10-Q 1 dp11633_10q.htm
 
 

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, 2008
 
Commission File Number: 0-29630
 
SHIRE PLC
(Exact name of registrant as specified in its charter)
 
Jersey
(State or other jurisdiction of incorporation or organization)
98-0484822
(I.R.S. Employer Identification No.)
 
Hampshire International Business Park, Chineham,
Basingstoke, Hampshire, England, RG24 8EP
(Address of principal executive offices and zip code)
 
+44 1256 894 000
(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 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 November 6, 2008 the number of outstanding ordinary shares of the Registrant was 560,026,882.
 


 
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, the Company’s results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE® (lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products, including, but not limited to, the impact of those on the Company’s ADHD franchise; patents, including but not limited to, legal challenges relating to the Company’s ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); the Company’s ability to secure new products for commercialization and/or development; the Company’s ability to successfully integrate its stake in Jerini AG, as well as realize the anticipated benefits of the acquisition; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2007.
 
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:
 
Shire Product
Active ingredient
ADDERALL® XR
(mixed salts of a single-entity amphetamine)
ADDERALL®
(mixed salts of a single-entity amphetamine)
AMIGAL
(migalastat hydrochloride) (trademark of Amicus Therapeutics (“Amicus”))
CALCICHEW® range
(calcium carbonate with or without vitamin D3)
CARBATROL®
(carbamazepine - extended-release capsules)
COMBIVIR®
(lamivudine) (trademark of GlaxoSmithKline (“GSK”))
DAYTRANA®
(methylphenidate transdermal system)
DYNEPO®
(epoetin delta) (trademark of Sanofi-Aventis)
ELAPRASE®
(idursulfase)
EPIVIR®
(lamivudine) (trademark of GSK)
EPZICOM®/KIVEXA (EPZICOM)
(lamivudine) (trademark of GSK)
FIRAZYR®
(icatibant)
FOSRENOL®
(lanthanum carbonate)
INTUNIV
(guanfacine – extended release)
JUVISTA®
(human TGFβ3) (trademark of Renovo)
LIALDA®
(mesalamine)
MEZAVANT® 
(mesalazine)
PENTASA®
(mesalamine) (trademark of Ferring)
PLICERA™
(isofagomine tartrate) (trademark of Amicus)
RAZADYNE®
(galantamine) (trademark of Johnson & Johnson (“J&J”))
RAZADYNE® ER
(galantamine) (trademark of J&J)
REMINYL®
(galantamine hydrobromide) (UK and Republic of Ireland)
REMINYL®
(galantamine) (trademark of J&J, excluding UK and Republic of Ireland)
REMINYL XL™
(galantamine hydrobromide) (UK and Republic of Ireland)
REMINYL XL™
(galantamine) (trademark of J&J, excluding UK and Republic of Ireland)
REPLAGAL®
(agalsidase alfa)
SEASONIQUE®
(trademark of Barr Laboratories Inc. (“Barr”))
VYVANSE®
(lisdexamfetamine dimesylate)
XAGRID
(anagrelide hydrochloride)
ZEFFIX®
(lamivudine) (trademark of GSK)
3TC®
(lamivudine) (trademark of GSK)
 

1

 
SHIRE PLC
Form 10-Q for the three months to September 30, 2008

Table of contents

 
     
 Page
PART I   FINANCIAL INFORMATION
   
     
ITEM 1.  FINANCIAL STATEMENTS
   
     
 
Unaudited Consolidated Balance Sheets at September 30, 2008 and December 31, 2007
 
3
       
 
Unaudited Consolidated Statements of Operations for the three months and nine months to September 30, 2008 and September 30, 2007
 
5
       
 
Unaudited Consolidated Statement of Changes in Shareholders’ Equity for the year to December 31, 2007
 
7
       
 
Unaudited Consolidated Statement of Changes in Shareholders’ Equity for the nine months to September 30, 2008
 
8
       
 
Unaudited Consolidated Statements of Comprehensive Income/(Loss) for the three months and nine months to September 30, 2008 and September 30, 2007
 
9
       
 
Unaudited Consolidated Statements of Cash Flows for the nine months to September 30, 2008 and September 30, 2007
 
10
       
 
Notes to the Unaudited Consolidated Financial Statements
 
12
ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
 
39
     
ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
58
     
ITEM 4.  CONTROLS AND PROCEDURES
 
58
     
PART II  OTHER INFORMATION
 
59
     
ITEM 1.  LEGAL PROCEEDINGS
 
59
     
ITEM 1A.  RISK FACTORS
 
59
     
ITEM 2.  UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
59
     
ITEM 3.  DEFAULTS UPON SENIOR SECURITIES
 
59
     
ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
 
59
     
ITEM 5.  OTHER INFORMATION
 
60
     
ITEM 6.  EXHIBITS
 
61

 
2

 
PART I.  FINANCIAL INFORMATION
 
ITEM 1.  FINANCIAL STATEMENTS
 
 
SHIRE PLC
 
   
Notes
   
September 30,
2008
$’M
   
December 31,
 2007
$’M
 
ASSETS
                 
Current assets:
                 
Cash and cash equivalents
          473.3       762.5  
Restricted cash
          31.8       39.5  
Accounts receivable, net
    5       489.8       441.5  
Inventories, net
    6       149.6       174.1  
Assets held for sale
    7       40.0       10.6  
Deferred tax asset
            97.3       143.3  
Prepaid expenses and other current assets
    8       143.6       125.3  
Total current assets
            1,425.4       1,696.8  
                         
Non current assets:
                       
Investments
    9       52.9       110.2  
Property, plant and equipment, net
            496.5       368.6  
Goodwill
            335.5       219.4  
Other intangible assets, net
    10       1,842.7       1,764.5  
Deferred tax asset
            124.1       143.7  
Other non-current assets
            76.7       26.9  
Total assets
            4,353.8       4,330.1  
LIABILITIES AND SHAREHOLDERS’ EQUITY
                       
Current liabilities:
                       
Accounts payable and accrued expenses
    11       703.1       674.2  
Deferred tax liability
            4.2       11.3  
Liability to dissenting shareholders
    20       567.5       480.2  
Other current liabilities
    12       64.0       96.5  
Total current liabilities
            1,338.8       1,262.2  
                         
Non-current liabilities
                       
Convertible bonds
            1,100.0       1,100.0  
Other long term debt
            32.2       32.9  
Deferred tax liability
            339.6       332.4  
Other non-current liabilities
    13       397.2       375.6  
Total non-current liabilities
            1,869.0       1,840.9  
                         
Total liabilities
            3,207.8       3,103.1  
Commitments and contingencies
    14                  
 
 
3

 
SHIRE PLC
UNAUDITED CONSOLIDATED BALANCE SHEETS (continued)
 
   
Notes
   
September 30,
2008
$’M
   
December 31,
2007
$’M
 
                   
Minority interest
          2.4       -  
                       
Shareholders’ equity:
                     
Common stock of 5p par value; 1,000 million shares authorized; and 560.0 million shares issued and outstanding (2007: 750 million shares authorized; and 556.8 million shares issued and outstanding)
          55.5       55.2  
Exchangeable shares: nil shares issued and outstanding
(2007: 0.7 million)
    17       -       33.6  
Treasury stock: 21.0 million shares (2007 : 10.3 million shares)
            (410.9 )     (280.8 )
Additional paid-in capital
            2,575.2       2,503.4  
Accumulated other comprehensive income
            85.6       55.7  
Accumulated deficit
            (1,161.8 )     (1,140.1 )
Total shareholders’ equity
            1,143.6       1,227.0  
Total liabilities and shareholders’ equity
            4,353.8       4,330.1  
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
 
4

 
SHIRE PLC
 

   
Notes
   
3 months to
September 30,
2008
$’M
   
3 months to
September 30,
2007(1)
$’M
   
9 months to
September 30,
2008
$’M
   
9 months to
September 30,
2007(1)
$’M
 
Revenues:
                             
Product sales
          712.5       543.1       2,049.9       1,508.8  
Royalties
          60.8       61.9       190.7       185.4  
Other revenues
          5.3       3.7       15.8       17.6  
Total revenues
          778.6       608.7       2,256.4       1,711.8  
Costs and expenses:
                                     
Cost of product sales (1) (2) (3)
          84.2       83.4       317.4       224.7  
Research and development (1) (3)
          127.1       181.4       394.4       365.7  
Selling, general and administrative (1) (2)
          320.4       328.4       1,083.7       847.5  
In-process R&D charge
          120.5       -       255.5       1,896.0  
Gain on sale of product rights
   
4
      (4.0 )     (7.1 )     (20.7 )     (12.1 )
Integration costs
            7.5       -       7.5       1.3  
Total operating expenses
            655.7       586.1       2,037.8       3,323.1  
Operating income/(loss)
            122.9       22.6       218.6       (1,611.3 )
                                         
Interest income
   
16
      3.8       8.0       23.0       42.7  
Interest expense
   
20
      (92.9 )     (18.0 )     (127.0 )     (53.8 )
Other (expenses)/income, net
            (52.0 )     (1.6 )     (38.6 )     0.7  
Total other expenses, net
            (141.1 )     (11.6 )     (142.6 )     (10.4 )
(Loss)/income from continuing operations  before income taxes, minority interest and equity in earnings of equity method investees
            (18.2 )     11.0       76.0       (1,621.7 )
Income taxes
            (18.7 )     23.2       (63.0 )     (43.9 )
                                         
Minority interest
            1.3       -       1.3       -  
                                         
Equity in earnings of equity method investees, net of taxes
            1.6       0.5       1.3       1.7  
(Loss)/income from continuing operations
            (34.0 )     34.7       15.6       (1,663.9 )
                                         
Loss from discontinued operations
            (0.9 )     -       (0.9 )     -  
Net (loss)/income
            (34.9 )     34.7       14.7       (1,663.9 )

 
 
(1)
For the three months to September 30, 2007 $4.6 million of depreciation was reclassified from Selling, general and administrative ("SG&A") costs to Cost of product sales ($2.1 million) and Research and development costs ($2.5 million).  For the nine months to September 30, 2007 $13.4 million of depreciation was reclassified from SG&A costs to Cost of product sales ($6.0 million) and Research and development costs ($7.4 million).
 
 
(2)
Cost of product sales includes amortization of intangible assets relating to favorable manufacturing contracts of $0.4 million for the three months to September 30, 2008 (2007: $0.5 million) and $1.3 million for the nine months to September 30, 2008 (2007: $0.5 million). SG&A costs includes amortization and impairment charges of intangible assets relating to intellectual property rights acquired of $30.1 million for the three months to September 30, 2008 (2007: $31.1 million) and $182.4 million for the nine months to September 30, 2008 (2007: $64.0 million).
 
 
(3)
Costs, predominantly relating to manufacturing set-up costs for new products, of $1.8 million and $5.4 million for the three months and nine months to September 30, 2007, have been reclassified from Research and development costs to Cost of product sales.
 
 
5

 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS (continued)
 

 
 
Notes
 
3 months to
September 30,
 2008
   
3 months to
September 30,
 2007
   
9 months to
September 30,
2008
   
9 months to
September 30,
2007
 
Earnings per ordinary share - basic
                         
(Loss)/ earnings from continuing operations
      (6.3c )     6.4 c     2.9 c     (308.8c )
Loss from discontinued operations
      (0.2c )     -       (0.2 c)     -  
(Loss)/ earnings per ordinary share - basic
      (6.5c )     6.4 c     2.7 c     (308.8c )
                                   
Earnings per ordinary share - diluted
                                 
(Loss)/earnings from continuing operations
      (6.3c )     6.3 c     2.9 c     (308.8c )
Loss from discontinued operations
      (0.2c )     -       (0.2 c)     -  
(Loss)/earnings per ordinary share – diluted
      (6.5c )     6.3 c     2.7 c     (308.8c )
                                   
Weighted average number of shares (millions):
                                 
Basic
18
    540.3       546.4       542.6       538.9  
Diluted
18
    540.3       554.7       545.3       538.9  

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

 
 

 
   
Common
stock
$’M
   
Common
stock
Number
of shares
M’s
   
Exchange-
able
shares
$’M
   
Exchange-
able shares
Number of
shares
M’s
   
Treasury
stock
$’M
   
Additional
paid-in
capital
$’M
   
Accumu-
lated other
compre-
hensive
 income
$’M
   
Retained
Earnings/
(Accumu-
lated deficit)
$’M
   
Total
share-
holders’
equity
$’M
 
As at January 1, 2007
    43.7       506.7       59.4       1.3       (94.8 )     1,493.2       87.8       353.0       1,942.3  
                                                                         
Effect of Scheme of Arrangement (cancellation)(1)
    (43.7 )     -       -       -       -       (1,493.2 )     -       -       (1,536.9 )
                                                                         
Effect of Scheme of Arrangement (issue) (1)
    50.2       -       -       -       -       1,486.7       -       -       1,536.9  
                                                                         
As at January 1, 2007 (restated)
    50.2       506.7       59.4       1.3       (94.8 )     1,486.7       87.8       353.0       1,942.3  
                                                                         
Net loss for the period
    -       -       -       -       -       -       -       (1,451.8 )     (1,451.8 )
                                                                         
Foreign currency translation
    -       -       -       -       -       -       (15.5 )     -       (15.5 )
                                                                         
Shares issued, net of issue costs
    4.3       42.8       -       -       -       873.0       -       -       877.3  
                                                                         
Exchange of exchangeable shares
    0.1       1.7       (25.8 )     (0.6 )     -       25.7       -       -       -  
                                                                         
Warrants exercised
    0.2       1.3       -       -       -       12.8       -       -       13.0  
                                                                         
Options exercised
    0.4       4.3       -       -       -       30.0       -       -       30.4  
                                                                         
Share-based compensation
    -       -       -       -       -       75.2       -       -       75.2  
                                                                         
Shares purchased by the Employee Share Ownership Trust (“ESOT”)
    -       -       -       -       (186.0 )     -       -       -       (186.0 )
                                                                         
Unrealized holding loss on available-for-sale securities, net of taxes
    -       -       -       -       -       -       (16.5 )     -       (16.5 )
                                                                         
Realized gain on available-for-sale securities, net of taxes
    -       -       -       -       -       -       (0.1 )     -       (0.1 )
                                                                         
Dividends
    -       -       -       -       -       -       -       (41.3 )     (41.3 )
As at December 31, 2007
    55.2       556.8       33.6       0.7       (280.8 )     2,503.4       55.7       (1,140.1 )     1,227.0  

 
 
(1)
Net increase to common stock of the Scheme of arrangement $6.5 million, see Note 2 for further details.
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
Dividends per share
 
During the year to December 31, 2007 the Company paid dividends totaling 7.39 US cents per ordinary share, equivalent to 22.18 US cents per American Depositary Share (“ADS”), and 25.32 Canadian cents per exchangeable share.
 

7

 

 

 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY (continued)
 
   
Comm-
on
stock
$’M
   
Common
stock
Number
of shares
M’s
   
Exchange-
able
shares
$’M
   
Exchange-
able
shares
Number of
shares
M’s
   
Treasury
stock
$’M
   
Additional
paid-in
capital
$’M
   
Accumu-
lated
other
compre-
hensive
income
$’M
   
Accumu-
lated
deficit
$’M
   
Total
share-
holders’
equity
$’M
 
As at January 1, 2008
    55.2       556.8       33.6       0.7       (280.8 )     2,503.4       55.7       (1,140.1 )     1,227.0  
                                                                         
Net income for the period
    -       -       -       -       -       -       -       14.7       14.7  
                                                                         
Foreign currency translation
    -       -       -       -       -       -       20.7       -       20.7  
                                                                         
Exchange of exchangeable shares
    0.2       2.3       (33.6 )     (0.7 )     -       33.4       -       -       -  
                                                                         
Costs associated with shares issued through  Scheme of Arrangement
    -       -       -       -       -       (2.9 )     -       -       (2.9 )
                                                                         
Options exercised
    0.1       0.9       -       -       -       1.6       -       -       1.7  
                                                                         
Share-based compensation
    -       -       -       -       -       52.0       -       -       52.0  
                                                                         
Tax deficit associated with exercise of stock options
    -       -       -       -       -       (2.2 )     -       -       (2.2 )
                                                                         
Shares purchased by the ESOT
    -       -       -       -       (140.2 )     -       -       -       (140.2 )
                                                                         
Shares released by ESOT to satisfy exercise of stock options
    -       -       -       -       10.1       (10.1 )     -       -       -  
                                                                         
Unrealized holding loss on available-for-sale securities, net of taxes
    -       -       -       -       -       -       (39.5 )     -       (39.5 )
                                                                         
Realized gain on available-for-sale securities, net of taxes
    -       -       -       -       -       -       (5.4 )     -       (5.4 )
                                                                         
Other than temporary impairment of available for sale securities
    -       -       -       -       -       -       54.1       -       54.1  
                                                                         
Dividends
    -       -       -       -       -       -       -       (36.4 )     (36.4 )
                                                                         
As at September 30, 2008
    55.5       560.0       -       -       (410.9 )     2,575.2       85.6       (1,161.8 )     1,143.6  

 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
Dividends per share
 
During the nine months to September 30, 2008 the Company declared and paid dividends of 6.47 US cents per ordinary share (equivalent to 19.41 US cents per ADS) totaling $36.4 million.
 
 
8

 
SHIRE PLC
 
   
3 months to
September 30,
 2008
   
3 months to
September 30,
 2007
   
9 months to
September 30,
 2008
   
9 months to
September 30,
 2007
 
   
$’M
      $’M       $’M       $’M  
                                 
Net (loss)/income
    (34.9 )     34.7       14.7       (1,663.9 )
Other comprehensive income/(loss):
                               
Foreign currency translation adjustments
    28.1       (5.0 )     20.7       (13.9 )
Unrealized holding loss on available-for-sale securities, net of taxes of $nil (2007: $nil)
    (10.8 )     (4.4 )     (39.5 )     (4.2 )
Other than temporary impairment of available-for-sale securities, net of taxes of $nil (2007: $nil)
    54.1       -       54.1       -  
Realized gain on available-for-sale securities, net of taxes of $4.0 million  (2007: $nil)
    -       -       (5.4 )     -  
Comprehensive income/(loss)
    36.5       25.3       44.6       (1,682.0 )

 
The components of accumulated other comprehensive income as at September 30, 2008 and December 31, 2007 are as follows:
 
   
September 30,
2008
$’M
   
December 31,
2007
$’M
 
Foreign currency translation adjustments
    85.6       64.9  
Unrealized holding loss on available-for-sale securities, net of taxes of $nil (2007: $5.2 million)
    -       (9.2 )
Accumulated other comprehensive income
    85.6       55.7  

 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
9

 
SHIRE PLC
 
   
9 months to
September 30,
2008
$’M
   
9 months to
September 30,
2007
$’M
 
CASH FLOWS FROM OPERATING ACTIVITIES:
           
Net income/(loss)
    14.7       (1,663.9 )
Adjustments to reconcile net income/(loss) to net cash provided by operating activities:
               
Loss from discontinued operations
    0.9       -  
Depreciation and amortization
    145.4       111.8  
Amortization of deferred financing charges
    3.8       10.6  
Interest on building financing obligation
    2.6       -  
Share-based compensation
    52.0       34.1  
In-process research and development charge
    120.5       1,896.0  
Impairment of intangible assets
    90.4       -  
Impairment of available-for-sale securities
    54.1       -  
Gain on sale of long-term assets
    (9.4 )     -  
Gain on sale of product rights
    (20.7 )     (12.1 )
Movement in deferred taxes
    13.9       (35.8 )
Equity in earnings of equity method investees
    (1.3 )     (1.7 )
Minority interest
    (1.3 )     -  
Change in operating assets and liabilities:
               
    Increase in accounts receivable
    (40.7 )     (64.2 )
Increase in sales deduction accrual
    36.9       19.3  
Decrease/(increase) in inventory
    39.6       (46.2 )
(Increase)/decrease in prepayments and other current assets
    (0.2 )     2.7  
(Increase)/decrease in other assets
    (53.5 )     1.3  
Increase in accounts and notes payable and other liabilities
    63.3       103.8  
Increase in deferred revenue
    7.4       45.6  
Returns on investment from joint venture
    7.1       6.8  
Net cash provided by operating activities (A)
    525.5       408.1  
                 
CASH FLOWS FROM INVESTING ACTIVITIES
               
Movement in short-term investments
    -       55.8  
Movement in restricted cash
    7.7       (12.0 )
Purchases of subsidiary undertakings, net of cash acquired
    (462.5 )     (2,458.6 )
Expenses relating to the acquisition of New River Pharmaceuticals Inc (“New River”)
    -       (60.4 )
Purchase of long-term investments
    (1.3 )     (56.7 )
Purchase of property, plant and equipment
    (166.5 )     (62.1 )
Purchase of intangible assets
    (25.0 )     (58.2 )
Proceeds from disposal of long term assets
    10.3       -  
Proceeds from disposal of property, plant and equipment
    1.8       -  
Proceeds/deposits received from sale of product rights
    5.0       24.3  
Returns of equity investments
    0.4       2.2  
Net cash used in investing activities (B)
    (630.1 )     (2,625.7 )
 
 
10

 
SHIRE PLC
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS (continued)
 
 
   
9 months to
September 30,
 2008
$’M
   
9 months to
September 30,
 2007
$’M
 
CASH FLOWS FROM FINANCING ACTIVITIES:
           
Proceeds from drawings under bank facility
    -       1,300.0  
Repayment of drawings under bank facility
    -       (1,300.0 )
Proceeds from issue of Shire 2.75% convertible bonds due 2014
    -       1,100.0  
Redemption of New River 3.5% convertible notes due 2013
    -       (279.4 )
Proceeds from exercise of New River purchased call option
    -       141.8  
Payment of debt arrangement and issuance costs
    -       (32.8 )
Payment under building financing obligation
    (1.3 )     -  
Proceeds from exercise of options
    1.7       25.6  
(Costs)/proceeds from issue of common stock, net
    (2.9 )     877.3  
Proceeds from exercise of warrants
    -       13.0  
Payment of dividend
    (36.4 )     (29.4 )
Payments to acquire shares by ESOT
    (140.2 )     (168.5 )
Net cash (used in) / provided by financing activities (C)
    (179.1 )     1,647.6  
Effect of foreign exchange rate changes on cash
and cash equivalents (D)
    (5.5 )     6.0  
Net decrease in cash and cash equivalents (A+B+C+D)
    (289.2 )     (564.0 )
Cash and cash equivalents at beginning of period
    762.5       1,126.9  
Cash and cash equivalents at end of period
    473.3       562.9  
 
 
Supplemental information:
 
9 months to
 September 30,
2008
$’M
   
9 months to
September 30,
2007
$’M
 
             
Interest received
    24.3       45.1  
Interest paid
    (25.1 )     (9.7 )
Income taxes paid
    (106.2 )     (24.9 )
                 
Non cash activities:
               
Proceeds from product out licensing:
               
Equity in Avexa Ltd (“Avexa”).
    5.0       2.9  
 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
 
11


 
SHIRE PLC
 
1.
Summary of Significant Accounting Policies
 
 
(a)
Basis of Presentation
 
These interim financial statements of Shire plc (formerly Shire Limited) 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 December 31, 2007 balance sheet was derived from audited financial statements but does not include all disclosures required by US GAAP.  However, the Company believes that the disclosures are adequate to make the information presented not misleading.
 
