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REG - AstraZeneca PLC - AZN: Full-Year 2017 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 4

- Part 4: For the preceding part double click  ID:nRSB7444Dc 

                                     639         (1,778)  
 Total comprehensive income for the period                                                                   3,507       1,628    
                                                                                                                                  
 Profit attributable to:                                                                                                          
 Owners of the Parent                                                                                        3,001       3,499    
 Non-controlling interests                                                                                   (133)       (93)     
                                                                                                             2,868       3,406    
                                                                                                                                  
 Total comprehensive income attributable to:                                                                                      
 Owners of the Parent                                                                                        3,640       1,722    
 Non-controlling interests                                                                                   (133)       (94)     
                                                                                                             3,507       1,628    
                                                                                                                                  
 Basic earnings per $0.25 Ordinary Share                                                                     $2.37       $2.77    
 Diluted earnings per $0.25 Ordinary Share                                                                   $2.37       $2.76    
 Weighted average number of Ordinary Shares in issue (millions)                                              1,266       1,265    
 Diluted weighted average number of Ordinary Shares in issue (millions)                                      1,267       1,266    
 
 
Diluted weighted average number of Ordinary Shares in issue (millions) 
 
1,267 
 
1,266 
 
Condensed Consolidated Statement of Comprehensive Income 
 
 For the quarter ended 31 December                                                                           2017 $m    2016 $m  
 Product Sales                                                                                               5,487      5,260    
 Externalisation Revenue                                                                                     290        325      
 Total Revenue                                                                                               5,777      5,585    
 Cost of sales                                                                                               (1,225)    (1,160)  
 Gross profit                                                                                                4,552      4,425    
 Distribution costs                                                                                          (85)       (83)     
 Research and development expense                                                                            (1,551)    (1,543)  
 Selling, general and administrative costs                                                                   (3,078)    (1,386)  
 Other operating income and expense                                                                          848        1,120    
 Operating profit                                                                                            686        2,533    
 Finance income                                                                                              49         23       
 Finance expense                                                                                             (316)      (362)    
 Share of after tax losses in associates and joint ventures                                                  (12)       (11)     
 Profit before tax                                                                                           407        2,183    
 Taxation                                                                                                    854        (366)    
 Profit for the period                                                                                       1,261      1,817    
                                                                                                                                 
 Other comprehensive income/(loss)                                                                                               
 Items that will not be reclassified to profit or loss                                                                           
 Remeasurement of the defined benefit pension liability                                                      (96)       552      
 Fair value movements related to own credit risk on bonds designated as fair value through profit or loss    (9)        -        
 Tax on items that will not be reclassified to profit or loss                                                (7)        (120)    
                                                                                                             (112)      432      
 Items that may be reclassified subsequently to profit or loss                                                                   
 Foreign exchange arising on consolidation                                                                   5          (360)    
 Foreign exchange arising on designating borrowings in net investment hedges                                 (117)      (397)    
 Fair value movements on cash flow hedges                                                                    85         (89)     
 Fair value movements on cash flow hedges transferred to profit or loss                                      (34)       154      
 Fair value movements on derivatives designated in net investment hedges                                     (9)        92       
 Net available for sale (losses)/gains taken to equity                                                       (47)       13       
 Tax on items that may be reclassified subsequently to profit or loss                                        92         23       
                                                                                                             (25)       (564)    
 Other comprehensive loss for the period, net of tax                                                         (137)      (132)    
 Total comprehensive income for the period                                                                   1,124      1,685    
                                                                                                                                 
 Profit attributable to:                                                                                                         
 Owners of the Parent                                                                                        1,301      1,842    
 Non-controlling interests                                                                                   (40)       (25)     
                                                                                                             1,261      1,817    
                                                                                                                                 
 Total comprehensive income attributable to:                                                                                     
 Owners of the Parent                                                                                        1,164      1,710    
 Non-controlling interests                                                                                   (40)       (25)     
                                                                                                             1,124      1,685    
                                                                                                                                 
 Basic earnings per $0.25 Ordinary Share                                                                     $1.03      $1.46    
 Diluted earnings per $0.25 Ordinary Share                                                                   $1.03      $1.45    
 Weighted average number of Ordinary Shares in issue (millions)                                              1,266      1,265    
 Diluted weighted average number of Ordinary Shares in issue (millions)                                      1,267      1,266    
 
