UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period ended JuneSeptember 30, 2005


Commission File Number: 0-29630

SHIRE PHARMACEUTICALS GROUP PLC
(Exact name of registrant as specified in its charter)

England and Wales98-0359573
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)

Hampshire International Business Park, Chineham,+44 1256 894 000
Basingstoke, Hampshire, England, RG24 8EP(Registrant’s telephone number, including area code)
(Address of principal executive offices and zip 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 Registrantregistrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

Yes [X]             No [   ]

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 of July 29,October 31, 2005, the number of outstanding ordinary shares of the Registrant was 493,004,145.494,828,582.

1






SHIRE PHARMACEUTICALS GROUP PLC
Form 10-Q for the three months to June 30, 2005
Table of contents
PART I FINANCIAL INFORMATION
ITEM1.Financial Statements4
     Condensed Consolidated Balance Sheets as of June 30, 2005 and December 31, 2004 4
     Condensed Consolidated Statements of Operations for the three months and six months to June 30, 2005 6
     and June 30, 2004 
     Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months to June 30, 20058
     Condensed Consolidated Statements of Comprehensive Income for the three months and six months to 9
     June 30, 2005 and June 30, 2004 
     Condensed Consolidated Statements of Cash Flows for the six months to June 30, 2005 and June 30, 200410
     Notes to the Condensed Consolidated Financial Statements 12
ITEM2.Management’s Discussion and Analysis of Financial Condition and Results of Operations32
ITEM3.Quantitative and Qualitative Disclosures about Market Risk46
ITEM4.Controls and Procedures46
PART II OTHER INFORMATION
ITEM1.Legal Proceedings46
ITEM2.Unregistered Sales of Equity Securities and Use of Proceeds48
ITEM3.Defaults Upon Senior Securities49
ITEM4.Submission of Matters to a Vote of Security Holders49
ITEM5.Other Information51
ITEM6.Exhibits52

2






THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated withwith: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization,commercialization; the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise,franchise; patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise,franchise; government regulation and approval, including, but not limited to, Health Canada's suspension of ADDERALL XR® sales in Canada and the expected product approval dates of MTS (METHYPATCH)DAYTRANA (MTS) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476MESAVANCE (SPD476) (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement AgencyAdministration in the United States,States; Shire’s ability to benefit from its acquisition of Transkaryotic Therapies, Inc. (TKT),; Shire's ability to secure new products for commercialization and/or developmentdevelopment; and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.

The following are trademarks of Shire Pharmaceuticals Group plc or its subsidiaries, which are the subject of trademark registrations in certain countries.

ADDERALL XR® (mixed
ADDERALL XR®(mixed salts of a single-entity amphetamine product)
ADDERALL®(mixed salts of a single-entity amphetamine product)
AGRYLIN®(anagrelide hydrochloride)
CALCICHEW®(range (calcium carbonate with or without vitamin D3))
CARBATROL®(carbamazepine)
COLAZIDE®(balsalazide)
EQUETRO™ (carbamazepine)
FOSRENOL®(lanthanum carbonate)
MESAVANCE™ (mesalazine)
REMINYL®(galantamine hydrobromide) (UK and Republic of Ireland)
REMINYL XL®(galantamine hydrobromide) (UK and Republic of Ireland)
REPLAGAL®(agalsidase alfa)
SOLARAZE®(3%, gel diclofenac sodium (3%w/w))
XAGRID®(anagrelide hydrochloride)
The following are trademarks of third parties referred to in this filing.

ADDERALL® (mixed salts of a single-entity amphetamine product)
AGRYLIN® (anagrelide hydrochloride)
CALCICHEW® (range (calcium carbonate with or without vitamin D3))
CARBATROL® (carbamazepine)
COLAZIDE® (balsalazide)
EQUETRO™ (carbamazepine)
FOSRENOL® (lanthanum carbonate)
REMINYL® (galantamine hydrobromide) (UK and Republic of Ireland)
SOLARAZE® (3%, gel diclofenac sodium (3%w/w))
XAGRID® (anagrelide hydrochloride)

The following are trademarks of third parties referred to in this filing.

3TC® (lamivudine) (trademark of GlaxoSmithKline (GSK))
AMARYL® (glimepiride) (trademark of Sanofi-Aventis)
METHYPATCH®(methylphenidate) (trademark of Noven Pharmaceuticals Inc. (Noven))*
PENTASA®(mesalamine) (trademark of Ferring AS)
RAZADYNE™ (galantamine hydrobromide) (trademark of Johnson & Johnson)
REMINYL® (galantamine hydrobromide) (trademark of Johnson & Johnson, excluding UK and Republic of Ireland)
ZEFFIX
® (lamivudine) (trademark of GSK)


* Referred to as MTS in this Form 10-Q

3





3TC®(trademark of GlaxoSmithKline (GSK))
AMARYL®(glimepiride) (trademark of Sanofi-Aventis)
DYNEPO®(epoetin delta) (trademark of Aventis Pharma Holdings GmbH)
DAYTRANA®(methylphenidate transdermal system) (trademark of Noven Pharmaceuticals Inc. (Noven))*
PENTASA®(trademark of Ferring AS)
RAZADYNE™ (galantamine hydrobromide) (trademark of Johnson & Johnson)
RAZADYNE ER™ (galantamine hydrobromide) (trademark of Johnson & Johnson)
REMINYL®(galantamine hydrobromide) (trademark of Johnson & Johnson, excluding UK and Republic of Ireland)
REMINYL XL®(galantamine hydrobromide) (trademark of Johnson & Johnson, excluding UK and Republic of Ireland)
ZEFFIX®(trademark of GSK)
* Previously referred to as MTS.

PART I. FINANCIAL INFORMATION

ITEM 1. Financial Statements

SHIRE PHARMACEUTICALS GROUP PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)

 NotesJune 30,
2005
$’000
December 31,
2004
$’000
 



ASSETS   
Current assets:   
Cash and cash equivalents 1,502,1791,111,477
Restricted cash 21,94321,627
Short-term investments 76,486324,411
Accounts receivable, net(3)246,611222,546
Inventories(4)47,67741,230
Deferred tax asset 59,72270,387
Prepaid expenses and other current assets(5)65,276137,271


Total current assets 2,019,8941,928,949
    
Investments 56,83563,267
Property, plant and equipment, net 153,766131,351
Goodwill 220,450235,396
Other intangible assets, net(6)280,441309,297
Deferred tax asset 27,8047,724
Other non-current assets 39,56738,895


Total assets 2,798,7572,714,879


LIABILITIES AND SHAREHOLDERS’ EQUITY   
Current liabilities:   
Accounts payable and accrued expenses(7)321,813311,231
Loan facility(2)13,25243,162
Other current liabilities(8)89,86177,558


Total current liabilities 424,926431,951


Long-term debt(9)116116
Other non-current liabilities 32,72832,159


Total liabilities 457,770464,226


Commitments and contingencies(10)  

42






     SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDForm 10-Q for the three months to September 30, 2005
Table of contents

Page
PART I FINANCIAL INFORMATION4
ITEM1. FINANCIAL STATEMENTS
   Consolidated balance sheets at September 30, 2005 and December 31, 20044
   Consolidated statements of operations for the three months and nine months to September 30, 2005 and6
         September 30, 2004
   Consolidated statements of changes in shareholders’ equity for the nine months to September 30, 20058
   Consolidated statements of comprehensive income for the three months and nine months to September9
         30, 2005 and September 30, 2004
   Consolidated statements of cash flows for the nine months to September 30, 2005 and September 30,10
         2004
   Notes to the condensed consolidated financial statements12
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS41
OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK59
ITEM 4. CONTROLS AND PROCEDURES59
PART II OTHER INFORMATION61
ITEM 1. LEGAL PROCEEDINGS61
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS66
ITEM 3. DEFAULTS UPON SENIOR SECURITIES66
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS66
ITEM 5. OTHER INFORMATION66
ITEM 6. EXHIBITS67

3      






PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
SHIRE PHARMACEUTICALS GROUP PLC
UNAUDITED CONSOLIDATED BALANCE SHEETS
(Unaudited)

 Notes June 30,
2005
$’000
  December 31,
2004
$’000
 


 
 
Shareholders’ equity:      
Common stock, 5p par value; 800,000,000 shares authorized;      
492,648,235 (2004: 484,916,034) shares issued and outstanding   40,666  40,064 
Exchangeable shares: 2,403,000 (2004: 4,226,476) shares issued      
and outstanding   111,233  195,830 
Treasury stock   (182 (264
Additional paid-in capital   1,176,390  1,072,407 
Accumulated other comprehensive income   84,604  131,939 
Retained earnings   928,276  810,677 

 
 
Total shareholders’ equity   2,340,987  2,250,653 

 
 
Total liabilities and shareholders’ equity   2,798,757  2,714,879 

 
 
The accompanying notes are an integral part of these condensed consolidated financial statements.      
    
    
  September 30,December 31,
  20052004
 Notes $’000$’000

 

ASSETS   
Current assets:   
Cash and cash equivalents 549,8201,111,477
Restricted cash 30,08521,627
Short-term investments 22,380324,411
Accounts receivable, net(6) 282,262222,546
Inventories, net(7) 145,69441,230
Deferred tax asset 35,60770,387
Prepaid expenses and other current assets(8) 81,159137,271


Total current assets 1,147,0071,928,949
       
Investments 47,20563,267
Property, plant and equipment, net(9) 218,108131,351
Goodwill, net(10) 381,747235,396
Other intangible assets, net(11) 749,375309,297
Deferred tax asset 49,7827,724
Other non-current assets 42,95538,895


       
Total assets 2,636,1792,714,879


LIABILITIES AND SHAREHOLDERS’ EQUITY   
Current liabilities:   
Loan facility -43,162
Accounts payable and accrued expenses(12) 374,941311,231
Outstanding TKT shareholders(2) 434,876-
Other current liabilities(13) 53,58377,558


Total current liabilities 863,400431,951
       
Long-term debt, excluding current installments(14) 116116
Other long-term liabilities(15) 45,06232,159


       
Total liabilities 908,578464,226


Commitments and contingencies(16)   

54      






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)BALANCE SHEETS (continued)

  Notes 3 months to
June 30,
2005
$’000
  3 months to
June 30,
2004
$’000
  6 months to
June 30,
2005
$’000
  6 months to
June 30,
2004
$’000
 

 
 
 
 
Revenues:           
Product sales    351,555  255,280  620,999  519,874 
Royalties    62,564  57,657  120,887  113,802 
Licensing and development    2,714  5,482  6,583  7,397 
Other revenues    7,763  2,541  9,820  3,487 

 
 
 
 
Total revenues    424,596  320,960  758,289  644,560 

 
 
 
 
Costs and expenses:           
Cost of product sales    41,945  26,984  75,278  61,077 
Research and development    65,457  47,375  176,989  86,001 
Selling, general and administrative    173,554  118,220  344,763  251,058 
Intangible asset impairment    3,000  -  3,000  - 
Reorganization costs  (2) -  18,167  2,878  21,980 

 
 
 
 
Total operating expenses    283,956  210,746  602,908  420,116 

 
 
 
 
Operating income  (12) 140,640  110,214  155,381  224,444 
               
Interest income    11,267  4,375  20,992  8,404 
Interest expense    (1,184 (2,101 (1,199 (4,227
Other income, net    802  14,081  736  9,262 

 
 
 
 
Total other income, net    10,885  16,355  20,529  13,439 

 
 
 
 
Income from continuing operations before           
 income taxes and equity in earnings of equity    151,525  126,569  175,910  237,883 
 method investees           
Income taxes    (36,295 (38,226 (43,098 (67,228
Equity in earnings of equity method investees    924  1,170  719  2,218 

 
 
 
 
Income from continuing operations    116,154  89,513  133,531  172,873 
Loss from discontinued operations    -  (11,349 -  (20,135
(Loss)/gain on disposition of discontinued    -  (44,157 3,125  (44,157
operations           

 
 
 
 
Net income    116,154  34,007  136,656  108,581 

 
 
 
 

  September 30,December 31, 
  20052004 
  $’000$’000 
  

 
Shareholders’ equity:  
Ordinary shares of 5p par value: 800,000,000 shares  
authorized; and 494,192,907 (2004: 484,916,034) shares  
issued and outstanding40,803 40,064 
Exchangeable shares: 2,363,000 (2004: 4,226,476) shares  
issued and outstanding109,377 195,830 
Treasury stock(144)(264)
Additional paid-in capital1,191,233 1,072,407 
Accumulated other comprehensive income91,653 131,939 
Retained earnings294,679 810,677 

 
 
      
Total shareholders’ equity1,727,601 2,250,653 

 
 
      
Total liabilities and shareholders’ equity2,636,179 2,714,879 

 
 

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

65      






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

  Notes 3 months to
June 30,
2005
  3 months to
June 30,
2004
  6 months to
June 30,
2005
  6 months to
June 30,
2004
 

 
 
 
 
Earnings per share - basic  (11)        
Income from continuing operations    23.2 18.1 26.8 34.9
Loss from discontinued operations    -  (2.3c)  -  (4.1c) 
(Loss)/gain on disposition of discontinued           
operations    -  (8.9c)  0.6 (8.9c) 

 
 
 
 
Net income    23.2 6.9 27.4 21.9

 
 
 
 
Earnings per share - diluted  (11)        
Income from continuing operations    23.0 17.9 26.5 33.9
Loss from discontinued operations    -  (2.3c)  -  (3.9c) 
(Loss)/gain on disposition of discontinued           
operations    -  (8.8c)  0.6 (8.5c) 

 
 
 
 
    23.0 6.8 27.1 21.5

 
 
 
 
Weighted average number of shares:           
Basic    499,664,524  496,074,144  499,333,386  495,896,175 
Diluted    504,030,518  499,241,832  503,862,040  517,822,110 

 
 
 
 
 3 months to 3 months to 9 months to 9 months to 
 September 30, September 30, September 30, September 30, 
 2005 2004 2005 2004 
 Notes$’000 $’000 $’000 $’000 


 
 
 
 
Revenues:    
Product sales309,150 283,723 930,149 803,597 
Royalties60,186 56,199 181,073 170,001 
Licensing and development4,586 2,820 11,169 10,217 
Other revenues2,155 2,167 11,975 5,654 

 
 
 
 
               
Total revenues376,077 344,909 1,134,366 989,469 

 
 
 
 
Costs and expenses:    
Cost of product sales60,081 38,933 135,359 100,010 
Research and development74,311 57,759 251,300 143,760 
Selling, general and administrative171,332 119,646 516,095 370,704 
Intangible asset impairment- 5,456 3,000 5,456 
Reorganization costs(4a)6,457 10,061 9,335 32,041 
Integration costs(3)3,520 - 3,520 - 
In-process R&D write-off(2e)673,000 - 673,000 - 

 
 
 
 
               
Total operating expenses988,701 231,855 1,591,609 651,971 

 
 
 
 
Operating (loss)/income(612,624)113,054 (457,243)337,498 
Interest income6,876 5,697 27,868 14,101 
Interest expense(3,519)(8,032)(4,718)(12,259)
Other income/(expense), net3,202 (4,859)3,938 4,403 

 
 
 
 
               
Total other income/(expense), net6,559 (7,194)27,088 6,245 

 
 
 
 
(Loss)/income from continuing    
 operations before income taxes and    
 equity in (loss)/earnings of equity    
 method investees(606,065)105,860 (430,155)343,743 
Income taxes(18,609)(29,960)(61,707)(97,188)
Equity in (loss)/earnings of equity    
method investees(569)1,140 150 3,358 

 
 
 
 
(Loss)/income from continuing    
 operations(625,243)77,040 (491,712)249,913 
Loss from discontinued operations(4b)- - - (20,135)
Gain/(loss) on disposition of    
discontinued operations(4b)1,049 - 4,174 (44,157)

 
 
 
 
               
Net (loss)/income(624,194)77,040 (487,538)185,621 

 
 
 
 

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

76      






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTSTATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)OPERATIONS (continued)

  Ordinary
Shares
$’000
  Ordinary
Shares
No. of
shares
000 ’s
  Exchange-
able
shares
$’000
  Exchange-
able
shares
No. of
shares
000’s
  Treasury
stock
$’000
  Additional
paid-in
capital
$’000
  Accumu-
lated
other
compre-
hensive
income
$’000
  Retained
earnings
$’000 
  Total
share-
holders’
equity
$’000 
 


 
 
 
 
 
 
 
 
As of January 1,                     
2005 40,064  484,916  195,830  4,226  (264) 1,072,407  131,939  810,677  2,250,653 
                      
Net income for the                     
period -  -  -  -  -  -  -  136,656  136,656 
                      
Foreign currency                     
translation -  -  -  -  -  -  (38,429) -  (38,429)
                      
Exchange of                     
exchangeable                     
shares 389  5,470  (84,597) (1,823) -  84,208  -  -  - 
                      
                      
Options exercised 213  2,262  -  -  -  18,251  -  -  18,464 
                      
Stock option                     
compensation -  -  -  -  -  96  -  -  96 
                      
Tax benefit                     
associated with                     
exercise of stock                     
options -  -  -  -  -  1,428  -  -  1,428 
                      
Re-issuance of                     
treasury stock -  -  -  -  82  -  -  -  82 
                      
Unrealized losses                     
on available-for-                     
sale securities -  -  -  -  -  -  (8,906) -  (8,906)
                      
Dividends -  -  -  -  -  -  -  (19,057) (19,057)


 
 
 
 
 
 
 
 
As of June 30,                     
2005 40,666  492,648  111,233  2,403  (182) 1,176,390  84,604  928,276  2,340,987 


 
 
 
 
 
 
 
 

  3 months to  3 months to  9 months to  9 months to 
  September 30,  September 30,  September 30,  September 30, 
 Notes 2005  2004  2005  2004 

  
  
  
 
Earnings per share – basic        
(Loss)/income from continuing        
operations (124.9c) 15.5c  (98.4c) 50.4c 
               
Loss from discontinued operations -  -  -  (4.1c)
Gain/(loss) on disposition on        
discontinued operations 0.2c  -  0.8c  (8.9c)

  
  
  
 
               
  (124.7c) 15.5c  (97.6c) 37.4c 

  
  
  
 
Earnings per share – diluted        
(Loss)/income from continuing        
operations (124.9c) 15.3c  (98.4c) 49.2c 
Loss from discontinued operations -  -  -  (3.9c)
Gain/(loss) on disposition on        
discontinued operations 0.2c  -  0.8c (8.6c)

  
  
  
 
               
  (124.7c) 15.3c  (97.6c) 36.7c 

  
  
  
 
Weighted average number of shares:        
Basic(17) 500,542,616  496,474,005  499,741,042  496,090,191 
Diluted(17) 500,542,616  509,777,052  499,741,042  515,070,302 

  
  
  
 

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

7      






SHIRE PHARMACEUTICALS GROUP PLC
UNAUDITED CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY

       Accumu-   
    Exchange   lated   
  Ordinary  -able   other  Total 
  Shares Exchange- Shares  Additionalcompre-  share- 
 OrdinaryNo. of able No. of Treasury paid-inhensive Retained holders’ 
 SharesShares Shares Shares stock capitalincome earnings equity 
 $’000000’s $’000 000’s $’000 $’000$’000 $’000 $’000 
 

 
 
 
 

 
 
 
As at January 1,         
200540,064484,916 195,830 4,226 (264)1,072,407131,939 810,677 2,250,653 
                    
Net loss for the         
period-- - - - -- (487,538)(487,538)
                    
Foreign currency         
translation-- - - - -(32,480)- (32,480)
                    
Exchange of         
exchangeable         
shares3985,591 (86,453)(1,863)- 86,055- - - 
                    
Options         
exercised3413,686 - - - 30,106- - 30,447 
          
Stock option         
compensation-- - - - 187- - 187 
                    
Tax benefit         
associated with         
exercise of stock         
options-- - - - 2,478- - 2,478 
                    
Re-issuance of         
treasury stock-- - - 120 -- - 120 
                    
Realized gain on         
available-for-sale         
securities-- - - - -(3,473)- (3,473)
          
Unrealized         
holding losses         
on available-for-         
sale securities-- - - - -(4,333)- (4,333)
                    
Dividends-- - - - -- (28,460)(28,460)
                    
 

 
 
 
 

 
 
 
As at         
September 30,         
200540,803494,193 109,377 2,363 (144)1,191,23391,653 294,679 1,727,601 
 

 
 
 
 

 
 
 

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

One Shire exchangeable share can be exchanged at any time for either 3three Shire ordinary shares or one Shire ADS.

8






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTSTATEMENTS OF COMPREHENSIVE INCOME
(Unaudited)

3 months to
June 30,
2005
$’000
 3 months to
June 30,
2004
$’000
 6 months to
June 30,
2005
$’000
 6 months to
June 30,
2004
$’000
 

 
 
 
 
Net income  116,154  34,007  136,656  108,581 
             
Other comprehensive income:         
Foreign currency translation adjustments  (28,546 (9,231 (38,429 (8,448
Unrealized holding losses on available-for-sale securities  (2,427 (10,005 (8,906 (7,433

 
 
 
 
Comprehensive income  85,181  14,771  89,321  92,700 

 
 
 
 

 3 months to  3 months to9 months to  9 months to 
 September 30,  September 30,September 30,  September 30, 
 2005  20042005  2004 
 $’000  $’000$’000  $’000 

  

  
 
Net (loss)/income(624,194) 77,040(487,538) 185,621 
             
Other comprehensive income/(loss):      
Foreign currency translation adjustments5,949  12,973(32,480) 4,525 
Realized gain on available-for-sale securities(3,473) -(3,473) (20,880)
Unrealized holding gain/(loss) on available-for-      
sale securities, net of tax4,573  2,695(4,333) 16,142 

  

  
 
             
Comprehensive (loss)/income(617,145) 92,708(527,824) 185,408 

  

  
 

The components of accumulated other comprehensive income as of Juneat September 30, 2005 and December 31, 2004 are as follows:

September 30,December 31, 
 June 30,
2005
$’000
 December 31,
2004
$’000
20052004 


$’000$’000 
    

 
Foreign currency translation adjustments 79,793 118,22285,742118,222 
Unrealized holding gain on available-for-sale securities 4,811 13,7175,91113,717 




 
Accumulated other comprehensive income 84,604 131,93991,653131,939 




 

There are no material tax effects related to the items included above.