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, 2007.
 
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 periods.  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 for interim reporting, 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.  Actual results could differ from those estimates.  Estimates and assumptions are primarily made in relation to provisions for litigation, valuation of intangible assets (including those acquired through business combinations), the valuation of equity investments, sales deductions, income taxes and share-based payments.
 
 
(c)
Accounting pronouncements adopted during the period
 
EITF 07-3
 
In June 2007, the Emerging Issues Task Force (“EITF”) reached a consensus regarding EITF 07-3, “Accounting for Non-refundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities” (“EITF 07-3”).  The scope of this Issue is limited to non-refundable advance payments for goods and services to be used or rendered in future research and development activities.  The EITF concluded that non-refundable advance payments for future research and development activities should be deferred and capitalized on the balance sheet. Such amounts should be recognized as an expense as the related goods are delivered or the related services are performed. Entities should continue to evaluate whether they expect the goods to be delivered or services to be rendered. If an entity does not expect the goods to be delivered or services to be rendered, the capitalized advance payment should be charged to expense.  On January 1, 2008 the Company adopted EITF 07-3. The adoption of EITF 07-3 had no impact on the Company’s financial statements as at January 1, 2008.
 
SFAS No. 157
 
On January 1, 2008 the Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 157, “Fair Value Measurements” (“SFAS No. 157”) for financial assets and liabilities, which provides a single definition of fair value, establishes a framework for the measurement of fair value and expands disclosure about the use of fair value to measure assets and liabilities. The adoption of SFAS No. 157 for financial assets and liabilities did not have a material impact on the Company’s financial statements as at January 1, 2008.
 
SFAS No. 159
 
On January 1, 2008 the Company adopted SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities - Including an Amendment of FASB Statement No. 115” (“SFAS No. 159”).  This standard permits an entity to choose to measure many financial instruments and certain other items at fair value.  The unrealized gains and losses on items for which the fair value option has been elected will be reported in earnings at each subsequent reporting date.  The fair value option: (a) may be applied instrument by instrument, with a few exceptions, such as investments otherwise accounted for by the equity method; (b) is irrevocable (unless a new election date occurs); and (c) is applied only to entire instruments and not to portions of instruments. The Company did not elect to fair value any items on adoption, and the adoption of SFAS No. 159 did not have a material impact on the Company’s financial statements.
 
 
12

 
(d)
New accounting pronouncements to be adopted in future periods
 
EITF 07-5
 
In June 2008, the FASB issued EITF 07-5 "Determining whether an Instrument (or Embedded Feature) is indexed to an Entity's Own Stock" ("EITF No. 07-5"). EITF 07-5 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early application is not permitted. Paragraph 11(a) of SFAS No. 133 "Accounting for Derivatives and Hedging Activities" ("SFAS 133") specifies that a contract that would otherwise meet the definition of a derivative but is both (a) indexed to the Company's own stock and (b) classified in stockholders' equity in the statement of financial position would not be considered a derivative financial instrument. EITF 07-5 provides a new two-step model to be applied in determining whether a financial instrument or an embedded feature is indexed to an issuer's own stock and thus able to qualify for the SFAS No. 133 paragraph 11(a) scope exception. The Company is currently evaluating the impact of adoption of EITF 07-5.
 
SFAS No. 162
 
In May 2008 the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted Accounting Principles” (“SFAS No. 162”). SFAS No. 162 identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements under US GAAP. SFAS No. 162 is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board amendments to AU Section 411, “The Meaning of Present Fairly in Conformity With Generally Accepted Accounting Principles”. It is not expected that SFAS No. 162 will change current practice.
 
FASB Staff Position (FSP) No. APB 14-1
 
In May 2008 the FASB issued FSP No. APB 14-1, “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (“FSP No. APB 14-1”). This FSP clarifies that convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) do not fall within the scope of paragraph 12 of Accounting Principles Board (APB) Opinion No. 14, “Accounting for Convertible Debt and Debt Issued with Stock Purchase Warrants” (“APB 14”). It requires issuers of such instruments to separately account for the liability and equity components of those instruments by allocating the proceeds from issuance of the instrument between the liability component and the embedded conversion option (i.e., the equity component). FSP No. APB 14-1 is effective for fiscal years beginning after December 15, 2008 and for interim periods within those fiscal years. It is required to be applied retrospectively to convertible debt instruments that are within the scope of the guidance and were outstanding during any period presented in the financial statements. A cumulative effect adjustment must be recognized as of the beginning of the first period presented. Early adoption of the guidance is not permitted. The Company is currently evaluating the impact of the adoption of FSP No. APB 14-1.
 
FASB Staff Position (FSP) No. FAS 142-3
 
In April 2008 the FASB issued FSP No. FAS 142-3, “Determination of the Useful Life of Intangible Assets” (“FSP No. FAS 142-3”). This FSP amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under FASB Statement No. 142, “Goodwill and Other Intangible Assets” (“SFAS No. 142”). The intent of FSP No. FAS 142-3 is to improve the consistency between the useful life of an intangible asset determined under SFAS No. 142 and the period of expected cash flows used to measure the fair value of the asset under FASB Statement No. 141, “Business Combinations”, (“SFAS No. 141”).  FSP No. FAS 142-3 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is prohibited. The Company is currently evaluating the impact of the adoption of FSP No. FAS 142-3.
 
SFAS No. 161
 
In March 2008 the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities – an amendment of FASB No. 133” (“SFAS No. 161”).  SFAS No. 161 requires enhanced disclosures about an entity’s derivative and hedging activities and thereby improves the transparency of financial reporting. SFAS No. 161 is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008 with early application encouraged. This Statement encourages, but does not require, comparative disclosures for earlier periods at initial adoption. The Company is currently evaluating the impact of the adoption of SFAS No. 161.
 
FASB Staff Position (FSP) No. FAS 157-2
 
In February 2008 the FASB issued FSP No. FAS 157-2, “Effective Date of FASB Statement No. 157” (“FSP No. FAS 157-2”). This FSP delays the effective date of SFAS No. 157 for non-financial assets and non-financial liabilities, except for items that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). SFAS No. 157 will therefore be applicable to non-financial assets and liabilities for the Company’s fiscal year commencing January 1, 2009. The Company is currently reviewing the impact of the adoption of SFAS No. 157 for all non-financial assets and liabilities on its financial statements.
 
EITF 07-1
 
In December 2007 the EITF reached a consensus regarding EITF 07-1, “Accounting for Collaborative Arrangements” (“EITF 07-1”).  The objective of this EITF 07-1 is to define collaborative arrangements and to establish reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties. EIFT 07-1 is effective for financial statements issued for fiscal years beginning after December 15, 2008 and interim periods within those fiscal years. EITF 07-1 shall be applied retrospectively to all prior periods presented for all collaborative arrangements existing as of the effective date. The Company is currently evaluating the impact of the adoption of EITF 07-1.
 
13

 
SFAS No. 160
 
In December 2007 the FASB issued SFAS No. 160, “Non-controlling Interests in Consolidated Financial Statements - An Amendment of ARB No. 51   (“SFAS No. 160”). SFAS No. 160 establishes new accounting and reporting standards for the non-controlling interest in a subsidiary and for the deconsolidation of a subsidiary. Specifically, this statement requires the recognition of a non-controlling interest (minority interest) as equity in the consolidated financial statements, separate from the parent's equity. The amount of net income attributable to the non-controlling interest will be included in consolidated net income on the face of the income statement. SFAS No. 160 also includes expanded disclosure requirements regarding the interests of the parent and its non-controlling interest.  SFAS No. 160 is effective for fiscal years, and interim periods beginning after January 1, 2009. The Company is currently evaluating the impact of the adoption of SFAS No. 160.
 
SFAS No. 141(R)
 
In December 2007 the FASB issued SFAS No. 141 (Revised 2007), “Business Combinations” (“SFAS No. 141(R)”). SFAS No. 141(R) will significantly change the accounting for business combinations. Under SFAS No. 141(R), an acquiring entity will be required to recognize all the assets acquired and liabilities assumed in a transaction at the acquisition-date fair value with limited exceptions. It also amends the accounting treatment for certain specific items including acquisition costs and non-controlling minority interests and includes a substantial number of new disclosure requirements. SFAS No. 141(R) applies prospectively to business combinations for which the acquisition date is on or after January 1, 2009. The Company is currently evaluating the impact of the adoption of SFAS No. 141(R).
 
2.
Change in reporting entity
 
On May 23, 2008 Shire Limited (now known as Shire plc), a public company limited by shares incorporated in Jersey and tax resident in the Republic of Ireland (“Shire”), became the holding company of Shire plc (the former holding company of the Shire Group) (“Old Shire”), a public limited company incorporated in England and Wales, pursuant to a scheme of arrangement under Sections 895 to 899 of the United Kingdom Companies Act 2006 that was approved by the High Court of Justice in England and Wales and the shareholders of Old Shire (the “Scheme of Arrangement”). Pursuant to the Scheme of Arrangement, ordinary shares, each having a nominal value of £0.05, of Old Shire (“Shire Ordinary Shares”) were exchanged for ordinary shares, each having a nominal value of £0.05, of Shire Limited (“Shire Limited Ordinary Shares”), on a one-for-one basis. As a result of the Scheme of Arrangement, Old Shire became a wholly-owned subsidiary of Shire Limited. The Shire Limited Ordinary Shares carry substantially the same rights as did the Shire Ordinary Shares.  The Scheme of Arrangement did not involve any payment for the Shire Limited Ordinary Shares.
 
Shire Limited immediately after the effectiveness of the Scheme of Arrangement had the same Board of Directors, management and corporate governance arrangements as Old Shire had immediately prior thereto. The consolidated assets and liabilities of Shire Limited immediately after the effective time of the Scheme of Arrangement are substantially the same as the consolidated assets and liabilities of Old Shire immediately prior thereto.
 
The Shire Ordinary Shares underlying the Shire American Depositary Shares (the “Shire ADSs”), each representing three Shire Ordinary Shares, participated in the Scheme of Arrangement like all other Shire Ordinary Shares. Upon the Scheme of Arrangement becoming effective, the Shire ADSs remained outstanding but became Shire Limited ADS’s, each representing three Shire Limited Ordinary Shares. The Scheme of Arrangement did not involve any payment for the Shire Limited ADSs.
 
In accordance with SFAS No. 141, the corporate restructuring has been accounted for as a reorganization of entities under common control. Accordingly, the historical financial statements prior to the reorganization are labeled as those of Shire Limited, but continue to represent the operations of Old Shire.
 
Earnings per share are unaffected by the reorganization.
 
All Old Shire stock options granted to directors and employees under stock option plans that were in existence immediately prior to the Scheme of Arrangement were exchangeable for stock options in Shire Limited on a one-for-one basis with no change in any terms or conditions, other than the acceleration of the vesting date of certain awards granted under the Shire plc 2000 Executive Share Option Scheme (“2000 Executive Scheme”) to the date of
 
14

 
the Scheme of Arrangement, May 23, 2008. The number of stock options for which this exchange did not take place was not material.
 
For presented periods prior to the 2008 corporate restructuring, the equity of Shire Limited represents the historical equity of Old Shire, restated to reflect the change in the nominal value of common stock as expressed in US dollars resulting from the corporate restructuring. The $6.5 million increase in the value of common stock at January 1, 2007 (being the earliest period presented) to $50.2 million on restatement is due to differences between the historic exchange rates used to convert Shire’s Sterling denominated nominal share capital into US Dollars, and the exchange rate at the time of the corporate restructuring. The offset is recorded in additional paid-in capital.
 
Shire Limited was incorporated on January 28, 2008. Prior to May 23, 2008 Shire Limited had not commenced trading or made any profits or trading losses. On October 1, 2008 Shire Limited changed its name to Shire plc following the approval of the change of name by shareholders at the Company’s Annual General Meeting.
 
 
3.
Business combinations
 
Jerini AG acquisition
 
On July 3, 2008 the Company announced that it was launching a voluntary public takeover offer for all outstanding shares in Jerini AG (“Jerini”), a German corporation, at a price of EUR 6.25 per share. During the third quarter of 2008 the Company, through its indirect wholly owned subsidiary, Shire Deutschland Investments GmbH, acquired a 92.7% voting interest in Jerini. The acquisition added Jerini’s hereditary angiodema (“HAE”), product FIRAZYR (icatibant), to Shire’s portfolio.
 
By August 6, 2008 the Company had acquired 80.1% of the voting interests in Jerini for a cash consideration of $456.3 million, by (i) subscribing for new Jerini shares; (ii) acquiring voting interests through the completion of sale and purchase agreements entered into with institutional shareholders and certain members of Jerini’s Management and Supervisory Boards; and (iii) acquiring voting interests through market purchases.
 
During August and September 2008 the Company acquired additional voting interests totaling 12.6% of Jerini’s issued share capital, for a cash consideration of $65.9 million obtained by shares tendered during the Offer process, and on and off market purchases. These additional voting interests have been accounted for as step-acquisitions using the purchase method of accounting.
 
By September 30, 2008 Shire had acquired a 92.7% voting interest in Jerini for a total consideration of $522.2 million, represented by Jerini shares, ($506.5 million), the cash cost of cancelling Jerini stock options ($9.4 million) and direct costs of acquisition ($6.3 million).
 
The acquisition of Jerini has been accounted for as a purchase business combination in accordance with SFAS 141, “Business Combinations” (“SFAS No. 141”). Under the purchase method of accounting, the assets acquired and the liabilities assumed from Jerini are recorded at the date of acquisition at their fair value. Financial statements and reported results of operations of Shire issued after the acquisition of this majority holding will reflect these values, with the results of Jerini included from August 1, 2008, in the Consolidated Statement of Operations. The purchase price has been allocated on a preliminary basis to the fair value of assets acquired and liabilities assumed. The final fair values of assets acquired and liabilities assumed will be determined as soon as possible and, in any event, no later than one year from the acquisition date if such fair values can be measured in this period. To the extent that estimates need to be adjusted, Shire will do so in future periods in accordance with SFAS No. 141.
 
 
15


 
The following table presents the Company’s preliminary allocation of the purchase price to the assets acquired and liabilities assumed at their fair values based on the Company’s 80.1% voting interest acquired by August 6, 2008:
 
 
   
Fair value
 
      $M  
ASSETS
       
Current assets:
       
Cash and cash equivalents
    56.7  
Restricted cash
    0.4  
Inventories, net
    1.9  
Assets held for sale
    29.6  
Other current assets
    4.9  
Total current assets
    93.5  
         
Property, plant and equipment
    3.6  
Goodwill
    115.8  
Other intangible assets
       
 - currently marketed product
    257.6  
 - in-process R&D
    104.1  
Deferred tax asset
    0.5  
Total assets
    575.1  
LIABILITIES
       
Current liabilities:
    31.3  
Deferred tax liability
    76.3  
Other long-term liabilities
    0.8  
 Total liabilities
    108.4  
         
Estimated fair value of identifiable assets acquired and liabilities assumed
    466.7  
         
Minority interests
    (10.4 )
         
Cost of 80.1% voting interest acquired
    456.3  

 
 
In respect of the subsequent step acquisitions made during August and September 2008 the Company has recognized additional goodwill of $13.6 million, intangible assets in respect of the currently marketed product of $39.5 million and in-process research and development (IPR&D) of $16.4 million.
 
 (a) Other intangible assets, currently marketed product
 
Other intangible assets includes $297.1 million (being $257.6 million acquired as of August 6, 2008 and $39.5 million in the subsequent step  acquisitions) relating to intellectual property rights in respect of Jerini’s currently marketed product, FIRAZYR, which received marketing authorization from the European Commission in July 2008 for the treatment of acute HAE in the EU. These intellectual property rights include the right to develop, use, market, sell and/or offer for sale the technical processes, intellectual property and institutional understanding (including the way in which FIRAZYR reacts in body, an understanding of the mechanisms of action which allow FIRAZYR to work and the knowledge related to the associated clinical and marketing studies performed to obtain approval of FIRAZYR).  The fair value of FIRAZYR in the EU has been determined using an income approach applying the multi-period excess earnings method, based on the present value of incremental after tax cash flows attributable to the asset after the deduction of contributory asset charges for the assets employed (including working capital, the assembled workforce and other fixed assets).
 
This intangible asset has an estimated useful life of 17 years, will be amortized on a straight line basis, and has been allocated to the HGT reporting segment.
 
 
16


(b) Other intangible assets, IPR&D
 
IPR&D is defined by FASB Interpretation No. 4, "Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method" ("FIN 4"), as being a development project that has been initiated and has achieved material progress but (i) has not yet reached technological feasibility or has not yet received the appropriate regulatory approval, (ii) has no alternative future use, and (iii) the fair value is estimable with reasonable certainty. A project-by-project valuation using the guidance in SFAS No. 141 and the American Institute of Certified Public Accountants (AICPA) Practice Aid "Assets Acquired in a Business Combination to Be Used In Research and Development Activities: A Focus on Software, Electronic Devices and Pharmaceutical Industries" has been performed to determine the fair value of research and development projects of Jerini which were in-process, but not yet completed as of the acquisition date.
 
The IPR&D assets of $120.5 million (being $104.1 million acquired as of August 6, 2008 and $16.4 million acquired in subsequent step acquisitions) relate to FIRAZYR for the treatment of acute HAE in the US ($60.3 million), and the rest of the world excluding the US and EU (“RoW”), ($60.2 million). These IPR&D assets have not yet received approval from the relevant regulatory authorities at the acquisition date: in the US FIRAZYR received a non approvable letter from the US Food and Drug Administration in April 2008. The Company considers that these IPR&D assets have no alternative future use outside of their current development projects and the fair value of these IPR&D assets has therefore been charged to the Consolidated Statement of Operations as of the acquisition date in accordance with FIN 4.
 
The fair value of the FIRAZYR IPR&D assets was determined using the income approach applying the multi-period excess earnings method. The fair value of the IPR&D assets has been based on the incremental cash flows expected to be generated by the development projects after the deduction of contributory asset charges in respect of other assets employed in these research projects, (including working capital, the assembled workforce and other fixed assets). These estimated future cash flows have then been probability adjusted to take into account the stage of completion and the remaining risks and uncertainties surrounding the future development and commercialization of FIRAZYR. These estimated probability adjusted, after tax cash flows have then been discounted at 17-18% to determine a present, or fair, value.
 
The major risks and uncertainties associated with the timely completion of the acquired IPR&D projects consist of the ability to confirm the efficacy of the technology based on data from the clinical trials, and obtaining the relevant regulatory approvals. The valuations have been based on information at the time of the acquisition and expectations and assumptions that (i) have been deemed reasonable by the Company’s management, and (ii) are based on information, expectations and assumptions that would be available to and be made by a market participant. However, no assurance can be given that the underlying assumptions or events associated with such assets will occur as projected. For these reasons, among others, the actual cash flows may vary from forecast future cash flows.
 
(c) Assets held for sale
 
On acquisition of Jerini the Company and Jerini commenced a strategic review of the acquired assets to identify which of the assets were non strategic to the newly combined business. In October 2008 Jerini announced that its Supervisory and Management Boards had concluded that it was in the best interests of Jerini to divest Jerini Ophthalmic, Inc, Jerini Peptide Technologies Gmbh and Jerini’s pre clinical projects. Consistent with SFAS No. 144, Accounting for the Impairment or Disposal of Long Lived Assets (“SFAS No. 144”) the Company has presented the fair value less costs to sell of those businesses that met the SFAS No. 144 criteria as assets held for sale at the acquisition date. The results of operations of those businesses meeting the SFAS No. 144 criteria have been presented as discontinued operations within the Consolidated Statement of Operations.
 
(d) Goodwill
 
Goodwill of $129.4 million resulting from the acquisition of 92.7% of the voting interests in Jerini has been wholly allocated to the HGT reporting segment.
 
The following unaudited pro forma financial information presents the combined results of the operations of Shire and Jerini as if the acquisition had occurred at the beginning of the periods presented based upon Shire’s ownership interest of 92.7% of Jerini at September 30, 2008. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations actually would have been had the acquisition been completed at the dates indicated. In addition, the unaudited pro forma financial information does not purport to project the future results of operations of the combined Company.
 
 
17



 
   
3 months to
September
30, 2008
   
3 months to
September
30, 2007
   
9 months to
September
30, 2008
   
9 months to
September
30, 2007
 
      $’M       $’M       $’M       $’M  
                                 
Revenues
    779.8       621.5       2,265.8       1,733.7  
Net (loss)/income
    (42.9 )     20.3       (36.8 )     (1,713.2 )
                                 
Per share amounts:
                               
Net (loss)/ income per ordinary share –basic and diluted
    (7.9c )     3.7 c     (6.8c )     (317.9c )

 
The unaudited pro forma financial information above reflects the following pro forma adjustments applied using the principles of SFAS No. 141:
 
(i) An adjustment to decrease interest income by $1.8 million and $7.2 million in the three months and nine months to September 30, 2008 respectively, and $5.7 million and $17.2 million in the three months and nine months to September 30, 2007 respectively, to reflect the interest foregone on the Company's cash resources used to fund the acquisition of Jerini.
 