 
Condensed Consolidated Statement of Financial Position 
 
 ASSETSNon-current assets                                                                    
 Property, plant and equipment                                         7,615       6,848     
 Goodwill                                                              11,825      11,658    
 Intangible assets                                                     26,188      27,586    
 Derivative financial instruments                                      504         343       
 Investments in associates and joint ventures                          103         99        
 Other investments                                                     933         727       
 Other receivables                                                     847         901       
 Deferred tax assets                                                   2,189       1,102     
                                                                       50,204      49,264    
 Current assets                                                                              
 Inventories                                                           3,035       2,334     
 Trade and other receivables                                           5,009       4,573     
 Other investments                                                     1,230       884       
 Derivative financial instruments                                      28          27        
 Income tax receivables                                                524         426       
 Cash and cash equivalents                                             3,324       5,018     
                                                                       13,150      13,262    
 Total assets                                                          63,354      62,526    
 LIABILITIESCurrent liabilities                                                              
 Interest-bearing loans and borrowings                                 (2,247)     (2,307)   
 Trade and other payables                                              (11,641)    (10,486)  
 Derivative financial instruments                                      (24)        (18)      
 Provisions                                                            (1,121)     (1,065)   
 Income tax payables                                                   (1,350)     (1,380)   
                                                                       (16,383)    (15,256)  
 Non-current liabilities                                                                     
 Interest-bearing loans and borrowings                                 (15,560)    (14,501)  
 Derivative financial instruments                                      (4)         (117)     
 Deferred tax liabilities                                              (3,995)     (3,956)   
 Retirement benefit obligations                                        (2,583)     (2,186)   
 Provisions                                                            (347)       (353)     
 Other payables                                                        (7,840)     (9,488)   
                                                                       (30,329)    (30,601)  
 Total liabilities                                                     (46,712)    (45,857)  
 Net assets                                                            16,642      16,669    
 EQUITY                                                                                      
 Capital and reserves attributable to equity holders of the Company                          
 Share capital                                                         317         316       
 Share premium account                                                 4,393       4,351     
 Other reserves                                                        2,029       2,047     
 Retained earnings                                                     8,221       8,140     
                                                                       14,960      14,854    
 Non-controlling interests                                             1,682       1,815     
 Total equity                                                          16,642      16,669    
 
 
Total equity 
 
16,642 
 
16,669 
 
Condensed Consolidated Statement of Cash Flows 
 
 Cash flows from operating activities                                                                       
 Profit before tax                                                                      2,227      3,552    
 Finance income and expense                                                             1,395      1,317    
 Share of after tax losses in associates and joint ventures                             55         33       
 Depreciation, amortisation and impairment                                              3,036      2,357    
 (Increase)/decrease in working capital and short-term provisions                       (50)       926      
 Gains on disposal of intangible assets                                                 (1,518)    (1,301)  
 Fair value movements on contingent consideration arising from business combinations    109        (1,158)  
 Non-cash and other movements                                                           (524)      (492)    
 Cash generated from operations                                                         4,730      5,234    
 Interest paid                                                                          (698)      (677)    
 Tax paid                                                                               (454)      (412)    
 Net cash inflow from operating activities                                              3,578      4,145    
 Cash flows from investing activities                                                                       
 Movement in short-term investments and fixed deposits                                  (345)      (166)    
 Purchase of property, plant and equipment                                              (1,326)    (1,446)  
 Disposal of property, plant and equipment                                              83         82       
 Purchase of intangible assets                                                          (294)      (868)    
 Disposal of intangible assets                                                          1,376      1,427    
 Purchase of non-current asset investments                                              (96)       (230)    
 Disposal of non-current asset investments                                              70         3        
 Payments to joint ventures                                                             (76)       (41)     
 Non-contingent payments on business combinations                                       (1,450)    (2,564)  
 Payment of contingent consideration from business combinations                         (434)      (293)    
 Interest received                                                                      164        140      
 Payments made by subsidiaries to non-controlling interests                             -          (13)     
 Net cash outflow from investing activities                                             (2,328)    (3,969)  
 Net cash inflow before financing activities                                            1,250      176      
 Cash flows from financing activities                                                                       
 Proceeds from issue of share capital                                                   43         47       
 Issue of loans                                                                         1,988      2,491    
 Repayment of loans                                                                     (1,750)    -        
 Dividends paid                                                                         (3,519)    (3,561)  
 Hedge contracts relating to dividend payments                                          (20)       18       
 Repayment of obligations under finance leases                                          (14)       (16)     
 Movement in short-term borrowings                                                      336        (303)    
 Net cash outflow from financing activities                                             (2,936)    (1,324)  
 Net decrease in cash and cash equivalents in the period                                (1,686)    (1,148)  
 Cash and cash equivalents at the beginning of the period                               4,924      6,051    
 Exchange rate effects                                                                  (66)       21       
 Cash and cash equivalents at the end of the period                                     3,172      4,924    
 Cash and cash equivalents consists of:                                                                     
 Cash and cash equivalents                                                              3,324      5,018    
 Overdrafts                                                                             (152)      (94)     
                                                                                        3,172      4,924    
                                                                                                              
