0000950103-13-006174.txt : 20131025 0000950103-13-006174.hdr.sgml : 20131025 20131025101333 ACCESSION NUMBER: 0000950103-13-006174 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20130930 FILED AS OF DATE: 20131025 DATE AS OF CHANGE: 20131025 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shire plc CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-29630 FILM NUMBER: 131169527 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: R924 8EP BUSINESS PHONE: 441256894000 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: R924 8EP FORMER COMPANY: FORMER CONFORMED NAME: Shire Ltd. DATE OF NAME CHANGE: 20080523 FORMER COMPANY: FORMER CONFORMED NAME: Shire plc DATE OF NAME CHANGE: 20051125 FORMER COMPANY: FORMER CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC DATE OF NAME CHANGE: 19980302 10-Q 1 dp41424_10q.htm FORM 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period ended September 30, 2013

Commission File Number: 0-29630
 
SHIRE PLC
(Exact name of registrant as specified in its charter)
 
Jersey (Channel Islands)
(State or other jurisdiction of incorporation or organization)
98-0601486
(I.R.S. Employer Identification No.)
 
5 Riverwalk, Citywest Business Campus, Dublin 24, Republic of Ireland
 (Address of principal executive offices and zip code)
 
+353 1 429 7700
(Registrant’s telephone number, including area code)
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months, and (2) has been subject to such filing requirements for the past 90 days.
 
Yes [X]                                No [  ]
 
Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (232,405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
 
Yes  [X]                               No [  ]
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer.
 
Large accelerated filer [X]      Accelerated filer [  ]      Non-accelerated filer [  ]      Smaller reporting company [  ]
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
 
Yes [  ]                                No [X]
 
As at October 18, 2013 the number of outstanding ordinary shares of the Registrant was 562,936,338.
 
 
 
 
1

 
 
 
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
 
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
 
 
·
Shire’s products may not be a commercial success;
 
 
·
revenues from ADDERALL XR are subject to generic erosion;
 
 
·
the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues and earnings;
 
 
·
Shire relies on a single source for manufacture of certain of its products and a disruption to the supply chain for those products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis;
 
 
·
Shire uses third party manufacturers to manufacture many of its products and is reliant upon third party contractors for certain goods and services, and any inability of these third party manufacturers to manufacture products, or any failure of these third party contractors to provide these goods and services, in each case in accordance with its respective contractual obligations, could adversely affect Shire’s ability to manage its manufacturing processes or to operate its business;
 
 
·
the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
 
 
·
the actions of certain customers could affect Shire's ability to sell or market products profitably and fluctuations in buying or distribution patterns by such customers could adversely impact Shire’s revenues, financial conditions or results of operations;
 
 
·
investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
 
 
·
adverse outcomes in legal matters and other disputes, including Shire’s ability to obtain, maintain, enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
 
and other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2012.
 
 
 
2

 
 
 

The following are trademarks either owned or licensed by Shire plc or its subsidiaries, which are the subject of trademark registrations in certain territories, or which are owned by third parties as indicated and referred to in this Form 10-Q:
 
ADDERALL XR® (mixed salts of a single entity amphetamine)
DAYTRANA® (trademark of Noven Therapeutics, LLC)
DERMAGRAFT® (human fibroblast-derived dermal substitute)
ELAPRASE® (idursulfase)
ELVANSE® (lisdexamfetamine dimesylate)
EQUASYM® (methylphenidate hydrochloride)
EQUASYM XL® (methylphenidate hydrochloride)
FIRAZYR® (icatibant)
FOSRENOL® (lanthanum carbonate)
INTUNIV® (guanfacine extended release)
INTUNIV XRTM (guanfacine hydrochloride extended-release; Canada)
LIALDA® (trademark of Nogra Pharma Limited (“Nogra”))
MEZAVANT® (trademark of Nogra)
PENTASA® (trademark of Ferring B.V. Corp (“Ferring”))
PREMIPLEX® (IGF-I/IGFBP-3)
REPLAGAL® (agalsidase alfa)
RESOLOR® (prucalopride)
VASCUGEL® (allogeneic aortic endothelial cells cultured in a porcine gelatin matrix [Gelfoam®] with cytokines, implanted)
VENVANSE® (lisdexamfetamine dimesylate)
VPRIV® (velaglucerase alfa)
VYVANSE® (lisdexamfetamine dimesylate)
XAGRID® (anagrelide hydrochloride)
ZEFFIX® (trademark of GlaxoSmithKline (“GSK”))
3TC® (trademark of GSK)
 
 
 
 
3

 
 
SHIRE PLC
Form 10-Q for the three months to September 30, 2013

Table of contents

     
 Page
PART I                 FINANCIAL INFORMATION
   
     
ITEM 1.  FINANCIAL STATEMENTS
   
     
 
Unaudited Consolidated Balance Sheets at September 30, 2013 and December 31, 2012
 
5
       
 
Unaudited Consolidated Statements of Income for the three months and nine months to September 30, 2013 and September 30, 2012
 
7
       
 
Unaudited Consolidated Statements of Comprehensive Income for the three months and nine months to September 30, 2013 and September 30, 2012
 
8
       
 
Unaudited Consolidated Statement of Changes in Equity for the nine months to September 30, 2013
 
9
       
 
Unaudited Consolidated Statements of Cash Flows for the nine months to September 30, 2013 and September 30, 2012
 
10
       
 
Notes to the Unaudited Consolidated Financial Statements
 
12
       
ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
34
     
ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
51
     
ITEM 4.  CONTROLS AND PROCEDURES
 
51
     
     
PART II                 OTHER INFORMATION
 
 
     
ITEM 1.  LEGAL PROCEEDINGS
 
51
     
ITEM 1A.  RISK FACTORS
 
51
     
ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
51
     
ITEM 3.  DEFAULTS UPON SENIOR SECURITIES
 
51
     
ITEM 4.  MINE SAFETY DISCLOSURES
 
51
     
ITEM 5.  OTHER INFORMATION
 
52
     
ITEM 6.  EXHIBITS
 
52
 

 
 
4

 
 
PART I: FINANCIAL INFORMATION
 
ITEM1: FINANCIAL STATEMENTS
 
 
SHIRE PLC
 
UNAUDITED CONSOLIDATED BALANCE SHEETS
 

 
 
 
   
September 30,
   
December 31,
 
 
 
 
   
2013
   
2012
 
 
 
Notes
      $’M       $’M  
ASSETS
 
 
                 
Current assets:
 
 
                 
Cash and cash equivalents
 
 
      1,686.1       1,482.2  
Restricted cash
 
 
      16.6       17.1  
Accounts receivable, net
    4       1,037.8       824.2  
Inventories
    5       480.5       436.9  
Deferred tax asset
            210.6       229.9  
Prepaid expenses and other current assets
    6       282.3       221.8  
Total current assets
            3,713.9       3,212.1  
 
                       
Non-current assets:
                       
Investments
            36.7       38.7  
Property, plant and equipment, net
            965.1       955.8  
Goodwill
    7       621.3       644.5  
Other intangible assets, net
    8       2,976.0       2,388.1  
Deferred tax asset
            40.4       46.5  
Other non-current assets
            34.5       31.5  
Total assets
            8,387.9       7,317.2  
LIABILITIES AND EQUITY
                       
Current liabilities:
                       
Accounts payable and accrued expenses
    9       1,581.6       1,501.5  
Convertible bonds
    10       1,100.0       -  
Other current liabilities
    11       163.2       144.1  
Total current liabilities
            2,844.8       1,645.6  
 
                       
Non-current liabilities:
                       
Convertible bonds
    10       -       1,100.0  
Deferred tax liability
            722.0       520.8  
Other non-current liabilities
    12       652.3       241.6  
Total liabilities
            4,219.1       3,508.0  
Commitments and contingencies
    13       -       -  
 
 
 
 
5

 
 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED BALANCE SHEETS (continued)


 
 
 
   
 
   
 
 
 
 
 
   
September 30,
   
December 31,
 
 
 
 
   
2013
   
2012
 
 
 
Notes
      $’M       $’M  
 
 
 
                 
Equity:
 
 
                 
Common stock of 5p par value; 1,000 million shares authorized; and 562.9 million shares issued and outstanding (2012: 1,000 million shares authorized; and 562.5 million shares issued and outstanding)
 
 
      55.8       55.7  
Additional paid-in capital
 
 
      3,045.6       2,981.5  
Treasury stock: 14.5 million shares (2012: 10.7 million shares)
 
 
      (466.6 )     (310.4 )
Accumulated other comprehensive income
    14       101.3       86.9  
Retained earnings
            1,432.7       995.5  
Total equity
            4,168.8       3,809.2  
Total liabilities and equity
            8,387.9       7,317.2  

The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
 
 
 
6

 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF INCOME
 
 
 
   
3 months to
   
3 months to
   
9 months to
   
9 months to
 
 
 
 
   
September 30,
   
September 30,
   
September 30,
   
September 30,
 
 
 
 
   
2013
   
2012
   
2013
   
2012
 
 
 
Notes
      $’M       $’M       $’M       $’M  
Revenues:                                      
  Product sales
 
 
      1,194.9       1,054.5       3,541.8       3,309.1  
  Royalties
 
 
      37.6       41.8       112.4       154.4  
  Other revenues
 
 
      4.1       4.1       18.8       16.5  
Total revenues
 
 
      1,236.6       1,100.4       3,673.0       3,480.0  
Costs and expenses:
 
 
                                 
  Cost of product sales
 
 
      197.1       167.9       528.7       478.8  
  Research and development(1)
 
 
      229.1       224.7       713.4       683.6  
  Selling, general and administrative (1)
 
 
      441.1       437.4       1,337.4       1,448.4  
  Goodwill impairment charge
    7       -       -       198.9       -  
  Gain on sale of product rights
            (3.6 )     (5.7 )     (14.6 )     (16.5 )
  Reorganization costs
    3       13.7       -       57.6       -  
  Integration and acquisition costs
            18.4       2.7       39.9       15.1  
Total operating expenses
            895.8       827.0       2,861.3       2,609.4  
 
                                       
Operating income
            340.8       273.4       811.7       870.6  
 
                                       
Interest income
            0.4       0.9       1.6       2.3  
Interest expense
            (9.0 )     (9.2 )     (27.0 )     (29.0 )
Other income/(expense), net
            0.6       3.5       (1.9 )     3.6  
Total other expense, net
            (8.0 )     (4.8 )     (27.3 )     (23.1 )
Income before income taxes and equity in (losses)/earnings of equity method investees
            332.8       268.6       784.4       847.5  
Income taxes
            (54.3 )     (41.6 )     (183.9 )     (144.6 )
Equity in (losses)/earnings of equity method investees, net of taxes
            (0.3 )     0.2       0.6       0.5  
Net income
            278.2       227.2       601.1       703.4  

Earnings per ordinary share - basic
    50.7 c     40.9 c     109.3 c     126.6 c
Earnings per ordinary share - diluted
    48.8 c     39.6 c     106.2 c     122.4 c
Weighted average number of shares (millions):
                         
Basic
    548.4       555.9       549.8       555.5  
Diluted
    585.7       593.1       587.5       594.0  

 
(1)
Research and development (“R&D”) includes intangible asset impairment charges of $19.9 million (2012: $27.0 million) for the nine months to September 30, 2013. Selling, general and administrative (“SG&A”) costs include amortization of intangible assets relating to intellectual property rights acquired of $44.4 million for the three months to September 30, 2013 (2012: $50.0 million) and $136.1 million for the nine months to September 30, 2013 (2012: $146.6 million).
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
 
 
7

 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME


 
 
3 months to
   
3 months to
   
9 months to
   
9 months to
 
 
 
September 30,
   
September 30,
   
September 30,
   
September 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
 
 
$'M
   
$'M
   
$'M
   
$'M
 
 
 
 
   
 
   
 
   
 
 
Net income
    278.2       227.2       601.1       703.4  
Other comprehensive income:
                               
Foreign currency translation adjustments
    48.9       22.7       14.4       5.0  
Unrealized holding gain/(loss) on available-for-sale securities (net of taxes of $0.1 million, $0.8 million, $1.2 million and $3.7 million)
    0.2       1.2       -       7.2  
Comprehensive income
    327.3       251.1       615.5       715.6  

The components of accumulated other comprehensive income as at September 30, 2013 and December 31, 2012 are as follows:
 


 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Foreign currency translation adjustments
    99.5       85.1  
Unrealized holding gain on available-for-sale securities, net of taxes
    1.8       1.8  
Accumulated other comprehensive income
    101.3       86.9  

The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
 
 
 
 
8

 
 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
(In millions of US dollars except share data)
 
 
 
 
Shire plc shareholders' equity
 
 
 
Common stock Number of shares
M's
   
Common stock
$'M
   
Additional paid-in capital
$’M
   
Treasury stock
$'M
   
Accumulated other comprehensive income
$'M
   
Retained earnings
$'M
   
Total equity
$'M
 
As at January 1, 2013
    562.5       55.7       2,981.5       (310.4 )     86.9       995.5       3,809.2  
Net income
    -       -       -       -       -       601.1       601.1  
Other comprehensive income, net of tax
    -       -       -       -       14.4       -       14.4  
Options exercised
    0.4       0.1       -       -       -       -       0.1  
Share-based compensation
    -       -       56.0       -       -       -       56.0  
Tax benefit associated with exercise of stock options
    -       -       8.1       -       -       -       8.1  
Shares purchased by employee benefit trust ("EBT")
    -       -       -       (50.3 )     -       -       (50.3 )
Shares purchased under share buy-back program
    -       -       -       (190.8 )     -       -       (190.8 )
Shares released by EBT  to satisfy exercise of stock options
    -       -       -       84.9       -       (84.7 )     0.2  
Dividends
    -       -       -       -       -       (79.2 )     (79.2 )
As at September 30, 2013
    562.9       55.8       3,045.6       (466.6 )     101.3       1,432.7       4,168.8  

The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
Dividends per share
 
During the nine months to September 30, 2013 Shire plc declared and paid dividends of 14.60 US cents per ordinary share (equivalent to 43.80 US cents per ADS) totalling $79.2 million.
 
 
 
 
9

 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS


9 months to September 30,
 
2013
   
2012
 
 
    $’M       $’M  
CASH FLOWS FROM OPERATING ACTIVITIES:
               
Net income
    601.1       703.4  
Adjustments to reconcile net income to net cash provided by operating activities:
               
Depreciation and amortization
    229.4       231.5  
Share based compensation
    55.2       65.0  
Change in fair value of contingent consideration
    28.4       3.3  
Impairment of intangible assets
    19.9       27.0  
Goodwill impairment charge
    198.9       -  
Gain on sale of product rights
    (14.6 )     (16.5 )
Other, net
    4.4       1.8  
Movement in deferred taxes
    16.1       (30.4 )
Equity in earnings of equity method investees
    (0.6 )     (0.5 )
 
               
Changes in operating assets and liabilities:
               
Increase in accounts receivable
    (215.2 )     (23.0 )
Increase in sales deduction accruals
    108.7       36.1  
Increase in inventory
    (39.9 )     (81.9 )
(Increase)/decrease in prepayments and other assets
    (70.9 )     17.8  
(Decrease)/increase in accounts payable and other liabilities
    (71.4 )     72.7  
Returns on investment from joint venture
    3.2       4.9  
Net cash provided by operating activities (A)
    852.7       1,011.2  
 
               
CASH FLOWS FROM INVESTING ACTIVITIES:
               
Movements in restricted cash
    0.5       1.7  
Purchases of subsidiary undertakings and businesses, net of cash acquired
    (227.8 )     (97.0 )
Purchases of non-current investments
    (9.9 )     (12.1 )
Purchases of property, plant and equipment ("PP&E")
    (110.3 )     (91.6 )
Purchases of intangible assets
    -       (43.5 )
Proceeds received on sale of product rights
    15.0       13.7  
Other, net
    11.5       13.2  
Net cash used in investing activities (B)
    (321.0 )     (215.6 )
 
 
 
 
10

 
 
 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)


 
 
2013
   
2012
 
 
    $’M       $’M  
CASH FLOWS FROM FINANCING ACTIVITIES:
               
Payments to acquire shares under share buy-back program
    (190.5 )     -  
Payment of dividend
    (79.2 )     (70.7 )
Payments to acquire shares by the Employee Benefit Trust ("EBT")
    (50.3 )     (50.9 )
Excess tax benefit associated with exercise of stock options
    9.5       38.6  
Contingent consideration payments
    (11.3 )     (3.0 )
Other, net
    (5.5 )     (2.6 )
Net cash used in financing activities(C)
    (327.3 )     (88.6 )
Effect of foreign exchange rate changes on cash and cash equivalents (D)
    (0.5 )     (5.1 )
Net increase in cash and cash equivalents (A+B+C+D)
    203.9       701.9  
Cash and cash equivalents at beginning of period
    1,482.2       620.0  
Cash and cash equivalents at end of period
    1,686.1       1,321.9  

Supplemental information associated with continuing
 
 
   
 
 
operations:
 
 
   
 
 
 
 
 
   
 
 
9 months to September 30,
 
2013
   
2012
 
 
    $’M       $’M  
 
               
Interest paid
    (17.6 )     (18.6 )
Income taxes paid
    (244.7 )     (134.6 )

 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
 
 
 
11

 
 
 
 
SHIRE PLC
NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS


1.           Summary of Significant Accounting Policies

(a)           Basis of preparation
 
These interim financial statements of Shire plc and its subsidiaries (collectively “Shire” or the “Company”) and other financial information included in this Form 10-Q, are unaudited. They have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for interim reporting.
 
The balance sheet as at December 31, 2012 was derived from audited financial statements but does not include all disclosures required by US GAAP.
 
These interim financial statements should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year to December 31, 2012.
 
Certain information and footnote disclosures normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period and the Company believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year.
 

(b)           Use of estimates in interim financial statements
 
The preparation of interim financial statements, in conformity with US GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of intangible assets, the valuation of equity investments, sales deductions, income taxes (including provisions for uncertain tax positions and the realization of deferred tax assets), provisions for litigation and legal proceedings, contingent consideration receivable from product divestments and contingent consideration payable in respect of business combinations and asset purchases. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate.
 

(c)           New accounting pronouncements

Adopted during the period

Indefinite-Lived Intangible Assets (Other than Goodwill) Impairment Testing

In July 2012 the Financial Accounting Standard Board (“FASB”) issued guidance on the testing of indefinite-lived intangible assets for impairment. The guidance permits an entity to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, performing the impairment test is unnecessary. The more-likely-than-not threshold is defined as a likelihood of more than 50 percent. An entity also has the option to bypass the qualitative assessment for any indefinite-lived intangible asset in any period and proceed directly to performing the impairment test and may resume performing the qualitative assessment in any subsequent period. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company’s consolidated financial position, results of operations or cash flows.

Disclosure about offsetting assets and liabilities
 
In December 2011 the FASB issued guidance on disclosures about offsetting assets and liabilities. In January 2013 the FASB amended the previous guidance to clarify the scope of guidance issued in December 2011. The amended guidance requires entities to disclose both gross and net information about derivatives including bifurcated embedded derivatives, repurchase agreements and reverse repurchase agreements, and securities borrowing and securities lending transactions
 
 
 
 
12

 
 
 
that are either offset in accordance with FASB guidance on topics “Balance Sheet” and “Derivatives and Hedging” or subject to an enforceable master netting arrangement or similar agreement; to enable users of financial statements to understand the effects or potential effects of those arrangements on its financial position. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company’s consolidated financial position, results of operations or cash flows. Enhanced disclosure of balance sheet offsetting as required by this guidance is included in Note 15.
 
Amounts reclassified out of Comprehensive Income
 
In February 2013 the FASB issued guidance on reporting amounts reclassified out of accumulated other comprehensive income. The guidance requires entities to provide information about the amount reclassified out of comprehensive income by component and presents either on the face of the financial statements or in the notes, significant amounts reclassified out of other comprehensive income by the respective line items of net income, but only if the amount reclassified is required under US GAAP to be reclassified to net income in its entirety in the same reporting period. For other amounts that are not required under US GAAP to be reclassified in their entirety to net income, an entity is required to cross-reference to other disclosures required under US GAAP that provide additional detail about those amounts. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company’s consolidated financial position, results of operations or cash flows.
 
To be adopted in future periods
 
Presentation of an unrecognized tax benefit
 
In July 2013 the FASB issued guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carry forward, a similar tax loss, or a tax credit carry forward exists. The guidance requires entities to present an unrecognized tax benefit or a portion of an unrecognized tax benefit in the financial statements as a reduction to a deferred tax asset for a net operating loss carry forward, a similar tax loss, or a tax credit carry forward, except as follows: to the extent a net operating loss carry forward, a similar tax loss, or a tax credit carry forward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The assessment of whether a deferred tax asset is available is based on the unrecognized tax benefit and deferred tax asset that exist at the reporting date and should be made presuming disallowance of the tax position at the reporting date. The guidance will be effective for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. The Company has not adopted this guidance in the period. The Company is assessing the impact that this guidance will have on its consolidated financial position, results of operations or cash flows.
 

2.           Business combinations

Acquisition of SARcode Bioscience Inc. (“SARcode”)
 
On April 17, 2013 Shire completed the acquisition of 100% of the outstanding share capital of SARcode. The acquisition date fair value of the consideration totaled $368 million, comprising cash consideration paid on closing of $151 million and the fair value of contingent consideration payable of $217 million. The maximum amount of contingent cash consideration which may be payable by Shire in future periods is $525 million dependent upon achievement of certain clinical, regulatory and net sales milestones.

This acquisition brings the new Phase 3 compound, Lifitegrast, currently under development for the signs and symptoms of dry eye disease, into Shire’s portfolio. Shire anticipates launching Lifitegrast in the United States as early as 2016 pending a positive outcome of the Phase 3 clinical development program and regulatory approvals. Shire is acquiring the global rights to Lifitegrast and will evaluate an appropriate regulatory filing strategy for markets outside of the United States.

The acquisition of SARcode has been accounted as a business combination using the acquisition method. The assets and liabilities assumed from SARcode have been recorded at their preliminary fair values at the date of acquisition, being April 17, 2013. The Company’s consolidated financial statements and results of operations include the results of SARcode from April 17, 2013. In the nine months to September 30, 2013 the Company’s consolidated income statement includes pre-tax losses of $17.4 million in relation to the post acquisition results of SARcode.

The purchase price allocation is preliminary pending the determination of the fair values of certain assets and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired in process research and
 
 
 
13

 
 
 
 
development (“IPR&D”) in respect of Lifitegrast ($412 million), net current liabilities assumed ($8.2 million), net non-current liabilities assumed, including deferred tax liabilities ($122.4 million) and goodwill ($86.6 million). The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $86.6 million, which is not deductible for tax purposes. Goodwill includes the value of the assembled workforce and the related scientific expertise in ophthalmology which allows for potential expansion into a new therapeutic area.

In the nine months to September 30, 2013 the Company expensed costs of $14.7 million (2012: $nil) relating to the acquisition of SARcode (including charges related to the change in fair value of contingent consideration payable), which have been recorded within integration and acquisition costs in the Company’s consolidated income statement. 
 
Acquisition of Premacure AB (“Premacure”)
 
On March 8, 2013 Shire completed the acquisition of 100% of the outstanding share capital of Premacure. The acquisition date fair value of the consideration totaled $140.2 million, comprising cash consideration paid on closing of $30.6 million, and the fair value of contingent consideration payable of $109.6 million. The maximum amount of contingent cash consideration which may be payable by Shire in future periods, dependent upon the successful completion of certain development and commercial milestones, is $169 million. Shire will also pay royalties on relevant net sales.
 
Premacure is developing a protein replacement therapy (“PREMIPLEX”), currently in Phase 2 development, for the prevention of Retinopathy of Prematurity (“ROP”). ROP is a rare and potentially blinding eye disorder that primarily affects premature infants and is one of the most common causes of visual loss in childhood. Together, the acquisitions of SARcode and Premacure build Shire’s presence in the ophthalmology therapeutic area.
 
The acquisition of Premacure has been accounted for as a business combination using the acquisition method. The assets and the liabilities assumed from Premacure have been recorded at their preliminary fair values at the date of acquisition, being March 8, 2013. The Company’s consolidated financial statements and results of operations include the results of Premacure from March 8, 2013.
 
The purchase price allocation is preliminary pending final determination of the fair values of certain assets acquired and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired IPR&D in respect of PREMIPLEX ($151.8 million), net current liabilities assumed ($11.7 million), net non-current liabilities assumed, including deferred tax liabilities ($29.5 million) and goodwill ($29.6 million). The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $29.6 million, which is not deductible for tax purposes.
 
In the nine months to September 30, 2013 the Company expensed costs of $9.8 million (2012: nil) relating to the acquisition of Premacure (including charges related to the change in fair value of contingent consideration payable), which have been recorded within integration and acquisition costs in the Company’s consolidated income statement.
 
Acquisition of Lotus Tissue Repair, Inc (“Lotus”)
 
On February 12, 2013 Shire completed the acquisition of 100% of the outstanding share capital of Lotus. The acquisition date fair value of consideration totaled $174.2 million, comprising cash consideration paid on closing of $49.4 million, and the fair value of contingent consideration payable of $124.8 million.  The maximum amount of contingent cash consideration which may be payable by Shire in future periods is $275 million. The amount of contingent cash consideration ultimately payable by Shire is dependent upon achievement of certain pre-clinical and clinical development milestones.
 
Lotus is developing a proprietary recombinant form of human collagen Type VII (“rC7”) as the first and only intravenous protein replacement therapy currently being investigated for the treatment of Dystrophic Epidermolysis Bullosa (“DEB”).  DEB is a devastating orphan disease for which there is no currently approved treatment option other than palliative care. The acquisition adds to Shire’s pipeline a late stage pre-clinical product for the treatment of DEB with global rights.
 
The acquisition of Lotus has been accounted for as a business combination using the acquisition method. The assets and the liabilities assumed from Lotus have been recorded at their preliminary fair values at the date of acquisition, being February 12, 2013. The Company’s consolidated financial statements and results of operations include the results of Lotus from February 12, 2013.
 
The purchase price allocation is preliminary pending final determination of the fair values of certain assets acquired and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired IPR&D in respect of rC7 ($176.7 million), net current assets assumed ($6.8 million), net non-current liabilities assumed, including deferred tax liabilities ($63.4 million) and goodwill ($54.1 million). The final determination of these fair values will be completed as soon
 
 
 
 
14

 
 
 
as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $54.1 million, which is not deductible for tax purposes.
 
In the nine months to September 30, 2013 the Company expensed costs of $4.6 million (2012: $nil) relating to the acquisition of Lotus, which have been recorded within integration and acquisition costs in the Company’s consolidated income statement.

Supplemental disclosure of pro forma information

The unaudited pro forma financial information to present the combined results of the operations of Shire, SARcode Premacure and Lotus are not provided as the collective impacts of these acquisitions were not material to the Company’s results of operations for any period presented.
 

3.           Reorganization costs

Turnhout, Belgium Site Closure

On January 23, 2013 Shire announced that it had decided to proceed with a collective dismissal and business closure at its site in Turnhout, Belgium. This decision follows the conclusion of an information and consultation process. Shire will continue to sell RESOLOR in Europe and the supply of RESOLOR for patients in Europe who rely on the medicine will not be affected. In the three and nine months to September 30, 2013 the Company incurred reorganization costs totaling $1.8 million and $21.0 million, respectively relating to employee involuntary termination benefits and other re-organization costs. The closure of the Turnhout site is expected to be completed by the end of 2013.

“One Shire” business reorganization

On May 2, 2013, the Company announced that there would be a reorganization of the business to integrate the three divisions into a simplified “One Shire” organization in order to drive future growth and innovation. In the three and nine months to September 30, 2013, the Company incurred reorganization costs totaling $11.9 million and $36.6 million respectively, relating to contract termination and other reorganization costs (of which $10.6 million is accrued at September 30, 2013). The Company is continuing to evaluate both the total costs expected to be incurred and the timeframe for completion of this reorganization.
 
Decision to discontinue the construction of the new manufacturing facility in San Diego
 
On October 22, 2013 Shire announced that it had decided to discontinue the construction of its new manufacturing facility in San Diego. Shire will continue to manufacture DERMAGRAFT in its existing facility in La Jolla, and Shire’s ability to meet expected future demand for DERMAGRAFT is not impacted by this decision.  Shire is currently assessing possible disposal opportunities in relation to this facility. It is reasonably possible that charges to write down the carrying value of the assets related to this manufacturing facility may be required in future periods.
 
 
4.           Accounts receivable, net

Accounts receivable at September 30, 2013 of $1,037.8 million (December 31, 2012: $824.2 million), are stated net of a provision for discounts and doubtful accounts of $51.6 million (December 31, 2012: $41.7 million).

Provision for discounts and doubtful accounts:

 
 
2013
   
2012
 
 
    $’M       $’M  
As at January 1,
    41.7       31.1  
Provision charged to operations
    225.3       214.9  
Provision utilization
    (215.4 )     (196.5 )
As at September 30,
    51.6       49.5  

At September 30, 2013 accounts receivable included $36.9 million (December 31, 2012: $38.5 million) related to royalty income.

 
 
 
15

 
 
 
5.           Inventories
 
Inventories are stated at the lower of cost or market and comprise:

 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Finished goods
    170.6       124.4  
Work-in-progress
    241.0       220.6  
Raw materials
    68.9       91.9  
 
    480.5       436.9  

6.           Prepaid expenses and other current assets
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Prepaid expenses
    39.1       31.7  
Income tax receivable
    179.9       130.6  
Value added taxes receivable
    18.7       20.9  
Other current assets
    44.6       38.6  
 
    282.3       221.8  

 
7.           Goodwill
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Goodwill arising on businesses acquired
    621.3       644.5  

In the nine months to September 30, 2013 the Company completed the acquisitions of SARcode, Premacure and Lotus, which resulted in goodwill of $86.6 million, $29.6 million and $54.1 million, respectively (see Note 2 for details).

As a result of the re-alignment of the business into a simplified “One Shire” organization, the Company now comprises one operating and one reportable segment (see note 18 for further details).

 
 
2013
   
2012
 
 
    $’M       $’M  
As at January 1,
    644.5       592.6  
Acquisitions
    170.3       48.1  
Goodwill impairment charge
    (198.9 )     -  
Foreign currency translation
    5.4       (1.5 )
As at September 30,
    621.3       639.2  
 
 
 
 
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Goodwill is tested for impairment at least annually as at October 1 each year. This assessment is also performed whenever there is a change in circumstances that indicates the carrying value of these assets may not be recoverable.
 
In the first quarter of 2013 the Company identified circumstances which indicated that the carrying value of goodwill in the Regenerative Medicine (“RM”) reporting unit may not be recoverable, which triggered an impairment test in advance of the annual testing date.
 
These circumstances included the results of an independent market research study of the DERMAGRAFT sales potential, commissioned by the Company, which was finalized late in the first quarter of 2013. In addition, while the Company still expects DERMAGRAFT to return to growth over coming quarters, the recently completed restructuring of the RM sales and marketing organization and the implementation of a new commercial model had a more pronounced impact than previously expected. As a result of these and other factors forecast future sales are now lower than at the time of acquisition.
 
