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INDV - Indivior News Story

148.1p 0.1  0.1%

Last Trade - 14/05/21

Market Cap £1.09bn
Enterprise Value £617.6m
Revenue £478.1m
Position in Universe 413th / 1826

Indivior PLC - Final Results - Part 2

Thu 15th February, 2018 7:00am
- Part 2: For the preceding part double click  ID:nRSO9372Ea 

                              $m                                         $m
 ASSETS
 Non-current assets
 Intangible assets                                      92                                         83
 Property, plant and equipment and other assets         54                                         27
 Deferred tax assets                             4      58                                         109
 Other receivables                                      15                                         -
                                                        219                                        219
 Current assets
 Inventories                                            52                                         41
 Trade and other receivables                            278                                        227
 Current tax receivable                                 32                                         30
 Cash and cash equivalents                       6      863                                        692
                                                                          1,225                    990
 Total assets                                           1,444                                      1,209
 LIABILITIES
 Current liabilities
 Borrowings                                      6      (5)                                        (101)
 Provision for liabilities and charges                  (143)                                      (219)
 Trade and other payables                        8      (665)                                      (658)
 Current tax liabilities                         4      (41)                                       (52)
                                                        (854)                                      (1,030)
 Non-current liabilities
 Borrowings                                      6      (477)                                      (434)
 Provisions for liabilities and charges                 (316)                                      (40)
                                                        (793)                                      (474)
 Total liabilities                                      (1,647)                                    (1,504)
 Net liabilities                                        (203)                                      (295)
 EQUITY
 Capital and reserves
 Share capital                                   9      72                                         72
 Share premium                                          2                                          -
 Other Reserves                                         (1,295)                                    (1,295)
 Foreign currency translation reserve                   (14)                                       (22)
 Retained Earnings                                      1,032                                      950
 Total equity                                           (203)                                      (295)
 
The notes are an integral part of these condensed consolidated financial
statements.
 
Condensed consolidated statement of changes in equity
 
 Audited                                           Share     Share     Other     Foreign       Retained   Total
                                                   Capital   Premium   Reserve   Currency      Earnings   equity
                                                   $m        $m        $m        Translation   $m         $m
                                                                                 Reserve
                                                                                 $m
 At January 1, 2016                                72        -         (1,295)   (23)          967        (279)
 Comprehensive income
 Net income                                        -         -         -         -             35         35
 Other comprehensive income                        -         -         -         1             -          1
 Total comprehensive income                        -         -         -         1             35         36
 Transactions recognised directly in equity
 Share-based plans                                 -         -         -         -             10         10
 Deferred taxation on share-based plans            -         -         -         -             7          7
 Dividends paid                                    -         -         -         -             (69)       (69)
 Total transactions recognised directly in equity  -         -         -         -             (52)       (52)
 Balance at December 31, 2016                      72        -         (1,295)   (22)          950        (295)
 Unaudited
 At January 1, 2017                                72        -         (1,295)   (22)          950        (295)
 Comprehensive income
 Net income                                        -         -         -         -             58         58
 Other comprehensive income                        -         -         -         8             -          8
 Total comprehensive income                        -         -         -         8             58         66
 Transactions recognised directly in equity
 Share-based plans                                 -         2         -         -             16         18
 Deferred taxation on share-based plans            -         -         -         -             8          8
 Total transactions recognised directly in equity  -         2         -         -             24         26
 Balance at December 31, 2017                      72        2         (1,295)   (14)          1,032      (203)
 
The notes are an integral part of these condensed consolidated financial
statements.
 
Condensed consolidated cash flow statement
 
 For the twelve months ended December 31               Unaudited  Audited
                                                       2017       2016
                                                       $m         $m
 CASH FLOWS FROM OPERATING ACTIVITIES
 Operating Profit                                      193        149
 Depreciation and amortization                         13         14
 Share-based payments                                  16         10
 Impact from foreign exchange movements                6          1
 (Increase) in trade and other receivables             (59)       (27)
 (Increase)/decrease in inventories                    (6)        4
 Increase in trade and other payables                  5          142
 Increase in provisions                                201        219
 Cash generated from operations                        369        512
 Net financing costs                                   (36)       (42)
 Transaction costs related to loan                     (5)        -
 Taxes paid                                            (33)       (63)
 Net cash inflow from operating activities             295        407
 CASH FLOWS FROM INVESTING ACTIVITIES
 Purchase of property, plant and equipment             (30)       (20)
 Purchase of intangible assets                         (13)       (15)
 Net cash (outflow) from investing activities          (43)       (35)
 CASH FLOWS FROM FINANCING ACTIVITIES
 Proceeds from borrowings                              487        -
 Repayment of borrowings                               (573)      (78)
 Dividends paid                                        -          (69)
 Proceeds from issuance of ordinary shares             2          -
 Net cash (outflow) from financing activities          (84)       (147)
 Net increase in cash and cash equivalents             168        225
 Cash and cash equivalents at beginning of the period  692        467
 Exchange differences                                  3          -
 Cash and cash equivalents at end of the period        863        692
 
The notes are an integral part of these condensed consolidated financial
statements.
 