(ii) An adjustment to increase amortization expense by approximately $2.8 million and $11.4 million for the three and nine months to September 30, 2008 respectively and by approximately $4.3 million and $12.8 million for the three and nine months to September 30, 2007 respectively, to reflect amortization of intangible assets relating to the currently marketed product, over the estimated useful life of 17 years.
 
Included in the pro-forma financial information for the three and nine months to September 30, 2008 is the PR&D charge of $120.5 million in respect of FIRAZYR outside of the EU.
 
New River acquisition
 
On April 19, 2007 Shire completed its acquisition of New River by way of a short-form merger, in an all-cash transaction. Total consideration, together with costs directly attributable to the business combination was $2,594.5 million at the price of $64 per share of New River common stock.
 
During the third quarter of 2008 the Company reduced the values ascribed to other intangible assets acquired through the New River acquisition by $25.3 million compared to amounts previously assigned to these assets in the purchase price allocation. The change to the value ascribed to other intangible assets arose from changes during the third quarter of 2008 to the Company’s estimates of deferred taxes made in the purchase price allocation exercise: accordingly the excess of the fair value of net assets acquired and liabilities assumed over the cost of the acquisition increased by $25.3 million in the third quarter of 2008. In accordance with SFAS No. 141 this excess has been allocated to reduce other intangible assets.
 
Gain on sale of product rights
 
Following receipt of the relevant regulatory or other consents during the three months and nine months to September 30, 2008 the Company recognized $4.0 million and $15.7 million respectively of the gains deferred at December 31, 2007 from the disposal of non-core products during the 2007 financial year, see Note 7.
 
In the nine months to September 30, 2008 Shire also received cash consideration of $5.0 million from the divestment of the Beta range of hormone replacement products to Meda AB, realizing a gain of $5.0 million.
 
During the three and nine months to September 30, 2007 the Company recognized gains of $7.1 million and $12.1 million respectively from the disposal of non-core products. All disposed non-core products were reported in the Specialty Pharmaceuticals operating segment.
 
18


 
Accounts receivable, net
 
Accounts receivable at September 30, 2008 of $489.8 million (December 31, 2007: $441.5 million), are stated net of a provision for discounts and doubtful accounts of $15.4 million (December 31, 2007: $9.8 million).
 
Provision for discounts and doubtful accounts:
 
      2008
$
’M
      2007
$
’M
 
As at January 1
    9.8       8.8  
Provision charged to operations
    64.8       45.2  
Provision utilization
    (59.2 )     (44.6 )
As at September 30
    15.4       9.4  
 
6.
Inventories, net
 
Inventories at September 30, 2008 of $149.6 million (December 31, 2007: $174.1 million) are stated at the lower of cost or market and are analyzed as follows:
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Finished goods
    41.6       67.6  
Work-in-process
    78.4       66.2  
Raw materials
    29.6       40.3  
      149.6       174.1  

 
During the nine months to September 30, 2008 the Company wrote down the value of its DYNEPO inventory to the lower of cost or market. Changes in the external environment in this period, including the launch of several competing bio-similars at lower prices has made DYNEPO uneconomic for the Company. Accordingly the Company has decided to stop commercializing DYNEPO. Product sales are winding down over the second half of 2008 as all patients are transferred off DYNEPO by the end of the year.
 
7.
Assets held for sale
 
At September 30, 2008 assets held for sale had a carrying value of $40.0 million (December 31, 2007: $10.6 million). Assets held for sale principally comprise certain businesses acquired through the Jerini acquisition which the company intends to divest; for further details in respect of these assets, see Note 3.
 
Other assets held for sale are represented by intangible assets and attributed goodwill for certain products divested to Laboratories Almirall S.A. (“Almirall”) in 2007 and a number of other non-core product licenses. The recognition of the gains arising on the disposal of these products and the de-recognition of the related assets have been deferred pending the completion of the transfer of the relevant regulatory and other consents to the acquirer. These assets divested to Almirall form part of the Specialty Pharmaceuticals operating segment.
 
 
Prepaid expenses and other current assets
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Prepaid expenses
    49.2       38.1  
Income tax receivable
    15.5       19.2  
Value added taxes receivable
    16.2       10.8  
Other current assets
    62.7       57.2  
      143.6       125.3  
 

 
19

 
At December 31, 2007 Other current assets included $23.0 million, payable by Shire’s insurance companies as a contribution towards the settlement of the TKT Class Action Shareholder Suit, see Note 14(c). This amount was paid into escrow by the insurance companies during the nine months to September 30, 2008. The settlement was approved by the Court on June 11, 2008.
 
Investments
 
Other than temporary impairment of available for sale securities
 
During the three and nine months to September 30, 2008 the Company recognized impairment charges in respect of its available-for-sale securities totaling $54.1 million (2007: $nil), including $43.7 million for the Company’s investment in Renovo. These amounts represent unrealized holding losses that have been reclassified out of other comprehensive income into earnings in the period, as  management has concluded that the impairment is other than temporary.
 
The decline in the market value of the Company’s investment in Renovo initially arose from the results of clinical trials for JUVISTA announced over 2007 and 2008. In considering whether the decline in value is temporary or “other than temporary” under US GAAP the Company had to consider the following factors: the severity of the decline from historical cost (87%) and its duration (eleven months); market analysts’ targets of Renovo’s share price for the next 18-24 months; and the revised expected filing date for JUVISTA due to the adoption of a sequential rather than parallel Phase 3 development plan.
 
These factors, together with the significant decline in global equity markets during the third quarter of 2008 mean that the Company is unable to reasonably estimate the period over which a full recovery in the value of its investment in Renovo could occur.  As such, the Company had to conclude that for US GAAP purposes the decline in value is “other than temporary”.
 
In such circumstances US GAAP requires the full difference between the book value of the investment and the fair (market) value be recognized as an other than temporary impairment.  Accordingly the Company has recognized an impairment charge of $43.7 million through the Statement of Operations in the three and nine months to September 30, 2008. If in the future JUVISTA’s Phase 3 trials report positively and Renovo’s other products progress through development, Renovo’s share price could react favorably and the Company may recover some or all of this impairment loss. Any future potential increases in the value of Renovo will be recognized through other comprehensive income.
 
Realized gain on divestment of available for sale securities
 
Other income includes a gain of $9.4 million from the sale of Shire’s available-for-sale investment in Questcor Pharmaceutical Inc., a specialty pharmaceutical company focused on providing prescription drugs for central nervous system (CNS) disorders.  Shire received cash consideration of $10.3 million on the sale of this investment.
 
 
Other intangible assets, net
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Intellectual property rights acquired
    2,374.7       2,116.8  
Favorable manufacturing contracts
    8.9       8.9  
      2,383.6       2,125.7  
Less: Accumulated amortization and impairment charges
    (540.9 )     (361.2 )
      1,842.7       1,764.5  
 
Intellectual property rights relate to currently marketed products. At September 30, 2008 the net book value of these intellectual property rights for products with sales recorded in the Specialty Pharmaceuticals operating segment was $1,267.6 million (December 31, 2007: $1,440.6 million) and in the Human Genetic Therapies operating segment was $574.2 million (December 31, 2007: $322.4 million).
 
 
20

 
The increase in the net book value of other intangible assets for the nine months to September 30, 2008 is shown in the table below:
 
   
Other intangible
assets
 
      $’M  
         
As at January 1, 2008
    1,764.5  
Acquisitions
    322.1  
Amortization charged
    (92.8 )
Impairment charges
    (90.9 )
Allocation of excess of fair value of net assets acquired over the cost of the New River acquisition(1)
    (25.3 )
Foreign currency translation
    (34.9 )
As at September 30, 2008
    1,842.7  

(1)
Following the resolution of uncertainties during the third quarter of 2008 principally relating to the tax treatment of certain items incurred by New River, the Company changed its estimates of deferred taxes made in the New River purchase price allocation. In accordance with EITF 93-7 "Uncertainties Related to Income Taxes in a Purchase Business Combination", the effect of resolving these uncertainties has been applied to decrease non current intangible assets as there was no goodwill arising on the acquisition, (see Note 3).
 
During the nine months to September 30, 2008 the Company acquired intangible assets totaling $322.1 million being $297.1 million for FIRAZYR for the treatment of acute HAE in the EU (acquired through the Jerini business combination), and $25.0 million for DAYTRANA. The weighted average amortization period for acquired assets is 17 years. Intangible asset acquisitions exclude $120.5 million of IPR&D acquired with Jerini which was immediately charged to the Consolidated Statement of Operations at the acquisition date (see Note 3).
 
During the nine months to September 30, 2008 the Company recognized impairment charges of $90.9 million  (2007: $nil), of which $90.4 million relates to the write-down of its DYNEPO intangible asset to its fair value ($nil). Changes in the external environment, including the launch of several competing bio-similars at lower prices has made DYNEPO uneconomic for the Company. Accordingly the Company has decided to stop commercializing DYNEPO. Product sales are winding down over the second half of 2008 as all patients are transferred off DYNEPO by the end of the year. The fair value of DYNEPO has been determined using an expected present value technique. The impairment charge has been recorded to Selling, general and administrative expenses, and relates to the Specialty Pharmaceuticals operating segment.
 
The useful economic lives of all intangible assets that continue to be amortized under SFAS No. 142, “Goodwill and Other Intangible Assets” have been assessed.  Management estimates that the annual amortization charge in respect of intangible fixed assets held at September 30, 2008 will be approximately $134 million for each of the five years to September 30, 2013.  Estimated amortization expense can be affected by various factors including future acquisitions, disposals of product rights, foreign exchange movements and the technological advancement and regulatory approval of competitor products.
 
21

 
 
11.
Accounts payable and accrued expenses
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Trade accounts payable
    79.7       79.6  
Accrued rebates – Medicaid
    129.1       114.3  
Accrued rebates – Managed care
    48.2       32.3  
Sales return reserve
    39.9       39.5  
Accrued bonuses
    55.5       59.6  
Accrued employee compensation and benefits payable
    38.0       35.0  
Accrued coupons
    4.0       9.0  
Research and development accruals
    73.5       38.2  
Marketing accruals
    35.7       19.0  
Deferred revenue
    13.0       11.1  
Accrued settlement costs
    1.2       51.5  
Other accrued expenses
    185.3       185.1  
      703.1       674.2  

 
At December 31, 2007 Accrued settlement costs included $50.0 million, for the settlement of the TKT Class Action Shareholder Suit, see Note 14(c). This amount was paid into escrow by Shire ($27.0 million) and Shire’s insurance companies ($23.0 million – see Note 8) during the nine months to September 30, 2008. The settlement was approved by the Court on June 11, 2008.
 
 
Other current liabilities
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Income taxes payable
    22.6       47.3  
Value added taxes
    9.0       6.0  
Other accrued liabilities
    32.4       43.2  
      64.0       96.5  
 
Other non-current liabilities
 
   
September 30,
2008
$’M
   
December 31,
2007
 $’M
 
Income taxes payable
    327.8       320.8  
Other accrued liabilities
    69.4       54.8  
      397.2       375.6  

 
14.
Commitments and contingencies
 
(a)
Leases
 
Future minimum lease payments presented below include operating lease payments and other fixed executory fees under lease arrangements as at September 30, 2008:
 
 
22

 
   
Operating
leases
$’M
 
2008
    9.0  
2009
    31.7  
2010
    25.5  
2011
    22.2  
2012
    15.0  
2013
    13.6  
Thereafter
    55.3  
      172.3  
 
(i)
Operating leases
 
The Company leases land, facilities, motor vehicles and certain equipment under operating leases expiring through 2025.  Lease and rental expense which is included in Selling, general and administrative expenses in the accompanying Statements of Operations amounted to $24.5 million for the nine months to September 30, 2008 (2007: $19.6 million).
 
 
(ii)
Restricted cash in respect of leases
 
At September 30, 2008 the Company had $0.3 million of restricted cash held as collateral for certain equipment leases (December 31, 2007: $8.0 million).
 
 
(b)
Letters of credit and guarantees
 
At September 30, 2008 the Company had irrevocable standby letters of credit with various banks, in the amount of $9.2 million, providing security on the recoverability of insurance claims.  The Company has restricted cash of $9.2 million, as required by these letters of credit.
 
 
(c)
Commitments
 
 
(i)
Alba Therapeutics Corporation (“Alba”)
 
On December 14, 2007 Shire acquired worldwide rights to SPD550 (also known as AT-1001), in markets outside of the US and Japan, from Alba. SPD550 is Alba’s lead inhibitor of barrier dysfunction in various gastrointestinal disorders that is currently in Phase 2 development for the treatment of Celiac disease. Shire has remaining obligations to pay development and sales milestones up to a maximum of $300 million.  Shire will also pay single or double digit tiered royalties on net sales of the product.

Alba and Shire have formed a joint development committee to monitor Research & Development (“R&D”) activities of SPD550. Alba will fund all development until SPD550 has completed Proof of Concept, which is expected to be in the first half of 2009, after which Shire and Alba will share equally development costs under a joint development plan.
 
(ii)
Amicus Therapeutics, Inc. (“Amicus”)
 
On November 7, 2007 Shire licensed from Amicus the rights to three pharmacological chaperone compounds in markets outside of the US: AMIGAL (HGT-3310) for Fabry disease, PLICERA (HGT-3410) for Gaucher disease and HGT-3510 (formerly referred to as AT2220) for Pompe disease. Shire will pay development and sales milestones up to a maximum of $390 million. Shire will also pay tiered, double digit, royalties on net sales of the products. Shire and Amicus will pursue a joint development program toward market approval in the US and Europe; expenses for this program will be shared equally.
 
(iii)
JUVISTA
 
On June 19, 2007 Shire signed an agreement with Renovo to develop and commercialize JUVISTA, Renovo’s novel drug candidate being investigated for the reduction of scarring in connection with surgery. JUVISTA is in Phase 2 development.  Under the terms of the agreement Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states.
 
Shire has remaining obligations to pay Renovo $25 million on the filing of JUVISTA with the US Food and Drug Administration (“FDA”); up to $150 million on FDA approval; royalties on net sales of JUVISTA; and up to $525 million on the achievement of very significant sales targets.

23

 
Shire will bear the cost of clinical trials designed specifically for obtaining US regulatory approval.  Renovo will bear the costs of clinical trials designed specifically for obtaining EU regulatory approval.  Shire and Renovo will share equally the costs of conducting global clinical trials that are designed for obtaining both US and EU regulatory approvals.
 
(iv)
Women’s Health Products
 
In September 2006, Shire and Duramed Pharmaceuticals, Inc (“Duramed”) entered into an agreement related to SEASONIQUE, a number of products using Duramed’s transvaginal ring technology and other oral products.  Shire has the right to market these products in a number of markets outside of North America, including the larger European markets.
 
Under this agreement, Shire will reimburse Duramed for US development expenses incurred going forward up to a maximum of $140 million over eight years from September 2006. US development expenditure reimbursement for the nine months to September 30, 2008 totaled $24.3 million. At September 30, 2008 the maximum future reimbursement for Duramed-incurred US development expenditure is $97.3 million. Shire will separately be responsible for development costs in its licensed territories.
 
(v)
Other R&D and sales milestones
 
In addition to the commitments set out in (i) to (iv), at September 30, 2008 the Company had fees payable and commitments payable on achievement of specified milestones for products under development in-licensed from third parties of $4.6 million (December 31, 2007: $5.3 million), of which $3.6 million could be paid in 2008.
 
 
(vi)
Clinical testing
 
At September 30, 2008 the Company had committed to pay approximately $128.1 million (December 31, 2007: $77.6 million) to contract vendors for administering and executing clinical trials.  The Company expects to pay $93.1 million of these commitments in 2008. However, the timing of these payments is dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities.
 
 
(vii)
Contract manufacturing
 
At September 30, 2008 the Company had committed to pay approximately $40.7 million (December 31, 2007: $109.7 million) in respect of contract manufacturing. The Company expects to pay $34.3 million of these commitments in 2008.
 
 
(viii)
Purchase and service commitments
 
At September 30, 2008 the Company had committed to pay approximately $39.4 million (December 31, 2007: $49.4 million) for future purchases and services, predominantly relating to active pharmaceutical ingredients sourcing and IT outsourcing. The Company expects to pay $18.8 million of these commitments in 2008.
 
 
(ix)
Investment commitments
 
At September 30, 2008 the Company had outstanding commitments to subscribe for interests in companies and partnerships for amounts totaling $6.7 million (December 31, 2007: $7.9 million) which may all be payable in 2008, depending on the timing of capital calls.
 
 
(x)
Capital commitments
 
At September 30, 2008 the Company had committed to spend $141.1 million (December 31, 2007: $52.0 million) on capital projects. This includes commitments for the expansion and modification of its head office in Basingstoke, UK and its facility in Lexington, Massachusetts.
 
 
(xi)
Legal proceedings
 
General
 
The Company accounts for litigation losses and insurance claims and provisions in accordance with SFAS No. 5, "Accounting for Contingencies" ("SFAS No. 5"). Under SFAS No. 5, loss contingency provisions are recorded for probable losses when management is able to reasonably estimate the loss. Where the estimated loss lies within a range and no particular amount within that range is a better estimate than any other amount, the minimum amount is recorded. In other cases management's best estimate of the loss is recorded. These estimates are developed substantially before the ultimate loss is known and the estimates are refined in each accounting period in light of additional information becoming known. In instances where the Company is unable to develop a reasonable estimate of loss, no litigation loss is recorded at that time. As information becomes known a loss provision is set up
 
24

 
 
when a reasonable estimate can be made. The estimates are reviewed quarterly and the estimates are changed when expectations are revised. Any outcome upon settlement that deviates from the Company’s estimate may result in an additional expense in a future accounting period. At September 30, 2008 provisions for litigation losses, insurance claims and other disputes totaled $21.2 million (December 31, 2007: $66.2 million) excluding the liability to dissenting shareholders.
 
Specific
 
There are various legal proceedings brought by and against Shire that are discussed in Shire’s Annual Report on Form 10-K for the year to December 31, 2007. Material updates to the proceedings discussed in Shire’s Annual Report on Form 10-K are described below. There is no assurance that the Company will be successful in any of these proceedings and if it is not, there may be a material impact on the Company’s results and financial position.
 
 
ADDERALL XR
 
(i)
Sandoz
 
In December 2006, Shire was notified that Sandoz Inc. (“Sandoz”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic versions of the 5mg, 10mg, 15mg, 20mg, 25mg and 30mg strengths of ADDERALL XR prior to the expiration of the Company’s ‘819 and ‘300 patents.  On January 26, 2007 Shire filed suit in the US District Court for the District of Colorado for infringement of the ‘819 and ‘300 Patents. Pursuant to the Hatch-Waxman Act, there will be a 30 month stay with respect to Sandoz’ proposed generic products.  In response to Shire’s complaint, Sandoz has alleged affirmative defenses and counterclaims of non- infringement and validity.  Sandoz has alleged sham litigation and patent misuse and the Company has filed a motion to strike these two affirmative defenses.  The Court has denied the motion without prejudice.  Expert reports were filed on September 21, 2007 and rebuttal reports were filed on October 12, 2007.  On December 21 and 26, 2007 Sandoz and Shire, respectively, each filed motions for summary judgment.  Opposition briefs were exchanged on February 8, 2008. Reply briefs were submitted on February 28, 2008.  In a decision dated September 24, 2008 the Court construed certain patent claim terms, denied Sandoz’s motion for summary judgment of noninfringement and granted Shire’s motion to dismiss Sandoz’s affirmative defenses of patent misuse and sham litigation.  On October 3, 2008, Sandoz moved for reconsideration of one aspect of this decision and for immediate appeal under 28 U.S.C. §1292(b) as two specific issues.  A pretrial conference was held on October 8, 2008 whereby the Court certified for immediate appeal the question of whether a later Court, in this case the Colorado Court, is bound by a claim construction from a different court, in this case the Delaware Court in Shire v. Impax.  The Court also denied as moot Sandoz’s motion for reconsideration.  Following these rulings, the case was administratively closed.  All pending motions were denied without prejudice to refile them after a decision from the Federal Circuit regarding collateral estoppel as to claim construction.
 
 
CARBATROL
 
(i)         Nostrum
 
In August 2003, the Company was notified that Nostrum Pharmaceuticals, Inc. (“Nostrum”) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of the 300mg strength of CARBATROL (Nostrum’s ANDA product) prior to the expiration date of the Company’s US patents for CARBATROL, US patent No. 5,912,013 (“the ‘013 Patent”) and US patent No. 5,326,570 (“the ‘570 Patent”).  The notification alleges that the ‘013 and ‘570 Patents are not infringed by Nostrum’s ANDA product.  On September 18, 2003, Shire filed suit against Nostrum in the United States District Court for the District of New Jersey alleging infringement of these two patents by Nostrum’s ANDA and ANDA product. The lawsuit triggered a stay of FDA approval of up to 30 months from Shire’s receipt of Nostrum’s notice letter. The 30 month stay expired on February 6, 2006.  Nostrum could be in a position to market its 300mg extended-release carbamazepine product upon FDA final approval of its ANDA.   On January 23, 2004 the Company amended the complaint to drop the allegations with respect to the ‘013 Patent while maintaining the suit with respect to the ‘570 Patent. On July 17, 2006 the Court entered an order staying discovery in this case until and through September 15, 2006. The parties requested, and the Court granted, an extension of the stay of discovery until and through December 29, 2006. The stay of discovery has been extended. Nostrum requested and the Court permitted Nostrum to file claim construction briefs in the Shire v. Corepharma case also pending in New Jersey. Opening briefs were submitted on October 3, 2007 and responding briefs on October 24, 2007. The case has been stayed pending a claim construction ruling in the Shire v. Corepharma action. The Court in the Corepharma case issued a claim construction decision on March 26, 2008.  Corepharma moved for reconsideration on April 9, 2008. The Court denied Corepharma’s motion on May 20, 2008.
 