The results of the Company’s March 31, 2013 impairment test showed that the carrying amount of the RM reporting unit exceeded its fair value and the implied value of the goodwill was $nil. As a result the Company recorded an impairment charge of $198.9 million related to the goodwill allocated to the RM reporting unit. The RM goodwill impairment charge is not deductible for tax purposes. This is the primary reason for the effective rate of tax in the nine months to September 30, 2013 (23%) being higher than the same period in 2012 (17%). Accumulated goodwill impairment as at September 30, 2013 was $198.9 million (December 31, 2012: $nil).
 
Key assumptions used to determine the fair value of the RM reporting unit included expected cash flows for the period from March 31, 2013 to December 31, 2023 and the associated discount rate of 15.1%, which was derived from management’s best estimate of the after-tax weighted average cost of capital for the RM reporting unit.
 
The Company determined the estimated fair value of the RM reporting unit using discounted cash flow analyses. Discounted cash flow analyses are dependent upon a number of quantitative and qualitative factors including estimates of forecasted revenue, profitability, earnings before interest, taxes, depreciation and amortization, and terminal values. The discount rates applied in the discounted cash flow analyses also have an impact on the estimates of fair value, as use of a higher rate will result in a lower estimate of fair value.
 

8.           Other intangible assets, net
 

 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Amortized intangible assets
               
Intellectual property rights acquired for currently marketed products
    2,467.9       2,462.0  
Acquired product technology
    710.0       710.0  
Other intangible assets
    45.3       44.5  
 
    3,223.2       3,216.5  
Unamortized intangible assets
               
Intellectual property rights acquired for IPR&D
    952.8       231.0  
 
    4,176.0       3,447.5  
 
               
Less: Accumulated amortization
    (1,200.0 )     (1,059.4 )
 
    2,976.0       2,388.1  
 
 
 
 
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The change in the net book value of other intangible assets for the nine months to September 30, 2013 and 2012 is shown in the table below:
 
 
 
Other intangible assets
 
 
 
2013
   
2012
 
 
    $’M       $’M  
As at January 1,
    2,388.1       2,493.0  
Acquisitions
    733.2       281.5  
Amortization charged
    (136.1 )     (147.3 )
Impairment charges
    (19.9 )     (27.0 )
Foreign currency translation
    10.7       (6.6 )
As at September 30,
    2,976.0       2,593.6  

In the nine months to September 30, 2013 the Company acquired intangible assets totaling $733.2 million, relating to intangible assets acquired with SARcode, Premacure and Lotus (see Note 2 for further details).

In the second quarter of 2013 the Company reviewed certain IPR&D intangible assets acquired through Movetis N.V. (“Movetis”) for impairment and recognized an impairment charge of $19.9 million (2012: $27.0 million) recorded within R&D in the consolidated income statement, to write-down these IPR&D assets to their fair value. The fair values of these assets were determined using the income approach, which used significant unobservable (Level 3) inputs (see Note 16 for further details).

Management estimates that the annual amortization charge in respect of intangible assets held at September 30, 2013 will be approximately $170 million for each of the five years to September 30, 2018. Estimated amortization expense can be affected by various factors including future acquisitions, disposals of product rights, regulatory approval and subsequent amortization of acquired IPR&D projects, foreign exchange movements and the technological advancement and regulatory approval of competitor products.

 
9.           Accounts payable and accrued expenses
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Trade accounts payable and accrued purchases
    187.8       208.1  
Accrued rebates – Medicaid
    511.7       455.6  
Accrued rebates – Managed care
    235.4       184.9  
Sales return reserve
    95.3       90.5  
Accrued bonuses
    101.6       109.0  
Accrued employee compensation and benefits payable
    89.1       64.5  
R&D accruals
    79.4       73.5  
Provisions for litigation losses and other claims
    78.3       118.2  
Other accrued expenses
    203.0       197.2  
 
    1,581.6       1,501.5  

10.           Convertible Bonds

Shire 2.75% Convertible Bonds due 2014

On May 9, 2007 Shire issued $1,100 million in principal amount of 2.75% convertible bonds due in 2014 and convertible into fully paid ordinary shares of Shire plc (the “Bonds”). The Bonds were issued at 100% of their principal amount, and
 
 
 
18

 
 
 
 
unless previously purchased and cancelled, redeemed or converted, will be redeemed on May 9, 2014 (the “Final Maturity Date”) at their principal amount.
 
The Bonds may be redeemed at the option of the Company, at their principal amount together with accrued and unpaid interest if: (i) at any time after May 23, 2012 if on no less than 20 dealing days in any period of 30 consecutive dealing days the value of Shire’s ordinary shares underlying each Bond in the principal amount of $100,000 would exceed $130,000; or (ii) at any time conversion rights have been exercised, and/or purchases and corresponding cancellations, and/or redemptions effected in respect of 85% or more in principal amount of Bonds originally issued
 
The Bonds are repayable in US dollars, but also contain provisions entitling the Company to settle redemption amounts in Pounds sterling or in the case of Final Maturity Date by delivery of the underlying ordinary shares and, if necessary, a cash top-up amount. As the Bonds will be redeemed within twelve months of the balance sheet date, the Bonds have been presented as a current liability at September 30, 2013.
 

11.           Other current liabilities
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Income taxes payable
    19.4       78.4  
Value added taxes
    28.7       23.6  
Contingent consideration payable
    86.0       16.0  
Other current liabilities
    29.1       26.1  
 
    163.2       144.1  

 
12.           Other non-current liabilities
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Income taxes payable
    81.5       58.9  
Deferred revenue
    10.3       11.4  
Deferred rent
    11.3       11.9  
Insurance provisions
    7.9       12.3  
Contingent consideration payable
    511.8       120.4  
Other non-current liabilities
    29.5       26.7  
 
    652.3       241.6  

 
 
 
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13.           Commitments and contingencies

(a)           Leases

Future minimum lease payments under operating leases at September 30, 2013 are presented below:
 
 
Operating
 
 
 
leases
 
 
    $’M  
2013 
    11.4  
2014 
    42.5  
2015 
    31.8  
2016 
    23.4  
2017 
    17.8  
2018 
    12.1  
Thereafter
    83.2  
 
    222.2  

The Company leases land, facilities, motor vehicles and certain equipment under operating leases expiring through 2032. Lease and rental expense amounted to $35.5 million and $31.4 million for the nine months to September 30, 2013 and 2012 respectively, which is predominately included in SG&A expenses in the Company’s consolidated income statement.

(b)           Letters of credit and guarantees

At September 30, 2013 the Company had irrevocable standby letters of credit and guarantees with various banks and insurance companies totaling $54 million, providing security for the Company’s performance of various obligations. These obligations are primarily in respect of the recoverability of insurance claims, lease obligations and supply commitments.

(c)           Collaborative arrangements

Details of significant updates in collaborative arrangements are included below:

In-licensing arrangements

Collaboration with Acceleron Pharma Inc. (“Acceleron”) for activin receptor type IIB class of molecules

In April 2013, following the results of toxicology studies, Shire discontinued development of HGT4510, returned Shire’s rights in the asset to Acceleron and discontinued the collaboration.
 
Out-licensing arrangements

Shire has entered into various collaborative arrangements under which the Company has out-licensed certain product or intellectual property rights for consideration such as up-front payments, development milestones, sales milestones and/or royalty payments. In some of these arrangements Shire and the licensee are both actively involved in the development and commercialization of the licensed product and have exposure to risks and rewards dependent on its commercial success. Under the terms of these arrangements, the Company may receive development milestone payments up to an aggregate amount of $39.0 million and sales milestones up to an aggregate amount of $71.5 million. The receipt of these substantive milestones is uncertain and contingent on the achievement of certain development milestones or the achievement of a specified level of annual net sales by the licensee. In the nine months to September 30, 2013 Shire received up-front and milestone payments totaling $3.0 million (2012: $6.0 million). In the nine months to September 30, 2013 Shire recognized milestone income of $4.5 million (2012: $6.7 million) in other revenues and $43.8 million (2012: $57.6 million) in product sales for shipment of product to the relevant licensee.

 
 
 
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(d)           Commitments

(i)           Clinical testing

At September 30, 2013 the Company had committed to pay approximately $332 million (December 31, 2012: $425 million) to contract vendors for administering and executing clinical trials. The timing of these payments is dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities.

(ii)           Contract manufacturing

At September 30, 2013 the Company had committed to pay approximately $84 million (December 31, 2012: $125 million) in respect of contract manufacturing. The Company expects to pay $46 million of these commitments in 2013.

(iii)           Other purchasing commitments

At September 30, 2013 the Company had committed to pay approximately $101 million (December 31, 2012: $145 million) for future purchases of goods and services, predominantly relating to active pharmaceutical ingredients sourcing. The Company expects to pay $89 million of these commitments in 2013.

(iv)           Investment commitments

At September 30, 2013 the Company had outstanding commitments to subscribe for interests in companies and partnerships for amounts totaling $15 million (December 31, 2012: $15 million) which may all be payable in 2013, depending on the timing of capital calls.

(v)           Capital commitments

At September 30, 2013 the Company had committed to spend $109 million (December 31, 2012: $97 million) on capital projects.

(e)           Legal and other proceedings

The Company expenses legal costs as they are incurred.

The Company recognizes loss contingency provisions for probable losses when management is able to reasonably estimate the loss. When the estimated loss lies within a range, the Company records a loss contingency provision based on its best estimate of the probable loss. If no particular amount within that range is a better estimate than any other amount, the minimum amount is recorded.  Estimates of losses may be developed substantially before the ultimate loss is known, and are therefore refined each accounting period as additional information becomes known. In instances where the Company is unable to develop a reasonable estimate of loss, no loss contingency provision is recorded at that time. As information becomes known a loss contingency provision is recorded when a reasonable estimate can be made. The estimates are reviewed quarterly and the estimates are changed when expectations are revised. An outcome that deviates from the Company’s estimate may result in an additional expense or release in a future accounting period. At September 30, 2013 provisions for litigation losses, insurance claims and other disputes totaled $86.2 million (December 31, 2012: $130.5 million).

The Company’s principal pending legal and other proceedings are disclosed below. The outcomes of these proceedings are not always predictable and can be affected by various factors. For those legal and other proceedings for which it is considered at least reasonably possible that a loss has been incurred, the Company discloses the possible loss or range of possible loss in excess of the recorded loss contingency provision, if any, where such excess is both material and estimable.

VYVANSE
 
In May and June 2011, Shire was notified that six separate Abbreviated New Drug Applications ("ANDAs") were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of VYVANSE. The notices were from Sandoz, Inc. ("Sandoz"); Amneal Pharmaceuticals LLC ("Amneal"); Watson Laboratories, Inc.; Roxane Laboratories, Inc. ("Roxane"); Mylan Pharmaceuticals, Inc.; and Actavis Elizabeth LLC and Actavis Inc. (collectively, "Actavis").  Within the requisite 45 day period, Shire filed lawsuits for infringement of certain of Shire's VYVANSE patents in the US District Court for the District of New Jersey against each of Sandoz, Roxane, Amneal and Actavis; in the US District Court for the Central District of California against Watson Laboratories, Inc.; and in the US District Court for the
 
 
21

 
 
Eastern District of New York against Mylan Pharmaceuticals, Inc. and Mylan Inc. (collectively "Mylan"). In February 2013, Shire withdrew its lawsuit against Watson following Watson’s withdrawal of its ANDA. On December 9, 2011, the District Court of New Jersey consolidated the Sandoz, Roxane, Amneal and Actavis cases. The filing of the lawsuits triggered a stay of approval of all six ANDAs for up to 30 months from the expiration of the new chemical entity exclusivity, which will expire on August 23, 2014. In December 2011 and February 2012, Shire received additional notifications that Mylan had filed further certifications challenging other VYVANSE patents listed in the Orange Book.  Within the requisite 45 day period, Shire filed a new lawsuit against Mylan, Johnson Matthey Pharmaceutical Materials and Johnson Matthey Inc. in New Jersey. In May 2012, the Mylan case that was filed in the Eastern District of New York was transferred and consolidated with the Mylan, Sandoz, Roxane, Amneal and Actavis cases in New Jersey. In December 2012, the parties completed a Markman briefing. A Markman hearing took place on August 5, 2013 and a ruling was rendered on August 8, 2013. No trial dates have been set.
 
INTUNIV
 
Between March 2010 and March 2011, Shire was notified that seven separate ANDAs had been submitted to the FDA under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of INTUNIV. The ANDA filers were Actavis Inc., Teva Pharmaceuticals USA, Inc., Anchen, Inc., Watson Pharmaceuticals, Inc., Impax Laboratories, Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc., and certain of their respective affiliates.  Shire filed lawsuits against each of these ANDA filers.  All of the lawsuits have now been settled.  Under the terms of the Actavis settlement, Actavis has a license to make and market Actavis' generic versions of INTUNIV in the United States on December 1, 2014.  Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis' exclusivity. All other parties with whom Shire has settled will be able to enter the market with their respective ANDA-approved products after Actavis’ 180 day exclusivity period has expired.  Each of the settlements included a consent judgment confirming that the proposed ANDA products infringe the patents-in-suit, U.S. Patents 6,287,599 and 6,811,794, and that those patents are valid and enforceable with respect to their respective proposed ANDA products.   U.S. Patent 5,854,290, which was originally asserted in some of the litigations, has been dedicated to the public.
 
FOSRENOL
 
Between February 2009 and December 2010 Shire was notified that four separate ANDAs had been submitted to the FDA under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of FOSRENOL. The ANDA filers were Barr Laboratories, Inc.; Mylan, Inc.; Natco Pharma Limited and Alkem Laboratories Ltd., and certain of their respective affiliates. Shire filed lawsuits against each of these ANDA filers.  In April 2011, Shire and Barr reached a settlement and the lawsuit against Barr was dismissed.  The settlement provides Barr with a license to market its own generic version of FOSRENOL upon receiving FDA approval in the US on the earlier of the date of entry of another company’s generic version of FOSRENOL to the US market, or October 1, 2021.  Shire’s lawsuits against Mylan, Alkem and Natco have each been dismissed, and consequently, each of Mylan, Alkem and Natco may enter the US market upon FDA approval of their respective ANDA products.
 
LIALDA

In May 2010 Shire was notified that Zydus Pharmaceuticals USA, Inc. (“Zydus”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of Delaware against Zydus and Cadila Healthcare Limited, doing business as Zydus Cadila. As of February 22, 2013, the case has been administratively closed.  No further activity will take place until after one of the parties files a motion to reopen the case.
 
In February 2012, Shire was notified that Osmotica Pharmaceutical Corporation ("Osmotica") had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA.  Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Northern District of Georgia against Osmotica. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. The court has appointed a special master to assist with a Markman hearing and to preside over any discovery disputes. A Markman hearing took place on August 22, 2013 but no ruling has been rendered. No trial date has been set.
 
In March 2012, Shire was notified that Watson Laboratories Inc.-Florida had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Southern District of Florida against Watson Laboratories Inc.-Florida and Watson Pharmaceuticals, Inc. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. In August 2012, Shire filed an amended complaint adding Watson Pharma, Inc. and Watson Laboratories, Inc. as defendants. A Markman hearing was held on December 20, 2012 and a written Markman decision was given by the court on January 17, 2013. A trial took place in April, 2013 and on May 9, 2013 the trial court issued a decision finding that the proposed generic product infringes the patent-in-suit and that the patent is not invalid.  Watson has appealed the trial court’s ruling to the Court of Appeals of the Federal Circuit and a hearing is scheduled for December 2, 2013.
 
 
22

 
 
In April 2012, Shire was notified that Mylan Pharmaceuticals, Inc. (“Mylan”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Middle District of Florida against Mylan. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. No date for a Markman hearing has been set. A trial is scheduled to occur in September, 2014.
 
ADDERALL XR
 
On November 1, 2010 Impax Laboratories, Inc. (“Impax”) filed suit against Shire in the US District Court for the Southern District of New York claiming that Shire was in breach of its supply contract for the authorized generic version of ADDERALL XR. On February 7, 2013 Shire and Impax settled this dispute and agreed to discontinue all court and related proceedings. Under the terms of the settlement Shire made a one-time cash payment to Impax of $48 million in the first quarter of 2013. Also as part of the settlement, the parties have entered into an amended supply agreement which will govern the supply of authorized generic ADDERALL XR from Shire to Impax until the end of the supply term on September 30, 2014.
 
In February 2011, Shire was notified that Watson Laboratories, Inc.-Florida had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of all approved strengths of ADDERALL XR. Shire filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and certain of its affiliates for infringement of certain of Shire’s ADDERALL XR patents. Par Pharmaceutical, Inc. (the successor in interest to Watson's ANDA for ADDERALL XR) has withdrawn its ANDA, and the litigation was dismissed on January 23, 2013 by agreement between Shire, Watson and Par Pharmaceutical, Inc..
 
 In February 2013, Shire was notified that Neos Therapeutics, Inc. had submitted a New Drug Application under section 505(b)(2) of the Hatch Waxman Act (“505(b)(2) Application”). The 505(b)(2) Application was submitted with a paragraph IV certification for U.S. Reissued Patent Nos. RE41,148 and 42,096 listed in the Orange Book.  Within the requisite 45 day period, Shire filed a lawsuit in the Northern District of Texas against Neos Therapeutics, Inc. for infringement of those patents. The filing of the lawsuit triggered a stay of final approval of the 505(b)(2) Application for 30 months.  No trial date has been set.
 
Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE

On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covered whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act.
 
On February 1, 2013 the Company announced it had reached an agreement in principle to resolve this matter.  The agreement also addresses sales and marketing practices relating to LIALDA and PENTASA pursuant to a subsequent voluntary disclosure made by the Company. Shire cooperated with the US Government throughout the process that led to this agreement in principle.
 
The Company has recorded a $57.5 million charge comprised of the agreement in principle amount, interest and costs, which has been charged to SG&A in the fourth quarter of 2012.  The agreement in principle is subject to change until this matter is finally resolved.  Discussions between the Company and the US Government are ongoing to establish a final resolution to the investigation.

Louisiana Complaint related to ADDERALL, ADDERALL XR, DAYTRANA, VYVANSE and INTUNIV

On July 22 and July 23, 2013, the State of Louisiana served Shire LLC and Shire US Inc., respectively, with a civil complaint filed in the 19th Judicial District Court for the Parish of East Baton Rouge. The complaint alleges that Shire’s sales, marketing, and promotion of ADDERALL, ADDERALL XR, DAYTRANA, VYVANSE and INTUNIV violated state law. The State is seeking monetary relief for its claims of fraud, redhibition, and unjust enrichment, as well as violations of Louisiana’s Medical Assistance Programs Integrity Law, Unfair Trade Practices Act, and anti-trust laws. Shire intends vigorously to defend these claims. Shire is not in a position at this time to predict the timing, result or outcome of these claims.
 
Investigation related to DERMAGRAFT

Shire understands that the Department of Justice, including the US Attorney’s Office for the Middle District of Florida, Tampa Division and the US Attorney’s Office for Washington, DC, is conducting civil and criminal investigations into the
 
 
23

 
 
sales and marketing practices of Advanced BioHealing Inc. (“ABH”) relating to DERMAGRAFT. Shire is cooperating fully with these investigations. Shire is not in a position at this time to predict the scope, duration or outcome of these investigations.
 
Civil Investigative Demand for ADDERALL XR, ADDERALL XR Authorized Generics and VYVANSE

On April 5, 2012 Shire received a Civil Investigative Demand (“CID”) from the United States Federal Trade Commission (“FTC”) requesting that Shire provide it with certain information regarding the supply and reported shortages of ADDERALL XR and its authorized generics and the marketing and sale of ADDERALL XR, its authorized generics and VYVANSE. Shire believes the CID was triggered by reports of product shortages of ADDERALL XR and the authorized generic products in 2011. Shire responded to the CID in 2012. On August 29, 2013, the FTC informed Shire that it was closing the investigation without taking any further action.
 

14.           Accumulated Other Comprehensive Income

The changes in accumulated other comprehensive income, net of their related tax effects, in the nine months to September 30, 2013 are included below:

 
Foreign
currency
translation
adjustment
 
Unrealized
holding
gain/(loss) on
available-for-
sale securities
 
Accumulated
other
comprehensive
income
 
$M
 
$M
 
$M
 
 
 
 
 
 
As at January 1, 2013
85.1 
 
1.8 
 
86.9 
Current period change:
 
 
 
 
 
Other Comprehensive income before reclassification
14.4 
 
2.2 
 
16.6 
Gain transferred to the income statement (within Other (expense)/income, net) on disposal of available-for-sale securities
 
(2.2)
 
(2.2)
Net current period other comprehensive income
14.4 
 
-  
 
14.4 
 
 
 
 
 
 
As at September 30, 2013
99.5 
 
1.8 
 
101.3 

15.           Financial instruments

Treasury policies and organization

The Company’s principal treasury operations are coordinated by its corporate treasury function. All treasury operations are conducted within a framework of policies and procedures approved annually by the Board. As a matter of policy, the Company does not undertake speculative transactions that would increase its currency or interest rate exposure.

Interest rate risk
 
The Company is exposed to interest rate risk on restricted cash, cash and cash equivalents and on foreign exchange contracts on which interest is at floating rates. This exposure is primarily related to US dollar, Pounds sterling and Euro interest rates. As the Company maintains all of its cash, liquid investments and foreign exchange contracts on a short term basis for liquidity purposes, this risk is not actively managed. In the nine months to September 30, 2013 the average interest rate received on cash and liquid investments was less than 1% per annum. The largest proportion of these cash and liquid investments was in US dollar money market and liquidity funds.
 
The Company incurs interest at a fixed rate of 2.75% on its $1,100 million in principal amount convertible bonds due 2014.
 
No derivative instruments were entered into during the nine months to September 30, 2013 to manage interest rate exposure. The Company continues to review its interest rate risk and the policies in place to manage the risk.
 
 
24

 
 
Credit risk
 
Financial instruments that potentially expose Shire to concentrations of credit risk consist primarily of short-term cash investments, derivative contracts and trade accounts receivable (from product sales and from third parties from which the Company receives royalties). Cash is invested in short-term money market instruments, including money market and liquidity funds and bank term deposits. The money market and liquidity funds in which Shire invests are all triple A rated by both Standard and Poor’s and by Moody’s credit rating agencies.
 
The Company is exposed to the credit risk of the counterparties with which it enters into derivative instruments. The Company limits this exposure through a system of internal credit limits which vary according to ratings assigned to the counterparties by the major rating agencies. The internal credit limits are approved by the Board and exposure against these limits is monitored by the corporate treasury function. The counterparties to these derivatives contracts are major international financial institutions.
 
The Company’s revenues from product sales in the US are mainly governed by agreements with major pharmaceutical wholesalers and relationships with other pharmaceutical distributors and retail pharmacy chains. For the year to December 31, 2012 there were three customers in the US that accounted for 50% of the Company’s product sales. However, such customers typically have significant cash resources and as such the risk from concentration of credit is considered acceptable. The Company has taken positive steps to manage any credit risk associated with these transactions and operates clearly defined credit evaluation procedures. However, an inability of one or more of these wholesalers to honor their debts to the Company could have an adverse effect on the Company’s financial condition and results of operations.
 
A substantial portion of the Company’s accounts receivable in countries outside of the United States is derived from product sales to government-owned or government-supported healthcare providers. The Company’s recovery of these accounts receivable is therefore dependent upon the financial stability and creditworthiness of the relevant governments.  In recent years the creditworthiness and general economic condition of a number of Eurozone countries (including Greece, Ireland, Italy, Portugal and Spain (the “Relevant Countries”)) has deteriorated. As a result, in some of these countries the Company is experiencing delays in the remittance of receivables due from government-owned or government-supported healthcare providers. The Company continued to receive remittances in relation to government-owned or government-supported healthcare providers in all the Relevant Countries in the nine months to September 30, 2013, including receipts of $53.5 million and $90.2 million in respect of Spanish and Italian receivables, respectively.
 
To date the Company has not incurred significant losses on accounts receivable in the Relevant Countries, and continues to consider that such accounts receivable are recoverable. The Company will continue to evaluate all its accounts receivable for potential collection risks and has made provision for amounts where collection is considered to be doubtful. If the financial condition of the Relevant Countries or other Eurozone countries suffer significant deterioration, such that their ability to make payments becomes uncertain, or if one or more Eurozone member countries withdraws from the Euro, additional allowances for doubtful accounts may be required, and losses may be incurred, in future periods. Any such loss could have an adverse effect on the Company’s financial condition and results of operations.
 
Foreign exchange risk
 
The Company trades in numerous countries and as a consequence has transactional and translational foreign exchange exposures.
 
Transactional exposure arises where transactions occur in currencies different to the functional currency of the relevant subsidiary. The main trading currencies of the Company are the US dollar, Pounds Sterling, Swiss Franc and the Euro. It is the Company’s policy that these exposures are minimized to the extent practicable by denominating transactions in the subsidiary’s functional currency.
 
Where significant exposures remain, the Company uses foreign exchange contracts (being spot, forward and swap contracts) to manage the exposure for balance sheet assets and liabilities that are denominated in currencies different to the functional currency of the relevant subsidiary. These assets and liabilities relate predominantly to intercompany financing and specific external receivables. The foreign exchange contracts have not been designated as hedging instruments. Cash flows from derivative instruments are presented within net cash provided by operating activities in the consolidated cash flow statement, unless the derivative instruments are economically hedging specific investing or financing activities.
 
Translational foreign exchange exposure arises on the translation into US dollars of the financial statements of non-US dollar functional subsidiaries.
 
At September 30, 2013 the Company had 25 swap and forward foreign exchange contracts outstanding to manage currency risk.  The swap and forward contracts mature within 90 days. The Company did not have credit risk related contingent features or collateral linked to the derivatives.  The Company has master netting agreements with a number of  counterparties to these foreign exchange contracts and on the occurrence of specified events, the Company has the
 
 
25

 
 
ability to terminate contracts and settle them with a net payment by one party to the other. The Company has elected to present derivative assets and derivative liabilities on a gross basis in the consolidated balance sheet. As at September 30, 2013  the potential effect of rights of set off associated with the foreign exchange contracts would be an offset to both assets and liabilities of $0.4 million, resulting in net derivative assets and derivative liabilities of $3.8 million and $3.5 million, respectively. Further details are included below:
 
 
Fair value
 
Fair value
 
 
September 30,
 
December 31,
 
 
2013 
 
2012 
 
 
$’M
 
$’M
 
 
 
 
 
Assets
Prepaid expenses and other current assets
4.2 
 
1.3 
Liabilities
Other current liabilities
3.9 
 
3.0 

Net (losses)/ gains (both realized and unrealized) arising on foreign exchange contracts have been classified in the consolidated statements of income as follows:

 
Location of net
(loss)/gain recognized in income
 
Amount of net (loss)/gain
recognized in income
 
 
 
 
 
 
In the nine months to
 
 
September 30,
 
September 30,
 
 
 
2013 
 
2012 
 
 
 
$’M
 
$’M
 
 
 
 
 
 
Foreign exchange contracts
Other income, net
 
(3.2)
 
9.5 

These net foreign exchange (losses)/gains are offset within Other income, net by net foreign exchange gains/(losses) arising on the balance sheet items that these contracts were put in place to manage.
 
 
26

 
 

16.   Fair value measurement

Assets and liabilities that are measured at fair value on a recurring basis

As at September 30, 2013 and December 31, 2012 the following financial assets and liabilities are measured at fair value on a recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).

 
 
Carrying
   
Fair value
 
 
 
value
   
 
   
 
   
 
   
 
 
 
 
 
   
Total
   
Level 1
   
Level 2
   
Level 3
 
At September 30, 2013
 
$'M
   
$'M
   
$'M
   
$'M
   
$'M
 
 
 
 
   
 
   
 
   
 
   
 
 
Financial assets:
 
 
   
 
   
 
   
 
   
 
 
Available-for-sale securities(1)
    12.0       12.0       12.0       -       -  
Contingent consideration receivable (2)
    39.6       39.6       -       -       39.6  
Foreign exchange contracts
    4.2       4.2       -       4.2       -  
 
                                       
Financial liabilities:
                                       
Foreign exchange contracts
    3.9       3.9       -       3.9       -  
Contingent consideration payable(3)
    597.8       597.8       -       -       597.8  
 
                                       
 
                                       
 
         
Total
   
Level 1
   
Level 2
   
Level 3
 
At December 31, 2012
 
$'M
   
$'M
   
$'M
   
$'M
   
$'M
 
 
                                       
Financial assets:
                                       
Available-for-sale securities(1)
    14.2       14.2       14.2       -       -  
Contingent consideration receivable (2)
    38.3       38.3       -       -       38.3  
Foreign exchange contracts
    1.3       1.3       -       1.3       -  
 
                                       
Financial liabilities:
                                       
Foreign exchange contracts
    3.0       3.0       -       3.0       -  
Contingent consideration payable(3)
    136.4       136.4       -       -       136.4  
 
(1) 
Available-for-sale securities are included within Investments in the consolidated balance sheet.
(2)
Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet.
(3)
Contingent consideration payable is included within Other current liabilities and Other non-current liabilities in the consolidated balance sheet.

Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company’s intent or ability to dispose of the financial instrument.

The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:

 
·
Available-for-sale securities – the fair values of available-for-sale securities are estimated based on quoted market prices for those investments.
 
·
Contingent consideration receivable – the fair value of the contingent consideration receivable has been estimated using the income approach (using a probability weighted discounted cash flow method).
 
·
Foreign exchange contracts – the fair values of the swap and forward foreign exchange contracts have been determined using an income approach based on current market expectations about the future cash flows.
 
·
Contingent consideration payable – the fair value of the contingent consideration payable has been estimated using the income approach (using a probability weighted discounted cash flow method).