Notes to the condensed consolidated financial statements
1.   BASIS OF PREPARATION AND ACCOUNTING POLICIES
Indivior PLC (the 'Company') is a public limited company incorporated and
domiciled in the United Kingdom on September 26, 2014. In these condensed
consolidated financial statements ('Financial Statements'), reference to the
'Group' means the Company and all its subsidiaries.
The financial information herein has been prepared in the basis of the
accounting policies set out in the annual accounts of the Group for the year
ended December 31, 2016. No standards or interpretations have been adopted
before the required implementation date. The Group prepares its annual
accounts in accordance with International Financial Reporting Standards (IFRS)
and IFRS Interpretations Committee (IFRIC) interpretations as adopted by the
European Union and the Companies Act 2006 (the Act) applicable to companies
reporting under IFRS. In preparing these condensed consolidated financial
statements, the significant judgments made by management in applying the
Group's accounting policies and the key sources of estimation uncertainty were
the same as those that applied to the consolidated financial statements for
the year ended December 31, 2016, with the exception of changes in estimates
that are required in determining the provision for income taxes for periods.
The consolidated financial statements do not include all the information and
disclosures required in the annual financial statements, and should be read in
conjunction with the Group's annual financial statements as at December 31,
2016. These consolidated financial statements have been authorized for issue
as at February 14, 2018.
As disclosed in Note 7, the Group carries a provision of $438m relating to the
Department of Justice and Federal Trade Commission investigations and
antitrust litigation. The final settlement amount may be materially different
than this provision. This could impact the Group's ability to operate, which
would be further adversely impacted should revenues decline and pipeline
products fail to obtain regulatory approval, all of which could mean the Group
could not continue in business without taking necessary measures to reduce its
cost base and improve its cash flow. As such, this indicates a material
uncertainty that may cast significant doubt on the Group's ability to continue
as a going concern. However, the Directors believe they have the ability to
carry out the measures that would be necessary and that the Group can continue
as a going concern for the foreseeable future. Accordingly, the Directors
continue to adopt the going concern basis for accounting in preparing these
financial statements, which do not include any adjustments that might result
from the outcome of this uncertainty.
The financial information contained in this document does not constitute
statutory accounts as defined in section 434 and 435 of the Act. For the
Group's financial statements for the year ended December 31, 2017, the
auditors expect to issue (1) an emphasis of matter dealing with the outcome of
the Department of Justice and Federal Trade Commission investigations and
antitrust litigation details of which are included above and in note 7; and
(2) a material uncertainty related to going concern section dealing with the
existence of a material uncertainty which may cast significant doubt about the
Group's ability to continue as a going concern in relation to the Group's
involvement in investigations by the Department of Justice and the Federal
Trade Commissions as well as antitrust litigation, which would be further
adversely impacted should revenues decline, pipeline products fail to obtain
regulatory approval and if the uptake of SUBLOCADE™ is slower than expected.
The inclusion of the above in the auditors' report would not represent a
modification to the auditors' report.
The auditors issued an unqualified opinion and did not contain a statement
under section 498 of the Act on the Group's statutory financial statements for
the year ended December 31, 2016. Emphasis of matters were included with
respect to the outcome of the ANDA litigation, as well as in respect of a
material uncertainty which may have cast doubt on the Group's ability to
continue as a going concern in relation to the Department of Justice and
Federal Trade Commission investigations and antitrust litigation. The
auditors' report on the Group's statutory financial statements for the year
ended December 31, 2016 was not modified in this respect.
2.   SEGMENT INFORMATION
Operating segments are reported in a manner consistent with the internal
reporting provided to the chief operating decision-maker ('CODM'). The CODM,
who is responsible for allocating resources and assessing performance of the
operating segments, has been identified as the Chief Executive Officer (CEO).
The Indivior Group is engaged in a single business activity, which is the
development, manufacture and sale of buprenorphine-based prescription drugs
for treatment of opioid dependence. The CEO reviews financial information on a
geographic basis for evaluating financial performance and allocating
resources. The Group has a single reportable segment.
 
Revenues
Revenues are attributed to countries based on the country where the sale
originates. The following table represents revenue from continuing operations
attributed to countries based on the country where the sale originates and
non-current assets, net of accumulated depreciation and amortization, by
country. Non-current assets for this purpose consist of property, plant and
equipment, intangible assets, and other receivables. Revenues and non-current
assets for FY 2017 and 2016 were as follows:
Revenues from sale of goods:
                Q4     Q4     FY     FY
                2017   2016   2017   2016
                $m     $m     $m     $m
 United States  207    206    877    857
 ROW            58     53     216    201
 Total          265    259    1,093  1,058
 
Non-current assets:
                2017  2016
                $m    $m
 United States  68    64
 ROW            93    46
 Total          161   110
 
3.   OPERATING COSTS AND EXPENSES
The table below sets out selected operating costs and expenses information:
                                               Q4     Q4     FY     FY
                                               2017   2016   2017   2016
                                               $m     $m     $m     $m
 Research and development expenses             (22)   (32)   (89)   (119)
 Marketing, selling and distribution expenses  (51)   (42)   (163)  (144)
 Administrative expenses                       (270)  (81)   (525)  (520)
 Depreciation and amortization                 (4)    (2)    (13)   (14)
 Operating lease rentals                       (1)    (2)    (6)    (5)
 Total                                         (326)  (127)  (707)  (683)
 
Exceptional Items (Pre-tax)
                          Q4     Q4     FY     FY
                          2017   2016   2017   2016
                          $m     $m     $m     $m
 Cost of sales            -      -      -      (11)
 Legal expenses           (185)  -      (210)  (220)
 Consulting costs         -      (1)    -      (7)
 Financing costs          (14)   -      (14)   -
 Total exceptional items  (199)  (1)    (224)  (238)
 
$210m of FY 2017 pre-tax exceptional items are for investigative and antitrust
litigation matters set out in Note 7. $14m of financing costs are non-cash and
relate to demerger debt issuance costs written off early due to the debt
restructuring.  $238m of pre-tax exceptional items in FY 2016 include legal
provisions, write offs of manufacturing costs and legal and advisory costs
related to the exploration of strategic initiatives for the event of a
potential negative ANDA ruling.
4.   TAXATION
In the year to December 2017, tax on total profits amounted to $79m and
represented a full year effective tax rate of 58% (2016: 64%). A benefit of
$9m is included relating to a release of provisions for unresolved tax
matters, netted by the impact of the re-measurement of deferred tax assets,
and are exceptional.  The company also benefited by $3m for Research credits
in both the US and the UK. Excluding the impact of exceptional items, the
effective tax rate for the year ended December 31, 2017 is 25% (2016: 25%).
The prior year included exceptionals of $19m in the full year and $30m in the
quarter.
The Group's balance sheet at December 31, 2017 included a tax payable
liability of $41m, corporate tax receivable of $32m, and deferred tax assets
of $58m.
On December 22, 2017, the US Tax Cuts and Jobs Act (H.R. 1), the tax reform
bill (the "Act"), was signed into law. The Act includes numerous changes in
existing tax law, including a permanent reduction in the federal corporate
income tax rate from 35% to 21%. The rate reduction takes effect on January 1,
2018. As a result of the reduction of federal corporate income tax rates, the
Group has recorded a one-time non-cash charge to tax expense for the
revaluation of the Group's deferred tax assets of $15m.
The United Kingdom ('UK') decision to withdraw from the European Union ('EU')
could have a material effect on our taxes. The impact of the withdrawal will
not be known until both the EU and the UK develop the exit plan and the
related changes in tax laws are enacted. We will adjust our current and
deferred income taxes when tax law changes related to the UK withdrawal are
substantively enacted and/or when EU law ceases to apply in the UK.
 
5.   EARNINGS PER SHARE
                                      Q4      Q4      FY      FY
                                      2017    2016    2017    2016
                                      cents   cents   cents   cents
 Basic earnings per share             (20)    11      8       5
 Diluted earnings per share           (20)    10      8       5
 Adjusted basic earnings per share    7       7       37      35
 Adjusted diluted earnings per share  7       7       36      34
 
Basic
Basic earnings per share ("EPS") is calculated by dividing profit for the
period attributable to owners of the Company by the weighted average number of
ordinary shares in issue during the period.
Diluted
Diluted earnings per share is calculated by adjusting the weighted average
number of ordinary shares outstanding to assume conversion of all dilutive
potential ordinary shares. The Company has dilutive potential ordinary shares
in the form of stock options and awards. The weighted average number of shares
is adjusted for the number of shares granted assuming the exercise of stock
options.
 Weighted average number of shares
                                        2017        2016
                                        thousands   thousands
 On a basic basis                       721,126     719,875
 Dilution for share awards and options  27,356      23,346
 On a diluted basis                     748,482     743,220
 
Adjusted Earnings
The Directors believe that diluted earnings per share, adjusted for the impact
of exceptional items after the appropriate tax amount, provides more
meaningful information on underlying trends to shareholders in respect of
earnings per ordinary share. A reconciliation of net income to adjusted net
income is as follows:
                                    Q4     Q4     FY     FY
                                    2017   2016   2017   2016
                                    $m     $m     $m     $m
 Net (loss)/income                  (145)  78     58     35
 Exceptional items                  199    1      224    238
 Tax effect of exceptional items    6      (1)    (3)    (6)
 Exceptional items within taxattegral part of these condensed consolidated financial
statements. 
 