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

9






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTSTATEMENTS OF CASH FLOWS
(Unaudited)

 9 months to 9 months to 
 September 30, September 30, 
 2005 2004 
 6 months to
June 30,
2005
$’000
 6 months to
June 30,
2004
$’000
  $’000 $’000 

 
  
 
 
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net income from continuing operations  133,531  172,873 
Adjustments to reconcile net income from continuing operations to net cash     
provided by operating activities:     
Net (loss)/income from continuing operations (491,712) 249,913 
Adjustments to reconcile net income to net cash provided by operating   
activities:   
Depreciation and amortization:        
Cost of goods  1,721  1,284 
Cost of product sales 2,682 1,965 
SG&A  27,841  25,583  44,085 40,474 
Increase in provision for sales deductions  20,441  25,342 
Stock option compensation  96  98  187 165 
In-process R&D write-off 673,000 - 
Write-down of long-term assets 11,005 19,392 
Gain on sale of long-term assets (3,866) (14,472)
Dissenting shareholders interest 2,435 - 
Movement in deferred taxes  (9,411 (7,232 34,307 (23,610)
Equity in earnings of equity method investees  (719 (2,218 (150) (3,358)
Write-down of long-term assets  10,461  8,453 
Gain on sale of long-term assets  (16 (14,883
Changes in operating assets and liabilities, net of acquisitions:        
(Increase)/decrease in accounts receivable  (27,789 23,672 
Increase in accounts receivable (33,893) (49,261)
Increase in provision for sales deductions 14,424 39,551 
Increase in inventory  (6,500 (6,754 (1,273) (2,864)
Decrease/(increase) in prepayments and other current assets  8,360  (13,467
(Increase)/decrease in prepayments and other current assets (24,403) 2,199 
(Increase)/decrease in other assets  (672 12,155  (779) 2,023 
Increase in accounts and notes payable and other liabilities  38,348  7,511  5,700 47,322 
Decrease in deferred revenue  (7,831 (551 (10,531) (288)
Cash flows used in discontinued operations  (362 (16,190 (362) (25,613)

 
  
 
 
Net cash provided by operating activities  187,499  215,676  220,856 283,538 

 
  
 
 
CASH FLOWS FROM INVESTING ACTIVITIES:        
Movements in short-term investments  243,989  31,972 
Movement in short-term investments 351,246 21,039 
Movements in restricted cash  (316 (1,770 (285) 15,573 
Loans made to ID Biomedical Corporation (IDB)  (29,910 - 
Purchase of subsidiary undertaking, net of cash and cash equivalents (1,099,650) - 
Expenses of acquisitions (24,112) - 
Purchase of long-term investments  (7,538 (5,514 (7,678) (5,720)
Purchase of property, plant and equipment (57,638) (24,840)
Purchase of intangible assets  (19,962 (12,000 (20,064) (12,385)
Purchase of property, plant and equipment  (44,157 (13,961
Proceeds from sale of long-term investments  -  26,733  10,135 26,733 
Proceeds from sale of property, plant and equipment  68  400  108 444 
Proceeds from redemption of IDB subscription receipts  60,000  - 
Additional proceeds from sale of the vaccines business  2,236  7,659 
Distribution from long-term investments  -  1,202 
Proceeds from assets held for resale - 11,289 
Dividends received from investments  2,420  1,834  8,483 5,245 
Cash flows used in discontinued operations  -  (12,715
Loans made to ID Biomedical Corporation (IDB) (43,162) (23,820)
Repayment of loan made to IDB 1,049 - 
Proceeds from IDB subscription receipts 60,000 - 
Deferred proceeds from sale of the vaccines business 32,236 30,000 
Cash flows from discontinued operations - (12,715)

 
  
 
 
Net cash provided by investing activities  206,830  23,840 
Net cash (used in)/provided by investing activities (789,332) 30,843 

 
  
 
 

The assets acquired with the purchase of Transkaryotic Therapies, Inc. (TKT) included: cash and cash equivalents ($56.8 million), restricted cash ($8.2 million) and short-term investments ($46.8 million).

10






SHIRE PHARMACEUTICALS GROUP PLC
CONDENSEDUNAUDITED CONSOLIDATED STATEMENTSTATEMENTS OF CASH FLOWS
(Unaudited) (continued)

 9 months to 9 months to 
 September 30, September 30, 
 2005 2004 
 6 months to
June 30,
2005
$’000
 6 months to
June 30,
2004
$’000
  $’000 $’000 

 
  

CASH FLOWS FROM FINANCING ACTIVITIES:        
Redemption of 2% convertible loan notes - (370,109)
Repayment of long-term debt and capital leases  -  (135 - (171)
Proceeds from exercise of options  18,464  5,351  30,447 7,531 
Tax benefit of stock option compensation, charged directly to equity  1,428  - 
Proceeds from issue of common stock, net  -  326  - 611 
Tax benefit of stock option compensation, charged directly to reserves 2,478 - 
Payment of dividend  (19,057 -  (19,057)- 
Cash flows used in discontinued operations  -  -  - - 

 
 

Net cash provided by financing activities  835  5,542 

 
        
Effect of foreign exchange rate changes on cash and cash equivalents from     
continuing operations  (4,462 (1,280
Cash flows used in discontinued operations  -  (10
Net cash provided by/(used in) financing activities 13,868 (362,138)

 
 

Net increase in cash and cash equivalents  390,702  243,768 
       
Effect of foreign exchange rate changes on cash and cash (7,049)2,295 
Discontinued operations - (10)


Net decrease in cash and cash equivalents (561,657)(45,472)
Cash and cash equivalents at beginning of period  1,111,477  1,063,362  1,111,477 1,063,362 



 
        
Cash and cash equivalents at end of period  1,502,179  1,307,130  549,820 1,017,890 

 
 

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

11






SHIRE PHARMACEUTICALS GROUP PLC
NOTES TO THE UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

1.   Summary of Significant Accounting Policies

(a) Basis of presentationPresentation

These interim financial statements of Shire Pharmaceuticals Group plc and its subsidiaries (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 Securities and Exchange Commission (SEC) regulations for interim reporting.

The December 31, 2004 balance sheet iswas 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 Company’s following filings at the SEC:

  • consolidated balance sheetsfinancial statements and accompanying notes included in Shire’s Annual Report on Form 10-Kfor the year to December 31, 2004;

  • consolidated financial statements and accompanying notes included in TKT’s Annual Report on Form 10-K and Form 10-K/A for the year to December 31, 2004;

  • unaudited consolidated financial statements and accompanying notes included in Shire's Quarterly Reports on Form 10-Q for the periods to March 31, 2005 and June 30, 2005; and

  • unaudited pro forma condensed combined financial statements and accompanying notes as ofat and for theperiod to March 31, 2005 and for the year to December 31, 2004 and 2003, and the related consolidated statements of operations, cash flows and changesincluded in shareholders’ equity for each of the three years in the period to December 31, 2004.

    Shire’s Form 8K/A, datedSeptember 26, 2005.

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, (consisting solely of normal recurring 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 Securities and Exchange Commission 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 sales deductions, valuation of intangible assets and fixed asset investments, contingent liabilities, and the valuation of tax assets and liabilities.liabilities, the valuation of in-process R+D and inventory acquired with TKT and the amount payable to those TKT shareholders who have asserted appraisal rights in relation to Shire’s acquisition of TKT which completed on July 27, 2005.

(c) Employee stock plans

The Company accounts for its stock options using the intrinsic-value method prescribed in Accounting Principles Board (APB) Opinion No. 25, “Accounting for Stock Issued to Employees” (APB No. 25). Accordingly, compensation cost of stock options is measured as the excess, if any, of the quoted market price of Shire’s stock at the measurement date over the option exercise price and is charged to operations over the vesting period. For plans where the measurement date occurs after the grant date, referred to as variable plans, compensation cost is re-measured on the basis of the current market value of Shire stock at the end of each reporting period. The CompanyShire recognizes compensation expense for variable plans with performance conditions if achievement of those conditions becomes probable. As required by Statement of Financial Accounting StandardsStandard (SFAS) No. 123, “Accounting for Stock Based on Compensation” (SFAS No. 123), the Company has included in these interim financial statements the required pro forma disclosures as if the fair-value method of accounting had been applied.

As of JuneAt September 30, 2005, the Company had six stock-based employee compensation plans, which are described more fully in the Company’s 2004 Form 10-K.

12






The following table illustrates the effect on net (loss)/income and (loss)/earnings per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation.

3 months to
June 30,
2005
$’000
 3 months to
June 30,
2004
$’000
 6 months to
June 30,
2005
$’000
 6 months to
June 30,
2004
$’000
 

 
 
 
 
Net income, as reported  116,154  34,007  136,656  108,581 
Add:         
Stock-based employee compensation charge         
included in reported net income, net of related tax  47  98  96  98 
effects         
Deduct:         
Total stock-based employee compensation         
expense determined under fair value based  (6,384 (9,713 (11,558 (18,593
method for all awards         

 
 
 
 
Pro forma net income  109,817  24,392  125,194  90,086 

 
 
 
 
Earnings per share         
Basic – as reported  23.2c  6.9c  27.4c  21.9c 
Basic – pro forma  22.0c  4.9c  25.1c  18.2c 
Diluted – as reported  23.0c  6.8c  27.1c  21.5c 
Diluted – pro forma  22.0c  4.9c  25.1c  18.0c 

 
 
 
 

12






 3 months to 3 months to 9 months to 9 months to 
 September 30, September 30, September 30, September 30, 
 2005 2004 2005 2004 
 $’000 $’000 $’000 $’000 

 
 
 
 
Net (loss)/income, as reported(624,194)77,040 (487,538)185,621 
Add:    
Stock-based employee compensation charge    
included in reported net income, net of related    
tax effects91 67 187 165 
Deduct:    
Total stock-based employee compensation    
expense determined under fair value based    
method for all awards(6,578)(7,075)(18,136)(25,665)








          
Pro forma net (loss)/income(630,681)70,032 (505,487)160,121 








          
(Loss)/earnings per share    
Basic – as reported(124.7c)15.5c (97.6c)37.4c 
Diluted – as reported(124.7c)15.3c (97.6c)36.7c 
Basic – pro forma(126.0c)14.1c (101.1c)32.3c 
          
Diluted – pro forma(126.0c)14.1c (101.1c)31.9c 








(d) Accounting pronouncements adopted during the period

EITF 05-06

In June 2005 the Emerging Issues Task Force (EITF) reached consensus on Issue 05-6, "Determining the Amortization Period for Leasehold Improvements Purchased after Lease Inception or Acquired in a Business Combination" (EITF 05-6). EITF 05-6 requires leasehold improvements acquired in a business combination to be amortized over the shorter of the useful life of the assets or a term that includes required lease periods and renewals deemed to be reasonably assured at the date of acquisition. Additionally, the IssueEITF 05-6 requires improvements placed in service significantly after and not contemplated at or near the beginning of the lease term to be amortized over the shorter of the useful life of the assets or a term that includes required lease periods and renewals deemed to be reasonably assured at the date the leasehold improvements are purchased. EITF 05-6 is effective immediately. The adoption of EITF 05-6 has had no material impact on the Company's consolidated financial position, results of operations or cash flows.

SFAS 153

In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 153, "Exchanges of Non-monetary Assets - an amendment of APB Opinion No. 29" (SFAS No. 153), which amends APB Opinion No. 29, "Accounting for Non-monetary Transactions" to eliminate the exception for non-monetary exchanges of similar productive assets and replaces it with a general exception for exchanges of non-monetary assets that do not have commercial substance. SFAS No. 153 is effective for non-monetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The adoption of SFAS No. 153 has had no material impact on the Company's consolidated financial position, results of operations or cash flows.

(e) New accounting pronouncements to be adopted in future periods

EITF 03-01

In March 2004, the EITF reached a consensus on Issue 03-01, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments” (EITF 03-01 or the Issue)03-01). EITF 03-01 is applicable to (a) debt and equity securities within the scope of FASSFAS No. 115, (b) debt and equity securities that are within the scope of SFAS No. 124 and those held by an investor that reports a performance indicator, and (c) equity securities not within the scope of SFAS No. 115 and not accounted for under the APBAccounting Principles Board Opinion No. 18's equity method (e.g., investments in private companies) cost method investments). EITF 03-01 provides a step model to determine whether an investment is impaired and if an impairment is other-than-temporary. In addition, it requires that investors provide certain disclosures for cost method investments in private companies and, if applicable, other information related specifically to cost method investments, in private companies, such as the aggregate carrying amount of cost method investments, in private companies, the aggregate amount of cost method investments in private companies that the investor did not evaluate for impairment because an impairment indicator was not present, and the situations under which the fair value of ana cost

13






method investment in a private company is not estimated. The disclosures relating to cost method investments in private companies should not be aggregated with other types of investments. The effective date for the prospective application of the EITF 03-01 impairment model to all current and future investments has been delayed by the FASB Issues FASB Staff Position (FSP) EITF 03-01.03-01-1. The disclosure requirements are effective for annual periods for fiscal years ending after June 15, 2004. The Company does not expect the adoption of EITF 03-01 to have a material impact on its consolidated financial position, results of operations or cash flows.

13






SFAS 123R

In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment“Share-Based Payment” (SFAS No. 123R). SFAS No.123R replaces SFAS No. 123 and supersedes APB No. 25. SFAS No. 123R requires that the cost resulting from all share-based payment transactions be recognized in the financial statements at fair value and that excess tax benefits be reported as a financing cash inflow rather than as a reduction of taxes paid. SFAS No. 123R is effective for the Company from January 1, 2006. SFAS No. 123R requires public companies to account for share-based payments using the modified-prospective method and permits public companies also to account for share based payments using the modified-retrospective method. Under the modified-prospective method, from the effective date, compensation cost is recognized based on the requirements of SFAS No. 123R for all new share-based awards and based on the requirements of SFAS No. 123 for all awards granted prior to the effective date of SFAS No. 123R that remain unvested on the effective date. The modified-retrospective method permits companies to restate, based on the amounts previously recognized under SFAS No. 123 for pro forma disclosure purposes, either all prior periods presented or prior interim periods in the year of adoption. The SFAS No. 123 pro forma disclosures given in Note 1(c) above show the impact of the Company adopting the modified-retrospective method in prior periods. On adoption of SFAS No. 123R, in prior periods. Thethe Company will adopt the modified-retrospective method.

FSP SFAS 123(R)-2

In October 2005, the FASB issued a staff position FSP SFAS No. 123(R)-2, “Practical Accommodation of Grant Date as Defined in FASB Statement No. 123(R)” (FSP SFAS No. 123(R)-2). FSP SFAS No. 123(R)-2 is in response to recent enquiries from constituents to provide guidance on the application of grant date as defined in SFAS No. 123R. One of the criteria in defining the grant date in SFAS No. 123(R) is a mutual understanding by the employer and the employee of the key terms and conditions of a share-based payment award. Practice has developed such that the grant date of an award is generally the date the award is approved in accordance with an entity’s corporate governance provisions, so long as the approved grant is communicated to employees within a relatively short period of time from the date of approval. For many companies, the number and geographic dispersion of employees receiving share-based awards limit the ability to communicate with each employee immediately after the awards have been approved by the Board of Directors. As a practical accommodation, a mutual understanding of the key terms and conditions of an award to an individual employee shall be presumed to exist at the date the award is approved if the award is a unilateral grant and the key terms and conditions of the award are expected to be communicated to an individual recipient within a relatively short time period from the date of approval. FSP SFAS No. 123(R)-2 is effective for the Company from January 1, 2006. The Company does not expect the adoption of FSP SFAS No. 123(R)-2 to have a material impact on its consolidated financial position, results of operations or cash flows.

SFAS 151

In November 2004, the FASB issued SFAS No. 151, "Inventory Costs - an amendment of ARB No. 43, Chapter 4" (SFAS No. 151). SFAS No. 151 clarifies that abnormal amounts of idle facility expense, freight, handling costs, and wasted materials (spoilage) should be recognized as current-period charges and requires the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. SFAS No. 151 is effective for fiscal years beginning after June 15, 2005. The Company does not expect the adoption of SFAS No. 151 to have a material impact on its consolidated financial position, results of operations or cash flows.

SFAS 153

In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 153, "Exchanges of Non-monetary Assets - an amendment of APB Opinion No. 29" (SFAS No. 153), which amends APB Opinion No. 29, "Accounting for Non-monetary Transactions" to eliminate the exception for non-monetary exchanges of similar productive assets and replaces it with a general exception for exchanges of non-monetary assets that do not have commercial substance. SFAS No. 153 is effective for non-monetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The Company does not expect the adoption of SFAS No. 153 to have a material impact on its consolidated financial position, results of operations or cash flows.

SFAS 154

In May 2005, SFAS No. 154, “Accounting Changes and Error Corrections - replacement of APB Opinion No. 20 and FASB Statement No. 3,” (SFAS No. 154) was issued. SFAS No. 154 changes the accounting for and reporting of a change in accounting principle by requiring retrospective application to prior periods’ financial statements of changes in accounting principle unless impracticable. SFAS No. 154 is effective for accounting changes made in fiscal years beginning after December 15, 2005. The Company can not determine the impactadoption of SFAS No. 154 as itwill have no impact on historical results; rather the impact depends upon future changes to accounting principles.

2.   Business combinations: TKT acquisition

On July 27, 2005 Shire completed its acquisition of TKT in an all-cash transaction. The acquisition was effected by merging a wholly owned subsidiary of Shire with and into TKT (the “Merger”), with TKT continuing as the surviving corporation. As consideration, Shire paid to TKT’s stockholders $37 in cash for each share of TKT common stock outstanding at the time of the acquisition, less any applicable withholding taxes.

The total cash consideration for the acquisition of TKT is expected to be approximately $1.6 billion, subject to change as may be required by the appraisal rights process (see below). As at September 30, 2005 shareholders owning approximately 24.4 million TKT shares had accepted the offer and $903 million has been paid to them, $83.4 million was paid in connection with TKT stock options and $170.1 million in connection with convertible notes, outstanding at the date of acquisition.

In connection with the acquisition, as at September 30, 2005, the holders of approximately 11.7 million shares of TKT common stock had submitted written demands for appraisal of their shares and, as a result, elected not to accept the $37 per share merger consideration. To the extent that these demands were validly asserted in accordance with the applicable requirements of Delaware law and these holders perfect their rights thereunder, such holders will be entitled to receive the fair value of their shares as determined by the Delaware Court of Chancery. The determination of fair value of the TKT shares 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. Shire has recognised a liability in respect of the fair value of those TKT shareholders who have asserted appraisal rights based on

14






$37 per share. If the court ascribes a different valuation to $37 this will result in an adjustment to goodwill. In addition, the Company has recorded a provision for interest, based on the $37 per share amount, of $2.5 million for the period to September 30, 2005, which has been charged to the income statement.

For accounting purposes, the acquisition of TKT 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 TKT are recorded at the date of acquisition at their respective fair values. Financial statements and reported results of operations of Shire issued after completion of the acquisition will reflect these values, with the results of TKT included from July 27, 2005 in the statement of operations.

The following is an estimate of the purchase price for TKT, as at July 27, 2005:

  $’000

Common stock  
Number of shares of TKT common stock – non-dissenting24,444,126 
Price per TKT share ($)37.00904,432
     
Number of shares of TKT common stock – dissenting11,714,150 
Price per TKT share ($)37.00433,424


     
Total number of shares of TKT common stock outstanding as at July 27, 200536,158,2761,337,856

Stock options  
Cash cost of settling TKT stock options 83,392
     
Convertible notes  
Nominal value of convertible loan notes as at July 27, 2005 (in $000s)85,000 
Conversion ratio into TKT common stock18.49 
Total shares payable upon conversion4,597,080 
Price per TKT share ($)37.00 

Cost of settling convertible notes 170,092
     
Direct costs of acquisition 35,106

     
Total estimated purchase price 1,626,446

The estimated purchase price stated above has been allocated on a preliminary basis according to Shire’s estimate of the fair value of assets acquired and liabilities assumed. The fair values of certain pre-acquisition contingencies, in particular those relating to the Purported Class Action Shareholder Suit and the Shareholder Derivative Suit (see Part II, Item 1 of this Form 10-Q for further details) are yet to be determined. Shire currently does not have sufficient information to measure the contingencies.

The 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 time frame. To the extent that estimates need to be adjusted, Shire will do so in future periods in accordance with SFAS 141.

15






The purchase price was allocated as follows:

  Book valueAdjustments Fair value
 Notes$’000$’000 $’000



 
ASSETS    
Current assets:    
Cash and cash equivalents 56,814- 56,814
Restricted cash 8,173- 8,173
Short-term investments 46,896- 46,896
Accounts receivable, net 28,361- 28,361
Inventories(a)12,89088,879 101,769
Prepaid expenses and other current assets 7,997- 7,997


 
Total current assets 161,13188,879 250,010
         
Property, plant and equipment, net 57,297- 57,297
Goodwill 39,038(39,038)-
- on TKT acquisition(c)-164,041 164,041
Other intangible assets, net(d)20,210460,790 481,000
In process R&D(e)-673,000 673,000
Deferred tax asset(b)-74,761 74,761
Other non-current assets 3,281- 3,281


 
         
Total assets 280,9571,422,433 1,703,390


 
LIABILITIES    
Current liabilities:    
Accounts payable and accrued expenses(f)35,365437 35,802
Deferred tax liability(b)-32,885 32,885
Other current liabilities 6,451- 6,451


 
         
Total current liabilities 41,81633,322 75,138


 
         
Other long-term liabilities 1,806- 1,806


 
         
         
Total liabilities 43,62233,322 76,944


 
Estimated fair value of identifiable assets 237,3351,389,111 1,626,446
 acquired and liabilities assumed    


 

16






(a) Inventory

Components of the increase in fair value for acquired inventory are as follows:

  Fair value 
 Book valueadjustmentFair value
 $’000$’000$’000



Finished goods3,37766,81470,191
Work-in-process7,02722,06529,092
       
Raw materials2,486-2,486



       
 12,89088,879101,769



(b) Deferred taxes

The estimated tax effects of the acquisition, including TKT trading losses and the effect of the fair value adjustments for inventory and other intangible assets are as follows:

$’000

Deferred tax asset on TKT losses carried forward (net of valuation allowance of
$49.7 million) – long-term245,253
Deferred tax liability on other intangible assets – long-term(170,492)

Deferred tax asset, net74,761
Deferred tax liability on inventory - current(32,885)

Deferred tax, net41,876


(c) Goodwill

In accordance with the requirements of SFAS No. 142, “Goodwill and Other Intangible Assets” (SFAS No. 142), the goodwill associated with the TKT acquisition will not be amortized. Goodwill resulting from this acquisition has been allocated to the Pharmaceutical Products segment.

(d) Other intangible assets

The acquired identifiable intangible assets are attributable to the following categories:

  Fair value  
 Book valueadjustmentFair valueAsset life
 $’000$’000$’000years




Intellectual property(1)-335,000335,00014 to 20
Customer relationships(2)14,909104,091119,00015
Other (finite-lived assets)5,30121,69927,0007



         
 20,210460,790481,000 



(1)Relates to REPLAGAL (excluding US and Japan) and DYNEPO (for the treatment of anemia associated with kidney disease)
(2)Relates to REPLAGAL (excluding US and Japan)

Acquired identifiable intangible assets have been allocated to the Pharmaceutical Products reporting segment.

Acquired identifiable intangible assets represent the value associated with developed technology to which the Company has all associated rights. These rights can 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 compounds react in body, an understanding of the mechanisms of action which allow the compound to work and the knowledge related to

17






the associated clinical and marketing studies performed for these compounds) that were acquired as part of the transaction with respect to products and/or processes that have been developed.

The fair value of all of the identifiable intangible assets has been determined using an income approach on a project-by-project basis. This method starts with a forecast of all of the expected future net cash flows either generated or saved as a result of ownership of the intellectual property, the customer relationships and the other intangible assets. These cash flows are then adjusted to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.

The forecast of future cash flows requires various assumptions to be made, including:

  • revenue that is reasonably likely to result from the sale of products including the estimated number of units to besold, estimated selling prices, estimated market penetration and estimated market share and year-over-yeargrowth rates over the product life cycles;
  • royalty or licence fees saved by owning the intellectual property associated with the products;
  • cost of sales for the products using historical data, industry data or other sources of market data;
  • sales and marketing expense using historical data, industry data or other sources of market data;
  • general and administrative expenses;
  • research and development expenses; and
  • the estimated life of the products.

The valuations are based on the information that is currently available and the expectations and assumptions that have been deemed reasonable by the Company’s management. No assurance can be given, however, that the underlying assumptions or events associated with such assets will occur as projected. For these reasons, among others, the actual results may vary from the projected results.

(e) In-process R&D

As required by FASB Interpretation No. 4, "Applicability of FASB Statement No. 2 to Business Combinations Accounted for by the Purchase Method" (FIN 4), the portion of the purchase price allocated to in-process R&D of $673 million will be immediately expensed.

A project-by-project valuation using the guidance in SFAS 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 by independent valuation specialists to determine the fair value of research and development projects of TKT which were in-process, but not yet completed.

The fair value was determined using the income approach on a project-by-project basis. This method starts with a forecast of the expected future net cash flows. These cash flows are then adjusted to present value by applying an appropriate discount rate that reflects the project's stage of completion and other risk factors. These other risk factors can include the nature of the product, the scientific data associated with the technology, the current patent situation and market competition.

The forecast of future cash flows required various assumptions to be made including:

  • revenue that is likely to result from specific in-process R&D projects, including estimated number of units to besold, estimated selling prices, estimated market penetration and estimated market share and year-over-yeargrowth rates over the product life cycles;
  • cost of sales related to the potential products using historical data, industry data or other sources of market data;
  • sales and marketing expense using historical data, industry data or other market data;
  • general and administrative expenses; and
  • research and development expenses.