 
 
27

 
 
Assets and Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3)

The change in the fair value of the Company’s contingent consideration receivable and payables, which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3), are as follows:

Contingent consideration receivable
 
 
 
 
 
2013
   
2012
 
 
 
$'M
   
$'M
 
 
 
 
   
 
 
Balance at January 1,
    38.3       37.8  
Gain recognized in the income statement (within Gain on sale of product rights) due to change in fair value during the period
    14.6       16.5  
Reclassification of amounts to Other receivables within Other current assets
    (13.9 )     (13.7 )
Amounts recorded to other comprehensive income (within foreign currency translation adjustments)
    0.6       0.4  
 
               
Balance at September 30,
    39.6       41.0  
 
               
Contingent consideration payable
               
 
    2013       2012  
 
 
$'M
   
$'M
 
 
               
Balance at January 1,
    136.4       -  
Initial recognition of contingent consideration payable
    451.4       127.8  
Change in fair value during the period with the corresponding adjustment recognized as a loss in the income statement (within Integration and acquisition costs)
    28.4       3.3  
Reclassification of amounts to Other current liabilities
    (11.1 )     (6.7 )
Change in fair value during the period with corresponding adjustment to the associated intangible asset
    (7.3 )     9.0  
 
               
Balance at September 30,
    597.8       133.4  
 
 
28

 
 
Quantitative Information about Assets and Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3)

Quantitative information about the Company’s recurring Level 3 fair value measurements is included below:

Financial assets:
 
Fair Value at the Measurement Date
   
 
 
 
 
 
 
 
At September 30, 2013
 
Fair value
 
 
Valuation
Technique
 
 
Significant unobservable Inputs
 
Range
   
$'M
 
 
 
 
 
 
                 
Contingent consideration receivable
("CCR")
 
39.6 
 
Income approach (probability weighted discounted cash flow)
 
• Probability weightings applied to different sales scenarios
 
• Future forecast royalties receivable at relevant contractual royalty rates
 
• Assumed market participant discount rate
 
 
10 to 45%
 
 
 
• $5 million to $158 million
 
 
 
• 5.9%
 
 
 
 
 
 
 
 
 
 
Financial liabilities:
 
Fair Value at the Measurement Date
 
 
 
 
 
 
 
 
 
At September 30, 2013
 
Fair value
 
 
Valuation
Technique
 
 
Significant
unobservable Inputs
 
Range
   
$'M
 
 
 
 
 
 
Contingent consideration payable
 
597.8 
 
Income approach (probability weighted discounted cash flow)
 
• Cumulative probability of  milestones being achieved
 
• Assumed market participant discount rate
 
 
• Periods in which milestones are expected to be achieved
 
• Forecast quarterly royalties payable on net sales of
relevant products
 
 
 
18 to 57% (Weighted average)
 
• 2.1 to 8.8% (Weighted average)
 
 
• 2014 to 2024
 
 
 
 
• $1.0 to $7.6 million
 
 

The Company re-measures the CCR (relating to contingent consideration due to the Company following divestment of one of the Company’s products) at fair value at each balance sheet date, with the fair value measurement based on forecast cash flows, over a number of scenarios which vary depending on the expected performance outcome of the product following divestment. The forecast cash flows under each of these differing outcomes have been included in probability weighted estimates used by the Company in determining the fair value of the CCR.
 
 
29

 

 
Contingent consideration payable represents future milestones the Company may be required to pay in conjunction with various business combinations and future royalties payable as a result of certain business combinations and licenses. The amount ultimately payable by Shire in relation to business combinations is dependent upon the achievement of specified future milestones, such as the achievement of certain future development, regulatory and sales milestones. The Company assesses the probability, and estimated timing, of these milestones being achieved and re-measures the related contingent consideration to fair value each balance sheet date. The amount of contingent consideration which may ultimately be payable by Shire in relation to future royalties is dependent upon future net sales of the relevant products over the life of the royalty term. The Company assesses the present value of forecast future net sales of the relevant products and re-measures the related contingent consideration to fair value each balance sheet date.

The fair value of the Company’s contingent consideration receivable and payable could significantly increase or decrease due to changes in certain assumptions which underpin the fair value measurements. Each set of assumptions and milestones are specific to the individual contingent consideration receivable or payable. The assumptions include, among other things, the probability and expected timing of certain milestones being achieved, the forecast future net sales of the relevant products and related future royalties payable, the probability weightings applied to different sales scenarios of one of the Company’s divested products and forecast future royalties receivable under scenarios developed by the Company, and the discount rates used to determine the present value of contingent future cash flows. The Company regularly reviews these assumptions, and makes adjustments to the fair value measurements as required by facts and circumstances.

Assets Measured At Fair Value on a Non-Recurring Basis in the period using Significant Unobservable Inputs (Level 3)

In the second quarter of 2013 the Company reviewed certain IPR&D intangible assets acquired through Movetis for impairment and recognized an impairment charge of $19.9 million, recorded within R&D in the consolidated income statement, to write-down these assets to their fair value. The fair value of these assets was determined using the income approach, which used significant unobservable (Level 3) inputs. These unobservable inputs included, among other things, risk-adjusted forecast future cash flows to be generated by these assets and the determination of an appropriate discount rate to be applied in calculating the present value of forecast future cash flows. The fair value of these assets, determined at the time of the impairment review, was $20.3 million.

Quantitative information about Non-Recurring Level 3 Fair Value Measurements which occurred in the period is included below:

 
 
Fair Value at the Measurement Date
   
 
 
 
 
 
 
 
At September 30, 2013
 
Fair value
 
 
Valuation
Technique
 
 
Significant unobservable Inputs
 
Rate used
   
$'M
 
 
 
 
 
 
   
 
 
 
 
 
 
 
Movetis-related IPR&D intangible assets
 
20.3 
 
Income approach (discounted cash flow)
 
• Decline in forecast peak sales since last impairment test
 
• Assumed market participant discount rate
 
 
 
• 50%
 
 
 
• 8.9%
 
 
 
 
 
30

 

 
Financial assets and liabilities that are not measured at fair value on a recurring basis

The carrying amounts and estimated fair values as at September 30, 2013 and December 31, 2012 of the Company’s financial assets and liabilities which are not measured at fair value on a recurring basis are as follows:

 
 
September 30, 2013
   
December 31, 2012
 
 
 
Carrying
   
 
   
Carrying
   
 
 
 
 
amount
   
Fair value
   
amount
   
Fair value
 
 
    $’M       $’M       $’M       $’M  
 
                               
 
                               
Financial liabilities:
                               
Convertible bonds (Level 1)
    1,100.0       1,382.9       1,100.0       1,228.2  
Building financing obligation (Level 3)
    7.8       10.4       8.0       10.3  

Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company’s intent or ability to dispose of the financial instrument.

The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:

 
·
Convertible bonds – the fair value of Shire’s $1,100 million 2.75% convertible bonds due 2014 is determined by reference to the market price of the instrument as the convertible bonds are publicly traded.

 
·
Building finance obligations - the fair value of building finance obligations are estimated based on the present value of future cash flows, and an estimate of the residual value of the underlying property at the end of the lease term, associated with these obligations.

The carrying amounts of other financial assets and liabilities materially approximate to their fair value because of the short-term maturity of these amounts.
 
 
31

 
 
17.           Earnings per share

The following table reconciles net income and the weighted average ordinary shares outstanding for basic and diluted earnings per share for the periods presented:

 
 
3 months to
   
3 months to
   
9 months to
   
9 months to
 
 
 
September 30,
   
September 30,
   
September 30,
   
September 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
 
    $’M       $’M       $’M       $’M  
Numerator for basic earnings per share
    278.2       227.2       601.1       703.4  
 
                               
Interest on convertible bonds, net of tax
    7.6       7.5       22.7       23.7  
Numerator for diluted earnings per share
    285.8       234.7       623.8       727.1  
 
                               
 
                               
Weighted average number of shares:
                               
 
 
Millions
   
Millions
   
Millions
   
Millions
 
Basic
    548.4       555.9       549.8       555.5  
Effect of dilutive shares:
                               
Share based awards to employees
    3.5       3.7       3.9       5.0  
Convertible bonds 2.75% due 2014
    33.8       33.5       33.8       33.5  
Diluted
    585.7       593.1       587.5       594.0  

1. Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock.
2. Calculated using the treasury stock method.
3. Calculated using the ‘if-converted’ method.

The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:

 
 
3 months to
     
3 months to
     
9 months to
     
9 months to
 
 
 
September 30,
     
September 30,
     
September 30,
     
September 30,
 
 
 
2013 
     
2012 
     
2013 
     
2012 
 
 
 
 No. of shares
     
No. of shares
     
 No. of shares
     
No. of shares
 
 
 
Millions
     
Millions
     
Millions
     
Millions
 
Share based awards to employees
 
0.5 
     
6.6 
     
4.5 
     
4.9 
 

 
1.
Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc’s average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date.
 
 
 
32

 
 
18.           Segmental reporting

Historically the Company had three business units and three reportable segments: Specialty Pharmaceuticals (“SP”), Human Genetic Therapies (“HGT”) and RM.
 
On May 2, 2013 the Company announced that there would be a reorganization of the Company’s business to integrate these business units into a simplified “One Shire” organization in order to drive future growth and innovation. Consequently the SP, HGT and RM segments no longer exist.
 
Shire now comprises a single operating and reportable segment, consistent with the “One Shire” approach that underpins the business simplification. This segment is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative specialist medicines to meet significant unmet patient needs. This segment is supported by several key functions: a global research and development organization and a global supply chain organization, managed through the newly established pipeline group and technical operations group respectively, are utilized and responsible for the development and delivery of products to the market. Products are distributed and sold through the newly established in-line marketed products group which consists of five commercial units focused exclusively on commercial delivery to drive optimum performance of currently marketed products. The business is also supported by a simplified, centralized corporate function group. None of these functional groups meets all of the criteria to be an operating segment.
 
The reorganization to a single operating and reportable segment is consistent with the financial information regularly reviewed by the Executive Committee (which is Shire’s chief operating decision maker) for the purposes of evaluating performance, allocating resources, and planning and forecasting future periods.
 
In the periods set out below, revenues by major product were as follows:

 
 
3 months to,
   
3 months to,
   
9 months to,
   
9 months to,
 
 
 
September 30,
   
September 30,
   
September 30,
   
September 30,
 
 
 
2013
   
2012
   
2013
   
2012
 
 
    $’M       $’M       $’M       $’M  
 
                               
VYVANSE
    299.2       247.1       897.9       773.3  
LIALDA/MEZAVANT
    141.9       104.4       379.9       288.5  
ELAPRASE
    129.1       110.5       392.6       358.3  
REPLAGAL
    108.5       121.7       336.6       379.3  
VPRIV
    87.8       74.9       251.9       229.3  
ADDERALL XR
    81.4       102.2       293.5       347.5  
INTUNIV
    80.8       69.0       248.9       206.6  
PENTASA
    70.6       67.0       215.2       196.7  
FIRAZYR
    62.6       30.3       153.8       81.7  
FOSRENOL
    51.9       38.1       136.3       126.8  
XAGRID
    24.2       22.0       74.1       70.7  
DERMAGRAFT
    23.9       33.7       64.7       134.9  
Other product sales
    33.0       33.6       96.4       115.5  
                                 
Total product sales
    1,194.9       1,054.5       3,541.8       3,309.1  

Further segment disclosures related to geographic area and major customers will be included in the 2013 Annual Report on Form 10-K.

 
33

 
 
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
The following discussion should be read in conjunction with Shire’s unaudited consolidated financial statements and related notes appearing elsewhere in this report.
 
Significant events in the three months to September 30, 2013 and recent developments
 
Pipeline

ABH-001 – for the treatment of Epidermolysis Bullosa

 
·
This program has been discontinued as part of the reprioritization of Shire’s pipeline.
 
OTHER DEVELOPMENTS
 
Decision to discontinue the construction of the new manufacturing facility in San Diego

·
On October 22, 2013 Shire announced that it had decided to discontinue the construction of its new manufacturing facility in San Diego. Shire will continue to manufacture DERMAGRAFT in its existing facility in La Jolla, and Shire’s ability to meet expected future demand for DERMAGRAFT is not impacted by this decision.  Shire is currently assessing possible disposal opportunities in relation to this facility.
 
Share Buy-Back Program
 
·
In the fourth quarter of 2012 Shire commenced a share buy-back program, for the purpose of returning funds to shareholders, of up to $500 million, through both direct purchases of Ordinary Shares and through the purchase of Ordinary Shares underlying American Depositary Receipts. As of October 22, 2013 Shire had made on-market repurchases totaling 9,807,835 Ordinary Shares at a cost of $299 million (excluding transaction costs).

Board and Committee Changes
 
·
On October 23, 2013 Shire announced that Dominic Blakemore will join the Shire Board of Directors effective January 1, 2014.  On joining the Board, Dominic will become a member of the Shire Audit, Compliance & Risk Committee. Dominic’s career experience includes finance and strategy roles with global corporations.  He is currently Group Finance Director of Compass Group plc.
 
Research and development

Products in registration as at September 30, 2013

FIRAZYR for the treatment of Acute Angiotensin Converting Enzyme Inhibitor-Induced Angioedema (ACE-I AE) in Europe
 
In December 2012, Shire submitted a supplemental Marketing Authorization Application (“MAA”), to the European Medicines Agency (“EMA”) seeking approval for FIRAZYR for the treatment of ACE-I AE in Europe.
 
Products in clinical development as at September 30, 2013

Phase 3
 
Lisdexamfetamine dimesylate (“LDX”)1 for the treatment of inadequate response in major depressive disorder (“MDD”)
 
A Phase 3 clinical program to assess the efficacy and safety of LDX as adjunctive therapy in patients with MDD was initiated in the fourth quarter of 2011 and enrollment is now complete. Shire anticipates being able to announce headline data in the first half of 2014.
 
LDX for the treatment of binge eating disorder (“BED”)
 
A Phase 3 clinical program to evaluate the efficacy and safety of LDX in adults with BED was initiated in the fourth quarter of 2012 and enrollment is now complete. Shire anticipates being able to announce headline data in the first half of 2014.
 
INTUNIV for the treatment of ADHD in the EU
 
INTUNIV for the treatment of ADHD in children aged 6 to 17 in the EU was initiated in the fourth quarter of 2011 and has been completed.  Submission for Marketing Authorization is targeted for the first half of 2014.
 
INTUNIV for the treatment of ADHD in Japan
 
Under a collaboration agreement, Shionogi and Shire will co-develop and sell ADHD products in Japan, including INTUNIV. A Phase 3 clinical program to evaluate the efficacy and safety of INTUNIV in Japanese patients aged 6 to 17 was initiated in the second quarter of 2013.
 
 
34

 
 
SHP6062 (formerly SPD-606) Lifitegrast for the treatment of signs and symptoms of dry eye disease
 
A Phase 3 clinical program to further assess the efficacy of SHP606 for the treatment of signs and symptoms of dry eye disease was initiated in the US in the fourth quarter of 2012 and enrollment is now complete. Shire anticipates that headline data for phase 3 from the Lifitegrast trials will be available during the first half of 2014.
 
XAGRID for the treatment of essential thrombocythaemia in Japan
 
A Phase 3 clinical program in Japan was initiated in the fourth quarter of 2010 to assess the safety and efficacy of XAGRID in adult essential thrombocythaemia patients treated with cytoreductive therapy who have become intolerant to their current therapy or whose platelet counts have not been reduced to an acceptable level. The program has been completed and submission for marketing authorization is targeted for the fourth quarter of 2013.
 
RESOLOR for the treatment of chronic constipation in males
 
A Phase 3 European clinical trial to further assess the efficacy of RESOLOR for the treatment of chronic constipation in males was initiated in 2010 and has been completed.
 
SHP5552 (formerly SPD-555) (prucalopride; marketed as RESOLOR in the EU) for the treatment of chronic constipation in the US
 
On January 10, 2012, Shire announced that it had acquired the rights to develop and market prucalopride in the US in an agreement with Janssen Pharmaceutica N.V. Discussions are planned with the FDA to determine potential clinical development pathways.
 
FIRAZYR for the treatment of ACE-I AE in the US
 
Following discussions and agreement with the FDA on a clinical development plan for the US, a Phase 3 study is expected to commence in the fourth quarter of 2013.
 
Phase 2
 
LDX for the treatment of ADHD in Japan
 
Under a collaboration agreement, Shionogi and Shire will co-develop and sell ADHD products in Japan, including LDX. A Phase 2 clinical program to evaluate the efficacy and safety of LDX in Japanese patients aged 6 to 17 was initiated in the second quarter of 2013.
 
SHP6022 (formerly SPD-602) iron chelating agent for the treatment of iron overload secondary to chronic transfusion
 
A Phase 2 trial in pediatric and adult patients with transfusional iron overload is ongoing. This product has received orphan drug designation by the EMA and the FDA for the treatment of chronic iron overload requiring chelation therapy.
 
SHP6092 (formerly HGT-2310) for the treatment of Hunter syndrome with CNS symptoms
 
SHP609 is in development as an enzyme replacement therapy (“ERT”) delivered intrathecally for Hunter syndrome patients with CNS symptoms. The Company initiated a Phase 1/2 clinical trial in the first quarter of 2010 which has now completed. Shire is currently planning a pivotal clinical trial which is expected to initiate in the fourth quarter of 2013. This product has been granted orphan designation in the US.
 
SHP6102 (formerly HGT-1410) for Sanfilippo A Syndrome (Mucopolysaccharidosis IIIA)
 
SHP610 is in development as an ERT delivered intrathecally for the treatment of Sanfilippo A Syndrome, a Lysosomal Storage Disorder (“LSD”). The Company initiated a Phase 1/2 clinical trial in August 2010 which has now completed. Shire is currently planning the next clinical trial for SHP610, designed to measure a clinical response, which is expected to initiate in the first quarter of 2014. The product has been granted orphan drug designation in the US and in the EU.
 
SHP6132 (formerly SRM-003 or VASCUGEL) for the treatment of improvement in patency of arteriovenous (“AV”) access in hemodialysis patients
 
SHP613 is a novel endothelial cell based therapy in development for enhancing blood vessel repair and improving hemodialysis access for patients with end-stage renal disease (“ESRD”).  This product has been granted orphan drug designation in the US and the EU. In March 2013, Shire enrolled the first patients in its two Phase 2 studies designed to evaluate the efficacy and safety of SHP613 (VASCUGEL) in improving AV Fistula (“AVF”) maturation and AV Graft (“AVG”) patency to facilitate hemodialysis in patients with ESRD.
 
 
35

 
 
SHP6072 (formerly HGT-ROP-001 or PREMIPLEX) for the treatment of Retinopathy of Prematurity (“ROP”)
 
SHP607 is in development as a protein replacement therapy for the preventative treatment of ROP, a rare eye disorder associated with premature birth. This product has been granted orphan drug designation both in the US and EU. A Phase 2 clinical trial is ongoing.

Phase 1
 
SHP6112 (formerly HGT-1110) for the treatment of Metachromatic Leukodystrophy (“MLD”)
 
SHP611 is in development as an ERT delivered intrathecally for the treatment of the late infantile form of MLD. This product has been granted orphan drug designation in the US and the EU. The Company initiated a Phase 1/2 clinical trial in August 2012. This trial is ongoing.
 
Other pre-clinical development projects
 
A number of additional projects, focused on rare diseases, are underway in various stages of pre-clinical development.
 
1 Currently marketed as VYVANSE in the US and ELVANSE in certain countries in the EU for the treatment of ADHD.
 
2 Following the announcement of the Company’s reorganization into a simplified “One Shire” organization the Company assigned new codes to its existing development programs.
 
 
36

 
 
Results of operations for the three months to September 30, 2013 and 2012

Financial highlights for the three months to September 30, 2013 are as follows:

 
·
Product sales in the third quarter of 2013 grew strongly (up 13% to $1,195 million). On a Constant Exchange Rate (“CER”) basis, which is a Non GAAP measure, product sales were up 13%.
 
Eight of the Company’s products delivered double digit growth including VYVANSE (up 21% to $299 million), LIALDA/MEZAVANT (up 36% to $142 million), ELAPRASE (up 17% to $129 million), VPRIV (up 17% to $88 million), INTUNIV (up 17% to $81 million) and FIRAZYR (up 107% to $63 million). LIALDA/MEZAVANT sales in the third quarter of 2013 were particularly strong primarily due to growth in US market share.

Growth in total product sales was moderated by DERMAGRAFT (down 29% to $24 million), ADDERALL XR (down 20% to $81 million) and REPLAGAL (down 11% to $109 million). REPLAGAL product sales continue to be impacted by the return of competition to the Fabry market.
 
 
·
Total revenues were up 12% to $1,237 million (2012: $1,100 million) as the growth in product sales was partially offset by lower royalties.

 
·
Operating income was up 25% to $341 million (2012: $273 million) as total operating costs in the third quarter of 2013 increased at a lower rate (up 8%) than total revenues (up 12%) demonstrating Shires focus on delivering efficient growth. Research and Development expenditure was up 2% and Selling, General and Administrative expenditure was up 1%.

 
·
Diluted earnings per ordinary share increased 23% to $0.49 (2012: $0.40), primarily due to higher operating income.

 
 
Results of operations for the three months to September 30, 2013 and 2012
 
Total revenues
 
The following table provides an analysis of the Company’s total revenues by source:
 

 
 
3 months to
   
3 months to
   
 
 
 
 
September 30,
   
September 30,
   
 
 
 
 
2013
   
2012
   
change
 
 
 
$'M
   
$'M
   
%
 
Product sales
    1,194.9       1,054.5       +13  
Royalties
    37.6       41.8       -10  
Other revenues
    4.1       4.1       -  
Total
    1,236.6       1,100.4       +12  

 
37

 
 
Product sales
 
The following table provides an analysis of the Company’s key product sales:
 

 
3 months to
3 months to
 
 
 
 
 
September 30,
September 30,
Product sales
Non-GAAP CER
US prescription
Exit market
 
2013 
2012 
growth
growth
growth
share
Net product sales:
$'M
$'M
%
%
%
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VYVANSE
299.2 
247.1 
21%
+21 
+7 
17 
LIALDA/MEZAVANT
141.9 
104.4 
36%
+36 
+23 
27 
ELAPRASE
129.1 
110.5 
17%
+17 
n/a
n/a
REPLAGAL
108.5 
121.7 
-11%
-10 
n/a
n/a
VPRIV
87.8 
74.9 
17%
+17 
n/a
n/a
ADDERALL XR
81.4 
102.2 
-20%
-20 
-2 
INTUNIV
80.8 
69.0 
17%
+17 
+8 
PENTASA
70.6 
67.0 
5%
+5 
-1 
14 
FIRAZYR
62.6 
30.3 
107%
+106 
n/a
n/a
FOSRENOL
51.9 
38.1 
36%
+35 
-17 
XAGRID
24.2 
22.0 
10%
+8 
n/a
n/a
DERMAGRAFT
23.9 
33.7 
-29%
-29 
n/a
n/a
Other product sales
33.0 
33.6 
-2%
-3 
n/a
n/a
Total product sales
1,194.9 
1,054.5 
13%
 
 
 

(1) 
Data provided by IMS Health National Prescription Audit (“IMS NPA”) relates solely to US-based prescriptions. Exit market share represents the average monthly US market share in the month ended September 30, 2013.
(2) 
IMS NPA Data not available.
(3)
Not sold in the US in the third quarter of 2013.
(4)
The Company’s management analyzes product sales and revenue growth for certain products sold in markets outside of the US on a constant exchange rate (“CER”) basis, so that product sales and revenue growth can be considered excluding movements in foreign exchange rates. Product sales and revenue growth on a CER basis is a Non-GAAP financial measure (“Non-GAAP CER”), computed by comparing 2013 product sales and revenues restated using 2012 average foreign exchange rates to 2012 actual product sales and revenues. Average exchange rates for the three months and nine months to September 30, 2013 were $1.53:£1.00 and $1.32:€1.00 (2012: $1.58:£1.00 and $1.25:€1.00) and $1.55:£1.00 and $1.31:€1.00 (2012: $1.58:£1.00 and $1.29:€1.00).
      
VYVANSE – ADHD
 
VYVANSE product sales showed strong growth (up 21%) in the third quarter of 2013 compared to the third quarter of 2012 due to higher prescription demand, which was up 7% in the quarter in addition to the benefit of price increases taken since the third quarter of 2012.
 
 
38

 
 
Litigation proceedings regarding Shire’s VYVANSE patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
LIALDA/MEZAVANT – Ulcerative Colitis
 
Product sales for LIALDA/MEZAVANT in the third quarter of 2013 were up 36% primarily due to higher prescription demand (up 23%) and stocking in the third quarter of 2013 compared to a slight destocking in the third quarter of 2012, the benefit of which was partially offset by higher sales deductions in the third quarter of 2013 as compared to the third quarter of 2012.
 
Litigation proceedings regarding Shire’s LIALDA patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
ELAPRASE – Hunter syndrome
 
ELAPRASE product sales in the third quarter of 2013 were up 17% compared to the third quarter of 2012 driven primarily by continued growth in the number of patients and higher utilization. Quarterly sales of ELAPRASE can be volatile due to the timings of large orders to certain markets which order less frequently. This accounts for the decline in sales from the second quarter of 2013 to the third quarter of 2013. The underlying number of patients being treated with ELAPRASE continues to grow.
 
REPLAGAL – Fabry disease
 
REPLAGAL sales were down 11% as compared to the third quarter of 2012 primarily due to lower volume in Europe due to the return of competition to the Fabry market and the timing of large orders in the third quarter of 2012 from markets that order less frequently.
 
VPRIV – Gaucher disease
 
VPRIV product sales were up 17% in the third quarter of 2013 compared to the third quarter of 2012 as the number of patients on therapy continues to grow.
 
ADDERALL XR – ADHD
 
ADDERALL XR product sales decreased (down 20%) in the third quarter of 2013 primarily due to higher sales deductions as a percentage of sales in the third quarter of 2013 as compared to the third quarter of 2012.
 
Litigation proceedings regarding Shire’s ADDERALL XR patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
INTUNIV – ADHD
 
The strong growth in INTUNIV product sales (up 17%) in the third quarter of 2013 was driven by a combination of increased US prescription demand (up 8%) and the effect of price increases 1 taken since the third quarter of 2012. The benefit of these increases was partially offset by higher sales deductions in the third quarter of 2013 as compared to the third quarter of 2012.
 
Further information about litigation proceedings regarding Shire’s INTUNIV patents can be found in PART I: ITEM 1 of this Form 10-Q.
 
PENTASA – Ulcerative Colitis
 
PENTASA product sales (up 5%) benefited from price increases1 taken since the third quarter of 2012, partially offset by higher sales deductions in the third quarter of 2013 as compared to the third quarter of 2012.
 
FIRAZYR – Hereditary Angioedema
 
FIRAZYR product sales growth (up 107%) was primarily driven by the US market, where the number of new patients on therapy continues to grow strongly.
 
DERMAGRAFT – Diabetic Foot Ulcers
 
DERMAGRAFT product sales were down 29% compared to the third quarter of 2012.
 
1 The actual net effect of price increases on current period net sales compared to the comparative period is difficult to quantify due to the various managed care rebates, Medicaid discounts, other discount programs in which the Company participates and fee for service agreements with wholesalers customers.
 
 
39

 
 
Royalties
 
The following table provides an analysis of Shire’s royalty income:

 
 
3 months to
   
3 months to
   
 
 
 
 
September 30,
   
September 30,
   
 
 
 
 
2013
   
2012
   
Change
 
 
 
$'M
   
$'M
   
%
 
FOSRENOL
    13.8       14.0       -1  
3TC and ZEFFIX
    10.1       10.6       -5  
ADDERALL XR
    6.2       11.2       -45  
Other
    7.5       6.0       +25  
Total royalties
    37.6       41.8       -10  
 
Cost of product sales
 
Cost of product sales increased to $197.1 million for the three months to September 30, 2013 (16% of product sales), from $167.9 million in the corresponding period in 2012 (16% of product sales). Cost of product sales as a percentage of product sales remained constant in the third quarter of 2013 as compared to the third quarter of 2012. For the three months to September 30, 2013 cost of product sales included depreciation of $11.0 million (2012: $9.4 million).
 
R&D
 
R&D expenditure increased by 2% to $229.1 million for the three months to September 30, 2013 (19% of product sales), compared to $224.7 million in the corresponding period in 2012 (21% of product sales), due to the Company’s continued investment in its R&D pipeline, primarily on non-ADHD programs for LDX, on SHP602 for iron overload and the impact of development programs acquired through business development in 2013 including Lifitegrast. This growth was offset by reduced costs in relation to programs which have been discontinued following the Companys pipeline prioritization review.
 
R&D in the three months to September 30, 2013 included depreciation of $6.3 million (2012: $5.5 million).
 
SG&A
 
SG&A expenditure increased by 1% to $441.1 million (37% of product sales) for the three months to September 30, 2013 from $437.4 million (41% of product sales) in the corresponding period in 2012, primarily due to higher legal and litigation costs incurred in the third quarter of 2013 compared to the third quarter of 2012.  Excluding legal and litigation costs SG&A remained broadly constant, as the Company continues to focus on simplifying its business and delivering efficient growth.
 
For the three months to September 30, 2013 SG&A included depreciation of $16.5 million (2012: $14.2 million) and amortization of $44.4 million (2012: $50.0 million).
 
Gain on sale of product rights
 
For the three months to September 30, 2013 Shire recorded a gain on sale of product rights of $3.6 million (2012: $5.7 million) following re-measurement of the contingent consideration receivable from the divestment of DAYTRANA.
 
Reorganization costs
 
For the three months to September 30, 2013 Shire recorded reorganization costs of $13.7 million (2012: $nil) primarily relating to the “One Shire” reorganization as the Company transitions to a new operating structure.
 
Integration and acquisition costs
 
For the three months to September 30, 2013 Shire recorded integration and acquisition costs of $18.4 million primarily associated with charges related to the change in fair value of contingent consideration and the costs of integrating SARcode Biosciences Inc. (“SARcode”) and Premacure AB (“Premacure”). In the third quarter of 2012 integration and acquisition costs ($2.7 million) primarily related to the acquisition of FerroKin Biosciences, Inc. (“FerroKin”) and the integration of Advanced BioHealing Inc. (“ABH”).
 
 
40

 
 
Interest expense
 
For the three months to September 30, 2013 Shire incurred interest expense of $9.0 million (2012: $9.2 million), which principally relates to the coupon on Shire’s $1,100 million 2.75% convertible bonds due May 2014.
 
Taxation
 
For the three months to September 30, 2013 the effective rate of tax was 16% (2012: 15%).
 
The effective rate of tax in the third quarter of 2013 is higher than the same period in 2012 due primarily to adverse changes in profit mix and changes in provisions for uncertain tax positions partially offset by changes in estimates of the amount of certain tax liabilities following the finalisation of various tax returns.
 
 
41

 
 
Results of operations for the nine months to September 30, 2013 and 2012

Total revenues
 
The following table provides an analysis of the Company’s total revenues by source:
 
 
 
9 months to
   
9 months to
   
 
 
 
 
September 30,
   
September 30,
   
 
 
 
 
2013
   
2012
   
change
 
 
 
$'M
   
$'M
   
%
 
Product sales
    3,541.8       3,309.1       +7  
Royalties
    112.4       154.4       -27  
Other revenues
    18.8       16.5       +14  
Total
    3,673.0       3,480.0       +6  

 
42

 
 
Product sales
 
The following table provides an analysis of the Company’s key product sales:
 

 
 
9 months to
   
9 months to
   
 
   
 
   
 
   
 
 
 
 
September 30,
   
September 30,
   
Product sales
   
Non-GAAP CER
   
US prescription
   
Exit market
 
 
 
2013
   
2012
   
growth
   
growth
   
growth1
   
share1
 
 
 
$'M
   
$'M
   
%
   
%
   
%
   
%
 
Net product sales:
 
 
   
 
   
 
   
 
   
 
   
 
 
 
 
 
   
 
   
 
   
 
   
 
   
 
 
VYVANSE
    897.9       773.3       16 %     +16       +7       17  
LIALDA/MEZAVANT
    379.9       288.5       32 %     +32       +16       27  
ELAPRASE
    392.6       358.3       10 %     +11       n/a     n/a
REPLAGAL
    336.6       379.3       -11 %     -10       n/a     n/a
VPRIV
    251.9       229.3       10 %     +10       n/a     n/a
ADDERALL XR
    293.5       347.5       -16 %     -15       -12       5  
INTUNIV
    248.9       206.6       20 %     +21       +10       4  
PENTASA
    215.2       196.7       9 %     +9       -1       14  
FIRAZYR
    153.8       81.7       88 %     +88       n/a     n/a
FOSRENOL
    136.3       126.8       7 %     +7       -18       4  
XAGRID
    74.1       70.7       5 %     +4       n/a 2     n/a
DERMAGRAFT
    64.7       134.9       -52 %     -52       n/a     n/a
Other product sales
    96.4       115.5       -17 %     -16       n/a       n/a  
Total product sales
    3,541.8       3,309.1       7 %                        
 
(1) 
Data provided by IMS Health National Prescription Audit (“IMS NPA”) relates solely to US-based prescriptions. Exit market share represents the average monthly US market share in the month ended September 30, 2013.
(2)
IMS NPA Data not available.
(3)
Not sold in the US in the nine months to September 30, 2013.
 