Condensed consolidated cash flow statement 
 
 For the twelve months ended December 31               Unaudited2017$m  Audited2016$m  
 CASH FLOWS FROM OPERATING ACTIVITIES                                                  
 Operating Profit                                      193              149            
 Depreciation and amortization                         13               14             
 Share-based payments                                  16               10             
 Impact from foreign exchange movements                6                1              
 (Increase) in trade and other receivables             (59)             (27)           
 (Increase)/decrease in inventories                    (6)              4              
 Increase in trade and other payables                  5                142            
 Increase in provisions                                201              219            
 Cash generated from operations                        369              512            
 Net financing costs                                   (36)             (42)           
 Transaction costs related to loan                     (5)              -              
 Taxes paid                                            (33)             (63)           
 Net cash inflow from operating activities             295              407            
                                                                                       
 CASH FLOWS FROM INVESTING ACTIVITIES                                                  
 Purchase of property, plant and equipment             (30)             (20)           
 Purchase of intangible assets                         (13)             (15)           
 Net cash (outflow) from investing activities          (43)             (35)           
                                                                                       
 CASH FLOWS FROM FINANCING ACTIVITIES                                                  
 Proceeds from borrowings                              487              -              
 Repayment of borrowings                               (573)            (78)           
 Dividends paid                                        -                (69)           
 Proceeds from issuance of ordinary shares             2                -              
 Net cash (outflow) from financing activities          (84)             (147)          
                                                                                       
 Net increase in cash and cash equivalents             168              225            
 Cash and cash equivalents at beginning of the period  692              467            
 Exchange differences                                  3                -              
 Cash and cash equivalents at end of the period        863              692            
 
 
The notes are an integral part of these condensed consolidated financial
statements. 
 
Notes to the condensed consolidated financial statements 
 
1.   BASIS OF PREPARATION AND ACCOUNTING POLICIES 
 
Indivior PLC (the 'Company') is a public limited company incorporated and
domiciled in the United Kingdom on September 26, 2014. In these condensed
consolidated financial statements ('Financial Statements'), reference to the
'Group' means the Company and all its subsidiaries. 
 
The financial information herein has been prepared in the basis of the
accounting policies set out in the annual accounts of the Group for the year
ended December 31, 2016. No standards or interpretations have been adopted
before the required implementation date. The Group prepares its annual
accounts in accordance with International Financial Reporting Standards (IFRS)
and IFRS Interpretations Committee (IFRIC) interpretations as adopted by the
European Union and the Companies Act 2006 (the Act) applicable to companies
reporting under IFRS. In preparing these condensed consolidated financial
statements, the significant judgments made by management in applying the
Group's accounting policies and the key sources of estimation uncertainty were
the same as those that applied to the consolidated financial statements for
the year ended December 31, 2016, with the exception of changes in estimates
that are required in determining the provision for income taxes for periods. 
 
The consolidated financial statements do not include all the information and
disclosures required in the annual financial statements, and should be read in
conjunction with the Group's annual financial statements as at December 31,
2016. These consolidated financial statements have been authorized for issue
as at February 14, 2018. 
 
As disclosed in Note 7, the Group carries a provision of $438m relating to the
Department of Justice and Federal Trade Commission investigations and
antitrust litigation. The final settlement amount may be materially different
than this provision. This could impact the Group's ability to operate, which
would be further adversely impacted should revenues decline and pipeline
products fail to obtain regulatory approval, all of which could mean the Group
could not continue in business without taking necessary measures to reduce its
cost base and improve its cash flow. As such, this indicates a material
uncertainty that may cast significant doubt on the Group's ability to continue
as a going concern. However, the Directors believe they have the ability to
carry out the measures that would be necessary and that the Group can continue
as a going concern for the foreseeable future. Accordingly, the Directors
continue to adopt the going concern basis for accounting in preparing these
financial statements, which do not include any adjustments that might result
from the outcome of this uncertainty. 
 
The financial information contained in this document does not constitute
statutory accounts as defined in section 434 and 435 of the Act. For the
Group's financial statements for the year ended December 31, 2017, the
auditors expect to issue (1) an emphasis of matter dealing with the outcome of
the Department of Justice and Federal Trade Commission investigations and
antitrust litigation details of which are included above and in note 7; and
(2) a material uncertainty related to going concern section dealing with the
existence of a material uncertainty which may cast significant doubt about the
Group's ability to continue as a going concern in relation to the Group's
involvement in investigations by the Department of Justice and the Federal
Trade Commissions as well as antitrust litigation, which would be further
adversely impacted should revenues decline, pipeline products fail to obtain
regulatory approval and if the uptake of SUBLOCADE is slower than expected.
The inclusion of the above in the auditors' report would not represent a
modification to the auditors' report. 
 
The auditors issued an unqualified opinion and did not contain a statement
under section 498 of the Act on the Group's statutory financial statements for
the year ended December 31, 2016. Emphasis of matters were included with
respect to the outcome of the ANDA litigation, as well as in respect of a
material uncertainty which may have cast doubt on the Group's ability to
continue as a going concern in relation to the Department of Justice and
Federal Trade Commission investigations and antitrust litigation. The
auditors' report on the Group's statutory financial statements for the year
ended December 31, 2016 was not modified in this respect. 
 
2.   SEGMENT INFORMATION 
 
Operating segments are reported in a manner consistent with the internal
reporting provided to the chief operating decision-maker ('CODM'). The CODM,
who is responsible for allocating resources and assessing performance of the
operating segments, has been identified as the Chief Executive Officer (CEO).
The Indivior Group is engaged in a single business activity, which is the
development, manufacture and sale of buprenorphine-based prescription drugs
for treatment of opioid dependence. The CEO reviews financial information on a
geographic basis for evaluating financial performance and allocating
resources. The Group has a single reportable segment. 
 