 
 
4,924 
 
Condensed Consolidated Statement of Changes in Equity 
 
                                                             Share       Share       Other         Retained     Total attributable to owners     Non-            Total    
                                                             capital     premium     reserves*     earnings     $m                               controlling     equity   
                                                             $m          account     $m            $m                                            interests       $m       
                                                                         $m                                                                      $m                       
 At 1 Jan 2016                                               316         4,304       2,036         11,834       18,490                           19              18,509   
 Profit for the period                                       -           -           -             3,499        3,499                            (93)            3,406    
 Other comprehensive income                                  -           -           -             (1,777)      (1,777)                          (1)             (1,778)  
 Transfer to other reserves                                  -           -           11            (11)         -                                -               -        
 Transactions with owners:                                                                                                                                                
 Dividends                                                   -           -           -             (3,540)      (3,540)                          -               (3,540)  
 Dividends paid by subsidiary to non-controlling interest    -           -           -             -            -                                (13)            (13)     
 Acerta put option                                           -           -           -             (1,825)      (1,825)                          -               (1,825)  
 Changes in non-controlling interest                         -           -           -             -            -                                1,903           1,903    
 Issue of Ordinary Shares                                    -           47          -             -            47                               -               47       
 Share-based payments charge for the period                  -           -           -             241          241                              -               241      
 Settlement of share plan awards                             -           -           -             (281)        (281)                            -               (281)    
 Net movement                                                -           47          11            (3,694)      (3,636)                          1,796           (1,840)  
 At 31 Dec 2016                                              316         4,351       2,047         8,140        14,854                           1,815           16,669   
                                                             Share       Share       Other         Retained     Total attributable to owners     Non-            Total    
                                                             capital     premium     reserves*     earnings     $m                               controlling     equity   
                                                             $m          account     $m            $m                                            interests       $m       
                                                                         $m                                                                      $m                       
 At 1 Jan 2017                                               316         4,351       2,047         8,140        14,854                           1,815           16,669   
 Profit for the period                                       -           -           -             3,001        3,001                            (133)           2,868    
 Other comprehensive income                                  -           -           -             639          639                              -               639      
 Transfer to other reserves                                  -           -           (18)          18           -                                -               -        
 Transactions with owners:                                                                                                                                                
 Dividends                                                   -           -           -             (3,543)      (3,543)                          -               (3,543)  
 Issue of Ordinary Shares                                    1           42          -             -            43                               -               43       
 Share-based payments charge for the period                  -           -           -             220          220                              -               220      
 Settlement of share plan awards                             -           -           -             (254)        (254)                            -               (254)    
 Net movement                                                1           42          (18)          81           106                              (133)           (27)     
 At 31 Dec 2017                                              317         4,393       2,029         8,221        14,960                           1,682           16,642   
 
 
*Other reserves include the capital redemption reserve and the merger reserve. 
 
Notes to the Interim Financial Statements 
 
1   BASIS OF PREPARATION AND ACCOUNTING POLICIES 
 
The preliminary announcement for the year ended 31 December 2017 has been prepared in accordance with International
Financial Reporting Standards (IFRSs) as adopted by the European Union (EU) and as issued by the International Accounting
Standards Board (IASB). 
 
The annual financial statements of the Group are prepared in accordance with IFRSs as adopted by the EU and as issued by
the IASB. Except as noted below, the preliminary announcement has been prepared applying the accounting policies and
presentation that were applied in the preparation of the Group's published consolidated financial statements for the year
ended 31 December 2016. From 1 January 2017 the Group early adopted the treatment of fair value changes arising from
changes in own credit risk in IFRS 9 Financial Instruments. The impact was not significant. 
 
We have revised the balance sheet presentation of deferred tax with effect from 1 January 2017 with no impact upon net
deferred tax, the Group's net assets, the cash flow statement or the income statement. This presentation change has
resulted in us showing gross, rather than net, deferred tax assets and deferred tax liabilities of a group entity. This
change has been made as that entity has transactions that are subject to tax by two different taxation authorities and has
the effect of separately disclosing the deferred tax effects for each country. The comparative balance sheet has not been
revised for this presentational change. If the 31 December 2016 balances were presented in a comparable way the deferred
tax assets would have been $2,093m. The deferred tax liabilities would have been $4,947m. 
 
