m
n/m
290
100
n/m
n/m









Initial Externalisation Revenue
1,492
65
12
12
-
-
n/m
n/m









Total Externalisation Revenue
2,313
100
37
38
290
100
(11)
(12)
            1Due to rounding, the sum of individual medicine percentages may not agree to totals.
            2May include, inter alia, option and profit sharing income.
 
A number of AstraZeneca medicines were externalised or disposed of in FY 2017, thus adversely impacting the Product Sales performance:
 
Completion
Medicine
Region
FY 2017*
FY 2016
Difference
Adverse Impact on FY 2017 Product Sales
$m
$m
$m
 
March
Zoladex
US and Canada
23
66
(43)
 
June
Seloken
Europe
52
90
(38)
 
June
Zomig
Global (excl. Japan)
58
78
(20)
 
October
Anaesthetics
Global
292
472
(180)
 







 
Total
 
425
706
(281)
1%
            *FY 2017 Product Sales here comprise sales made to partners under manufacturing and supply agreements.
            Examples of transactions that include Ongoing Externalisation Revenue are shown below:
Completion
Medicine
Partner
Region
Externalisation Revenue
July 2017
Lynparza
MSD
Global
●    Initial $1.0bn revenue
●    Up to $0.75bn for certain licence options, including $0.25bn paid in Q4 2017
●    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
March 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
August 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
October 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
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 Notes 6 and 7.
 
Therapy Area
Medicine
FY 2017
Q4 2017
$m
 
% of total*
 
% change
 
$m
 
% of total
 
% change
 
Actual
 
CER
 
Actual
 
CER
 
Oncology
 
Tagrisso
 
955
 
5
 
126
 
126
 
304
 
6
 
107
 
105
 
Iressa
 
528
 
3
 
3
 
3
 
130
 
2
 
10
 
8
 
Lynparza
 
297
 
1
 
36
 
35
 
100
 
2
 
61
 
58
 
Imfinzi
 
19
 
-
 
n/m
 
n/m
 
18
 
-
 
n/m
 
n/m
 
Calquence
 
3
 
-
 
n/m
 
n/m
 
3
 
-
 
n/m
 
n/m
 
Legacy:
 
 
 
 
 
 
 
 
 
Faslodex
 
941
 
5
 
13
 
13
 
238
 
4
 
7
 
5
 
Zoladex
 
735
 
4
 
(10)
 
(9)
 
187
 
3
 
(20)
 
(21)
 
Casodex
 
215
 
1
 
(13)
 
(11)
 
54
 
1
 
(10)
 
(8)
 
Arimidex
 
217
 
1
 
(6)
 
(4)
 
57
 
1
 
-
 
(2)
 
Others
 
114
 
-
 
10
 
13
 
29
 
1
 
-
 
3
 
Total Oncology
 
4,024
 
20
 
19
 
19
 
1,120
 
20
 
20
 
19
 
CVMD
 
 
 
Brilinta
 
1,079
 
5
 
29
 
29
 
299
 
5
 
27
 
24
 
Farxiga
 
1,074
 
5
 
29
 
28
 
332
 
6
 
39
 
37
 
Onglyza
 
611
 
3
 
(15)
 
(16)
 
180
 
3
 
21
 
19
 
Bydureon
 
574
 
3
 
(1)
 
(1)
 
147
 
3
 
4
 
2
 
Byetta
 
176
 
1
 
(31)
 
(30)
 
48
 
1
 
(13)
 
(13)
 
Symlin
 
48
 
-
 
20
 
20
 
13
 
-
 
-
 
-
 
Qtern
 
5
 
-
 
n/m
 
n/m
 
5
 
-
 
n/m
 
n/m
 
Legacy:
 
 
 
 
 
 
 
 
 
Crestor
 
2,365
 
12
 
(30)
 
(30)
 
594
 
11
 
(6)
 
(7)
 
Seloken/Toprol-XL
 
695
 
3
 
(6)
 
(4)
 
168
 
3
 
(6)
 
(7)
 
Atacand
 
300
 
1
 
(5)
 
(3)
 
73
 
1
 
(10)
 
(10)
 
Others
 
339
 
2
 
(15)
 
(13)
 
80
 
1
 
(8)
 
(10)
 
Total CVMD
 
7,266
 
36
 
(10)
 
(10)
 
1,939
 
35
 
7
 
6
 
Respiratory
 
Symbicort
 
2,803
 
14
 
(6)
 
(6)
 
752
 
14
 
2
 
-
 
Pulmicort
 
1,176
 
6
 
11
 
12
 
371
 
7
 
29
 
26
 
Daliresp/Daxas
 
198
 
1
 
29
 
28
 
53
 
1
 
29
 
27
 
Tudorza/Eklira
 
150
 
1
 
(12)
 
(12)
 
42
 
1
 
17
 
11
 
Duaklir
 
79
 
-
 
25
 
25
 
23
 
-
 
21
 
16
 
Bevespi
 
16
 
-
 
n/m
 
n/m
 
8
 
-
 
n/m
 
n/m
 
Others
 
284
 
1
 
(10)
 
(9)
 
85
 
2
 
1
 
(2)
 
Total Respiratory
 
4,706
 
23
 
(1)
 
(1)
 
1,334
 
24
 
10
 
8
 
Other
 
Nexium
1,952
10
(4)
(3)
427
8
(13)
(12)
Synagis
 
687
3
1
1
234
 
4
 
(23)
 
(23)
 
Losec/Prilosec
 
271
1
(2)
(1)
69
 
1
 
17
 
14
 
Seroquel XR
 
332
2
(55)
(55)
108
 
2
 
(8)
 
(9)
 
Movantik/Moventig
 
122
1
34
34
30
 
1
 
15
 
15
 
FluMist/Fluenz
 
78
-
(25)
(28)
58
 
1
 
(13)
 
(18)
 
Others
 
714
4
(38)
(38)
168
 
3
 
(32)
 
(33)
 
Total Other
 
4,156
21
(18)
(17)
1,094
 
20
 
(16)
 
(17)
 
 
Total
Product Sales
 
20,152
100
(5)
(5)
5,487
 
100
 
4
 
3
 
 
*Due to rounding, the sum of individual medicine percentages may not agree to totals.
 
Product Sales Summary
_______________________________________________________________________________________
ONCOLOGY
Product Sales of $4,024m; an increase of 19%. Oncology Product Sales represented 20% of total Product Sales, up from 16% in FY 2016.
 