In May 2008, the company was notified that Nostrum Pharmaceuticals LLC had submitted an amendment to the above referenced ANDA seeking permission to market its generic versions of the 100mg and 200mg strengths of CARBATROL prior to the expiration date of the Company’s ‘013 and ‘570 Patents. The notification alleges that the ‘013 and ‘570 Patents are not infringed by Nostrum’s ANDA products. On July 2, 2008 Shire filed suit against Nostrum in the United States District Court for the District of New Jersey alleging infringement of these two patents
 
25

 
by Nostrum’s ANDA and ANDA products.  This case was referenced as related to the earlier filed case on Nostrum’s 300 mg product and has been assigned to the same Judge as the earlier ongoing case. The Court issued an Order to Show Cause seeking the parties’ positions as to whether the two cases should be consolidated. Shire submitted papers in support of consolidation. Nostrum opposed consolidation. The Court has not yet issued a ruling on this question.  No trial date has been set.
 
(ii)        Corepharma
 
On March 30, 2006 the Company was notified that Corepharma LLC (“Corepharma”) had filed an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of carbamazepine extended release products in 100mg, 200mg and 300mg strengths prior to the expiration date of the ‘013 and the ‘570 Patents.  On May 17, 2006 Shire filed suit against Corepharma in the United States District Court for the District of New Jersey alleging infringement of these two patents by Corepharma’s ANDA and ANDA products. Pursuant to the Hatch-Waxman Act, there will be a 30 month stay with respect to Corepharma’s proposed generic products. On September 1, 2006 the Company amended the complaint to drop the allegations with respect to the ‘013 Patent while maintaining the suit with respect to the ‘570 Patent. On May 4, 2007 Corepharma filed a motion for summary judgment of non- infringement of the ‘570 Patent. Shire’s opposition to that motion was filed on July 30, 2007. The Court informed the parties on August 30, 2007 that Corepharma’s motion was denied without prejudice. The Court set a Markman schedule and opening briefs were exchanged on October 3, 2007 (including an amicus brief, filed with the Court’s permission by Nostrum). Responding briefs were exchanged on October 24, 2007. The Court has also entered a discovery schedule. The Court rendered a claim construction ruling on March 26, 2008. Corepharma moved for reconsideration of the claim construction ruling.  The Court denied the motion on May 20, 2008. Expert reports were exchanged and expert depositions were completed on June 13, 2008.  On June 20, 2008, Corepharma filed another summary judgment motion directed to the ‘570 Patent. Following briefing, on September 23, 2008 the Court issued a decision denying Corepharma’s ‘570 summary judgment motion for noninfringement.
 
On July 7, 2008, following briefing and oral argument on Corepharma’s motion to vacate an earlier Court order granting Shire’s motion to dismiss Corepharma’s ‘013 noninfringement counterclaims due to lack of subject matter jurisdiction and denying as moot Corepharma’s motion for judgment on the pleadings for noninfringement of the ‘013 patent, the Court vacated its earlier order in view of recent Court of Appeals for the Federal Circuit authority. The Court also denied Corepharma’s request for judgment on the pleadings and directed the parties to conduct summary judgment briefing on the ‘013 patent infringement issues. On August 1, 2008 Corepharma filed its ‘013 summary judgment motion. Shire’s opposition was filed on September 18, 2008. Corepharma’s reply was filed on October 14, 2008. The parties have been instructed that they will have approximately one week to submit a joint pretrial order after the Court rules on the summary judgment motions. No trial date has been set.
 
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(iii)       Teva
 
On March 20, 2007 the Company was notified that Teva USA had filed an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of carbamazepine extended release products in 100mg, 200mg and 300mg strengths prior to the expiration date of the ‘013 and the ‘570 Patents. On May 2, 2007, Shire filed suit against Teva in the US District Court for the Southern District of New York alleging infringement of the ‘013 and the ‘570 Patents by Teva’s ANDA and ANDA products. On August 23, 2007 Shire amended the complaint to drop the allegations with respect to the ‘013 Patent while maintaining the suit with respect to the ‘570 Patent. Teva USA raised counterclaims that the ‘570 and ‘013 Patents were not infringed.  Shire has offered Teva USA a covenant not to sue with respect to the ‘013 Patent. The Court held a status conference on October 16, 2007. Teva withdrew its counterclaim directed to the ‘013 patent. The parties have submitted a discovery schedule to the Court. The Court conducted another status conference on June 19, 2008. The parties have submitted a revised discovery schedule for the Court’s consideration. Fact and expert discovery is to be completed by February 27, 2009. No trial date has been set.
 
 
(iv)       Apotex
 
In May 2008, Shire was notified that Apotex Inc. had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of carbamazepine extended release products in 100mg, 200mg and 300mg prior to the expiration date of the ‘013 and the ‘570 Patents.  On July 2, 2008, Shire filed a lawsuit in the U.S. District Court for the Eastern District of Texas against Apotex Inc., Apotex Corp. and Apotex Pharmaceutical Holdings Inc. (collectively; “Apotex”) alleging infringement of the ‘013 and ‘570 Patents by Apotex ANDA and ANDA products. On July 17, 2008 Apotex Inc. filed a declaratory judgment complaint against Shire for noninfringement and invalidity of the ‘570 and ‘013 patents in the District of New Jersey. Apotex sought and the case was assigned to the same New Jersey Judge hearing the Shire v. Corepharma case. Apotex has also filed in Texas, motions to dismiss and a motion in the alternative to transfer the Texas case to New Jersey. Shire has opposed these three motions.  Following a September 23, 2008 scheduling conference in Texarkana, Texas, the Court set oral argument on the jurisdictional and transfer questions for November 12, 2008. In New Jersey, Shire has filed a motion to dismiss, stay or transfer the New Jersey case to the first filed action in Texas. Briefing on this motion was completed on October 14, 2008. The Court has not set a date for oral argument. The Texas Court has set a Markman hearing date for December 17, 2009 and an October 2010 trial date.
 
 
(v)        Actavis
 
Shire has been notified that Actavis South Atlantic LLC has submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of carbamazepine extended release products in 200mg and 300mg strengths prior to the expiration date of the ‘013 and the ‘570 Patents.  On July 24, 2008, Shire filed a lawsuit in the U.S. District Court for the Eastern District of Texas against Actavis South Atlantic LLC and Actavis Inc. (collectively “Actavis”) alleging infringement of the ‘013 and ‘570 Patents by the Actavis ANDA and ANDA products.
 
 
DYNEPO
 
Since 1997, Shire HGT and Sanofi-Aventis have been involved in ongoing patent litigation regarding Amgen Inc’s (“Amgen”) allegations that DYNEPO infringes claims of five of Amgen’s patents.  In 2001, the United States District Court of Massachusetts concluded that DYNEPO infringed certain claims of the patents that Amgen had asserted.  This decision was appealed to the United States Court of Appeals for the Federal Circuit (the “Federal Circuit”) which affirmed in part, reversed in part, and remanded the action to the United States District Court of Massachusetts for further proceedings.
 
In 2004, the United States District Court of Massachusetts issued a decision on the remanded issues, finding that certain claims related to four of the patents asserted by Amgen are infringed by Shire HGT and Sanofi-Aventis.  This decision was subsequently appealed to the Federal Circuit which affirmed in part, reversed in part, and once again remanded certain issues to the District Court.  Amgen filed a petition for a writ of Certiorari with the Supreme Court in March 2007, requesting review of the Federal Circuit’s 2004 decision.  Amgen’s petition was denied on May 14, 2007 and the case was remanded to the District Court. In October 2008 the District Court entered a declaratory judgment that Shire HGT and Sanofi-Aventis are enjoined from infringement for the life of the Amgen patents.  Shire HGT and Sanofi-Aventi have the right to appeal this decision within 30 days from judgment.
 
Under the existing decisions, the Company and Sanofi-Aventis would be precluded from making, using and selling DYNEPO in the United States until the expiration of the relevant patents.  The Company is required to reimburse Sanofi-Aventis, which controls the litigation and is paying the litigation expenses, for 50% of the expenses incurred in connection with the litigation from and after March 26, 2004.
 
 
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REMINYL
 
On January 29, 2008 Generics UK Ltd commenced a rectification action in the UK seeking a declaration that the duration of the Supplementary Protection Certificate (“SPC”) for EP 236684, the patent that claims the use of galantamine for the treatment of Alzheimer’s disease, is zero (ie the period of exclusivity conferred by the patent has already expired), or alternatively that it expires on December 31, 2008. This SPC represents the primary patent protection for REMINYL in the EU. The current term of the SPC extension runs to January 2012.  Absent the SPC extension, the patent would have expired in January 2007.  REMINYL is entitled to ten years data exclusivity in the UK, which will not expire until March 2010.  A two day trial is scheduled for the week of December 8, 2008.
 
 
Appraisal Rights
 
In connection with Shire’s merger with TKT, former holders of approximately 11.7 million shares of TKT common stock submitted written demands to the Delaware Court of Chancery for appraisal of these shares and, as a result, elected not to accept the $37 per share merger consideration.  On October 10, 2005 at the request of one of the holders to tender 365,000 shares at the merger price of $37 per share, TKT filed a motion to dismiss the holder’s demand.  On October 12, 2005 the Delaware Court of Chancery granted this motion, and the holder tendered the shares at the merger consideration of $37 per share.  Therefore, as at September 30, 2008 former holders of approximately 11.3 million shares of TKT common stock maintained written demands for appraisal of these shares and have elected not to accept the $37 merger consideration.  In November 2005, the Delaware Court of Chancery approved a stipulated consolidation order whereby actions brought by all petitioners have been consolidated as one case.
 
Such former holders will be entitled to receive the fair value of these shares as determined by the Delaware Court of Chancery. The determination of fair value will be made excluding any element of value arising from the transaction, such as cost savings or business synergies. The Delaware Court of Chancery may ascribe a valuation to the shares that is greater than, less than or equal to $37 per share and may award interest on the amount determined in the appraisal process.
 
On March 8, 2007 certain of the former TKT shareholders who previously asserted appraisal rights in connection with the Shire/TKT merger filed a second suit in the Delaware Chancery Court alleging, among other claims, breaches of fiduciary duty by TKT and certain members of its board in connection with the merger with Shire. Shire and TKT have been named as defendants as are four former directors of TKT. The new complaint also asserts a claim that the merger itself was not properly approved by a majority of the outstanding stock of TKT entitled to vote. The complaint seeks rescissory damages with interest, attorneys’ fees and costs. In January 2008 Shire and three of the other defendants (former TKT directors) filed a motion for summary judgment in respect to the five counts included in the second suit. In June 2008 the Court granted the motion in full with respect to the three other defendants and in part with respect to Shire. The remaining counts of the second suit relate to alleged breaches of fiduciary duty by Dr. Dennis Langer (a former TKT director) and Shire as well as the claim that the merger was not properly approved.
 
On November 5, 2008 Shire announced that it had successfully settled all aspects of this litigation with all parties.  Shire paid the same price of $37 per share originally offered to all TKT shareholders at the time of the July 2005 merger, plus interest.  The Delaware Chancery Court has approved dismissal of the case, and Shire made payment to the dissenting shareholders on November 7, 2008.  The settlement which was recorded as a liability at September 30, 2008, represents a total payment of $567.5 million, representing consideration at $37 per share of $419.9 million and an interest cost of $147.6 million.
 
Class Action Shareholder Suit
 
In January and February 2003, various parties filed purported securities fraud class action lawsuits against TKT and Richard Selden, TKT's former Chief Executive Officer, in the United States District Court for the District of Massachusetts. In April 2003, the Court appointed a Lead Plaintiff and Lead Counsel and consolidated the various matters under one matter: In re Transkaryotic Therapies, Inc., Securities Litigation, C.A. No. 03-10165-RWZ.
 
In July 2003, the plaintiffs filed a Consolidated and Amended Class Action Complaint (the "Amended Complaint") against TKT; Dr Selden; Daniel Geffken, TKT's former Chief Financial Officer; Walter Gilbert, Jonathan S. Leff, Rodman W. Moorhead, III, and Wayne P. Yetter, then members of TKT's board of directors; William R. Miller and James E. Thomas, former members of TKT's board of directors; and SG Cowen Securities Corporation, Deutsche
 
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Bank Securities Inc., Pacific Growth Equities, Inc. and Leerink Swann & Company, underwriters of TKT’s common stock in prior public offerings.
 
The Amended Complaint alleges that the defendants made false and misleading statements and failed to disclose material information concerning the status and progress for obtaining United States marketing approval of REPLAGAL during the period between January 4, 2001 and January 10, 2003. The Amended Complaint asserts claims against Dr. Selden and TKT under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder; and against Dr. Selden under Section 20(a) of the Exchange Act. The Amended Complaint also asserts claims based on TKT's public offerings of June 29, 2001, December 18, 2001 and December 26, 2001 against each of the defendants under Section 11 of the Securities Act of 1933 and against Dr. Selden under Section 15 of the Securities Act; and against SG Cowen Securities Corporation, Deutsche Bank Securities Inc., Pacific Growth Equities, Inc. and Leerink Swann & Company under Section 12(a) (2) of the Securities Act. The plaintiffs seek equitable and monetary relief, an unspecified amount of damages, with interest, and attorneys' fees and costs.
 
In May 2004, the Court granted in part and denied in part TKT's motion to dismiss. In particular, the Court dismissed allegations against TKT to the extent they arose out of certain forward-looking statements protected by the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and dismissed claims based on the public offerings of June 29, 2001 and December 18, 2001. The Court allowed all other allegations to remain. In July 2004, the plaintiffs voluntarily dismissed all claims based on the third public offering dated December 26, 2001.
 
In November 2005, the Court granted the plaintiffs’ motion for class certification.  On May 23, 2005, the Court entered judgment on all claims alleged against SG Cowen Securities Corporation, Deutsche Bank Securities Inc., Pacific Growth Equities, Inc. and Leerink Swann & Company.  On June 5, 2006, the Court entered judgment on all claims alleged against Messrs. Gilbert, Leff, Moorhead, Yetter, Miller, and Thomas.  On November 9, 2006, Mr. Geffken filed an Agreement for Judgment on all claims alleged against him.  On September 1, 2007 the SEC filed suit against Dr Selden.  The case is entitled Securities and Exchange Commission v. Richard F Selden, Civil Action No. 05-11805-NMG (D. Mass.) (“the SEC Action”).  On July 10, 2008 the Court entered a final judgment against Selden which permanently enjoins him from violating the anti-fraud and other provisions of the federal securities laws, and orders him to pay approximately $1.2 million in penalties.
 
In October 2007, the parties reached an agreement in principle to resolve the Class Action Shareholder Suit, subject to Court approval, for $50 million. In February 2008 the US District Court for the District of Massachusetts granted preliminary approval to the settlement.  Shire has contributed $27 million held in escrow towards the settlement and its insurance companies have contributed the remaining $23 million. The settlement was approved by the Court on June 11, 2008.
 
 
15.
Fair value measurement
 
As outlined in Note 1(c), on January 1, 2008 the Company adopted the provisions of SFAS No. 157 as they relate to financial assets and financial liabilities. The following are the major categories of financial assets and liabilities measured at fair value on a recurring basis during the nine months to September 30, 2008 using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).
 
   
Total
$M
   
Level 1
$M
   
Level 2
$M
   
Level 3
$M
 
Financial assets:
                       
Available-for-sale securities
    13.0       13.0       -       -  
Equity method investments
    8.2       -       8.2       -  
Derivatives(1)
    5.0       -       5.0       -  
                                 
Financial liabilities:
                               
Derivatives(1)
    9.0       -       9.0       -  
(1) Derivatives consist of swap and forward foreign exchange contracts
 
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:
 
 
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·
Available-for-sale securities – The fair values of available-for-sale investments are estimated based on quoted market prices for those investments.
 
 
·
Equity method investments – The Company’s equity method investments comprise quoted and unquoted investments. The fair values of quoted investments within the funds are estimated based on quoted market prices for those investments. For unquoted investments within the fund, the fair value is estimated using directly observable inputs other than quoted prices.
 
 
·
Derivatives – derivative instruments comprise swap and forward foreign exchange contracts.   The fair value of the swap and forward foreign exchange contracts has been determined using an income approach based on current market expectations about the future cashflows.
 
 
Interest income
 
ID Biomedical Corporation (“IDB”) Loan
 
On September 9, 2004 the Company completed the disposition of its vaccines business to IDB. As part of the transaction, Shire entered into an agreement to provide IDB with a loan facility of up to $100.0 million, which was drawn down in 2005. The $100.0 million loan was segregated into drawings for injectable flu development of $70.6 million and drawings for pipeline development of $29.4 million. In 2005, a provision of $70.0 million was recognized against all of the pipeline development tranche ($29.4 million) and against $40.6 million of the $70.6 million injectable flu development tranche. In 2006 IDB repaid the $70.6 million injectable flu development drawings, together with accrued interest.
 
On March 28, 2008 Shire agreed to a final settlement with IDB of $4.0 million for the outstanding pipeline development advances and interest. The amount received has been recorded within interest income in the nine months to September 30, 2008 in accordance with the method of allocating receipts between interest and advances in the loan agreement.
 
 
Shareholders’ Equity
 
Reduction of Capital and Distributable Reserves
 
On June 11, 2008 the Jersey Court approved a reduction of Shire plc’s (formerly Shire Limited) share capital to take effect on June 12, 2008. The reduction increased the distributable reserves potentially available to Shire plc at the time of reduction  to approximately $3.7 billion by recharacterizing amounts standing to the credit of Shire plc’s share premium account as a distributable reserve. The purpose of the reduction of capital is to create a distributable reserve which would be available to be distributed as dividends, at the discretion of the Directors of Shire plc, from time to time or for any other lawful purpose to which such a reserve may be applied (including share buy backs). The reduction of capital was designed to create in Shire plc a level of distributable reserves similar to that previously available in Shire Biopharmaceuticals Holdings Limited (formerly Shire plc, the former holding company of the Shire
 
30

 
group, see Note 2) and to enable Shire plc to continue Shire’s existing dividend policy in a financially and operationally efficient manner.
 
 
Income Access Share Arrangements
 
Shire has put into place income access share arrangements which enable Shire ordinary shareholders, other than Shire ADS holders, to elect to receive their dividends from a company resident for tax purposes in the Republic of Ireland or receive their dividends under the income access share arrangements from a Shire Group company resident for tax purposes in the UK.
 
Shire Biopharmaceuticals Holdings Limited (formerly Shire plc) (“Old Shire”) has issued one income access share which is held by the income access share trustee pursuant to the income access share trust. The income access share trust is constituted pursuant to a trust deed which provides that (inter alia):
 
(i) the income access share trustee will hold any dividends paid (not just declared) on the income access share on trust for the Shire ordinary shareholders who have elected (or are deemed to have elected) to receive dividends pursuant to these arrangements;
 
(ii) the income access share itself will be held on trust for Shire; and
 
(iii) each registered holder of Shire ordinary shares on a dividend record date who has made (or is deemed to have made) a valid income access share election (described below) will be entitled to receive from the income access share trustee an amount equal to the dividend it would have received from Shire, to the extent the income access share trustee has actually received an amount equal to such amount by way of dividend from Old Shire.
 
To ensure compliance with technical trust law rules, the period during which the income access share trust may continue will be restricted. However, the income access share trust should be able to continue for 80 years.
 
This mechanism is reflected in the articles of association of both Shire and Old Shire that the mechanics of the arrangements will be as follows:
 
The Shire articles of association provide that if (i) a dividend is announced or declared by Shire on the Shire ordinary shares, (ii) an amount is paid by Old Shire by way of a dividend on the income access share to the income access share trustee, and (iii) such amount is paid by the income access share trustee to the Shire ordinary shareholders who have elected (or are deemed to have elected) to receive dividends under these arrangements, the dividend which would otherwise be payable by Shire to such Shire ordinary shareholders will be reduced by an amount equal to the amount paid to such Shire ordinary shareholders by the income access share trustee.
 
If the dividend paid on the income access share and on-paid by the income access share trustee to the Shire ordinary shareholders is less than the total amount of the dividend announced or declared by Shire on the Shire ordinary shares in respect of which an election has been made (or is deemed to have been made) to receive dividends under these arrangements, Shire will be obliged to pay a dividend on the Shire ordinary shares to those Shire ordinary shareholders who have so elected (or are deemed to have so elected) of the amount of the shortfall. In such a case, any dividend paid on the Shire ordinary shares will generally be subject to Irish withholding tax at the rate of 20% or such lower rate as may be applicable under exemptions from withholding tax contained in Irish law.
 
A Shire ordinary shareholder is entitled to make an income access share election such that he will receive his dividends (which would otherwise be payable by Shire) under these arrangements from Old Shire.
 
A Shire ordinary shareholder who held 25,000 or fewer Shire ordinary shares at the time he became a Shire ordinary shareholder pursuant to the Scheme of Arrangement, and who did not make a contrary election, is deemed to have made an election (pursuant to the Shire articles of association) such that he will receive his dividends under these arrangements from Old Shire.
 
Equally, where a Shire ordinary shareholder who first acquires his Shire ordinary shares after the date of the Scheme of Arrangement, who holds 25,000 or fewer Shire ordinary shares on the first dividend record date after he becomes a Shire ordinary shareholder, and who does not make a contrary election, will be deemed to have made an election (pursuant to the Shire articles of association) such that he will receive his dividends under these arrangements from Old Shire.
 
In accordance with the provisions of the Shire ADS deposit agreement, the Depositary has made an election on behalf of all holders of Shire ADSs such that they will receive dividends from Old Shire under the income access share arrangements. Dividends paid by Old Shire under the income access share arrangements will not under current legislation be subject to any UK or Irish withholding taxes. If a holder of Shire ADSs does not wish to receive dividends from Old Shire under the income access share arrangements, he must withdraw his Shire ordinary shares from the Shire ADS program prior to the dividend record date set by the Depositary and request delivery of the Shire ordinary shares. This will enable him to receive dividends from Shire (if necessary, by making an election to that effect).
 