Revenues 
 
Revenues are attributed to countries based on the country where the sale
originates. The following table represents revenue from continuing operations
attributed to countries based on the country where the sale originates and
non-current assets, net of accumulated depreciation and amortization, by
country. Non-current assets for this purpose consist of property, plant and
equipment, intangible assets, and other receivables. Revenues and non-current
assets for FY 2017 and 2016 were as follows: 
 
Revenues from sale of goods: 
 
                Q42017$m  Q42016$m  FY2017$m  FY2016$m  
 United States  207       206       877       857       
 ROW            58        53        216       201       
 Total          265       259       1,093     1,058     
 
 
Non-current assets: 
 
                2017$m  2016$m  
 United States  68      64      
 ROW            93      46      
 Total          161     110     
 
 
3.   OPERATING COSTS AND EXPENSES 
 
The table below sets out selected operating costs and expenses information: 
 
                                               Q42017$m  Q42016$m  FY2017$m  FY2016$m  
 Research and development expenses             (22)      (32)      (89)      (119)     
                                                                                       
 Marketing, selling and distribution expenses  (51)      (42)      (163)     (144)     
 Administrative expenses                       (270)     (81)      (525)     (520)     
 Depreciation and amortization                 (4)       (2)       (13)      (14)      
 Operating lease rentals                       (1)       (2)       (6)       (5)       
 Total                                         (326)     (127)     (707)     (683)     
 
 
Exceptional Items (Pre-tax) 
 
                          Q42017$m  Q42016$m  FY2017$m  FY2016$m  
 Cost of sales            -         -         -         (11)      
 Legal expenses           (185)     -         (210)     (220)     
 Consulting costs         -         (1)       -         (7)       
 Financing costs          (14)      -         (14)      -         
 Total exceptional items  (199)     (1)       (224)     (238)     
 
 
$210m of FY 2017 pre-tax exceptional items are for investigative and antitrust
litigation matters set out in Note 7. $14m of financing costs are non-cash and
relate to demerger debt issuance costs written off early due to the debt
restructuring.  $238m of pre-tax exceptional items in FY 2016 include legal
provisions, write offs of manufacturing costs and legal and advisory costs
related to the exploration of strategic initiatives for the event of a
potential negative ANDA ruling. 
 
4.   TAXATION 
 
In the year to December 2017, tax on total profits amounted to $79m and
represented a full year effective tax rate of 58% (2016: 64%). A benefit of
$9m is included relating to a release of provisions for unresolved tax
matters, netted by the impact of the re-measurement of deferred tax assets,
and are exceptional.  The company also benefited by $3m for Research credits
in both the US and the UK. Excluding the impact of exceptional items, the
effective tax rate for the year ended December 31, 2017 is 25% (2016: 25%). 
The prior year included exceptionals of $19m in the full year and $30m in the
quarter. 
 
The Group's balance sheet at December 31, 2017 included a tax payable
liability of $41m, corporate tax receivable of $32m, and deferred tax assets
of $58m. 
 
On December 22, 2017, the US Tax Cuts and Jobs Act (H.R. 1), the tax reform
bill (the "Act"), was signed into law. The Act includes numerous changes in
existing tax law, including a permanent reduction in the federal corporate
income tax rate from 35% to 21%. The rate reduction takes effect on January 1,
2018. As a result of the reduction of federal corporate income tax rates, the
Group has recorded a one-time non-cash charge to tax expense for the
revaluation of the Group's deferred tax assets of $15m. 
 
The United Kingdom ('UK') decision to withdraw from the European Union ('EU')
could have a material effect on our taxes. The impact of the withdrawal will
not be known until both the EU and the UK develop the exit plan and the
related changes in tax laws are enacted. We will adjust our current and
deferred income taxes when tax law changes related to the UK withdrawal are
substantively enacted and/or when EU law ceases to apply in the UK. 
 
5.   EARNINGS PER SHARE 
 
                                      Q42017cents  Q42016cents  FY2017cents  FY2016cents  
                                                                                          
 Basic earnings per share             (20)         11           8            5            
 Diluted earnings per share           (20)         10           8            5            
                                                                                          
 Adjusted basic earnings per share    7            7            37           35           
 Adjusted diluted earnings per share  7            7            36           34           
 
 
Basic 
 
Basic earnings per share ("EPS") is calculated by dividing profit for the
period attributable to owners of the Company by the weighted average number of
ordinary shares in issue during the period. 
 
Diluted 
 
Diluted earnings per share is calculated by adjusting the weighted average
number of ordinary shares outstanding to assume conversion of all dilutive
potential ordinary shares. The Company has dilutive potential ordinary shares
in the form of stock options and awards. The weighted average number of shares
is adjusted for the number of shares granted assuming the exercise of stock
options. 
 
 Weighted average number of shares      2017thousands  2016thousands  
 On a basic basis                       721,126        719,875        
 Dilution for share awards and options  27,356         23,346         
 On a diluted basis                     748,482        743,220        
 
 
Adjusted Earnings 
 
The Directors believe that diluted earnings per share, adjusted for the impact
of exceptional items after the appropriate tax amount, provides more
meaningful information on underlying trends to shareholders in respect of
earnings per ordinary share. A reconciliation of net income to adjusted net
income is as follows: 
 
                                    Q42017$m  Q42016$m  FY2017$m  FY2016$m  
 Net (loss)/income                  (145)     78        58        35        
 Exceptional items                  199       1         224       238       
 Tax effect of exceptional items    6         (1)       (3)       (6)       
 Exceptional items within taxation  (6)       (29)      (9)       (13)      
 Adjusted net income                54        49        270       254       
 
 
6.   FINANCIAL LIABILITIES - BORROWINGS 
 
 Current     December 312017$m  December 312016$m  
                                                   
 Bank loans  (5)                (101)              
             (5)                (101)              
 
 
 Non-current  December 312017$m  December 312016$m  
                                                    
 Bank loans   (477)              (434)              
              (477)              (434)              
 
 
 Analysis of net cash       December 312017$m  December 312016$m  
 Cash and cash equivalents  863                692                
 Borrowings*                (487)              (561)              
 Net cash at end of period  376                131                
 
 
*Borrowings reflects the outstanding principal amount drawn, before respective
issuance costs of $5m and $26m, respectively. 
 
 Reconciliation of net cash/(debt)             December 312017$m  December 312016$m  
 The movements in the period were as follows:                                        
 Net cash/(debt) at beginning of period        131                (174)              
 Increase in cash and cash equivalents         171                225                
 Net repayment of borrowings and overdraft     86                 78                 
 Exchange adjustment                           (12)               2                  
 Net cash at end of period                     376                131                
 
 
The net carrying value of current borrowings before issuance costs and cash at
bank, as well as trade receivables and trade payables are assumed to
approximate their fair values. The terms of the loan in effect at December 31,
2017 are as follows: 
 
                       Currency  Nominalinterestmargin  Maturity  Required annual repayments  Maximum leverage ratio  
 Term loan facility    USD       LIBOR (1%) + 4.5%      2022      1%                          3.0                     
 Term loan facility    EUR       LIBOR (0%) + 4.5%      2022      1%                          3.0                     
 
 
• Nominal interest margin is calculated over 3m LIBOR subject to the LIBOR
floor. 
 
• The maximum leverage ratio is a financial covenant to maintain net secured
leverage below a specified maximum (Adjusted net debt to Adjusted EBITDA
ratio) which stands at 3.0x, following the debt restructuring. 
 
7.   CONTINGENT LIABILITIES 
 
The Group increased its provision for investigative and antitrust litigation
matters to $438m. Because these matters are in various stages, Indivior cannot
predict with any certainty the ultimate resolutions, costs or timing of the
resolutions of any of the matters. The final aggregate settlement amount may
be materially different from this provision. The Group continues in
discussions with the Department of Justice about a possible resolution to its
investigation. The Group cannot predict with any certainty whether it will
reach an ultimate resolution with the Department of Justice or any or all of
the parties to the other matters noted below under State Subpoenas and FTC
Investigation and Antitrust Litigation. 
 