Lung Cancer
Tagrisso
Product Sales of $955m; an increase of 126%. In the year, the medicine became AstraZeneca's largest-selling Oncology medicine and, by the end of 2017, the medicine had received regulatory approval in more than 60 countries. Global growth partly reflected higher testing rates, led by Japan and the US.
Sales in the US were $405m and grew by 59%, with a steady increase in epidermal growth factor receptor (EGFR) T790M-mutation testing rates. In September 2017, US National Comprehensive Cancer Network (NCCN) clinical-practice guidelines were updated to include the use of Tagrisso as a 1st-line treatment of patients with metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The use of Tagrisso in this indication is not yet approved by the US FDA.
Within Emerging Markets, Tagrisso sales were $135m in the year (FY 2016: $10m). In Europe, sales of $187m represented growth of 146% (142% at CER) and were driven by a continued uptake, positive reimbursement decisions and further growth in testing rates. Tagrisso was reimbursed in 15 European countries at the end of the year and was under reimbursement review in additional European countries, with positive decisions anticipated in 2018.
Testing rates in Japan continued to exceed 90%, with full-year sales of $219m (FY 2016: $82m) reflecting a high penetration rate in the currently-approved 2nd-line EGFR T790M-mutation setting.
 
Iressa
Product Sales of $528m; an increase of 3%.
Emerging Markets sales increased by 8% to $251m. China Product Sales increased by 24% (28% at CER) to $144m, reflecting an improvement in patient access following the conclusion of the national negotiation process in 2016; Iressa was subsequently included on the National Reimbursement Drug List (NRDL). Other Emerging Markets sales, however, were adversely impacted by competition from branded and generic medicines, most notably in the Republic of Korea.
Sales in the US increased by 70% to $39m and declined in Europe by 7% (8% at CER) to $112m. Given the significant future potential of Tagrisso, the Company continues to prioritise commercial support for Tagrisso in established markets over Iressa.
 
Other Cancers
Lynparza
Product Sales of $297m; an increase of 36% (35% at CER). By the end of 2017, the medicine had received regulatory approval in 57 countries, with reviews underway in a number of additional markets.
US sales grew by 11% in the year to $141m. First-half sales were adversely impacted by the introduction of competing poly ADP ribose polymerase (PARP)-inhibitor medicines. A much-improved performance in the second half, however, reflected the launch of Lynparza tablets for patients regardless of BRCA-mutation status, for the treatment of 2nd-line ovarian cancer. This was illustrated by sequential quarterly US sales from Q3 2017 to Q4 2017, where sales grew by 46%, from $37m to $54m. By the end of November 2017, Lynparza was the leading PARP inhibitor in the US, measured by total prescription volumes.
Sales in Europe increased by 60% (58% at CER) to $130m, reflecting high BRCA-testing rates and a number of successful launches, most recently in Finland and the Republic of Ireland.
On 27 July 2017, AstraZeneca and MSD announced a global strategic oncology collaboration to co-develop Lynparza and the potential medicine selumetinib for multiple cancer types as monotherapies and in combinations. The integration of development and commercial activities is progressing well.
Imfinzi
Product Sales of $19m ($18m in Q4 2017); launched in the US in May 2017. By the end of 2017, Imfinzi had also received regulatory approvals in Canada, Brazil and Israel.
Imfinzi was approved under the US FDA's Accelerated-Approval pathway and launched on the same day as a fast-to-market, limited commercial opportunity, indicated for the 2nd-line treatment of patients with locally-advanced or metastatic urothelial carcinoma (bladder cancer).
The Company is actively preparing for the potential launch of Imfinzi in locally-advanced, unresectable NSCLC in H1 2018, reflecting the US FDA regulatory submission acceptance and the award of Priority Review status in the quarter.
Calquence
Product Sales of $3m. Approved and launched in the US on 31 October 2017, Calquence delivered a promising performance in the number of new-patient starts in previously-treated mantle cell lymphoma (MCL). The medicine was included within NCCN MCL guidelines on 15 November 2017.
Legacy: Faslodex
Product Sales of $941m; an increase of 13%.
Emerging Markets sales grew by 20% (18% at CER) to $115m. In 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 29% in the year (14% at CER) to $18m.
US sales increased by 12% to $492m, 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 12% (11% at CER) to $256m but increased by only 5% (down by 3% at CER) to $62m in the quarter, reflecting the impact of generic entrants in certain markets. In June 2017, a label extension based upon the FALCON trial in the 1st-line setting was approved in Japan, where sales grew by 14% (17% at CER) in the year to $72m.
Legacy: Zoladex
Product Sales of $735m; a decline of 10% (9% at CER).
Emerging Markets sales declined by 1% to $353m in the year. Sales in Europe declined by 10% (8% at CER) to $141m, reflecting the impact of generic competition, mainly in Central and Eastern Europe. In Established Rest Of World (ROW, comprising Japan, Canada, Australia and New Zealand), sales fell by 16% (15% at CER) to $226m, driven by increased competition. On 31 March 2017, the Company completed an agreement with TerSera for the sale of the commercial rights to Zoladex in the US and Canada.
CVMD
Product Sales of $7,266m; a decline of 10%. CVMD Product Sales represented 36% of total Product Sales, down from 38% in FY 2016.
Within the New CVMD Growth Platform, comprising Brilinta and Diabetes and excluding medicines such as Crestor, sales grew by 9% to $3,567m. Strong performances were delivered by Farxiga and Brilinta, each becoming blockbusters by exceeding $1bn in sales in the year.
 
Brilinta 
Product Sales of $1,079m; an increase of 29%.
Emerging Markets sales of Brilinta in the year grew by 19% (21% at CER) to $224m. Growth in Emerging Markets was reflected in a continued outperformance of growth in the oral anti-platelet market. Encouraging sales performances were delivered in many markets.
US sales of Brilinta, at $509m, represented an increase of 46% for the full year, including growth of 47% in the quarter. The performance was driven primarily by an increase in the average duration of therapy and strong growth in the number of patients sent home from hospital with Brilinta. Furthermore, Brilinta achieved a record total-prescription market share of 7.2% at the end of the year; days-of-therapy volume market-share data was particularly encouraging. The performance reflected the growth in demand that was partly supported 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 is the standard of care in the treatment of ST-segment elevation myocardial infarction (STEMI) and remained the branded oral anti-platelet market leader in the US in the period.
Sales of Brilique in Europe increased by 14% (13% at CER) to $295m, reflecting indication leadership across a number of markets and bolstered by the inclusion in high-risk, post myocardial infarction (HR PMI) guidelines from the European Society of Cardiology in 2017. Volume share reached 6.5% at the end of the year, with improvements delivered across the major markets; Brilique continued to outperform the oral anti-platelet market in the year. Brilique gained further reimbursement in key markets in its HR PMI indication with the 60mg dose.
 