VYVANSE – ADHD
 
VYVANSE product sales showed strong growth in the nine months to September 30, 2013, up 16% compared to the same period in 2012, primarily as a result of higher prescription demand (up 7%) and in addition to the benefit of price increases1 taken since September 30, 2012, the benefit of which was partially offset by higher sales deductions and higher destocking in the nine months to September 30, 2013 compared to the same period in 2012.
 
Litigation proceedings regarding Shire’s VYVANSE patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
 
43

 
 
LIALDA/MEZAVANT – Ulcerative Colitis
 
Product sales for LIALDA/MEZAVANT showed strong growth in the nine months to September 30, 2013, up 32%. The growth is primarily due to higher prescription demand (up 16%) which benefited from new Managed Care contracts in the US and stocking in the nine months to September 30, 2013 compared to destocking in the same period in 2012. To a lesser extent1 sales also benefited from the effect of a price increase taken since September 30, 2012, offset by the effect of higher US sales deductions.
 
Litigation proceedings regarding Shire’s LIALDA patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
ELAPRASE – Hunter syndrome
 
Product sales from ELAPRASE in the nine months to September 30, 2013 were up 10% compared to the same period in 2012, primarily due to growth in underlying patient numbers.
 
REPLAGAL – Fabry disease
 
REPLAGAL revenues were down 11% in the nine months to September 30, 2013 compared to the same period in 2012, primarily due to the return of competition to the Fabry market in Europe and the impact of price.
 
ADDERALL XR – ADHD
 
ADDERALL XR product sales decreased in the nine months to September 30, 2013 (down 16%) compared to the same period in 2012, primarily as a result of lower US prescription demand (down 12%) following the introduction of a new generic competitor in June 2012 and the effect of higher sales deductions partially offset by the effect of stocking in the nine months to September 30, 2013 compared to destocking in the same period in 2012.
 
Litigation proceedings regarding Shire’s ADDERALL XR patents are ongoing. Further information about this litigation can be found in PART I: ITEM 1 of this Form 10-Q.
 
INTUNIV – ADHD
 
The strong growth in INTUNIV product sales (up 20%) in the nine months to September 30, 2013 was driven by both growth in US prescription demand and the effect1 of price increases taken since September 30, 2012, the benefit of which was partially offset by higher destocking in the nine months to September 30, 2013 compared to the same period in 2012.
 
Further information about litigation proceedings regarding Shire’s INTUNIV patents can be found in PART I: ITEM 1 of this Form 10-Q.
 
VPRIV – Gaucher disease
 
VPRIV product sales increased by 10% in the nine months to September 30, 2013, primarily due to the continued growth in the number of patients on therapy.
 
PENTASA – Ulcerative Colitis
 
PENTASA product sales (up 9%) benefited from both price increases1 taken since September 30, 2012 and the impact of stocking in the nine months to September 30, 2013 compared to destocking in the same period in 2012.
 
FIRAZYR – Hereditary Angioedema (“HAE”)
 
FIRAZYR product sales (up 88%) showed strong growth reflecting the continuing global growth of the product, particularly in the US market.
 
DERMAGRAFT – DFU
 
DERMAGRAFT product sales in the nine months to September 30, 2013 were down by 52% compared to the same period in 2012.
 
1 The actual net effect of price increases on current period net sales compared to the comparative period is difficult to quantify due to the various managed care rebates, Medicaid discounts, other discount programs in which the Company participates and fee for service agreements with wholesalers customers.
 
 
44

 
 
Royalties
 
The following table provides an analysis of Shire’s royalty income:

 
9 months to
 
9 months to
 
 
 
September 30,
 
September 30,
 
 
 
2013 
 
2012 
 
Change
 
$'M
 
$'M
 
%
FOSRENOL
33.6 
 
37.0 
 
-9 
3TC and ZEFFIX
33.9 
 
34.8 
 
-3 
ADDERALL XR
19.2 
 
62.2 
 
-69 
Other
25.7 
 
20.4 
 
+26 
Total royalties
112.4 
 
154.4 
 
-27 

Royalties from ADDERALL XR in the nine months to September 30, 2013 were significantly impacted by both reduced sales volume and a lower royalty rate being payable to Shire by Impax Laboratories, Inc. for its authorised generic product, following the launch of a new generic product in June 2012.
 
Cost of product sales
 
Cost of product sales increased to $528.7 million for the nine months to September 30, 2013 (15% of product sales), up from $478.8 million in the corresponding period in 2012 (14% of product sales). Cost of product sales as a percentage of product sales remained broadly constant.
 
For the nine months to September 30, 2013 cost of product sales included depreciation of $28.8 million (2012: $23.6 million).
 
R&D
 
R&D expenditure increased to $713.4 million for the nine months to September 30, 2013 (20% of product sales), compared to $683.6 million in the corresponding period in 2012 (21% of product sales). In the nine months to September 30, 2012 R&D included payments of $23.0 million in respect of in-licensed and acquired products and intangible asset impairment charges of $27.0 million compared to impairment charges of $19.9 million in 2013. Excluding these costs R&D increased by $60 million or 9% due to the Company’s continued investment in its R&D pipeline, primarily on non-ADHD programs for LDX, SHP602 for iron overload, and the impact of development programs acquired through business development in 2013 including Lifitegrast. This growth was offset by reduced costs in relation to programs which have been discontinued following the Companys pipeline prioritization review.
 
R&D in the nine months to September 30, 2013 included depreciation of $15.2 million (2012: $18.3 million), and impairment charges in respect of the Company’s RESOLOR IPR&D intangible assets of $19.9 million (2012: $27.0 million).
 
SG&A
 
SG&A expenditure decreased to $1,337.4 million (38% of product sales) for the nine months to September 30, 2013 from $1,448.4 million (44% of product sales) in the corresponding period in 2012, primarily due to the Company’s continuing focus on simplifying its business and delivering efficient growth. In the nine months to September 30, 2012 SG&A also included higher legal and litigation costs and higher intangible amortization expense which were not incurred in the same period in 2013.
 
For the nine months to September 30, 2013 SG&A included depreciation of $49.3 million (2012: $42.3 million) and amortization of $136.1 million (2012: $146.6 million).
 
Goodwill impairment charges
 
In the nine months to September 30, 2013 Shire recorded a goodwill impairment charge of $198.9 million (2012: $nil) in relation to the RM business. Following a review of future forecasts for the RM business unit, management determined in the first quarter of 2013 that future sales were expected to be lower than anticipated at the time of acquisition and
 
 
45

 
 
consequently in accordance with US GAAP, it was determined that the goodwill attributable to the RM business unit was impaired.
 
Gain on sale of product rights
 
For the nine months to September 30, 2013 Shire recorded a gain on sale of product rights of $14.6 million (2012: $16.5 million) following re-measurement of the contingent consideration receivable from the divestment of DAYTRANA.
 
Reorganization costs
 
For the nine months to September 30, 2013 Shire recorded reorganization costs of $57.6 million (2012: $nil), relating to the collective dismissal and business closure at Turnhout, Belgium and the “One Shire” reorganization as the Company transitions to a new operating structure.
 
Integration and acquisition costs
 
For the nine months to September 30, 2013 Shire recorded integration and acquisition costs of $39.9 million primarily associated with the acquisitions of SARcode and Lotus and the integration of FerroKin in addition to charges related to the change in fair value of contingent consideration. In 2012 integration and acquisition costs of $15.1 million primarily related to the acquisition of FerroKin and the integration of ABH.
 
Interest expense
 
For the nine months to September 30, 2013 Shire incurred interest expense of $27.0 million (2012: $29.0 million), which principally relates to the coupon on Shire’s $1,100 million 2.75% convertible bonds due 2014.
 
Taxation
 
For interim reporting purposes, the Company calculates its tax expense by estimating its global annual effective tax rate and applies that rate in providing for income taxes on a year-to-date basis. The Company has calculated an expected annual effective tax rate, excluding significant, unusual or extraordinary items, and the tax effect of jurisdictions with losses for which a tax benefit cannot be recognized.  In the nine months to September 30, 2013 the effective rate of tax was 23% (2012: 17%). The effective rate of tax for the nine months to September 30, 2013 is higher than the same period in 2012 due primarily to the impact of the goodwill impairment charge recorded in the first quarter of 2013 which is not deductible for tax purposes and adverse changes in profit mix partially offset by changes in estimates of the amount of certain tax liabilities following the finalization of various tax returns.
 
 
46

 
 
Financial condition at September 30, 2013 and December 31, 2012
 
Accounts receivable, net
 
Accounts receivable, net increased by $213.6 million to $1,037.8 million (December 31, 2012: $824.2 million), primarily due to the increase in revenue in the nine months to September 30, 2013. Days sales outstanding increased to 55 days (December 31, 2012: 50 days).
 
Other intangible assets, net
 
Other intangible assets increased by $587.9 million to $2,976.0 million (December 31, 2012: $2,388.1 million), due to the IPR&D assets acquired with SARcode, Premacure and Lotus, offset by intangible asset amortization, IPR&D impairment and foreign exchange movements.
 
Convertible bonds
 
Current liabilities have increased by $1,100 million due to the reclassification of the Company’s $1,100 million 2.75% convertible bonds due 2014 from non-current to current liabilities in 2013 as the Company is required to redeem the Bonds within twelve months of the balance sheet date.
 
Non-current deferred tax liabilities
 
Non-current deferred tax liabilities increased by $201.2 million to $722.0 million (December 31, 2012: $520.8 million), primarily due to deferred tax liabilities arising on the IPR&D assets acquired with SARcode, Premacure and Lotus.
 
Other non-current liabilities
 
Other non-current liabilities increased by $410.7 million to $652.3 million (December 31, 2012: $241.6 million) primarily due to the recognition of non-current contingent consideration payable related to the SARcode, Premacure and Lotus business combinations.
 
 
47

 

 
Liquidity and capital resources
 
General
 
The Company’s funding requirements depend on a number of factors, including the timing and extent of its development programs; corporate, business and product acquisitions; the level of resources required for the expansion of certain manufacturing and marketing capabilities as the product base expands; increases in accounts receivable and inventory which may arise with any increase in product sales; competitive and technological developments; the timing and cost of obtaining required regulatory approvals for new products; the timing and quantum of milestone payments on collaborative projects; the timing and quantum of tax and dividend payments; the timing and quantum of purchases by the EBT of Shire shares in the market to satisfy awards granted under Shire’s employee share plans; the timing and quantum of purchases of Shire shares under the share buy-back program; and the amount of cash generated from sales of Shire’s products and royalty receipts.
 
An important part of Shire’s business strategy is to protect its products and technologies through the use of patents, proprietary technologies and trademarks, to the extent available. The Company intends to defend its intellectual property and as a result may need cash for funding the cost of litigation.
 
The Company finances its activities through cash generated from operating activities; credit facilities; private and public offerings of equity and debt securities; and the proceeds of asset or investment disposals.
 
Shire’s balance sheet includes $1,686.1 million of cash and cash equivalents at September 30, 2013. Substantially all of Shire’s debt relates to its $1,100 million 2.75% convertible bonds due 2014 (the “Bonds”). In addition, Shire has a revolving credit facility of $1,200 million which matures in 2015 (the “RCF”), which is currently undrawn.
 
Financing
 
Shire anticipates that its operating cash flow together with available cash, cash equivalents and the RCF will be sufficient to meet its anticipated future operating expenses, share buy-back program, capital expenditures, tax and interest payments, lease obligations and milestone payments as they become due over the next twelve months.
 
If the Company decides to acquire other businesses, it expects to fund these acquisitions from existing cash resources, the RCF and possibly through new borrowings and the issue of new equity if necessary.
 
Share buy-back program
 
Shire has a strong balance sheet and continued robust cash generation, and considers efficient use of capital on behalf of shareholders an important objective. Therefore, during the year to December 31, 2012 the Company commenced a share buy-back program, for the purpose of returning funds to shareholders, of up to $500 million through both direct purchases of ordinary shares and through the purchase of ordinary shares underlying American Depository Receipts (“ADRs”).
 
At September 30, 2013 the Company had made on-market repurchases totaling 9,755,400 Ordinary shares at a cost of $297.0 million (excluding transaction costs). This represents 1.73% of the issued share capital of the Company as at the end of the quarter. Ordinary Shares purchased may be cancelled or be held as treasury shares, in accordance with the authority renewed by shareholders at the Company’s Annual General Meeting (“AGM”).  At its AGM on April 24, 2012 the Company was authorized to make market purchases of up to 56,253,208 of its own Ordinary Shares. That authority expired at the AGM held on April 30, 2013 and was renewed.  Under the new authority, which expires on the earlier of July 29, 2014 or the conclusion of the 2014 AGM, the Company was authorized to make market purchases of up to 55,741,587 of its own Ordinary Shares.
 
 
48

 
 
The following table provides information about purchases by the Company in the nine months to September 30, 2013 of equity securities that are registered by the Company pursuant to Section 12 of the Exchange Act.
 

Period
 
Total
Number of
ordinary
shares
Purchased
 
Average Price
Paid Per
ordinary share
(£)
 
Total Number of
ordinary shares
underlying ADRs
Purchased
 
Average Price
Paid Per ordinary
share underlying
ADRs ($)
 
Approximate
Dollar Value of
ordinary shares
that May Yet Be
Purchased Under
the Share Buy-
back Program
January 2013
  715,203   19.934   336,300   32.360  
$360 million
February 2013
  448,896   20.748   164,100   31.954  
$340 million
March 2013
  466,918   20.110   244,200   30.518  
$318 million
April 2013
  866,594   19.731   500,400   30.263  
$277 million
May 2013
  1,136,618   19.383   418,698   30.081  
$231 million
June 2013
  320,688   20.716   181,857   32.247  
$215 million
July 2013
  112,365   21.833   46,782   32.727  
$209 million
August 2013
  59,513   24.020   26,331   37.291  
$206 million
September 2013
  52,350   24.679   26,016   39.411  
$203 million
 
Sources and uses of cash
 
The following table provides an analysis of the Company’s gross and net cash/ debt position (excluding restricted cash), as at September 30, 2013 and December 31, 2012:
 
 
 
September 30,
   
December 31,
 
 
 
2013
   
2012
 
 
    $’M       $’M  
Cash and cash equivalents
    1,686.1       1,482.2  
Convertible bonds
    1,100.0       1,100.0  
Other
    8.9       9.3  
Total debt
    1,108.9       1,109.3  
Net cash
    577.2       372.9  
 
(1) Substantially all of the Company’s cash and cash equivalents are held by foreign subsidiaries (i.e. those subsidiaries incorporated outside of Jersey, Channel Islands, the jurisdiction of incorporation of Shire plc, Shire’s holding company). The amount of cash and cash equivalents held by foreign subsidiaries has not had, and is not expected to have, a material impact on the Company’s liquidity and capital resources.
 
Cash flow activity
 
Net cash provided by operating activities for the nine months to September 30, 2013 decreased by 16% or $158.5 million to $852.7 million (2012: $1,011.2 million), as higher cash receipts from gross product sales were more than offset by higher cash tax payments, lower royalty receipts and the payment to settle the litigation with Impax ($48 million) (see note 13 for details). The nine months to September 30, 2012 also included strong cash receipts from government-supported healthcare providers in Spain.
 
Net cash used in investing activities was $321.0 million in the nine months to September 30, 2013, principally relating to the cash paid (net of cash acquired) for the acquisitions of SARcode, Premacure and Lotus and for purchases of PP&E.
 
 
49

 
 
Net cash used in investing activities was $215.6 million in the nine months to September 30, 2012, relating to the payment of $97.0 million to acquire Ferrokin and certain assets and liabilities from Pervasis, $43.5 million for the purchase of intangible assets, and $91.6 million on the purchase of PP&E.
 
Net cash used in financing activities was $327.3 million for the nine months to September 30, 2013, principally due to the purchase of shares under the share buy-back program, purchase of shares by the EBT and the dividend payment.
 
Net cash used in financing activities was $88.6 million for the nine months to September 30, 2012, principally the dividend payment and the purchase of shares by the EBT, which more than offset the excess tax benefit associated with the exercise of stock options.
 
Obligations and commitments
 
During the nine months to September 30, 2013 there have been no material changes outside the ordinary course of the Company’s business to the contractual obligations previously disclosed in PART II: ITEM 7 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.
 
 
50

 
 
ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Note 15 to the unaudited consolidated financial statements included in PART I: ITEM 1 of this Form 10-Q and PART II: ITEM 7A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2012 contains a discussion of the Company’s exposure to market and other risks.
 
ITEM 4.  CONTROLS AND PROCEDURES
 
The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in reports that the Company files under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
 
As at September 30, 2013 the Company, under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and the Chief Financial Officer, performed an evaluation of the effectiveness of the Company’s disclosure controls and procedures, including those with respect to the Income Access Share (“IAS”) Trust. The Company’s management necessarily applied its judgment in assessing the costs and benefits of such controls and procedures, which by their nature can provide only reasonable assurance regarding management’s control objectives. Based on this evaluation, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures, including those with respect to the IAS Trust, are effective at the reasonable level of assurance to ensure that information required to be disclosed in reports that the Company files under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC.
 
There has been no change in the Company’s internal control over financial reporting that occurred during the period covered by this quarterly report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
 
PART II.  OTHER INFORMATION
 
ITEM 1. LEGAL PROCEEDINGS
 
The information required by this Item is incorporated herein by reference to Note 13 to the unaudited consolidated financial statements included in PART I: ITEM 1 of this Form 10-Q.
 
ITEM 1A.  RISK FACTORS
 
There have been no material changes from the risk factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012.
 
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
None.
 
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
 
None.
 
ITEM 4. MINE SAFETY DISCLOSURES
 
Not applicable.

 
 
51

 
 
ITEM 5. OTHER INFORMATION
 
None.
 
ITEM 6. EXHIBITS
 
EXHIBITS
 
2.01 
Agreement and Plan of Merger by and among Shire Pharmaceuticals Group plc, Transkaryotic Therapies, Inc. and Sparta Acquisition Corporation, dated as of April 21, 2005.(1)
 
2.02 
Agreement of Merger dated as of February 20, 2007 among Shire plc, Shuttle Corporation and New River Pharmaceuticals, Inc.(2)
 
2.03 
Business Combination Agreement dated as of July 3, 2008 between Maia Elfte Vermögensverwaltungs GmbH and Jerini AG.(3)
 
2.04 
Heads of Agreement by and among Shire plc and Movetis NV relating to a friendly tender offer, dated August 3, 2010.(4)
 
2.05 
Agreement and Plan of Merger, dated as of May 17, 2011, by and among Shire Pharmaceuticals Inc., ABH Merger Sub Inc., Advanced Biohealing, Inc., and solely for the limited purposes set forth therein, Canaan VII L.P. and Shire plc.(5)
 
2.06 
Agreement and Plan of Merger, dated as of March 14, 2012, by and among Shire Pharmaceuticals LLC, Pelegrina Corporation, FerroKin BioSciences, Inc. and Shareholder Representative Services LLC, solely for the limited purposes set forth therein.(6)
 
3.01 
Form of Memorandum of Association of Shire plc as adopted by a special resolution passed on April 10, 2008 and amended by a special resolution passed on September 24, 2008.(7)
 
3.02 
Form of Article of Association of Shire plc as amended by a special resolution passed on April 26, 2011 and adopted by a special resolution passed on April 26, 2011.(8)
 
4.01 
Form of Assignment and Novation Agreement between Shire Limited, Shire plc, JPMorgan Chase Bank, N.A. dated April 16, 2008 relating to the Deposit Agreement among Shire plc, JPMorgan Chase Bank, N.A. as depositary and all holders from time to time of ADRs issued thereunder dated November 21, 2005.(9)
 
4.02 
Form of Deposit Agreement among Shire plc, JPMorgan Chase Bank, N.A. as depositary and all holders from time to time of ADRs issued thereunder dated November 21, 2005.(10)
 
4.03 
Form of Ordinary Share Certificate of Shire Limited.(11)
 
4.04 
Form of American Depositary Receipt Certificate of Shire Limited.(12)
 
4.05 
Trust Deed for the New Shire Income Access Trust, dated August 29, 2008.(13)
 
4.06 
Form of Amended and Restated Deposit Agreement among Shire plc, Citibank, N.A. as successor depositary, and all holders from time to time of ADRs thereunder dated May 23, 2011.(14)
 
10.01 
Tender and Support Agreement dated as of February 20, 2007 among Shire plc, Mr. Randal J. Kirk and the other parties named therein.(15)
 
10.02 
Multicurrency Term and Revolving Facilities Agreement as of February 20, 2007 by and among Shire plc, ABN AMRO Bank N.V., Barclays Capital, Citigroup Global Markets Limited, The Royal Bank of Scotland plc, and Barclays Bank plc.(16)
 
10.03 
Accession and Amendment Deed dated April 15, 2008 between Shire Limited, Shire plc, certain subsidiaries of Shire plc and Barclays Bank PLC as Facility Agent relating to a US $1,200,000,000 facility agreement dated February 20, 2007 (as amended by a syndication and amendment agreement dated July 19, 2007).(17)
 
10.04 
Subscription Agreement dated May 2, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and ABN AMRO Bank N.V. and NM Rothschild & Sons Limited (trading together as ABN AMRO Rothschild, an unincorporated equity capital markets joint venture) and Barclays Bank PLC and Citigroup Global Markets Limited and Goldman Sachs International and Morgan Stanley & Co. International plc and others.(18)
 
10.05
Amending Subscription Agreement dated May 8, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and ABN AMRO Bank N.V. and NM Rothschild & Sons Limited (trading together as ABN AMRO Rothschild, an unincorporated equity capital markets joint venture) and Barclays Bank PLC and Citigroup Global Markets Limited and Goldman Sachs International and Morgan Stanley & Co. International plc and others.(19)
 
 
52

 
 
 
10.06 
Trust Deed dated May 9, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and BNY Corporate Trustee Services Limited.(20)
 
10.07 
Supplemental Trust Deed dated April 15, 2008 between Shire Limited, Shire plc and BNY Corporate Trustee Services Limited relating to a trust deed dated May 9, 2007 relating to US $1,100,000,000 2.75% Convertible Bonds due 2014.(21)
 
10.08 
Accession and Amendment Agreement dated April 15, 2008 between Shire Limited, Shire plc, BNY Corporate Trustee Services Limited and The Bank of New York relating to a paying and conversion agency agreement dated May 9, 2007 relating to US $1,100,000,000 2.75% Convertible Bonds due 2014.(22)
 
10.09* 
Revised and Restated Master License Agreement dated November 20, 1995 among Shire BioChem Inc (f/k/a BioChem Pharma Inc.), Glaxo Group Limited, Glaxo Wellcome Inc. (formerly Glaxo Canada Inc.), Glaxo Wellcome Inc. (formerly Glaxo Inc.), Tanaud Holdings (Barbados) Limited, Tanaud International B.V. and Tanaud LLC.(23)
 
10.10* 
Settlement Agreement, dated August 14, 2006 by and between Shire Laboratories Inc. and Barr.(24)
 
10.11* 
Product Development and License Agreement, dated August 14, 2006 by and between Shire LLC and Duramed Pharmaceuticals, Inc.(25)
 
10.12* 
Product Acquisition and License Agreement, dated August 14, 2006 by and among Shire LLC, Shire plc and Duramed Pharmaceuticals, Inc.(26)
 
10.13 
Novation Agreement dated November 21, 2005 relating to the Employment Agreement of Angus Russell dated March 10, 2004.(27)
 
10.14 
Novation Agreement dated April 11, 2008 relating to the Employment Agreement of Angus Russell dated March 10, 2004, as previously novated on November 21, 2005.(28)
 
10.15 
Form of Amended and Restated Employment Agreement between Shire plc and Mr Matthew Emmens, dated March 12, 2004.(29)
 
10.16 
Amendment Agreement dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004.(30)
 
10.17 
Ratification and Guaranty dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004.(31)
 
10.18 
Amendment Agreement dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004, as amended on November 21, 2005.(32)
 
10.19 
Ratification and Guaranty dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004.(33)
 
10.20 
Form of Indemnity Agreement for Directors of Shire Limited.(34)
 
10.21 
Service Agreement between Shire Limited and Mr Graham Hetherington, dated July 2, 2008.(35)
 
10.22 
Form of Settlement Agreement and Mutual Release in re: Transkaryotic Therapies, Inc., by and between Shire Human Genetic Therapies, Inc., Shire plc and the parties set forth therein.(36)
 
10.23 
Amended Agreement dated February 24, 2009 relating to the Product Development and License Agreement dated August 14, 2006.(37)
 
10.24 
Amendment to the Shire Portfolio Share Plan as approved by the Annual General meeting held on April 27, 2010.(38)
 
10.25 
Multicurrency revolving and swingline facilities agreement as at November 23, 2010 by and among Shire plc & with a number of financial institutions, for which Abbey National Treasury Services Plc (trading as Santander Global Banking and Markets), Bank of America Securities Limited, Barclays Capital, Citigroup Global Markets Limited, Lloyds TSB Bank plc and The Royal Bank of Scotland plc acted as mandated lead arrangers and bookrunners and Credit Suisse AG, London Branch, Deutsche Bank AG, London Branch, Goldman Sachs International, Morgan Stanley Bank, N.A. and Sumitomo Mitsui Banking Corporation, Brussels Branch acted as arrangers.(39)
 
10.26 
Service Agreement between Shire plc and Mr. Flemming Ornskov, dated October 24, 2012. (40)
 
 
53

 
 
31.1 
Certification of Flemming Ornskov pursuant to Rule 13a - 14 under The Exchange Act.
 
31.2 
Certification of Graham Hetherington pursuant to Rule 13a - 14 under The Exchange Act.
 
32.1 
Certification of Flemming Ornskov and Graham Hetherington pursuant to Section 906 of the Sarbanes - Oxley Act of 2002.
 
101.INS XBRL Instance Document
 
101.SCH XBRL Taxonomy Extension Schema Document
 
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
 
101.DEF XBRL Taxonomy Definition Linkbase Document
 
101.LAB XBRL Taxonomy Extension Label Linkbase Document
 
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
 
Certain portions of this exhibit have been omitted intentionally, subject to a confidential treatment request. A complete version of this agreement has been filed separately with the Securities and Exchange Commission.
 
(1) 
Incorporated by reference to Exhibit 99.02 to Shire's Form 8-K filed on April 25, 2005.
 
(2) 
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on February 23, 2007.
 
(3) 
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on July 10, 2008.
 
(4) 
Incorporated by reference to Exhibit 2.04 to Shire's Form 10-Q filed on November 5, 2010.
 
(5) 
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on June 30, 2011.
 
(6) 
Incorporated by reference to Exhibit 2.06 to Shire's Form 10-Q filed on May 23, 2012.
 
(7) 
Incorporated by reference to Exhibit 99.02 to Shire's Form 8-K filed on October 1, 2008.
 
(8) 
Incorporated by reference to Exhibit 3.1 to Shire's Form 8-K filed on April 29, 2011.
 
(9) 
Incorporated by reference to Exhibit 4.01 to Shire's Form 8-K filed on May 23, 2008.
 
(10) 
Incorporated by reference to Exhibit 4.02 to Shire's Form 8-K filed on May 23, 2008.
 
(11) 
Incorporated by reference to Exhibit 4.03 to Shire's Form 8-K filed on May 23, 2008.
 
(12) 
Incorporated by reference to Exhibit 4.04 to Shire's Form 8-K filed on May 23, 2008.
 
(13) 
Incorporated by reference to Exhibit 4.05 to Shire's Form 10-K filed on February 27, 2009.
 
(14) 
Incorporated by reference to Exhibit (a) to Shire's Form F-6 filed on April 27, 2011.
 
(15) 
Incorporated by reference to Exhibit 99.1 to Shire's Form 8-K filed on February 23, 2007.
 
(16) 
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on May 1, 2007.
 
(17) 
Incorporated by reference to Exhibit 10.01 to Shire's Form 8-K filed on May 23, 2008.
 
(18) 
Incorporated by reference to Exhibit 10.1 to Shire's Form 10-Q filed on August 2, 2007.
 
(19) 
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on August 2, 2007.
 
(20) 
Incorporated by reference to Exhibit 10.3 to Shire's Form 10-Q filed on August 2, 2007.
 
(21) 
Incorporated by reference to Exhibit 10.02 to Shire's Form 8-K filed on May 23, 2008.
 
(22) 
Incorporated by reference to Exhibit 10.03 to Shire's Form 8-K filed on May 23, 2008.
 
(23) 
Incorporated by reference to Exhibit 10.09 to Shire's Form 10-K/A filed on May 30, 2008.
 
(24) 
Incorporated by reference to Exhibit 10.1 to Shire's Form 10-Q filed on November 7, 2006.
 
(25) 
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on November 7, 2006.
 
(26) 
Incorporated by reference to Exhibit 10.3 to Shire's Form 10-Q filed on November 7, 2006.
 
(27) 
Incorporated by reference to Exhibit 10.03 to Shire's Form 8-K filed on November 25, 2005.
 
(28) 
Incorporated by reference to Exhibit 10.06 to Shire's Form 8-K filed on May 23, 2008.
 
(29) 
Incorporated by reference to Exhibit 10.13 to Shire's Form 10-K filed on March 12, 2004.
 
 
54

 
 
(30) 
Incorporated by reference to Exhibit 10.01 to Shire's Form 8-K filed on November 25, 2005.
 
(31) 
Incorporated by reference to Exhibit 10.02 to Shire's Form 8-K filed on November 25, 2005.
 
(32) 
Incorporated by reference to Exhibit 10.04 to Shire's Form 8-K filed on May 23, 2008.
 
(33) 
Incorporated by reference to Exhibit 10.05 to Shire's Form 8-K filed on May 23, 2008.
 
(34) 
Incorporated by reference to Exhibit 10.07 to Shire's Form 8-K filed on May 23, 2008.
 
(35) 
Incorporated by reference to Exhibit 10.23 to Shire's Form 10-Q filed on November 10, 2008.
 
(36) 
Incorporated by reference to Exhibit 10.24 to Shire's Form 10-Q filed on November 10, 2008.
 
(37) 
Incorporated by reference to Exhibit 10.25 to Shire's Form 10-Q filed on May 7, 2009.
 
(38) 
Incorporated by reference to Exhibit 10.27 to Shire's Form 10-Q filed on May 6, 2010.
 
(39) 
Incorporated by reference to Exhibit 10.28 to Shire's Form 10-K filed on February 23, 2011.
 