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It is the expectation, although there can be no certainty, that dividends will be paid by Old Shire through the income access share trustee to Shire ordinary shareholders who make (or are deemed to make) an income access share election.
 
It is the expectation, although there can be no certainty, that Old Shire will distribute dividends on the income access share to the income access share trustee for the benefit of all Shire ordinary shareholders who make (or are deemed to make) an income access share election in an amount equal to what would have been such Shire ordinary shareholders’ entitlement to dividends from Shire in the absence of the income access share election. To the extent that any dividend paid on the income access share to the income access share trustee and on-paid by the income access share trustee to the Shire ordinary shareholders is less than an amount equal to what would have been such Shire ordinary shareholders’ entitlement to dividends from Shire in the absence of the income access share election, the dividend on the income access share received by the income access share trustee will be allocated pro rata to such Shire ordinary shareholders and Shire will pay the balance by way of dividend. In such circumstances, there will be no grossing up by Shire in respect of, and Old Shire and Shire will not compensate those Shire ordinary shareholders for, any adverse consequences including any Irish withholding tax consequences.
 
Shire will be able to suspend or terminate these arrangements at any time, in which case the full Shire dividend will be paid directly by Shire to those Shire ordinary shareholders (including the Depositary) who have made (or are deemed to have made) an income access share election. In such circumstances, there will be no grossing up by Shire in respect of, and Old Shire and Shire will not compensate those Shire ordinary shareholders for, any adverse consequences including any Irish withholding tax consequences.
 
On October 7, 2008 Old Shire paid dividends totalling $9.5m on the income access share to the income access share trustee in an amount equal to the dividend Shire ordinary shareholders would have received from Shire.
 
Exchangeable Shares
 
On February 12, 2008 a subsidiary of Shire exercised a redemption call right and purchased each exchangeable share of Shire Acquisition Inc. (“SAI”) remaining in public ownership.  Exchangeable shareholders received either three ordinary shares of Shire plc or one American Depositary Share (“ADS”) representing three ordinary shares of Shire plc for each Exchangeable Share held.  Exchangeable Shares were issued to Canadian resident shareholders of Biochem Pharma Inc. (now Shire Canada, Inc.) in 2001 as consideration for the acquisition by the Shire group of Biochem Pharma Inc.  The Exchangeable Shares have now been de-listed from the Toronto Stock Exchange.
 
 
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18.
Earnings per share
 
The following table reconciles the net (loss)/income from operations and the weighted average ordinary shares outstanding for basic and diluted earnings per share for the periods presented:
 
 
 
3 months to
September
30,
2008
$’M
   
3 months to
September
30,
2007
$’M
   
9 months to
September
30,
2008
$’M
   
9 months to
September
30,
2007
$’M
 
(Loss)/income from continuing operations
    (34.0 )     34.7       15.6       (1,663.9 )
Loss from discontinued operations
    (0.9 )     -       (0.9 )     -  
Numerator for basic and diluted earnings per share
    (34.9 )     34.7       14.7       (1,663.9 )

 
Weighted average number of shares:
 
 
No. of shares
Millions
   
No. of shares
Millions
   
No. of shares
Millions
   
No. of shares
Millions
 
Basic(1)
    540.3       546.4       542.6       538.9  
Effect of dilutive shares:
                               
Stock based awards to employees(2)
    -       8.2       2.7       -  
Warrants(2)
    -       0.1       -       -  
      -       8.3       2.7       -  
Diluted
    540.3       554.7       545.3       538.9  

(1) Excludes shares purchased by the ESOT and presented by the Company as treasury stock.
(2) Calculated using the treasury stock method.

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

   
3 months to
September
30, 2008(2)
   
3 months to
September 30,
2007(1) (3)
   
9 months to
September 30,
2008(1)(3)
   
9 months to
September 30,
2007(2)
 
   
No. of shares
Millions
   
No. of shares
Millions
   
No. of shares
Millions
   
No. of shares
Millions
 
Stock options in the money
    1.2       -       -       7.8  
Stock options out of the money
    17.0       1.0       17.0       2.0  
Warrants
    -       -       -       0.4  
Convertible bonds 2.75% due 2014
    32.7       32.7       32.7       17.3  

 
(1)
For the nine months ended September 30, 2008 and the three months ended September 30, 2007, certain stock options have been excluded from the calculation of diluted EPS because their exercise prices exceeded Shire plc’s average share price during the calculation period.
 
(2)
For the three months ended September 30, 2008 and the nine months ended September 30, 2007 no share options, warrants or ordinary shares underlying the convertible bonds have been included in the calculation of the diluted weighted average number of shares, because the Company made a net loss during the calculation period and the inclusion of these items would be anti-dilutive.
 
(3)
For the nine months ended September 30, 2008 and the three months ended September 30, 2007, the convertible bonds were not included in the calculation of the diluted weighted average number of shares, because their effect would be anti-dilutive in the period.
 
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19.
Segmental reporting
 
SFAS No. 131, “Disclosures about Segments of an Enterprise and Related Information” (“SFAS No. 131”) establishes standards for reporting information about operating segments and related disclosures, products and services, geographic areas and major customers.  Operating segments are components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision-maker to decide how to allocate resources and to assess performance.
 
Shire’s internal financial reporting is in line with a business unit and management reporting structure based on two segments: Specialty Pharmaceuticals and Human Genetic Therapies (“HGT”).
 
The Specialty Pharmaceuticals and HGT operating segments represent the Company’s revenues and costs in respect of currently promoted and sold products, together with the costs of developing projects for future commercialization.  ‘All Other’ has been included in the table below in order to reconcile the two operating segments to the total consolidated figures.
 
The Company evaluates performance based on revenue and operating income. The Company does not have inter-segment transactions. Assets that are directly attributable to the segments have been separately disclosed.
 
   
Specialty
Pharmaceuticals
   
HGT
   
All Other
   
Total
 
3 months to September 30, 2008
    $’M       $’M       $’M       $’M  
Product sales
    589.5       123.0       -       712.5  
Royalties
    0.3       -       60.5       60.8  
Other revenues
    1.3       1.5       2.5       5.3  
Total revenues
    591.1       124.5       63.0       778.6  
                                 
Cost of product sales(1) (2)
    66.0       17.1       1.1       84.2  
Research and development(1) (2)
   
72.6
      50.4       4.1       127.1  
Selling, general and administrative(1) (2)
    222.8       37.5       60.1       320.4  
In-process R&D charge
    -       120.5       -       120.5  
Gain on sale of product rights
    (4.0 )     -       -       (4.0 )
Integration costs
    -       -       7.5       7.5  
Total operating expenses
    357.4       225.5       72.8       655.7  
Operating income/(loss)
    233.7       (101.0 )     (9.8 )     122.9  
                                 
Total assets
    2,240.4       1,131.7       981.7       4,353.8  
Long lived assets
    191.9       228.5       80.3       500.7  
Capital expenditure on long lived assets
    14.6       63.2       6.5       84.3  
 
 
(1)
Stock-based compensation of $16.2 million is included in: cost of product sales ($1.0 million), research and development ($4.8 million) and selling, general and administrative ($10.4 million).
(2)
Depreciation from manufacturing plants ($3.2 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in cost of product sales; depreciation of research and development assets ($3.4 million) is included in research and development; and all other depreciation, amortization and intangible asset impairment charges ($42.1 million) are included in selling, general and administrative.
 
 
34


 
3 months to September 30, 2007  
Specialty
Pharmaceuticals
$’M
   
HGT
$’M
   
All Other
$’M
   
Total
$’M
 
Product sales
    447.3       95.8       -       543.1  
Royalties
    0.3       -       61.6       61.9  
Other revenues
    1.5       0.7       1.5       3.7  
Total revenues
    449.1       96.5       63.1       608.7  
                                 
Cost of product sales(1) (2)
    66.2       13.5       3.7       83.4  
Research and development(1)
    140.6       40.8       -       181.4  
Selling, general and administrative(1) (2)
    238.1       28.9       61.4       328.4  
Gain on sale of product rights
    (7.1 )     -       -       (7.1 )
Total operating expenses
    437.8       83.2       65.1       586.1  
Operating income/(loss)
    11.3       13.3       (2.0 )     22.6  
                                 
Total assets
    2,383.3       605.7       1,099.7       4,088.7  
Long lived assets
    164.9       96.3       76.4       337.6  
Capital expenditure on long lived assets
    13.7       11.0       3.8       28.5  
 
(1)
Stock-based compensation of $11.7 million is included in: cost of product sales ($0.9 million), research and development ($3.3 million) and selling, general and administrative ($7.5 million).
(2)
Depreciation from manufacturing plants ($3.1 million) and amortization of favorable manufacturing contracts ($0.5 million) is included in cost of product sales, depreciation of research and development assets ($2.9 million) is included in research and development, and all other depreciation and amortization ($41.6 million) is included in selling, general and administrative.
 

 

35

 
 
 
   
Specialty
Pharmaceuticals
   
HGT
   
All Other
   
Total
 
9 months to September 30, 2008
    $’M       $’M       $’M       $’M  
Product sales
    1,687.4       362.5       -       2,049.9  
Royalties
    1.3       -       189.4       190.7  
Other revenues
    5.5       2.8       7.5       15.8  
Total revenues
    1,694.2       365.3       196.9       2,256.4  
                                 
Cost of product sales(1) (2)
    264.6       44.9       7.9       317.4  
Research and development(1) (2)
    244.8       145.5       4.1       394.4  
Selling, general and administrative(1) (2)
    818.2       113.7       151.8       1,083.7  
In-process R&D charge
    -       255.5       -       255.5  
Gain on sale of product rights
    (20.7 )     -       -       (20.7 )
Integration costs
    -       -       7.5       7.5  
Total operating expenses
    1,306.9       559.6       171.3       2,037.8  
Operating income/(loss)
    387.3       (194.3 )     25.6       218.6  
                                 
Total assets
    2,240.4       1,131.7       981.7       4,353.8  
Long lived assets
    191.9       228.5       80.3       500.7  
Capital expenditure on long lived assets
    34.3       127.2       20.3       181.8  
 
(1)
Stock-based compensation of $52.0 million is included in: cost of product sales ($3.4 million), research and development ($15.0 million) and selling, general and administrative ($33.6 million).
(2)
Depreciation from manufacturing plants ($8.8 million) and amortization of favorable manufacturing contracts ($1.3 million) is included in cost of product sales; depreciation of research and development assets ($9.4 million) is included in research and development; and all other depreciation, amortization and intangible asset impairment charges ($216.3million) are included in selling, general and administrative.
 

36

 
   
Specialty
Pharmaceuticals
   
HGT
   
All Other
   
Total
 
9 months to September 30, 2007
  $’M     $’M     $’M     $’M  
Product sales
    1,279.3       229.5       -       1,508.8  
Royalties
    1.3       -       184.1       185.4  
Other revenues
    8.2       5.5       3.9       17.6  
Total revenues
    1,288.8       235.0       188.0       1,711.8  
                                 
Cost of product sales(1) (2)
    186.7       28.8       9.2       224.7  
Research and development(1) (2)
    254.1       111.6       -       365.7  
Selling, general and administrative(1) (2)
    621.2       92.8       133.5       847.5  
In-process R&D charge
    1,896.0       -       -       1,896.0  
Gain on sale of product rights
    (12.1 )     -       -       (12.1 )
Integration costs
    1.3       -       -       1.3  
Total operating expenses
    2,947.2       233.2       142.7       3,323.1  
Operating (loss)/income
    (1,658.4 )     1.8       45.3       (1,611.3 )
                                 
Total assets
    2,383.3       605.7       1,099.7       4,088.7  
Long lived assets
    164.9       96.3       76.4       337.6  
Capital expenditure on long lived assets
    17.6       21.2       23.3       62.1  
 
(1)
Stock-based compensation of $34.1 million is included in: cost of product sales ($2.6 million), research and development ($8.9 million) and selling, general and administrative ($22.6 million).
(2)
Depreciation from manufacturing plants ($9.0 million), and amortization of favorable manufacturing contracts ($0.5 million) is included in cost of product sales, depreciation of research and development assets ($8.4 million) is included in research and development, and all other depreciation and amortization and intangible asset impairment charges ($93.9 million) is included in selling, general and administrative.
 
 
37

 
20.
Subsequent events
 
During November 2008, the Company settled all pending litigation brought by certain former dissenting shareholders of Transkaryotic Therapies, Inc. (“TKT”). As disclosed in Note 14, before completion of the merger, certain dissenting shareholders holding approximately 11.7 million of TKT shares, elected not to accept the $37 per share merger consideration offered by the Company and submitted written demands for appraisal of the fair value of these shares. The former holders of 365,000 shares subsequently withdrew their appraisal demand and accepted the $37 per share merger consideration, leaving former holders of approximately 11.3 million shares of TKT seeking appraisal of their shares. A second lawsuit was brought in March 2007 alleging, among other claims, breaches of fiduciary duty by certain members of TKT’s Board. The majority of that second lawsuit was dismissed by the Court at summary judgment in June 2008. A trial date of December 10, 2008 was set for both cases.
 
As a result of this settlement, the Company will pay $37 per share, the same amount per share paid to non-dissenting shareholders in July 2005 at the time of the merger between the Company and TKT, plus interest. The Delaware Chancery Court approved dismissal of the case, and the Company made payment to the dissenting shareholders on November 7, 2008. The settlement represents a total payment of $567.5 million, representing consideration at $37 per share of $419.9 million and an interest cost of $147.6 million.  The payment of $567.5 million will be funded entirely from the Company’s existing cash resources and by drawing $190 million on its $1,200 million revolving credit facility.
 
Prior to reaching this settlement, the Company accrued interest based on a reasonable estimate of the amount that may be awarded by the Court to those former TKT shareholders who requested appraisal.  This estimate of interest was based on Shire’s cost of borrowing. Between the close of the merger and September 30, 2008 the Company applied this interest rate on a quarterly compounding basis to the $419.9 million of consideration to calculate its provision for interest.
 
Upon reaching agreement in principle with all the dissenting shareholders, the Company determined that settlement had become the probable manner through which the appraisal rights litigation would be resolved.  Under current law, (although not applicable in this case because the merger was entered into before the relevant amendment to the law became effective) the court presumptively awards interest in appraisal rights cases at a statutory rate that is 5 percentage points above the Federal Reserve discount rate (as it varies over the duration of the case). In connection with the settlement, the Company agreed to an interest rate that approximates to this statutory rate. Based on the settlement, the Company amended the method of determining its interest provision to reflect this revised manner of resolution, and recorded an additional provision for interest of $73.0 million as an adjusting post balance sheet event in its third quarter financial statements.
 
The interest cost of $147.6 million has been recorded as interest expense in the Company’s Statement of Operations since the time of the merger, including $77.0 million and $87.3 million recorded in the three and nine months to September 30, 2008 (2007: $7.3 million and $20.7 million) respectively.
 
 
38

 
 
 
The following discussion should be read in conjunction with the Company’s unaudited consolidated financial statements and related notes appearing elsewhere in this report.
 
Overview
 
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder ("ADHD"), human genetic therapies ("HGT"), gastrointestinal ("GI") diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with relatively small-scale sales forces will deliver strong results.
 
Recent Developments
 
Settlement of TKT Shareholder Appraisal Rights Litigation
 
On November 5, 2008 the Company announced that it had settled all pending litigation in connection with the former dissenting shareholders of TKT. The Company has paid the former dissenting shareholders the same price of $37 per share originally offered to all TKT shareholders at the time of the July 2005 merger, plus interest. The total cost of the settlement is $567.5 million (see ITEM 1, Note 20 for further details).
 
Change of name
 
Since the end of June 2008 Jersey company law has permitted a public company to use “plc” in its name and it was considered appropriate that the Company adopt this nomenclature. Consequently on September 24, 2008 at the Company’s AGM, it was resolved that the name of Shire Limited be changed to Shire plc.
 
Significant events in the three months to September 30, 2008
 
Product highlights
 
VYVANSETM (lisdexamfetamine dimesylate) – Attention Deficit and Hyperactivity Disorder (“ADHD”)
 
The launch of VYVANSE for adult ADHD in June 2008 has helped to make VYVANSE the third highest prescribed ADHD product in the US. For the nine months to September 30, 2008 VYVANSE product sales totaled $215.6 million.
 
On July 2, 2008 Shire shipped to wholesalers stocks of three additional dosage strengths (20mg, 40mg and 60mg) for VYVANSE representing product sales of approximately $24 million.  These product sales have been recognized into revenue in Q3 2008.
 
FOSRENOL® (lanthanum Carbonate) - Hyperphosphatemia
 
FOSRENOL was approved in Japan in October 2008. Shire’s out-licensee, Bayer Yakuhin Limited, is now progressing pricing and reimbursement negotiations in that market.
 
Business highlights
 
Acquisition of Jerini
 
During Q3 2008 Shire acquired a majority voting interest in Jerini and published an Offer Document in respect of acquiring the remaining shares in Jerini that it did not already own.  By September 30, 2008 Shire had acquired over 90% of the shares in Jerini and now owns approximately 93% of the shares. The acquisition has added Jerini’s HAE product, FIRAZYR, to the portfolio (See ITEM1, Note 3 for further details).
 
Sale of non-core assets
 
Following the transfer of the relevant marketing consents Shire recognised previously deferred gains of $4 million arising from the divestment of non-core products to Laboratorios Almirall S.A (“Almirall”) in 2007.
 
 
Research and development

Products in registration September 30, 2008

FOSRENOL for the treatment of pre-dialysis chronic kidney disease (“CKD”)
Following the FDA Cardiovascular and Renal Drugs Advisory Committee recommendation in October of 2007 on the use of phosphate binders, including FOSRENOL, to treat hyperphosphatemia in pre-dialysis CKD patients, Shire continues to work with the FDA to agree to a regulatory pathway for approval for use in pre-dialysis patients.
 
VYVANSE for ADHD in Canada
 
In March 2008 the Canadian new drug submission was accepted for filing for the treatment of ADHD in children. Review is ongoing.
 
39

 

INTUNIV for ADHD
On June 21, 2007 Shire received an approvable letter from the FDA for INTUNIV.  Shire is conducting additional clinical work which is designed to enhance the label. While the precise timing for the approval of INTUNIV is unknown, it is anticipated that launch for use in children and adolescents will occur in the second half of 2009.

DAYTRANA for ADHD in EU & Canada
Regulatory submissions were filed for approval of the product with Health Canada on November 29, 2007 and in the EU via the decentralized procedure with the Netherlands as the reference member state on December 12, 2007. Reviews are ongoing.

LIALDA/MEZAVANT for Ulcerative Colitis
A Regulatory submission for MEZAVANT for the treatment of ulcerative colitis was made to the Australian Regulatory Authorities (TGA) in September  2008.

FIRAZYR for HAE in the US
Jerini received a not approvable letter for FIRAZYR for use in the US from the FDA in April 2008, and plans to provide a complete response by the end of the year.

Products in clinical development as at September 30, 2008

Phase 3

VYVANSE for ADHD in Europe
Shire plans to submit the regulatory filing for VYVANSE in Europe for the treatment of ADHD in children aged 6 to 17 in 2010.

LIALDA/MEZAVANT for the maintenance of remission in ulcerative colitis
Phase 3 trials investigating the use of the product to maintain remission in patients who have ulcerative colitis were initiated in 2006 and are continuing.

LIALDA/MEZAVANT for the treatment of diverticulitis
Phase 3 worldwide clinical trials investigating the use of the product for the treatment of diverticulitis were initiated in 2007 and are continuing.

SEASONIQUE
Shire is evaluating the scientific advice received following meetings in 2007 with the regulatory authorities in Europe in order to formulate the regulatory filing strategy.

Velaglucerase alfa
Shire has completed enrolment in a worldwide Phase 3 clinical program for velaglucerase alfa, an enzyme replacement therapy being developed for the treatment of Gaucher disease. This comprehensive development program includes the evaluation of velaglucerase alfa in naïve patients and patients previously treated with imiglucerase across three clinical studies. It is anticipated that this development program will support global filings in the second half of 2009.

Phase 2
 
JUVISTA for the improvement of scar appearance
 
Renovo Limited (“Renovo”) intends to initiate its first pivotal European Phase 3 trial in scar revision in the fourth quarter of 2008 in support of Renovo’s filing of a European regulatory dossier. If the outcome from Renovo’s multi centre, EU Phase 3 study is suitably positive, the data will be used to inform the strategy and design of Shire’s US development plan and to strengthen the chances of regulatory and commercial success in the US.
 
SPD550 for the treatment of Celiac disease
On December 14, 2007 Shire acquired the worldwide rights to SPD550 (Larazotide Acetate) (also known as AT-1001) in markets outside of the US and Japan from Alba Therapeutics Corporation (“Alba”). The two parties have established Joint Committees which will guide the development, manufacture, and commercialization of the product.  Alba has initiated and is responsible for executing the agreed upon ongoing Phase 2 program and certain non-clinical studies for the treatment of Celiac disease. Additional development studies may be conducted jointly or by the individual companies prior to or after initiation of Phase 3.

40

 
Transvaginal Ring (“TVR”) technology
The TVR technology products are in various stages of development.

MLD program
Shire has an ongoing enzyme replacement therapy program for the treatment of MLD, which is a lysosomal storage disorder that results from a deficiency in the enzyme arylsulfatase-A (“ASA”). On June 4, 2008 Shire completed its acquisition from Zymenex A/S (“Zymenex”) of the global rights to a clinical candidate ASA, currently known as METAZYM. METAZYM has completed a Phase 1b clinical trial in 12 MLD patients in Europe and an extension to this study is ongoing.  The product has been granted orphan drug designation in the US and in the EU. The current plan is to initiate a Phase 2/3 clinical trial as soon as possible following discussions with regulatory authorities in Q4 2008. This product will now be referred to as HGT-1111.
 
HGT-1110 was in development at Shire for the treatment of MLD following successful pre-clinical proof of concept studies. The HGT-1110 program was replaced with the HGT-1111 development program upon completion of the acquisition.
 