In addition the Company considered:

  • the project’s stage of completion;
  • the costs incurred to date;
  • the projected costs to complete;
  • the contribution, if any, of the acquired identifiable intangible assets;
  • the projected launch date of the potential product; and
  • the estimated life of the potential product.

18






To the extent that the in-process R&D project is expected to utilize the acquired identified intangible assets, the value of the in-process R&D project has been reduced to reflect this utilization. The acquired identified intangible assets include the technical processes, intellectual property, and institutional understanding with respect to products and processes that have been completed and that may aid in the development of future products or processes.

(f) Accounts payable and accrued expenses

Included in “Accounts payable and accrued expenses” are the following fair value adjustments:

(i) Restructuring costs

An estimate of restructuring costs that impact goodwill, pursuant to EITF Issue No. 95-3, “Recognition of Liabilities in Connection with Purchase Business Combinations” (EITF 95-3). Such costs total approximately $2.0 million and are associated with the involuntary termination of 15 TKT employees all of whom had left the company by September 30, 2005. As at September 30, 2005, $1.7 million had been paid and $0.3 million was outstanding; and

(ii) Deferred revenue

A fair value adjustment of $1.6 million in respect of a deferred revenue stream relating to pre-acquisition activities of TKT.

The following unaudited pro forma financial information presents the combined results of the operations of Shire and TKT as if the acquisition had occurred as at the beginning of the periods presented. 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.

 3 months to 3 months to 9 months to 9 months to 
 September 30, September 30, September 30, September 30, 
 2005 2004 2005 2004 
 $’000 $’000 $’000 $’000 

 
 
 
 
Revenues384,167 364,467 1,187,925 1,044,628 
Income before extraordinary items and    
cumulative effect of change in accounting    
principles52,527 55,314 114,945 123,729 
Net income52,527 55,314 114,945 123,729 

 
 
 
 
          
Per share amounts:    
Net income per common share -basic10.5c 11.1c 23.0c 24.9c 
Net income per common share -diluted10.4c 10.9c 22.8c 24.7c 

 
 
 
 

The unaudited pro forma financial information above reflects the following pro forma adjustments applied using the principles of Article 11 of Regulation S-X under the Securities Exchange Act of 1934:

(i) Elimination of historical amortization expense recorded by legacy TKT for definite-lived intangible assets;

(ii)Elimination of interest expense recorded by legacy TKT on convertible loan notes;

(iii)An adjustment to increase interest expense by $1.3 million and $8.8 million in the three months and nine months to September 30, 2005, and $1.6 million and $4.7 million in the three months and nine months to September 30, 2004, to reflect the interest payable to dissenting shareholders.

(iv)An adjustment to decrease interest income by $2.7 million and $18.6 million in the three months and nine months to September 30, 2005, and $4.2 million and $12.5 million in the three months and nine months to September 30, 2004, to reflect the cash consideration paid to TKT shareholders, option holders and convertible note holders; and

(v)Revised amortization expense based on the estimated fair value of identifiable intangible assets from the purchase price allocation, which are being amortized over their estimated useful lives over a range of 7 to 20 years, of approximately $5.9 million and $17.6 million in the three months and nine months to September 30, 2005, respectively and $5.9 million and $17.6 million in the three months and nine months to September 30, 2004, respectively.

In addition, the unaudited pro forma financial information above excludes the following material, non-recurring purchase accounting adjustments in the three months and nine months to September 30, 2005 as follows:

19






  • an in-process R&D charge of $673 million;
  • a $17.2 million charge relating to the use or sale of purchased inventory that was written up to fair value reportedin cost of product sales; and
  • a $7.6 million credit relating to the current deferred tax liability with regard to the purchased inventory charge incost of product sales above.

3. Integration costs

In connection with the acquisition of TKT, which completed on July 27, 2005, Shire management approved and initiated plans to restructure the operations of the enlarged Company to eliminate duplicate facilities and reduce costs.

Integration costs represent incremental costs incurred by the Company directly related to the absorption of the TKT business into the Company, including expenditures for consulting and systems integration. The charges have been presented as integration costs in the statement of operations and are accounted for solely within the Pharmaceutical Products reporting segment.

Integration costs expensed in the three and nine months to September 30, 2005 were:

 Costs recorded inPaid in 3 and 9  
 3 and 9 months tomonths to  
 September 30,September 30, Closing
 20052005 liability
 $’000$’000 $’000


 
Retention payments for key employees2,751(562)2,189
Other769(769)-


 
       
 3,520(1,331)2,189


 

4. Reorganizations

(a) North American site consolidation

As previously disclosed, Shirethe Company began a consolidation of its North American sites in 2004, with the aim of decreasing the number of sites from 16 to 4, including the opening of a new US headquarters office in Wayne, Pennsylvania. The Company recorded reorganization costs of $48.5 million in 2004, (of which $22.0$32.0 million was in the sixnine months to JuneSeptember 30, 2004), $2.9and $9.4 million in the sixnine months to JuneSeptember 30, 2005 and estimates further reorganization costs of approximately $9 million relating to2005. Following the cost of duplicate facilities following the planned closure of the Newport site in July 2005, the second half of 2005. The site consolidation is now complete and no further reorganization costs are expected to be complete by the end of 2005.incurred.

The primary costs associated with the site consolidation include:

  • severance costs relating to 138137 employees;

  • retention payments to key employees;

  • relocation costs relating to 85 employees who relocated to Wayne, Pennsylvania;

14






  • costs of duplicate facilities (including lease exit costs); and

  • other incremental costs associated with the site closures, such as legal and consultancy costs, the writedown of property, plant and equipment and information technology costs.

In the 1821 months to JuneSeptember 30, 2005, 135all 137 employees had left the Company. The cost of the employee severance has been ratably recognized over the period from the communication date to the termination date. In addition, all 85 of those employees who had agreed to relocate have relocated. The cost of relocation was recorded in the financial statements as it was incurred.

The following table presents the costcosts of the reorganization recorded to date and the total estimated costs of the reorganization. Management believes that the presentation of the reorganization costs to date, including those recorded in the 12 months to December 31, 2004, may be useful. After the reorganization is finalized and actions are completed, the Company will continue to update its reorganization accruals based on changes in estimates.

  6 months to
June 30,
2005
$m
 12 months to
December 31,
2004
$m
 18 months to
June 30,
2005
$m
 Total
estimated
costs
$m
 




 
Employee severance 1.6 20.0 21.6 22.0 
Relocation costs - 13.8 13.8 13.8 
Write-off of property, plant and equipment - 1.2 1.2 1.2 
Consultancy costs 0.5 2.9 3.4 3.4 
Duplicate facilities 0.7 5.1 5.8 14.5 
Information technology costs - 2.1 2.1 2.1 
Other costs 0.1 3.4 3.5 3.5 




 
  2.9 48.5 51.4 60.5 




 

The20






 9 months to12 months to21 months toTotal
 September 30,December 31,September 30,estimated
 200520042005costs
 $m$m$m$m




Employee severance1.620.021.621.6
Relocation costs-13.813.813.8
Write-off of property, plant and equipment-1.21.21.2
Consultancy costs0.52.93.43.4
Duplicate facilities7.25.112.312.3
Information technology costs-2.12.12.1
Other costs0.13.43.53.5
 



 9.448.557.957.9
 




These charges have been reflected within reorganization costs in the statement of operations and are accounted for solely within the Pharmaceutical Products reporting segment.

  3 months to
June 30,
2005
$m
 3 months to
June 30,
2004
$m
 6 months to
June 30,
2005
$m
 6 months to
June 30,
2004
$m
 




 
Employee severance - 7.5 1.6 9.9 
Relocation costs - 7.2 - 7.9 
Consultancy costs - - 0.5 - 
Duplicate facilities - - 0.7 - 
Other costs - 3.5 0.1 4.2 




 
  - 18.2 2.9 22.0 




 

15





 3 months to3 months to9 months to9 months to
 September 30,September 30,September 30,September 30,
 2005200420052004
 $m$m$m$m
 



Employee severance-2.61.612.5
Relocation costs-3.6-11.5
Duplicate facilities6.5-7.2-
Other costs-3.90.68.0
 



 6.510.19.432.0
 




As noted above, certain of the costs associated with the reorganization will be paid in subsequent periods, a portion of which are reflected as accrued expenses and other non-current liabilities. The following provides a reconciliation of the liability to date:

 Costs recordedUtilization  
Openingin 3 months toin 3 months to Closing
liabilitySeptember 30, 2005September 30, 2005 liability
Opening
  liability
  $m
 Costs recorded
in 3 months to
  June 30, 2005
  $m
  Utilization
  in 3 months to
June 30, 2005
$m 
  Closing
liability
  $m
$m$m$m $m

 
  
  



 
Employee severance2.1  -  (0.9 1.21.2-(1.2)-
Relocation costs1.7  -  (0.4 1.31.3-(0.2)1.1
Duplicate facilities2.2  -  (0.2 2.02.06.5(0.4)8.1


 
 



 
6.0  -  (1.5 4.54.56.5(1.8)9.2


 
 



 
Current liabilities (Note 7)3.8  1.6  (1.5 3.9
Current liabilities3.92.2(1.8)4.3
Other long-term liabilities2.2  (1.6 -  0.60.64.3- 4.9


 
 



 
6.0  -  (1.5 4.54.56.5(1.8)9.2


 
 



 

The employee severance and relocation costs willare expected to be paid in 2005. The duplicate facilities costs will be paid for over the remaining life of the relevant lease,leases, which is due to terminate in 2009.all expire on or before October 31, 2012.

(b)Disposal of the vaccines business

On September 9, 2004 the Company completed itsthe disposal of theits vaccines business to ID Biomedical Corporation (IDB). The total consideration for the sale was $120 million comprising $30 million of cash received at completion, $30

21






million of cash held in escrow and due on the first anniversary of completion and $60 million received at completion in the form of 4,931,864 subscription receipts of IDB. If, prior to January 10, 2005, IDB were to raise up to $60 million from equity related issuances, then it was required under the terms of the sale agreement to redeem the subscription receipts from Shire for $60 million. Accordingly, following the completion of such a fund raising on January 7, 2005, IDB redeemed the subscription receipts from Shire for $60 million in cash. On the first anniversary of completion, Shire received the $30 million of cash held in escrow.

As part of the transaction, Shire entered into an agreement to provide IDB with a loan facility of up to $100 million, which can be drawn down over the four years following completion. It is expected thatAs at September 30, 2005 IDB will drawhad drawn down the entire $100 million loan. This facility can be used by IDB to fund the development of injectable flu and pipeline products within the vaccines business acquired from Shire. Drawings under the loan facility are segregated into two components:

(i)drawings Drawings for injectable flu development with a minimum drawing of $30 million. Such drawings under the loan facility are repayable out of income generated by IDB on future non-Canadian injectable flu products, subject to minimum annual repayments in respect of the first $30 million of the drawing, to be made between 2007 and 2017; and

(ii)drawings Drawings for pipeline development from the balance of the $100 million loan facility of up to $70 million. Such drawings will be repayable out of income generated by IDB on future pipeline products and have no fixed repayment schedule.

The combined drawings of the two components of the loan facility cannot exceed $100 million. As of Juneat September 30, 2005, IDB had drawn down $86.7$100.0 million, $57.3$70.6 million for injectable flu development and $29.4 million for pipeline development. As of Juneat September 30, 2005 $13.3$1.0 million of the pipeline development loan has been repaid. This part repayment of the pipeline loan was in compliance with the terms of the loan agreement requiring IDB to make such payment in the event IDB sold and leased back any property acquired from Shire as part of the sale of the vaccines business. Under the terms of the loan facility remains undrawn.amounts repaid may not be redrawn by IDB.

The transaction gave rise to an overall loss on disposition of the vaccines business of $41.1$40.0 million, recorded as a loss on disposition at completion in 2004 of $44.2 million and a subsequent provision release of $3.1$4.2 million being recognized during the sixnine months to JuneSeptember 30, 2005. This net loss on disposal of $41.1$40.0 million comprises a gain on disposal of net assets of $28.9$30.0 million together with a provision for a loss of $70 million out of the $100 million loan facility available to IDB. This provision was made on the basis that those loan repayments based solely on future sales of flu and pipeline products in development provided no certainty of recovery.

165. Short-term investments






In July 2005, the Company liquidated short-term investments to provide funds for the acquisition of TKT. At September 30, 2005, the Company had short-term investments of $22.4 million (December 31, 2004: $324.4 million).

3.6. Accounts receivable, net

Trade receivables at JuneSeptember 30, 2005 of $246.6$282.3 million (December 31, 2004: $222.5 million), are stated net of a provisionaprovision for doubtful accounts and sales discounts of $9.2$9.8 million (June 30,(December 2004: $7.4$4.3 million).

The movement in the provision for doubtful accounts and sales discounts is as follows:    
 2005 2004 
 $’000  $’000 

 
 
As at January 1,4,264  7,853 
Charged to operations27,022  18,319 
Utilization(22,048 (18,748

 
 
As at June 30,9,238  7,424 

 
 

4. Inventories
 June 30  December 31 
 2005  2004 
 $’000  $’000 

 
 
Finished goods24,068   22,349  
Work-in-process12,879   11,831  
Raw materials10,730   7,050  

 
 
 47,677   41,230  

 
 


5. Prepaid expensesProvision for doubtful debts and other current assetsdiscounts:

June 30, December 31, 
2005 2004 
$’000  $’000 


 
Prepaid expenses16,179   31,401  
Subscription receipts (see Note 2)  60,000  
Cash held in escrow (see Note 2)30,000   30,000  
Supplemental Executive Retirement Plan (SERP) investment1,784   1,784  
Other current assets17,313   14,086  


 
 65,276   137,271  


 
 2005 2004 
 $’000 $’000 

 
 
As at January 1,4,264 7,853 
Provision charged to operations38,511 28,307 
Provision released to operations- (3,395)
Provision utilization(33,001)(27,473)

 
 
      
As at September 30,9,774 5,292 

 
 

6. Other intangible assets, net22

June 30,   December 31,  
2005   2004  
$’000   $’000  

 
 
Intellectual property rights acquired528,698  543,969 
Less: Accumulated amortization(248,257 (234,672

 
 
 280,441  309,297 

 
 





7. Inventories, net   
 September 30,  December 31, 
 2005  2004 
 $’000  $’000 

  
 
Finished goods82,330  22,349 
Work-in-process47,372  11,831 
Raw materials15,992  7,050 

  
 
 145,694  41,230 

  
 
       
The Company acquired $101.8 million of inventory at fair value as part of the acquisition of TKT (see note 2).
       
8. Prepaid expenses and other current assets   
 September 30,  December 31, 
 2005  2004 
 $’000  $’000 

  
 
 Prepaid expenses34,174  31,401 
 Income tax receivable14,147  - 
 Value added taxes receivable9,344  2,533 
 Supplemental Executive Retirement Plan (SERP) investment1,784  1,784 
 Other current assets21,710  11,553 
 Subscription receipts (see note 4b)-  60,000 
 Cash held in escrow (see note 4b)-  30,000 

  
 
       
 81,159  137,271 

  
 
       
       
9. Property, plant and equipment, net   
 September 30,  December 31, 
 2005  2004 
 $’000  $’000 

  
 
Land and buildings142,262  80,631 
Office furniture, fittings and equipment100,966  67,301 
Warehouse, laboratory and manufacturing equipment42,853  34,823 

  
 
 286,081  182,755 
       
Less: Accumulated depreciation(67,973) (51,404)

  
 
       
 218,108  131,351 

  
 
       
The Company acquired $57.3 million of property, plant and equipment at fair value as part of the acquisition of TKT (see note 2).

23      






10. Goodwill, net  
 September 30, December 31, 
 2005 2004 
 $’000 $’000 

 
 
Goodwill arising on businesses acquired429,497 296,607 
Less: Accumulated amortization(47,750)(61,211)

 
 
 381,747 235,396 

 
 
The Company recognized $164 million as goodwill on acquisition of TKT (see note 2), in accordance with SFAS No. 141. This goodwill is recorded in the Pharmaceutical Product segment.
   
      
11. Other intangible assets, net  
 September 30, December 31, 
 2005 2004 
 $’000 $’000 

 
 
Intellectual property rights acquired982,985 543,969 
Less: Accumulated amortization(233,610)(234,672)

 
 
 749,375 309,297 

 
 

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 charges in respect of intangible fixed assets held at JuneSeptember 30, 2005 will be approximately $40$88 million for each of the five years to JuneSeptember 30, 2010. Estimated amortization expense can be affected by various factors including future acquisitions, disposals of product rights and the technological advancement and regulatory approval of competitor products.

17The Company acquired $481 million of other identifiable intangible assets at fair value, as part of the acquisition of TKT (see note 2). The weighted average amortization of these assets is 16.8 years. These assets relate to intellectual property ($335 million), customer relationships ($119 million) and other finite-lived assets ($27 million).






7.12. Accounts payable and accrued expenses

September 30,December 31,
20052004
June 30,
2005
$’000
 December 31,
2004
$’000
$’000$’000

 


Trade accounts payable21,872 35,00829,05535,008
Accrued rebates - Medicaid92,386 84,75882,61184,758
Accrued rebates - Managed care19,210 14,667
Accrued rebates – Managed care19,84814,667
Sales return reserve27,974 22,53030,52922,530
Accrued bonuses22,137 23,17133,55923,171
Accrued coupons14,535 15,86910,29715,869
R&D accruals10,362 10,924
Research and development accruals16,89910,924
Marketing accrual28,993 26,09526,80226,095
Deferred revenue9,619 14,47213,50114,472
Reorganization accrual (see Note 2)3,920 1,936
Reorganization accrual (see note 4)4,3341,936
TKT acquisition costs accrual11,334-
Other accrued expenses70,805 61,80196,17261,801




321,813 311,231374,941311,231





24      






8.13. Other current liabilities
 June 30,
2005
$’000
 December 31,
2004
$’000
 
 
Income taxes payable50,516  12,597 
Deferred payments 18,980 
SERP1,904  1,904 
Other accrued liabilities37,441  44,077 


 89,861  77,558 



During the six months to June 30, 2005 the Company paid the remaining $19 million due in connection with the acquisition in 2004 of the exclusive commercialization rights to REMINYL in the UK and Republic of Ireland.

 September 30,December 31,
 20052004
 $’000$’000


Income taxes payable-12,597
Dividends payable9,191-
Deferred payments-18,980
SERP1,9041,904
     
Other accrued liabilities42,48844,077


     
 53,58377,558


9.14. Long-term debt, excluding current installments

On July 27, 2005,(i) Convertibles notes due 2011
The $0.1 million debt relates to the outstanding guaranteed convertible loan notes due 2011, which were issued by a wholly owned subsidiary of Shire completed its acquisition of Transkaryotic Therapies Inc. (TKT) in an all-cash transaction at $37 per outstanding TKT share, or approximately $1.6 billion.August 2001.

(ii) Multicurrency Revolving Facilities Agreement
In connection with the acquisition of TKT, described in note 13 below, Shire and certain members of the Shire Group entered into a Multicurrency Revolving Facilities Agreement (the “Facilities Agreement”) with ABN AMRO Bank N.V., Barclays Bank PLC, Citicorp International Plc,plc, Citigroup Global Markets Limited, HSBC Bank plc and The Royal Bank of Scotland plc (the “Lenders”) on June 15, 2005. The Facilities Agreement comprises two credit facilities: (i) a multicurrency three year revolving loan facility in an aggregate amount of $500 million (“Facility A”) and (ii) a 364 day revolving loan facility in an aggregate amount of $300 million (“Facility B” and together with Facility A, the “Facilities”). Shire has agreed to act as guarantor for any of its subsidiaries that borrowsborrow under the Facilities Agreement.

Facility A may be used for general corporate purposes, including financing the purchase price and other costs with respect to the acquisition of TKT (including refinancing TKT’s existing indebtedness). Facility B may be used only for financing certain milestone payments due under the agreement between Shire, and inter alia, New River Pharmaceuticals Inc. (New River), dated January 31, 2005.

18






Facility A terminates on June 15, 2008 and Facility B terminates on June 14, 2006. At Shire’s request, the Lenders may agree to successive annual extensions of Facility B, but not beyond the maturity date of Facility A. Alternatively, Shire has the right to draw Facility B or convert existing loans under Facility B into a term loan with the same maturity date as Facility A.

The availability of loans under each of the Facilities is subject to customary conditions, including the absence of any defaults thereunder and the accuracy (in all material respects) of Shire’s representations and warranties contained therein.

The Facilities include representations and warranties, covenants and events of default, including requirements that Shire’s ratio of Net Debt to EBITDA (as defined in the Facilities Agreement) not exceed 3.0 to 1 and that the ratio of EBITDA to Net Interest be not less than 4.0 to 1, both in respect of the most recently ended fiscal year, and limitations on the creation of liens, disposal of assets, incurrence of indebtedness, making of loans and giving of guarantees.

Interest on loans under the Facilities will be payable on the last day of each interest period, which period may be one, two, three or six months at the election of Shire (or as otherwise agreed with the Lenders). The interest rate on each loan for each interest period is the percentage rate per annum which is the aggregate of the applicable margin (ranging from 0.35 to 0.65 per cent per annum, depending on the ratio of Net Debt to EBITDA), LIBOR, and mandatory cost, if any (as calculated in accordance with Schedule 5 of the Facilities Agreement). Shire shall also pay fees equal to 35 per cent per annum of the applicable margin on available commitments under Facility A for the availability period applicable to Facility A and 20 per cent per annum of the applicable margin on available commitments under Facility B for the availability period applicable to Facility B in respect of the period prior to January 1, 2007, and 30 per cent per annum of the applicable margin thereafter. Interest on overdue amounts under the Facilities will accrue at a rate, which is one percent higher than the rates otherwise applicable to the loans under the Facilities.

Upon a change of control of Shire or upon the occurrence of an event of default and the expiration of any applicable cure period, the total commitments under the Facilities may be cancelled, all or part of the loans, together with accrued interest and all other amounts accrued or outstanding may be immediately due and payable and all or part of the loans may become payable on demand. Events of default under the Facilities include: (i) non-payment of any amounts due under the Facilities, (ii) failure to satisfy any financial covenants, (iii) material misrepresentation in any of the finance documents, (iv) failure to pay, or certain other defaults under, other financial indebtedness, (v) certain insolvency events or proceedings, (vi) material adverse changes in the business, operations, assets or financial condition of the group, (vii) certain ERISA breaches which would have a material adverse effect, (viii) change of control of a subsidiary of Shire that is a party to the Facilities Agreement, or (ix) if it becomes illegal for Shire or any of its subsidiaries that are parties to the Facility Agreement to perform their obligations or they repudiate the Facilities Agreement or any Finance Document (as defined in the Facilities Agreement).

There is a 90 day grace period for events of default relating to TKT.

The Facilities Agreement is governed by English law.

1925






As at September 30, 2005, the Company had not drawn-down on these facilities.

As at September 30, 2005 all of TKT Inc.’s 1.25% 2011 Convertible Notes had been converted and redeemed.

10.15. Other long-term liabilities

 September 30,
2005
$’000
December 31,
2004
$’000


SERP4,3313,591
Long-term bonuses3,2104,425
Deferred revenue7,2209,074
Insurance provisions11,4229,274
Lease improvement allowance6,065-
Onerous lease provision4,9671,500
Reorganization accrual4,8662,488
Other accrued liabilities2,9811,807


 45,06232,159



16. Commitments and contingencies

(a) Leases

Future minimum lease payments presented below include principal lease payments and other fixed executory fees under lease arrangements as of Juneat September 30, 2005:


Operating leases
 $’000Operating
leases
$’000
 

2005 6,4423,059
2006 14,66114,458
2007 13,83224,561
2008 12,30723,996
2009 10,28220,518
2010 7,84418,856
Thereafter 38,12954,710


 103,497160,158


 

(i) Operating leases

The Company leases facilities, motor vehicles and certain equipment under operating leases expiring through 2015.2016. Lease and rental expense included in selling, general and administrative expenses in the accompanying statements of operations amounted to $9.6$17.6 million for the sixnine months to JuneSeptember 30, 2005 (2004: $6.2$10.0 million).