(40) 
Incorporated by reference to Exhibit 10.29 to Shire's Form 10-K filed on February 25, 2013.
 
 
55

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934 (the “Exchange Act”) the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
Date: October 25, 2013
/s/ Flemming Ornskov
Flemming Ornskov
Chief Executive Officer
 
   
Date: October 25, 2013
 
/s/ Graham Hetherington
Graham Hetherington
Chief Financial Officer
 
 
 
56
 
EX-31.1 2 dp41424_ex3101.htm EXHIBIT 31.1

EXHIBIT 31.1
 
CERTIFICATION OF FLEMMING ORNSKOV PURSUANT TO
RULE 13A-14 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
FORM 10-Q FOR THE QUARTER ENDED
SEPTEMBER 30, 2013 OF
SHIRE PLC

 
I, Flemming Ornskov, certify that:
 
1.
I have reviewed this quarterly report on Form 10-Q of Shire plc;
 
2.
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
4.
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d - 15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d - 15(f)) for the registrant and have:
 
 
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
 
 
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
 
 
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
 
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
 
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 
 
Date: October 25, 2013   By: /s/ Flemming Ornskov  
        Name: Flemming Ornskov  
        Title: Chief Executive Officer  
 
 
57

 
 
 
EX-31.2 3 dp41424_ex3102.htm EXHIBIT 31.2
 
EXHIBIT 31.2
 
CERTIFICATION OF GRAHAM HETHERINGTON PURSUANT TO
RULE 13A-14 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
FORM 10-Q FOR THE QUARTER ENDED
SEPTEMBER 30, 2013 OF
SHIRE PLC
I, Graham Hetherington, certify that:
 
1. 
I have reviewed this quarterly report on Form 10-Q of Shire plc;
          
2.
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
 
4.
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d - 15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d - 15(f)) for the registrant and have:
 
 
a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
 
 
b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
c)
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
 
 
d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
 
5.
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
 
 
a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
 
b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
 
Date: October 25, 2013   By: /s/ Graham Hetherington  
        Name: Graham Hetherington  
        Title: Chief Financial Officer  
 
58

EX-32.1 4 dp41424_ex3201.htm EXHIBIT 32.1
EXHIBIT 32.1
 
 
The certification set forth below is being submitted in connection with the Quarterly Report on Form 10-Q of Shire plc for the quarter ended September 30, 2013 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
Flemming Ornskov, the Chief Executive Officer and Graham Hetherington, the Chief Financial Officer of Shire plc, each certifies that, to the best of his knowledge:
 
1.
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
 
2.  
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Shire plc.
 
 
Date: October 25, 2013   By: /s/ Flemming Ornskov  
        Name: Flemming Ornskov  
        Title: Chief Executive Officer  
 
             
      By: /s/ Graham Hetherington  
        Name: Graham Hetherington  
        Title: Chief Financial Officer  
 
 
59

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text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">(215.4)</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">(196.5)</font></td></tr><tr style="height: 11px"><td style="width: 498px; text-align:left;border-color:#000000;min-width:498px;">&#160;</td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr><tr style="height: 18px"><td style="width: 498px; text-align:left;border-color:#000000;min-width:498px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: left;">As at September 30,</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">51.6</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">49.5</font></td></tr><tr style="height: 11px"><td style="width: 498px; text-align:left;border-color:#000000;min-width:498px;">&#160;</td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr></table></div><p style='margin-top: 0pt; margin-bottom: 0pt;'></p><p style='margin-top:12pt; margin-bottom:0pt'><font style="font-family:Arial;font-size:10pt;margin-left:0px;">At </font><font style="font-family:Arial;font-size:10pt;">September 30</font><font style="font-family:Arial;font-size:10pt;">, 2013 accounts </font><font style="font-family:Arial;font-size:10pt;">receivable </font><font style="font-family:Arial;font-size:10pt;">included $</font><font style="font-family:Arial;font-size:10pt;">3</font><font style="font-family:Arial;font-size:10pt;">6</font><font style="font-family:Arial;font-size:10pt;">.</font><font style="font-family:Arial;font-size:10pt;">9</font><font style="font-family:Arial;font-size:10pt;">&#160;million</font><font style="font-family:Arial;font-size:10pt;"> (December 31, 2012: $</font><font style="font-family:Arial;font-size:10pt;">3</font><font style="font-family:Arial;font-size:10pt;">8</font><font style="font-family:Arial;font-size:10pt;">.</font><font style="font-family:Arial;font-size:10pt;">5</font><font style="font-family:Arial;font-size:10pt;"> million) </font><font style="font-family:Arial;font-size:10pt;">related to </font><font style="font-family:Arial;font-size:10pt;">royalty</font><font style="font-family:Arial;font-size:10pt;"> income</font><font style="font-family:Arial;font-size:10pt;">.</font></p><p style='margin-top:0pt; 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margin-bottom: 0pt;'></p><div><table style="border-collapse:collapse;margin-top:20px;"><tr style="height: 17px"><td style="width: 475px; text-align:left;border-color:#000000;min-width:475px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">December 31,</font></td></tr><tr style="height: 17px"><td style="width: 475px; text-align:left;border-color:#000000;min-width:475px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td></tr><tr style="height: 17px"><td style="width: 475px; 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text-align:left;border-color:#000000;min-width:475px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">$&#8217;M</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;"> $&#8217;M</font></td></tr><tr style="height: 11px"><td style="width: 475px; text-align:left;border-color:#000000;min-width:475px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr><tr style="height: 18px"><td style="width: 475px; 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text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">1,581.6</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">1,501.5</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">________________</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">________________</font></td></tr></table></div> <div><table style="border-collapse:collapse;margin-top:20px;"><tr style="height: 17px"><td style="width: 444px; 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text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">$&#8217;M</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;"> $&#8217;M</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">________________</font></td><td style="width: 120px; text-align:right;border-color:#000000;min-width:120px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">________________</font></td></tr><tr style="height: 18px"><td style="width: 444px; 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A</font><font style="font-family:Arial;font-size:10pt;">s the Bonds will be redeemed within twelve months of the balance sheet date, the Bonds have been presented </font><font style="font-family:Arial;font-size:10pt;">as a current liability at </font><font style="font-family:Arial;font-size:10pt;">September</font><font style="font-family:Arial;font-size:10pt;"> 30, 2013</font><font style="font-family:Arial;font-size:10pt;">.</font></p> 1100000000 1 0.0275 The Bonds may be redeemed at the option of the Company, at their principal amount together with accrued and unpaid interest if: (i) at any time after May 23, 2012 if on no less than 20 dealing days in any period of 30 consecutive dealing days the value of Shire&#8217;s ordinary shares underlying each Bond in the principal amount of $100,000 would exceed $130,000; or (ii) at any time conversion rights have been exercised, and/or purchases and corresponding cancellations, and/or redemptions effected in respect of 85% or more in principal amount of Bonds originally issued The Bonds are repayable in US dollars, but also contain provisions entitling the Company to settle redemption amounts in Pounds sterling or in the case of Final Maturity Date by delivery of the underlying ordinary shares and, if necessary, a cash top-up amount. 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text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td></tr><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">$&#8217;M</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;"> $&#8217;M</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Income taxes payable</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">19.4</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">78.4</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Value added taxes</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">28.7</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">23.6</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Contingent consideration payable</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">86.0</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">16.0</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Other current liabilities</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">29.1</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">26.1</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">163.2</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">144.1</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr></table></div> <div><table style="border-collapse:collapse;margin-top:20px;"><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">December 31,</font></td></tr><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td></tr><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">$&#8217;M</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;"> $&#8217;M</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Income taxes payable</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">19.4</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">78.4</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Value added taxes</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">28.7</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">23.6</font></td></tr><tr style="height: 18px"><td style="width: 444px; 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text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">163.2</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">144.1</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">_____________</font></td></tr></table></div> 19400000 78400000 28700000 23600000 86000000 29100000 16000000 26100000 <p style='margin-top:0pt; margin-bottom:6pt'><font style="font-family:Arial;font-size:10pt;font-weight:bold;margin-left:0px;">12</font><font style="font-family:Arial;font-size:10pt;font-weight:bold;">.</font><font style="font-family:Arial;font-size:10pt;font-weight:bold;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;Other non-current liabilities</font></p><p style='margin-top: 0pt; margin-bottom: 0pt;'></p><div><table style="border-collapse:collapse;margin-top:20px;"><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">December 31,</font></td></tr><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td></tr><tr style="height: 17px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">$&#8217;M</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;"> $&#8217;M</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:right;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Income taxes payable</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">81.5</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">58.9</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Deferred revenue</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">10.3</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">11.4</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Deferred rent</font></td><td style="width: 121px; 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text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr><tr style="height: 18px"><td style="width: 444px; text-align:left;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">652.3</font></td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">241.6</font></td></tr><tr style="height: 11px"><td style="width: 444px; text-align:right;border-color:#000000;min-width:444px;">&#160;</td><td style="width: 121px; text-align:right;border-color:#000000;min-width:121px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 121px; 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The swap</font><font style="font-family:Arial;font-size:10pt;"> and forward contracts mature within 90 days. The Company did not have credit risk related contingent features or collateral linked to the derivatives. The Company has master netting agreements with a number of counterparties to&#160;the</font><font style="font-family:Arial;font-size:10pt;">se</font><font style="font-family:Arial;font-size:10pt;"> foreign exchange contracts and on the occurrence of specified events, the Company has the ability to terminate contracts and settle them with a net payment by one party to the other. </font><font style="font-family:Arial;font-size:10pt;">T</font><font style="font-family:Arial;font-size:10pt;">he Company </font><font style="font-family:Arial;font-size:10pt;">has </font><font style="font-family:Arial;font-size:10pt;">elected to present derivative assets and derivative liabilities on a gross basis in the consolidated balance sheet. 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text-align:left;border-color:#000000;min-width:250px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 9pt;COLOR: #000000;TEXT-ALIGN: left;">At September 30, 2013</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 9pt;COLOR: #000000;TEXT-ALIGN: right;">Fair value </font></td><td style="width: 114px; text-align:right;border-color:#000000;min-width:114px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 9pt;COLOR: #000000;TEXT-ALIGN: right;">Valuation Technique </font></td><td style="width: 142px; text-align:right;border-color:#000000;min-width:142px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 9pt;COLOR: #000000;TEXT-ALIGN: right;">Significant unobservable Inputs</font></td><td style="width: 107px; text-align:right;border-color:#000000;min-width:107px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 9pt;COLOR: #000000;TEXT-ALIGN: right;">Range </font></td></tr><tr style="height: 17px"><td style="width: 250px; 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text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">299.2</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">247.1</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">897.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">773.3</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">LIALDA/MEZAVANT</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">141.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">104.4</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">379.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">288.5</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">ELAPRASE</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">129.1</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">110.5</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">392.6</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">358.3</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">REPLAGAL</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">108.5</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">121.7</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">336.6</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">379.3</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">VPRIV</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">87.8</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">74.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">251.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">229.3</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">ADDERALL XR</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">81.4</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">102.2</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">293.5</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">347.5</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">INTUNIV</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">80.8</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">69.0</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">248.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">206.6</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">PENTASA</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">70.6</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">67.0</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">215.2</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">196.7</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">FIRAZYR</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">62.6</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">30.3</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">153.8</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">81.7</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">FOSRENOL</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">51.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">38.1</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">136.3</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">126.8</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">XAGRID</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">24.2</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">22.0</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">74.1</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">70.7</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">DERMAGRAFT</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">23.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">33.7</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">64.7</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">134.9</font></td></tr><tr style="height: 18px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Other product sales</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">33.0</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">33.6</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">96.4</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">115.5</font></td></tr><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;">Total product sales</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">1,194.9</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">1,054.5</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">3,541.8</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">3,309.1</font></td></tr><tr style="height: 8px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr></table></div><p style='margin-top: 0pt; margin-bottom: 0pt;'></p><p style='margin-top:12pt; margin-bottom:0pt'><font style="font-family:Arial;font-size:10pt;margin-left:0px;">Further segment disclosures related to geographic area and major customers will be included in the 2013 Annual Report on Form 10-K.</font></p> <div><table style="border-collapse:collapse;margin-top:20px;"><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">3 months to,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">3 months to,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">9 months to,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">9 months to,</font></td></tr><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">September 30,</font></td></tr><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2013</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-WEIGHT: bold;FONT-FAMILY: Arial;FONT-SIZE: 10pt;COLOR: #000000;TEXT-ALIGN: right;">2012</font></td></tr><tr style="height: 17px"><td style="width: 288px; 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text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">___________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">___________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">___________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">___________</font></td></tr><tr style="height: 17px"><td style="width: 288px; text-align:left;border-color:#000000;min-width:288px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;">&#160;</td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;">&#160;</td><td style="width: 110px; 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text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td><td style="width: 110px; text-align:right;border-color:#000000;min-width:110px;"><font style="FONT-FAMILY: Arial;FONT-SIZE: 6pt;COLOR: #000000;TEXT-ALIGN: right;">____________</font></td></tr></table></div> 247100000 104400000 110500000 121700000 74900000 102200000 69000000 30300000 38100000 33700000 392600000 379900000 136300000 897900000 64700000 215200000 251900000 336600000 248900000 153800000 293500000 126800000 379300000 196700000 229300000 773300000 288500000 134900000 358300000 81700000 206600000 347500000 299200000 141900000 129100000 108500000 87800000 81400000 80800000 70600000 62600000 51900000 24200000 23900000 33000000 67000000 22000000 33600000 74100000 70700000 96400000 115500000 1194900000 1054500000 3541800000 3309100000 Available-for-sale securities are included within Investments in the consolidated balance sheet. Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet. Contingent consideration payable is included within Other current liabilities and Other non-current liabilities in the consolidated balance sheet. Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock. Calculated using the treasury stock method. Calculated using the ‘if-converted’ method. Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc’s average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date. Research and development (“R&D”) includes intangible asset impairment charges of $19.9 million (2012: $27.0 million) for the nine months to September 30, 2013. Selling, general and administrative (“SG&A”) costs include amortization of intangible assets relating to intellectual property rights acquired of $44.4 million for the three months to September 30, 2013 (2012: $50.0 million) and $136.1 million for the nine months to September 30, 2013 (2012: $146.6 million). Dividends per share During the nine months to September 30, 2013 Shire plc declared and paid dividends of 14.60 US cents per ordinary share (equivalent to 43.80 US cents per ADS) totalling $79.2 million. 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Goodwill
9 Months Ended
Sep. 30, 2013
Goodwill and Intangible Assets Disclosure [Abstract]  
Goodwill Disclosure

7.       Goodwill

 September 30,December 31,
 20132012
 $’M$’M
 ________________________
Goodwill arising on businesses acquired621.3644.5
 ________________________

In the nine months to September 30, 2013 the Company completed the acquisitions of SARcode, Premacure and Lotus, which resulted in goodwill of $86.6 million, $29.6 million and $54.1 million, respectively (see Note 2 for details).

 

As a result of the re-alignment of the business into a simplified “One Shire” organization, the Company now comprises one operating and one reportable segment (see note 18 for further details).

 20132012
 $’M$’M
 ________________________
As at January 1, 644.5592.6
Acquisitions 170.348.1
Goodwill impairment charge(198.9)-
Foreign currency translation5.4(1.5)
 ________________________
As at September 30,621.3639.2
 ________________________

Goodwill is tested for impairment at least annually as at October 1 each year. This assessment is also performed whenever there is a change in circumstances that indicates the carrying value of these assets may not be recoverable.

In the first quarter of 2013 the Company identified circumstances which indicated that the carrying value of goodwill in the Regenerative Medicine (“RM”) reporting unit may not be recoverable, which triggered an impairment test in advance of the annual testing date.

These circumstances included the results of an independent market research study of the DERMAGRAFT sales potential, commissioned by the Company, which was finalized late in the first quarter of 2013. In addition, while the Company still expects DERMAGRAFT to return to growth over coming quarters, the recently completed restructuring of the RM sales and marketing organization and the implementation of a new commercial model had a more pronounced impact than previously expected. As a result of these and other factors forecast future sales are now lower than at the time of acquisition.

The results of the Company's March 31, 2013 impairment test showed that the carrying amount of the RM reporting unit exceeded its fair value and the implied value of the goodwill was $nil. As a result the Company recorded an impairment charge of $198.9 million related to the goodwill allocated to the RM reporting unit. The RM goodwill impairment charge is not deductible for tax purposes. This is the primary reason for the effective rate of tax in the nine months to September 30, 2013 (23%) being higher than the same period in 2012 (17%). Accumulated goodwill impairment as at September 30, 2013 was $198.9 million (December 31, 2012: $nil).

Key assumptions used to determine the fair value of the RM reporting unit included expected cash flows for the period from March 31, 2013 to December 31, 2023 and the associated discount rate of 15.1%, which was derived from management's best estimate of the after-tax weighted average cost of capital for the RM reporting unit.

The Company determined the estimated fair value of the RM reporting unit using discounted cash flow analyses. Discounted cash flow analyses are dependent upon a number of quantitative and qualitative factors including estimates of forecasted revenue, profitability, earnings before interest, taxes, depreciation and amortization, and terminal values. The discount rates applied in the discounted cash flow analyses also have an impact on the estimates of fair value, as use of a higher rate will result in a lower estimate of fair value.

XML 12 R53.htm IDEA: XBRL DOCUMENT v2.4.0.8
Convertible Bonds (Details) (USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Debt Instrument [Line Items]  
Debt issuance date May 09, 2007
Issuance price to principal amount, percent 100.00%
Final maturity date May 09, 2014
Repayment terms The Bonds may be redeemed at the option of the Company, at their principal amount together with accrued and unpaid interest if: (i) at any time after May 23, 2012 if on no less than 20 dealing days in any period of 30 consecutive dealing days the value of Shire’s ordinary shares underlying each Bond in the principal amount of $100,000 would exceed $130,000; or (ii) at any time conversion rights have been exercised, and/or purchases and corresponding cancellations, and/or redemptions effected in respect of 85% or more in principal amount of Bonds originally issued The Bonds are repayable in US dollars, but also contain provisions entitling the Company to settle redemption amounts in Pounds sterling or in the case of Final Maturity Date by delivery of the underlying ordinary shares and, if necessary, a cash top-up amount. As the Bonds will be redeemed within twelve months of the balance sheet date, the Bonds have been presented as a current liability at September 30, 2013
Stated interest rate 2.75%
Principal amount $ 1,100
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Consolidated Statements of Income (USD $)
In Millions, except Per Share data, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Revenues:        
Product sales $ 1,194.9 $ 1,054.5 $ 3,541.8 $ 3,309.1
Royalties 37.6 41.8 112.4 154.4
Other revenues 4.1 4.1 18.8 16.5
Total revenues 1,236.6 1,100.4 3,673.0 3,480.0
Costs and expenses:        
Cost of product sales 197.1 167.9 528.7 478.8
Research and development 229.1 [1] 224.7 [1] 713.4 [1] 683.6 [1]
Selling, general and administrative 441.1 [1] 437.4 [1] 1,337.4 [1] 1,448.4 [1]
Goodwill Impairment charge 0 0 198.9 0
Gain on sale of product rights (3.6) (5.7) (14.6) (16.5)
Reorganization costs 13.7 0 57.6 0
Integration and acquisition costs 18.4 2.7 39.9 15.1
Total operating expenses 895.8 827.0 2,861.3 2,609.4
Operating income 340.8 273.4 811.7 870.6
Interest income 0.4 0.9 1.6 2.3
Interest expense (9.0) (9.2) (27.0) (29.0)
Other income/(expense), net 0.6 3.5 (1.9) 3.6
Total other expense, net (8.0) (4.8) (27.3) (23.1)
Income before income taxes and equity in (losses)/earnings of equity method investees 332.8 268.6 784.4 847.5
Income taxes (54.3) (41.6) (183.9) (144.6)
Equity in (losses)/earnings of equity method investees, net of taxes (0.3) 0.2 0.6 0.5
Net income $ 278.2 $ 227.2 $ 601.1 $ 703.4
Earnings per ordinary share - basic $ 0.507 $ 0.409 $ 1.093 $ 1.266
Earnings per ordinary share - diluted $ 0.488 $ 0.396 $ 1.062 $ 1.224
Weighted average number of shares:        
Basic 548.4 [2] 555.9 [2] 549.8 [2] 555.5 [2]
Diluted 585.7 593.1 587.5 594.0
[1] Research and development (“R&D”) includes intangible asset impairment charges of $19.9 million (2012: $27.0 million) for the nine months to September 30, 2013. Selling, general and administrative (“SG&A”) costs include amortization of intangible assets relating to intellectual property rights acquired of $44.4 million for the three months to September 30, 2013 (2012: $50.0 million) and $136.1 million for the nine months to September 30, 2013 (2012: $146.6 million).
[2] Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock.
XML 15 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Cash Flows (USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net income $ 601.1 $ 703.4
Adjustments to reconcile net income to net cash provided by operating activities:    
Depreciation and amortization 229.4 231.5
Share based compensation 55.2 65.0
Change in fair value of contingent consideration 28.4 3.3
Goodwill Impairment charge 198.9 0
Impairment of intangible assets 19.9 27.0
Gain on sale of product rights (14.6) (16.5)
Other, net 4.4 1.8
Movement in deferred taxes 16.1 (30.4)
Equity in earnings of equity method investees (0.6) (0.5)
Changes in operating assets and liabilities:    
Increase in accounts receivable (215.2) (23.0)
Increase in sales deduction accrual 108.7 36.1
Increase in inventory (39.9) (81.9)
(Increase)/decrease in prepayments and other assets (70.9) 17.8
(Decrease)/increase in accounts payable and other liabilities (71.4) 72.7
Returns on investment from joint venture 3.2 4.9
Net cash provided by operating activities 852.7 1,011.2
CASH FLOWS FROM INVESTING ACTIVITIES:    
Movements in restricted cash 0.5 1.7
Purchases of subsidiary undertakings and businesses, net of cash acquired (227.8) (97.0)
Purchases of non-current investments (9.9) (12.1)
Purchases of property, plant and equipment ("PPE") (110.3) (91.6)
Purchases of intangible assets 0 (43.5)
Proceeds received on sale of product rights 15.0 13.7
Other, net 11.5 13.2
Net cash used in investing activities (321.0) (215.6)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Excess tax benefit associated with exercise of stock options 9.5 38.6
Payments to acquire shares (240.8) (50.9)
Contingent consideration payments (11.3) (3.0)
Payment of dividend (79.2) (70.7)
Other, net (5.5) (2.6)
Net cash used in financing activities (327.3) (88.6)
Effect of foreign exchange rate changes on cash and cash equivalents (0.5) (5.1)
Net increase in cash and cash equivalents 203.9 701.9
Cash and cash equivalents at beginning of period 1,482.2 620.0
Cash and cash equivalents at end of period 1,686.1 1,321.9
Supplemental information associated with continuing operations:    
Interest paid (17.6) (18.6)
Income taxes paid (244.7) (134.6)
EBT
   
CASH FLOWS FROM FINANCING ACTIVITIES:    
Payments to acquire shares (50.3) (50.9)
Share Buy-back Program
   
CASH FLOWS FROM FINANCING ACTIVITIES:    
Payments to acquire shares $ (190.5) $ 0
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Accumulated Other Comprehensive Income
9 Months Ended
Sep. 30, 2013
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract]  
Accumulated Other Comprehensive Income (Loss)

14.       Accumulated Other Comprehensive Income

 

The changes in accumulated other comprehensive income, net of their related tax effects, in the nine months to September 30, 2013 are included below:

  Foreign currency translation adjustment Unrealized holding gain/(loss) on available-for-sale securities Accumulated other comprehensive income
  $M $M $M
       
As at January 1, 201385.1 1.8 86.9
Current period change:     
 Other Comprehensive income before reclassification14.4 2.2 16.6
 Gain transferred to the income statement (within Other (expense)/income, net) on disposal of available-for-sale securities0 (2.2) (2.2)
Net current period other comprehensive income14.4 -  14.4
       
As at September 30, 201399.5 1.8 101.3
       
XML 18 R67.htm IDEA: XBRL DOCUMENT v2.4.0.8
Segmental Reporting (Revenue by Product) (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Revenue from External Customer [Line Items]        
Product sales $ 1,194.9 $ 1,054.5 $ 3,541.8 $ 3,309.1
VYVANSE
       
Revenue from External Customer [Line Items]        
Product sales 299.2 247.1 897.9 773.3
ADDERALL XR
       
Revenue from External Customer [Line Items]        
Product sales 81.4 102.2 293.5 347.5
INTUNIV
       
Revenue from External Customer [Line Items]        
Product sales 80.8 69.0 248.9 206.6
LIALDA and MEZAVANT
       
Revenue from External Customer [Line Items]        
Product sales 141.9 104.4 379.9 288.5
PENTASA
       
Revenue from External Customer [Line Items]        
Product sales 70.6 67.0 215.2 196.7
FOSRENOL
       
Revenue from External Customer [Line Items]        
Product sales 51.9 38.1 136.3 126.8
XAGRID
       
Revenue from External Customer [Line Items]        
Product sales 24.2 22.0 74.1 70.7
Other Products
       
Revenue from External Customer [Line Items]        
Product sales 33.0 33.6 96.4 115.5
REPLAGAL
       
Revenue from External Customer [Line Items]        
Product sales 108.5 121.7 336.6 379.3
ELAPRASE
       
Revenue from External Customer [Line Items]        
Product sales 129.1 110.5 392.6 358.3
VPRIV
       
Revenue from External Customer [Line Items]        
Product sales 87.8 74.9 251.9 229.3
FIRAZYR
       
Revenue from External Customer [Line Items]        
Product sales 62.6 30.3 153.8 81.7
DERMAGRAFT
       
Revenue from External Customer [Line Items]        
Product sales $ 23.9 $ 33.7 $ 64.7 $ 134.9
XML 19 R56.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies (Leases, and LC and Guarantees ) (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Mar. 31, 2012
Sep. 30, 2013
Sep. 30, 2012
Future Minimum Lease Payments under Operating Leases      
2013   $ 11.4  
2014   42.5  
2015   31.8  
2016   23.4  
2017   17.8  
2018   12.1  
Thereafter   83.2  
Future minimum lease payments, total   222.2  
Operating Leases, Rent Expense      
Lease and rental expense 31.4 35.5 31.4
Letters of credit and guarantees      
Irrevocable standby letters of credit and guarantees   $ 54.0  
XML 20 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Intangible Assets, Net
9 Months Ended
Sep. 30, 2013
Intangible Assets, Net (Excluding Goodwill) [Abstract]  
Other Intangible Assets Disclosure

8.       Other intangible assets, net

  September 30,December 31,
  20132012
  $’M $’M
  ________________________________
Amortized intangible assets  
 Intellectual property rights acquired for currently marketed products2,467.92,462.0
 Acquired product technology710.0710.0
 Other intangible assets45.344.5
  ________________________________
  3,223.23,216.5
Unamortized intangible assets  
 Intellectual property rights acquired for IPR&D952.8231.0
  ________________________________
  4,176.03,447.5
    
Less: Accumulated amortization(1,200.0)(1,059.4)
  ________________________________
  2,976.02,388.1
  ________________________________

The change in the net book value of other intangible assets for the nine months to September 30, 2013 and 2012 is shown in the table below:

 

 Other intangible assets
 20132012
 $’M$’M
 ________________________________
As at January 1, 2,388.12,493.0
Acquisitions733.2281.5
Amortization charged (136.1)(147.3)
Impairment charges(19.9)(27.0)
Foreign currency translation10.7(6.6)
 ________________________________
As at September 30, 2,976.02,593.6
 ________________________________

In the nine months to September 30, 2013 the Company acquired intangible assets totaling $733.2 million, relating to intangible assets acquired with SARcode, Premacure and Lotus (see Note 2 for further details).

 

In the second quarter of 2013 the Company reviewed certain IPR&D intangible assets acquired through Movetis N.V. (“Movetis”) for impairment and recognized an impairment charge of $19.9 million (2012: $27.0 million) recorded within R&D in the consolidated income statement, to write-down these IPR&D assets to their fair value. The fair values of these assets were determined using the income approach, which used significant unobservable (Level 3) inputs (see Note 16 for further details).

 

Management estimates that the annual amortization charge in respect of intangible assets held at September 30, 2013 will be approximately $170 million for each of the five years to September 30, 2018. Estimated amortization expense can be affected by various factors including future acquisitions, disposals of product rights, regulatory approval and subsequent amortization of acquired IPR&D projects, foreign exchange movements and the technological advancement and regulatory approval of competitor products.

XML 21 R48.htm IDEA: XBRL DOCUMENT v2.4.0.8
Prepaid Expenses and Other Current Assets (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Prepaid Expense and Other Assets, Current [Abstract]    
Prepaid expenses $ 39.1 $ 31.7
Income tax receivable 179.9 130.6
Value added taxes receivable 18.7 20.9
Other current assets 44.6 38.6
Prepaid expenses and other current assets, total $ 282.3 $ 221.8
XML 22 R57.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies (Collaborative Arrangements) (Details) (Out-licensing Arrangement, USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Out-licensing arrangements    
Milestone payments received $ 3.0 $ 6.0
Other Revenues
   
Out-licensing arrangements    
Milestone revenues recognized 4.5 6.7
Product Sales
   
Out-licensing arrangements    
Milestone revenues recognized 43.8 57.6
Development Milestone
   
Out-licensing arrangements    
Maximum milestone payment receivable 39.0  
Sales Milestone
   
Out-licensing arrangements    
Maximum milestone payment receivable $ 71.5  
XML 23 R38.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies (Tables)
9 Months Ended
Sep. 30, 2013
Commitments and Contingencies Disclosure [Abstract]  
Future Minimum Lease Payments under Operating Leases
  Operating
  leases
  $’M
  _____________
2013 11.4
2014 42.5
2015 31.8
2016 23.4
2017 17.8
2018 12.1
Thereafter 83.2
  _____________
  222.2
  _____________
XML 24 R27.htm IDEA: XBRL DOCUMENT v2.4.0.8
Earnings Per Share
9 Months Ended
Sep. 30, 2013
Earnings Per Share [Abstract]  
Earnings Per Share Disclosure

17.       Earnings per share

 

The following table reconciles net income and the weighted average ordinary shares outstanding for basic and diluted earnings per share for the periods presented:

       
  3 months to3 months to9 months to9 months to 
  September 30,September 30,September 30,September 30, 
  2013201220132012 
  $’M$’M$’M$’M 
  ____________________________________________________________________ 
 Numerator for basic earnings per share278.2227.2601.1703.4 
       
 Interest on convertible bonds, net of tax 7.67.522.723.7 
  ____________________________________________________________________ 
 Numerator for diluted earnings per share285.8234.7623.8727.1 
  ____________________________________________________________________ 
       
       
 Weighted average number of shares:     
  MillionsMillionsMillionsMillions 
  ____________________________________________________________________ 
 Basic 1548.4555.9549.8555.5 
 Effect of dilutive shares:     
 Share based awards to employees 23.53.73.95.0 
 Convertible bonds 2.75% due 2014 333.8 33.533.833.5 
  ____________________________________________________________________ 
 Diluted585.7593.1587.5594.0 
  ____________________________________________________________________ 
       

1. Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock.