AMIGAL (HGT-3310 for the treatment Fabry disease)
Amicus Therapeutics Inc. (“Amicus”) met with the FDA to discuss the AMIGAL development program in June 2008, and discussions are ongoing. Discussions are ongoing with the EMEA. A final decision on the global development strategy will follow the conclusion of the discussions with both agencies. Shire has rights to AMIGAL in markets outside the US.

PLICERA (HGT-3410 for the treatment of Gaucher disease)
In March 2008 Amicus announced positive data from its Phase 2 clinical trial. Results from the Phase 2 trial support the previously reported interim findings that PLICERA was generally safe and well tolerated at all doses and increased target enzyme activity levels in a majority of patients. Shire has rights to PLICERA in markets outside the US.

HGT-3510 for the treatment of Pompe disease
In June 2008 Amicus initiated Phase 2 clinical trials of HGT-3510, an orally administered, small molecule pharmacological chaperone being jointly developed for the treatment of Pompe disease by Shire and Amicus. Shire has rights to HGT-3510 in markets outside the US.

Phase 1

SPD487 (Amphetamine transdermal system (“ATS”))
Shire is currently reviewing formulation data provided by Noven Pharmaceuticals Inc.

HGT-2310 - Hunter syndrome with significant central nervous system symptoms
Following the acceptance by the FDA in January 2008 of Shire’s IND application for idursulfase-IT (HGT-2310 - formerly referred to as ELAPRASE for Hunter syndrome patients with significant central nervous system symptoms - “Hunter CNS”) the Company is now in the process of planning clinical trials.

Products in pre-clinical development as at September 30, 2008

HGT-1410 for Sanfilippo Syndrome (Mucopolysaccharidosis IIIA)
On May 22, 2008 orphan drug designation was granted by the FDA for HGT-1410, an enzyme replacement therapy being developed for the treatment of Sanfilippo Syndrome, a lysosomal storage disorder.  Pre-clinical development for this product is continuing.

A number of projects are underway in the early stages of development (pre-clinical) for the Specialty Pharmaceutical and HGT businesses.


41

 
 
 
Total revenues
 
The following table provides an analysis of the Company’s total revenues by source:

   
3 months to
September 30,
2008
$M
   
3 months to
September 30,
2007
$M
   
change
%
 
Product sales
    712.5       543.1       31  
Royalties
    60.8       61.9       -2  
Other
    5.3       3.7       43  
Total
    778.6       608.7       28  
 
Product sales
 
The following table provides an analysis of the Company’s key product sales:
 
   
3 months to
September 30,
2008
$M
   
3 months to
September 30,
2007
$M
   
Product sales
growth
%
   
US prescription
growth
 %
 
Specialty Pharmaceuticals
                       
ADHD
                       
ADDERALL XR
    268.7       249.0       8       -5%  
VYVANSE
    96.0       10.6       806       n/a  
DAYTRANA
    18.1       9.4       93       -14%  
                                 
GI
                               
PENTASA
    49.2       43.7       13       n/a  
LIALDA / MEZAVANT
    40.4       16.3       148       143%  
                                 
General Products (“GP”)
                               
FOSRENOL
    43.0       28.7       50       -1%  
DYNEPO
    5.2       4.4       18       n/a  
CALCICHEW
    13.3       13.5       -1       n/a  
CARBATROL
    21.6       19.3       12       -3%  
REMINYL/REMINYL XL
    9.6       8.2       17       n/a  
XAGRID
    19.4       16.8       15       n/a  
                                 
Other product sales
    5.0       27.4       -82          
      589.5       447.3       32          
Human Genetic Therapies
                               
ELAPRASE
    78.2       55.1       42       n/a  
REPLAGAL
    44.6       40.7       10       n/a  
FIRAZYR
    0.2       -       n/a       n/a  
      123.0       95.8       28          
Total product sales
    712.5       543.1       31          
 
 
42

 
The following discussion includes references to prescription and market share data for the Company’s key products.  The source of this data is IMS Health, September 2008.  IMS Health is a leading global provider of business intelligence for the pharmaceutical and healthcare industries.
 
US ADHD market share
 
Shire’s average quarterly market share of the US ADHD market rose to 32.9% in the three months to September 30, 2008 (2007: 29.7%), driven by the continued growth in market share of VYVANSE. The overall US ADHD market grew by 8% in the same period. Shire has the leading portfolio of products in the US ADHD market.
 
ADDERALL XR – ADHD
 
As a result of the launch of VYVANSE in July 2007, ADDERALL XR’s average quarterly market share of the US ADHD market for Q3 2008 fell to 22.3% (2007: 25.2%), a decrease of 12% compared to the same period in 2007.  US prescriptions for ADDERALL XR in the three months to September 30, 2008 decreased by 5% compared to the same period in 2007 due to the 12% decrease in the average market share offset by 8% growth in the US ADHD market.
 
Sales of ADDERALL XR for the three months to September 30, 2008 were $268.7 million, an increase of 8% compared to the same period in 2007 (2007: $249.0 million).  Product sales grew despite the decline in US prescriptions primarily due to price increases.
 
Litigation proceedings concerning Shire’s ADDERALL XR patents are on-going. Further information on this litigation can be found in ITEM 1 of Part I of this Form 10-Q.
 
VYVANSE – ADHD
 
VYVANSE was launched in the US market in July 2007.  Product sales for the three months to September 30, 2008 were $96.0 million (2007: $10.6 million) representing a 47% increase compared to sales of $65.2 million in Q2 2008.
 
Product sales growth was driven by a 19% increase in prescription demand compared to Q2 2008, a price increase and the stocking impact of the new dosage strengths.  For the three months to September 30, 2008 VYVANSE’s average quarterly market share was 9.0% (2007: 2.4%) of the US ADHD market.
 
By October 17, 2008 VYVANSE had achieved a US ADHD average weekly market share of 10.2%, based on weekly prescription volumes.
 
DAYTRANA – ADHD
 
Product sales for the three months to September 30, 2008 were $18.1 million (2007: $9.4 million).  Prescriptions declined by 14% from the same period last year due to a reduction in DAYTRANA’s average quarterly market share of the US ADHD market to 1.6% (2007: 2.1%).
 
Despite the decrease in prescriptions compared to 2007, sales of DAYTRANA grew 93% compared to the same period last year due to lower sales deductions in 2008 over 2007, when a provision was made for returns following the voluntary market withdrawal of a limited number of DAYTRANA patches.
 
On August 19, 2008 Shire announced a voluntary recall of two lots of DAYTRANA patches because these patches did not meet their release liner removal specifications which may have resulted in some patients and caregivers having difficulties removing the liners. The voluntary recall was not due to safety issues. Shire and Noven Pharmaceuticals Inc. (Noven) (the manufacturer of DAYTRANA) continue to pursue enhancements to the product and to work closely with the FDA to implement changes that may improve the usability of DAYTRANA. No interruption in the production of DAYTRANA is anticipated. Shire and Noven may take additional corrective action.
 
US oral mesalamine market share
 
Shire’s average quarterly market share of the US oral mesalamine market rose to 29.3% in the three months to September 30, 2008 (2007: 22.5%), driven by the growth of LIALDA since its launch in March 2007.  The overall US oral mesalamine market grew by 2.4% in the same period.
 
LIALDA/MEZAVANT – Ulcerative colitis
 
Shire launched LIALDA in the US oral mesalamine market in March 2007, and during the three months to September 30, 2008 LIALDA had reached an average quarterly market share of 12.7% (2007: 5.4%).  Product sales of LIALDA in the US for the three months to September 30, 2008 were $38.6 million (2007: $16.3 million).
 
Sales of MEZAVANT outside the US for the three months ended September 30, 2008 were $1.8 million (2007: $nil). As of September 30, 2008 LIALDA/MEZAVANT was available in five EU countries. Launches are planned in other countries during 2008 and 2009, subject to the successful conclusion of pricing and reimbursement negotiations.
 
 
43


 
 
PENTASA – Ulcerative colitis
 
Sales of PENTASA in the US for the three months to September 30, 2008 were $49.2 million, an increase of 13% compared to the same period in 2007 (2007: $43.7 million). During the three months to September 30, 2008 Pentasa had an average market share of 16.6% (2007: 17.1%). Sales grew despite flat prescriptions due to the impact of price increases.
 
FOSRENOL – Hyperphosphatemia
 
FOSRENOL is now available in 29 countries and global sales totaled $43.0 million for the three months to September 30, 2008 (2007: $28.7 million).  US sales of FOSRENOL for the three months to September 30, 2008 were up 50% to $24.5 million compared to the same period in 2007 (2007: $16.3 million).  Sales of FOSRENOL outside the US for the same period were up 49% to $18.5 million (2007: $12.4 million), with favorable exchange rate movements against the US dollar accounting for 8% .
 
FOSRENOL’s average quarterly prescription share of the US phosphate binder retail market decreased  to 8.1% for the three months to September 30, 2008 (2007: 8.5%). Product sales increased despite the decrease in prescriptions due to price increases and an increase in FOSRENOL’s share of the non retail market (increased to 16% in August 2008 compared to 12% in August 2007) as a consequence of focusing on specialist physicians in clinics and dialysis centers.
 
XAGRID – Thrombocythemia
 
Sales for the three months to September 30, 2008 were $19.4 million, an increase of 15% compared to the same period in 2007 (2007: $16.8 million).  Expressed in transaction currencies (XAGRID is primarily sold in Euros and Pounds Sterling), sales increased by 11% due to growth in many of Shire’s existing markets, with exchange rate movements against the US dollar accounting for the remaining 4% increase.
 
Human Genetic Therapies
 
ELAPRASE – Hunter syndrome
 
Sales for the three months to September 30, 2008 were $78.2 million, an increase of 42% compared to the same period in 2007 (2007: $55.1 million).  The sales growth was primarily driven by increased unit sales in North America, EU, Latin America, and the Asia Pacific. The product is now approved for marketing and commercial distribution in 42 countries.  Exchange rate movements against the US dollar contributed 5% to the growth compared to the prior year.
 
REPLAGAL – Fabry disease
 
Sales for the three months to September 30, 2008 were $44.6 million, an increase of 10% compared to the same period in 2007 (2007: $40.7 million).  The sales growth was primarily driven by increased unit sales in the EU and Asia Pacific. The product is now approved for marketing and commercial distribution in 43 countries.  Exchange rate movements against the US dollar contributed 5% to the growth compared to the prior year.
 
FIRAZYR – HAE
 
In September 2008, FIRAZYR was launched in Germany and the UK, recognizing sales of $0.2 million (2007: $nil). Launches will continue across Europe as reimbursement negotiations proceed.
 
 
44

 
 
Foreign exchange effect
 
As many of the Company’s sales revenues are earned in currencies other than US dollars (primarily Euros and Pounds sterling), revenue growth reported in US dollars includes the impact of translating the sales made in a local currency, into US dollars.  The table below shows the effect of foreign exchange translations on the revenue growth of the key affected products as well as the underlying performance of key products in their local currency:
   
 
 
3 months to
September
30, 2008
sales
$M
   
3 months to
September
30, 2008
sales growth
in local
currency
 %
   
3 months to
September
30, 2008
sales growth
in US dollars
%
   
 
 
Impact of
translation to
US dollars
%
 
XAGRID sales in Euros
    12.5       +9       +20       +11  
REPLAGAL sales in Euros
    27.3       +8       +18       +10  
ELAPRASE sales in Euros
    39.3       +21       +33       +11  
XAGRID sales in Pounds Sterling
    6.9       +15       +8       -7  
CALCICHEW sales in Pounds Sterling
    11.8       +3       -3       -6  
REMINYL and REMINYL XL sales in Pounds Sterling
    9.1       +26       +18       -8  
REPLAGAL sales in Pounds Sterling
    6.5       -3       -9       -6  
ELAPRASE sales in Pounds Sterling
    7.3       +16       +10       -6  
 

Royalties
 
Royalty revenue decreased by 2% to $60.8 million for the three months to September 30, 2008 (2007: $61.9 million).  The following table provides an analysis of Shire’s royalty income:
 
   
3 months to
September 30,
2008
$M
   
3 months to
September 30,
2007
$M
   
Change
%
 
3TC
    35.9       36.7       -2
 
ZEFFIX
    8.6       10.2       -16
 
Others
    16.3       15.0       9  
Total
    60.8       61.9       -2  
 
3TC – HIV infection and AIDS
 
Shire receives royalties from GSK on worldwide 3TC sales.  Royalties from sales of 3TC for the three months to September 30, 2008 were $35.9 million, (2007: $36.7 million). Excluding unfavorable foreign exchange movements of 6%, there has been growth of 4% compared to the same period in 2007.  The growth of 4% (excluding foreign exchange movements) primarily relates to the phasing of royalty income over Q2 and Q3 2008 and is not representative of trends in the overall 3TC market.  While the nucleoside analogue market for HIV has continued to grow, competitive pressures from new products and entrants to the market have increased and are expected to lead to an overall decline in 3TC sales.
 
ZEFFIX – Chronic hepatitis B infection
 
Shire receives royalties from GSK on worldwide ZEFFIX sales.  Royalties from sales of ZEFFIX for the three months to September 30, 2008 were $8.6 million, a decrease of 16% (2007: $10.2 million).  The impact of foreign exchange movements has contributed 10% to the reported decline; excluding unfavorable foreign exchange movements there has been a decrease of 6% compared to the same period in 2007.
 
 
45

 
 
Other
 
Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. (“Janssen”), an affiliate of Johnson & Johnson.  Shire has exclusive marketing rights in the UK and the Republic of Ireland.
 
In the US, patent infringement litigation brought by Synaptech and Janssen against several ANDA filers culminated in a trial in Delaware in 2007. Following a decision on August 28, 2008 which rendered the relevant patent invalid, generic versions of RAZADYNE were permitted to enter the US market.
 
Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer’s type, continue to grow in most countries however the entry of generics into the US market has severely decreased sales in that region.  This decline was expected and is included in our forecasts.
 
Litigation proceedings relating to RAZADYNE, RAZADYNE ER, REMINYL, REMINYL XL are ongoing.  Further information on these litigations can be found in ITEM 1 of Part I of this Form 10-Q.
 
Cost of product sales
 
The cost of product sales increased to $84.2 million for the three months to September 30, 2008 (12% of product sales), from $83.4 million in the corresponding period in 2007 (2007: 15% of product sales). Cost of product sales as a percentage of product sales in the three months to September 30, 2008 compared to the same period in 2007 decreased by 3% points due to favorable charges in product mix.
 
For the three months to September 30, 2008 cost of product sales included depreciation of $3.2 million (2007: $3.1 million) and amortization of $0.4 million (2007: $0.5 million).  Excluding these charges, cost of product sales decreased as a percentage of product sales to 11% (2007: 15% of product sales).
 
Research and development (R&D)
 
R&D expenditure decreased to $127.1 million for the three months to September 30, 2008 (18% of product sales), from $181.4 million in the corresponding period in 2007 (33% of product sales).   For the three months to September 30, 2008 R&D included depreciation of $3.4 million (2007: $2.9 million). For the three months to September 30, 2007 R&D included the up-front payment of $75.0 million to Renovo in respect of JUVISTA (14% of product sales).
 
Contributing to R&D expenditure in the third quarter of 2008 over 2007 were costs associated with projects in-licensed and acquired since the second half of 2007 including PLICERA, SPD550, AMIGAL, FIRAZYR and METAZYM together with Phase 3(b) and Phase 4 studies to support new product launches.
 
Selling, general and administrative (SG&A) expenses
 
SG&A expenses decreased by $8.0 million to $320.4 million (45% of product sales) for the three months to September 30, 2008 compared to $328.4 million (60% of product sales) for the corresponding period in 2007. SG&A expenses for the third quarter of 2008 include amortization of intangible assets of $29.7 million (2007: $31.1 million), costs associated with the introduction of a new holding company of $2.0 million (2007: $nil) and depreciation charges of $12.0 million, (2007: $10.5 million). SG&A for the three months to September 30, 2007 also included charges of $27.0 million in respect of legal settlement provisions for the TKT Class Action Shareholder Suit. SG&A was further reduced as a percentage of product sales reflecting the sales impact in the three months to September 30, 2008 of the successful launches of VYVANSE, LIALDA/MEZAVANT and ELAPRASE.
 
In Process R&D charge
 
During the three months to September 30, 2008 the Company recorded an in-process R&D charge of $120.5 million (2007: $nil) in respect of FIRAZYR in markets outside of the EU which, at the acquisition date, had not been approved by the relevant regulatory authorities.
 
Gain on sale of product rights
 
For the three months to September 30, 2008 Shire recognized gains of $4.0 million arising from the sale of non-core products to Laboratorios Almirall S.A in 2007. These gains were deferred at December 31, 2007 pending the transfer of the relevant consents.
 
In the three months to September 30, 2007 Shire recognized gains of $7.1 million on the disposal of EQUETRO to Validus Pharmaceuticals Inc.
 
Integration costs
 
During the three months to September 30, 2008 the Company recorded integration costs of $7.5 million (2007: $nil) in respect of Jerini, primarily being acquisition related costs incurred by Jerini.
 
 
46

 
 
Interest income
 
For the three months to September 30, 2008 Shire received interest income of $3.8 million (2007: $8.0 million).  Interest income primarily relates to interest received on cash and cash equivalents.  Interest income for the three months to September 30, 2008 is lower than the same period in 2007 due to lower average cash and cash equivalent balances and lower average US Dollar interest rates.
 
Interest expense
 
For the three months to September 30, 2008 the Company incurred interest expense of $92.9 million (2007: $18.0 million).
 
Interest expense for the three months to September 30, 2008 includes $77.0 million (2007: $7.3 million) in respect to the TKT appraisal rights litigation. This pending litigation was settled in November 2008. Prior to reaching this settlement, the Company accrued interest based on a reasonable estimate of the amount that may be awarded by the Court to those former TKT shareholders who requested appraisal. After reaching the settlement, the Company accrued additional interest expense of $73.0 million consistent with the terms of the settlement agreement. For further details on the settlement of this litigation, see ITEM 1, Note 20 of this Form 10-Q.
 
Other (expenses)/income, net
 
Other (expenses)/income for three months to September 30, 2008 includes impairment charges in respect of available for sale securities totaling $54.1 million (2007 : $nil), including $43.7 million relating to the Company’s investment in Renovo. These amounts reflect unrealized losses that have been reclassified out of other comprehensive income into earnings in the period, as management have concluded that the impairment is other than temporary.
 
The decline in the market value of the Company’s investment in Renovo initially arose from the results of clinical trials for JUVISTA announced by Renovo over 2007 and 2008. In considering whether the decline in value is temporary or “other than temporary” under US GAAP the Company had to consider the following factors:  the severity of the decline from historical cost (87%) and its duration (eleven months); market analysts’ targets of Renovo’s share price for the next 18-24 months; and the revised expected filing date for JUVISTA due to the adoption of a sequential rather than parallel Phase 3 development plan.
 
These factors, together with the significant decline in global equity markets during the third quarter of 2008 mean that the Company is unable to reasonably estimate the period over which a full recovery in the value of its investment in Renovo could occur.  As such, the Company had to conclude that for US GAAP purposes the decline in value is “other than temporary”.
 
In such circumstances US GAAP requires the full difference between the book value of the investment and the fair (market) value be recognized as an other than temporary impairment.  Accordingly the Company has recognized an impairment charge of $43.7 million through the Statement of Operations in the three months to September 30, 2008. If in the future JUVISTA’s Phase 3 trials report positively and Renovo’s other products progress through development, Renovo’s share price could react favorably and the Company may recover some or all of this impairment loss. Any future potential increases in the value of Renovo will be recognized through other comprehensive income.
 
Taxation
 
The Company accounts for income taxes during interim periods in accordance with SFAS No. 109, “Accounting for Income Taxes,” Accounting Principles Board, (“APB”) No. 28, “Interim Financial Reporting,” and FIN 18, “Accounting for Income Taxes in Interim Periods, an interpretation of APB Opinion No. 28”. For interim reporting purposes, these rules require that a company determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a year-to-date basis. Accordingly, the Company has calculated an expected annual effective tax rate, excluding significant, unusual or extraordinary items, for ordinary income associated with operations for which the Company currently expects to have annual taxable income.
 
The annual effective tax rate applied to the results for the three months to September 30, 2008 was adversely influenced by items (such as the United States research and development tax credit which at September 30, 2008 has yet to be reinstated) that cannot at this time be included in the Company’s estimate of the expected annual effective tax rate. The impact of such items may subsequently be recognized within the expected annual effective tax rate when, in the case of the US research tax credit, tax law changes are enacted.
 
The effective tax rate for the three months to September 30, 2008 was a negative rate of 102.8% (2007: -211%).  In the three months to September 30, 2008 the negative effective tax rate of 102.8% primarily arose due to the IPR&D charge in respect of FIRAZYR in non-EU markets which is not deductible for tax. Excluding this IPR&D charge the effective rate of tax for the third quarter of 2008 was 18%. The Company has recorded a tax charge in 2008 compared to a tax credit in 2007 due to higher profits and lower levels of tax deductible expenditure in higher tax territories in 2008 compared to 2007. The negative effective tax rate in the third quarter of  2007 was primarily due to higher than forecast levels of tax deductible expenditure, (including amounts paid to Renovo in respect of JUVISTA and legal settlement fees), in high tax territories and reductions to specific tax liabilities following tax filings made in Q3 2007.
 
47

 
 
Equity in earnings of equity method investees
 
Earnings of equity method investees of $1.6 million were recorded for the three months to September 30, 2008 (2007: $0.5 million).  This comprised earnings of $1.6 million from the 50% share of the anti-viral commercialization partnership with GSK in Canada (2007: $1.7 million).
 