During the sixnine months to JuneSeptember 30, 2004, Shire Inc., a wholly owned subsidiary of Shire, signed an eleven-yeartwo eleven year operating leaseleases on a propertyproperties in Wayne, Pennsylvania.Pennsylvania expiring through 2016. Shire US, Inc., another wholly owned subsidiary, acts as guarantor in respect of this lease.these leases. The future minimum lease payments under the lease agreementagreements are $34.4$57.6 million in aggregate.

26






(ii) Restricted cash in respect of leases

At JuneAs at September 30, 2005 the Company had $5.4 million of restricted cash held as collateral for certain equipment leases (December 31, 2004: $5.3 million).

(b) Letters of credit and guarantees

As of Juneat September 30, 2005, the Company had the following letters of credit:

(i) an irrevocable standby letter of credit with Barclays Bank plc, in the amount of $15.0 million, providing security on the recoverability of insurance claims. The Company has restricted cash of $15.0 million, as required by this letter of credit; and

(ii) an irrevocable standby letter of credit with Bank of America in the amount of $7.8 million, providing security on the payment of lease obligations. The Company has restricted cash of $7.8 million, as required by this letter of credit.

(c) Commitments

(i)Interests in companies and partnerships

The Company has undertaken to subscribe for interests in companies and partnerships for amounts totaling $16.2$24.5 million (December 31, 2004: $22.0$22.2 million) of which $8.3 million is committed to be paid in 2005 and a further $3.5$3.2 million could be payable in 2005, depending on the timing of capital calls.

(ii)Manufacturing facilityfacilities

The Company has committed to the expansion and modification of its two manufacturing facilityfacilities at Owings Mills, Maryland and Cambridge, Massachusetts to facilitate the production and packaging of additional strategic products. The Company has committed to spend a further $1.0$2.0 million by the end of 2005 and $1.6 million in 2006, and has an additional commitment of $3.0$1.9 million for the design and construction of a technology center at Owings Mills, which is expected to be incurred in 2005.

(iii)Wayne, Pennsylvania fit out

The Company is in the process of fitting out its new US headquarters at Wayne, Pennsylvania. As of JuneAt September 30, 2005 the Company had an outstanding commitment of $2.4$1.5 million, which is expected to be incurred in 2005.

(iv)NRP104Basingstoke, UK expansion
The Company is in the process of expanding its UK headquarters at Basingstoke, UK. As at September 30, 2005, the Company had an outstanding commitment of $4.9 million, which is expected to be incurred throughout 2005 and into 2006.

(v)NRP104
In connection with the Company’s collaboration with New River Pharmaceuticals Inc. (New River) to commercialize NRP104, the Company has an obligation to make certain payments on the achievement of the following milestones:



$50 $50 million upon the US Food and Drug Administration’s (FDA’s) acceptance of filing of the New Drug Application (NDA);up to $300 million following the first commercial sale of the product, depending on the characteristics of the approved product labelling; $100 million as a sales bonus on achieving a significant sales target; and $5 million following the first commercial sale in certain specified EU markets. An upfront payment of $50 million was expensed as an R&D cost during the first quarter of 2005. Regulatory submission is currently expected to be in the last quarter of 2005.

(v)(vi)MTSDAYTRANA (MTS)

In connection with the Company’s purchase of MTSDAYTRANA (MTS) in 2003, Shire has an obligation to make certain payments on the achievement of the following milestones: $50 million upon regulatory approval of the product, which will be capitalized and amortized over its useful economic life; and up to $75 million, linked to future sales performance. Regulatory approval is currently expected to be in the last quarter of 2005.

(vi)(vii)FOSRENOL patent rights

In connection with the Company’s purchase of the global patents for FOSRENOL, Shire now owns the FOSRENOL patents in the US and throughout the world (excluding Europe and Japan) and has agreed to pay AnorMED Inc. $6 million when FOSRENOL is approved in certain European countries for the assignment of the European patents and $6 million upon receipt of regulatory approval in Japan for the Japanese patents.

(vii)(viii)Other R&D commitments

As of Juneat September 30, 2005, the Company had commitments of $9.7$14.5 million on achievement of specified milestones.milestones of which $1.4 million is committed to be paid in 2005 and $8.1 million is expected to be paid in 2006.

27






(ix)TKT shareholders seeking appraisal rights
As at September 30, 2005, the holders of approximately 11.7 million shares of TKT common stock had submitted written demands for appraisal of their shares. For further information see Item 1 of Part II of this Form 10-Q. As at September 30, 2005 the Company included a liability of $433 million based on the merger consideration of $37 per share for the 11.7 million shares outstanding at that time. On October 10, 2005, at the request of one of the petitioners to tender 365,000 shares at the merger price of $37 per share, TKT filed a motion to dismiss the petitioner's demand. On October 12, 2005, the Delaware Court of Chancery granted this motion, and the petitioner tendered the shares at the merger consideration of $37 per share. Therefore, as at October 31, 2005, the holders of approximately 11.3 million shares of TKT common stock maintain their written demands for appraisal of their shares and have elected not to accept the $37 merger consideration. Until such time as the appraisal process is complete the Company is unable to determine the extent of its liability. For every $1 increase/decrease in the merger consideration applicable to those TKT shareholders who have asserted appraisal rights, the total estimated purchase price would increase/decrease by approximately $11.3 million.

(x)Clinical testing
As at September 30, 2005, the Company had committed to pay approximately $13.0 million to contract vendors for administering and executing clinical trials. The timing of payments is not reasonably certain as payments are dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities. However, the Company expects to pay for these commitments throughout 2005 and into 2006 as ongoing trials are completed.

(xi)Contract manufacturing
As at September 30, 2005, the Company had committed to pay approximately $16.8 million in respect of contract manufacturing over the next 12 months.

(d) Legal proceedings

(i)General
The Company accounts for litigation losses 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 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.

(ii)Specific
There are various legal proceedings brought by and against the CompanyShire that are discussed in the Company’sShire’s Annual Report on Form 10-K for the year to December 31, 2004. Material updates to the proceedings discussed in the Company’sShire’s Annual Report on Form 10-K are described below. On July 27, 2005, Shire completed its acquisition of TKT. In addition to the disclosures in Shire’s Annual Report on Form 10-K for the year to December 31, 2004 (as updated in Shire’s subsequent filings with the SEC), there are various legal proceedings brought by and against TKT which are described below. There is no assurance that the Companyenlarged Group will be successful in any of these proceedings and if it is not, there may be a material impact on the Company’senlarged Group’s results and financial position.

ADDERALL XR

(a)(i) Barr Laboratories, Inc.

Shire’s extended release "once daily" version of ADDERALL, ADDERALL XR is covered by US patent No. 6,322,819 (the ‘819 Patent) and US patent No. 6,605,300 (the ‘300 Patent). In January 2003 the Company was notified that Barr Laboratories, Inc. (Barr) had submitted an Abbreviated New Drug Application (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 (Barr’s ANDA products) prior to the expiration date of the Company’s ‘819 Patent, and alleging that the ‘819 Patent is not infringed by Barr's ANDA products. In August 2003 Shire was notified that Barr also was seeking permission to market its ANDA products prior to the expiration date of the ‘300 Patent and alleging that the ‘300 Patent is invalid. Shire Laboratories Inc (Shire Laboratories) filed suit against Barr for infringement of the ‘819 Patent in February 2003 and for infringement of the ‘300 Patent in September 2003. The schedules for the lawsuits against Barr with respect to the ‘819 and ‘300 Patents were consolidated in December 2003 and a trial date is scheduled for January 2006. The Company is seeking a ruling that Barr’s ANDA and ANDA products infringe the ‘819 and ‘300 Patents and its ANDA should not be approved before the expiration date of the patents. The Company is also seeking injunctions to prevent Barr from commercializing its ANDA products before the expiration of the ‘819 and ‘300

28






Patents, damages in the event that Barr should engage in such commercialization, and its attorneys’ fees and costs. On September 27, 2004 Barr filed an amended Answer, Affirmative Defense and Counterclaim in which Barr added the following



counterclaims: invalidity of the ‘819 patent, non-infringement of the ‘300 Patent and unenforceability of the ‘819 and ‘300 Patents due to inequitable conduct. Shire has asserted affirmative defenses, alleging, among other things, that Barr has waived its right to assert the counterclaims set forth in its September 27, 2004 amended answers. Under the Court’s schedule summary judgment motions were to be filed and fully briefed by October 14, 2005. Neither Shire nor Barr filed summary judgment motions. Trial in this action is scheduled for January 2006.

On October 19, 2005 Shire brought another lawsuit against Barr in the Southern District of New York alleging infringement of recently issued U.S. Patent No. 6,913,768 (the ‘768 patent). The Company is seeking injunctions to prevent Barr from infringing the ‘768 patent, damages in the event that Barr should commercialize its ANDA products, attorneys’ fees and costs.

(b)(ii) Impax Laboratories, Inc.

In November 2003, Shire was notified that Impax Laboratories, Inc. (Impax) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of the 30mg strength of ADDERALL XR (Impax’s ANDA product) prior to the expiration date of the ‘819 and ‘300 Patents. In December 2003, Shire Laboratories filed suit against Impax for infringement of the ‘819 and ‘300 Patents. The Company is seeking a ruling that Impax’s ANDA product infringes the ‘819 and ‘300 Patents and that its ANDA should not be approved before the expiration date of the ‘819 and ‘300 Patents. The Company is also seeking injunctions to prevent Impax from commercializing its ANDA product before the expiration of the ‘819 and ‘300 Patents, damages in the event that Impax should engage in such commercialization, and its attorneys’ fees and costs. Impax’s affirmative defenses include non-infringement and invalidity of both the ‘819 and ‘300 Patents.

In December 2004, Shire received an additional notification from Impax advising of the filing of an amendment to its ANDA for a generic version of the 5mg, 10mg, 15mg, 20mg and 25mg strengths of ADDERALL XR in addition to the 30mg strength, the subject of Impax’s initial ANDA. In January 2005, Shire Laboratories filed suit against Impax for infringement of the ‘819 and ‘300 Patents. The Company is seeking a ruling that Impax’s amended ANDA infringes the ‘819 and ‘300 patents and should not be approved before the expiration dates of the ‘819 and ‘300 Patents. The Company is also seeking an injunction to prevent Impax from commercializing its amended ANDA products before the expiration of the ‘819 and ‘300 Patents, damages in the event that Impax should engage in such commercialization, as well as its attorneys’ fees and costs. Impax’s affirmative defenses include non-infringement, invalidity and unenforceability of both the ‘819 and ‘300 Patents. Impax is also requesting that costs be assessed against the Company.

The Delaware District Court had set an October 11, 2005 trial date for the first Impax case. Following a scheduling conference with the same Court in the second case, a consolidated February 23, 2006 trial date has now been set for both cases. Impax has also filed for summary judgment of noninfringement with respect to the ‘819 and ‘300 patents. The Delaware District Court has not yet ruled on Impax’s motion.

As part of the October 19, 2005 lawsuit against Barr, Shire also brought suit in the Southern District of New York against Impax for infringing the ‘768 patent. The Company is seeking injunctions to prevent Impax from infringing the ‘768 patent, damages in the event that Impax should commercialize its ANDA products, attorneys’ fees and costs.

(c)(iii) Colony Pharmaceuticals Inc.

In December 2004, Shire was notified that Colony Pharmaceuticals, Inc. (Colony) 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 date of the Company’s ‘819 and ‘300 Patents. Shire has chosen not to sue Colony.

(d)(iv) Teva Pharmaceuticals USA, Inc.

In February 2005, Shire was notified that Teva Pharmaceuticals, USA, Inc. (Teva) had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic versions of the 10mg and 30mg strengths of ADDERALL XR prior to the expiration date of the Company’s ‘819 and ‘300 Patents. In June 2005, Shire was notified that Teva had amended it'sits ANDA to seek permission to market additional strengths of 5mg, 15mg and 20mg of ADDERALL XR prior to the expiration of the '819 and '300 Patents. Shire has chosen not to sue Teva.

None of Barr, Impax, Colony or Teva may launch their generic versions of ADDERALL XR before they receive final FDA approval of their respective ANDAs. In respect of Barr’s and Impax’s ANDAs, the lawsuits triggered stays of final FDA approval of up to 30 months from the date of the Company’s receipt of, respectively, Barr’s and Impax’s notice letters. Even if Barr and/or Impax receive tentative FDA approval of their ANDAs, neither of them can lawfully launch their generic versions of ADDERALL XR before the earlier of the expiration of the respective stays (Barr - February 2006; Impax - May 2006 in the case of the 30mg strength and June 2007 in the case of the 5mg, 10mg,15mg, 20mg and 25mg strengths) or a district court decision in its favor. In the event that the Company does not prevail in the Barr suit, Barr could be in a position to market its ANDA products upon FDA final approval of its ANDA. In the event the Company does not prevail in the Impax suit, Impax could be in a position to market its ANDA product upon FDA final approval of its ANDA and upon expiry of any exclusivity that Barr may hold. The FDA may grant 180 days of generic market exclusivity to the “first to file”.

29






Neither Colony nor Teva may market their ANDA products until FDA final approval of their ANDAs and upon the expiration of the first to file’s exclusivity rights.

The Hatch-Waxman exclusivity period for ADDERALL XR expired on April 11, 2005.



CARBATROL


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 Laboratories 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 Company was seeking a ruling that Nostrum’s ANDA infringes the ‘013 and ‘570 Patents and should not be approved before the expiration date of the ‘013 and ‘570 Patents. The Company was also seeking an injunction to prevent Nostrum from commercializing its ANDA product before the expiration of the ‘013 and ‘570 Patents, damages in the event that Nostrum should engage in such commercialization, as well as its attorneys’ fees and costs. On January 23, 2004 the Company amended the complaint to delete the allegations with respect to the ‘013 Patent while maintaining the suit with respect to the ‘570 Patent. By way of counterclaims Nostrum is seeking a declaration that the ‘570 and ‘013 Patents are not infringed by Nostrum’s ANDA product. Nostrum also was seeking actual and punitive damages for alleged abuse of process by Shire. On July 12, 2004 the Court dismissed Nostrum’s abuse of process counterclaim for failure to state a claim upon which relief can be granted. On December 10, 2004 Nostrum filed a summary judgment motion seeking a declaration of non-infringement of the ‘570 Patent. Shire’s opposition to this motion was filed on January 14, 2005. Summary judgment arguments were presented to the Court on July 15, 2005. The Court ruled duringAt the conclusion of the hearing thatthe Court denied Nostrum's motion for summary judgment was denied.judgment. Expert discovery will now continue. The Court will also set a new discoverycontinue and pretrial schedule.is scheduled to be completed by December 31, 2005. No trial date has been set.

Nostrum may not launch a generic version of CARBATROL before it receives final approval of its ANDA from the FDA. The lawsuit triggered a stay of FDA approval of up to 30 months from Shire’s receipt of Nostrum’s notice letter. Even if Nostrum receives tentative approval from the FDA for its ANDA, it cannot lawfully launch its generic version before the earlier of the expiration of the stay (February 2006) or a district court decision in its favor. In the event that the Company does not prevail, then Nostrum could be in a position to market its 300mg extended-release carbamazepine product upon FDA final approval of its ANDA.

TKT

Shire
On July 27, 2005, the Company completed its acquisition of TKT. There are various legal proceedings brought by and against TKT which are described below.

GA-GCB

In January 2005, Genzyme Corporation (Genzyme) filed suit against TKT in the District Court of Tel-Aviv-Jaffa, Israel, claiming that TKT's Phase 1/2 clinical trial in Israel evaluating GA-GCB for the treatment of Gaucher disease infringes one or more claims of Israeli Patent No. 100,715. In addition, Genzyme filed a motion for preliminary injunction, including a request for anex partehearing and relief on the merits, to immediately seize and destroy all GA-GCB being used to treat patients and to prevent TKT from submitting data generated from the clinical trial to regulatory agencies. In March 2005 the District Court refused to grant Genzyme's motion for a preliminary injunction. No trial date has been set.

DYNEPO

In April 1997, Amgen Inc. (Amgen) commenced a patent infringement action against TKT and Sanofi-Aventis in the United States District Court of Massachusetts. In January 2001, the United States District Court of Massachusetts concluded that DYNEPO infringed eight of the 18 claims of five patents that Amgen had asserted. Amgen did not seek and was not awarded monetary damages. This decision was subsequently appealed to the United States Court of Appeals for the Federal Circuit.

In January 2003, the United States Court of Appeals for the Federal Circuit issued a decision affirming in part and reversing in part the decision of the United States District Court of Massachusetts, remanded the action to the UnitedStates District Court of Massachusetts for further proceedings and instructed the United States District Court of Massachusetts to reconsider the validity of Amgen's patents in the light of potentially invalidating prior art.

30






In October 2004, the United States District Court of Massachusetts issued a decision on the remanded issues, finding that certain claims related to four patents held by Amgen are infringed by TKT and Sanofi-Aventis. In December 2004, TKT and Sanofi-Aventis filed a notice of appeal of the decision of the United States District Court of Massachusetts to the United States Court of Appeals for the Federal Circuit. TKT and Sanofi-Aventis filed an appeal brief in April 2005.

If TKT and Sanofi-Aventis are not successful in the DYNEPO litigation at the appellate level, TKT and Sanofi-Aventis would be precluded from making, using and selling DYNEPO in the United States until the expiration of the relevant patents. TKT 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. Sanofi-Aventis is entitled to deduct up to 50% of any royalties that Sanofi-Aventis may otherwise owe to TKT with respect to the sale of DYNEPO until Sanofi-Aventis has recouped the full amount of TKT's share of the litigation expenses. TKT has the right to control any other litigation that might arise outside of the United States and is responsible for all litigation expenses incurred in connection with such litigation from and after March 26, 2004.

Gene Activation

In 1996, Applied Research Systems Holding N.V., a wholly-owned subsidiary of Serono S.A. (Serono) and Cell Genesys became involved in a patent interference involving Serono's US Patent No. 5,272,071 (the "071 patent"), which purportedly covers certain methods of gene activation. In June 2004, the Board of Patent Appeals and Interferences of the US Patent and Trademark Office (PTO) held that both Serono and Cell Genesys were entitled to certain claims in their respective patent and patent application, and Serono and Cell Genesys each appealed the decision of the interference to the US District Court of Massachusetts and the US District Court of the District of Columbia, respectively. TKT was not a party to this interference.

In August 2004, Serono served TKT with an amended complaint in the appeal of the PTO decision that was filed in the US District Court of Massachusetts. The amended complaint alleges that TKT infringes Serono's '071 patent. In August 2005, the US District Court of Massachusetts severed and stayed the infringement action pending resolution of the interference claim at the District Court level.

Appraisal Rights

In connection with Shire’s merger with TKT, as at September 30, 2005, the holders of approximately 11.7 million shares of TKT common stock submitted written demands for appraisal of their 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 petitioners to tender 365,000 shares at the merger price of $37 per share, TKT filed a motion to dismiss the petitioner’s demand. On October 12, 2005, the Delaware Court of Chancery granted this motion, and the petitioner tendered the shares at the merger consideration of $37 per share. Therefore, as at October 28, 2005, the holders of approximately 11.3 million shares of TKT common stock maintain their written demands for appraisal of their shares and have elected not to accept the $37 merger consideration. To the extent that the remaining demands were validly asserted in accordance with the applicable requirements of Delaware law and these holders perfect their rights thereunder, such holders will be entitled to receive the fair value of their shares as determined by the Delaware Court of Chancery. The determination of fair value of the TKT shares 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.

Total consideration, including amounts payable in respect of stock options and convertible securities, is approximately $1.6 billion at the merger price of $37 per share. This could change if Shire is required to pay a different amount of consideration in respect of the approximately 11.3 million shares for which holders have exercised appraisal rights. Until such time as the appraisal process is complete the Company is unable to determine the extent of its liability.

Purported Class Action Shareholder Suit

In January and February 2003, various parties filed purported 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. The complaints generally allege securities fraud during the period from January 2001 through January 2003. Each of the complaints asserts claims under Section 10(b) of the Securities Exchange Act of 1934, Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act, and alleges that TKT and its officers made false and misleading

31






statements and failed to disclose material information concerning the status and progress for obtaining United States marketing approval of TKT's REPLAGAL product to treat Fabry disease during that period.

In March 2003, various plaintiffs filed motions to consolidate, to appoint lead plaintiff, and to approve plaintiffs' selections of lead plaintiffs' counsel. In April 2003, various plaintiffs filed a Joint Stipulation and Proposed Order of Lead Plaintiff Applicants to Consolidate Actions, to Appoint Lead Plaintiffs and to Approve Lead Plaintiffs' Selection of Lead Counsel, Executive Committee and Liaison Counsel. In April 2003, the Court endorsed the Proposed Order, thereby consolidating the various matters under one matter: In re Transkaryotic Therapies, Inc., Securities Litigation, C.A. No. 03-10165-RWZ.

In July 27,2003, 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, 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 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 securities fraud during the period from January 4, 2001 through January 10, 2003. 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 that period. The Amended Complaint asserts claims against Dr. Selden and TKT under Section 10(b) of the Exchange Act 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, 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 September 2003, TKT filed a motion to dismiss the Amended Complaint. A hearing of the motion occurred in December 2003. In May 2004, the United States District Court for the District of Massachusetts issued a Memorandum of Decision and Order denying in part and granting in part TKT's motion to dismiss the purported class action lawsuit. In the Memorandum, the Court found several allegations against TKT arose out of forward-looking statements protected by the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 (PSLRA). The Court dismissed those statements as falling within the PSLRA's safe harbor provisions. The Court also dismissed claims based on the public offerings of June 29, 2001 and December 18, 2001 because no plaintiff had standing to bring such claims. The Court allowed all other allegations to remain.

In June 2004, TKT submitted an unopposed motion seeking clarification from the Court that the Memorandum dismissed claims based on the first two offerings as to all defendants. The Court granted the motion. In July 2004, the plaintiffs voluntarily dismissed all claims based on the third offering because no plaintiff had standing to bring such claims.

The plaintiffs subsequently filed a motion seeking permission to notify certain TKT investors of the dismissal of the claims based on the offerings, and to inform those investors of their opportunity to intervene in the lawsuit. TKT filed an opposition to this motion in July 2004. A hearing on this motion was held in September 2004. The Court denied this motion. TKT filed an answer to the Amended Complaint in July 2004. The plaintiffs then filed a motion for class certification in July 2004. TKT filed an opposition to this motion in March 2005, and the plaintiffs filed a reply in April 2005. A hearing on class certification was held in April 2005. Following that hearing, TKT filed a supplemental brief in opposition to the motion for class certification and the plaintiffs filed a supplemental brief in support of the motion. The court has not yet ruled on this motion.

On September 14, 2005, the plaintiffs filed a Notice of Related Case Pursuant to Local Rule 40.1(G), in which they appeared to seek reassignment of a matter filed on September 1, 2005, entitled Securities and Exchange Commission v. Richard B. Selden, Civil Action No. 05-11805-NMG (D. Mass.) (the SEC Action), to the Court considering this matter. On September 15, 2005, the defendants filed a response to the notice, opposing reassignment of the SEC Action. On October 7, 2005, the plaintiffs filed a memorandum in response to the defendants' response.

Shareholder Derivative Suit

In April 2003, South Shore Gastrointerology UA 6/6/1980 FBO Harold Jacob, and Nancy R. Jacob Ttee filed a Shareholder Derivative Complaint against Dr. Selden; against the following members of TKT's board of directors: Jonathan S. Leff, Walter Gilbert, Wayne P. Yetter, Rodman W. Moorhead, III; against the following former members of

32






TKT's board of directors: James E. Thomas and William Miller; and against TKT as nominal defendant, in Middlesex Superior Court in the Commonwealth of Massachusetts, Civil Action No. 03-1669. On May 29, 2003, the parties moved to transfer venue to the Business Litigation Session in Suffolk Superior Court in the Commonwealth of Massachusetts. The parties' motion was allowed, and in June 2003 the matter was accepted into the Business Litigation Session as Civil Action No. 03-02630-BLS.