Department of Justice Investigation 
 
·      A U.S. federal criminal grand jury investigation of Indivior initiated
in December 2013 is continuing, and includes marketing and promotion
practices, pediatric safety claims, and overprescribing of medication by
certain physicians. The U.S. Attorney's Office for the Western District of
Virginia has served a number of subpoenas relating to SUBOXONE Film, SUBOXONE
Tablet, SUBUTEX Tablet, buprenorphine and our competitors, among other issues.
The Group continues in discussions with the Department of Justice about a
possible resolution to its investigation. It is not possible at this time to
predict with any certainty the potential impact of this investigation on us or
to quantify the ultimate cost of a resolution. We are cooperating fully with
the relevant agencies and prosecutors and will continue to do so. 
 
State Subpoenas 
 
·      On October 12th, 2016, Indivior was served with a subpoena for records
from the State of Connecticut Office of the Attorney General under its
Connecticut civil false claims act authority. The subpoena requests documents
related to the Group's marketing and promotion of SUBOXONE products and its
interactions with a non-profit third-party organization. On November 16th,
2016, Indivior was served with a subpoena for records from the State of
California Department of Insurance under its civil California insurance code
authority. The subpoena requests documents related to SUBOXONE Film, SUBOXONE
Tablet, and SUBUTEX Tablet. The State has served additional deposition
subpoenas on Indivior in 2017. The Group is fully cooperating in these civil
investigations. 
 
FTC investigation and Antitrust Litigation 
 
·      The U.S. Federal Trade Commission's investigation remains pending.
Litigation regarding privilege claims has now been resolved. Indivior has
produced certain documents that it had previously withheld as privileged;
other such documents have not been produced. 
 
·      Fact discovery is continuing in the antitrust class action litigation.
Plaintiffs allege, among other things, that Indivior violated U.S. federal and
state antitrust laws in attempting to delay generic entry of alternatives to
SUBOXONE tablets, and plaintiffs further allege that Indivior unlawfully acted
to lower the market share of these products. 
 
·      Amneal Pharmaceuticals LLC (Amneal), a manufacturer of generic
buprenorphine / naloxone tablets, alleged antitrust violations similar in
nature to those alleged in the class action complaints, and Amneal also
alleged violations of the U.S. Lanham Act. The Company has settled the dispute
with Amneal, and Amneal has dismissed its claims against the Company with
prejudice. 
 
·      A group of states, now numbering 41, and the District of Columbia filed
suit against Indivior in the same district where the antitrust class action
litigation is pending. The States' complaint is similar to the other antitrust
complaints, and alleges violations of U.S. state and federal antitrust and
consumer protection laws. This lawsuit relates to the antitrust investigation
conducted by various states, as discussed in previous filings. Discovery has
been coordinated with the antitrust class action litigation. 
 
ANDA Litigation and Inter Partes Review 
 
·      The ruling after trial against Actavis and Par in the lawsuit involving
the Orange Book-listed patents for SUBOXONE Film issued on June 3rd, 2016. The
ruling found the asserted claims of the '514 patent valid and infringed; the
asserted claims of the '150 patent valid but not infringed; and the asserted
claims of the '832 patent invalid, but found that certain claims would be
infringed if they were valid. In an August 31st, 2017 ruling, the Court denied
motions of Actavis and Par to reopen the June 2016 judgment. 
 
·      Based on the ruling as to the '514 patent, Actavis and Par are
currently enjoined from launching a generic product until April 2024. Par and
Actavis have appealed this ruling, and Indivior has filed notices of
cross-appeal. On October 24th, 2017 Actavis received tentative approval from
FDA for at least its 8 mg/2 mg generic product under ANDA 204383 and on
November 15th, 2017 it received tentative approval for its 12 mg/3 mg generic
product under ANDA 207087. A tentative approval does not allow the applicant
to market the generic drug product and postpones the final approval until all
patent/exclusivity issues have been resolved. Actavis therefore remains
enjoined by the Delaware court ruling. 
 
·      Trial against Dr. Reddy's, Actavis and Par in the lawsuits involving
the process patent (U.S. Patent No. 8,900,497) took place on November 16th and
21st - 23rd, 2016. Trial against Dr. Reddy's in the lawsuit involving two of
the Orange Book-listed patents for SUBOXONE Film (U.S. Patent Nos. 8,017,150
and 8,603,514) took place on November 7th, 16th, and 21st - 23rd, 2016. The
rulings in these trials issued on August 31st, 2017. The rulings found the
asserted claims of the '497, '514, and '150 patents valid but not infringed.
Teva had filed a 505(b)(2) New Drug Application (NDA) for a 16 mg/4 mg
strength of buprenorphine/naloxone film. The parties had agreed that
infringement by Teva's 16 mg/4 mg dosage strength would be governed by the
infringement ruling as to Dr. Reddy's 8 mg/2 mg dosage strength that was the
subject of the trial in November 2016; therefore, the non-infringement ruling
in the Dr. Reddy's case means that the Teva 16 mg/4 mg dosage strength has
been found not to infringe. Indivior has appealed the Dr. Reddy's and Teva
rulings. 
 
·      Dr. Reddy's 30-month stay of FDA approval expired on April 17th, 2017.
So far as Indivior is aware, FDA to date has not granted tentative or final
marketing authorization to Dr. Reddy's generic SUBOXONE Film alternative. 
 
·      If FDA were to grant final approval to Dr. Reddy's (or Teva for the 16
mg / 4 mg strength of buprenorphine/naloxone film) this would enable them to
market a generic film alternative to SUBOXONE® Film in the U.S. However, any
market launch by Dr. Reddy's (or by Teva) before the court of appeals renders
its decision would be on an "at risk" basis because Indivior would have a
claim for damages against Dr. Reddy's (or Teva) if Indivior ultimately
prevails after any appeal. 
 
·      Trial against Alvogen in the lawsuit involving the '514 Orange
Book-listed patent and the '497 process patent for SUBOXONE Film took place on
September 26th - 27th, 2017. Trial was limited to the issue of infringement
because Alvogen did not challenge the validity of either patent. The 30-month
stay of FDA approval of Alvogen's Abbreviated New Drug Application was set to
expire October 29th, 2017. Alvogen agreed not to launch until March 29th, 2018
or until it receives a favourable ruling from the District Court. That
agreement has been extended until April 19th, 2018 in light of a 3-week
extension of the post-trial briefing schedule. 
 
·      By a Court order dated August 22nd, 2016, Indivior's SUBOXONE Film
patent litigation against Sandoz has been dismissed without prejudice because
Sandoz is no longer pursuing Paragraph IV certifications for its proposed
generic formulations of SUBOXONE Film. 
 
·      On September 25th, 2017, Indivior settled its SUBOXONE Film patent
litigation in District Court against Mylan. 
 