Results of operations for the nine months to September 30, 2008 and 2007
 
Total revenues
 
The following table provides an analysis of the Company’s total revenues by source:

   
9 months to
September 30,
2008
   
9 months to
September 30,
2007
   
change
 
      $M       $M    
%
 
Product sales
    2,049.9       1,508.8       36  
Royalties
    190.7       185.4       3  
Other
    15.8       17.6       -10  
Total
    2,256.4       1,711.8       32  
 
Product sales
 
The following table provides an analysis of the Company’s key product sales:
 
   
9 months to
September 30,
2008
$M
   
9 months to
September 30,
2007
$M
   
Product sales
growth
%
   
US prescription
growth
 %
 
Specialty Pharmaceuticals
                       
ADHD
                       
ADDERALL XR
    826.6       753.2       10       -5%  
VYVANSE
    215.6       10.6       n/a       n/a  
DAYTRANA
    61.0       41.2       48       -10%  
                                 
GI
                               
PENTASA
    138.2       127.7       8       -1%  
LIALDA / MEZAVANT
    99.6       21.3       n/a       n/a  
                                 
GP
                               
FOSRENOL
    121.6       76.0       60       -4%  
DYNEPO
    18.9       6.3       n/a       n/a  
CALCICHEW
    40.8       39.1       4       n/a  
CARBATROL
    55.7       52.7       6       -4%  
REMINYL/REMINYL XL
    26.6       22.8       17       n/a  
XAGRID
    58.7       48.4       21       n/a  
                                 
Other product sales
    24.1       80.0       -70       n/a  
      1,687.4       1,279.3       32          
Human Genetic Therapies
                               
                                 
ELAPRASE
    230.5       124.4       85       n/a  
REPLAGAL
    131.8       105.1       25       n/a  
FIRAZYR
    0.2       -       -       n/a  
      362.5       229.5       58          
Total product sales
    2,049.9       1,508.8       36          
 
 
 
 
48

 
 
The following discussion includes references to prescription and market share data for the Company’s key products.  The source of this data is IMS Health, September 2008. IMS Health is a leading global provider of business intelligence for the pharmaceutical and healthcare industries.
 
Specialty Pharmaceuticals
 
ADDERALL XR
 
As a result of the launch of VYVANSE in July 2007 ADDERALL XR’s average share of the US ADHD market for the nine months to September 30, 2008 fell to 23.0% (2007: 26.0%). US prescriptions for ADDERALL XR for the nine months to September 30, 2008 decreased by 5% compared to the same period in 2007 due to a 3% decrease in average market share offset by 7% growth in the US ADHD market.
 
Sales of ADDERALL XR for the nine months to September 30, 2008 were $826.6 million, an increase of 10% compared to the same period in 2007 (2007: $753.2 million). Product sales grew despite the decline in US prescriptions primarily due to price increases.
 
Litigation proceedings concerning the Company’s ADDERALL XR patents are ongoing. Further information on this litigation can be found in ITEM 1 of Part I of this Form 10-Q.
 
VYVANSE
 
For the nine months to September 30, 2008 VYVANSE’s average market share was 7.5% of the US ADHD market (2007: 0.8%). Product sales for the nine months to September 30, 2008 were $215.6 million (2007: $10.6 million).
 
By October 17, 2008 VYVANSE had achieved a US ADHD average weekly market share of 10.2% based on weekly prescription volumes.
 
DAYTRANA
 
Product sales for the nine months to September 30, 2008 were $61.0 million (2007: $41.2 million). Prescriptions reduced by 9.8% compared to the same period in 2007 due to a reduction in DAYTRANA’s average share of the US ADHD market from 2.1% in 2007 to 1.8% in 2008.
 
Despite the decrease in prescriptions compared to 2007, sales of DAYTRANA grew 48% due to lower sales deductions (primarily lower coupon deductions compared to 2007 which was impacted by launch coupon programs) and a price increase.
 
On August 19, 2008 Shire announced a voluntary recall of two lots of DAYTRANA patches because these patches did not meet their release liner removal specifications which may have resulted in some patients and caregivers having difficulties removing the liners. The voluntary recall was not due to safety issues. Shire and Noven Pharmaceuticals Inc. (the manufacturer of DAYTRANA) continue to pursue enhancements to the product and to work closely with the FDA to implement changes that may improve the usability of DAYTRANA. No interruption in the production of DAYTRANA is anticipated. Shire and Noven may take additional corrective actions.
 
The addition of VYVANSE combined with ADDERALL XR and DAYTRANA’s market share helped Shire grow its total average share of the US ADHD market to 32.3% for the nine months to September 30, 2008 (2007: 28.9%). Shire has the leading portfolio of products in the US ADHD market.
 
PENTASA
 
Sales of PENTASA for the nine months to September 30, 2008 were $138.2 million, an increase of 8% compared to the same period in 2007 (2007: $127.7 million).  Sales grew despite a decrease in prescriptions due to the impact of price increases.
 
US prescriptions for the nine months to September 30, 2008 were down 1% compared to the same period in 2007 primarily due to a 2% decrease in PENTASA’s US average market share from 17.4% in 2007 to 16.8% in 2008, offset by a 2% increase in the US oral mesalamine prescription market.
 
 
49

 
 
LIALDA/MEZAVANT
 
For the nine months to September 30, 2008 LIALDA had reached an average market share in the US of 10.9% (2007: 2.7%). LIALDA’s product sales in the US for the nine months to September 30, 2008 were $96.2 million (2007: $21.3 million).
 
Sales of MEZAVANT outside the US for the nine months ended September 30, 2008 were $3.4 million (2007: $nil). 2007. Following launch in the Netherlands in October, 2008, LIALDA/MEZAVANT is now available in six countries with further launches planned in certain other EU countries during 2008 and 2009, subject to the successful conclusion of pricing and reimbursement negotiations.
 
Since the launch of LIALDA in March 2007, PENTASA and LIALDA’s combined average market share of the US oral mesalamine market grew to 27.7% for the nine months to September 30, 2008 up from 20.1% for the corresponding period to September 30, 2007.
 
FOSRENOL
 
FOSRENOL is now available in 29 countries and global sales totaled $121.6 million for the nine months to September 30, 2008 (2007: $76.0 million). US sales of FOSRENOL for the nine months to September 30, 2008 were up 42% to $68.1 million compared to the same period in 2007 (2007: $48.0 million). Sales of FOSRENOL outside the US for the nine months ended September 30, 2008 were $53.5 million (2007: $28.0 million).
 
FOSRENOL’s average prescription share of the US phosphate binder retail market for the nine months to September 30, 2008 decreased to 8.2% (2007: 8.6%). Sales increased despite the market share decline due to price increases.  As a consequence of focusing on specialist physicians, clinics and dialysis centers, FOSRENOL’s  share of the non-retail market has increased to 16% in August 2008 compared to 12.0% in August 2007.
 
XAGRID
 
Sales for the nine months to September 30, 2008 were $58.7 million, an increase of 21% compared to the same period in 2007 (2007: $48.4 million). Expressed in transaction currencies (XAGRID is primarily sold in Euros and Pounds Sterling), sales increased by 13% due to growth in many of Shire’s existing markets, with exchange rate movements against the US dollar accounting for the remaining 8% increase.
 
Human Genetic Therapies
 
ELAPRASE
 
Sales for the nine months to September 30, 2008 were $230.5 million, an increase of 85% compared to the same period in 2007 (2007: $124.4 million).  The sales growth was primarily driven by increased unit sales in major markets in the EU, North America, Latin America, and Asia Pacific. The product is now approved for marketing and commercial distribution in 42 countries. Exchange rate movements against the US dollar contributed 10% to the growth compared to the prior year. In order to support the very rapid growth of ELAPRASE globally, additional manufacturing capacity is currently being added in Lexington, MA, which is expected to come on line in late 2009. Supply is sufficient to support all existing patients and allow for forecasted growth in 2009. Inventory will be managed in order to meet forecast demand.
 
REPLAGAL
 
Sales for the nine months to September 30, 2008 were $131.8 million, an increase of 25% compared to the same period in 2007 (2007: $105.1 million). The sales growth was primarily driven by increased unit sales in markets in the EU and Latin America. The product is now approved for marketing and commercial distribution in 42 countries. Exchange rate movements against the US dollar contributed 6% to the growth compared to prior year.
 
FIRAZYR
 
In September 2008, FIRAZYR was launched in Germany and the UK, recognizing sales of $0.2m (2007: nil). Launches will continue across Europe as reimbursement negotiations proceed.
 
 
50

 
 
Foreign exchange effect
 
As many of the Company’s sales revenues are earned in currencies other than US dollars (primarily Euros and Pounds sterling), revenue growth reported in US dollars includes the impact of translating the sales made in a local currency, into US dollars.  The table below shows the effect of foreign exchange translations on the revenue growth of the key affected products as well as the underlying performance of key products in their local currency:
   
 
 
9 months to
September
30, 2008
sales
$M
   
9 months to
September
30, 2008
sales growth
in local
currency
%
   
9 months to
September
30, 2008
sales growth
in US dollars
%
   
 
 
Impact of
translation to
US dollars
%
 
XAGRID sales in Euros
    38.0       +10       +25       +15  
REPLAGAL sales in Euros
    78.9       +17       +29       +12  
ELAPRASE sales in Euros
    111.7       +51       +70       +19  
XAGRID sales in Pounds Sterling
    20.7       +17       +15       -2  
CALCICHEW sales in Pounds Sterling
    37.1       +7       +5       -2  
REMINYL and REMINYL XL sales in Pounds Sterling
    24.9       +21       +18       -3  
REPLAGAL sales in Pounds Sterling
    19.4       +22       +20       -2  
ELAPRASE sales in Pounds Sterling
    21.8       +65       +61       -4  
 

Royalties
 
Royalty revenue increased by 3% to $190.7 million for the nine months to September 30, 2008 (2007: $185.4 million).  The following table provides an analysis of Shire’s royalty income:
 
   
9 months to
September 30,
2008
$M
   
9 months to
September 30,
2007
$M
   
Change
%
 
3TC
    108.8       111.2       -2
 
ZEFFIX
    29.8       29.6       1
 
Others
    52.1       44.6       17  
Total
    190.7       185.4       3  
 
3TC
 
Shire receives royalties from GSK on worldwide 3TC sales.  Royalties from sales of 3TC for the nine months to September 30, 2008 were $108.8 million (2007: $111.2 million). Excluding unfavorable foreign exchange movements of 1%, there has been a decline of 1% compared to the same period in 2007. While the nucleoside analogue market for HIV has continued to grow, competitive pressures from new products and entrants to the market have increased and are expected to lead to an overall decline in 3TC sales.
 
ZEFFIX
 
Shire receives royalties from GSK on worldwide ZEFFIX sales.  Royalties from sales of ZEFFIX for the nine months to September 30, 2008 were $29.8 million, an increase of 1% compared to the same period in 2007 (2007: $29.6 million). Excluding unfavorable foreign exchange movements of 2%, there has been growth of 3% compared to the same period in 2007.
 
 
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Other
 
Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland) by Janssen Pharmaceutical N.V. (“Janssen”), an affiliate of Johnson & Johnson.  Shire has the exclusive marketing rights in the UK and the Republic of Ireland.
 
In the US, patent infringement litigation brought by Synaptech and Janssen against several ANDA filers culminated in a trial in Delaware in 2007. Following a decision on August 28, 2008 which rendered the relevant patent invalid, generic versions of RAZADYNE were permitted to enter the US market.
 
Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer’s type, continue to grow in most countries however the entry of generics into the US market has severely decreased sales in that region.  This decline was expected however and is included in our forecasts.
 
For further information about the litigation proceedings relating to RAZADYNE, RAZADYNE ER, REMINYL, REMINYL XL see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings.
 
Cost of product sales
 
The cost of product sales increased by 41% to $317.4 million for the nine months to September 30, 2008 (15% of product sales), up from $224.7 million in the corresponding period in 2007 (2007: 15% of product sales). For the nine months to September 30, 2008 cost of product sales included charges of $53.4 million (3% of product sales) (2007: $nil) relating to the write down of inventory and other exit costs in respect of DYNEPO which the Company has decided to stop commercializing, depreciation of $8.8 million (2007: $9.0 million) and amortization of $1.3 million (2007: $0.5 million).
 
Research and development (R&D)
 
R&D expenditure increased to $394.4 million for the nine months to September 30, 2008 (19% of product sales), up from $365.7 million in the corresponding period in 2007 (2007: 24% of product sales). For the nine months to September 30, 2008 R&D included $6.5 million (2007: $nil) relating to the cost of exiting post-approval marketing commitments for DYNEPO, which the Company has decided to stop commercializing. For the nine months to 30 September, 2007 R&D included $80.9 million in respect of up-front and milestone payments made to Renovo for Juvista ($75.0 million) and to Noven in respect of ATS ($5.9 million).
 
Contributing to the increased R&D expenditure in 2008 over 2007 are projects in-licensed and acquired since the second half of 2007 including SPD 550, PLICERA, AMIGAL, FIRAZYR and METAZYM together with Phase 3(b) and Phase 4 studies to support new product launches. R&D also includes depreciation of $9.4 million (2007: $8.4 million).
 
Selling, general and administrative (SG&A) expenses
 
Total SG&A costs increased by 28% to $1,083.7 million in the nine months to September 30, 2008 compared to $847.5 million in the nine months to September 30, 2007.  As a percentage of product sales, SG&A expenses were 53% (2007: 56%).
 
SG&A for the nine months to September 30, 2008 includes intangible asset impairment charges of $90.4 million (4% of product sales) (2007: $nil) in respect of DYNEPO, increased amortization of intangible assets of $91.5 million (2007: $64.0 million) (increased due to VYVANSE, launched July 2007), and costs associated with the introduction of a new holding company of $14.2 million (2007: $nil). SG&A for the nine months to September 30, 2007 included charges of $27.0 million in respect of legal settlement provisions for the TKT Class Action Shareholders Suit. Other increases in SG&A expenses mainly relate to the increase in advertising, promotional and marketing spend to support VYVANSE, LIALDA/MEZAVANT and ELAPRASE. SG&A includes depreciation charges of $34.0 million (2007: $29.9 million).
 
In Process R&D charge
 
For the nine months to September 30, the Company recorded an in-process R&D charge of $255.5 million in respect of FIRAZYR in markets outside of the EU ($120.5 million) and the acquisition of the global rights to the clinical candidate arylsultatase – A currently known as METAZYM (HGT–1111), being investigated for the treatment of MLD acquired from Zymenex ($135.0 million).
 
The IPR&D charge in respect of FIRAZYR of $120.5 million relates to the US ($60.3 million) and ROW ($60.2 million). In the US FIRAZYR received a not approvable letter from the FDA in April 2008, and in ROW it has not been approved by the regulatory authorities. At the time of the acquisition of FIRAZYR, Shire’s management estimated that future R&D costs until regulatory approval would be approximately $20.0 million. This estimate can be affected by various factors, both internal and external, and is part based upon management estimates and assumptions. For this reason, amongst others, the actual cash flows may vary from future estimated cashflows.
 
 
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METAZYM has completed a Phase 1b clinical trial in 12 MLD patients in Europe and an extension to this study is ongoing. The product has been granted orphan drug designation in the US and in the EU. This product will now be referred to as HGT-1111. At the time of the acquisition of METAZYM, Shire’s management estimated that future R&D costs until regulatory approval for METAZYM for the treatment of MLD in the US and the EU will be approximately $80 to $90 million. This estimate can be affected by various factors both internal and external and is, in part, based on management’s estimate and assumptions. For this reason, among others, the actual cash flows may vary from forecast future cash flows.
 
During the nine months to September 30, 2007 Shire expensed the portion of the New River purchase price allocated to in-process R&D totaling $1,896.0 million. This amount represented the value of those acquired development projects which, at the acquisition date, had not been approved by the FDA or other regulatory authorities, including the adult indication of VYVANSE. On April 23, 2008 Shire announced that the FDA had approved the adult indication for VYVANSE, and Shire launched VYVANSE for adult ADHD in the US in June 2008. In March 2008 the Canadian new drug submission was accepted for filing for the treatment of ADHD in children, and Shire expects to submit the regulatory filing for VYVANSE in Europe for the treatment of ADHD in children aged 6 to 17 in 2010. At September 30, 2008 management estimated that future R&D costs until regulatory approval for VYVANSE for ADHD in RoW are approximately $50 to $70 million. These estimates can be affected by various factors and are, in part, based on management’s estimate and assumptions.  For these reasons, among others, the actual cash flows may vary from forecast future cash flows.
 
Gain on sale of product rights
 
For the nine months to September 30, 2008 Shire recognized gains of $20.7 million (2007: $12.1 million) on the sale of non-core product rights. In the nine months to September 30, 2008 Shire realized a gain of $5.0 million from the sale of certain hormone replacement therapy products to Meda AB and also realized $15.7 million of gains deferred at December 31, 2007 resulting from the sale of other non-core products during 2007. These gains were deferred at December 31, 2007 pending the transfer of the relevant consents.
 
Integration costs
 
During the nine months to September 30, 2008 the Company recorded integration costs of $7.5 million in respect of Jerini, primarily being acquisition related costs incurred by Jerini.
 
During the nine months to September 30, 2007 the Company incurred integration costs of $1.3 million in respect of the acquisition of New River.
 
Interest income
 
For the nine months to September 30, 2008 Shire received interest income of $23.0 million (2007: $42.7 million).  Interest income primarily relates to interest received on cash and cash equivalents.  Interest income for the nine months to September 30, 2008 is lower than the same period in 2007 due to lower average cash balances and lower average US Dollar interest rates.
 
Interest expense
 
For the nine months to September 30, 2008 the Company incurred interest expense of $127.0 million (2007: $53.8 million).
 
Interest expense for the nine months to September 30, 2008 includes $87.3 million (2007: $20.7 million) in respect to the TKT appraisal rights litigation. This pending litigation was settled in November 2008. Prior to reading this settlement, the Company accrued interest based on a reasonable estimate of the amount that may be awarded by the Court to those former TKT shareholders who requested appraisal. After reading the settlement, the Company accrued additional interest expense of $73.0 million consistent with the terms of the settlement agreement. For further details on the settlement of this litigation, see ITEM 1, Note 20 of this Form 10-Q.
 
In 2007 interest expense also included a $7.9 million write-off of deferred financing costs on repayment of term loans used to fund the acquisition of New River following the issue of the $1.1 billion convertible bonds in May 2007.
 
Other (expenses)/income, net
 
Other (expenses)/ income for the nine months to September 30, 2008 includes impairment charges in respect of  available for sale securities totaling $54.1 million (2007: $nil), including $43.7 million relating to the Company’s investment in Renovo. These amounts reflect unrealized holding losses that have been reclassified out of other comprehensive income into earnings in the period, as management have concluded that the impairment is other than temporary.
 
The decline in the market value of the Company’s investment in Renovo initially arose from the results of clinical trials for JUVISTA announced by Renovo over 2007 and 2008. In considering whether the decline in value is temporary or “other than temporary”  under US GAAP the Company had to consider the following factors: the severity of the decline from historical cost (87%) and its duration (eleven months); market analysts’ targets of Renovo’s share price for the next 18-24 months; and the revised expected filing date for JUVISTA due to the adoption of a sequential rather than parallel Phase 3 development plan.
 
 
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These factors, together with the significant decline in global equity markets during the third quarter of 2008 mean that the Company is unable to reasonably estimate the period over which a full recovery in the value of its investment in Renovo could occur. As such, the Company had to conclude that for US GAAP purposes the decline in value is “other than temporary”.
 
In such circumstances US GAAP requires the full difference between the book value of the investment and fair (market) value be recognized as an other than temporary impairment. Accordingly the Company has recognized an impairment charge of $43.7 million through the Statement of Operations in the nine months to September 30, 2008. If in the future JUVISTA’s Phase 3 trials report positively and Renovo’s other products progress through development, Renovo’s share price could react favorably and the Company may recover some or all of this impairment loss. Any further  potential increases in the value of Renovo will be recognized through other comprehensive income.
 
Other income also includes a gain of $9.4 million arising from the sale of Shire’s minority equity investment in Questcor Pharmaceutical Inc., a specialty pharmaceutical company focused on providing prescription drugs for central nervous system (CNS) disorders. Shire received cash consideration of $10.3 million.
 
Taxation
 
The Company accounts for income taxes during interim periods in accordance with SFAS No. 109, “Accounting for Income Taxes,” Accounting Principles Board, (“APB”) No. 28, “Interim Financial Reporting,” and FIN 18, “Accounting for Income Taxes in Interim Periods an interpretation of APB Opinion No. 28. For interim reporting purposes, these rules require that a company determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a year-to-date basis.   Accordingly, the Company has calculated an expected annual effective tax rate, excluding significant, unusual or extraordinary items, for ordinary income associated with operations for which the Company currently expects to have annual taxable income.
 
The annual effective tax rate applied to the results for the nine months to September 30, 2008 was adversely influenced by items (such as the United States research and development tax credit which at September 30, 2008 has yet to be reinstated) that cannot at this time be included in the Company’s estimate of the expected annual effective tax rate. The impact of such items may subsequently be recognized within the expected annual effective tax rate when, in the case of the US research and development tax credit, tax law changes are enacted.
 
The effective tax rate for the nine months to September 30, 2008 was 82.9% (2007: -2.7%). Excluding the IPR&D charges that arose of $255.5 million in relation to FIRAZYR in non-EU markets acquired with Jerini and METAZYM acquired from Zymanex in 2008 and $1,896.0 million in relation to VYVANSE in non-pediatric indicators in the US and the Rest of the World acquired with New River in 2007, the effective tax rate is 19.0% (2007:16%). The increase in the effective tax rate excluding R & D charges is due to higher profits and lower levels of tax deductible expenditure in higher tax territories in 2008 compared to 2009.
 
Equity in earnings of equity method investees
 
Earnings of equity method investees of $1.3 million were recorded for the nine months to September 30, 2008 (2007: $1.7 million). This comprised earnings of $4.4 million from the 50% share of the anti-viral commercialization partnership with GSK in Canada (2007: $4.8 million) offset by losses of $3.1 million being the Company’s share of losses in the GeneChem, AgeChem and EGS Funds (2007: losses $3.1 million).
 