Farxiga
Product Sales of $1,074m; an increase of 29% (28% at CER), consolidating its global leadership position within the sodium-glucose co-transporter 2 (SGLT2) inhibitor class.
Emerging Markets sales increased by 74% (73% at CER) to $232m, reflecting ongoing launches and improved levels of patient access. In March 2017, Forxiga became the first SGLT2-inhibitor medicine to be approved in China.
US sales in the year increased by 7% to $489m. The first-half performance, with a sales decline of 1% to $206m, was adversely impacted by the Company's level of participation in affordability programmes. Significant changes to the Company's approach to these programmes, however, saw a much-improved performance in the second half, illustrated by Q4 2017 sales growth of 15% to $150m. SGLT2-class growth was supported by growing evidence around cardiovascular (CV) benefits, including data from the CVD-REAL study that was published in March 2017.
Sales in Europe increased by 29% (28% at CER) to $242m as the medicine continued to gain market share in the innovative oral class; it also retained leadership in the SGLT2 class, which had the strongest class growth amongst innovative oral diabetes medicines in the year. In Japan, where Ono Pharmaceutical Co., Ltd is a partner and records in-market sales, sales to the partner amounted to $53m, representing a growth of 89% (93% at CER).
 
Onglyza 
Product Sales of $611m in the year, a decline of 15% (16% at CER). Onglyza sales, however, grew by 21% in Q4 2017 (19% at CER) to $180m. The performance in the latter period partly reflected favourable true-up adjustments relating to the first nine months of 2017 in the US, as well as an encouraging performance in Emerging Markets. Given the significant future potential of Farxiga, the Company continues to prioritise its commercial support over Onglyza.
The full-year performance reflected adverse pressures on the dipeptidyl peptidase-4 (DPP-4) class and an acceleration of ongoing Diabetes market dynamics, where patients are moving to medicines and classes of medicines with documented CV benefits.
Sales in Emerging Markets declined by 8% (10% at CER) to $130m. Onglyza, however, entered the NRDL in China in the year, underpinning Q4 2017 Emerging Markets sales growth of 16% (13% at CER) in the quarter to $37m. Sales in Europe in the year declined by 21% to $104m, reflecting the broader dynamic of shift away from the DPP-4 class. In Japan, in-market sales are recorded by Kyowa Hakko Kirin Co., Ltd, to whom sales totalled $13m.
 
Bydureon
Product Sales of $574m; a decline of 1%, driven by pricing pressures. Favourable sales volumes were a result of continued growth in the glucagon-like peptide-1 (GLP-1) class at the expense of insulin.
Sales of Bydureon in Emerging Markets were $9m. In 2016, AstraZeneca entered a strategic collaboration with 3SBio for the rights to commercialise Bydureon in China as the Company focused on its oral Diabetes strategy.
Sales in the US declined by 1% to $458m, reflecting the level of competition and resulting price pressures. US sales in the quarter grew by 1% to $115m, partly reflecting market growth and the impact of the aforementioned true-up sales adjustments. In the third quarter of the year, the Company successfully launched the injectable suspension autoinjector, known as Bydureon BCise in the US. The new autoinjector is a new formulation of Bydureon injectable suspension in an improved once-weekly, single-dose autoinjector device. It is designed for patient convenience in a pre-filled device with a pre-attached, hidden needle.
Bydureon sales in Europe declined by 12% (11% at CER) in the year to $88m, resulting from the impact of increased levels of competition.
 
Legacy: Crestor
Product Sales of $2,365m; a decline of 30%.
Sales in China grew by 20% (23% at CER) to $373m. In the US, sales declined by 70% to $373m, driven by the market entry in July 2016 of multiple Crestor generic medicines. In the quarter, US sales increased by 34% to $127m, benefitting from true-up adjustments. In Europe, sales declined by 23% to $666m; in Q4 2017, Europe sales of Crestor declined by 27% (32% at CER) to $152m, reflecting the impact of generic medicines in certain markets, such as France and Spain. This impact on Europe sales is anticipated to continue in FY 2018.
In Japan, where Shionogi Co. Ltd is a partner, Crestor maintained its position as the leading statin, despite sales declining by 6% (4% at CER) to $489m. This decline reflected the recent entry of multiple Crestor competitors in the market in the latter stages of the year.
 
RESPIRATORY
Product Sales of $4,706m; a decline of 1%. Respiratory Product Sales represented 23% of total Product Sales, from 22% in FY 2016.
Symbicort
Product Sales of $2,803m; a decline of 6%. In Q4 2017, sales increased by 2% (stable at CER) to $752m, partly reflecting the aforementioned favourable true-up adjustments relating to the first nine months of 2017 in the US.
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 9% (10% at CER) to $439m, partly reflecting growth in China of 13% (17% at CER) to $177m and in Latin America (ex-Brazil), where sales grew by 24% (30% at CER) to $46m.
In contrast, US sales declined by 12% to $1,099m, in line with expectations of continued challenging market 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. Symbicort sales in the US in the quarter grew by 1% to $288m, driven by market growth, the impact of the aforementioned true-up sales adjustments and increased demand in government and non-retail channels.
In Europe, sales declined by 10% to $819m, reflecting the level of competition from other branded and Symbicort-analogue medicines. Symbicort, however, continued to retain its class-leadership position and stabilise its volume market share in the LABA/ICS class.
In Japan, where Astellas Pharma Co. Ltd assists as a promotional partner, sales declined by 3% (stable at CER) to $205m.
 
Pulmicort 
Product Sales of $1,176m; an increase of 11% (12% at CER).
Emerging Markets sales increased by 20% (23% at CER) to $840m, reflecting strong underlying volume growth, with sales in China, Middle East and North Africa proving particularly encouraging. Emerging Markets represented 71% of global sales and, in the quarter, sales increased by 37% (34% at CER), reflecting a significant level of seasonal demand. Usage in China progressed further, with an increasing prevalence of acute COPD and paediatric asthma accompanied by continued investment by the Company in new hospital nebulisation centres by around 2,000 to 15,000.
Sales in the US and Europe declined by 10% to $156m and by 7% (8% at CER) to $92m, respectively.
 