As disclosed in our 2016 Annual Report on Page 181, the Group has entered into a number of financial derivative
transactions with commercial banks. The Group has agreements with some bank counterparties whereby the parties agree to
post cash collateral, for the benefit of the other, equivalent to the market valuation of the derivative positions above a
predetermined threshold. We have revised the balance sheet presentation of these collateral balances with effect from 1
January 2017, so that the cash collateral is included in cash and cash equivalents, with an offsetting liability presented
in current interest-bearing loans and borrowings and the movement presented in movement in short-term borrowings in the
statement of cash flows. This revision has no impact on the Group's net assets, or the income statement. The comparative
balance sheet has not been revised for this presentational change. If the 31 December 2016 balances were presented in a
comparable way the cash and cash equivalents balance would have been $5,260m. Current interest-bearing loans and borrowings
would have been $2,629m, and current investments would have been $964m. 
 
Following clarification by the IASB Interpretations Committee in September 2017, the Group has revised its presentation of
interest and tax positions. Interest income and expense, which was previously presented in the tax charge in the income
statement, is now presented in finance income and expense and corresponding assets and liabilities, which were previously
presented as income tax receivables and payables in the balance sheet, are now presented in trade and other receivables and
trade and other payables. This revision has no impact on the Group's net assets and cash flows, or retained profit. The
Group has assessed this presentational change as not material for restatement and, therefore, the comparative income
statement and balance sheets have not been revised for this presentational change. If the 31 December 2016 balances were
presented in a comparable way, finance income and expense would have been $1,239m, the tax charge would have been $224m,
income tax payables would have been $1,287m, and trade and other payables would have been $10,579m. 
 
Legal proceedings 
 
The information contained in Note 5 updates the disclosures concerning legal proceedings and contingent liabilities in the
Group's Annual Report and Form 20-F Information 2016, the interim financial statements for the three months ended 31 March
2017, the interim financial statements for the three months ended 30 June 2017 and the interim financial statements for the
three months ended 30 September 2017. 
 
Going concern 
 
The Group has considerable financial resources available. As at 31 December 2017 the Group has $4.1bn in financial
resources (cash balances of $3.3bn and undrawn committed bank facilities of $3.0bn which are available until April 2022,
with only $2.2bn of debt due within one year). The Group's revenues are largely derived from sales of products which are
covered by patents which provide a relatively high level of resilience and predictability to cash inflows, although our
revenue is expected to continue to be significantly impacted by the expiry of patents over the medium term. In addition,
government price interventions in response to budgetary constraints are expected to continue to adversely affect revenues
in many of our mature markets. However, we anticipate new revenue streams from both recently launched medicines and
products in development, and the Group has a wide diversity of customers and suppliers across different geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business risks successfully. 
 
On the basis of the above paragraph, the going concern basis has been adopted in these interim financial statements. 
 
Financial information 
 
The financial information contained in the preliminary announcement does not constitute statutory accounts of the Group for
the years ended 31 December 2017 and 2016 but is derived from those accounts. Statutory accounts for 2016 have been
delivered to the registrar of companies and those for 2017 will be delivered in due course. Those accounts have been
reported on by the Group's auditors; their report was (i) unqualified, (ii) did not include a reference to any matters to
which the auditors drew attention by way of emphasis without qualifying their report, and (iii) did not contain a statement
under section 498(2) or (3) of the Companies Act 2006. The quarterly information for the three month period to 31 December
2017 and to 31 December 2016 has not been subject to audit. 
 
2   RESTRUCTURING COSTS 
 
Profit before tax for the year ended 31 December 2017 is stated after charging restructuring costs of $807m ($163m for the
fourth quarter of 2017). These have been charged to profit as follows: 
 
                                              FY 2017    FY 2016    Q4 2017    Q4 2016  
                                              $m         $m         $m         $m       
 Cost of sales                                181        130        53         43       
 Research and development expense             201        178        24         32       
 Selling, general and administrative costs    347        823        83         319      
 Other operating income and expense           78         (24)       3          -        
 Total                                        807        1,107      163        394      
 
 
3   NET DEBT 
 
The table below provides an analysis of net debt and a reconciliation of net cash flow to the movement in net debt. 
 
The Group monitors net debt as part of its capital management policy as described in Note 26 of the Annual Report and Form
20-F Information 2016. Net debt is a non-GAAP financial measure. 
 