·      Mylan filed a petition seeking an inter partes review (IPR) of the '514
and '497 patents. On May 12th, 2017, the US Patent & Trademark Office decided
to institute the '514 IPR proceedings. On September 29th, 2017, Mylan and
MonoSol submitted joint motions to terminate the '514 and '497 IPRs in light
of the parties' settlement of their disputes in the District Court litigation.
On October 6th, 2017 the Patent Board terminated both the '514 and '497 IPR
proceedings as to MonoSol and Mylan. Dr. Reddy's and Par had filed petitions
and motions in June 2017 to join the Mylan '514 IPR proceeding. On October
20th, 2017 the Patent Board refused to institute IPR proceedings and dismissed
Dr. Reddy and Par's petitions. 
 
·      Since August 2017, Indivior received Paragraph IV Notice letters from
Actavis, Par, Alvogen, Mylan, and Dr. Reddy's for Indivior's recently granted
'454 patent. Indivior has filed suit against Alvogen, Dr. Reddy's, Par, and
Teva in the District of New Jersey; and against Actavis in the District of
Utah. Par has filed a corresponding declaratory judgment action in the
District of Virginia. Motions to transfer to another District are pending in
all the cases. Although a complaint against Mylan was filed in the District of
West Virginia, it was dismissed in light of the parties' settlement of their
disputes in the Delaware District Court litigation. 
 
·      Indivior has in February 2018 filed suit against Dr. Reddy's, Actavis,
Par, Alvogen and Teva for infringement of US Patent No. 9,855,221 (the '221
patent), which is listed in the FDA's Orange Book and relates to certain
polymer film compositions having a substantially uniform distribution of
active drug. 
 
·      In the event that one or more of the generic companies are successful
in their patent challenges on a final non-appealable basis, and should there
be FDA approval of one or more of the ANDAs and subsequent commercial launch
of generic SUBOXONE Film, including the potential on an 'at-risk' basis, and
the Group's pipeline products, including SUBLOCADE, fail to launch
successfully or obtain regulatory approval, there is the likelihood that
revenues and operating profits of the Group will significantly decline. In
these circumstances the Directors believe they would be able to take the
required steps to reduce the cost base, however, this would result in a
significant change to the structure of the business. 
 
Rhodes Pharmaceuticals 
 
·      On December 23rd, 2016 Rhodes Pharmaceuticals filed a complaint against
Indivior in the District of Delaware, alleging that Indivior's sale of
SUBOXONE Film in the U.S. infringes one or more claims of a patent. The
asserted patent, which was issued in June 2016 traces back to an application
filed in August 2007. Indivior believes this claim is without merit and will
continue to vigorously defend this action. 
 
Estate of John Bradley Allen 
 
·      On December 27th, 2016, the Estate of John Bradley Allen filed a civil
complaint against Indivior, among other parties, in the Northern District of
New York seeking relief under Connecticut's products liability and unfair
trade practices statutes for damages allegedly caused by SUBOXONE. Indivior
believes this lawsuit is without merit and will continue to vigorously defend
this action. 
 
IRS Notice on Manufacturing Deductions 
 
In 2015, the IRS issued notices of a proposed adjustment for the disallowance
of certain manufacturing deductions claimed by the Group following its audit
of the 2010 to 2014 income tax years. The IRS audits for income tax years 2010
to 2014 have now been completed and the company has accrued for all taxes due
for the agreed audit adjustments, and have no unagreed audit positions for
these periods. The company continues to maintain tax reserves for uncertain
tax positions in open tax periods. 
 
8.   TRADE AND OTHER PAYABLES 
 
                                         December 312017$m  December 312016$m  
 Sales returns and rebates               (433)              (402)              
 Trade payables                          (40)               (33)               
 Accruals                                (179)              (212)              
 Other tax and social security payables  (13)               (11)               
 Total                                   (665)              (658)              
 
 
Sales return and rebate accruals, primarily in the US, are provided for by the
Group at the point of sale in respect of the estimated rebates, discounts or
allowances payable to direct and indirect customers. Accruals are made at the
time of sale but the actual amounts to be paid are based on claims made some
time after the initial recognition of the sale. The estimated amounts may not
fully reflect the final outcome and are subject to change dependent upon,
amongst other things, the payor channel (e.g. Medicaid, Medicare, Managed
Care, etc.) and product mix. Accrual balances are reviewed and adjusted
quarterly in the light of historical experience of actual rebates, discounts
or allowances given and returns made and any changes in arrangements. Future
events could cause the assumptions on which the accruals are based to change,
which could affect the future results of the Group. 
 
9.   SHARE CAPITAL 
 
                          Equityordinaryshares  Nominalvalue$m  
 Issued and fully paid                                          
 At January 1, 2017       720,597,566           72              
 Allotments               865,167               -               
 At December 31, 2017     721,462,733           72              
 
 
                          Equityordinaryshares  Nominalvalue$m  
 Issued and fully paid                                          
 At January 1, 2016       718,577,618           72              
 Allotments               2,019,948             -               
 At December 31, 2016     720,597,566           72              
 
 
Allotment of ordinary shares 
 
During the period, 865,167 ordinary shares (2016: 2,019,948) were allotted to
satisfy vestings/exercises under the Group's Long Term Incentive Plan and US
Employee Stock Purchase Plan. 
 
10. RELATED PARTIES 
 
Indivior's former parent, Reckitt Benckiser Group PLC, was a related party
through 2016 as a result of certain transition management agreements. During
FY 2016, Indivior purchased certain services such as office space rental and
other operational services on commercial terms and on an arm's length basis.
The amount included within administrative expenses in respect of these
services was $4m. 
 
11. POST BALANCE SHEET EVENTS 
 
Indivior entered into an agreement on January 3, 2018 to secure exclusive
global license rights to Addex Therapeutics' GABAB positive allosteric
modulator program.  Under the terms of the agreement, Indivior is making an
upfront payment to Addex of $5m, and will also invest in joint research
efforts. 
 
This information is provided by RNS
The company news service from the London Stock Exchange 
 
ion  (6)    (29)   (9)    (13)
 Adjusted net income                54     49     270    254
 
6.   FINANCIAL LIABILITIES - BORROWINGS
 Current     December 31  December 31
             2017         2016
             $m           $m
 Bank loans  (5)          (101)
             (5)          (101)
 
 Non-current  December 31  December 31
              2017         2016
              $m           $m
 Bank loans   (477)        (434)
              (477)        (434)
 
 Analysis of net cash       December 31  December 31
                            2017         2016
                            $m           $m
 Cash and cash equivalents  863          692
 Borrowings*                (487)        (561)
 Net cash at end of period  376          131
*Borrowings reflects the outstanding principal amount drawn, before respective
issuance costs of $5m and $26m, respectively.
 