2. Calculated using the treasury stock method.

3. Calculated using the 'if-converted' method.

 

The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:

 3 months to3 months to9 months to9 months to
 September 30,September 30,September 30,September 30,
 2013201220132012
  No. of sharesNo. of shares No. of sharesNo. of shares
 MillionsMillionsMillionsMillions
 ____________________________________________________________________
Share based awards to employees10.56.64.54.9
 ____________________________________________________________________

  • Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc's average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date.

 

XML 25 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurement
9 Months Ended
Sep. 30, 2013
Fair Value Disclosures [Abstract]  
Fair Value Disclosures

16.       Fair value measurement

 

Assets and liabilities that are measured at fair value on a recurring basis

 

As at September 30, 2013 and December 31, 2012 the following financial assets and liabilities are measured at fair value on a recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).

  CarryingFair value
  value    
   TotalLevel 1Level 2Level 3
At September 30, 2013 $'M$'M$'M$'M$'M
  _________________________________________________________
Financial assets:      
Available-for-sale securities(1) 12.012.012.0- -
Contingent consideration receivable (2) 39.639.6- - 39.6
Foreign exchange contracts 4.24.2- 4.2-
       
Financial liabilities:      
Foreign exchange contracts 3.93.9- 3.9-
Contingent consideration payable(3) 597.8597.8- - 597.8
  _________________________________________________________
       
   TotalLevel 1Level 2Level 3
At December 31, 2012 $'M$'M$'M$'M$'M
  _________________________________________________________
Financial assets:      
Available-for-sale securities(1) 14.214.214.2- -
Contingent consideration receivable (2) 38.338.3- - 38.3
Foreign exchange contracts 1.31.3- 1.3-
       
Financial liabilities:      
Foreign exchange contracts 3.03.0- 3.0-
Contingent consideration payable(3)1136.4136.4- - 136.4
  _________________________________________________________

(1)       Available-for-sale securities are included within Investments in the consolidated balance sheet.

(2)       Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet.

(3)       Contingent consideration payable is included within Other current liabilities and Other non-current liabilities in the consolidated balance sheet.

 

Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company's intent or ability to dispose of the financial instrument.

 

The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:

 

  • Available-for-sale securities – the fair values of available-for-sale securities are estimated based on quoted market prices for those investments.
  • Contingent consideration receivable – the fair value of the contingent consideration receivable has been estimated using the income approach (using a probability weighted discounted cash flow method).
  • Foreign exchange contracts – the fair values of the swap and forward foreign exchange contracts have been determined using an income approach based on current market expectations about the future cash flows.
  • Contingent consideration payable – the fair value of the contingent consideration payable has been estimated using the income approach (using a probability weighted discounted cash flow method).

 

Assets and Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3)

 

The change in the fair value of the Company's contingent consideration receivable and payables, which are measured at fair value on a recurring basis using significant unobservable inputs (Level 3), are as follows:

 

Contingent consideration receivable  
 20132012
 $'M$'M
 ________________________
   
Balance at January 1,38.337.8
Gain recognized in the income statement (within Gain on sale of product rights) due to change in fair value during the period14.616.5
Reclassification of amounts to Other receivables within Other current assets(13.9)(13.7)
Amounts recorded to other comprehensive income (within foreign currency translation adjustments) 0.60.4
   
Balance at September 30,39.641.0
   
Contingent consideration payable  
 20132012
 $'M$'M
 ________________________
   
Balance at January 1,136.4-
Initial recognition of contingent consideration payable451.4127.8
Change in fair value during the period with the corresponding adjustment recognized as a loss in the income statement (within Integration and acquisition costs)28.43.3
Reclassification of amounts to Other current liabilities(11.1)(6.7)
Change in fair value during the period with corresponding adjustment to the associated intangible asset(7.3)9.0
   
Balance at September 30,597.8133.4
   

 

Quantitative Information about Assets and Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3)

 

Quantitative information about the Company's recurring Level 3 fair value measurements is included below:

 

 

Financial assets:Fair Value at the Measurement Date
    
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRange
$'M   
_____________________________________________
Contingent consideration receivable ("CCR")39.6Income approach (probability weighted discounted cash flow)• Probability weightings applied to different sales scenarios • Future forecast royalties receivable at relevant contractual royalty rates • Assumed market participant discount rate • 10 to 45% • $5 million to $158 million • 5.9%
 ________________________________________________
     
Financial liabilities:Fair Value at the Measurement Date
     
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRange
$'M   
_____________________________________________
Contingent consideration payable597.8Income approach (probability weighted discounted cash flow)• Cumulative probability of milestones being achieved • Assumed market participant discount rate • Periods in which milestones are expected to be achieved • Forecast quarterly royalties payable on net sales of relevant products • 18 to 57% (Weighted average) • 2.1 to 8.8% (Weighted average) • 2014 to 2024 • $1.0 to $7.6 million
 ________________________________________________

The Company re-measures the CCR (relating to contingent consideration due to the Company following divestment of one of the Company's products) at fair value at each balance sheet date, with the fair value measurement based on forecast cash flows, over a number of scenarios which vary depending on the expected performance outcome of the product following divestment. The forecast cash flows under each of these differing outcomes have been included in probability weighted estimates used by the Company in determining the fair value of the CCR.

 

Contingent consideration payable represents future milestones the Company may be required to pay in conjunction with various business combinations and future royalties payable as a result of certain business combinations and licenses. The amount ultimately payable by Shire in relation to business combinations is dependent upon the achievement of specified future milestones, such as the achievement of certain future development, regulatory and sales milestones. The Company assesses the probability, and estimated timing, of these milestones being achieved and re-measures the related contingent consideration to fair value each balance sheet date. The amount of contingent consideration which may ultimately be payable by Shire in relation to future royalties is dependent upon future net sales of the relevant products over the life of the royalty term. The Company assesses the present value of forecast future net sales of the relevant products and re-measures the related contingent consideration to fair value each balance sheet date.

 

The fair value of the Company's contingent consideration receivable and payable could significantly increase or decrease due to changes in certain assumptions which underpin the fair value measurements. Each set of assumptions and milestones are specific to the individual contingent consideration receivable or payable. The assumptions include, among other things, the probability and expected timing of certain milestones being achieved, the forecast future net sales of the relevant products and related future royalties payable, the probability weightings applied to different sales scenarios of one of the Company's divested products and forecast future royalties receivable under scenarios developed by the Company, and the discount rates used to determine the present value of contingent future cash flows. The Company regularly reviews these assumptions, and makes adjustments to the fair value measurements as required by facts and circumstances.

 

Assets Measured At Fair Value on a Non-Recurring Basis in the period using Significant Unobservable Inputs (Level 3)

 

In the second quarter of 2013 the Company reviewed certain IPR&D intangible assets acquired through Movetis for impairment and recognized an impairment charge of $19.9 million, recorded within R&D in the consolidated income statement, to write-down these assets to their fair value. The fair value of these assets was determined using the income approach, which used significant unobservable (Level 3) inputs. These unobservable inputs included, among other things, risk-adjusted forecast future cash flows to be generated by these assets and the determination of an appropriate discount rate to be applied in calculating the present value of forecast future cash flows. The fair value of these assets, determined at the time of the impairment review, was $20.3 million.

 

Quantitative information about Non-Recurring Level 3 Fair Value Measurements which occurred in the period is included below:

 

 Fair Value at the Measurement Date
    
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRate used
$'M   
_____________________________________________
Movetis-related IPR&D intangible assets20.3Income approach (discounted cash flow)• Decline in forecast peak sales since last impairment test • Assumed market participant discount rate • 50% • 8.9%
 ________________________________________________

Financial assets and liabilities that are not measured at fair value on a recurring basis

 

The carrying amounts and estimated fair values as at September 30, 2013 and December 31, 2012 of the Company's financial assets and liabilities which are not measured at fair value on a recurring basis are as follows:

  September 30, 2013 December 31, 2012
  Carrying  Carrying 
  amountFair value amountFair value
  $’M$’M $’M$’M
  ________________________ _______________________
       
Financial liabilities:      
Convertible bonds (Level 1) 1,100.01,382.9 1,100.01,228.2
Building financing obligation (Level 3)  7.810.4 8.010.3
  ________________________ _______________________

Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company's intent or ability to dispose of the financial instrument.

 

The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:

 

  • Convertible bonds – the fair value of Shire's $1,100 million 2.75% convertible bonds due 2014 is determined by reference to the market price of the instrument as the convertible bonds are publicly traded.

     

  • Building finance obligations - the fair value of building finance obligations are estimated based on the present value of future cash flows, and an estimate of the residual value of the underlying property at the end of the lease term, associated with these obligations.

 

The carrying amounts of other financial assets and liabilities materially approximate to their fair value because of the short-term maturity of these amounts.

XML 26 R46.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Receivable, Net (Details) (USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Dec. 31, 2012
Provision for discounts and doubtful accounts      
As at January 1, $ 41.7 $ 31.1  
Provision charged to operations 225.3 214.9  
Provision utilization (215.4) (196.5)  
As at September 30, 51.6 49.5  
Accounts receivable, net 1,037.8   824.2
Accounts receivable related to royalty income $ 36.9   $ 38.5
XML 27 R34.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Intangible Assets, Net (Tables)
9 Months Ended
Sep. 30, 2013
Intangible Assets, Net (Excluding Goodwill) [Abstract]  
Schedule of Other Intangible Assets
  September 30,December 31,
  20132012
  $’M $’M
  ________________________________
Amortized intangible assets  
 Intellectual property rights acquired for currently marketed products2,467.92,462.0
 Acquired product technology710.0710.0
 Other intangible assets45.344.5
  ________________________________
  3,223.23,216.5
Unamortized intangible assets  
 Intellectual property rights acquired for IPR&D952.8231.0
  ________________________________
  4,176.03,447.5
    
Less: Accumulated amortization(1,200.0)(1,059.4)
  ________________________________
  2,976.02,388.1
  ________________________________
Intangible Assets (Excluding Goodwill) Roll Forward
 Other intangible assets
 20132012
 $’M$’M
 ________________________________
As at January 1, 2,388.12,493.0
Acquisitions733.2281.5
Amortization charged (136.1)(147.3)
Impairment charges(19.9)(27.0)
Foreign currency translation10.7(6.6)
 ________________________________
As at September 30, 2,976.02,593.6
 ________________________________
XML 28 R40.htm IDEA: XBRL DOCUMENT v2.4.0.8
Financial Instruments (Tables)
9 Months Ended
Sep. 30, 2013
Derivative Instrument Detail [Abstract]  
Schedule of Foreign Exchange Contracts, Statement of Financial Position
 Fair valueFair value
  September 30,December 31,
  20132012
  $’M$’M
  __________________________
AssetsPrepaid expenses and other current assets4.21.3
LiabilitiesOther current liabilities3.93.0
  __________________________
Schedule of Foreign Exchange Contracts, Gain (Loss) in Other Income (Expense)
 Location of net (loss)/gain recognized in incomeAmount of net (loss)/gain recognized in income
 __________________________________________________________
In the nine months to September 30,September 30,
  20132012
  $’M$’M
  __________________________
Foreign exchange contractsOther income, net(3.2)9.5
  __________________________
XML 29 R49.htm IDEA: XBRL DOCUMENT v2.4.0.8
Goodwill (Details) (USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Dec. 31, 2012
Sep. 30, 2013
Lotus
Feb. 12, 2013
Lotus
Sep. 30, 2013
Premacure AB
Sep. 30, 2013
SARcode Biosciences Inc
Apr. 17, 2013
SARcode Biosciences Inc
Sep. 30, 2013
Regenerative Medicine
Goodwill [Line Items]                  
Business Acquisition, Purchase Price Allocation, Assets Acquired (Liabilities Assumed), Net         $ 174.2     $ 368.0  
Goodwill       54.1   29.6 86.6   0
Effective rate of tax 23.00% 17.00%              
Goodwill facts and circumstances leading to impairment Goodwill is tested for impairment at least annually as at October 1 each year. This assessment is also performed whenever there is a change in circumstances that indicates the carrying value of these assets may not be recoverable. In the first quarter of 2013 the Company identified circumstances which indicated that the carrying value of goodwill in the Regenerative Medicine (“RM”) reporting unit may not be recoverable, which triggered an impairment test in advance of the annual testing date. These circumstances included the results of an independent market research study of the DERMAGRAFT sales potential, commissioned by the Company, which was finalized late in the first quarter of 2013. In addition, while the Company still expects DERMAGRAFT to return to growth over coming quarters, the recently completed restructuring of the RM sales and marketing organization and the implementation of a new commercial model had a more pronounced impact than previously expected. As a result of these and other factors forecast future sales are now lower than at the time of acquisition.                
Discount Rate 15.10%                
Goodwill impairment method for fair value determination The results of the Company’s March 31, 2013 impairment test showed that the carrying amount of the RM reporting unit exceeded its fair value and the implied value of the goodwill was $nil. As a result the Company recorded an impairment charge of $198.9 million related to the goodwill allocated to the RM reporting unit. The RM goodwill impairment charge is not deductible for tax purposes. This is the primary reason for the effective rate of tax in the nine months to September 30, 2013 (23%) being higher than the same period in 2012 (17%). Accumulated goodwill impairment as at September 30, 2013 was $198.9 million (December 31, 2012: $nil). Key assumptions used to determine the fair value of the RM reporting unit included expected cash flows for the period from March 31, 2013 to December 31, 2023 and the associated discount rate of 15.1%, which was derived from management’s best estimate of the after-tax weighted average cost of capital for the RM reporting unit. The Company determined the estimated fair value of the RM reporting unit using discounted cash flow analyses. Discounted cash flow analyses are dependent upon a number of quantitative and qualitative factors including estimates of forecasted revenue, profitability, earnings before interest, taxes, depreciation and amortization, and terminal values. The discount rates applied in the discounted cash flow analyses also have an impact on the estimates of fair value, as use of a higher rate will result in a lower estimate of fair value                
Accumulated Goodwill Impairment 198.9   0            
Business Acquisition, Cost of Acquired Entity, Cash Paid         49.4     151.0  
Goodwill [Roll Forward]                  
As at January 1, 644.5 592.6              
Acquisition 170.3 48.1              
Goodwill impairment charge (198.9) 0              
Foreign currency translation 5.4 (1.5)              
As at September 30, $ 621.3 $ 639.2              
XML 30 R31.htm IDEA: XBRL DOCUMENT v2.4.0.8
Inventories (Tables)
9 Months Ended
Sep. 30, 2013
Inventory Disclosure [Abstract]  
Schedule of Inventory
 September 30,December 31,
 20132012
 $’M $’M
 ________________________
Finished goods170.6124.4
Work-in-progress241.0220.6
Raw materials68.991.9
 ________________________
 480.5436.9
 ________________________
XML 31 R64.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurement (Assets and Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs) (Details) (USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Change in the Fair Value of Contigent Consideration Receivable    
Balance at beginning of period $ 38.3 $ 37.8
Gain/(loss) recognized in the income statement (within Gain/(loss) on sale of product rights) due to change in fair value during the period 14.6 16.5
Reclassification of amounts due to Other receivables within Other current assets (13.9) (13.7)
Amounts recorded to other comprehensive income (within foreign currency translation adjustments) 0.6 0.4
Balance at end of period 39.6 41.0
Change in the Fair Value of Contigent Consideration Payable    
Balance at beginning of period 136.4 0
Initial recognition of contingent consideration payable 451.4 127.8
Change in fair value during the period with the corresponding adjustment recognized as a loss in the income statement (within Integration and acquisition costs) 28.4 3.3
Reclassification of amounts to Other current liabilities (11.1) (6.7)
Change in fair value during the period with corresponding adjustment to the associated intangible asset (7.3) 9.0
Balance at end of period $ 597.8 $ 133.4
XML 32 R63.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurement (Assets and Liabilities That are Measured and Not Measured at Fair Value on a Recurring Basis) (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Financial liabilities:    
Convertible bonds $ 1,100.0 $ 0
Convertible bonds 0 1,100.0
Carrying value
   
Financial liabilities:    
Building financing obligation 7.8 8.0
Convertible bonds 1,100.0  
Convertible bonds   1,100.0
Estimated fair value
   
Financial liabilities:    
Convertible bond 1,382.9 1,228.2
Building financing obligation 10.4 10.3
Recurring Basis
   
Financial assets:    
Available-for-sale securities 12.0 [1] 14.2 [1]
Contingent consideration receivable 39.6 [2] 38.3 [2]
Foreign exchange contracts, asset 4.2 1.3
Financial liabilities:    
Foreign exchange contracts, liability 3.9 3.0
Contingent consideration payable 597.8 [3] 136.4 [3]
Recurring Basis | Carrying value
   
Financial assets:    
Available-for-sale securities 12.0 [1] 14.2 [1]
Contingent consideration receivable 39.6 [2] 38.3 [2]
Foreign exchange contracts, asset 4.2 1.3
Financial liabilities:    
Foreign exchange contracts, liability 3.9 3.0
Contingent consideration payable 597.8 [3] 136.4 [3]
Recurring Basis | Level 1
   
Financial assets:    
Available-for-sale securities 12.0 [1] 14.2 [1]
Contingent consideration receivable 0 [2] 0 [2]
Foreign exchange contracts, asset 0 0
Financial liabilities:    
Foreign exchange contracts, liability 0 0
Contingent consideration payable 0 [3] 0 [3]
Recurring Basis | Level 2
   
Financial assets:    
Available-for-sale securities 0 [1] 0 [1]
Contingent consideration receivable 0 [2] 0 [2]
Foreign exchange contracts, asset 4.2 1.3
Financial liabilities:    
Foreign exchange contracts, liability 3.9 3.0
Contingent consideration payable 0 [3] 0 [3]
Recurring Basis | Level 3
   
Financial assets:    
Available-for-sale securities 0 [1] 0 [1]
Contingent consideration receivable 39.6 [2] 38.3 [2]
Foreign exchange contracts, asset 0 0
Financial liabilities:    
Foreign exchange contracts, liability 0 0
Contingent consideration payable $ 597.8 [3] $ 136.4 [3]
[1] Available-for-sale securities are included within Investments in the consolidated balance sheet.
[2] Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet.
[3] Contingent consideration payable is included within Other current liabilities and Other non-current liabilities in the consolidated balance sheet.
XML 33 R43.htm IDEA: XBRL DOCUMENT v2.4.0.8
Segmental Reporting (Tables)
9 Months Ended
Sep. 30, 2013
Segment Reporting [Abstract]  
Schedule of Segment Revenue from Major Products
 3 months to,3 months to,9 months to,9 months to,
 September 30,September 30,September 30,September 30,
 2013201220132012
 $’M$’M$’M$’M
 ____________________________________________
     
VYVANSE299.2247.1897.9773.3
LIALDA/MEZAVANT141.9104.4379.9288.5
ELAPRASE129.1110.5392.6358.3
REPLAGAL108.5121.7336.6379.3
VPRIV87.874.9251.9229.3
ADDERALL XR81.4102.2293.5347.5
INTUNIV80.869.0248.9206.6
PENTASA70.667.0215.2196.7
FIRAZYR62.630.3153.881.7
FOSRENOL51.938.1136.3126.8
XAGRID24.222.074.170.7
DERMAGRAFT23.933.764.7134.9
Other product sales33.033.696.4115.5
 ________________________________________________
Total product sales1,194.91,054.53,541.83,309.1
 ________________________________________________
XML 34 R25.htm IDEA: XBRL DOCUMENT v2.4.0.8
Financial Instruments
9 Months Ended
Sep. 30, 2013
Derivative Instrument Detail [Abstract]  
Financial Instruments Disclosure

15.       Financial instruments

 

Treasury policies and organization

 

The Company's principal treasury operations are coordinated by its corporate treasury function. All treasury operations are conducted within a framework of policies and procedures approved annually by the Board. As a matter of policy, the Company does not undertake speculative transactions that would increase its currency or interest rate exposure.

 

Interest rate risk

The Company is exposed to interest rate risk on restricted cash, cash and cash equivalents and on foreign exchange contracts on which interest is at floating rates. This exposure is primarily related to US dollar, Pounds sterling and Euro interest rates. As the Company maintains all of its cash, liquid investments and foreign exchange contracts on a short term basis for liquidity purposes, this risk is not actively managed. In the nine months to September 30, 2013 the average interest rate received on cash and liquid investments was less than 1% per annum. The largest proportion of these cash and liquid investments was in US dollar money market and liquidity funds.

The Company incurs interest at a fixed rate of 2.75% on its $1,100 million in principal amount convertible bonds due 2014.

No derivative instruments were entered into during the nine months to September 30, 2013 to manage interest rate exposure. The Company continues to review its interest rate risk and the policies in place to manage the risk.

Credit risk

Financial instruments that potentially expose Shire to concentrations of credit risk consist primarily of short-term cash investments, derivative contracts and trade accounts receivable (from product sales and from third parties from which the Company receives royalties). Cash is invested in short-term money market instruments, including money market and liquidity funds and bank term deposits. The money market and liquidity funds in which Shire invests are all triple A rated by both Standard and Poor's and by Moody's credit rating agencies.

The Company is exposed to the credit risk of the counterparties with which it enters into derivative instruments. The Company limits this exposure through a system of internal credit limits which vary according to ratings assigned to the counterparties by the major rating agencies. The internal credit limits are approved by the Board and exposure against these limits is monitored by the corporate treasury function. The counterparties to these derivatives contracts are major international financial institutions.

The Company's revenues from product sales in the US are mainly governed by agreements with major pharmaceutical wholesalers and relationships with other pharmaceutical distributors and retail pharmacy chains. For the year to December 31, 2012 there were three customers in the US that accounted for 50% of the Company's product sales. However, such customers typically have significant cash resources and as such the risk from concentration of credit is considered acceptable. The Company has taken positive steps to manage any credit risk associated with these transactions and operates clearly defined credit evaluation procedures. However, an inability of one or more of these wholesalers to honor their debts to the Company could have an adverse effect on the Company's financial condition and results of operations.

A substantial portion of the Company's accounts receivable in countries outside of the United States is derived from product sales to government-owned or government-supported healthcare providers. The Company's recovery of these accounts receivable is therefore dependent upon the financial stability and creditworthiness of the relevant governments. In recent years the creditworthiness and general economic condition of a number of Eurozone countries (including Greece, Ireland, Italy, Portugal and Spain (the “Relevant Countries”)) has deteriorated. As a result, in some of these countries the Company is experiencing delays in the remittance of receivables due from government-owned or government-supported healthcare providers. The Company continued to receive remittances in relation to government-owned or government-supported healthcare providers in all the Relevant Countries in the nine months to September 30, 2013, including receipts of $53.5 million and $90.2 million in respect of Spanish and Italian receivables, respectively.

To date the Company has not incurred significant losses on accounts receivable in the Relevant Countries, and continues to consider that such accounts receivable are recoverable. The Company will continue to evaluate all its accounts receivable for potential collection risks and has made provision for amounts where collection is considered to be doubtful. If the financial condition of the Relevant Countries or other Eurozone countries suffer significant deterioration, such that their ability to make payments becomes uncertain, or if one or more Eurozone member countries withdraws from the Euro, additional allowances for doubtful accounts may be required, and losses may be incurred, in future periods. Any such loss could have an adverse effect on the Company's financial condition and results of operations.

Foreign exchange risk

The Company trades in numerous countries and as a consequence has transactional and translational foreign exchange exposures.

Transactional exposure arises where transactions occur in currencies different to the functional currency of the relevant subsidiary. The main trading currencies of the Company are the US dollar, Pounds Sterling, Swiss Franc and the Euro. It is the Company's policy that these exposures are minimized to the extent practicable by denominating transactions in the subsidiary's functional currency.

Where significant exposures remain, the Company uses foreign exchange contracts (being spot, forward and swap contracts) to manage the exposure for balance sheet assets and liabilities that are denominated in currencies different to the functional currency of the relevant subsidiary. These assets and liabilities relate predominantly to intercompany financing and specific external receivables. The foreign exchange contracts have not been designated as hedging instruments. Cash flows from derivative instruments are presented within net cash provided by operating activities in the consolidated cash flow statement, unless the derivative instruments are economically hedging specific investing or financing activities.

Translational foreign exchange exposure arises on the translation into US dollars of the financial statements of non-US dollar functional subsidiaries.

At September 30, 2013 the Company had 25 swap and forward foreign exchange contracts outstanding to manage currency risk. The swap and forward contracts mature within 90 days. The Company did not have credit risk related contingent features or collateral linked to the derivatives. The Company has master netting agreements with a number of counterparties to these foreign exchange contracts and on the occurrence of specified events, the Company has the ability to terminate contracts and settle them with a net payment by one party to the other. The Company has elected to present derivative assets and derivative liabilities on a gross basis in the consolidated balance sheet. As at September 30, 2013 the potential effect of rights of set off associated with the foreign exchange contracts would be an offset to both assets and liabilities of $0.4 million, resulting in net derivative assets and derivative liabilities of $3.8 million and $3.5 million, respectively. Further details are included below:

 Fair valueFair value
  September 30,December 31,
  20132012
  $’M$’M
  __________________________
AssetsPrepaid expenses and other current assets4.21.3
LiabilitiesOther current liabilities3.93.0
  __________________________

Net (losses)/ gains (both realized and unrealized) arising on foreign exchange contracts have been classified in the consolidated statements of income as follows:

 

 Location of net (loss)/gain recognized in incomeAmount of net (loss)/gain recognized in income
 __________________________________________________________
In the nine months to September 30,September 30,
  20132012
  $’M$’M
  __________________________
Foreign exchange contractsOther income, net(3.2)9.5
  __________________________

These net foreign exchange (losses)/gains are offset within Other income, net by net foreign exchange gains/(losses) arising on the balance sheet items that these contracts were put in place to manage.

XML 35 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Comprehensive Income (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Dec. 31, 2012
Statement of Income and Comprehensive Income [Abstract]          
Net income $ 278.2 $ 227.2 $ 601.1 $ 703.4  
Other comprehensive income:          
Foreign currency translation adjustments 48.9 22.7 14.4 5.0  
Unrealized holding gain/(loss) on available-for-sale securities (net of taxes of $0.1 million, $0.8 million, $1.2 million and $3.7 million) 0.2 1.2    7.2  
Comprehensive income 327.3 251.1 615.5 715.6  
Components of accumulated other comprehensive income          
Foreign currency translation adjustments 99.5   99.5   85.1
Unrealized holding gain/(loss) on available-for-sale securities, net of taxes 1.8   1.8   1.8
Accumulated other comprehensive income $ 101.3   $ 101.3   $ 86.9
XML 36 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Changes in Equity (USD $)
In Millions
Total
EBT
Share Buy-back Program
Common stock
Additional paid-in capital
Treasury stock
Treasury stock
EBT
Treasury stock
Share Buy-back Program
Accumulated other comprehensive income
Retained earnings/(accumulated deficit)
As at Dec. 31, 2012 $ 3,809.2     $ 55.7 $ 2,981.5 $ (310.4)     $ 86.9 $ 995.5
Shares as at Dec. 31, 2012 562.5     562.5            
Net income 601.1                 601.1
Net current period other comprehensive income 14.4               14.4  
Options exercised 0.1     0.1 0          
Option exercised (in shares)       0.4            
Share-based compensation 56.0       56.0          
Tax benefit associated with exercise of stock options 8.1       8.1          
Shares repurchased   (50.3) (190.8)       (50.3) (190.8)    
Shares released by EBT to satisfy exercise of stock options 0.2           84.9     (84.7)
Dividends [1] (79.2)                 (79.2)
As at Sep. 30, 2013 $ 4,168.8     $ 55.8 $ 3,045.6 $ (466.6)     $ 101.3 $ 1,432.7
Shares as at Sep. 30, 2013 562.9     562.9            
[1] Dividends per share During the nine months to September 30, 2013 Shire plc declared and paid dividends of 14.60 US cents per ordinary share (equivalent to 43.80 US cents per ADS) totalling $79.2 million.
XML 37 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2013
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

1.       Summary of Significant Accounting Policies

 

(a)       Basis of preparation

 

These interim financial statements of Shire plc and its subsidiaries (collectively “Shire” or the “Company”) and other financial information included in this Form 10-Q, are unaudited. They have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for interim reporting.

The balance sheet as at December 31, 2012 was derived from audited financial statements but does not include all disclosures required by US GAAP.

These interim financial statements should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the year to December 31, 2012.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period and the Company believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year.

 

(b)       Use of estimates in interim financial statements

The preparation of interim financial statements, in conformity with US GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of intangible assets, the valuation of equity investments, sales deductions, income taxes (including provisions for uncertain tax positions and the realization of deferred tax assets), provisions for litigation and legal proceedings, contingent consideration receivable from product divestments and contingent consideration payable in respect of business combinations and asset purchases. If actual results differ from the Company's estimates, or to the extent these estimates are adjusted in future periods, the Company's results of operations could either benefit from, or be adversely affected by, any such change in estimate.

 

(c)       New accounting pronouncements

 

Adopted during the period

 

Indefinite-Lived Intangible Assets (Other than Goodwill) Impairment Testing

 

In July 2012 the Financial Accounting Standard Board (“FASB”) issued guidance on the testing of indefinite-lived intangible assets for impairment. The guidance permits an entity to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, performing the impairment test is unnecessary. The more-likely-than-not threshold is defined as a likelihood of more than 50 percent. An entity also has the option to bypass the qualitative assessment for any indefinite-lived intangible asset in any period and proceed directly to performing the impairment test and may resume performing the qualitative assessment in any subsequent period. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows.

 

Disclosure about offsetting assets and liabilities

 

In December 2011 the FASB issued guidance on disclosures about offsetting assets and liabilities. In January 2013 the FASB amended the previous guidance to clarify the scope of guidance issued in December 2011. The amended guidance requires entities to disclose both gross and net information about derivatives including bifurcated embedded derivatives, repurchase agreements and reverse repurchase agreements, and securities borrowing and securities lending transactions that are either offset in accordance with FASB guidance on topics “Balance Sheet and Derivatives and Hedging or subject to an enforceable master netting arrangement or similar agreement; to enable users of financial statements to understand the effects or potential effects of those arrangements on its financial position. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows. Enhanced disclosure of balance sheet offsetting as required by this guidance is included in Note 15.

Amounts reclassified out of Comprehensive Income

In February 2013 the FASB issued guidance on reporting amounts reclassified out of accumulated other comprehensive income. The guidance requires entities to provide information about the amount reclassified out of comprehensive income by component and presents either on the face of the financial statements or in the notes, significant amounts reclassified out of other comprehensive income by the respective line items of net income, but only if the amount reclassified is required under US GAAP to be reclassified to net income in its entirety in the same reporting period. For other amounts that are not required under US GAAP to be reclassified in their entirety to net income, an entity is required to cross-reference to other disclosures required under US GAAP that provide additional detail about those amounts. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows.