                                          At 1 Jan 2017 $m    Cash Flow $m    Non-cash& Other$m    Exchange Movements$m    At 31 Dec 2017 $m  
 Loans due after one year                 (14,495)            (1,988)         1,389                (466)                   (15,560)           
 Finance leases due after one year        (6)                 -               6                    -                       -                  
 Total long-term debt                     (14,501)            (1,988)         1,395                (466)                   (15,560)           
                                                                                                                                              
 Current instalments of loans             (1,769)             1,750           (1,378)              -                       (1,397)            
 Current instalments of finance leases    (87)                14              69                   (1)                     (5)                
 Total current debt                       (1,856)             1,764           (1,309)              (1)                     (1,402)            
                                                                                                                                              
 Other investments - current              884                 345             -                    1                       1,230              
 Other investments - non-current          14                  56              -                    -                       70                 
 Net derivative financial instruments     235                 20              249                  -                       504                
 Cash and cash equivalents                5,018               (1,629)         -                    (65)                    3,324              
 Overdrafts                               (94)                (57)            -                    (1)                     (152)              
 Short-term borrowings                    (357)               (336)           -                    -                       (693)              
                                          5,700               (1,601)         249                  (65)                    4,283              
 Net debt                                 (10,657)            (1,825)         335                  (532)                   (12,679)           
 
 
Non-cash movements in the period include fair value adjustments under IAS 39. 
 
4   FINANCIAL INSTRUMENTS 
 
As detailed in the Group's most recent annual financial statements, our principal financial instruments consist of
derivative financial instruments, other investments, trade and other receivables, cash and cash equivalents, trade and
other payables, and interest-bearing loans and borrowings. The accounting policies for financial instruments, including
fair value measurement, can be found on pages 144 and 145 of the Company's Annual Report and Form 20-F Information 2016.
There have been no significant new or revised accounting standards applied in the year ended 31 December 2017 and there
have been no changes of significance to the categorisation or fair value hierarchy classification of our financial
instruments. During the year, we revised the balance sheet presentation of cash collateral balances held with commercial
bank counterparties, effective from 1 January 2017 (see Note 1). 
 
Financial instruments measured at fair value include $1,230m of other investments, $1,247m of loans, and $504m of
derivatives as at 31 December 2017. The total fair value of interest-bearing loans and borrowings at 31 December 2017 which
have a carrying value of $17,807m in the Condensed Consolidated Statement of Financial Position, was $19,280m. Contingent
consideration liabilities arising on business combinations have been classified under Level 3 in the fair value hierarchy
and movements in fair value are shown below: 
 
                     DiabetesAlliance2017    Other 2017    Total 2017    Total 2016  
                     $m                      $m            $m            $m          
 At 1 January        4,240                   1,217         5,457         6,411       
 Settlements         (284)                   (150)         (434)         (293)       
 Revaluations        208                     (99)          109           (1,158)     
 Discount unwind     313                     89            402           497         
 Foreign exchange    -                       -             -             -           
 At 31 December      4,477                   1,057         5,534         5,457       
 
 
5    LEGAL PROCEEDINGS AND CONTINGENT LIABILITIES 
 
AstraZeneca is involved in various legal proceedings considered typical to its business, including litigation and
investigations relating to product liability, commercial disputes, infringement of intellectual property rights, the
validity of certain patents, anti-trust law and sales and marketing practices. The matters discussed below constitute the
more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual
Report and Form 20-F Information 2016, the interim financial statements for the three months ended 31 March 2017, the
interim financial statements for the three months ended 30 June 2017, and the interim financial statements for the three
months ended 30 September 2017 (the Disclosures). Unless noted otherwise below or in the Disclosures, no provisions have
been established in respect of the claims discussed below. 
 
As discussed in the Disclosures, for the majority of claims in which AstraZeneca is involved it is not possible to make a
reasonable estimate of the expected financial effect, if any, that will result from ultimate resolution of the proceedings.
In these cases, AstraZeneca discloses information with respect only to the nature and facts of the cases but no provision
is made. 
 
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been assessed and which are
not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate of the loss, we record the
loss absorbed or make a provision for our best estimate of the expected loss. 
 
The position could change over time and the estimates that we have made and upon which we have relied in calculating these
provisions are inherently imprecise. There can, therefore, be no assurance that any losses that result from the outcome of
any legal proceedings will not exceed the amount of the provisions that have been booked in the accounts. The major factors
causing this uncertainty are described more fully in the Disclosures and herein. 
 
AstraZeneca has full confidence in, and will vigorously defend and enforce, its intellectual property. 
 
Matters disclosed in respect of the fourth quarter of 2017 and to 2 February 2018. 
 