The complaint alleges that the individual defendants breached fiduciary duties owed to TKT and its shareholders by disseminating materially false and misleading statements to the market and causing or allowing TKT to conduct its business in an unsafe, imprudent and unlawful manner. The complaint purports to assert derivative claims against the individual defendants for breach of fiduciary duty, and to assert a claim for contribution and indemnification on behalf of TKT for any liability TKT incurs as a result of the individual defendants' alleged misconduct. The complaint seeks declaratory, equitable and monetary relief, an unspecified amount of damages, with interest, and attorneys' fees and costs.

In August 2003, the plaintiff filed its Verified Amended Derivative Complaint (the "Amended Derivative Complaint"). The Amended Derivative Complaint alleges that the individual defendants breached fiduciary duties owed to TKT and its stockholders by causing TKT to issue materially false and misleading statements to the public, by signing TKT's Annual ReportReports on Form 10-K for the year ended December 31,years 2000 and 2001 and by signing a registration statement. The Amended Derivative Complaint also alleges that defendant Dr. Selden sold TKT's stock while in possession of material non-public information. The plaintiff seeks declaratory, equitable and monetary relief, an unspecified amount of damages, with interest, and attorneys' fees and costs.

In September 2003, TKT filed a motion to dismiss the Amended Derivative Complaint. A hearing of the motion was held in January 2004. In May 2004, the Court granted TKT's motion to dismiss. In June 2004, the plaintiff filed a Notice of Appeal appealing the dismissal of the Amended Derivative Complaint to the Massachusetts Court of Appeals. There have been no further developments with respect to this action.

SEC Investigation

In May 2003, TKT received a copy of a formal order of investigation by the Securities and Exchange Commission. The order of investigation relates to TKT's disclosures and public filings with regard to REPLAGAL and the status of the approval process of the FDA for REPLAGAL, as well as transactions in TKT's securities.

In July 2004, TKT and Dr. Selden, its Quarterly Report on Form 10-Qformer Chief Executive Officer, received "Wells" notices from the staff of the SEC, in connection with the SEC investigation. The Wells notices state that the SEC staff has preliminarily determined to recommend that the Commission bring a civil action for possible violations of the three months ended March 31,federal securities laws. In September 2005, TKT described certain legal proceedings to whichthe Commission filed a suit against Dr. Selden and is seeking an injunction disgorgement, civil penalties and an order barring Dr. Selden from serving as an officer or director of a public company. Also in September 2005, the SEC staff informed the Company that it is a party.no longer recommending any enforcement action against TKT.

33






11.17. Earnings per share

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

 3 months to 3 months to 6 months to 6 months to3 months to
September 30,
2005
$’000
 3 months to
September 30,
2004
$’000
9 months to
September 30,
2005
$’000
 9 months to
September 30,
2004
$’000
 June 30, June 30, June 30, June 30,
 

 
 2005 2004 2005 2004
 $’000 $’000 $’000 $’000
 



Income from continuing operations 116,154 89,513 133,531 172,873
Loss from discontinued operations, net of tax - (11,349) - (20,135)
(Loss)/gain on disposition of discontinued operations - (44,157) 3,125 (44,157)




Numerator for basic earnings per share 116,154 34,007 136,656 108,581(624,194)77,040(487,538)185,621
Interest charged on convertible debt, net of tax - - 1 2,666
Interest charged on convertible debt, net of      
tax- 766- 3,432





 

 
Numerator for diluted earnings per share 116,154 34,007 136,657 111,247(624,194)77,806(487,538)189,053




        
 

 
Weighted average number of shares: No. of shares No. of shares No. of shares No. of sharesNo. of shares No. of sharesNo. of shares No. of shares





 

 
Basic 499,664,524 496,074,144 499,333,386 495,896,175500,542,616 496,474,005499,741,042 496,090,191
Effect of dilutive shares:          
Stock options 4,135,344 3,115,296 4,287,982 3,460,629- 2,474,699- 3,086,390
Warrants 224,894 52,392 234,916 94,742- -- 55,579
Convertible debt 5,756 - 5,756 18,370,564- 10,828,348- 15,838,142





 

 
 4,365,994 3,167,688 4,528,654 21,925,935




Diluted 504,030,518 499,241,832 503,862,040 517,822,110500,542,616 509,777,052499,741,042 515,070,302





 

 

TheFor the three and nine months ended September 30, 2005, the share options, warrants and convertible debt not included withinin the calculation of the diluted weighted average number of shares, (due to theirbecause the Company made a net loss during the calculation period, are shown below:

For the three and nine months ended September 30, 2004, the share options, warrants and convertible debt not included in the calculation of the diluted weighted average number of shares, because the exercise prices exceedingexceeded the Company’s average share price during the calculation period),period, are shown below:

 3 months to 3 months to 6 months to 6 months to3 months to
September 30,
2005
No. of shares
3 months to
September 30,
2004
No. of shares
9 months to
September 30,
2005
No. of shares
9 months to
September 30,
2004
No. of shares
 June 30, June 30, June 30, June 30,



 2005 2004 2005 2004
 $’000 $’000 $’000 $’000
 



Share options 6,899,222 17,996,604 6,907,099 14,566,902
Stock options23,092,43918,866,41520,278,37017,567,632
Warrants1,346,4071,346,4071,346,407-
Convertible debt - 18,370,564 - -5,756-5,756-








 6,899,222 36,367,168 6,907,099 14,566,90224,444,60220,212,82221,630,53317,567,632









12.18. 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 in deciding how to allocate resources and in assessing performance.

Shire sells a number of pharmaceutical products in multiple geographic markets across the world. The Company is continuously looking to develop and replenish its pharmaceutical product pipeline and has continued to focus on meeting the needs of the specialist physician in targeting therapeutic areas within its strategic aim.

In previous reporting periods, the Company’s internal management reporting structure was based on a combination of geography and function. As a result the Company provided segment information, which showed geographic sales and costs for the US and International sales and marketing businesses, R&D costs and a Corporate segment which included corporate costs and royalty income.

Following a restructuring of operational management into therapeutic areas, management has re-evaluated and amended its internal reporting structures giving rise to a change in reporting segments of the business.

Effective January 1, 2005, Shire’s internal management reporting structures have been changed to show two segments, Pharmaceutical Products and Royalties. The Pharmaceutical Products segment comprises threefour therapeutic areas, central nervous system (CNS), gastro-intestinal (GI), human genetic therapies (HGT) and general products (GP) and all products have been aggregated for reporting purposes within this segment.

34






The Company evaluates performance based on revenue and operating income. The Company does not have inter-segment transactions. Prior period amounts have been reclassified to conform to the new, current period presentation.

The Pharmaceutical Products segment represents the Company’s commercial operations and costs in respect of products currently promoted and sold together with costs of developing projects for future commercialization. The Royalties segment represents royalties earned from the out-licensing of products to third parties. These projects have been developed and commercialized by the third party and royalties are being received on the sale of the commercialized product. ‘All Other’ has been included in the table below in order to reconcile the segments to the total consolidated figures. Costs have not been allocated to Royalties below as the magnitude of the costs incurred in respect of managing this segment is small and the internal reporting consequently does not allocate costs to this segment. Assets that are directly attributable to the Royalty segment have been separately disclosed from the Pharmaceutical Products reportable segment.

3 months to September 30, 2005Pharmaceutical
Products
$’000
 Royalties
$’000
Segment
Sub-total
$’000
 All Other
$’000
Total
$’000
 

 

 

 
Product sales309,150 -309,150 -309,150 
Royalties- 60,18660,186 -60,186 
Licensing and development- -- 4,5864,586 
Other revenues- -- 2,1552,155 

 

 

 
Total revenues309,150 60,186369,336 6,741376,077 

 

 

 
Cost of product sales60,081 -60,081 -60,081 
Research and development72,956 -72,956 1,35574,311 
Selling, general and administrative154,912 -154,912 -154,912 
Depreciation and amortization(1)16,420 -16,420 -16,420 
Reorganization costs6,457 -6,457 -6,457 
Integration costs3,520 -3,520 -3,520 
In-process R&D write-off673,000 -673,000 -673,000 

 

 

 
Total operating expenses987,346 -987,346 1,355988,701 

 

 

 
Operating (loss)/income(678,196)60,186(618,010)5,386(612,624)

 

 

 
Total assets2,577,420 58,7592,636,179 -2,636,179 
Long lived assets1,489,172 -1,489,172 -1,489,172 
Capital expenditure on long lived assets13,723 -13,723 -13,723 

 

 

 

(1)Depreciation from manufacturing plants ($1.0 million) is included in cost of product sales.

35



Shire’s reportable segments for periods to June 30, 2004 and 2005 are as follows:

3 months to June 30, 2005 Pharmaceutical  Segment  
 Products Royalties Sub-total All Other Total
 $’000 $’000 $’000 $’000 $’000





Product sales 351,555 - 351,555 - 351,555
Royalties - 62,564 62,564 - 62,564
Licensing and development - - - 2,714 2,714
Other revenues - - - 7,763 7,763





Total revenues 351,555 62,564 414,119 10,477 424,596
           
Cost of product sales 41,945 - 41,945 - 41,945
Research and development 63,967 - 63,967 1,490 65,457
Selling, general and administrative 153,475 - 153,475 - 153,475
Depreciation and amortization(1) 20,079 - 20,079 - 20,079
Intangible asset impairment 3,000  3,000 - 3,000





Total operating expenses 282,466 - 282,466 1,490 283,956





Operating income 69,089 62,564 131,653 8,987 140,640





           
Total assets 2,739,945 58,812 2,798,757 - 2,798,757
Long-lived assets 778,863 - 778,863 - 778,863
Capital expenditure on long-lived assets 29,952 - 29,952 - 29,952









3 months to September 30, 2004Pharmaceutical
Products
$’000
 Royalties
$’000
Segment
Sub-total
$’000
 All Other
$’000
Total
$’000
 

 

 

 
Product sales283,723 -283,723 -283,723 
Royalties- 56,19956,199 -56,199 
Licensing and development- -- 2,8202,820 
Other revenues- -- 2,1672,167 

 

 

 
Total revenues283,723 56,199339,922 4,987344,909 

 

 

 
Cost of product sales38,933 -38,933 -38,933 
Research and development56,999 -56,999 76057,759 
Selling, general and administrative104,755 -104,755 -104,755 
Depreciation and amortization(1)14,891 -14,891 -14,891 
Intangible asset impairment5,456 -5,456 -5,456 
Reorganization costs10,061 -10,061 -10,061 

 

 

 
Total operating expenses231,095 -231,095 760231,855 

 

 

 
Operating income52,628 56,199108,827 4,227113,054 

 

 

 
Total assets from continuing operations2,518,596 46,6912,565,287 -2,565,287 
Long lived assets783,467 -783,467 -783,467 
Capital expenditure on long lived assets11,470 -11,470 -11,470 

 

 

 
  
(1) Depreciation from manufacturing plants ($0.7 million) is included in cost of product sales. 
         
9 months to September 30, 2005Pharmaceutical  Segment    
 Products RoyaltiesSub-total All OtherTotal 
 $’000 $’000$’000 $’000$’000 

 

 

 
Product sales930,149 -930,149 -930,149 
Royalties- 181,073181,073 -181,073 
Licensing and development- -- 11,16911,169 
Other revenues- -- 11,97511,975 

 

 

 
Total revenues930,149 181,0731,111,222 23,1441,134,366 

 

 

 
Cost of product sales135,359 -135,359 -135,359 
Research and development246,928 -246,928 4,372251,300 
Selling, general and administrative465,960 -465,960 -465,960 
Depreciation and amortization(1)50,135 -50,135 -50,135 
Intangible asset impairment3,000 -3,000 -3,000 
Reorganization costs9,335 -9,335 -9,335 
Integration costs3,520 -3,520 -3,520 
In-process R&D write-off673,000 -673,000 -673,000 

 

 

 
Total operating expenses1,587,237 -1,587,237 4,3721,591,609 

 

 

 
Operating (loss)/ income(657,088)181,073(476,015)18,772(457,243)

 

 

 
Total assets from continuing operations2,577,420 58,7592,636,179 -2,636,179 
Long lived assets1,489,172 -1,489,172 -1,489,172 
Capital expenditure on long lived assets85,380 -85,380 -85,380 

 

 

 

(1) Included in depreciation and amortization is the write-down of property, plant and equipment of $5.9 million. Depreciation from manufacturing plants ($0.92.7 million) is included in cost of product sales.

3 months to June 30, 2004 Pharmaceutical  Segment  
 Products Royalties Sub-total All Other Total
 $’000 $’000 $’000 $’000 $’000





Product sales 255,280 - 255,280 - 255,280
Royalties - 57,657 57,657 - 57,657
Licensing and development - - - 5,482 5,482
Other revenues - - - 2,541 2,541





Total revenues 255,280 57,657 312,937 8,023 320,960
           
Cost of product sales 26,984 - 26,984 - 26,984
Research and development 46,424 - 46,424 951 47,375
Selling, general and administrative 105,141 - 105,141 - 105,141
Depreciation and amortization(1) 13,079 - 13,079 - 13,079
Reorganization costs 18,167 - 18,167 - 18,167





Total operating expenses 209,795 - 209,795 951 210,746





Operating income 45,485 57,657 103,142 7,072 110,214





           
Total assets from continuing operations 2,617,074 57,166 2,674,240 - 2,674,240
Long-lived assets 700,258 - 700,258 - 700,258
Capital expenditure on long-lived assets 22,933 - 22,933 - 22,933





(1) Included in depreciation and amortization are the write-downs of property, plant and equipment of $0.8 million. Depreciation from manufacturing plants ($0.7 million) is included in cost of product sales.36



6 months to June 30, 2005 Pharmaceutical  Segment  
 Products Royalties Sub-total All Other Total
 $’000 $’000 $’000 $’000 $’000





Product sales 620,999 - 620,999 - 620,999
Royalties - 120,887 120,887 - 120,887
Licensing and development - - - 6,583 6,583
Other revenues - - - 9,820 9,820





Total revenues 620,999 120,887 741,886 16,403 758,289
           
Cost of product sales 75,278 - 75,278 - 75,278
Research and development 173,972 - 173,972 3,017 176,989
Selling, general and administrative 311,048 - 311,048 - 311,048
Depreciation and amortization(1) 33,715 - 33,715 - 33,715
Intangible asset impairment 3,000  3,000 - 3,000
Reorganization costs 2,878 - 2,878 - 2,878





Total operating expenses 599,891 - 599,891 3,017 602,908





Operating income 21,108 120,887 141,995 13,386 155,381





           
Total assets 2,739,945 58,812 2,798,757 - 2,798,757
Long-lived assets 778,863 - 778,863 - 778,863
Capital expenditure on long-lived assets 71,657 - 71,657 - 71,657









9 months to September 30, 2004Pharmaceutical
Products
$’000
 Royalties
$’000
Segment
Sub-total
$’000
 All Other
$’000
Total
$’000
 

 

 

 
Product sales803,597-803,597-803,597 
Royalties-170,001170,001-170,001 
Licensing and development---10,21710,217 
Other revenues---5,6545,654 





 
Total revenues803,597170,001973,59815,871989,469 





 
Cost of product sales100,010-100,010-100,010 
Research and development141,223-141,2232,537143,760 
Selling, general and administrative330,230-330,230-330,230 
Depreciation and amortization(1)40,474-40,474-40,474 
Intangible asset impairment5,456-5,456-5,456 
Reorganization costs32,041-32,041-32,041 





 
Total operating expenses649,434-649,4342,537651,971 





 
Operating income154,163170,001324,16413,334337,498 





 
Total assets from continuing operations2,518,59646,6912,565,287-2,565,287 
Long lived assets783,467-783,467-783,467 
Capital expenditure on long lived assets42,945-42,945-42,945 





 

(1) Included in depreciation and amortization is the write-down of property, plant and equipment of $5.9 million. Depreciation from manufacturing plants ($1.7 million) is included in cost of product sales.

6 months to June 30, 2004 Pharmaceutical  Segment  
 Products Royalties Sub-total All Other Total
 $’000 $’000 $’000 $’000 $’000





Product sales 519,874 - 519,874 - 519,874
Royalties - 113,802 113,802 - 113,802
Licensing and development - - - 7,397 7,397
Other revenues - - - 3,487 3,487





Total revenues 519,874 113,802 633,676 10,884 644,560
           
Cost of product sales 61,077 - 61,077 - 61,077
Research and development 84,224 - 84,224 1,777 86,001
Selling, general and administrative 225,475 - 225,475 - 225,475
Depreciation and amortization(1) 25,583 - 25,583 - 25,583
Reorganization costs 21,980 - 21,980 - 21,980





Total operating expenses 418,339 - 418,339 1,777 420,116





Operating income 101,535 113,802 215,337 9,107 224,444





           
Total assets from continuing operations 2,617,074 57,166 2,674,240 - 2,674,240
Long-lived assets 700,258 - 700,258 - 700,258
Capital expenditure on long-lived assets 31,475 - 31,475 - 31,475






(1) Included in depreciation and amortization are the write-downs of property, plant and equipment of $1.2 million. Depreciation from manufacturing plants ($1.32.0 million) is included in cost of product sales.


Supplemental information

To improve comparability between periods for investors, the previous reporting format has also been used to report the current period to JuneSeptember 30, 2005 together with the previously reported segmental analysis for the periods to JuneSeptember 30, 2004. Whilst there is no requirement to include this disclosure under SFAS No. 131 as the new internal reporting format has been used for the current and historic period, management believes that during 2005, it may be useful to include the previously reported segmental analysis for comparative purposes. This internal management-reporting format is no longer used as the basis for making decisions within the business.

3 months to June 30, 2005 US International Corporate R&D Total
 $’000 $’000 $’000 $’000 $’000





Product sales 301,480 50,075 - - 351,555
Royalties 262 1,957 60,345 - 62,564
Licensing and development 2,318 396 - - 2,714
Other revenues 3,796 3,967 - - 7,763





Total revenues 307,856 56,395 60,345 - 424,596
           
Cost of product sales 27,286 14,659 - - 41,945
Research and development - - - 65,457 65,457
Selling, general and administrative 103,566 27,936 21,973 - 153,475
Depreciation and amortization(1) 13,850 2,512 3,717 - 20,079
Intangible asset impairment 3,000 - - - 3,000





Total operating expenses 147,702 45,107 25,690 65,457 283,956





Operating income/(loss) 160,154 11,288 34,655 (65,457) 140,640





           
Total assets 1,204,263 403,792 1,127,566 63,136 2,798,757
Long-lived assets 314,518 132,380 291,030 40,935 778,863
Capital expenditure on long-lived assets 21,363 31 8,558 - 29,952





           

37







3 months to September 30, 2005US
$’000
International
$’000
Corporate
$’000
R&D
$’000
 TKT
$’000
 Total
$’000
 




 
 
 
Product sales240,37752,817-- 15,956 309,150 
Royalties1031,88358,200- - 60,186 
Licensing and development3,937649-- - 4,586 
Other revenues6071,333-- 215 2,155 




 
 
 
Total revenues245,02456,68258,200- 16,171 376,077 




 
 
 
Cost of product sales34,3166,381-- 19,384 60,081 
Research and development---60,114 14,197 74,311 
Selling, general and administrative100,50324,92522,521- 6,963 154,912 
Depreciation and amortization(1)4,3582,0203,531- 6,511 16,420 
Reorganization costs6,457--- - 6,457 
Integration costs203-464- 2,853 3,520 
In-process R&D write-off---- 673,000 673,000 




 
 
 
Total operating expenses145,83733,32626,51660,114 722,908 988,701 




 
 
 
Operating income/(loss)99,18723,35631,684(60,114)(706,737)(612,624)




 
 
 
Total assets from continuing793,073281,743707,23659,376 794,751 2,636,179 
operations         
Long lived assets268,315121,114692,91839,472 367,353 1,489,172 
Capital expenditure on long lived         
assets11,1704061,281- 866 13,723 




 
 
 

(1) Included in depreciation and amortization is the write-down of property, plant and equipment of $5.9 million included in the US segment. Depreciation from manufacturing plants ($0.91.0 million) is included in cost of product sales in the US segment. Depreciation and amortization relating to R&D assets are included in the US and International segments.

3 months to September 30, 2004US
$’000
International
$’000
Corporate
$’000
R&D
$’000
 Total
$’000
 




 
 
Product sales237,11246,611-- 283,723 
Royalties-2,28753,912- 56,199 
Licensing and development2,163657-- 2,820 
Other revenues1,198969-- 2,167 




 
 
Total revenues240,47350,52453,912- 344,909 




 
 
Cost of product sales22,27416,659-- 38,933 
Research and development---57,759 57,759 
Selling, general and administrative69,39718,94716,411- 104,755 
Depreciation and amortization(1)9,9883,3311,572- 14,891 
Intangible asset impairment1,5083,948-- 5,456 
Reorganization costs6,5012761,1832,101 10,061 




 
 
Total operating expenses109,66843,16119,16659,860 231,855 




 
 
Operating income/(loss)130,8057,36334,746(59,860)113,054 




 
 
Total assets from continuing operations975,842439,2721,092,83357,340 2,565,287 
Long-lived assets255,944241,735242,33343,455 783,467 
Capital expenditure on long lived assets6,5503854,158377 11,470 




 
 


3 months to June 30, 2004 US International Corporate R&D Total
 $’000 $’000 $’000 $’000 $’000





Product sales 210,004 45,276 - - 255,280
Royalties - 2,837 54,820 - 57,657
Licensing and development 4,395 1,087 - - 5,482
Other revenues 716 1,825 - - 2,541





Total revenues 215,115 51,025 54,820 - 320,960





Cost of product sales 20,101 6,883 - - 26,984
Research and development - - - 47,375 47,375
Selling, general and administrative 67,421 24,204 13,516 - 105,141
Depreciation and amortization(1) 7,158 2,956 2,965 - 13,079
Reorganization costs 9,563 2,696 2,839 3,069 18,167





Total operating expenses 104,243 36,739 19,320 50,444 210,746





Operating income/(loss) 110,872 14,286 35,500 (50,444) 110,214





Total assets from continuing operations 878,185 370,111 1,361,520 64,424 2,674,240
Long-lived assets 241,106 178,283 236,144 44,725 700,258
Capital expenditure on long-lived assets 2,893 1,000 18,773 267 22,933






(1) Included in depreciation and amortization are the write-downs of property, plant and equipment of $0.8 million included in the US segment. Depreciation from manufacturing plants ($0.7 million) is included in cost of product sales in the US segment. Depreciation and amortization relating to R&D assets are included in the US and International segmentssegments.

38


..

6 months to June 30, 2005 US International Corporate R&D Total
 $’000 $’000 $’000 $’000 $’000





Product sales 524,920 96,079 - - 620,999
Royalties 534 4,522 115,831 - 120,887
Licensing and development 5,544 1,039 - - 6,583
Other revenues 4,036 5,784 - - 9,820





Total revenues 535,034 107,424 115,831 - 758,289
           
Cost of product sales 46,333 28,945 - - 75,278
Research and development - - - 176,989 176,989
Selling, general and administrative 216,962 58,931 35,155 - 311,048
Depreciation and amortization(1) 21,347 5,246 7,122 - 33,715
Intangible asset impairment 3,000 - - - 3,000
Reorganization costs 2,228 - 307 343 2,878





Total operating expenses 289,870 93,122 42,584 177,332 602,908





Operating income/(loss) 245,164 14,302 73,247 (177,332) 155,381





           
Total assets 1,204,263 403,792 1,127,566 63,136 2,798,757
Long-lived assets 314,518 132,380 291,030 40,935 778,863
Capital expenditure on long-lived assets 37,731 1,050 32,876 - 71,657









9 months to September 30, 2005US
$’000
International
$’000
Corporate
$’000
R&D
$’000
 TKT
$’000
 Total
$’000
 




 
 
 
Product sales765,297148,896-- 15,956 930,149 
Royalties6376,405174,031- - 181,073 
Licensing and development9,4811,688-- - 11,169 
Other revenues4,6437,117-- 215 11,975 




 
 
 
Total revenues780,058164,106174,031- 16,171 1,134,366 




 
 
 
Cost of product sales80,64935,326-- 19,384 135,359 
Research and development---237,103 14,197 251,300 
Selling, general and administrative317,46583,85657,676- 6,963 465,960 
Depreciation and amortization(1)25,7057,26610,653- 6,511 50,135 
Intangible asset impairment3,000--- - 3,000 
Reorganization costs8,685-307343 - 9,335 
Integration costs203-464- 2,853 3,520 
In-process R&D write-off---- 673,000 673,000 




 
 
 
Total operating expenses435,707126,44869,100237,446 722,908 1,591,609 




 
 
 
Operating income/(loss)344,35137,658104,931(237,446)(706,737)(457,243)




 
 
 
Total assets from continuing793,073281,743707,23659,376 794,751 2,636,179 
operations         
Long-lived assets268,315121,114692,91839,472 367,353 1,489,172 
Capital expenditure on long lived         
assets48,9011,45634,157- 866 85,380 




 
 
 

(1) Included in depreciation and amortization are the write-downs of intangible assets of $3.0 million and property, plant and equipment of $5.9 million included in the US segment. Depreciation from manufacturing plants ($1.72.7 million) is included in cost of product sales in the US segment. Depreciation and amortization relating to R&D assets are included in the US and International segments.