 Reconciliation of net cash/(debt)             December 31  December 31
                                               2017         2016
                                               $m           $m
 The movements in the period were as follows:
 Net cash/(debt) at beginning of period        131          (174)
 Increase in cash and cash equivalents         171          225
 Net repayment of borrowings and overdraft     86           78
 Exchange adjustment                           (12)         2
 Net cash at end of period                     376          131
 
The net carrying value of current borrowings before issuance costs and cash at
bank, as well as trade receivables and trade payables are assumed to
approximate their fair values. The terms of the loan in effect at December 31,
2017 are as follows:
                         Currency  Nominal            Maturity  Required annual repayments  Maximum leverage ratio
                                   interest
                                   margin
 Term loan facility      USD       LIBOR (1%) + 4.5%  2022      1%                          3.0
 Term loan facility      EUR       LIBOR (0%) + 4.5%  2022      1%                          3.0
• Nominal interest margin is calculated over 3m LIBOR subject to the LIBOR
floor.
• The maximum leverage ratio is a financial covenant to maintain net secured
leverage below a specified maximum (Adjusted net debt to Adjusted EBITDA
ratio) which stands at 3.0x, following the debt restructuring.
 
7.   CONTINGENT LIABILITIES
The Group increased its provision for investigative and antitrust litigation
matters to $438m. Because these matters are in various stages, Indivior cannot
predict with any certainty the ultimate resolutions, costs or timing of the
resolutions of any of the matters. The final aggregate settlement amount may
be materially different from this provision. The Group continues in
discussions with the Department of Justice about a possible resolution to its
investigation. The Group cannot predict with any certainty whether it will
reach an ultimate resolution with the Department of Justice or any or all of
the parties to the other matters noted below under State Subpoenas and FTC
Investigation and Antitrust Litigation.
 
Department of Justice Investigation
·      A U.S. federal criminal grand jury investigation of Indivior
initiated in December 2013 is continuing, and includes marketing and promotion
practices, pediatric safety claims, and overprescribing of medication by
certain physicians. The U.S. Attorney's Office for the Western District of
Virginia has served a number of subpoenas relating to SUBOXONE® Film,
SUBOXONE® Tablet, SUBUTEX® Tablet, buprenorphine and our competitors, among
other issues. The Group continues in discussions with the Department of
Justice about a possible resolution to its investigation. It is not possible
at this time to predict with any certainty the potential impact of this
investigation on us or to quantify the ultimate cost of a resolution. We are
cooperating fully with the relevant agencies and prosecutors and will continue
to do so.
State Subpoenas
·      On October 12th, 2016, Indivior was served with a subpoena for
records from the State of Connecticut Office of the Attorney General under its
Connecticut civil false claims act authority. The subpoena requests documents
related to the Group's marketing and promotion of SUBOXONE® products and its
interactions with a non-profit third-party organization. On November 16th,
2016, Indivior was served with a subpoena for records from the State of
California Department of Insurance under its civil California insurance code
authority. The subpoena requests documents related to SUBOXONE® Film,
SUBOXONE® Tablet, and SUBUTEX® Tablet. The State has served additional
deposition subpoenas on Indivior in 2017. The Group is fully cooperating in
these civil investigations.
FTC investigation and Antitrust Litigation
·      The U.S. Federal Trade Commission's investigation remains
pending. Litigation regarding privilege claims has now been resolved. Indivior
has produced certain documents that it had previously withheld as privileged;
other such documents have not been produced.
·      Fact discovery is continuing in the antitrust class action
litigation. Plaintiffs allege, among other things, that Indivior violated U.S.
federal and state antitrust laws in attempting to delay generic entry of
alternatives to SUBOXONE® tablets, and plaintiffs further allege that
Indivior unlawfully acted to lower the market share of these products.
·      Amneal Pharmaceuticals LLC (Amneal), a manufacturer of generic
buprenorphine / naloxone tablets, alleged antitrust violations similar in
nature to those alleged in the class action complaints, and Amneal also
alleged violations of the U.S. Lanham Act. The Company has settled the dispute
with Amneal, and Amneal has dismissed its claims against the Company with
prejudice.
·      A group of states, now numbering 41, and the District of Columbia
filed suit against Indivior in the same district where the antitrust class
action litigation is pending. The States' complaint is similar to the other
antitrust complaints, and alleges violations of U.S. state and federal
antitrust and consumer protection laws. This lawsuit relates to the antitrust
investigation conducted by various states, as discussed in previous filings.
Discovery has been coordinated with the antitrust class action litigation.
ANDA Litigation and Inter Partes Review
·      The ruling after trial against Actavis and Par in the lawsuit
involving the Orange Book-listed patents for SUBOXONE® Film issued on June
3rd, 2016. The ruling found the asserted claims of the '514 patent valid and
infringed; the asserted claims of the '150 patent valid but not infringed; and
the asserted claims of the '832 patent invalid, but found that certain claims
would be infringed if they were valid. In an August 31st, 2017 ruling, the
Court denied motions of Actavis and Par to reopen the June 2016 judgment.
·      Based on the ruling as to the '514 patent, Actavis and Par are
currently enjoined from launching a generic product until April 2024. Par and
Actavis have appealed this ruling, and Indivior has filed notices of
cross-appeal. On October 24th, 2017 Actavis received tentative approval from
FDA for at least its 8 mg/2 mg generic product under ANDA 204383 and on
November 15th, 2017 it received tentative approval for its 12 mg/3 mg generic
product under ANDA 207087. A tentative approval does not allow the applicant
to market the generic drug product and postpones the final approval until all
patent/exclusivity issues have been resolved. Actavis therefore remains
enjoined by the Delaware court ruling.
·      Trial against Dr. Reddy's, Actavis and Par in the lawsuits
involving the process patent (U.S. Patent No. 8,900,497) took place on
November 16th and 21st - 23rd, 2016. Trial against Dr. Reddy's in the lawsuit
involving two of the Orange Book-listed patents for SUBOXONE® Film (U.S.
Patent Nos. 8,017,150 and 8,603,514) took place on November 7th, 16th, and
21st - 23rd, 2016. The rulings in these trials issued on August 31st, 2017.
The rulings found the asserted claims of the '497, '514, and '150 patents
valid but not infringed. Teva had filed a 505(b)(2) New Drug Application (NDA)
for a 16 mg/4 mg strength of buprenorphine/naloxone film. The parties had
agreed that infringement by Teva's 16 mg/4 mg dosage strength would be
governed by the infringement ruling as to Dr. Reddy's 8 mg/2 mg dosage
strength that was the subject of the trial in November 2016; therefore, the
non-infringement ruling in the Dr. Reddy's case means that the Teva 16 mg/4 mg
dosage strength has been found not to infringe. Indivior has appealed the Dr.
Reddy's and Teva rulings.
·      Dr. Reddy's 30-month stay of FDA approval expired on April 17th,
2017. So far as Indivior is aware, FDA to date has not granted tentative or
final marketing authorization to Dr. Reddy's generic SUBOXONE® Film
alternative.
·      If FDA were to grant final approval to Dr. Reddy's (or Teva for
the 16 mg / 4 mg strength of buprenorphine/naloxone film) this would enable
them to market a generic film alternative to SUBOXONE(®) Film in the U.S.
However, any market launch by Dr. Reddy's (or by Teva) before the court of
appeals renders its decision would be on an "at risk" basis because Indivior
would have a claim for damages against Dr. Reddy's (or Teva) if Indivior
ultimately prevails after any appeal.
·      Trial against Alvogen in the lawsuit involving the '514 Orange
Book-listed patent and the '497 process patent for SUBOXONE® Film took place
on September 26th - 27th, 2017. Trial was limited to the issue of infringement
because Alvogen did not challenge the validity of either patent. The 30-month
stay of FDA approval of Alvogen's Abbreviated New Drug Application was set to
expire October 29th, 2017. Alvogen agreed not to launch until March 29th, 2018
or until it receives a favourable ruling from the District Court. That
agreement has been extended until April 19th, 2018 in light of a 3-week
extension of the post-trial briefing schedule.
·      By a Court order dated August 22nd, 2016, Indivior's SUBOXONE®
Film patent litigation against Sandoz has been dismissed without prejudice
because Sandoz is no longer pursuing Paragraph IV certifications for its
proposed generic formulations of SUBOXONE® Film.
·      On September 25th, 2017, Indivior settled its SUBOXONE® Film
patent litigation in District Court against Mylan.
·      Mylan filed a petition seeking an inter partes review (IPR) of
the '514 and '497 patents. On May 12th, 2017, the US Patent & Trademark
Office decided to institute the '514 IPR proceedings. On September 29th, 2017,
Mylan and MonoSol submitted joint motions to terminate the '514 and '497 IPRs
in light of the parties' settlement of their disputes in the District Court
litigation. On October 6th, 2017 the Patent Board terminated both the '514 and
'497 IPR proceedings as to MonoSol and Mylan. Dr. Reddy's and Par had filed
petitions and motions in June 2017 to join the Mylan '514 IPR proceeding. On
October 20th, 2017 the Patent Board refused to institute IPR proceedings and
dismissed Dr. Reddy and Par's petitions.
·      Since August 2017, Indivior received Paragraph IV Notice letters
from Actavis, Par, Alvogen, Mylan, and Dr. Reddy's for Indivior's recently
granted '454 patent. Indivior has filed suit against Alvogen, Dr. Reddy's,
Par, and Teva in the District of New Jersey; and against Actavis in the
District of Utah. Par has filed a corresponding declaratory judgment action in
the District of Virginia. Motions to transfer to another District are pending
in all the cases. Although a complaint against Mylan was filed in the District
of West Virginia, it was dismissed in light of the parties' settlement of
their disputes in the Delaware District Court litigation.
·      Indivior has in February 2018 filed suit against Dr. Reddy's,
Actavis, Par, Alvogen and Teva for infringement of US Patent No. 9,855,221
(the '221 patent), which is listed in the FDA's Orange Book and relates to
certain polymer film compositions having a substantially uniform distribution
of active drug.
·      In the event that one or more of the generic companies are
successful in their patent challenges on a final non-appealable basis, and
should there be FDA approval of one or more of the ANDAs and subsequent
commercial launch of generic SUBOXONE® Film, including the potential on an
'at-risk' basis, and the Group's pipeline products, including SUBLOCADE™,
fail to launch successfully or obtain regulatory approval, there is the
likelihood that revenues and operating profits of the Group will significantly
decline. In these circumstances the Directors believe they would be able to
take the required steps to reduce the cost base, however, this would result in
a significant change to the structure of the business.
Rhodes Pharmaceuticals
·      On December 23rd, 2016 Rhodes Pharmaceuticals filed a complaint
against Indivior in the District of Delaware, alleging that Indivior's sale of
SUBOXONE® Film in the U.S. infringes one or more claims of a patent. The
asserted patent, which was issued in June 2016 traces back to an application
filed in August 2007. Indivior believes this claim is without merit and will
continue to vigorously defend this action.
Estate of John Bradley Allen
·      On December 27th, 2016, the Estate of John Bradley Allen filed a
civil complaint against Indivior, among other parties, in the Northern
District of New York seeking relief under Connecticut's products liability and
unfair trade practices statutes for damages allegedly caused by SUBOXONE®.
Indivior believes this lawsuit is without merit and will continue to
vigorously defend this action.
IRS Notice on Manufacturing Deductions
In 2015, the IRS issued notices of a proposed adjustment for the disallowance
of certain manufacturing deductions claimed by the Group following its audit
of the 2010 to 2014 income tax years. The IRS audits for income tax years 2010
to 2014 have now been completed and the company has accrued for all taxes due
for the agreed audit adjustments, and have no unagreed audit positions for
these periods. The company continues to maintain tax reserves for uncertain
tax positions in open tax periods.
 