Patent litigation 
 
Faslodex (fulvestrant) 
 
US patent proceedings 
 
As previously disclosed, in March and October 2017, AstraZeneca received Paragraph IV notices regarding NDAs submitted
pursuant to 21 U.S.C. § 355(b)(2) by Teva Pharmaceuticals USA, Inc. (Teva) and Fresenius Kabi USA LLC (Fresenius),
respectively, relating to four FDA Orange Book-listed patents. As previously disclosed, in April 2017, AstraZeneca filed a
lawsuit against Teva in the US District Court for the District of New Jersey (the District Court). In December 2017,
AstraZeneca filed lawsuits against Fresenius in both the District Court and the US District Court for the District of
Delaware. In January 2018, AstraZeneca settled the lawsuits against both Teva and Fresenius and consent judgements have
been entered, ending the lawsuits. 
 
Calquence (acalabrutinib) 
 
US patent proceedings 
 
As previously disclosed, in November 2017, Pharmacyclics LLC filed a complaint in the US District Court for the District of
Delaware against Acerta Pharma B.V., Acerta Pharma LLC, and AstraZeneca (collectively, AstraZeneca) alleging that Calquence
infringes certain claims of US Patent Nos. 9,079,908; 9,139,591; and 9,556,182. In January 2018, AstraZeneca filed an
answer to the complaint alleging, inter alia, that the asserted patents are invalid and not infringed. 
 
Byetta (exenatide) 
 
US patent proceedings 
 
As previously disclosed, in December 2015, AstraZeneca filed a patent infringement lawsuit in response to a Paragraph IV
notice from Amneal Pharmaceuticals LLC (Amneal) relating to patents listed in the FDA Orange Book with reference to Byetta.
In October 2017, AstraZeneca settled the patent litigation against Amneal. A consent judgment was entered in the US
District Court for the District of Delaware which will enjoin Amneal from launching its proposed exenatide Abbreviated New
Drug Application product until April 2018, subject to regulatory approval. 
 
Patent proceedings outside the US 
 
In December 2017, the Barcelona Court of Appeals lifted a nationwide interim injunction that AstraZeneca had previously
obtained against Sandoz Farmacéutica, S. A. (Sandoz) after Sandoz received regulatory approval to market generic versions
of Faslodex in Spain. 
 
Tagrisso (osimertinib) 
 
Patent proceedings outside the US 
 
In Europe, in October 2016, Stada Arzneimittel AG filed an opposition to the grant of European Patent No. 2,736,895 (the
'895 patent). The European Patent Office Opposition Hearing took place in January 2018 and the '895 patent was upheld. 
 
Product liability litigation 
 
Byetta/Bydureon(exenatide) 
 
As previously disclosed, in the US, Amylin Pharmaceuticals, LLC, a wholly owned subsidiary of AstraZeneca, and/or
AstraZeneca are among multiple defendants in various lawsuits filed in federal and state courts involving claims of
physical injury from treatment with Byetta and/or Bydureon. The lawsuits allege several types of injuries including
pancreatitis, pancreatic cancer, thyroid cancer, and kidney cancer. A multi-district litigation has been established in the
US District Court for the Southern District of California (the District Court) in regard to the alleged pancreatic cancer
cases in federal courts. Further, a coordinated proceeding has been established in Los Angeles, California in regard to the
various lawsuits in California state courts. 
 
In November 2015, the District Court granted the defendants' motion for summary judgment and dismissed all claims alleging
pancreatic cancer that accrued prior to 11 September 2015. In November 2017, the US Court of Appeals for the Ninth Circuit
annulled the District Court's order and remanded for further discovery. The appeal of a similar motion, which was granted
in favour of defendants in the California state coordinated proceeding in May 2016, remains pending 
 
Crestor (rosuvastatin calcium) 
 
As previously disclosed, in the US, AstraZeneca was defending a number of lawsuits alleging multiple types of injuries
caused by the use of Crestor, including diabetes mellitus, various cardiac injuries, rhabdomyolysis, and/or liver and
kidney injuries. AstraZeneca has resolved all active claims with regard to this matter. 
 
Seroquel (quetiapine fumarate) 
 
In November 2017, AstraZeneca was named as one of several defendants in a lawsuit filed in Missouri involving one plaintiff
alleging, among other things, wrongful death from treatment with Seroquel. 
 
Commercial litigation 
 
Array BioPharma 
 
In December 2017, AstraZeneca was served with a complaint filed in New York State court by Array BioPharma, Inc. (Array)
that alleged, among other things, breaches of contractual obligations relating to a 2003 collaboration agreement between
AstraZeneca and Array. 
 