9 months to September 30, 2004US
$’000
International
$’000
Corporate
$’000
R&D
$’000
 Total
$’000
 




 
 
Product sales670,412133,185-- 803,597 
Royalties-7,922162,079- 170,001 
Licensing and development8,4421,775-- 10,217 
Other revenues2,6373,017-- 5,654 




 
 
Total revenues681,491145,899162,079- 989,469 




 
 
Cost of product sales64,13535,875-- 100,010 
Research and development---143,760 143,760 
Selling, general and administrative214,01368,75247,465- 330,230 
Depreciation and amortization(1)27,0978,7414,636- 40,474 
Intangible asset impairment1,5083,948-- 5,456 
Reorganization costs18,9252,9724,0836,061 32,041 
Total operating expenses325,678120,28856,184149,821 651,971 




 
 
Operating income/(loss)355,81325,611105,895(149,821)337,498 




 
 
Total assets from continuing operations975,842439,2721,092,83357,340 2,565,287 
Long-lived assets255,944241,735242,33343,455 783,467 
Capital expenditure on long lived assets13,4282,54225,5091,466 42,945 




 
 

39


6 months to June 30, 2004 US International Corporate R&D Total
 $’000 $’000 $’000 $’000 $’000





Product sales 433,300 86,574 - - 519,874
Royalties - 5,635 108,167 - 113,802
Licensing and development 6,279 1,118 - - 7,397
Other revenues 1,439 2,048 - - 3,487





Total revenues 441,018 95,375 108,167 - 644,560





Cost of product sales 41,861 19,216 - - 61,077
Research and development - - - 86,001 86,001
Selling, general and administrative 144,616 49,805 31,054 - 225,475
Depreciation and amortization(1) 17,109 5,410 3,064 - 25,583
Reorganization costs 12,424 2,696 2,900 3,960 21,980





Total operating expenses 216,010 77,127 37,018 89,961 420,116





Operating income/(loss) 225,008 18,248 71,149 (89,961) 224,444





           
Total assets from continuing operations 878,185 370,111 1,361,520 64,424 2,674,240
Long-lived assets 241,106 178,283 236,144 44,725 700,258
Capital expenditure on long-lived assets 6,878 2,157 21,351 1,089 31,475









(1) Included in depreciation and amortization are the write-downs of property, plant and equipment of $1.2$1.6 million ($0.40.5 million in the Corporate segment and $0.8$1.1 million in the US segment). Depreciation from manufacturing plants ($1.32.0 million) is included in cost of product sales in the US segment. Depreciation and amortization relating to R&D assets are included in the US and International segments.

13. Subsequent events

Acquisition of TKT

On July 27, 2005, Shire Pharmaceuticals Group plc completed its acquisition of TKT pursuant to the Agreement and Plan of Merger, dated April 21, 2005 (the “Merger Agreement”), among Shire, Sparta Acquisition Corp., a Delaware corporation and wholly owned subsidiary of Shire (“Merger Sub”), and TKT. Shire’s acquisition of TKT was effected by merging Merger Sub with and into TKT (the “Merger”), with TKT continuing as the surviving corporation. As consideration for the Merger and pursuant to the terms of the Merger Agreement, Shire paid to TKT’s stockholders $37.00 in cash, without interest, for each share of TKT common stock outstanding at the time of the Merger, less any applicable withholding taxes. In addition, each outstanding option to purchase TKT common stock that was granted or committed to be granted prior to the date of the Merger Agreement became the right to receive the difference between $37.00 per share and the per share exercise price of such option, less any applicable withholding taxes, and each outstanding option to purchase TKT common stock that was granted pursuant to an offer of employment made on or after the date of the Merger Agreement was cancelled and will be substituted with an option having equivalent value under an equity compensation plan of Shire.

In connection with the merger, the holders of 12,318,765 shares of TKT common stock submitted written demands for appraisal of their shares and have, as a result, elected not to accept the $37.00 per share merger consideration. To the extent that these demands were validly asserted in accordance with the applicable requirements of Delaware law and these holders perfect their rights thereunder, such holders will be entitled to receive the fair value of their shares as determined by the Delaware Court of Chancery. The determination of fair value of the TKT shares 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 $37.00 per share and may award interest on the amount determined in the appraisal process. TKT shareholders who have asserted appraisal rights may within 60 days after the effective time of the Merger withdraw their demand for appraisal and accept the $37.00 per share Merger consideration in cash.

For accounting purposes, the acquisition of TKT will be accounted for as an acquisition in accordance with SFAS 141, “Business Combinations”.



Funding of the Acquisition

The total cost of the acquisition of approximately $1.6 billion will be funded from Shire’s existing cash resources and drawings from a $500 million general purpose bank facility. In addition Shire has arranged a separate $300 million bank facility solely for the purpose of financing certain milestone payments due under the agreement between Shire and New River relating to NRP104. For details of the Facilities Agreement see Note 9.

14.19. Related parties

In April 2005, Shire BioChem Inc. (BioChem) contributed cash of $4.1 million (CAN$ 5.05 million) to ViroChem Pharma Inc. in return for an additional equity interest. Dr Bellini, a non-executive director of BioChem had an indirect substantial interest in a company which is a co-investor of ViroChem Pharma Inc.

In October 2005, the Company sub-leased its office premises in Newport to Xanodyne Pharmaceuticals Inc. Dr James Cavanaugh, the non-executive Chairman of the Company, is the Chairman of Xanodyne Pharmaceuticals Inc.

40






ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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 pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system (CNS), gastrointestinal (GI), general products (GP) and rarehuman genetic diseasestherapies (HGT) - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through product or project acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small scalesmall-scale sales force will deliver strong results.

Shire’s focused strategy is to develop and market products for specialty physicians. This approach aims to deliver increased returns and lower risks. Shire’s in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

In accordance with this strategy Shire completed theThe acquisition of TKT on July 27, 2005.2005 added the HGT business to Shire and Shire views TKTthis business as complementary to and consistent with Shire's stated strategy of meeting the needs of the specialist physician using small scale sales forces.physician.

TKT’s business is focused on enzyme replacement therapy (ERT) prescribed by a small number of specialist physicians, who can also be reached through small scale sales forces. The ERT business has a relatively small number of competitors and the diseases that TKT focuses on generally result in products that have long lifecycles, aided by orphan drug status.

Significant events in the three months to JuneSeptember 30, 2005

Generic versions of AGRYLINTranskaryotic Therapies, Inc.

AGRYLIN’s pediatric marketing exclusivity expiredOn July 27, 2005, Shire completed its acquisition of TKT. As consideration, Shire paid to TKT’s stockholders $37 in cash for each share of TKT common stock outstanding at the time of the acquisition.

The total cash consideration for the acquisition of TKT is expected to be approximately $1.6 billion, subject to change as may be required by the appraisal rights process. As at September 2004 in30, 2005 shareholders owning approximately 24.4 million TKT shares had accepted the USoffer and on April 18, 2005during the FDA rejected Shire’s Citizens’ Petition, whichperiod $903 million had been filedpaid to them, $83.4 million was paid in connection with TKT stock options and $170.1 million in connection with convertible notes, outstanding at the FDAdate of acquisition.

See note 2 to the unaudited consolidated financial statements in August 2004. The FDA subsequently approved several generic versions of AGRYLIN which, as expected, adversely affected Shire’s sales of this product inForm 10-Q for further information on the US.acquisition.

Generic version of ADDERALL XR

In JuneFDA approval of the adolescent indication for ADDERALL XR was received during July.

ADDERALL XR in Canada

On August 24, 2005, Shire was notifiedannounced that Teva had submitted an ANDA underHealth Canada would reinstate the US Hatch-Waxman Act seeking permission to market its generic versions of the 5mg, 15mg and 20mg strengthsmarketing authorization of ADDERALL XR prior toin Canada effective August 26, 2005. This reinstatement followed the expiration dateacceptance by Health Canada of the Company’s patents. This isrecommendations from the New Drug Committee (NDC), which was appointed by Health Canada at Shire’s request to review the suspension in addition to Teva’s February 2005 notification regarding 10mg and 30mg strengths. On April 11, 2005 the Company announced that it had chosen not to sue Teva in respect of the 10mg and 30mg strengths and on July 19, 2005, the Company announced that it would not sue Teva in respect of the 5mg, 15mg and 20mg strengths.

Shire has also been notified that Barr, Impax and Colony have submitted applications to the FDA seeking permission to market generic versionsCanada of ADDERALL XR. For further information see ITEM 1The NDC, comprised of Part IIthree highly qualified, independent experts in the fields of this Form 10-Q: Legal Proceedings.pediatric cardiology, pediatric development and behavioral problems, and pharmacoepidemiology, examined the scientific evidence made available to them by both Shire and Health Canada. The NDC recommended that Health Canada reinstate ADDERALL XR’s marketing authorization.

REMINYL

Shire has submitted its response to the preliminary Appraisal Consultation Document issued by theThe National Institute for Health and Clinical Excellence in England and Wales (NICE) which recommended thatis reviewing all existing approved products for the symptomatic treatment of mild to moderate Alzheimer's disease in England and Wales, werewhich includes a proposal to no longer to be reimbursablereimburse these products under the National Health Service (NHS) when used by new patients. NICE’s final recommendation was expected to be published in June 2005. However, on July 18, 2005, NICE announced that it had delayed its decision and asked the pharmaceutical companies that market drugs to treat Alzheimer's disease to identify sub-groups of patients who may get benefit from the treatments. Shire and the other concerned pharmaceutical companies are in ongoingon-going discussions with NICE.



Shire and Janssen’s affiliate, Johnson & Johnson Pharmaceutical Research & Development, LLC, are in the final stages of discussions with the UK and Irish regulatory authorities in relation to updated wording of the labeling for REMINYL. When finalized, the new label will incorporate information from the investigational studies in mild cognitive impairment.

On April 11, 2005, Ortho-McNeil Neurologics Inc. (Janssen’s US affiliate company) announced that REMINYL would be marketed in the US under the new product name of RAZADYNE. Ortho-McNeil Neurologics Inc. worked closely with the FDA on a name change following dispensing errors in the US, between REMINYL and the Type 2 diabetes mellitus drug known as AMARYL. Shire is unaware of any similar dispensing errors outside the US and REMINYL continues to be marketed outside the US under its original name.

North American site consolidation

The Company is continuingShire has completed its North American site consolidation, which commenced in 2004. Although noThe remaining costs of $6.5 million were incurred in the three months to JuneSeptember 30, 2005, the Company intends to closewhen Shire closed its Newport site in the second half of 2005 and this will represent the final element of the reorganization program. The remaining costs in respect of the site consolidation are expected to be approximately $9 million.site. See Note 2note 4 to the condensedunaudited consolidated financial statements in this Form 10-Q for further information.

41






Recent developments

Transkaryotic Therapies, Inc.ADDERALL XR

On July 27, 2005, (i) Patent litigation
Shire completedcontinues to defend its acquisition of TKT in an all-cash transaction at $37 per outstanding TKT share, or approximately $1.6 billion. See Note 13 to the condensed consolidated financial statements in this Form 10-Q for further information.

ADDERALL XR adolescent

Intellectual Property. In September 2004 a supplemental new drug application (sNDA) for the use of ADDERALL XR in the adolescent population was submitted to the FDA. On July 22,October 2005, Shire announced that the FDA approvedit has filed a lawsuit against Barr and Impax with respect to US patent No. 6,913,768 (‘768). Shire believes that both Barr’s and Impax’s generic ADDERALL XR as a once-daily treatment for adolescents aged 13 to 17 with ADHD.

CARBATROLproducts infringe the ‘768 patent litigation

On July 15, 2005,claims. The case was filed in the United States District Court for theSouthern District of New Jersey denied Nostrum’s motionYork. The earlier filed cases against Barr and Impax involving the ‘819 and ‘300 patents are scheduled to go to trial in January 2006 and on February 23, 2006 respectively. There will be no 30 month stay associated with the filing of the ‘768 patent case. The ‘768 patent is directed to pharmaceutical compositions comprising a once-a-day sustained release formulation of at least one amphetamine salt for the treatment of ADHD. Impax has filed for summary judgment. Consequently,judgment in respect to non-infringement of the lawsuit between‘819 and ‘300 patents in the district court of Delaware. The Court has not yet ruled on Impax’s motion. The schedule in the Barr case provided that summary judgement motions were to be filed and fully briefed by October 14, 2005. Neither Shire nor Barr filed summary judgement motions. Trial in the Barr case is scheduled for January 2006.

Litigation proceedings relating to the Company’s ADDERALL XR patents are in progress. For further information see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings. Any decrease in the sales of ADDERALL XR could significantly reduce revenues and Nostrumearnings.

(ii) Citizen petition
During October 2005, Shire filed a Citizen Petition with the FDA requesting that the FDA require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference ADDERALL XR, before they can be approved. Shire believes that these requested criteria will continueensure that generic formulations of ADDERALL XR or follow-on drug products will be clinically effective and safe. The FDA has six months to move toward trial. No trial date has yet been set byrespond to Shire’s petition, however it does not preclude the Court.FDA from granting approval or tentative approval to generic or follow-on product referencing ADDERALL XR during that time.

Research and development

Shire focuses its resources on projects within its core therapeutic areas in late stage development, which Shire believes are at lower risk. The Company presently has one

Products in pre-launch at September 30, 2005

DYNEPO: DYNEPO was approved in the EU in March 2002 and is indicated in "treatment of anemia in patients with chronic renal failure. It may be used in patients on dialysis and patients not under dialysis". Shire expects to commence a staged launch in Europe of the product in registration for the treatmentsecond half of ADHD (MTS) and four projects2006. DYNEPO is being evaluated in a controlled Phase 3 of development – three(P3) trial for the treatment of ADHD (NRP104, SPD465, SPD503) and one for the treatment of ulcerative colitis (SPD476).anemia associated with cancer chemotherapy.

Products in registration at JuneSeptember 30, 2005

MTS:DAYTRANA (MTS): On October 27, 2005 Shire acquired the worldwide sales and marketing rights to MTS, a methylphenidate transdermal delivery system for the once daily treatment of ADHD, from Noven in February 2003. In April 2003 Noven received a “not approvable” letter from the FDA. A complete response to the “not approvable” letter was submitted on June 28, 2005 following the completion of an extensive clinical program designed to address concerns raised by the FDA. On July 26, 2005 the Company announced that the FDA had acceptedamended New Drug Application (NDA) will be reviewed by the FDA’s Psychopharmacologic Drugs Advisory Committee at their scheduled open session on December 2, 2005. The NDA amendment to the NDA and confirmed that the amendment will receivehas been assigned a six month review.Prescription Drug User Fee Act date of December 28, 2005.

In addition to FDA approval, an application must be made to the US Drug Enforcement AgencyAdministration (DEA) for procurement quotas in order to obtain access to methylphenidate. Pursuant to recent legislation, the DEA cannot establish procurement quotas following FDA approval of a NDA for a controlled substance (including methylphenidate) until after the DEA reviews and provides public comment on the labeling, promotion, risk management plan and other documents associated with the product. Any delay by the DEA in establishing Shire's procurement quotas for methylphenidate could delay the launch of MTS.DAYTRANA (MTS).



Products in late stage development as of Juneat September 30, 2005

  • SPD476MESAVANCE (SPD476) for ulcerative colitis, which is in Phase 3P3 development. During the three months to JuneSeptember 30, 2005, Shiremet withactivities to support the FDA and EU Regulatory Agencies to discuss the proposedfirst regulatory filing strategy. The FDA filingis anticipated(anticipated in late 2005;2005) continued;

  • NRP104 for ADHD which is in Phase 3 development in collaboration with New River. During the three monthsto June 30, 2005 New River reported positive Phase 3 data for NRP104.(P3). Shire is working with New River tosupportto support their activities leading to regulatorysubmission, which New River has stated it expects to make in thefourth quarter of 2005;

  • SPD503 for ADHD (P3). The FDA filing is anticipated in the first half of 2006;

42






  • SPD465 for ADHD which is in Phase 3 development.(P3). During the three months to September 30, 2005, encouraging data was received fromthe first pivotal P3 study. The FDA filing is anticipated in the first half of 2006; and

  • SPD503I2S for ADHD, which isHunter Syndrome (P3). Shire expects to file for regulatory approval for I2S in Phase 3 development. Duringboth the three months to JuneUS and Europe inthe fourth quarter of 2005.

Products in early stage development as at September 30, 2005 Shire met withthe FDA

  • SPD483 for the treatment of ADHD entered Phase I (P1) / Phase 2 (P2) development with plans to discusstransitioninto P3 during 2006; and

  • GA-GCB for Gaucher disease (P1/P2). In April 2004, a clinical trial to evaluate the proposed regulatory filing strategy. In order to optimize the characterization of theproductsafety and clinical activity ofGA-GCB was initiated. Results from this study will be announced in the label , Shire has agreed with the FDA to include results from an ongoing study in its submissionpackage. As a result the FDA filing is now anticipated in the firstsecond half of 2005 and, assumingfavourable results, Shire intends to commence a P3 pivotal clinical trial in 2006.

43






Results of operations for the three months to JuneSeptember 30, 2005 and 2004

Overview

On July 27, 2005, Shire completed the acquisition of TKT. This acquisition added the HGT business to Shire. The results for the three months to September 30, 2005 include the results of TKT from the date of acquisition.

Total revenues

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

 3 months to 3 months to  3 months to3 months to
 June 30, June 30,  September 30,September 30,
 2005 2004 Change 20052004change
 $’000 $’000 % $’000$’000%






Product sales 351,555 255,280 +38309,150283,723+9
Royalties 62,564 57,657 +960,18656,199+7
Licensing and development 2,714 5,482 -504,5862,820+63
Other 7,763 2,541 +2062,1552,167-






Total 424,596 320,960 +32376,077344,909+9






Product sales

Product sales

For the three months to JuneSeptember 30, 2005 product sales increased 38% ($96.3 million)9% to $351.6$309.2 million (2004: $255.3$283.7 million) and represented 83%82% of total revenues (2004: 80%82%).

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

 3 months to 3 months to Product US 3 months to3 months toProductUS
 June 30, June 30, sales prescription September 30,September 30,salesprescription
 2005 2004 growth growth 20052004growthgrowth
 $’000 $’000 % % $’000$’000%%








CNS    
ADDERALL XR 205,424 143,484 +43 +15165,863140,051+18+11
ADDERALL 12,053 1,261 n/a n/a9,57111,736-18n/a
CARBATROL 21,785 11,863 +84 -516,12911,225+44-12
    
GI    
PENTASA 30,989 26,433 +17 +1036,56833,025+11+6
COLAZIDE 2,185 2,004 +9 n/a2,2882,126+8n/a
    
GP    
AGRYLIN and XAGRID* 29,667 33,974 -13 -35
AGRYLIN and XAGRID
North America (US & Canada)4,78340,993-88-71
RoW11,9788,728+37n/a
FOSRENOL 9,865 - n/a n/a9,722-n/an/a
CALCICHEW 10,082 9,066 +11 n/a10,1249,550+6n/a
SOLARAZE3,3432,444+37n/a
REMINYL/REMINYL XL2,3272,609-11n/a
HGT
REPLAGAL*15,956-n/an/a
    
OTHERS20,49821,236-3n/a



309,150283,723+9




* This represents REPLAGAL sales for the two month period since acquisition.

44


SOLARAZE 3,031 2,188 +39 n/a
REMINYL/RAZADYNE 2,898 2,828 +2 n/a
        
Other product sales 23,576 22,179 +6 



 351,555 255,280 +38 




*XAGRID is not included in US prescription growth


Note: 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, JuneSeptember 2005. IMS Health is a leading global provider of business intelligence for the pharmaceutical and healthcare industries.

ADDERALL XR

US prescriptions for ADDERALL XR for the three months to JuneSeptember 30, 2005 were up 15% due primarily to an 8%11%. ADDERALL XR enhanced its leading market position with a 1% increase in the total US ADHD market share, in a market that grew 4% overall compared to the same period in 2004 and an increase in ADDERALL XR’s market share.2004.

ADDERALL XR had a 24%25% share of the total US ADHD market in JuneSeptember 2005 (June 2004: 23%) and continues to maintainstrengthened its position as the leading brand in the US ADHD market.

Product sales growth was higher than prescription growth for the quarter due mainly to the impact of price increases in JuneDecember 2004 and December 2004August 2005 and lower sales deductions.

FDA approval of the adolescent indication for ADDERALL XR was received during July 2005.

On August 24, 2005, Shire is continuing with its appeal in relation toannounced that Health Canada would reinstate the February 2005 suspension of salesmarketing authorization of ADDERALL XR in Canada effective August 26, 2005. This reinstatement follows the acceptance by Health Canada.

Canada of the recommendations from the NDC, which was appointed by Health Canada at Shire’s request to review the suspension in Canada of ADDERALL XR’s pediatric exclusivityXR. The NDC, comprised of three highly qualified, independent experts in the fields of pediatric cardiology, pediatric development and behavioral problems, and pharmacoepidemiology, examined the scientific evidence made available to them by both Shire and Health Canada. The NDC recommended that Health Canada reinstate ADDERALL XR.

During October 2005, Shire filed a Citizen Petition with the FDA requesting that the FDA require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference ADDERALL XR, before they can be approved. Shire believes that these requested criteria will ensure that generic formulations of ADDERALL XR or follow-on drug products will be clinically effective and safe. The FDA has six months to respond to Shire’s petition, however it does not preclude the FDA from granting approval or tentative approval to generic or follow-on products referencing ADDERALL XR during that time.

Shire continues to defend its intellectual property. In October 2005, Shire announced that it has filed a lawsuit against Barr and Impax with respect to US underpatent No. 6,913,768 (‘768). Shire believes that both Barr’s and Impax’s generic ADDERALL XR products infringe the Hatch-Waxman regulations expired‘768 patent claims. The case was filed in the Southern District of New York. The earlier filed cases against Barr and Impax involving the ‘819 and ‘300 patents are scheduled to go to trial in January 2006 and on April 11,February 23, 2006 respectively. There will be no 30 month stay associated with the filing of the ‘768 patent case. The ‘768 patent is directed to pharmaceutical compositions comprising a once-a-day sustained release formulation of at least one amphetamine salt for the treatment of ADHD. Impax has filed for summary judgment in respect to non-infringement of the ‘819 and ‘300 patents in the district court of Delaware. The Court has not yet ruled on Impax’s motion. The schedule in the Barr case provided that summary judgement motions were to be filed and fully briefed by October 14, 2005. Neither Shire nor Barr filed any summary judgement motions. Trial in the Barr case is scheduled for January 2006.

LitigationFor further information about the litigation proceedings relating to the Company’sCompany‘s ADDERALL XR patents are in progress. For further information see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings. Any decrease in the sales of ADDERALL XR could significantly reduce revenues and earnings.

CARBATROL

US prescriptions for the three months to JuneSeptember 30, 2005 were down 5%12%, compared to the same period in 2004. This was due primarily to limited promotion of this product duringsupply constraints and a 6% decrease in the quarter as promotional resources were diverted to other products.total US carbamazepine prescription market. The supply constraints have now been resolved.