8.   TRADE AND OTHER PAYABLES
                                         December 31  December 31
                                         2017         2016
                                         $m           $m
 Sales returns and rebates               (433)        (402)
 Trade payables                          (40)         (33)
 Accruals                                (179)        (212)
 Other tax and social security payables  (13)         (11)
 Total                                   (665)        (658)
 
Sales return and rebate accruals, primarily in the US, are provided for by the
Group at the point of sale in respect of the estimated rebates, discounts or
allowances payable to direct and indirect customers. Accruals are made at the
time of sale but the actual amounts to be paid are based on claims made some
time after the initial recognition of the sale. The estimated amounts may not
fully reflect the final outcome and are subject to change dependent upon,
amongst other things, the payor channel (e.g. Medicaid, Medicare, Managed
Care, etc.) and product mix. Accrual balances are reviewed and adjusted
quarterly in the light of historical experience of actual rebates, discounts
or allowances given and returns made and any changes in arrangements. Future
events could cause the assumptions on which the accruals are based to change,
which could affect the future results of the Group.
9.   SHARE CAPITAL
                            Equity       Nominal
                            ordinary     value
                            shares       $m
 Issued and fully paid
 At January 1, 2017         720,597,566  72
 Allotments                 865,167      -
 At December 31, 2017       721,462,733  72
 
                            Equity       Nominal
                            ordinary     value
                            shares       $m
 Issued and fully paid
 At January 1, 2016         718,577,618  72
 Allotments                 2,019,948    -
 At December 31, 2016       720,597,566  72
 
Allotment of ordinary shares
During the period, 865,167 ordinary shares (2016: 2,019,948) were allotted to
satisfy vestings/exercises under the Group's Long Term Incentive Plan and US
Employee Stock Purchase Plan.
10. RELATED PARTIES
Indivior's former parent, Reckitt Benckiser Group PLC, was a related party
through 2016 as a result of certain transition management agreements. During
FY 2016, Indivior purchased certain services such as office space rental and
other operational services on commercial terms and on an arm's length basis.
The amount included within administrative expenses in respect of these
services was $4m.
11. POST BALANCE SHEET EVENTS
Indivior entered into an agreement on January 3, 2018 to secure exclusive
global license rights to Addex Therapeutics' GABA(B) positive allosteric
modulator program.  Under the terms of the agreement, Indivior is making an
upfront payment to Addex of $5m, and will also invest in joint research
efforts.
This information is provided by RNS
The company news service from the London Stock Exchange
 
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