Daliresp/Daxas
Product Sales of $198m; an increase of 29% (28% at CER).
US sales, representing 84% of global sales, increased by 25% to $167m, driven by increased adoption of the medicine which is the only oral, selective, long-acting inhibitor of the enzyme phosphodiesterase-4, an inflammatory agent in COPD. Sales in Europe increased by 73% to $26m.
 
Tudorza/Eklira
Product Sales of $150m; a decline of 12%.
Sales in the US declined by 14% to $66m, reflecting lower levels of use of inhaled monotherapy medicines for COPD and the Company's commercial focus on the launch of Bevespi. 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 and, in the quarter, sales increased by 19% to $19m. AstraZeneca books Product Sales of Tudorza in the US.
Sales in Europe declined by 12% (11% at CER) to $73m, impacted by the decline of the overall LAMA monotherapy class.
 
Duaklir
Product Sales of $79m; an increase of 25%.
Duaklir, the Company's first inhaled dual bronchodilator, is now available for patients in over 25 countries, with almost all sales emanating from Europe. The growth in sales in the year was favourably impacted by the performances in Germany and the UK, as well as the recent launch in Italy. The LAMA/LABA class continued to grow strongly, albeit below expectations. 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 $16m; launched in early 2017. Q4 2017 sales of $8m.
Bevespi was launched commercially in the US during early 2017. Prescriptions in the period tracked in line with other LAMA/LABA launches. The overall class in the US, however, continued to grow more slowly than anticipated. Bevespi was the first medicine launched using the Company's Aerosphere Delivery Technology delivered in a pressurised metered-dose inhaler.
 
OTHER
Product Sales of $4,156m; a decline of 18% (17% at CER). Other Product Sales represented 21% of total Product Sales, down from 24% in FY 2016.
 
Nexium 
Product Sales of $1,952m; a decline of 4% (3% at CER).
Emerging Markets sales declined by 1% (up 2% at CER) to $684m. Sales in the US declined by 10% to $499m in the year and by 58% in the quarter to $57m, reflecting a true-up adjustment. Sales in Europe declined by 1% (3% at CER) in the year to $248m. In Japan, where Daiichi Sankyo is a partner, sales increased by 1% (4% at CER) to $439m.
 
Synagis 
Product Sales of $687m; an increase of 1%.
US sales decreased by 2% to $317m, constrained by the guidelines from the American Academy of Pediatrics Committee on Infectious Diseases, which restricted 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 5% to $370m.
 
Seroquel XR
Product Sales of $332m; a decline of 55%.
Sales of Seroquel XR in the US, where several competitors launched generic Seroquel XR medicines from November 2016, declined by 66% to $175m. Sales of Seroquel XR in Europe declined by 42% to $78m, also reflecting the impact of generic-medicine competition.
 
FluMist/Fluenz
Product Sales of $78m; a decline of 25% (28% at CER).
No US sales of FluMist were recorded in the quarter due to the continued absence of a recommendation for use by the US Advisory Committee on Immunization Practices (ACIP) during the 2017-2018 influenza season. FluMist continues to be recommended for use outside the US. Sales in Europe increased by 17% (12% at CER) to $76m, driven primarily by higher usage rates in the UK, which reflected the favourable impact of the UK National Immunisation Programme.
 
 
Regional Product Sales

 
 
FY 2017
Q4 2017
$m
% of total1
% change
$m
% of total
% change
Actual
CER
Actual
CER
Emerging Markets2
6,149
31
6
8
1,630
30
10
9
 
China
2,955
15
12
15
813
15
33
30
 
Ex. China
3,194
16
1
2
817
15
(7)
(6)
 
 
 
 
 
 
 
 
 
US
6,169
31
(16)
(16)
1,770
32
9
9
 
 
 
 
 
 
 
 
 
Europe
4,753
24
(6)
(7)
1,293
24
(3)
(9)
 
 
 
 
 
 
 
 
 
Established ROW
3,081
15
-
1
794
14
(4)
-
 
Japan
2,208
11
1
4
563
10
(5)
2
 
Canada
484
2
(3)
(5)
131
2
4
(2)
 
Other
Established ROW
389
2
(6)
(9)
100
2
(7)
(8)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total
20,152
100
(5)
(5)
5,487
100
4
3
 
1Due to rounding, the sum of individual medicine percentages may not agree to totals.
2Emerging Markets comprises all remaining Rest of World markets, including Brazil, China, India, Mexico, Russia and Turkey.
 
Emerging Markets
Product Sales of $6,149m; an increase of 6% (8% at CER).
China sales grew by 12% (15% at CER) to $2,955m, representing 48% of total Emerging Markets sales. Onglyza and Iressa were included on the NRDL in China in the year, as were Brilinta, Faslodex and Seroquel XR; the benefits of this inclusion are anticipated to favourably impact Product Sales after FY 2017. 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. In the quarter, China sales grew strongly by 33% (30% at CER), reflecting strong performances from newly-launched medicines. Tagrisso was launched in China in April 2017.
Emerging Markets sales excluding China, however, declined by 7% (6% at CER) in Q4 2017, primarily driven by challenging conditions in Russia and Latin America, as well as the adverse impact of medicines externalised or disposed of in FY 2017. Sales in Latin America (ex-Brazil) declined by 12% (10% at CER) to $453m. Brazil sales increased by 4% (but declined by 5% at CER) to $361m. Russia sales declined by 1% (14% at CER) to $231m. Sales of Symbicort grew by 9% (10% at CER) to $439m, reflecting higher prescription demand, with notable performances in Latin America and China.
 
US
Product Sales of $6,169m; a decline of 16%. Q4 2017 sales in the US grew by 9% to $1,770m, partly reflecting favourable true-up adjustments relating to the first nine months of 2017.
The decline in sales in the year 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 12% to $1,099m.
The New Oncology Growth Platform in the US grew by 50% to $607m, primarily driven by encouraging Tagrisso sales growth of 59% to $405m in the year (FY 2016: $254m). Brilinta sales grew by 46% in the US to $509m. The New CVMD Growth Platform increased sales by 5% in the US to $1,942m, reflecting strong performances from Farxiga and Brilinta.
 