Product sales for the three months to JuneSeptember 30, 2005 were up 84%44%, compared to the same period in 2004. The difference between sales growth and the lower level of prescriptions is due to a significant wholesaler re-stocking in order to replenish a previously low pipeline, aDecember 2004 price increase in August 2004 and significantly lower sales deductions.deductions in comparison to the high levels in the same period in 2004.

CARBATROL had a 43% share of the total US extended release carbamazepine prescription market in JuneSeptember 2005 (June(September 2004: 45%).

Patent litigation proceedings with Nostrum relating to CARBATROL are in progress. On July 18, 2005, the United States Federal District Court in Trenton, New Jersey denied Nostrum’s motion for summary judgment. Consequently, the lawsuit between Shire and Nostrum will continue to move toward trial. No trial date has been set by the Court. For further information see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings.

45






PENTASA

US prescriptions for the three months to JuneSeptember 30, 2005 were up 10%6%, compared to the same period in 2004. The increase was largely due to the success of the co-promotional agreement with Solvay Pharmaceuticals, Inc. and the impact of the 500mg dosage form launched in the third quarter of 2004.2004, in conjunction with a 2% increase in the total US oral mesalamine prescription market.

Product sales for the three months to JuneSeptember 30, 2005 were up 17%11%, compared to the same period in 2004. The difference between sales growth and prescription growth is due to the impact of the September 2004 price increase which more than offset some limited wholesaler de-stocking and increased sales deductions.increase.

PENTASA had a 19%an 18% share of the total US oral mesalamine prescription market in JuneSeptember 2005 (June(September 2004: 17%).



AGRYLIN and XAGRID

AGRYLIN/XAGRID sales worldwide for the three months to JuneSeptember 30, 2005 were $29.7$16.8 million, down 13%66% compared to the same period in 2004 (Q2(Q3 2004: $34.0$49.7 million).

USAs expected, North American sales were down 31%88% due to the impact of generic versions of AGRYLIN being approved in the US market in April after2005.

Rest of the FDA rejected Shire’s Citizens’ Petition.

International SalesWorld sales (all sales outside the US) reported in US dollarsNorth America) were up 23%37%, primarily due to the successful launch of XAGRID in the UK, Germany and France in the first quarter of 2005. In accordance with current orphan drug legislation in the EU, XAGRID will have up to 10 years of marketing exclusivity in the EU.

FOSRENOL

US prescriptions for the three months to JuneSeptember 30, 2005 were up 100%19%, to 36,00043,000 prescriptions, compared to the previous quarter (Q1(Q2 2005: 18,000)36,000). FOSRENOL was launched in the US in January 2005.

Product sales for the three months to JuneSeptember 30, 2005 were up 101%,$9.7 million (Q2 2005: $9.9 million). The difference between sales and prescription growth is due to $9.9 million, compared topipeline inventories declining from a comparatively high level of stocking in the previousprior quarter (Q1 2005: $4.9 million).after the initial launch of FOSRENOL in the first quarter.

FOSRENOL had an 8% share of the total US phosphate binding market in JuneSeptember 2005.

Shire continues its discussions relating to FOSRENOL with regulatory authorities across Europe and other regions. Launches willare anticipated to begin in Europe during 2005,shortly, subject to obtaining national approvals and concluding pricing and concluding reimbursement negotiations.

REPLAGAL

REPLAGAL was acquired by Shire as part of the TKT acquisition, which completed on July 27, 2005. Product sales for the period since acquisition were $16 million. The majority of REPLAGAL sales are in Europe.

Royalties

Royalty revenue increased 9%7% to $62.6$60.2 million for the three months to JuneSeptember 30, 2005 (2004: $57.7$56.2 million) and represented 15%16% of total revenues (2004: 18%16%). The following table provides an analysis of Shire’s royalty income:

  3 months to3 months to
  September 30,September 30,
  20052004change
  $’000$’000%



3TC39,59937,871+5
ZEFFIX7,7317,034+10
Others12,85611,294+14



Total60,18656,199+7




46






3TC

 3 months to 3 months to 
 June 30, June 30, 
 2005 2004 change
 $’000 $’000 %



 3TC 40,475 39,636 +2
 ZEFFIX 7,736 6,802 +14
 Others 14,353 11,219 +28



 Total 62,564 57,657 +9



3TC   

Royalties from sales of 3TC for the three months to JuneSeptember 30, 2005 were $40.5$39.6 million, an increase of 2%5% compared to the three months to JuneSeptember 30, 2004 ($39.637.9 million). This was due to the continued growth in the nucleoside analogue market for HIV and the positive impact of foreign exchange movements.

Shire receives royalties from GSK on worldwide 3TC worldwide sales, with the exception of Canada where a commercialization partnership with GSK exists.sales. GSK’s worldwide sales of 3TC for the three months to JuneSeptember 30, 2005 were $309$301 million (2004: $298$291 million).

ZEFFIX

Royalties from sales of ZEFFIX for the three months to JuneSeptember 30, 2005 were $7.7 million, an increase of 14%10% compared to the three months to JuneSeptember 30, 2004 ($6.87.0 million), due to strong growth in the Japanese market and the positive impact of foreign exchange movements.market.

Shire receives ZEFFIX royalties from GSK on worldwide sales, with the exception of Canada where a commercialization partnership with GSK exists.ZEFFIX sales. GSK’s worldwide sales of ZEFFIX for the three months to JuneSeptember 30, 2005 were $68$67 million (2004: $60$61 million).



Other

Other royalties are primarily in respect of REMINYL and REMINYL XL (now marketed as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide by Janssen, with the exception of the United Kingdom and the Republic of Ireland where Shire acquired the exclusive marketing rights from May 2004.

On April 11, 2005, Ortho-McNeil Neurologics Inc. (Janssen’s US affiliate company) announced that REMINYL would be marketed in the US under the new product name of RAZADYNE. Ortho-McNeil Neurologics Inc. worked closely with the FDA on a name change following dispensing errors in the US, between REMINYL and the Type 2 diabetes mellitus drug known as AMARYL. Shire is unaware of any similar dispensing errors outside the US and REMINYL continues to be marketed outside the US under its original name. Shire is only aware of one similar dispensing error outside the US.

Sales of the REMINYL/RAZADYNE arange, for the symptomatic treatment forof mild to moderately severe dementia of the Alzheimer’s type, are growing well in the Alzheimer’s market.

Shire and Janssen’s affiliate, Johnson & Johnson Pharmaceutical Research & Development, LLC, are in the final stages ofongoing discussions with the UK and IrishEuropean regulatory authorities in relation to updated wordingtheir assessment of the labelingdata for REMINYL. When finalized, the new label will incorporate informationREMINYL from the investigational studies in mild cognitive impairment. Labeling changes have now been agreed.

Shire has submitted its response to the preliminary Appraisal Consultation Document issued by the National Institute for Health and Clinical Excellence in England and Wales (NICE) which recommended. This preliminary appraisal recommends that all existing approved products for the symptomatic treatment of mild to moderate Alzheimer's disease in England and Wales wereare no longer to be reimbursable underby the National Health Service (NHS) when used by new patients. NICE’s final recommendation was expected to be published in June 2005. However, on July 18, 2005 NICE announced that it had delayed its decision and asked the pharmaceutical companies that market drugs to treat Alzheimer's disease to identify sub-groups of patients who may get benefit from the treatments. Shire and the other concerned pharmaceutical companies are in ongoing discussions with NICE.

Cost of product sales

For the three months to JuneSeptember 30, 2005 the cost of product sales amounted to 12%19% of product sales (2004: 11%14%). The decrease in gross margin is primarily driven by the addition of REPLAGAL to Shire’s product portfolio following the acquisition of TKT. REPLAGAL’s cost of product sales relates entirely to acquired inventories and is therefore based on the fair value of that acquired inventory. In accordance with US GAAP acquired finished goods have been valued at 97% of the expected sales price of REPLAGAL and so virtually no margin will be reflected for REPLAGAL sales until acquired finished goods have been sold (anticipated Q3 2006). For the three months to September 30, 2005 the REPLAGAL cost of product sales includes a change$17.2 million adjustment in respect of the product mix, with more income being generated from loweracquired inventory, of which $15.1 million related to sales of acquired finished goods and $2.1 million was a write off of damaged work in progress. The fair value adjustment decreased gross margin products.by 5%.

Research and development (R&D)

R&D expenditure increased from $47.4$57.8 million in the three months to JuneSeptember 30, 2004 to $65.5$74.3 million in the three months to JuneSeptember 30, 2005. Expressed as a percentage of total revenues, R&D expenditure was 15%20% for the three months to JuneSeptember 30, 2005 (2004: 15%17%). The increase in R&D expenditure is primarily the result of adding two significant projects following the acquisition of TKT. Such projects represented 3% of R&D expenditure as a percentage of revenues. Shire’s pipeline is now well advanced with fiveseven projects in late stage development or registration.

47






Selling, general and administrative (SG&A)

Total SG&A expensescosts increased from $118.2$119.6 million in the three months to JuneSeptember 30, 2004 to $173.6$171.3 million in the three months to JuneSeptember 30, 2005, an increase of 47%43%. As a percentage of product sales, SG&A expenses were 49%55% (2004: 46%42%).

3 months to June 30, 2005 2004 Change
 $M $M %



Sales costs 49.6 34.8 +43
Marketing costs 61.2 44.1 +39
Other SG&A costs 42.7 26.2 +63



 153.5 105.1 +46
Depreciation and amortization1 20.1 13.1 +53



Total SG&A costs 173.6 118.2 +47



     
3 months to September 30,20052004Change
$M$M%



Sales costs45.835.8+28
Marketing costs58.743.1+36
Other SG&A costs50.425.8+95



154.9104.8+48
Depreciation and amortization116.414.8+11



Total SG&A costs171.3119.6+43



1. Excludes depreciation from manufacturing plants of $0.9$1.0 million (2004: $0.7 million) which is included in cost of product sales.



Sales, marketing and other SG&A costs increased from $104.8 million in the three months to JuneSeptember 30, 2004 to $154.9 million in the three months to September 30, 2005 increased 46% to $153.5 millionan increase of 48%. As a percentage of product sales, these expenses were 50% (2004: $105.1 million)37%).

This increase was expected with additional costs in the three months to JuneSeptember 30, 2005 attributable to four product launches in the first half of 2005. In addition there is anduring 2005, incremental costcosts in 2005 associated with the FOSRENOL and EQUETRO sales forces. Sales, marketing and otherforces, $7.0 million of SG&A costs have moderated (Q1: $157.6 million)associated with TKT and this trend is expected$4.5 million relating to continue throughout the remainderset up of 2005.the new listed holding company for the Shire group.

The depreciation charge for the three months to JuneSeptember 30, 2005 was $11.1$4.6 million (2004: $3.1$5.3 million) which includes a write-down of property, plant and equipment of $5.9 million.. Amortization charges, including the amortization on acquired products, were $9.0$11.8 million for the three months to JuneSeptember 30, 2005 (2004: $10.0$9.5 million).

Intangible asset impairment
Reorganization costs
The intangible asset impairment charge for

During the three months to JuneSeptember 30, 2005 was $3.0Shire incurred costs of $6.5 million (2004: $nil). The impairment charge arose as a result$10.1 million) following the closure of the economic valueNewport, Kentucky site in July 2005. Following this closure, the site consolidation is now complete and strategic worth of the product concerned being less than its carrying value.

Reorganizationno further reorganization costs
The Company incurred no costs in are expected to be incurred. During the three months to JuneSeptember 30, 2004 the reorganization costs related to employee severance ($2.6 million), relocation ($3.6 million) and other costs associated with the reorganization ($3.9 million).

Integration costs

For the three months to September 30, 2005, in relation to the reorganizationCompany incurred $3.5 million of costs associated with the integration of the TKT business announced in 2004 (2004: $18.2 million). There are expected remaining costs of approximately $9 million in respectinto the Group. This primarily related to retention payments for key staff.

In-process R&D

During the three months to September 30, 2005, as required under US GAAP (business combination accounting), Shire wrote off the portion of the reorganization relatingTKT purchase price allocated to duplicate facilities. These costs will be booked whenin-process R&D of $673.0 million. This amount represents the Company ceases to use its Newport facility,fair value of those intangible assets acquired as part of the TKT acquisition which is expected to occurhave not been approved by the end of 2005.

For further information see NoteFDA or other regulatory authorities. See note 2 to the condensedunaudited consolidated financial statements in this Form 10-Q.10-Q for further information.

48






Interest income and expense

For the three months to JuneSeptember 30, 2005 the Company received interest income of $11.3$6.9 million (2004: $4.4$5.7 million). This increase in interest income is primarily due to higher interest rates on the Company'sour US cash deposits.deposits partially offset by the interest foregone by Shire on the net payments of $1.1 billion made to date in respect of the acquisition of TKT.

For the three months to JuneSeptember 30, 2005 the Company hadincurred interest expense of $1.2$3.5 million. This expense includes a $2.5 million provision in respect of interest, which primarily relatedmay arise as a result of the court appraisal process on amounts due to shareholders who have requested appraisal of the acquisition consideration payable for their shares.

The charge in Q3 2004 of $8.0 million included the write-off of deferred issuance costs capitalized at the time of a bridging loan to finance the TKT transaction (2004: interest onShire’s convertible loan notes: $2.1 million).notes issue in 2001. These costs were being amortized over the life of the notes but were written off following the redemption of $370.1 million of loan notes in Q3 2004.

Other income,income/(expense), net

For the three months to JuneSeptember 30, 2005 other income totaled $0.8$3.2 million (2004: $14.1expense of $4.9 million). During the three months to JuneSeptember 30, 2004,2005 other income was primarily attributable to the realized gain onincome generated from the sale of acertain portfolio investment.

Taxation
The effective rate of tax forinvestments. During the three months to JuneSeptember 30, 2004 other expense was primarily attributable to the write down of certain portfolio investments.

Taxation

In respect of the three month period to September 30, 2005, the tax charge was 24% (2004: 30%). The Company’scalculated using the expected effective rate for the period of 28% and was adjusted for the effect of the non-deductible write-off of in-process R&D, resulting in an effective tax rate was 4% lower than infor the first quarter of 2005. The reduction in rate this quarter followed the conclusion of a routine tax audit. -3% (2004: 28%).

At JuneSeptember 30, 2005 net deferred tax assets of $87.5$85.4 million were recognized (December 31, 2004: $78.1 million).

Equity in earnings of equity method investees
Earnings

Losses of $0.9$0.6 million were recorded for the three months to JuneSeptember 30, 2005 (2004:(2004 earnings of: $1.1 million) being the earnings of $1.2 million). Earnings of $1.3 million representing afrom the 50% share of earnings from the antiviral commercialization partnership with GSK in Canada (2004: $1.2$1.1 million) were, offset by the share of losses in the GeneChem and EGS Healthcare Funds of $0.4$1.8 million (2004: $nil).

Discontinued operations

During the three months to September 30, 2005 $1.0 million of the pipeline loan to IDB was repaid. The pipeline loan had been fully provided for in 2004 at the time of the sale of the vaccines business to IDB. This part repayment of the pipeline loan was in compliance with the terms of the loan agreement requiring IDB to make such payment in the event IDB sold and leased back any property acquired from Shire as part of the sale of the vaccines business.

49






Results of operations for the sixnine months to JuneSeptember 30, 2005 and 2004

Overview

On July 27, 2005, Shire completed the acquisition of TKT. This acquisition added the HGT business to Shire. The results for the three months to September 30, 2005 include the results of TKT from the date of acquisition.

Total revenues

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

 6 months to 6 months to  9 months to9 months to
 June 30, June 30,  September 30,September 30,
 2005 2004 Change 20052004change
 $’000 $’000 % $’000$’000%






Product sales 620,999 519,874 +19930,149803,597+16
Royalties 120,887 113,802 +6181,073170,001+7
Licensing and development 6,583 7,397 -1111,16910,217+9
Other 9,820 3,487 +18211,9755,654+112






Total 758,289 644,560 +181,134,366989,469+15






   

Product sales

For the sixnine months to JuneSeptember 30, 2005, product sales increased 19% ($101.1 million)16% to $621.0$930.1 million (2004: $519.9$803.6 million) and represented 82% of total revenues (2004: 81%). The following table provides an analysis of the Company’s key product sales:

 6 months to 6 months to Product US
 June 30, June 30, sales prescription
 2005 2004 growth growth
 $’000 $’000 % %




 CNS    
 ADDERALL XR 350,960 282,946 +24 +15
 ADDERALL 21,462 10,675 +101 n/a
 CARBATROL 38,694 27,648 +40 -2
     
 GI    
 PENTASA 57,209 53,680 +7 +8
 COLAZIDE 4,232 3,818 +11 n/a
     
 GP    
 AGRYLIN and XAGRID* 61,617 72,274 -15 -15
 FOSRENOL 14,762 - n/a n/a
 CALCICHEW 18,229 17,975 +1 n/a
 SOLARAZE 5,433 3,770 +44 n/a
 REMINYL/RAZADYNE 5,833 5,374 +9 n/a
 Other product sales 42,568 41,714 +2 



 620,999 519,874 +19 



      
*XAGRID is not included in US prescription growth
  9 months to9 months toProductUS
  September 30,September 30,salesprescription
  20052004growthgrowth
  $’000$’000%%




CNS
ADDERALL XR516,823422,997+22+14
ADDERALL31,03322,411+38n/a
CARBATROL54,82338,873+41-5
 
GI
PENTASA93,77786,705+8+7
COLAZIDE6,5205,944+10n/a
 
GP
AGRYLIN AND XAGRID
 North America (US & Canada)41,95096,840-57-35
 RoW36,42825,155+45n/a
FOSRENOL24,484-n/an/a
CALCICHEW28,35327,525+3n/a
SOLARAZE8,7766,214+41n/a
REMINYL/RAZADYNEREMINYL XL9,3847,983+17n/a
 
HGT
REPLAGAL15,956-n/an/a
     
OTHERS61,84262,950n/an/a



930,149803,597+16




50





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, JuneSeptember 2005. IMS Health is a leading global provider of business intelligence for the pharmaceutical and healthcare industries.

ADDERALL XR

US prescriptions for ADDERALL XR for the sixnine months to JuneSeptember 30, 2005 were up 15%,14%. ADDERALL XR enhanced its leading market position with a 1% increase in US market share, in a market that grew 6% overall compared to the same period in 2004, due to2004.

ADDERALL XR had a 1% increase in ADDERALL XR’s total25% share of the US ADHD market, from 23% in June 2004 to 24% in June 2005 and a 7% increase in the total US ADHD market in September 2005 and strengthened its position as the leading brand in the US ADHD market.



Product sales growth of 24% was higher than US prescription growth of 15% for the sixnine months to September 30, 2005, due mainly to the impact of price increases in JuneDecember 2004 and December 2004 offset by modest destockingAugust 2005 and modest increases inlower sales deductions.

In February 2005, Shire announced that Health Canada had suspended sales of ADDERALL XR in Canada where sales in 2004 amounted to $7.8 million. The suspension followed Health Canada’s interpretation of adverse event data as part of routine label updating. The FDA has reviewed the same adverse event data as Health Canada both at the time of the Health Canada suspension and again when the FDA was reviewing the ADDERALL XR sNDA for use in adolescents. On both occasions the FDA concluded that Health Canada’s regulatory action was not warranted and the FDA approved the sNDA on July 22, 2005. Although Shire is complying with Health Canada’s suspension request, the Company strongly disagrees with the conclusions drawn by Health Canada and has lodged an appeal.

ADDERALL XR’s pediatric marketing exclusivity in the US under the Hatch-Waxman regulations expired on April 11, 2005.

LitigationFDA approval of the adolescent indication for ADDERALL XR was received during July.

On August 24, 2005, Shire announced that Health Canada would reinstate the marketing authorization of ADDERALL XR in Canada effective August 26, 2005. This reinstatement follows the acceptance by Health Canada of the recommendations from the New Drug Committee (NDC), which was appointed by Health Canada at Shire’s request to review the suspension in Canada of ADDERALL XR. The NDC, comprised of three highly qualified, independent experts in the fields of pediatric cardiology, pediatric development and behavioral problems, and pharmacoepidemiology, examined the scientific evidence made available to them by both Shire and Health Canada. The NDC recommended that Health Canada reinstate ADDERALL XR.

During October 2005, Shire filed a Citizen Petition with the FDA requesting that the FDA require more rigorous bioequivalence testing or additional clinical testing for generic or follow-on drug products that reference ADDERALL XR, before they can be approved. Shire believes that these requested criteria will ensure that generic formulations of ADDERALL XR or follow-on drug products will be clinically effective and safe. The FDA has six months to respond to Shire’s petition, however it does not preclude the FDA from granting approval or tentative approval to generic or follow-on product referencing ADDERALL XR during that time.

Shire continues to defend its Intellectual Property. In October 2005, Shire announced that it has filed a lawsuit against Barr and Impax with respect to US patent No. 6,913,768 (‘768). Shire believes that both Barr’s and Impax’s generic ADDERALL XR products infringe the ‘768 patent claims. The case was filed in the Southern District of New York. The earlier filed cases against Barr and Impax involving the ‘819 and ‘300 patents are scheduled to go to trial in January 2006 and February 23, 2006 respectively. There will be no 30 month stay associated with the filing of the ‘768 patent case. The ‘768 patent is directed to pharmaceutical compositions comprising a once-a-day sustained release formulation of at least one amphetamine salt for the treatment of ADHD. Impax has filed for summary judgment in respect to non-infringement of the ‘819 and ‘300 patents in the district court of Delaware. The Court has not yet ruled on Impax’s motion. The schedule in the Barr case provided that summary judgement motions were to be filed and fully briefed by October 14, 2005. Neither Shire nor Barr filed summary judgement motions. Trial in the Barr case is scheduled for January 2006.

For further information about the litigation proceedings relating to the Company'sCompany‘s ADDERALL XR patents are in progress. For further information see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings. Any decrease in the sales of ADDERALL XR could significantly reduce revenues and earnings.

CARBATROL

US prescriptions for the sixnine months to JuneSeptember 30, 2005 were down 2%5%, compared to the same period in 2004. This was due primarily to limited promotion of this product by Shire during first six months of 2005 as promotional resources were diverted to other products.supply constraints and a 4% decrease in the total US extended release carbamazepine prescription market. The supply constraints have now been resolved.

Product sales increased by 40%.for the nine months to September 30, 2005 were up 41%, compared to the same period in 2004. The difference between sales growth and the lower level of prescriptions is due to significant wholesaler re-stocking in order to replenish a previously low pipeline, aDecember 2004 price increase in August 2004 and significantly lower sales deductions.deductions in comparison to the high levels in the same period in 2004.

CARBATROL had a 43% share of the total US extended release carbamazepine prescription market in JuneSeptember 2005 (June(September 2004: 45%).

Patent litigation proceedings with Nostrum Pharmaceuticals, Inc. (Nostrum) relating to CARBATROL are in progress. On July 18, 2005, the United States Federal District Court in Trenton, New Jersey denied Nostrum’s motion for summary judgment. Consequently, the lawsuit between Shire and Nostrum will continue to move

51





toward trial. No trial date has been set by the Court. For further information see ITEM 1 of Part II of this Form 10-Q: Legal Proceedings.

PENTASA

US prescriptions for the sixnine months to JuneSeptember 30, 2005 were up 8%7%, compared to the same period in 2004. The increase was largely due to the success of the co-promotional agreement with Solvay Pharmaceuticals Inc. and the impact of the 500mg dosage form launched in the third quarter of 2004.2004, in conjunction with a 2% increase in the total US oral mesalamine prescription market.

Product sales for the sixnine months to JuneSeptember 30, 2005 were up 7% mainly8%, compared to the same period in 2004. The difference between sales growth and prescription growth is due to the increase in prescriptions and a price increase inimpact of the September 2004 offset by wholesaler destocking and increased sales deductions.

price increase. PENTASA had a 19%an 18% share of the total US oral mesalamine prescription market in JuneSeptember 2005 (June(September 2004: 17%).

AGRYLIN and XAGRID

AGRYLIN and AGRYLIN/XAGRID sales worldwide for the sixnine months to JuneSeptember 30, 2005 were $61.6$78.4 million, down 15%,36% compared to the same period in 2004.2004 (2004: $122.0 million).