To be adopted in future periods

Presentation of an unrecognized tax benefit

In July 2013 the FASB issued guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carry forward, a similar tax loss, or a tax credit carry forward exists. The guidance requires entities to present an unrecognized tax benefit or a portion of an unrecognized tax benefit in the financial statements as a reduction to a deferred tax asset for a net operating loss carry forward, a similar tax loss, or a tax credit carry forward, except as follows: to the extent a net operating loss carry forward, a similar tax loss, or a tax credit carry forward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The assessment of whether a deferred tax asset is available is based on the unrecognized tax benefit and deferred tax asset that exist at the reporting date and should be made presuming disallowance of the tax position at the reporting date. The guidance will be effective for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. The Company has not adopted this guidance in the period. The Company is assessing the impact that this guidance will have on its consolidated financial position, results of operations or cash flows.

XML 38 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Changes in Equity (Parenthetical) (USD $)
In Millions, except Per Share data, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Dividends paid $ 79.2 [1]
Ordinary Shares
 
Dividends per share declared $ 0.146
Dividends per share paid $ 0.146
ADS
 
Dividends per share declared $ 0.438
Dividends per share paid $ 0.438
[1] Dividends per share During the nine months to September 30, 2013 Shire plc declared and paid dividends of 14.60 US cents per ordinary share (equivalent to 43.80 US cents per ADS) totalling $79.2 million.
XML 39 R41.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurement (Tables)
9 Months Ended
Sep. 30, 2013
Fair Value Disclosures [Abstract]  
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis
  CarryingFair value
  value    
   TotalLevel 1Level 2Level 3
At September 30, 2013 $'M$'M$'M$'M$'M
  _________________________________________________________
Financial assets:      
Available-for-sale securities(1) 12.012.012.0- -
Contingent consideration receivable (2) 39.639.6- - 39.6
Foreign exchange contracts 4.24.2- 4.2-
       
Financial liabilities:      
Foreign exchange contracts 3.93.9- 3.9-
Contingent consideration payable(3) 597.8597.8- - 597.8
  _________________________________________________________
       
   TotalLevel 1Level 2Level 3
At December 31, 2012 $'M$'M$'M$'M$'M
  _________________________________________________________
Financial assets:      
Available-for-sale securities(1) 14.214.214.2- -
Contingent consideration receivable (2) 38.338.3- - 38.3
Foreign exchange contracts 1.31.3- 1.3-
       
Financial liabilities:      
Foreign exchange contracts 3.03.0- 3.0-
Contingent consideration payable(3)1136.4136.4- - 136.4
  _________________________________________________________

(1)       Available-for-sale securities are included within Investments in the consolidated balance sheet.

(2)       Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet.

(3)       Contingent consideration payable is included within Other current liabilities and Other non-current liabilities in the consolidated balance sheet.

 

Assets Measured at Fair Value on a Recurring Basis Using Significant Unobervable Inputs (Level 3)
Contingent consideration receivable  
 20132012
 $'M$'M
 ________________________
   
Balance at January 1,38.337.8
Gain recognized in the income statement (within Gain on sale of product rights) due to change in fair value during the period14.616.5
Reclassification of amounts to Other receivables within Other current assets(13.9)(13.7)
Amounts recorded to other comprehensive income (within foreign currency translation adjustments) 0.60.4
   
Balance at September 30,39.641.0
   
Liabilities Measured at Fair Value on a Recurring Basis Using Significant Unobervable Inputs (Level 3)
Contingent consideration payable  
 20132012
 $'M$'M
 ________________________
   
Balance at January 1,136.4-
Initial recognition of contingent consideration payable451.4127.8
Change in fair value during the period with the corresponding adjustment recognized as a loss in the income statement (within Integration and acquisition costs)28.43.3
Reclassification of amounts to Other current liabilities(11.1)(6.7)
Change in fair value during the period with corresponding adjustment to the associated intangible asset(7.3)9.0
   
Balance at September 30,597.8133.4
   
Fair Value Inputs, Assets Quantitative Information Table
Financial assets:Fair Value at the Measurement Date
    
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRange
$'M   
_____________________________________________
Contingent consideration receivable ("CCR")39.6Income approach (probability weighted discounted cash flow)• Probability weightings applied to different sales scenarios • Future forecast royalties receivable at relevant contractual royalty rates • Assumed market participant discount rate • 10 to 45% • $5 million to $158 million • 5.9%
 ________________________________________________
     

 Fair Value at the Measurement Date
    
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRate used
$'M   
_____________________________________________
Movetis-related IPR&D intangible assets20.3Income approach (discounted cash flow)• Decline in forecast peak sales since last impairment test • Assumed market participant discount rate • 50% • 8.9%
 ________________________________________________
Fair Value Inputs, Liabilities Quantitative Information Table
Financial liabilities:Fair Value at the Measurement Date
     
At September 30, 2013Fair value Valuation Technique Significant unobservable InputsRange
$'M   
_____________________________________________
Contingent consideration payable597.8Income approach (probability weighted discounted cash flow)• Cumulative probability of milestones being achieved • Assumed market participant discount rate • Periods in which milestones are expected to be achieved • Forecast quarterly royalties payable on net sales of relevant products • 18 to 57% (Weighted average) • 2.1 to 8.8% (Weighted average) • 2014 to 2024 • $1.0 to $7.6 million
 ________________________________________________
Schedule of Fair Value, Assets and Liabilities Not Measured at Fair Value on Recurring Basis
  September 30, 2013 December 31, 2012
  Carrying  Carrying 
  amountFair value amountFair value
  $’M$’M $’M$’M
  ________________________ _______________________
       
Financial liabilities:      
Convertible bonds (Level 1) 1,100.01,382.9 1,100.01,228.2
Building financing obligation (Level 3)  7.810.4 8.010.3
  ________________________ _______________________
XML 40 R28.htm IDEA: XBRL DOCUMENT v2.4.0.8
Segmental Reporting
9 Months Ended
Sep. 30, 2013
Segment Reporting [Abstract]  
Segment Reporting Disclosure

18.       Segmental reporting

 

Historically the Company had three business units and three reportable segments: Specialty Pharmaceuticals (“SP”), Human Genetic Therapies (“HGT”) and RM.

On May 2, 2013 the Company announced that there would be a reorganization of the Company's business to integrate these business units into a simplified “One Shire” organization in order to drive future growth and innovation. Consequently the SP, HGT and RM segments no longer exist.

Shire now comprises a single operating and reportable segment, consistent with the “One Shire” approach that underpins the business simplification. This segment is engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative specialist medicines to meet significant unmet patient needs. This segment is supported by several key functions: a global research and development organization and a global supply chain organization, managed through the newly established pipeline group and technical operations group respectively, are utilized and responsible for the development and delivery of products to the market. Products are distributed and sold through the newly established in-line marketed products group which consists of five commercial units focused exclusively on commercial delivery to drive optimum performance of currently marketed products. The business is also supported by a simplified, centralized corporate function group. None of these functional groups meets all of the criteria to be an operating segment.

The reorganization to a single operating and reportable segment is consistent with the financial information regularly reviewed by the Executive Committee (which is Shire's chief operating decision maker) for the purposes of evaluating performance, allocating resources, and planning and forecasting future periods.

In the periods set out below, revenues by major product were as follows:

 

 3 months to,3 months to,9 months to,9 months to,
 September 30,September 30,September 30,September 30,
 2013201220132012
 $’M$’M$’M$’M
 ____________________________________________
     
VYVANSE299.2247.1897.9773.3
LIALDA/MEZAVANT141.9104.4379.9288.5
ELAPRASE129.1110.5392.6358.3
REPLAGAL108.5121.7336.6379.3
VPRIV87.874.9251.9229.3
ADDERALL XR81.4102.2293.5347.5
INTUNIV80.869.0248.9206.6
PENTASA70.667.0215.2196.7
FIRAZYR62.630.3153.881.7
FOSRENOL51.938.1136.3126.8
XAGRID24.222.074.170.7
DERMAGRAFT23.933.764.7134.9
Other product sales33.033.696.4115.5
 ________________________________________________
Total product sales1,194.91,054.53,541.83,309.1
 ________________________________________________

Further segment disclosures related to geographic area and major customers will be included in the 2013 Annual Report on Form 10-K.

XML 41 R32.htm IDEA: XBRL DOCUMENT v2.4.0.8
Prepaid Expenses and Other Current Assets (Tables)
9 Months Ended
Sep. 30, 2013
Prepaid Expense and Other Assets, Current [Abstract]  
Prepaid Expense and Other Assets, Current
 September 30,December 31,
 20132012
 $’M $’M
 __________________________
Prepaid expenses39.131.7
Income tax receivable179.9130.6
Value added taxes receivable18.720.9
Other current assets44.638.6
 ____________________________
 282.3221.8
 ____________________________
XML 42 R37.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Non-current Liabilities (Tables)
9 Months Ended
Sep. 30, 2013
Other Liabilities, Noncurrent [Abstract]  
Schedule of Other Noncurrent Liabilities
 September 30,December 31,
 20132012
 $’M $’M
 ________________________
Income taxes payable81.558.9
Deferred revenue10.311.4
Deferred rent11.311.9
Insurance provisions7.912.3
Contingent consideration payable511.8120.4
Other non-current liabilities29.526.7
 ________________________
 652.3241.6
 ________________________
XML 43 R55.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Non-current Liabilities (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Other Liabilities, Noncurrent [Abstract]    
Income taxes payable $ 81.5 $ 58.9
Deferred revenue 10.3 11.4
Deferred rent 11.3 11.9
Insurance provisions 7.9 12.3
Contingent consideration payable 511.8 120.4
Other non-current liabilities 29.5 26.7
Other noncurrent liabilities, total $ 652.3 $ 241.6
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In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Sep. 30, 2012
Dec. 31, 2011
Intangible Assets (Excluding Goodwill) [Line Items]        
Amortized intangible assets $ 3,223.2 $ 3,216.5    
Other intangible assets, gross 4,176.0 3,447.5    
Less: Accumulated amortization (1,200.0) (1,059.4)    
Other intangible assets, net 2,976.0 2,388.1 2,593.6 2,493.0
Estimates of Annual Amortization        
2014 170.0      
2015 170.0      
2016 170.0      
2017 170.0      
2018 170.0      
Currently Marketed Products
       
Intangible Assets (Excluding Goodwill) [Line Items]        
Amortized intangible assets 2,467.9 2,462.0    
Acquired Product Technology
       
Intangible Assets (Excluding Goodwill) [Line Items]        
Amortized intangible assets 710.0 710.0    
Other Intangible Assets
       
Intangible Assets (Excluding Goodwill) [Line Items]        
Amortized intangible assets 45.3 44.5    
IPR&D
       
Intangible Assets (Excluding Goodwill) [Line Items]        
Unamortized intangible assets $ 952.8 $ 231.0    
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In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Reorganization Costs        
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Turnhout
       
Reorganization Costs        
Reorganization costs 1.8   21.0  
"One Shire" business re-alignment
       
Reorganization Costs        
Reorganization costs 11.9   36.6  
Reorganization costs liability $ 10.6   $ 10.6  
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In Millions, except Per Share data, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Statement of Financial Position [Abstract]    
Common Stock, Par Value £ 0.05 £ 0.05
Common Stock, Shares Authorized 1,000 1,000
Common Stock, Shares, Issued 562.9 562.5
Common Stock, Shares, Outstanding 562.9 562.5
Treasury Stock, Shares 14.5 10.7
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Accounts Receivable, Net
9 Months Ended
Sep. 30, 2013
Receivables [Abstract]  
Accounts Receivable Disclosure

4.       Accounts receivable, net

 

Accounts receivable at September 30, 2013 of $1,037.8 million (December 31, 2012: $824.2 million), are stated net of a provision for discounts and doubtful accounts of $51.6 million (December 31, 2012: $41.7 million).

 

Provision for discounts and doubtful accounts:

 20132012
 $’M$’M
 __________________________
As at January 1,41.731.1
Provision charged to operations225.3214.9
Provision utilization(215.4)(196.5)
 __________________________
As at September 30,51.649.5
 __________________________

At September 30, 2013 accounts receivable included $36.9 million (December 31, 2012: $38.5 million) related to royalty income.

 

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In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Intangible Assets (Excluding Goodwill) [Line Items]        
Amortization of intangible assets     $ 136.1 $ 147.3
Impairment charges 19.9 27.0 19.9 27.0
Acquired Intellectual Property Rights
       
Intangible Assets (Excluding Goodwill) [Line Items]        
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In Millions, unless otherwise specified
9 Months Ended 9 Months Ended
Sep. 30, 2013
Dec. 31, 2012
Sep. 30, 2013
INTUNIV
Sep. 30, 2013
Settlement costs related to agreement in principle to resolve a civil subpoena
Sep. 30, 2013
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Sep. 30, 2013
Clinical Testing
Dec. 31, 2012
Clinical Testing
Sep. 30, 2013
Contract Manufacturing
Dec. 31, 2012
Contract Manufacturing
Sep. 30, 2013
Other Purchasing Commitment
Dec. 31, 2012
Other Purchasing Commitment
Sep. 30, 2013
Investment Commitment
Dec. 31, 2012
Investment Commitment
Sep. 30, 2013
Capital Commitment
Dec. 31, 2012
Capital Commitment
Commitment [Line Items]                              
Commitment amount           $ 332.0 $ 425.0 $ 84.0 $ 125.0 $ 101.0 $ 145.0 $ 15.0 $ 15.0 $ 109.0 $ 97.0
Commitments expected to be paid in next year               46.0   89.0          
Legal Matters [Line Items]                              
Provisions for litigation loss, insurance claims and other disputes 86.2 130.5   57.5                      
Cash payment to Impax         $ 48.0                    
Settlement of litigation     Payment of a royalty of 25% of gross profits                        
XML 52 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Balance Sheets (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Current assets:    
Cash and cash equivalents $ 1,686.1 $ 1,482.2
Restricted cash 16.6 17.1
Accounts receivable, net 1,037.8 824.2
Inventories 480.5 436.9
Deferred tax asset 210.6 229.9
Prepaid expenses and other current assets 282.3 221.8
Total current assets 3,713.9 3,212.1
Non-current assets:    
Investments 36.7 38.7
Property, plant and equipment, net 965.1 955.8
Goodwill 621.3 644.5
Other intangible assets, net 2,976.0 2,388.1
Deferred tax asset 40.4 46.5
Other non-current assets 34.5 31.5
Total assets 8,387.9 7,317.2
Current liabilities:    
Accounts payable and accrued expenses 1,581.6 1,501.5
Convertible bonds 1,100.0 0
Other current liabilities 163.2 144.1
Total current liabilities 2,844.8 1,645.6
Non-current liabilities    
Convertible bonds 0 1,100.0
Deferred tax liability 722.0 520.8
Other non-current liabilities 652.3 241.6
Total liabilities 4,219.1 3,508.0
Commitments and contingencies      
Equity:    
Common stock of 5p par value; 1,000 million shares authorized; and 562.9 million shares issued and outstanding (2012: 1,000 million shares authorized; and 562.5 million shares issued and outstanding) 55.8 55.7
Additional paid-in capital 3,045.6 2,981.5
Treasury stock: 14.5 million shares (2012: 10.7 million shares) (466.6) (310.4)
Accumulated other comprehensive income 101.3 86.9
Retained earnings 1,432.7 995.5
Total equity 4,168.8 3,809.2
Total liabilities and equity $ 8,387.9 $ 7,317.2
XML 53 R51.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Intangible Assets, Net (Roll Forward) (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Other Intangible Assets Roll Forward        
As at January 1,     $ 2,388.1 $ 2,493.0
Acquisitions     733.2 281.5
Amortization charged     (136.1) (147.3)
Impairment charges (19.9) (27.0) (19.9) (27.0)
Foreign currency translation     10.7 (6.6)
As at September 30, $ 2,976.0 $ 2,593.6 $ 2,976.0 $ 2,593.6
XML 54 R29.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2013
Basis of preparation

(a)       Basis of preparation

 

These interim financial statements of Shire plc and its subsidiaries (collectively “Shire” or the “Company”) and other financial information included in this Form 10-Q, are unaudited. They have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for interim reporting.

The balance sheet as at December 31, 2012 was derived from audited financial statements but does not include all disclosures required by US GAAP.

These interim financial statements should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the year to December 31, 2012.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period and the Company believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year.

Use of estimates in consolidated financial statements

(b)       Use of estimates in interim financial statements

The preparation of interim financial statements, in conformity with US GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of intangible assets, the valuation of equity investments, sales deductions, income taxes (including provisions for uncertain tax positions and the realization of deferred tax assets), provisions for litigation and legal proceedings, contingent consideration receivable from product divestments and contingent consideration payable in respect of business combinations and asset purchases. If actual results differ from the Company's estimates, or to the extent these estimates are adjusted in future periods, the Company's results of operations could either benefit from, or be adversely affected by, any such change in estimate.

New accounting pronouncements

(c)       New accounting pronouncements

 

Adopted during the period

 

Indefinite-Lived Intangible Assets (Other than Goodwill) Impairment Testing

 

In July 2012 the Financial Accounting Standard Board (“FASB”) issued guidance on the testing of indefinite-lived intangible assets for impairment. The guidance permits an entity to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination that it is more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount. If, after assessing the totality of events or circumstances, an entity determines it is not more likely than not that the fair value of an indefinite-lived intangible asset is less than its carrying amount, performing the impairment test is unnecessary. The more-likely-than-not threshold is defined as a likelihood of more than 50 percent. An entity also has the option to bypass the qualitative assessment for any indefinite-lived intangible asset in any period and proceed directly to performing the impairment test and may resume performing the qualitative assessment in any subsequent period. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows.

 

Disclosure about offsetting assets and liabilities

 

In December 2011 the FASB issued guidance on disclosures about offsetting assets and liabilities. In January 2013 the FASB amended the previous guidance to clarify the scope of guidance issued in December 2011. The amended guidance requires entities to disclose both gross and net information about derivatives including bifurcated embedded derivatives, repurchase agreements and reverse repurchase agreements, and securities borrowing and securities lending transactions that are either offset in accordance with FASB guidance on topics “Balance Sheet and Derivatives and Hedging or subject to an enforceable master netting arrangement or similar agreement; to enable users of financial statements to understand the effects or potential effects of those arrangements on its financial position. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows. Enhanced disclosure of balance sheet offsetting as required by this guidance is included in Note 15.

Amounts reclassified out of Comprehensive Income

In February 2013 the FASB issued guidance on reporting amounts reclassified out of accumulated other comprehensive income. The guidance requires entities to provide information about the amount reclassified out of comprehensive income by component and presents either on the face of the financial statements or in the notes, significant amounts reclassified out of other comprehensive income by the respective line items of net income, but only if the amount reclassified is required under US GAAP to be reclassified to net income in its entirety in the same reporting period. For other amounts that are not required under US GAAP to be reclassified in their entirety to net income, an entity is required to cross-reference to other disclosures required under US GAAP that provide additional detail about those amounts. The guidance has been adopted prospectively from January 1, 2013. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows.

To be adopted in future periods

Presentation of an unrecognized tax benefit

In July 2013 the FASB issued guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss carry forward, a similar tax loss, or a tax credit carry forward exists. The guidance requires entities to present an unrecognized tax benefit or a portion of an unrecognized tax benefit in the financial statements as a reduction to a deferred tax asset for a net operating loss carry forward, a similar tax loss, or a tax credit carry forward, except as follows: to the extent a net operating loss carry forward, a similar tax loss, or a tax credit carry forward is not available at the reporting date under the tax law of the applicable jurisdiction to settle any additional income taxes that would result from the disallowance of a tax position or the tax law of the applicable jurisdiction does not require the entity to use, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be combined with deferred tax assets. The assessment of whether a deferred tax asset is available is based on the unrecognized tax benefit and deferred tax asset that exist at the reporting date and should be made presuming disallowance of the tax position at the reporting date. The guidance will be effective for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. The Company has not adopted this guidance in the period. The Company is assessing the impact that this guidance will have on its consolidated financial position, results of operations or cash flows.

XML 55 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies
9 Months Ended
Sep. 30, 2013
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Disclosure

13.       Commitments and contingencies

 

(a)       Leases

 

Future minimum lease payments under operating leases at September 30, 2013 are presented below:

  Operating
  leases
  $’M
  _____________
2013 11.4
2014 42.5
2015 31.8
2016 23.4
2017 17.8
2018 12.1
Thereafter 83.2
  _____________
  222.2
  _____________

The Company leases land, facilities, motor vehicles and certain equipment under operating leases expiring through 2032. Lease and rental expense amounted to $35.5 million and $31.4 million for the nine months to September 30, 2013 and 2012 respectively, which is predominately included in SG&A expenses in the Company's consolidated income statement.

 

(b)       Letters of credit and guarantees

 

At September 30, 2013 the Company had irrevocable standby letters of credit and guarantees with various banks and insurance companies totaling $54 million, providing security for the Company's performance of various obligations. These obligations are primarily in respect of the recoverability of insurance claims, lease obligations and supply commitments.

 

(c)       Collaborative arrangements

 

Details of significant updates in collaborative arrangements are included below:

 

In-licensing arrangements

 

Collaboration with Acceleron Pharma Inc. (“Acceleron”) for activin receptor type IIB class of molecules

 

In April 2013, following the results of toxicology studies, Shire discontinued development of HGT4510, returned Shire's rights in the asset to Acceleron and discontinued the collaboration.

 

Out-licensing arrangements

 

Shire has entered into various collaborative arrangements under which the Company has out-licensed certain product or intellectual property rights for consideration such as up-front payments, development milestones, sales milestones and/or royalty payments. In some of these arrangements Shire and the licensee are both actively involved in the development and commercialization of the licensed product and have exposure to risks and rewards dependent on its commercial success. Under the terms of these arrangements, the Company may receive development milestone payments up to an aggregate amount of $39.0 million and sales milestones up to an aggregate amount of $71.5 million. The receipt of these substantive milestones is uncertain and contingent on the achievement of certain development milestones or the achievement of a specified level of annual net sales by the licensee. In the nine months to September 30, 2013 Shire received up-front and milestone payments totaling $3.0 million (2012: $6.0 million). In the nine months to September 30, 2013 Shire recognized milestone income of $4.5 million (2012: $6.7 million) in other revenues and $43.8 million (2012: $57.6 million) in product sales for shipment of product to the relevant licensee.

 

(d)       Commitments

 

(i)       Clinical testing

 

At September 30, 2013 the Company had committed to pay approximately $ 332 million (December 31, 2012: $ 425 million) to contract vendors for administering and executing clinical trials. The timing of these payments is dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities.

 

(ii)       Contract manufacturing

 

At September 30, 2013 the Company had committed to pay approximately $ 84 million (December 31, 2012: $ 125 million) in respect of contract manufacturing. The Company expects to pay $ 46 million of these commitments in 2013.

 

(iii)       Other purchasing commitments

 

At September 30, 2013 the Company had committed to pay approximately $ 101 million (December 31, 2012: $ 145 million) for future purchases of goods and services, predominantly relating to active pharmaceutical ingredients sourcing. The Company expects to pay $ 89 million of these commitments in 2013.

 

(iv)       Investment commitments

 

At September 30, 2013 the Company had outstanding commitments to subscribe for interests in companies and partnerships for amounts totaling $ 15 million (December 31, 2012: $ 15 million) which may all be payable in 2013, depending on the timing of capital calls.

 

(v)       Capital commitments

 

At September 30, 2013 the Company had committed to spend $ 109 million (December 31, 2012: $ 97 million) on capital projects.

 

(e)       Legal and other proceedings

 

The Company expenses legal costs as they are incurred.

 

The Company recognizes loss contingency provisions for probable losses when management is able to reasonably estimate the loss. When the estimated loss lies within a range, the Company records a loss contingency provision based on its best estimate of the probable loss. If no particular amount within that range is a better estimate than any other amount, the minimum amount is recorded.  Estimates of losses may be developed substantially before the ultimate loss is known, and are therefore refined each accounting period as additional information becomes known. In instances where the Company is unable to develop a reasonable estimate of loss, no loss contingency provision is recorded at that time. As information becomes known a loss contingency provision is recorded when a reasonable estimate can be made. The estimates are reviewed quarterly and the estimates are changed when expectations are revised. An outcome that deviates from the Company's estimate may result in an additional expense or release in a future accounting period. At September 30, 2013 provisions for litigation losses, insurance claims and other disputes totaled $86.2 million (December 31, 2012: $130.5 million).

 

The Company's principal pending legal and other proceedings are disclosed below. The outcomes of these proceedings are not always predictable and can be affected by various factors. For those legal and other proceedings for which it is considered at least reasonably possible that a loss has been incurred, the Company discloses the possible loss or range of possible loss in excess of the recorded loss contingency provision, if any, where such excess is both material and estimable.

 

VYVANSE

In May and June 2011, Shire was notified that six separate Abbreviated New Drug Applications ("ANDAs") were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of VYVANSE. The notices were from Sandoz, Inc. ("Sandoz"); Amneal Pharmaceuticals LLC ("Amneal"); Watson Laboratories, Inc.; Roxane Laboratories, Inc. ("Roxane"); Mylan Pharmaceuticals, Inc.; and Actavis Elizabeth LLC and Actavis Inc. (collectively, "Actavis"). Within the requisite 45 day period, Shire filed lawsuits for infringement of certain of Shire's VYVANSE patents in the US District Court for the District of New Jersey against each of Sandoz, Roxane, Amneal and Actavis; in the US District Court for the Central District of California against Watson Laboratories, Inc.; and in the US District Court for the Eastern District of New York against Mylan Pharmaceuticals, Inc. and Mylan Inc. (collectively "Mylan"). In February 2013, Shire withdrew its lawsuit against Watson following Watson's withdrawal of its ANDA. On December 9, 2011, the District Court of New Jersey consolidated the Sandoz, Roxane, Amneal and Actavis cases. The filing of the lawsuits triggered a stay of approval of all six ANDAs for up to 30 months from the expiration of the new chemical entity exclusivity, which will expire on August 23, 2014. In December 2011 and February 2012, Shire received additional notifications that Mylan had filed further certifications challenging other VYVANSE patents listed in the Orange Book. Within the requisite 45 day period, Shire filed a new lawsuit against Mylan, Johnson Matthey Pharmaceutical Materials and Johnson Matthey Inc. in New Jersey. In May 2012, the Mylan case that was filed in the Eastern District of New York was transferred and consolidated with the Mylan, Sandoz, Roxane, Amneal and Actavis cases in New Jersey. In December 2012, the parties completed a Markman briefing. A Markman hearing took place on August 5, 2013 and a ruling was rendered on August 8, 2013. No trial dates have been set.

INTUNIV

Between March 2010 and March 2011, Shire was notified that seven separate ANDAs had been submitted to the FDA under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of INTUNIV. The ANDA filers were Actavis Inc., Teva Pharmaceuticals USA, Inc., Anchen, Inc., Watson Pharmaceuticals, Inc., Impax Laboratories, Inc., Mylan Pharmaceuticals, Inc., Sandoz, Inc., and certain of their respective affiliates.  Shire filed lawsuits against each of these ANDA filers.  All of the lawsuits have now been settled.  Under the terms of the Actavis settlement, Actavis has a license to make and market Actavis' generic versions of INTUNIV in the United States on December 1, 2014.  Such sales will require the payment of a royalty of 25% of gross profits to Shire during the 180 day period of Actavis' exclusivity. All other parties with whom Shire has settled will be able to enter the market with their respective ANDA-approved products after Actavis' 180 day exclusivity period has expired.  Each of the settlements included a consent judgment confirming that the proposed ANDA products infringe the patents-in-suit, U.S. Patents 6,287,599 and 6,811,794, and that those patents are valid and enforceable with respect to their respective proposed ANDA products.   U.S. Patent 5,854,290, which was originally asserted in some of the litigations, has been dedicated to the public.

FOSRENOL

Between February 2009 and December 2010 Shire was notified that four separate ANDAs had been submitted to the FDA under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of FOSRENOL. The ANDA filers were Barr Laboratories, Inc.; Mylan, Inc.; Natco Pharma Limited and Alkem Laboratories Ltd., and certain of their respective affiliates. Shire filed lawsuits against each of these ANDA filers.  In April 2011, Shire and Barr reached a settlement and the lawsuit against Barr was dismissed.  The settlement provides Barr with a license to market its own generic version of FOSRENOL upon receiving FDA approval in the US on the earlier of the date of entry of another company's generic version of FOSRENOL to the US market, or October 1, 2021.  Shire's lawsuits against Mylan, Alkem and Natco have each been dismissed, and consequently, each of Mylan, Alkem and Natco may enter the US market upon FDA approval of their respective ANDA products.

LIALDA

 

In May 2010 Shire was notified that Zydus Pharmaceuticals USA, Inc. (“Zydus”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of Delaware against Zydus and Cadila Healthcare Limited, doing business as Zydus Cadila. As of February 22, 2013, the case has been administratively closed. No further activity will take place until after one of the parties files a motion to reopen the case.

In February 2012, Shire was notified that Osmotica Pharmaceutical Corporation ("Osmotica") had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA.  Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Northern District of Georgia against Osmotica. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. The court has appointed a special master to assist with a Markman hearing and to preside over any discovery disputes. A Markman hearing took place on August 22, 2013 but no ruling has been rendered. No trial date has been set.

In March 2012, Shire was notified that Watson Laboratories Inc.-Florida had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Southern District of Florida against Watson Laboratories Inc.-Florida and Watson Pharmaceuticals, Inc. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. In August 2012, Shire filed an amended complaint adding Watson Pharma, Inc. and Watson Laboratories, Inc. as defendants. A Markman hearing was held on December 20, 2012 and a written Markman decision was given by the court on January 17, 2013. A trial took place in April, 2013 and on May 9, 2013 the trial court issued a decision finding that the proposed generic product infringes the patent-in-suit and that the patent is not invalid.  Watson has appealed the trial court's ruling to the Court of Appeals of the Federal Circuit and a hearing is scheduled for December 2, 2013.

In April 2012, Shire was notified that Mylan Pharmaceuticals, Inc. (“Mylan”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Middle District of Florida against Mylan. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. No date for a Markman hearing has been set. A trial is scheduled to occur in September, 2014.

ADDERALL XR

On November 1, 2010 Impax Laboratories, Inc. (“Impax”) filed suit against Shire in the US District Court for the Southern District of New York claiming that Shire was in breach of its supply contract for the authorized generic version of ADDERALL XR. On February 7, 2013 Shire and Impax settled this dispute and agreed to discontinue all court and related proceedings. Under the terms of the settlement Shire made a one-time cash payment to Impax of $48 million in the first quarter of 2013. Also as part of the settlement, the parties have entered into an amended supply agreement which will govern the supply of authorized generic ADDERALL XR from Shire to Impax until the end of the supply term on September 30, 2014.

In February 2011, Shire was notified that Watson Laboratories, Inc.-Florida had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of all approved strengths of ADDERALL XR. Shire filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc. and certain of its affiliates for infringement of certain of Shire's ADDERALL XR patents. Par Pharmaceutical, Inc. (the successor in interest to Watson's ANDA for ADDERALL XR) has withdrawn its ANDA, and the litigation was dismissed on January 23, 2013 by agreement between Shire, Watson and Par Pharmaceutical, Inc..