Europe
Product Sales of $4,753m; a decline of 6% (7% at CER).
The New Oncology Growth Platform in Europe grew by 102% (99% at CER) to $317m, partly driven by Tagrisso sales of $187m. Lynparza sales of $130m represented growth of 60% (58% at CER). Forxiga sales growth of 29% (28% at CER) to $242m was accompanied by Brilique growth of 14% (13% at CER) to $295m. These performances were more than offset by declines in other areas, however, including a 10% decline in Symbicort sales to $819m. Symbicort maintained its position, however, as the number one ICS/LABA medicine, despite competition from branded and analogue medicines. Crestor sales declined by 23% to $666m, reflecting the entry of generic medicines in certain markets in the year.
 
Established ROW
Product Sales of $3,081m; stable (up 1% at CER).
Japan sales increased by 1% (4% at CER) to $2,208m. EGFR T790M-mutation testing rates in Japan continued to exceed 90% through the year, with full-year Tagrisso sales of $219m (FY 2016: $82m) reflecting a high penetration rate in the currently-approved 2nd-line setting. Faslodex sales in Japan were favourably impacted by a new label in the year; Faslodex sales in Japan increased by 14% (17% at CER) to $72m.
The first generic competitor to Crestor was launched in Japan in Q3 2017 and further generic competition entered the market in the final quarter. Full-year Crestor sales in Japan declined by 6% (4% at CER) to $489m; in the quarter, they declined by 26% (21% at CER) to $95m. Nexium sales in Japan increased by 1% (4% at CER) in the year to $439m and sales of Forxiga increased by 89% (93% at CER) in the year to $53m.
 
 
Financial Performance
 

 
 
 
Reported
FY 2017
FY 2016
Actual
CER
$m
$m
% change
Total Revenue
22,465
23,002
(2)
(2)
Product Sales
20,152
21,319
(5)
(5)
Externalisation Revenue
2,313
1,683
37
38





Cost of Sales
(4,318)
(4,126)
5
7
\




Gross Profit
18,147
18,876
(4)
(4)
Gross Margin*
79.6%
80.8%
-1
-1

 
 
 
 
Distribution Expense
(310)
(326)
(5)
(3)
% Total Revenue
1.4%
1.4%
-
-
R&D Expense
(5,757)
(5,890)
(2)
(1)
% Total Revenue
25.6%
25.6%
-
-
SG&A Expense
(10,233)
(9,413)
9
10
% Total Revenue
45.5%
40.9%
-5
-5
Other Operating Income and Expense
1,830
1,655
11
11
% Total Revenue
8.1%
7.2%
+1
+1
 
 
 
 
 
Operating Profit
3,677
4,902
(25)
(28)
% Total Revenue
16.4%
21.3%
-5
-6
Net Finance Expense
(1,395)
(1,317)
6
(4)
Joint Ventures and Associates
(55)
(33)
66
66
Profit Before Tax
2,227
3,552
(37)
(38)
Taxation
641
(146)
 
 
Tax Rate
(29)%
4%
 
 
Profit After Tax
2,868
3,406
(16)
(16)
 
 
 
 
 
Earnings Per Share
$2.37
$2.77
(14)
(15)
            *Gross Margin, as a percentage of Product Sales, reflects Gross Profit derived from Product Sales, divided by Product Sales.
            FY 2017 Cost of Sales included $198m of costs relating to externalisation activities, which is excluded from the calculation of Gross Margin (FY 2016: $32m). Movements in Gross Margin are expressed in percentage points.


 
 
Reported
Q4 2017
Q4 2016
Actual
CER
$m
$m
% change
Total Revenue
5,777
5,585
3
2
Product Sales
5,487
5,260
4
3
Externalisation Revenue
290
325
(11)
(12)





Cost of Sales
(1,225)
(1,160)
6
2
\




Gross Profit
4,552
4,425
3
2
Gross Margin*
77.6%
77.9%
-
-

 
 
 
 
Distribution Expense
(85)
(83)
3
-
% Total Revenue
1.5%
1.5%
-
-
R&D Expense
(1,551)
(1,543)
-
(2)
% Total Revenue
26.8%
27.6%
+1
+1
SG&A Expense
(3,078)
(1,386)
n/m
n/m
% Total Revenue
53.3%
24.8%
-28
-28
Other Operating Income and Expense
848
1,120
(24)
(25)
% Total Revenue
14.7%
20.1%
-5
-5
 
 
 
 
 
Operating Profit
686
2,533
(73)
(71)
% Total Revenue
11.9%
45.4%
-33
-32
Net Finance Expense
(267)
(339)
(21)
(27)
Joint Ventures and Associates
(12)
(11)
19
19
Profit Before Tax
407
2,183
(81)
(78)
Taxation
854
(366)
 
 
Tax Rate
(210)%
17%
 
 
Profit After Tax
1,261
1,817
(31)
(25)
 
 
 
 
 
Earnings Per Share
$1.03
$1.46
(29)
(24)
            *Gross Margin, as a percentage of Product Sales, reflects Gross Profit derived from Product Sales, divided by Product Sales.
            Q4 2017 Cost of Sales included $2m of income relating to externalisation activities (Q4 2016: $nil), which is excluded from the calculation of Gross Margin. Movements in Gross Margin are expressed in percentage points.
 
            Reconciliation of Reported Profit Before Tax to EBITDA>
 
FY 2017
Q4 2017
 
$m
% change
$m
% change
Actual
CER
Actual
CER
Reported Profit Before Tax
2,227
(37)
(38)
407
(81)
(78)
Net Finance Expense
1,395
6
(4)
267
(21)
(27)
Joint Ventures and Associates
55
66
66
12
19
19
Depreciation, Amortisation and Impairment
3,036
29
29
1,107
88
81
 
 
 
 
 
 
 
EBITDA*
6,713
(8)
(10)
1,793
(43)
(42)
            *EBITDA is a non-GAAP financial measure. See the Operating and Financial Review for a definition of EBITDA.          
            Reconciliation of Reported to Core Financial Measures>
FY 2017
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core2
Core
Actual
CER
$m
$m
$m
$m
$m
$m
% change
Gross Profit
18,147
181
149
-
-
18,477
(3)
(3)
Gross Margin3
79.6%
-
-
-
-
81.2%
-1
-1









Distribution Expense
(310)
-
-
-
-
(310)
(5)
(3)
R&D Expense
(5,757)
201
144
-
-
(5,412)
(4)
(3)
SG&A Expense
(10,233)
347
1,469
641
(77)
(7,853)
(4)
(3)
Other Operating Income and Expense
1,830
78
45
-
-
1,953
14
14