6    product analysis - FY 2017 
 
The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting
year-on-year growth. 
 
                      World        Emerging Markets        US             Europe           Established ROW  
                      FY 2017$m    Actual%           CER%      FY 2017$m          Actual%  CER                FY 2017$m    Actual%    FY 2017$m    Actual%  CER%    FY 2017$m    Actual%  CER%  
                                                                                           %                                                                                                    
 Oncology                                                                                                                                                                                       
 Tagrisso             955          126               126       135                n/m      n/m                405          59         187          146      142     228          175      183   
 Iressa               528          3                 3         251                8        8                  39           70         112          (7)      (8)     126          (8)      (6)   
 Lynparza             297          36                35        18                 n/m      n/m                141          11         130          60       58      8            n/m      n/m   
 Imfinzi              19           n/m               n/m       -                  -        -                  19           n/m        -            -        -       -            -        -     
 Calquence            3            n/m               n/m       -                  -        -                  3            n/m        -            -        -       -            -        -     
 Legacy:                                                                                                                                                                                        
 Faslodex             941          13                13        115                20       18                 492          12         256          12       11      78           15       18    
 Zoladex              735          (10)              (9)       353                (1)      (1)                15           (57)       141          (10)     (8)     226          (16)     (15)  
 Casodex              215          (13)              (11)      108                1        4                  (1)          n/m        22           (19)     (19)    86           (23)     (21)  
 Arimidex             217          (6)               (4)       118                7        10                 7            (50)       34           (8)      (8)     58           (18)     (15)  
 Others               114          10                13        28                 12       16                 -            -          3            (63)     (63)    83           17       20    
 Total Oncology       4,024        19                19        1,126              19       20                 1,120        25         885          21       20      893          10       12    
                                                                                                                                                                                                
 CVMD                                                                                                                                                                                           
 Brilinta             1,079        29                29        224                19       21                 509          46         295          14       13      51           16       11    
 Farxiga              1,074        29                28        232                74       73                 489          7          242          29       28      111          91       90    
 Onglyza              611          (15)              (16)      130                (8)      (10)               320          (15)       104          (21)     (21)    57           (19)     (20)  
 Bydureon             574          (1)               (1)       9                  125      75                 458          (1)        88           (12)     (11)    19           73       73    
 Byetta               176          (31)              (30)      12                 (50)     (50)               114          (30)       34           (24)     (22)    16           (24)     (24)  
 Symlin               48           20                20        -                  -        -                  48           20         -            -        -       -            -        -     
 Qtern                5            n/m               n/m       1                  n/m      n/m                4            n/m        -            -        -       -            -        -     
 Legacy:                                                                                                                                                                                        
 Crestor              2,365        (30)              (30)      784                9        11                 373          (70)       666          (23)     (23)    542          (8)      (6)   
 Seloken/Toprol-XL    695          (6)               (4)       593                11       12                 37           (61)       52           (42)     (41)    13           (19)     (19)  
 Atacand              300          (5)               (3)       178                10       12                 19           (47)       86           (11)     (11)    17           (15)     (15)  
 Others               339          (15)              (13)      204                (11)     (7)                -            -          92           (23)     (24)    43           (14)     (12)  
 Total CVMD           7,266        (10)              (10)      2,367              11       12                 2,371        (26)       1,659        (12)     (13)    869          (1)      -     
                                                                                                                                                                                                
 Respiratory                                                                                                                                                                                    
 Symbicort            2,803        (6)               (6)       439                9        10                 1,099        (12)       819          (10)     (10)    446          2        2     
 Pulmicort            1,176        11                12        840                20       23                 156          (10)       92           (7)      (8)     88           (2)      (1)   
 Daliresp/Daxas       198          29                28        4                  -        -                  167          25         26           73       73      1            -        -     
 Tudorza/Eklira       150          (12)              (12)      2                  n/m      n/m                66           (14)       73           (12)     (11)    9            -        -     
 Duaklir              79           25                25        -                  n/m      n/m                -            -          77           24       24      2            -        -     
 Bevespi              16           n/m               n/m       -                  -        -                  16           n/m        -            -        -       -            -        -     
 Others               284          (10)              (9)       103                (25)     (24)               5            (44)       129          10       10      47           (6)      (8)   
 Total Respiratory    4,706        (1)               (1)       1,388              12       13                 1,509        (8)        1,216        (5)      (5)     593          1        1     
                                                                                                                                                                                                