In February 2013, Shire was notified that Neos Therapeutics, Inc. had submitted a New Drug Application under section 505(b)(2) of the Hatch Waxman Act (“505(b)(2) Application”). The 505(b)(2) Application was submitted with a paragraph IV certification for U.S. Reissued Patent Nos. RE41,148 and 42,096 listed in the Orange Book.  Within the requisite 45 day period, Shire filed a lawsuit in the Northern District of Texas against Neos Therapeutics, Inc. for infringement of those patents. The filing of the lawsuit triggered a stay of final approval of the 505(b)(2) Application for 30 months.  No trial date has been set.

Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE

 

On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covered whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act.

On February 1, 2013 the Company announced it had reached an agreement in principle to resolve this matter.  The agreement also addresses sales and marketing practices relating to LIALDA and PENTASA pursuant to a subsequent voluntary disclosure made by the Company. Shire cooperated with the US Government throughout the process that led to this agreement in principle.

The Company has recorded a $57.5 million charge comprised of the agreement in principle amount, interest and costs, which has been charged to SG&A in the fourth quarter of 2012.  The agreement in principle is subject to change until this matter is finally resolved.  Discussions between the Company and the US Government are ongoing to establish a final resolution to the investigation.

 

Louisiana Complaint related to ADDERALL, ADDERALL XR, DAYTRANA, VYVANSE and INTUNIV

 

On July 22 and July 23, 2013, the State of Louisiana served Shire LLC and Shire US Inc., respectively, with a civil complaint filed in the 19th Judicial District Court for the Parish of East Baton Rouge. The complaint alleges that Shire's sales, marketing, and promotion of ADDERALL, ADDERALL XR, DAYTRANA, VYVANSE and INTUNIV violated state law. The State is seeking monetary relief for its claims of fraud, redhibition, and unjust enrichment, as well as violations of Louisiana's Medical Assistance Programs Integrity Law, Unfair Trade Practices Act, and anti-trust laws. Shire intends vigorously to defend these claims. Shire is not in a position at this time to predict the timing, result or outcome of these claims.

 

Investigation related to DERMAGRAFT

 

Shire understands that the Department of Justice, including the US Attorney's Office for the Middle District of Florida, Tampa Division and the US Attorney's Office for Washington, DC, is conducting civil and criminal investigations into the sales and marketing practices of Advanced BioHealing Inc. (“ABH”) relating to DERMAGRAFT. Shire is cooperating fully with these investigations. Shire is not in a position at this time to predict the scope, duration or outcome of these investigations.

Civil Investigative Demand for ADDERALL XR, ADDERALL XR Authorized Generics and VYVANSE

 

On April 5, 2012 Shire received a Civil Investigative Demand (“CID”) from the United States Federal Trade Commission (“FTC”) requesting that Shire provide it with certain information regarding the supply and reported shortages of ADDERALL XR and its authorized generics and the marketing and sale of ADDERALL XR, its authorized generics and VYVANSE. Shire believes the CID was triggered by reports of product shortages of ADDERALL XR and the authorized generic products in 2011. Shire responded to the CID in 2012. On August 29, 2013, the FTC informed Shire that it was closing the investigation without taking any further action.

XML 56 R44.htm IDEA: XBRL DOCUMENT v2.4.0.8
Business Combinations (SARcode, Premacure and Lotus) (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended 9 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Lotus
Sep. 30, 2012
Lotus
Feb. 12, 2013
Lotus
Feb. 12, 2013
Lotus
purchase price allocation
Sep. 30, 2013
SARcode Biosciences Inc
Sep. 30, 2012
SARcode Biosciences Inc
Apr. 17, 2013
SARcode Biosciences Inc
Apr. 17, 2013
SARcode Biosciences Inc
purchase price allocation
Sep. 30, 2013
Premacure AB
Sep. 30, 2012
Premacure AB
Mar. 08, 2013
Premacure AB
Mar. 08, 2013
Premacure AB
purchase price allocation
Business Acquisition [Line Items]                                
Percentage of voting interests acquired             100.00%       100.00%       100.00%  
Cash consideration paid             $ 49.4       $ 151.0       $ 30.6  
Maximum amount of contingent cash consideration             275.0       525.0       169.0  
Integration and acquisition costs 18.4 2.7 39.9 15.1 4.6 0     14.7 0     9.8 0    
Acquisition-date fair value of consideration totaled             174.2       368.0       140.2  
Fair value of contingent consideration payable             124.8       217.0       109.6  
Net current assets assumed               6.8                
Goodwill         54.1     54.1 86.6     86.6       29.6
Net non-current liabilities assumed (including deferred tax liabilities)               63.4       122.4       29.5
Post acquisition pre-tax losses included in consolidated statement of income                 17.4 0            
IPR&D               176.7       412.0       151.8
Net current liabilities assumed                       $ 8.2       $ 11.7
XML 57 R54.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Current Liabilities (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Other Liabilities, Current [Abstract]    
Income taxes payable $ 19.4 $ 78.4
Value added taxes 28.7 23.6
Contingent consideration payable 86.0 16.0
Other current liabilities 29.1 26.1
Other current liabilities, total $ 163.2 $ 144.1
XML 58 R65.htm IDEA: XBRL DOCUMENT v2.4.0.8
Fair Value Measurement (Quantitative Information About Recurring and Non-recurring Level 3 Fair Value Measurements) (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Fair Value Inputs        
Impairment of intangible assets $ 19.9 $ 27.0 $ 19.9 $ 27.0
Recurring Basis | Contingent Consideration Payable | Minimum
       
Fair Value Inputs        
Assumed market participant discount rate     2.10%  
Cumulative probability of milestones being achieved     18.00%  
Periods in which milestones are expected to be achieved 2014   2014  
Forecast quarterly royalties payable on net sales of relevant products 1.0   1.0  
Recurring Basis | Contingent Consideration Payable | Maximum
       
Fair Value Inputs        
Assumed market participant discount rate     8.80%  
Cumulative probability of milestones being achieved     57.00%  
Periods in which milestones are expected to be achieved 2024   2024  
Forecast quarterly royalties payable on net sales of relevant products 7.6   7.6  
Recurring Basis | Contingent Consideration Payable | Income approach (probability weighted discounted cash flow)
       
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items]        
Liabilities 597.8   597.8  
Recurring Basis | Contingent Consideration Receivable
       
Fair Value Inputs        
Assumed market participant discount rate     5.90%  
Recurring Basis | Contingent Consideration Receivable | Minimum
       
Fair Value Inputs        
Probability weightings applied to different sales scenarios     10.00%  
Future forecast royalties receivable at relevant contractual royalty rates 5   5  
Recurring Basis | Contingent Consideration Receivable | Maximum
       
Fair Value Inputs        
Probability weightings applied to different sales scenarios     45.00%  
Future forecast royalties receivable at relevant contractual royalty rates 158   158  
Recurring Basis | Contingent Consideration Receivable | Income approach (probability weighted discounted cash flow)
       
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items]        
Assets 39.6   39.6  
Nonrecurring Basis | Movetis-related IPR&D intangible assets
       
Fair Value Inputs        
Assumed market participant discount rate     8.90%  
Decline in forecast peak sales     50.00%  
Nonrecurring Basis | Movetis-related IPR&D intangible assets | Income approach (discounted cash flow)
       
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items]        
Assets $ 20.3   $ 20.3  
XML 59 R39.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accumulated Other Comprehensive Income (Tables)
9 Months Ended
Sep. 30, 2013
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract]  
Changes in Accumulated Other Comprehensive Income, Net of Tax
  Foreign currency translation adjustment Unrealized holding gain/(loss) on available-for-sale securities Accumulated other comprehensive income
  $M $M $M
       
As at January 1, 201385.1 1.8 86.9
Current period change:     
 Other Comprehensive income before reclassification14.4 2.2 16.6
 Gain transferred to the income statement (within Other (expense)/income, net) on disposal of available-for-sale securities0 (2.2) (2.2)
Net current period other comprehensive income14.4 -  14.4
       
As at September 30, 201399.5 1.8 101.3
       
XML 60 R35.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Payable and Accrued Expenses (Tables)
9 Months Ended
Sep. 30, 2013
Accounts Payable and Accrued Liabilities, Current [Abstract]  
Schedule of Accounts Payable and Accrued Expenses
 September 30,December 31,
 20132012
 $’M $’M
 ________________________________
Trade accounts payable and accrued purchases187.8208.1
Accrued rebates – Medicaid511.7455.6
Accrued rebates – Managed care235.4184.9
Sales return reserve95.390.5
Accrued bonuses101.6109.0
Accrued employee compensation and benefits payable89.164.5
R&D accruals79.473.5
Provisions for litigation losses and other claims78.3118.2
Other accrued expenses203.0197.2
 ________________________________
 1,581.61,501.5
 ________________________________
XML 61 R36.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Current Liabilities (Tables)
9 Months Ended
Sep. 30, 2013
Other Liabilities, Current [Abstract]  
Schedule of Other Current Liabilities
 September 30,December 31,
 20132012
 $’M $’M
 __________________________
Income taxes payable19.478.4
Value added taxes28.723.6
Contingent consideration payable86.016.0
Other current liabilities29.126.1
 __________________________
 163.2144.1
 __________________________
XML 62 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
Reorganization Costs
9 Months Ended
Sep. 30, 2013
Restructuring and Related Activities [Abstract]  
Reorganization Costs Disclosure

3.       Reorganization costs

 

Turnhout, Belgium Site Closure

 

On January 23, 2013 Shire announced that it had decided to proceed with a collective dismissal and business closure at its site in Turnhout, Belgium. This decision follows the conclusion of an information and consultation process. Shire will continue to sell RESOLOR in Europe and the supply of RESOLOR for patients in Europe who rely on the medicine will not be affected. In the three and nine months to September 30, 2013 the Company incurred reorganization costs totaling $1.8 million and $21.0 million, respectively relating to employee involuntary termination benefits and other re-organization costs. The closure of the Turnhout site is expected to be completed by the end of 2013.

 

“One Shire” business reorganization

 

On May 2, 2013, the Company announced that there would be a reorganization of the business to integrate the three divisions into a simplified “One Shire” organization in order to drive future growth and innovation. In the three and nine months to September 30, 2013, the Company incurred reorganization costs totaling $11.9 million and $36.6 million respectively, relating to contract termination and other reorganization costs (of which $10.6 million is accrued at September 30, 2013). The Company is continuing to evaluate both the total costs expected to be incurred and the timeframe for completion of this reorganization.

 

Decision to discontinue the construction of the new manufacturing facility in San Diego

 

On October 22, 2013 Shire announced that it had decided to discontinue the construction of its new manufacturing facility in San Diego. Shire will continue to manufacture DERMAGRAFT in its existing facility in La Jolla, and Shire's ability to meet expected future demand for DERMAGRAFT is not impacted by this decision. Shire is currently assessing possible disposal opportunities in relation to this facility. It is reasonably possible that charges to write down the carrying value of the assets related to this manufacturing facility may be required in future periods.

XML 63 R62.htm IDEA: XBRL DOCUMENT v2.4.0.8
Financial Instruments (Foreign Exchange Risk and Its Effect on Income Statement) (Details) (Foreign Exchange Contract, Other income, net, USD $)
In Millions, unless otherwise specified
9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Foreign Exchange Contract | Other income, net
   
Derivative Instruments, Gain (Loss) [Line Items]    
Amount of net income (loss) recognized in income $ (3.2) $ 9.5
XML 64 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Receivable, Net (Tables)
9 Months Ended
Sep. 30, 2013
Receivables [Abstract]  
Provision for discounts and doubtful accounts
 20132012
 $’M$’M
 __________________________
As at January 1,41.731.1
Provision charged to operations225.3214.9
Provision utilization(215.4)(196.5)
 __________________________
As at September 30,51.649.5
 __________________________
XML 65 R42.htm IDEA: XBRL DOCUMENT v2.4.0.8
Earnings Per Share (Tables)
9 Months Ended
Sep. 30, 2013
Earnings Per Share [Abstract]  
Schedule of Calculation of Numerator and Denominator in Earnings Per Share
  2013201220132012 
  $’M$’M$’M$’M 
  ____________________________________________________________________ 
 Numerator for basic earnings per share278.2227.2601.1703.4 
       
 Interest on convertible bonds, net of tax 7.67.522.723.7 
  ____________________________________________________________________ 
 Numerator for diluted earnings per share285.8234.7623.8727.1 
  ____________________________________________________________________ 
       
Schedule of Weighted Average Number of Shares
 Weighted average number of shares:     
  MillionsMillionsMillionsMillions 
  ____________________________________________________________________ 
 Basic 1548.4555.9549.8555.5 
 Effect of dilutive shares:     
 Share based awards to employees 23.53.73.95.0 
 Convertible bonds 2.75% due 2014 333.8 33.533.833.5 
  ____________________________________________________________________ 
 Diluted585.7593.1587.5594.0 
  ____________________________________________________________________ 
       

1. Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock.

2. Calculated using the treasury stock method.

3. Calculated using the 'if-converted' method.

 

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
 3 months to3 months to9 months to9 months to
 September 30,September 30,September 30,September 30,
 2013201220132012
  No. of sharesNo. of shares No. of sharesNo. of shares
 MillionsMillionsMillionsMillions
 ____________________________________________________________________
Share based awards to employees10.56.64.54.9
 ____________________________________________________________________

  • Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc's average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date.
XML 66 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Prepaid Expenses and Other Current Assets
9 Months Ended
Sep. 30, 2013
Prepaid Expense and Other Assets, Current [Abstract]  
Prepaid Expense and Other Assets, Current

6.       Prepaid expenses and other current assets

 September 30,December 31,
 20132012
 $’M $’M
 __________________________
Prepaid expenses39.131.7
Income tax receivable179.9130.6
Value added taxes receivable18.720.9
Other current assets44.638.6
 ____________________________
 282.3221.8
 ____________________________
XML 67 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
Business Combinations
9 Months Ended
Sep. 30, 2013
Business Combinations [Abstract]  
Business Combination Disclosure

2.       Business combinations

 

Acquisition of SARcode Bioscience Inc. (“SARcode”)

On April 17, 2013 Shire completed the acquisition of 100% of the outstanding share capital of SARcode. The acquisition date fair value of the consideration totaled $368 million, comprising cash consideration paid on closing of $151 million and the fair value of contingent consideration payable of $217 million. The maximum amount of contingent cash consideration which may be payable by Shire in future periods is $525 million dependent upon achievement of certain clinical, regulatory and net sales milestones.

 

This acquisition brings the new Phase 3 compound, Lifitegrast, currently under development for the signs and symptoms of dry eye disease, into Shire's portfolio. Shire anticipates launching Lifitegrast in the United States as early as 2016 pending a positive outcome of the Phase 3 clinical development program and regulatory approvals. Shire is acquiring the global rights to Lifitegrast and will evaluate an appropriate regulatory filing strategy for markets outside of the United States.

 

The acquisition of SARcode has been accounted as a business combination using the acquisition method. The assets and liabilities assumed from SARcode have been recorded at their preliminary fair values at the date of acquisition, being April 17, 2013. The Company's consolidated financial statements and results of operations include the results of SARcode from April 17, 2013. In the nine months to September 30, 2013 the Company's consolidated income statement includes pre-tax losses of $17.4 million in relation to the post acquisition results of SARcode.

 

The purchase price allocation is preliminary pending the determination of the fair values of certain assets and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired in process research and development (“IPR&D”) in respect of Lifitegrast ($412 million), net current liabilities assumed ($8.2 million), net non-current liabilities assumed, including deferred tax liabilities ($122.4 million) and goodwill ($86.6 million). The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $86.6 million, which is not deductible for tax purposes. Goodwill includes the value of the assembled workforce and the related scientific expertise in ophthalmology which allows for potential expansion into a new therapeutic area.

 

In the nine months to September 30, 2013 the Company expensed costs of $14.7 million (2012: $nil) relating to the acquisition of SARcode (including charges related to the change in fair value of contingent consideration payable), which have been recorded within integration and acquisition costs in the Company's consolidated income statement. 

Acquisition of Premacure AB (“Premacure”)

On March 8, 2013 Shire completed the acquisition of 100% of the outstanding share capital of Premacure. The acquisition date fair value of the consideration totaled $140.2 million, comprising cash consideration paid on closing of $30.6 million, and the fair value of contingent consideration payable of $109.6 million. The maximum amount of contingent cash consideration which may be payable by Shire in future periods, dependent upon the successful completion of certain development and commercial milestones, is $169 million. Shire will also pay royalties on relevant net sales.

Premacure is developing a protein replacement therapy (“PREMIPLEX”), currently in Phase 2 development, for the prevention of Retinopathy of Prematurity (“ROP”). ROP is a rare and potentially blinding eye disorder that primarily affects premature infants and is one of the most common causes of visual loss in childhood. Together, the acquisitions of SARcode and Premacure build Shire's presence in the ophthalmology therapeutic area.

The acquisition of Premacure has been accounted for as a business combination using the acquisition method. The assets and the liabilities assumed from Premacure have been recorded at their preliminary fair values at the date of acquisition, being March 8, 2013. The Company's consolidated financial statements and results of operations include the results of Premacure from March 8, 2013.

The purchase price allocation is preliminary pending final determination of the fair values of certain assets acquired and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired IPR&D in respect of PREMIPLEX ($151.8 million), net current liabilities assumed ($11.7 million), net non-current liabilities assumed, including deferred tax liabilities ($29.5 million) and goodwill ($29.6 million). The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $29.6 million, which is not deductible for tax purposes.

In the nine months to September 30, 2013 the Company expensed costs of $9.8 million (2012: nil) relating to the acquisition of Premacure (including charges related to the change in fair value of contingent consideration payable), which have been recorded within integration and acquisition costs in the Company's consolidated income statement.

Acquisition of Lotus Tissue Repair, Inc (“Lotus”)

On February 12, 2013 Shire completed the acquisition of 100% of the outstanding share capital of Lotus. The acquisition date fair value of consideration totaled $174.2 million, comprising cash consideration paid on closing of $49.4 million, and the fair value of contingent consideration payable of $124.8 million. The maximum amount of contingent cash consideration which may be payable by Shire in future periods is $275 million. The amount of contingent cash consideration ultimately payable by Shire is dependent upon achievement of certain pre-clinical and clinical development milestones.

Lotus is developing a proprietary recombinant form of human collagen Type VII (“rC7”) as the first and only intravenous protein replacement therapy currently being investigated for the treatment of Dystrophic Epidermolysis Bullosa (“DEB”).  DEB is a devastating orphan disease for which there is no currently approved treatment option other than palliative care. The acquisition adds to Shire's pipeline a late stage pre-clinical product for the treatment of DEB with global rights.

The acquisition of Lotus has been accounted for as a business combination using the acquisition method. The assets and the liabilities assumed from Lotus have been recorded at their preliminary fair values at the date of acquisition, being February 12, 2013. The Company's consolidated financial statements and results of operations include the results of Lotus from February 12, 2013.

The purchase price allocation is preliminary pending final determination of the fair values of certain assets acquired and liabilities assumed. The purchase price has been allocated on a preliminary basis to acquired IPR&D in respect of rC7 ($176.7 million), net current assets assumed ($6.8 million), net non-current liabilities assumed, including deferred tax liabilities ($63.4 million) and goodwill ($54.1 million). The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. This acquisition resulted in goodwill of $54.1 million, which is not deductible for tax purposes.

In the nine months to September 30, 2013 the Company expensed costs of $4.6 million (2012: $nil) relating to the acquisition of Lotus, which have been recorded within integration and acquisition costs in the Company's consolidated income statement.

Supplemental disclosure of pro forma information

 

The unaudited pro forma financial information to present the combined results of the operations of Shire, SARcode Premacure and Lotus are not provided as the collective impacts of these acquisitions were not material to the Company's results of operations for any period presented.

 

XML 68 R7.htm IDEA: XBRL DOCUMENT v2.4.0.8
Consolidated Statements of Comprehensive Income (Parenthetical) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Statement of Income and Comprehensive Income [Abstract]        
Unrealized holding gain (loss) on available-for-sale securities, tax $ 0.1 $ 0.8 $ 1.2 $ 3.7
XML 69 R52.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Payable and Accrued Expenses (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Accounts Payable and Accrued Liabilities, Current [Line Items]    
Trade accounts payable and accrued purchases $ 187.8 $ 208.1
Accrued rebate - Medicaid 511.7 455.6
Accrued rebate - Managed care 235.4 184.9
Sales return reserve 95.3 90.5
Accrued bonuses 101.6 109.0
Accrued employee compensation and benefits payable 89.1 64.5
R&D accruals 79.4 73.5
Provisions for litigation losses and other claims 78.3 118.2
Other accrued expenses 203.0 197.2
Accounts payable and accrued expenses, total $ 1,581.6 $ 1,501.5
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Inventories (Details) (USD $)
In Millions, unless otherwise specified
Sep. 30, 2013
Dec. 31, 2012
Schedule of Inventory    
Finished goods $ 170.6 $ 124.4
Work-in-progress 241.0 220.6
Raw materials 68.9 91.9
Total inventories $ 480.5 $ 436.9
XML 72 R33.htm IDEA: XBRL DOCUMENT v2.4.0.8
Goodwill (Tables)
9 Months Ended
Sep. 30, 2013
Goodwill and Intangible Assets Disclosure [Abstract]  
Schedule of Acquired Goodwill
 September 30,December 31,
 20132012
 $’M$’M
 ________________________
Goodwill arising on businesses acquired621.3644.5
 ________________________
Schedule of Goodwill
 20132012
 $’M$’M
 ________________________
As at January 1, 644.5592.6
Acquisitions 170.348.1
Goodwill impairment charge(198.9)-
Foreign currency translation5.4(1.5)
 ________________________
As at September 30,621.3639.2
 ________________________
XML 73 R66.htm IDEA: XBRL DOCUMENT v2.4.0.8
Earnings Per Share (Details) (USD $)
In Millions, except Per Share data, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Schedule of Calculation of Numerator and Denominator in Earnings Per Share        
Numerator for basic earnings per share $ 278.2 $ 227.2 $ 601.1 $ 703.4
Interest on convertible bonds, net of tax 7.6 7.5 22.7 23.7
Numerator for diluted earnings per share $ 285.8 $ 234.7 $ 623.8 $ 727.1
Schedule of Weighted Average Number of Shares        
Basic 548.4 [1] 555.9 [1] 549.8 [1] 555.5 [1]
Effect of dilutive shares:        
Share based awards to employees 3.5 [2] 3.7 [2] 3.9 [2] 5.0 [2]
Convertible bonds 2.75% due 2014 33.8 [3] 33.5 [3] 33.8 [3] 33.5 [3]
Diluted 585.7 593.1 587.5 594.0
Earning per ordinary share - basic        
Earnings per ordinary share attributable to Shire plc shareholders - basic $ 0.507 $ 0.409 $ 1.093 $ 1.266
Earnings per ordinary share - diluted        
Earnings per ordinary share attributable to Shire plc shareholders - diluted $ 0.488 $ 0.396 $ 1.062 $ 1.224
Share Awards
       
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share 0.5 [4] 6.6 [4] 4.5 [4] 4.9 [4]
[1] Excludes shares purchased by the EBT and under the share buy-back program and presented by Shire as treasury stock.
[2] Calculated using the treasury stock method.
[3] Calculated using the ‘if-converted’ method.
[4] Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc’s average share price during the calculation period or (b) the required performance conditions were not satisfied as at the balance sheet date.
XML 74 R59.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accumulated Other Comprehensive Income (Details) (USD $)
In Millions, unless otherwise specified
3 Months Ended 9 Months Ended
Sep. 30, 2013
Sep. 30, 2012
Sep. 30, 2013
Sep. 30, 2012
Accumulated Other Comprehensive Income (Loss)        
As at January 1, 2013     $ 86.9  
Net current period other comprehensive income - Available for sale securities 0.2 1.2    7.2
Net current period other comprehensive income     14.4  
As at September 30, 2013 101.3   101.3  
Foreign currency translation adjustment
       
Accumulated Other Comprehensive Income (Loss)        
As at January 1, 2013     85.1  
Other Comprehensive income before reclassification     14.4  
Amounts reclassified from accumulated other comprehensive income     0  
Net current period other comprehensive income- Foreign Currency     14.4  
As at September 30, 2013 99.5   99.5  
Unrealized holding gain/(loss) on available-for-sale securities
       
Accumulated Other Comprehensive Income (Loss)        
As at January 1, 2013     1.8  
Other Comprehensive income before reclassification     2.2  
Net current period other comprehensive income - Available for sale securities     0  
Gain recognized in the income statement (within Other (expense)/income) on disposal of available-for-sale securities     (2.2)  
As at September 30, 2013 1.8   1.8  
Accumulated other comprehensive income
       
Accumulated Other Comprehensive Income (Loss)        
As at January 1, 2013     86.9  
Other Comprehensive income before reclassification     16.6  
Gain recognized in the income statement (within Other (expense)/income) on disposal of available-for-sale securities     (2.2)  
Net current period other comprehensive income     14.4  
As at September 30, 2013 $ 101.3   $ 101.3  
XML 75 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Payable and Accrued Expenses
9 Months Ended
Sep. 30, 2013
Accounts Payable and Accrued Liabilities, Current [Abstract]  
Accounts Payable and Accrued Expenses Disclosure

9.       Accounts payable and accrued expenses

 September 30,December 31,
 20132012
 $’M $’M
 ________________________________
Trade accounts payable and accrued purchases187.8208.1
Accrued rebates – Medicaid511.7455.6
Accrued rebates – Managed care235.4184.9
Sales return reserve95.390.5
Accrued bonuses101.6109.0
Accrued employee compensation and benefits payable89.164.5
R&D accruals79.473.5
Provisions for litigation losses and other claims78.3118.2
Other accrued expenses203.0197.2
 ________________________________
 1,581.61,501.5
 ________________________________
XML 76 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
Inventories
9 Months Ended
Sep. 30, 2013
Inventory Disclosure [Abstract]  
Inventory Disclosure

5.       Inventories

 

Inventories are stated at the lower of cost or market and comprise:

 September 30,December 31,
 20132012
 $’M $’M
 ________________________
Finished goods170.6124.4
Work-in-progress241.0220.6
Raw materials68.991.9
 ________________________
 480.5436.9
 ________________________
XML 77 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Other Non-current Liabilities
9 Months Ended
Sep. 30, 2013
Other Liabilities, Noncurrent [Abstract]  
Other Noncurrent Liabilities Disclosure

12.       Other non-current liabilities

 September 30,December 31,
 20132012
 $’M $’M
 ________________________
Income taxes payable81.558.9
Deferred revenue10.311.4
Deferred rent11.311.9
Insurance provisions7.912.3
Contingent consideration payable511.8120.4
Other non-current liabilities29.526.7
 ________________________
 652.3241.6
 ________________________
XML 78 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
Convertible Bonds
9 Months Ended
Sep. 30, 2013
Convertible Debt [Abstract]  
Convertible Bonds Disclosure

10.       Convertible Bonds

 

 

Shire 2.75% Convertible Bonds due 2014

 

On May 9, 2007 Shire issued $1,100 million in principal amount of 2.75% convertible bonds due in 2014 and convertible into fully paid ordinary shares of Shire plc (the “Bonds”). The Bonds were issued at 100% of their principal amount, and unless previously purchased and cancelled, redeemed or converted, will be redeemed on May 9, 2014 (the “Final Maturity Date”) at their principal amount.

The Bonds may be redeemed at the option of the Company, at their principal amount together with accrued and unpaid interest if: (i) at any time after May 23, 2012 if on no less than 20 dealing days in any period of 30 consecutive dealing days the value of Shire's ordinary shares underlying each Bond in the principal amount of $100,000 would exceed $130,000; or (ii) at any time conversion rights have been exercised, and/or purchases and corresponding cancellations, and/or redemptions effected in respect of 85% or more in principal amount of Bonds originally issued

The Bonds are repayable in US dollars, but also contain provisions entitling the Company to settle redemption amounts in Pounds sterling or in the case of Final Maturity Date by delivery of the underlying ordinary shares and, if necessary, a cash top-up amount. As the Bonds will be redeemed within twelve months of the balance sheet date, the Bonds have been presented as a current liability at September 30, 2013.

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    Document and Entity Information (USD $)
    In Billions, except Share data in Millions, unless otherwise specified
    9 Months Ended
    Sep. 30, 2013
    Oct. 18, 2013
    Jun. 30, 2013
    Document and Entity Information [Abstract]      
    Document Type 10-Q    
    Document Period End Date Sep. 30, 2013    
    Amendment Flag false    
    Current Fiscal Year End Date --12-31    
    Entity Central Index Key 0000936402    
    Entity Current Reporting Status Yes    
    Entity Filer Category Large Accelerated Filer    
    Entity Registrant Name Shire plc    
    Entity Voluntary Filers No    
    Entity Well-known Seasoned Issuer Yes    
    Entity Common Stock, Shares Outstanding   562.9  
    Document Fiscal Year Focus 2013    
    Document Fiscal Period Focus Q3    
    Entity Public Float     $ 17.4
    XML 81 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
    Other Current Liabilities
    9 Months Ended
    Sep. 30, 2013
    Other Liabilities, Current [Abstract]  
    Other Current Liabilities

    11.       Other current liabilities

     September 30,December 31,
     20132012
     $’M $’M
     __________________________
    Income taxes payable19.478.4
    Value added taxes28.723.6
    Contingent consideration payable86.016.0
    Other current liabilities29.126.1
     __________________________
     163.2144.1
     __________________________
    XML 82 R61.htm IDEA: XBRL DOCUMENT v2.4.0.8
    Financial Instruments (Foreign Exchange Risk and Its Classification on Balance Sheet) (Details) (USD $)
    In Millions, unless otherwise specified
    9 Months Ended
    Sep. 30, 2013
    contract
    Sep. 30, 2013
    Foreign Exchange Contract
    Sep. 30, 2013
    Foreign Exchange Contract
    Prepaid expenses and other current assets
    Dec. 31, 2012
    Foreign Exchange Contract
    Prepaid expenses and other current assets
    Sep. 30, 2013
    Foreign Exchange Contract
    Other current liabilities
    Dec. 31, 2012
    Foreign Exchange Contract
    Other current liabilities
    Derivatives, Fair Value            
    Assets     $ 4.2 $ 1.3    
    Liabilities         3.9 3.0
    Net derivative fair value Assets 3.8          
    Net derivative fair value liabilities 3.5          
    Potential effect of rights of set off associated with the foreign exchange contracts $ 0.4          
    Number of swap and forward foreign exchange contracts outstanding 25          
    Swaps and forward contracts maturity   90 days        
    XML 83 R60.htm IDEA: XBRL DOCUMENT v2.4.0.8
    Financial Instruments (Interest Rate and Credit Risks) (Details) (USD $)
    In Millions, unless otherwise specified
    9 Months Ended 12 Months Ended
    Sep. 30, 2013
    Dec. 31, 2012
    Interest rate risk    
    Average interest rate received on cash and liquid investments less than 1% per annum.  
    Debt Instrument [Line Items]    
    Principal amount $ 1,100  
    Stated interest rate 2.75%  
    Accounts Receivable    
    Revenues by major customer, percent   50.00%
    United States
       
    Accounts Receivable    
    Number of major external customers   3
    Italy
       
    Accounts Receivable    
    Accounts receivable received 90.2  
    Spain
       
    Accounts Receivable    
    Accounts receivable received $ 53.5  

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