Operating Profit
3,677
807
1,807
641
(77)
6,855
2
-
% Total Revenue
16.4%
-
-
-
-
30.5%
+1
+1









Net Finance Expense
(1,395)
-
-
313
432
(650)
(2)
(4)









Taxation
641
(169)
(453)
(198)
(681)
(860)
31
23









Earnings Per Share
$2.37
$0.50
$1.07
$0.60
$(0.26)
$4.28
(1)
(2)
            1Other adjustments include fair value adjustments relating to contingent consideration on business combinations (see Note 4), discount unwind on acquisition-related liabilities (see Note 4), provision charges related to certain legal matters (see Note 5), foreign-exchange gains and losses relating to the classification of certain non-structural intra-group loans and a one-off adjustment of $617m reflecting adjustments to             deferred taxes in line with the recently reduced US federal income tax rate.
            2Each of the measures in the Core column in the above table are non-GAAP financial measures. See the Operating and Financial Review for related definitions.
           3Gross Margin, as a percentage of Product Sales, reflects gross profit derived from Product Sales, divided by Product Sales. FY 2017 Cost of Sales included $198m of costs relating to externalisation activities (FY 2016: $32m), which is excluded from the calculation of Gross Margin. Movements in Gross Margin are expressed in percentage points.
 
Q4 2017
Reported
Restructuring
Intangible Asset
Amortisation & Impairments
Diabetes Alliance
Other1
Core2
Core
Actual
CER
$m
$m
$m
$m
$m
$m
% change
Gross Profit
4,552
53
46
-
-
4,651
3
3
Gross Margin3
77.6%
-
-
-
-
79.4%
-
+1









Distribution Expense
(85)
-
-
-
-
(85)
3
-
R&D Expense
(1,551)
24
71
-
-
(1,456)
(2)
(4)
SG&A Expense
(3,078)
82
696
406
(281)
(2,175)
6
5
Other Operating Income and Expense
848
3
1
-
-
852
(25)
(26)









Operating Profit
686
162
814
406
(281)
1,787
(12)
(11)
% Total Revenue
11.9%
-
-
-
-
30.9%
-5
-5









Net Finance Expense
(267)
-
-
79
64
(124)
(28)
(31)









Taxation
854
(34)
(213)
(54)
(595)
(42)
(87)
(100)









Earnings Per Share
$1.03
$0.10
$0.48
$0.34
$(0.65)
$1.30
7
13
        1Other adjustments include fair value adjustments relating to contingent consideration on business combinations (see Note 4), discount unwind on acquisition-related liabilities (see Note 4), provision charges related to certain legal matters (see Note 5), foreign-exchange gains and losses relating to the classification of certain non-structural intra-group loans and a one-off adjustment of $617m reflecting adjustments to             deferred taxes in line with the recently reduced US federal income tax rate.
       2Each of the measures in the Core column in the above table are non-GAAP financial measures. See the Operating and Financial Review for related definitions.
       3Gross Margin, as a percentage of Product Sales, reflects gross profit derived from Product Sales, divided by Product Sales. Q4 2017 Cost of Sales included $2m of income relating to externalisation activities (Q4 2016: $nil), 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
 
Gross Profit
Reported Gross Profit declined by 4% to $18,147m; Core Gross Profit declined by 3% to $18,477m, one percentage point more than the Total Revenue decline. Externalisation Revenue of $2,313m included $1,247m received as part of the Lynparza and selumetinib collaboration with MSD. This was outweighed by the adverse impact of product mix, the ramp-up of manufacturing capacity for new medicines and the inclusion of the profit-share on the aforementioned collaboration.
The calculation of Reported and Core Gross Margin excludes the impact of Externalisation Revenue, thereby reflecting the underlying performance of Product Sales. The Reported Gross Margin declined by one percentage point to 79.6%. The Core Gross Margin declined by one percentage point to 81.2%. The declines were primarily driven by the effect of losses of exclusivity on higher-margin Crestor and Seroquel XR, as well as the factors mentioned above.
In the quarter, the Reported Gross Margin was stable at 77.6%; the Core Gross Margin was stable (increased by one percentage point at CER) to 79.4%.
 
Operating Expenses: R&D
Reported R&D costs declined by 2% (1% at CER) to $5,757m, with the Company continuing to focus on resource prioritisation and cost discipline. Core R&D costs declined by 4% (3% at CER) to $5,412m. The movement vs. the prior year was in line with commitments made in February 2017.
 