 Other                                                                                                                                                                                          
 Nexium               1,952        (4)               (3)       684                (1)      2                  499          (10)       248          (1)      (3)     521          (3)      (1)   
 Synagis              687          1                 1         -                  -        -                  317          (2)        370          5        5       -            -        -     
 Losec/Prilosec       271          (2)               (1)       140                9        10                 11           10         77           (7)      (7)     43           (22)     (20)  
 Seroquel XR          332          (55)              (55)      62                 (10)     (12)               175          (66)       78           (42)     (42)    17           -        -     
 Movantik/Moventig    122          34                34        -                  n/m      n/m                120          33         2            n/m      n/m     -            -        -     
 FluMist/Fluenz       78           (25)              (28)      (1)                n/m      n/m                -            (100)      76           17       12      3            (50)     (50)  
 Others               714          (38)              (38)      383                (34)     (32)               47           (55)       142          (47)     (49)    142          (28)     (28)  
 Total Other          4,156        (18)              (17)      1,268              (14)     (12)               1,169        (28)       993          (14)     (15)    726          (11)     (9)   
                                                                                                                                                                                                
 TOTAL PRODUCT SALES  20,152       (5)               (5)       6,149              6        8                  6,169        (16)       4,753        (6)      (7)     3,081        -        1     
 
 
7   product analysis - Q4 2017 
 
The table below provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting
year-on-year growth. 
 
                      World        Emerging Markets        US             Europe           Established ROW  
                      Q4 2017$m    Actual%           CER%      Q4 2017$m          Actual%  CER                Q4 2017$m    Actual%    Q4 2017$m    Actual%  CER%    Q4 2017$m    Actual%  CER%  
                                                                                           %                                                                                                    
 Oncology                                                                                                                                                                                       
 Tagrisso             304          107               105       50                 n/m      n/m                128          73         63           133      115     63           58       68    
 Iressa               130          10                8         51                 11       7                  12           71         32           10       3       35           (3)      3     
 Lynparza             100          61                58        7                  n/m      n/m                54           74         36           44       32      3            n/m      n/m   
 Imfinzi              18           n/m               n/m       -                  -        -                  18           n/m        -            -        -       -            -        -     
 Calquence            3            n/m               n/m       -                  -        -                  3            n/m        -            -        -       -            -        -     
 Legacy:                                                                                                                                                                                        
 Faslodex             238          7                 5         27                 4        4                  124          6          62           5        (3)     25           25       30    
 Zoladex              187          (20)              (21)      93                 (21)     (22)               (1)          n/m        37           (5)      (10)    58           (18)     (14)  
 Casodex              54           (10)              (8)       30                 20       20                 (2)          n/m        5            (38)     (38)    21           (22)     (19)  
 Arimidex             57           -                 (2)       33                 22       22                 2            -          8            (20)     (20)    14           (22)     (17)  
 Others               29           -                 3         7                  40       40                 -            -          (1)          -        -       23           15       20    
 Total Oncology       1,120        20                19        298                17       15                 338          41         242          20       12      242          3        9     
                                                                                                                                                                                                
 CVMD                                                                                                                                                                                           
 Brilinta             299          27                24        49                 (8)      (8)                154          47         82           24       15      14           17       8     
 Farxiga              332          39                37        72                 76       76                 150          15         71           39       31      39           129      124   
 Onglyza              180          21                19        37                 16       13                 103          43         26           (13)     (17)    14           (7)      (13)  
 Bydureon             147          4                 2         4                  n/m      n/m                115          1          23           (8)      (8)     5            67       67    
 Byetta               48           (13)              (13)      3                  (40)     (40)               33           (11)       8            -        -       4            (20)     (20)  
 Symlin               13           -                 -         -                  -        -                  13           -          -            -        -       -            -        -     
 Qtern                5            n/m               n/m       1                  n/m      n/m                4            n/m        -            -        -       -            -        -     
 Legacy:                                                                                                                                                                                        
 Crestor              594          (6)               (7)       207                14       14                 127          34         152          (27)     (32)    108          (26)     (23)  
 Seloken/Toprol-XL    168          (6)               (7)       156                16       14                 3            (79)       4            (83)     (83)    5            (17)     (17)  
 Atacand              73           (10)              (10)      43                 (4)      (4)                2            (75)       23           -        -       5            -        -     
 Others               80           (8)               (10)      47                 4        -                  (2)          n/m        23           (23)     (27)    12           -        -     
 Total CVMD           1,939        7                 6         619                15       14                 702          19         412          (11)     (16)    206          (7)      (5)   
                                                                                                               

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