Liquidity and Capital Resources
 
General
 
The Company’s funding requirements depend on a number of factors, including its development programs; corporate, business and product acquisitions; the level of resources required for the expansion of marketing capabilities as the product base expands; increases in accounts receivable and inventory which may arise as sales levels increase; 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 of Shire shares in the market to satisfy option exercises and the continuing cash generated from sales of Shire’s key products.
 
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 to fund the cost of litigation.
 
The Company ordinarily 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.
 
On November 7, 2008 the Company made a payment of $567.5 million to dissenting shareholders in settlement of the TKT appraisal rights litigation, (see ITEM 1, Note 20 of this Form 10-Q for further details). This payment was funded from the Company’s existing cash resources and by drawing $190 million on its existing credit facility (see below).
 
 
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Financing
 
Shire’s current financing arrangements comprise of $1,100 million in principal amount of 2.75% convertible bonds due 2014, a $1,200 million revolving credit facility and a €40 million term facility.
 
To facilitate the provision of the financing confirmation required in connection with the tender offer for Jerini AG, Shire Limited (now known as Shire plc) entered into a €100 million three month committed term facility on 7 August 2008. Shire plc has entered into a separate agreement with Shire Deutschland Investments GmbH (formerly known as Maia Elfte Vermogenverwaltungs GmbH (“Bidco”)) under which Bidco has the right to submit utilisation requests in respect of this facility on behalf of Shire plc. Amounts borrowed under the facility may only be used to satisfy claims resulting from shareholders in Jerini accepting the tender offer. On September 30, 2008 the facility was reduced to €40 million.
 
The margin payable over LIBOR on drawings under the facility is 95 basis points per annum. The commitment fee on undrawn amounts is 35 basis points per annum. The availability of loans under the facility is subject to customary conditions, including the absence of any major events of default and the accuracy of the major representations contained therein. The facility does not contain financial covenants, but includes a cross default clause.
 
Shire anticipates that its operating cash flow together with available cash, cash equivalents and short-term investments and the above mentioned revolving credit facility will be sufficient to meet its anticipated future operating expenses, capital expenditures and debt service and lease obligations 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 revolving credit facility discussed above and possibly through new borrowings and the issue of new equity if necessary.
 
Facility agreement
 
In connection with the Scheme of Arrangement, with effect from May 23, 2008, Shire plc, (the former holding company of the Shire Group, “Old Shire”) entered into an accession and amendment deed dated April 15, 2008 between Shire plc (formerly Shire Limited), Old Shire, certain subsidiaries of Shire plc and Barclays Bank PLC as Facility Agent (the “Accession and Amendment Deed”) relating to the Company’s $1,200 million facility agreement dated February 20, 2007 (as amended by a syndication and amendment agreement dated July 19, 2007) between, among others, ABN AMRO Bank N.V., Barclays Capital, Citigroup Global Markets Limited, The Royal Bank of Scotland plc, Lloyds TSB Bank plc, Bank of America, N.A. and Morgan Stanley Bank (the “Facility Agreement”). The following is a description of the material amendments to the Facility Agreement, affected pursuant to the Accession and Amendment Deed, which took effect on May 23, 2008, immediately prior to the Scheme of Arrangement becoming effective.
 
Shire plc acceded to the Facility Agreement as a borrower and guarantor, and Shire Holdings UK Limited, a wholly-owned subsidiary of Old Shire , acceded to the Facility Agreement as a borrower. Old Shire ceased to be a party to the Facility Agreement as a guarantor (although it remains a party to the Facility Agreement as a borrower). The Facility Agreement was amended and restated in order to take account of the fact that Shire plc is incorporated in Jersey and tax resident in the Republic of Ireland, exclude the Scheme of Arrangement between Shire plc and its shareholders from the mandatory prepayment provisions contained in the Facility Agreement, and amend the financial covenants contained in the Facility Agreement in order to ensure that if the level of interest awarded in the TKT appraisal rights litigation differs from that provided for in Shire’s accounts, any excess or shortfall would be treated as if it had been provided for on a pro rata basis in accounting periods up to the time of judgement, to avoid a technical breach of the Facility Agreement in the accounting period in which the judgement occurs.
 
On November 7, 2008 Shire drew down $190.0 million from the facility to part fund the TKT appraisal rights litigation settlement.
 
2.75% Convertible Bonds due 2014
 
In connection with the Scheme of Arrangement Shire entered into:
 
(i)      a supplemental trust deed dated April 15, 2008 between Shire plc, Old Shire and BNY Corporate Trustee Services Limited as Trustee (the “Supplemental Trust Deed”) relating to a trust deed dated May 9, 2007 (the “Trust Deed”) constituting the US $1,100,000,000 2.75% Convertible Bonds due 2014 (the “Convertible Bonds”) originally issued by Shire; and
 
(ii)      an accession and amendment agreement dated April 15, 2008 between Shire plc, Old Shire  BNY Corporate Trustee Services Limited as Trustee and The Bank of New York as Paying and Conversion Agent (the “Accession and Amendment Agreement”) relating to a paying and conversion agency agreement dated May 9, 2007 (the “Agency Agreement”) between Old Shire, BNY Corporate Trustee Services Limited as Trustee and The Bank of New York as Paying and Conversion Agent.
 
The following is a description of the material amendments to the Trust Deed, effected pursuant to the Supplemental Trust Deed, and to the Agency Agreement, effected pursuant to the Accession and Amendment Agreement, each of which took effect on May 23, 2008, immediately prior to the Scheme of Arrangement becoming effective.
 
 
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Shire plc was substituted in place of Old Shire as principal obligor under, and issuer of, the Convertible Bonds, and Shire plc acceded to, and assumed all Old Shire obligations under, the Trust Deed and the Agency Agreement. Old Shire ceased to be a party to the Trust Deed and the Agency Agreement. The Trust Deed, the Agency Agreement and the terms and conditions of the Convertible Bonds were amended and restated in order to, among other things, provide that the Convertible Bonds will, following the substitution, be convertible into ordinary shares of Shire plc.
 
Sources and uses of cash
 
The following table provides an analysis of the Company’s gross and net debt/cash funds (excluding restricted cash), as at September 30, 2008 and September 30, 2007:
 
   
September 30,
2008
$’M
   
September 30,
2007
$’M
 
Cash and cash equivalents
    473.3       562.9  
Convertible debt
    (1,100.0 )     (1,100.0 )
Building financing obligation
    (34.3 )     (32.7 )
Total debt
    (1,134.3 )     (1,132.7 )
Net debt
    (661.0 )     (569.8 )
 
Cash flow activity
 
Net cash provided by operating activities for the nine months to September 30, 2008 was $525.5 million compared to $408.1 million for the nine months to September 30, 2007. Cash provided by operating activities was higher in 2008 than 2007 due to strong cash flows from operations which were only partially offset by the payments in respect of the acquisition of METAZYM from Zymenex, tax payments and settlement of the 2003 TKT class action law suit.
 
Net cash used in investing activities was $630.1 million in the nine months to September 30, 2008. This included the cash cost of purchasing a majority voting interest in Jerini ($462.5 million, net of cash acquired), expenditure on purchases of property, plant and equipment of $166.5 million, the final sales milestone payment of $25.0 million for DAYTRANA to Noven and long-term investments of $1.3 million, which were partially offset by receipts of $10.3 million from the sale of long term assets and $5.0 million received from the sale of product rights. Capital expenditure on property, plant and equipment included $96.5 million on construction work at Shire’s office and manufacturing facilities in Lexington, Massachusetts, and $4.7 million on construction work at the Basingstoke, UK Office.
 
Net cash used in investing activities was $2,625.7 million in the nine months to September 30, 2007. This included expenditure on the acquisition of New River, net of cash acquired, of $2,458.6 million and acquisition expenses of $60.4m, purchases of property, plant and equipment of $62.1 million, intangible assets of $58.2 million and long-term investments of $56.7 million (which included expenditure of $50 million on an equity investment in Renovo), which were partially offset by deposits/proceeds from the sale of product rights of $24.3 million and $55.8 million received on maturity of New River short term investments. Capital expenditure on property, plant and equipment included $18.7 million on IT at the Wayne, Pennsylvania, US headquarters and $9.5 million on IT at the Basingstoke, UK Office; $6.6 million on construction work at Shire’s manufacturing facility at Owings Mills, Maryland; and $4.7 million on leasehold improvements, $5.9 million on laboratory equipment and $7.1 million on IT equipment at Shire’s site in Cambridge, Massachusetts.  Capital expenditure on intangible assets included a $50 million sales milestone paid to Noven for DAYTRANA.
 
Net cash used in financing activities was $179.1 million for the nine months to September 30, 2008 of which $140.2 million related to payments to acquire shares by the ESOT and $36.4 million to the dividend payment.
 
Net cash provided by financing activities was $1,647.6 million for the nine months to September 30, 2007. On April 18, 2007 the Company fully utilized Term Loan A of $1,000 million and Term Loan B of $300 million under the Facility Agreement to partially fund the acquisition of New River, which were subsequently repaid in the period. Shire incurred $14.5 million of arrangement costs in the nine months to September 30, 2007. In May 2007 Shire issued $1.1 billion principal amount of convertible bonds due 2014. The net proceeds of the issue of the Bonds were $1.1 billion with associated issue costs of $18.3 million. On February 20, 2007 the Company raised $877.3 million, net of associated costs, through the private placement of 42.9 million new ordinary shares to certain institutional investors at a price of 1075 pence per share.  In addition, the Company received $13.0 million from the exercise of warrants and $25.6 million from the exercise of stock options, made payments to acquire treasury stock of $168.5 million and paid a dividend of $29.4 million. Shire also paid $279.4 million to holders of New River’s 3.5% Convertible Subordinated Notes due 2013 and received $141.8 million from Merrill Lynch in settlement of a purchased call option entered into by New River prior to the acquisition in April 2007.
 

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Obligations and commitments
 
Other than the settlement of the TKT appraisal rights litigation (see ITEM 1, Note 20 of this Form 10-Q for further details), during the nine months to September 30, 2008 there have been no material changes outside the ordinary course of the Company’s business to the contractual obligations previously disclosed in the Company’s Annual report on Form 10-K for the year ended December 31, 2007. See ITEM 1, Note 14 for further details.
 
During November 2008 the Company announced that it had settled all pending litigation brought by certain former dissenting shareholders of TKT. The Company will pay the former dissenting shareholders the same price of $37 per share originally offered to all TKT shareholders at the time of the July 2005 merger, plus interest. The total cost of the settlement is $567.5 million, (see ITEM 1, Note 20 for further details). On November 7, 2008 the Company made a payment of $567.5 million to the dissenting shareholders; this payment was funded from the Company’s existing cash resources and by drawing $190 million on its existing credit facility.
 
Critical Accounting Estimates
 
The preparation of interim financial statements, in conformity with US GAAP and SEC regulations for interim reporting, 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. Actual results could differ from those estimates.  Estimates and assumptions are primarily made in relation to provisions for litigation, valuation of intangible assets (including those acquired through business combinations), the valuation of equity investments, sales deductions, income taxes and share-based payments.
 
Critical accounting estimates are discussed in Shire’s Annual Report on Form 10-K for the year to December 31, 2007. Material updates to those estimates discussed in Shire’s Annual Report on Form 10-K are discussed below.
 
Valuation of intangible assets
 
(a)      General
 
The Company has acquired and continues to acquire significant intangible assets, recorded at acquisition cost. As at September 30, 2008 the carrying value of such intangibles was $1,843 million, which primarily related to the Company’s DAYTRANA ($136 million), FIRAZYR ($270 million), FOSRENOL ($18 million), PENTASA ($74 million), REMINYL ($19 million), REPLAGAL ($305 million), VYVANSE ($1,001 million) and XAGRID ($11 million) products.  Those assets which do not yet have a defined revenue stream and for which there are no alternative uses are expensed upon acquisition, and those that do have a defined revenue stream (namely commercial products or rights to products awaiting final regulatory approval) are capitalized and amortized over their estimated useful life. Management’s estimate of the useful life considers, inter alia, the following factors: the expected use of the asset by the Company; any legal, regulatory, or contractual provisions that may limit the useful life and the effects of demand; competition; and other economic factors (such as the stability of the industry, known technological advances, legislative action that results in an uncertain or changing regulatory environment, and expected changes in distribution channels).
 

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ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Item 7A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2007 contains a detailed discussion of the Company’s market risk exposure. The global financial crisis has increased the Company’s credit risk exposure. The Company continues to operate its financial management in accordance with the policies set out in the Item 7A of the Company’s Form 10-K for the year ended December 31, 2007 but has increased the frequency with which it reviews counterparty credit risk. There has been no significant deterioration in the value of assets held by the Company as a result of credit risk and the Company has not suffered any material losses as a result of the global financial crisis. There have been no material changes in the Company’s exposure to market risk since December 31, 2007.
 
 
As at September 30, 2008, the Company, under the supervision and with the participation of the Company’s management, including the Chief Executive Officer and the Chief Financial Officer, had performed an evaluation of the effectiveness of the Company’s disclosure controls and procedures.  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 are effective at the reasonable level of assurance for gathering, analyzing and disclosing the information the Company is required to disclose in the reports it files under the Securities Exchange Act of 1934, within the time periods specified in the SEC’s rules and forms.
 
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.
 
 
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PART II.  OTHER INFORMATION
 
 
 
ITEM 1A.  RISK FACTORS
 
There have been no material changes from the risk factors set forth in the Company’s Form 10-K for the year ended December 31, 2007.
 
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
On May 23, 2008 Shire plc (formerly Shire Limited) became the holding company of Shire plc (the former holding company of the Shire Group) (“Old Shire”) pursuant to a scheme of arrangement under Sections 895 to 899 of the United Kingdom Companies Act 2006 that was approved by the High Court of Justice in England and Wales and the shareholders of Old Shire. Pursuant to the Scheme of Arrangement, ordinary shares, each having a nominal value of £0.05, of Old Shire were exchanged for ordinary shares, each having a nominal value of £0.05, of Shire plc, on a one-for-one basis. The Scheme of Arrangement did not involve any payment for the Shire plc Ordinary Shares.
 
The Shire Ordinary Shares underlying the Shire American Depositary Shares, each representing three Shire Ordinary Shares, participated in the Scheme of Arrangement like all other Shire Ordinary Shares. The Scheme of Arrangement did not involve any payment for the Shire plc ADSs.
 
Shire plc effected the Scheme of Arrangement after a hearing upon the fairness of the terms of the Scheme of Arrangement to holders of old Shire ordinary shares within the meaning of Section 3(a)(10) under the US Securities Act of 1933, as amended, and the New Shire Ordinary Shares were not registered thereunder in reliance on the exemption from registration provided by Section 3(a)(10).
 
For further information, see Form 8-K filed May 23, 2008.
 
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
 
None.
 
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
 
An Annual General Meeting of Shareholders was held on September 24, 2008.The resolutions were approved on a show of hands at the meeting. Had the resolutions been put to a poll, the proxy votes which would have been voted at the meeting are described below:
 
Resolution
For*
Against
Votes withheld**
1.  To elect Mr Matthew Emmens as a Director of the Company
301,376,910
4,696,170
25,441,808
2.  To elect Mr Angus Russell as a Director of the Company
331,225,599
138,229
151,060
3.  To elect Mr Graham Hetherington as a Director of the Company
331,234,635
127,173
153,080
4. To elect Dr Barry Price as a Director of the Company
328,858,454
2,501,778
154,656
5. To elect Mr David Kappler as a Director of the Company
330,945,634
412,470
156,784
6. To elect Dr Jeffrey Leiden as a Director of the Company
331,221,109
138,828
154,951
 
 
 
 
 
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Resolution
For*
Against
Votes withheld**
7. To elect Mr Patrick Langlois as a Director of the Company
330,949,493
412,089
153,306
8. To elect Ms Kate Nealon as a Director of the Company
331,014,606
346,949
153,333
9. To elect Mr David Mott as a Director of the Company
327,884,774
2,101,928
1,528,186
10. To elect Dr Michael Rosenblatt as a Director of the Company
331,232,603
126,815
155,470
11. To re-appoint Deloitte & Touche LLP as Auditors of the Company
327,634,578
1,301,388
2,578,922
12. To authorise the Audit, Compliance and Risk Committee to determine the remuneration of the auditors
331,225,599
1,470,679
159,584
13. To authorise the allotment of shares
328,104,104
3,189,130
221,654
14. To authorise the disapplication of pre-emption rights
329,760,418
1,575,955
178,515
15. To authorise market purchases
330,598,450
729,745
186,693
16. To change the name of the Company to Shire plc
331,323,817
31,609
159,462

* These figures included discretionary votes
** Votes withheld enable the voter to abstain on any particular resolution

 
 
None.
 
 
60

 
 
 
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)
   
3.01
Form of Amended Memorandum and Articles of Association of Shire plc as adopted by special resolution passed on April 10, 2008 and amended by special resolution on September 24, 2008.(4)
   
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.(5)
   
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. (6)
   
4.03
Form of Ordinary Share Certificate of Shire Limited. (7)
   
4.04
Form of American Depositary Receipt Certificate of Shire Limited. (8)
   
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. (9)
   
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. (10)
   
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). (11)
   
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. (12)
   
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. (13)
   
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. (14)
   
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. (15)
   
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. (16)
   
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. (17)
   
10.10*
Settlement Agreement, dated August 14, 2006 by and between Shire Laboratories Inc. and Barr Laboratories, Inc. (18)
 
 
61

 
 
 
10.11*
Product Development and License Agreement, dated August 14, 2006 by and between Shire LLC and Duramed Pharmaceuticals, Inc. (19)
   
10.12*
Product Acquisition and License Agreement, dated August 14, 2006 by and among Shire LLC, Shire plc and Duramed Pharmaceuticals, Inc. (20)
   
10.13
Service Agreement between Shire plc and Mr Angus Russell, dated March 10, 2004. (21)
   
10.14
Novation Agreement dated November 21, 2005 relating to the Employment Agreement of Angus Russell dated March 10, 2004. (22)
   
10.15
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. (23)
   
10.16
Form of Amended and Restated Employment Agreement between Shire plc and Mr Matthew Emmens, dated March 12, 2004. (24)
   
10.17
Amendment Agreement dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (25)
   
10.18
Ratification and Guaranty dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (26)
   
10.19
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. (27)
   
10.20
Ratification and Guaranty dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (28)
   
10.21
Form of Indemnity Agreement for Directors of Shire Limited. (29)
   
10.22
Service Agreement between Shire Limited and Mr Angus Russell, dated July 2, 2008.
   
10.23
Service Agreement between Shire Limited and Mr Graham Hetherington, dated July 2, 2008.
   
10.24 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.
   
21
List of Subsidiaries. (30)
   
31.1
Certification of Angus Russell 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 Angus Russell and Graham Hetherington pursuant to Section 906 of the Sarbanes – Oxley Act of 2002.
   
*
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 99.02 to Shire’s Form 8-K filed on October 1, 2008.
   
(5)
Incorporated by reference to Exhibit 4.01 to Shire’s Form 8-K filed on May 23, 2008.
   
(6)  
 Incorporated by reference to Exhibit 4.02 to Shire’s Form 8-K filed on May 23, 2008.
   
(7)   
Incorporated by reference to Exhibit 4.03 to Shire’s Form 8-K filed on May 23, 2008.
   
(8)   
Incorporated by reference to Exhibit 4.04 to Shire’s Form 8-K filed on May 23, 2008.
   
(9) 
Incorporated by reference to Exhibit 99.1 to Shire’s Form 8-K filed on February 23, 2007.
   
(10) 
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on May 1, 2007.
   
(11)
Incorporated by reference to Exhibit 10.01 to Shire’s Form 8-K filed on May 23, 2008.
   
(12)
Incorporated by reference to Exhibit 10.1 to Shire’s Form 10-Q filed on August 2, 2007.
   
(13)
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on August 2, 2007.
   
(14)
Incorporated by reference to Exhibit 10.3 to Shire’s Form 10-Q filed on August 2, 2007.
   
(15)
Incorporated by reference to Exhibit 10.02 to Shire’s Form 8-K filed on May 23, 2008.
   
(16)
Incorporated by reference to Exhibit 10.03 to Shire’s Form 8-K filed on May 23, 2008.
   
(17)
Incorporated by reference to Exhibit 10.09 to Shire’s Form 10-K/A filed on May 30, 2008.
   
(18)
Incorporated by reference to Exhibit 10.1 to Shire’s Form 10-Q filed on November 7, 2006.
   
(19)
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on November 7, 2006.
 
 
62

 
 
 
(20)
Incorporated by reference to Exhibit 10.3 to Shire’s Form 10-Q filed on November 7, 2006.
   
(21)
Incorporated by reference to Exhibit 10.11 to Shire’s Form 10-K filed on March 12, 2004.
   
(22)
Incorporated by reference to Exhibit 10.03 to Shire’s Form 8-K filed on November 25, 2005.
   
(23)
Incorporated by reference to Exhibit 10.06 to Shire’s Form 8-K filed on May 23, 2008.
   
(24)
Incorporated by reference to Exhibit 10.13 to Shire’s Form 10-K filed on March 12, 2004.
   
(25)
Incorporated by reference to Exhibit 10.01 to Shire’s Form 8-K filed on November 25, 2005.
   
(26)
Incorporated by reference to Exhibit 10.02 to Shire’s Form 8-K filed on November 25, 2005.
   
(27)
Incorporated by reference to Exhibit 10.04 to Shire’s Form 8-K filed on May 23, 2008.
   
(28)
Incorporated by reference to Exhibit 10.05 to Shire’s Form 8-K filed on May 23, 2008.
   
(29)
Incorporated by reference to Exhibit 10.07 to Shire’s Form 8-K filed on May 23, 2008.
   
(30)
Incorporated by reference to Exhibit 21 to Shire’s Form 10-K/A filed on May 30, 2008.
 
 
 
 
63

 
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities and Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 

 

 
 
 
SHIRE PLC
(Registrant)
Date:
November 10, 2008
 
 
    /s/ Angus Russell
By:   Angus Russell
        Chief Executive Officer
 
Date:
November 10, 2008
 
    /s/ Graham Hetherington
By:   Graham Hetherington
        Chief Financial Officer