Operating Expenses: SG&A
Reported SG&A costs increased by 9% (10% at CER) to $10,233m in the year and by 122% (119% at CER) to $3,078m in the quarter. This reflected the impact of fair-value adjustments to contingent consideration on business combinations in the comparative period and, to a lesser extent, impairment charges recorded in the quarter.
Core SG&A costs declined by 4% (3% at CER) to $7,853m. This was in line with commitments made in February 2017 and despite strategic investment in new launches.
Core SG&A costs in the quarter increased by 6% (5% at CER) to $2,175m. This reflected the aforementioned increased investment, including in medical-affairs capability and capacity in order to support the launches and early-stage commercialisation phases of specialty-care medicines such as Tagrisso, Imfinzi, Lynparza and Fasenra. SG&A general infrastructure costs declined in the quarter as the Company maintained its focus on cost discipline. The Company booked a one-time gain of $92m in the quarter following adjustments to its retirement benefit plans in the US.
In the year, the Company continued to consolidate its operations that support the business. It is committed to driving simplification and standardisation through targeted centralisation of back and middle office activities that are currently performed in various enabling units, including Finance, Compliance, HR, Procurement and IT. As a result, underlying operational-infrastructure costs were consistently reduced, in line with prior trends. The recently-launched Global Business Services organisation provides integration of governance, locations and business practices to 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 11% in the year to $1,830m and included:
        ● $555m resulting from the sale of remaining rights to the anaesthetics portfolio to Aspen
        ● $301m resulting from the sale of rights to Seloken in Europe to Recordati S.p.A (Recordati)
        ● $175m of milestone receipts in relation to the disposal of Zavicefta to Pfizer Inc.
        ● $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
        ● Other gains on disposal of intangible assets
Core Other Operating Income and Expense increased by 14% to $1,953m, 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 declined by 25% (28% at CER) in the year to $3,677m. In the quarter, Reported Operating Profit declined by 73% (71% at CER) to $686m, driven by higher Other Operating Income and Expense in Q4 2016. The Reported Operating Profit margin declined by five percentage points (six percentage points at CER) to 16% of Total Revenue. Core Operating Profit increased by 2% (stable at CER) to $6,855m. The Core Operating Profit margin increased by one percentage point to 31% of Total Revenue.
Brexit Planning
Following the UK referendum outcome of a decision for the UK to leave the European Union (EU) in June 2016, the progress of current negotiations between the UK Government and the EU will likely determine the future terms of the UK's relationship with the EU, as well as to what extent the UK will be able to continue to benefit from the EU's single market and its regulatory frameworks.
In response to this, the Company has taken the decision to implement certain actions to mitigate the potential risk of disruption to the supply of medicines including but not limited to duplication of release testing and procedures for products based in the EU27 and the UK, transfer of regulatory licenses, customs and duties set up for introduction or amendment of existing tariffs or processes and associated IT systems upgrades. The costs associated with this and certain other actions directly related to Brexit will be charged as restructuring with the majority of such costs expected to be cash costs. However, until the Brexit negotiation process is completed, it is difficult to anticipate the overall potential impact on AstraZeneca's operations and hence the final expected costs to be incurred.
Net Finance Expense
Reported Net Finance Expense increased by 6% in the year to $1,395m, primarily reflecting a foreign-exchange impact relating to the classification of certain non-structural intra-group loans. Reported Net Finance Expense declined by 4% at CER, reflecting reduced levels of discount unwind on acquisition-related liabilities resulting from the diabetes alliance with Bristol-Myers Squibb Company (BMS). Excluding the discount unwind on acquisition-related liabilities and the adverse foreign-exchange impact, the Core Net Finance Expense declined by 2% (4% at CER) to $650m.
Profit Before Tax
Reported Profit Before Tax declined by 37% (38% at CER) to $2,227m, reflecting the lower Reported Gross Margin and an increase in Reported SG&A costs. EBITDA declined by 8% (10% at CER) to $6,713m.
Taxation
The Reported Tax Rate of (29)% in the year benefitted from a favourable net adjustment of $617m to deferred taxes, reflecting the recently reduced US federal income tax rate and non-taxable remeasurements of acquisition-related liabilities. Additionally, there was a $321m benefit in the final quarter to the Reported and Core Tax Rates, reflecting:
          ● reductions in tax provisions and provision to return adjustments, reflecting:
                − the expiry of statute of limitations
                − favourable progress of discussions with tax authorities
          ● the recognition of previously unrecognised tax losses
          ● the favourable impact of UK Patent box profits
The Core Tax Rate for the year was 14%. Excluding these benefits, both the Reported and Core Tax Rates would have been 22%. The net cash tax paid for the year was $454m, representing 20% of Reported Profit Before Tax.
The Reported and Core Tax Rates for the comparative period were 4% and 11% 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 period from 2004-2016. Excluding this effect, the Reported and Core Tax Rates for the comparative period were 17% and 18% respectively. The cash tax paid for the comparative period was $412m, which was 12% of Reported Profit Before Tax.
Earnings Per Share (EPS)
Reported EPS of $2.37 represented a decline of 14% (15% at CER) in the year. The performance was driven by a decline in Total Revenue and increased SG&A costs, partly offset by the aforementioned net tax benefit, continued progress on R&D cost control and an increase in Other Operating Income and Expense. Core EPS declined by 1% (2% at CER) to $4.28.
Dividend Per Share and Dividend Commitment
The Board has declared a second interim dividend of $1.90 per share (133.6 pence, 14.97 SEK) bringing the dividend per share for the full year to $2.80 (202.5 pence, 22.37 SEK). The Board reaffirms its commitment to the Company's progressive dividend policy.
For holders of the Company's American Depositary Shares (ADSs), the $1.90 per Ordinary Share equates to $0.95 per ADS. Two ADSs equal one Ordinary Share.
 
Cash Flow and Balance Sheet
Cash Flow
 
 
FY 2017
FY 2016
Difference
$m
$m
$m
Reported operating profit
3,677
4,902
(1,225)
Depreciation, amortisation and impairment
3,036
2,357
679
 
 
 
 
(Increase)/decrease in working capital and short-term provisions
(50)
926
(976)
(Gains)/losses on disposal of intangible assets
(1,518)
(1,301)
(217)
Fair value movement on contingent consideration arising from business combinations
109
(1,158)
1,267
Non-cash and other movements
(524)
(492)
(32)
Interest paid
(698)
(677)
(21)
Tax paid
(454)
(412)
(42)
 
 
 
 
Net cash inflow from operating activities
3,578
4,145
(567)
 
The Company generated a net cash inflow from operating activities of $3,578m in the year, compared with $4,145m in FY 2016. 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.
Net cash outflows from investing activities were $2,328m in the year compared with $3,969m in FY 2016. In the final quarter, $1.5bn was paid to shareholders of Acerta Pharma B.V. (Acerta Pharma), a contractual obligation triggered by the first regulatory approval for Calquence. 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 BMS share of the global Diabetes alliance amounted to $284m in the year, which included a $100m milestone payment in respect of Qtern and royalty payments.
Net cash outflows from financing activities were $2,936m in the year compared to $1,324m in FY 2016, as the Company repaid a loan falling due.
 
Capital Expenditure
Capital expenditure amounted to $1,326m in the year, 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 31 Dec 2017
At 31 Dec 2016
$m
$m
Cash and cash equivalents
3,324
5,018
Other investments
1,300
898
Net derivatives
504
235



Cash, short-term investments and derivatives
5,128
6,151

 
 
Overdrafts and short-term borrowings
(845)
(451)
Finance leases
(5)
(93)
Current instalments of loans
(1,397)
(1,769)
Loans due after one year
(15,560)
(14,495)
 
 
 
Interest-bearing loans and borrowings (gross debt)
(17,807)
(16,808)
 
 
 
Net Debt
(12,679)
(10,657)
 
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 vs. USD
 
Impact Of 5% Strengthening in Exchange Rate vs. USD ($m)1
Currency
Primary Relevance
FY 2017
YTD 20182
% change
Product Sales
Core Operating Profit
EUR
Product Sales
0.89
0.82
+8
+160
+93
JPY
Product Sales
112.18
111.07
+1
+117
+82
CNY
Product Sales
6.75
6.43
+5
+146
+75
SEK
Costs
8.54
8.06
+6
+5
-44
GBP
Costs
0.78
0.73
+7
+23
-46
Other3
 
 
 
 
+193
+97
                1Based on 2017 results at 2017 actual exchange rates.
                2Based on average daily spot rates between 1 January and 31 January 2018.
                3Other important currencies include AUD, BRL, CAD, KRW and RUB.
 
Foreign-Exchange Hedging
The Group's transactional currency exposures on working-capital balances, which typically extend for up to three months, are hedged where practicable using forward foreign-exchange contracts against the individual Group Companies' reporting currency. In addition, the Group's external dividend payments, paid principally in pounds sterling and Swedish krona, are fully hedged from announcement to payment date. Foreign-exchange gains and losses on forward contracts for transactional hedging are taken to profit.
 
Corporate and Business Development Update
________________________________________________________________________________________
 
On 20 December 2017, it was announced by ANI Pharmaceuticals, Inc. that it had acquired the rights to market Atacand, Arimidex and Casodex from AstraZeneca for $47m in cash upfront, recorded as Other Operating Income and Expense in the Company's financial statements in the quarter. AstraZeneca will receive future royalties and sales-based milestones.
 
Research and Development Update
________________________________________________________________________________________
 comprehensive table comprising AstraZeneca's pipeline of medicines in human trials can be found later in this document. Highlights of developments in the Company's late-stage pipeline since the prior results announcement are shown below:
 
Regulatory Approvals
7
-     Faslodex - breast cancer (combinations) (US, EU)
-       Lynparza - ovarian cancer (JP)
-     Lynparza - breast cancer (US)
-     Fasenra - severe, uncontrolled asthma (US, EU, JP)
 
Regulatory Submissions and/or Acceptances
4
-     Tagrisso - lung cancer (1st line) (US - Priority Review, EU, JP)
-     ZS-9 - hyperkalaemia (US)
Major Phase III
Data Readouts and Developments
4
-       Lynparza - ovarian cancer: Priority review (CN)
-     roxadustat - anaemia: Priority review (CN)
-     PT010 - COPD (KRONOS trial): Most primary endpoints met1
-     tezepelumab - severe, uncontrolled asthma: First patient commenced dosing
New Molecular Entities(NMEs) in Phase III Trials or Under Regulatory Review and Major Lifecycle Medicines
15
Oncology
-     Lynparza - multiple cancers2
-     Tagrisso - lung cancer2
-     Imfinzi - multiple cancers2
-     Calquence - blood cancers
-     Imfinzi + treme - multiple cancers
-     moxetumomab pasudotox - leukaemia
-     selumetinib - thyroid cancer
-     savolitinib - kidney cancer
 
CVMD
-     ZS-9 (sodium zirconium cyclosilicate) - hyperkalaemia2
-     roxadustat - anaemia2
 
Respiratory
-     Fasenra - COPD
-     PT010 - COPD, asthma
-     tezepelumab - severe, uncontrolled asthma
 
Other
-     anifrolumab - lupus
-     lanabecestat - Alzheimer's disease
 
Projects in Clinical Pipeline
132
 
        1Eight of the nine primary endpoints in the KRONOS trial were met, including two non-inferiority endpoints to qualify PT009, one of the comparators
        2Under Regulatory Review. The table shown above as at today.
 
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 the treatment of lung, ovarian, breast and blood cancers, as one of AstraZeneca's Growth Platforms.
During the period, the Company presented Lynparza data at the San Antonio Breast Cancer annual symposium; highlights included data from the MEDIOLA combination trial (Lynparza + Imfinzi) and the Asian-cohort data from the OlympiAD Lynparza metastatic breast-cancer trial. The Company also presented data from the new and emerging haematology portfolio at the American Society of Hematology (ASH) annual meeting; highlights included Calquence data in several cancer types, including MCL and chronic lymphocytic leukaemia (CLL).
a) Faslodex (breast cancer)
On 13 November 2017, the Company announced that the European Medicines Agency (EMA) had approved a new indication for Faslodex in Europe in combination with a CDK4/6 inhibitor, palbociclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), locally-advanced or metastatic breast cancer in patients who have received prior endocrine therapy.
On 14 November 2017, the Company announced that the US FDA had approved a new indication for Faslodex, expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of HR+, HER2- advanced or metastatic breast cancer in patients with disease progression after endocrine therapy.
b) Lynparza (multiple cancers)
On 12 January 2018, the Company announced that the US FDA had approved Lynparza for use in patients with deleterious or suspected deleterious germline BRCA (gBRCA)-mutated HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. The approval was based on data from the randomised, open-label, Phase III OlympiAD trial, which investigated Lynparza vs. physician's choice of chemotherapy (capecitabine, eribulin or vinorelbine). In the trial, Lynparza significantly prolonged progression-free survival (PFS) compared with chemotherapy and reduced the risk of disease progression or death by 42% (Hazard Ratio (HR) 0.58; median PFS of 7.0 vs 4.2 months).
On 19 January 2018, AstraZeneca and MSD announced that the Japanese Ministry of Health, Labour and Welfare had approved Lynparza tablets (300mg twice daily) for use in patients as a maintenance therapy for platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who are in response to their last platinum-based chemotherapy. Lynparza was the first PARP inhibitor to be approved in Japan. During the period, the Company also received priority review status for Lynparza in platinum-sensitive relapsed ovarian cancer from the China FDA.
During the period, the Company presented an analysis of the comparison in endpoints from the Phase III trials of Lynparza and niraparib in patients with platinum-sensitive, relapsed germline BRCA (gBRCA)-mutated ovarian cancer at the International Society for PharmacoEconomics and Outcomes Research European Congress. Lynparza and niraparib are PARP inhibitors.
A key summary of the efficacy and tolerability measures are detailed in the table below, which includes an investigator-assessed 14.8 months of median PFS (mPFS) for niraparib in gBRCA patients:
Efficacy - platinum-sensitive, relapsed gBRCA-mutated ovarian cancer
 
PARP inhibitor
Trial
HR and
mPFS
(Independent Review Committee)
HR and
mPFS
(Investigator Assessed)
HR
(median time to first subsequent therapy or death)
Lynparza 300mg tablets, bid1
SOLO-2
(Lynparza vs. placebo)
0.25
 
30.2m vs. 5.5m
0.30
 
19.1m vs. 5.5m
0.28
 
27.9m vs. 7.1m
niraparib 300mg capsules, qd2
NOVA
(niraparib vs. placebo)
0.27
 
21.0m vs. 5.5m
0.27
 
14.8m vs. 5.5m
0.31
 
21.0m vs. 8.4m
                1bid = twice daily.
             &#x