USAs expected North American sales were down 31%57% due to the impact of generic versions of AGRYLIN being approved in the US market in April after2005.

Rest of the FDA rejected Shire’s Citizens’ Petition.

International SalesWorld sales (all sales outside the US) reported in US dollarsNorth America) were up 20%45%, primarily due to the successful launch of XAGRID in the UK, Germany and France in the first quarter of 2005. In accordance with current orphan drug legislation in the EU, XAGRID will have up to 10 years of marketing exclusivity in the EU.



FOSRENOL

US prescriptions for the nine months to September 30, 2005 were 97,000. FOSRENOL was launched in the US in January 2005.

Product sales for the nine months to September 30, 2005 andwere $24.5 million.

FOSRENOL had acheived an 8% share of the total US phosphate binding market in JuneSeptember 2005.

Product sales for the six months to June 30, 2005 were $14.8 million.

Shire continues its discussions relating to FOSRENOL with regulatory authorities across Europe and other regions. Launches willare anticipated to begin in Europe during 2005,shortly, subject to obtaining national approvals and concluding pricing and concluding reimbursement negotiations.

REPLAGAL

REPLAGAL was acquired by Shire as part of the TKT acquisition, which completed on July 27, 2005. Product sales for the period since acquisition were $16.0 million. The majority of REPLAGAL sales are in Europe.

52





Royalties

Royalty revenue increased 6%7% to $120.9$181.1 million for the sixnine months to JuneSeptember 30, 2005 (2004: $113.8$170.0 million) and represented 16% of total revenues (2004: 17%). The following table provides an analysis of Shire’s royalty income:

 6 months to 6 months to 9 months to 9 months to 
 June 30, June 30, September 30, September 30, 
 2005 2004 change2005 2004 Change
 $’000 $’000 %$’000 $’000 %






3TC 79,868 77,802 +3119,467 115,673 +3
ZEFFIX 14,237 13,140 +821,969 20,174 +9
Other 26,782 22,860 +17
Others39,637 34,154 +16






Total 120,887 113,802 +6181,073 170,001 +7







3TC

Royalties from 3TC for the sixnine months to JuneSeptember 30, 2005 were $79.9$119.5 million, an increase of 3% compared to the sixnine months to JuneSeptember 30, 2004 ($77.8115.7 million). This was due to the continued growth in the nucleoside analogue market for HIV and the positive impact of foreign exchange movements.

Shire receives royalties from GSK on 3TC worldwide sales with the exception of Canada where a commercialization partnership with GSK exists.3TC. GSK’s worldwide sales of 3TC for the sixnine months to JuneSeptember 30, 2005 were $606$907 million, (2004: $587an increase of 3% compared to the nine months to September 30, 2004 ($879 million).

ZEFFIX

Royalties from ZEFFIX for the sixnine months to JuneSeptember 30, 2005 were $14.2$22.0 million, an increase of 8%9% compared to the sixnine months to JuneSeptember 30, 2004 ($13.120.2 million). This was due to strong growth in the Japanese market and the positive impact of foreign exchange movements.

Shire receives ZEFFIX royalties from GSK on worldwide sales, with the exception of Canada where a commercialization partnership with GSK exists.sales. GSK’s worldwide sales of ZEFFIX for the sixnine months to JuneSeptember 30, 2005 were $124$191 million, an increase of 8% compared to the nine months to September 30, 2004 (2004: $115$177 million).

Other

Other royalties are primarily in respect of REMINYL and REMINYL XL (now marketed as RAZADYNE and RAZADYNE ER in the US), a product marketed worldwide by Janssen, with the exception of the United Kingdom and the Republic of Ireland where Shire acquired the exclusive marketing rights from May 2004.

On April 11, 2005, Ortho-McNeil Neurologics Inc. (Janssen’s US affiliate company) announced that REMINYL would be marketed in the US under the new product name of RAZADYNE. Ortho-McNeil Neurologics Inc. worked closely with the FDA on a name change following dispensing errors in the US, between REMINYL and the Type 2 diabetes mellitus drug known as AMARYL. REMINYL continues to be marketed outside the US under its original name. Shire is only aware of one similar dispensing error outside the US.

Sales of the REMINYL/RAZADYNE arange, for the symptomatic treatment forof mild to moderately severe dementia of the Alzheimer’s type, are growing well in the Alzheimer’s market.

Shire and Janssen’s affiliate, Johnson & Johnson Pharmaceutical Research & Development, LLC, are in ongoing discussions with the European regulatory authorities in relation to their assessment of the data for REMINYL from investigational studies in mild cognitive impairment. Labeling changes have now been agreed.

Shire has submitted its response to the preliminary Appraisal Consultation Document issued by the National Institute for Clinical Excellence in England and Wales (NICE). This preliminary appraisal recommends that all existing approved products for the symptomatic treatment of mild to moderate Alzheimer's disease in England and Wales are no longer reimbursable by the National Health Service when used by new patients. NICE’s final recommendation was expected to be published in June 2005. However, on July 18, 2005 NICE announced that it had delayed its decision and asked

53






the pharmaceutical companies that market drugs to treat Alzheimer's disease to identify sub-groups of patients who may benefit from the treatments.

Cost of product sales

For the sixnine months to JuneSeptember 30, 2005, the cost of product sales was 12%amounted to 15% of product sales (2004: 12%). The decrease in gross margin is primarily driven by the addition of REPLAGAL to Shire’s product portfolio following the acquisition of TKT. REPLAGAL’s cost of product sales relates entirely to acquired inventories and is therefore based on the fair value of that acquired inventory. In accordance with US GAAP, acquired finished goods have been valued at 97% of the expected sales price of REPLAGAL and so virtually no margin will be reflected for REPLAGAL sales until acquired finished goods have been sold (anticipated Q3 2006). For the nine months to September 30, 2005 the REPLAGAL cost of product sales includes a $17.2 million adjustment in respect of the acquired inventory, of which $15.1 million related to sales of acquired finished goods and $2.1 million was a write off of damaged work in progress. The fair value adjustment decreased gross margin by 2%.



Research and development (R&D)

R&D expenditure increased from $86.0$143.8 million in the sixnine months to JuneSeptember 30, 2004 to $177.0$251.3 million in the sixnine months to JuneSeptember 30, 2005. Expressed as a percentage of total revenues, R&D expenditure was 23%22% for the sixnine months to JuneSeptember 30, 2005 (2004: 13%15%). This increase included an initial payment to New River of $50 million in respect on NRP104, which has been expensed in accordance with the Company’s accounting policy. R&D expenditure other thanwas primarily due to:

an initial payment to New River of $50 million in respect on NRP104, which has been expensed in accordancewith the Company’s accounting policy.
the addition of two significant projects following the acquisition of TKT.

The New River payment comprised 17%and the TKT projects, represented 6% of total revenues. The level ofR&D expenditure for items other than the New River payment in the six months to June 30, 2004 was below normal levels partially due to the phasing of project spend and partiallyexpressed as a resultpercentage of the accounting applied to the impending disposal of the vaccines business. revenues.

Shire’s pipeline is now well advanced with fiveseven projects in late stage development or registration.

Selling, general and administrative (SG&A)

Total SG&A expensescosts increased from $251.1$370.7 million in the sixnine months to JuneSeptember 30, 2004 to $344.8$516.1 million in the sixnine months to JuneSeptember 30, 2005, an increase of 37%39%. As a percentage of product sales, SG&A expenses were 56%55% (2004: 48%46%).

6 months to June 30, 2005 2004 Change
 $M $M %



Sales costs 97.5 73.3 +33
Marketing costs 130.8 95.0 +38
Other SG&A costs 82.8 57.2 +45



Total SG&A costs 311.1 225.5 +38
Depreciation and amortization1 33.7 25.6 +32



Total SG&A costs 344.8 251.1 +37



     
1 Excludes depreciation from manufacturing plants of $1.7 million (2004: $1.3 million) which is included in cost of product sales.
9 months to September 30,2005 2004 Change
$M $M %



Sales costs136.6 109.2 +25
Marketing costs189.5 138.1 +37
Other SG&A costs139.9 82.9 +69



Total SG&A costs466.0 330.2 +41
Depreciation and amortization150.1 40.5 +24



Total SG&A costs516.1 370.7 +39



1. Excludes depreciation from manufacturing plants of $2.7 million (2004: $2.0 million) which is included in cost of product sales.   

Sales, marketing and other SG&A costs in the sixnine months to JuneSeptember 30, 2005 increased 38%41% to $311.1$466.0 million (2004: $225.5$330.2 million).

This increase was expected with additional costs in the sixnine months to JuneSeptember 30, 2005 attributable to four product launches in the first half of 2005. In addition there is anduring 2005, incremental costcosts in 2005 associated with the FOSRENOL and EQUETRO sales forces.forces, $7.0 million of SG&A costs associated with TKT and $4.5 million relating to the set up of the new listed holding company for the Shire group.

The depreciation charge for the sixnine months to JuneSeptember 30, 2005 was $15.5$20.2 million (2004: $6.5$11.8 million), which includes a write-down of property, plant and equipment of $5.9$6.6 million. Amortization charges were $18.2$29.9 million for the sixnine months to JuneSeptember 30, 2005 (2004: $19.1$28.7 million).

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Intangible asset impairment

The intangible asset impairment charge for the sixnine months to JuneSeptember 30, 2005 was $3.0 million (2004: $nil)5.5 million). The impairment charge arose as a result of the economic value and strategic worth of the product concerned being less than its carrying value.

Reorganization costs

Reorganization costs  
     
6 months to June 30, 2005 2004
 $M $M


Employee severance 1.6 9.9
Relocation costs - 7.9
Consultancy costs 0.5 -
Duplicate facilities 0.7 -
Other costs 0.1 4.2


 2.9 22.0



There

During the nine months to September 30, 2005, Shire incurred costs of $9.3 million (2004: $32.0 million) following the closure of the Newport, Kentucky site in July 2005 and final employee severance costs. Following this closure, the site consolidation is now complete and no further reorganization costs are expected remainingto be incurred.

During the nine months to September 30, 2004, Shire incurred costs related to employee severance ($12.5 million), relocation costs ($11.5 million) and other costs associated with the reorganization ($8.0 million).

Integration costs

For the nine months to September 30, 2005, the Company incurred $3.5 million of approximately $9 million in respectcosts associated with the integration of the reorganization relatingTKT business into the Group (2004: nil). This primarily related to duplicate facilities. These costs will be booked whenretention payments for key staff.

In-process R&D

During the Company ceasesnine months to use its Newport facility,September 30, 2005, as required by FIN 4, Shire wrote off the portion of the TKT purchase price allocated to in-process R&D of $673.0 million. This amount represents the fair value of those intangible assets acquired as part of the TKT acquisition which is expected to occurhave not been approved, by the end of 2005. For further information see NoteFDA or other regulatory authorities. See note 2 to the condensedunaudited consolidated financial statements in this Form 10-Q.



10-Q for further information.

Interest income and expense

For the sixnine months to JuneSeptember 30, 2005, the CompanyShire received interest income of $21.0$27.9 million (2004: $8.4$14.1 million). This increase in interest income is primarily due to higher interest rates on the Company'sCompany’s US cash deposits.deposits partially offset by the interest foregone by Shire on the net payments of $1.1 billion made to date in respect of the acquisition of TKT.

For the sixnine months to JuneSeptember 30, 2005, the CompanyShire had interest expense of $1.2$4.7 million, of which primarily$1.0 million related to costs of a bridging loan to finance the TKT transaction, (2004:and $2.5 million in respect of a provision for interest, which may arise as a result of the court appraisal process on amounts due to shareholders who have requested appraisal of the acquisition consideration payable for their shares.

For the nine months to September 30, 2004, Shire had interest expense of $12.3 million. This expense related to Shire’s convertible loan notes: $4.2 million).notes issued in 2001. In addition to the interest payable on the loan notes of $4.3 million, there was an $8.0 million write-off of deferred issuance costs capitalized at the time of the convertible loan notes issue. These costs were being amortized over the life of the notes but were written-off following the redemption of $370.1 million of loan notes in the third quarter of 2004.

Other income, net

For the sixnine months to JuneSeptember 30, 2005, other income was $0.7totaled $3.9 million (2004: $9.3$4.4 million). InDuring the nine months to September 30, 2005 and September 30, 2004, other income net was primarily attributable to the realized gain onincome from the sale of a portfolio investment offset by the write down of certain portfolio investments.

Taxation
The

In respect of the nine month period to September 30, 2005, the tax charge was calculated using the expected effective rate of tax for the six months to June 30, 2005period of 25% and was 25% (2004: 28%). The Company’sadjusted for the effect of the non-deductible write-off of in-process R&D, resulting in an effective tax rate was 3% lower than infor the first halfperiod of 2004. The reduction in rate follows the conclusion of a routine tax audit in the second quarter of 2005. -14% (2004: 28%).

At JuneSeptember 30, 2005, net deferred tax assets of $87.5$85.4 million were recognized (December 31, 2004:2004; $78.1 million). Realization is dependent upon generating sufficient taxable income to utilize such assets. Although realization of these assets is not assured, management believe it is more likely than not that the deferred tax assets will be realized.

55






Equity in earningsearnings/(losses) of equitymethod investees

Earnings of $0.7$0.2 million were recorded for the sixnine months to JuneSeptember 30, 2005 (2004: $2.2$3.4 million). Earnings, being earnings of $2.7$3.9 million, representing a 50% share of earnings from the antiviral commercialization partnership with GSK in Canada (2004: $2.2$3.4 million) were, offset by the share of losses in the GeneChem and EGS Healthcare Funds of $2.0$3.7 million (2004: $nil).

Discontinued operations

During the periodnine months to September 30, 2005, gains on disposition of discontinued operations totalled $4.2 million. In July, 2005, $1.0 million of the pipeline loan to IDB was repaid. The pipeline loan had been fully provided for in 2004 at the time of the sale of the vaccines business to IDB. This part repayment of the pipeline loan was in compliance with the terms of the loan agreement requiring IDB to make such payment in the event IDB sold and leased back any property acquired from Shire as part of the sale of the vaccines business. In addition, a provision for $3.1 million adjustment, arising from the finalization of the working capital agreement with IDB recorded in 2004 as part of the sale of the vaccines business to IDB, was released and this positively impacted net income for the year to date. This adjustment arose from the finalization of the working capital agreement with IDB. For further information of this transaction see Note 2 to the condensed consolidated financial statements in this Form 10-Q.released.

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 of tax payments 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 for funding litigation expenses incurred.

The Company ordinarily finances its activities through cash generated from operating activities, private and public offerings of equity and debt securities and the proceeds of asset or investment disposals.

In connection with the acquisition of TKT, Shire entered into a Multicurrency Revolving Facilities Agreement (the “Facilities Agreement”) with ABN AMRO Bank N.V., Barclays Bank PLC, Citicorp International Plc,plc, Citigroup Global Markets Limited, HSBC Bank plc and The Royal Bank of Scotland plc (the “Lenders”) on June 15, 2005. The Facilities Agreement includes two credit facilities: (i) a multicurrency three year revolving loan facility in an aggregate amount of $500 million (“Facility A”) and (ii) a 364 day revolving loan facility in an aggregate amount of $300 million (“Facility B” and together with Facility A, the “Facilities”) see Note 9. See note 14 to the condensedunaudited consolidated financial statements in this Form 10-Q.

Shire anticipates that its operating cash flow together with available cash, cash equivalents and short-term investments and the above mentioned debt facility will be sufficient to meet its anticipated future operating expenses, the cost ofacquiring TKT, capital expenditures and debt service and lease obligations as they become due over the next twelve months.



If the Company decides to seek to acquire other businesses, it expects to fund these acquisitions from existing cash resources, the debt facility discussed above and possibly through new borrowings and the issue of new equity if necessary.

Sources and uses of cash

The following table provides an analysis of the Company’s gross and net cash funds, including restricted cash, as at JuneSeptember 30, 2005 and December 31, 2004:

 June 30, December 31,
 2005 2004
 $’000 $’000


Cash and cash equivalents 1,502,179 1,111,477
Restricted cash 21,943 21,627
Short-term investments 76,486 324,411


Gross cash funds, including restricted cash 1,600,608 1,457,515
Total debt (116) (116)


Net cash funds 1,600,492 1,457,399


56





September 30, December 31,
2005 2004
$’000 $’000

 
 
Cash and cash equivalents549,820 1,111,477
Restricted cash30,085 21,627
Short term investments22,380 324,411

 
 
Gross cash funds, including restricted cash602,285 1,457,515
Total debt(116) (116)

 
 
Net cash funds, including restricted cash602,169 1,457,399

 
 

Cash flow activity

Net cash provided by operating activities for the sixnine months to JuneSeptember 30, 2005 was $187.5$220.9 million compared to $215.7$283.5 million for the sixnine months to JuneSeptember 30, 2004. The reduction in cash generation is primarily due to the $50 million upfront payment to New River and the timing of working capital payments.

Net cash provided byused in investing activities was $206.8$789.3 million in the sixnine months to JuneSeptember 30, 2005. Decreases in short-term investments of $244.0$351.2 million along with proceeds of $60$60.0 million forfrom the redemption by IDB of itits subscription receipts wereand the receipt from IDB of additional proceeds from the sale of the vaccines business of $32.2 million, offset primarily bycash paid on the purchase of TKT (net of cash and cash equivalents) of $1,099.7 million, loans made to IDB of $29.9$43.2 million, capital expenditure on property, plant and equipment of $44.2$57.6 million and on intangible assets of $20.0$20.1 million. Capital expenditure on property, plant and equipment included $21.8$22.8 million leasehold building improvements, $4.7$9.8 million on computer equipment and $3.1 million on furniture and fittings for the new Shire US headquarters at Wayne, $5.1Pennsylvania, $6.2 million on software purchases at the Basingstoke Head Office, $5.7$9.7 million of factory construction work and $1.3$2.4 million of plant equipment for Shire US Manufacturing Inc. in the US.Capital expenditure on intangible assets included the final paymentof the acquisition of the exclusive commercialization rights to REMINYL in the UK and Republic of Ireland in 2004.Ireland.

Net cash provided by investing activities was $23.8$30.8 million in the sixnine months to JuneSeptember 30, 2004. This was primarily dueDecreases in short-term investments and restricted cash of $36.6 million, along with proceeds of $38.5 million from the sale of long-term assets and an initial $30 million received from IDB for the sale of the vaccines business, were offset by loans made to outflowsIDB of $31.5$23.8 million, of net capital expenditure on long-term investments, intangible assets and property, plant and equipment of $24.8 million and $12.7 million from discontinued operations, offset by a reductionintangible assets of $32.0 million of cash placed on short-term deposit and proceeds from the sale of a listed investment of $26.7$12.4 million. Capital expenditure on property, plant and equipment for the six months to June 30, 2004 was $14.0included $8.9 million with the main expenditure being in relation toon the manufacturing facility in Owing Mills ($6.0 million) and $8.4 million on computer software ($3.9 million). Other capitalsoftware. Capital expenditure related to the purchase of long-term investments ($5.5 million) and the purchase ofon intangible assets ($12.0 million) relating toincluded the purchase ofinitial payment for the acquisition for the exclusive commercialization rights ofto REMINYL in the UK and Republic of Ireland.

Net cash provided by financing activities was $0.8$13.9 million for the sixnine months to JuneSeptember 30, 2005. This was primarily due to inflows of $19.9$30.4 million from the exercise of employee stock options being offset by the dividend payment of $19.1 million in respect of the six months to December 31, 2004. Net cash provided byused in financing activities was $5.5$362.1 million for the sixnine months to JuneSeptember 30, 2004 primarily due to the redemption of the 2% convertible loan notes of $370.1 million, offset by proceeds from the exercise of employee stock options.options of $7.5 million.

The total cash consideration for the acquisition of TKT which completed on July 27, 2005 is expected to be approximately $1.6 billion. Shareholdersbillion, subject to change as may be required by the appraisal rights process (see below). As at September 30, 2005 shareholders owning 23.8approximately 24.4 million TKT shares havehad accepted the offer and approximately $1.1 billion will be$903 million had been paid to them, upon$83.4 million was paid in connection with TKT stock options and $170.1 million in connection with convertible notes, outstanding at the presentationdate of appropriate certificates.acquisition. Following the exercise of appraisal rights by shareholders owning the remaining 12.311.7 million shares, the remaining $0.5 billion$433 million will be paid subject to the appraisal process outlined below.in Item 1 of Part II of this Form 10-Q.

As a result of the acquisition of TKT, cash balances have been significantly reduced and interest receivable will decrease accordingly.

44

Obligations and commitments




Cash requirements

Aggregate contractual obligations

Contractual obligations

As of JuneAt September 30, 2005 the Company’s contractual obligations had altered from those disclosed in the Table of Contractual Obligations in the Company’s 2004 Form 10-K and Form 10-Q for the three months to June 30, 2005 as follows:

57






Interests in companies and partnerships

The Company has undertaken to subscribe for interests in companies and partnerships for amounts totaling $16.2$24.5 million (December 31, 2004: $22.0$22.2 million) of which $8.3 million is committed to be paid in 2005 and a further $3.5$3.2 million could be payable in 2005, depending on the timing of capital calls.

Manufacturing facilityfacilities

The Company has committed to the expansion and modification of its two manufacturing facilityfacilities at Owings Mills, Maryland and Cambridge, Massachusetts to facilitate the production and packaging of additional strategic products. The Company has committed to spend a further $1.0$2.0 million by the end of 2005 and $1.6 million in 2006, and has an additional commitment of $3.0$1.9 million for the design and construction of a technology center at Owings Mills, which is expected to be incurred in 2005.

Wayne, Pennsylvania fit out

The Company is in the process of fitting out its new US headquarters at Wayne, Pennsylvania. At JuneSeptember 30, 2005 the Company had an outstanding commitment of $2.4$1.5 million, which is expected to be incurred in 2005.

REMINYLBasingstoke, UK expansion

DuringThe Company is in the six months to Juneprocess of expanding its UK headquarters at Basingstoke, UK. As at September 30, 2005, the Company paid the remaining $19had an outstanding commitment of $4.9 million, due in connection with the acquisition of the exclusive commercialization rightswhich is expected to REMINYL in the UKbe incurred throughout 2005 and Republic of Ireland in 2004.into 2006.

IDB

As part of the sale of the vaccines business on September 9, 2004, Shire entered into an agreement to provide IDB with a loan facility of up to $100 million, which can be drawn down over the four years following completion. As of Juneat September 30, 2005 IDB had drawn down $86.7the full $100 million under the facility. The remaining $13.3 million was drawn down in July 2005.

Other

The Company has assumed that other long-term liabilities, which comprise primarily insurance provisions ($10.711.4 million), SERP liabilities ($2.84.3 million) and long-term bonuses ($2.63.2 million), are due before 2008.

In addition to contractual obligations referred to above the Company has certain milestones and other commitments. The most significant are as follows:

NRP104

In connection with the Company’s collaboration with New River to commercialize NRP104, the Company has an obligation to make certain payments on the achievement of the following milestones: $50 million upon the FDA’s acceptance of filing of the NDA;up to $300 million following the first commercial sale of the product, depending on the characteristics of the approved product labelling; $100 million as a sales bonus on achieving a significant sales target; and $5 million following the first commercial sale in certain specified EU markets. An upfront payment of $50 million was expensed as an R&D cost during the first quarter of 2005. Regulatory submission is currently expected in the last quarter of 2005.

MTSDAYTRANA (MTS)

In connection with the Company’s purchase of MTSDAYTRANA (MTS) in 2003, Shire has an obligation to make certain payments on the achievement of the following milestones: $50 million upon regulatory approval of the product, which will be capitalized and amortized over its useful economic life; and up to $75 million, linked to future sales performance. Regulatory approval is currently expected in the last quarter of 2005.



FOSRENOL patent rights

In connection with the Company’s purchase of the global patents for FOSRENOL, Shire now owns the FOSRENOL patents in the US and throughout the world (excluding Europe and Japan) and has agreed to pay AnorMED Inc. $6 million when FOSRENOL is approved in certain European countries for the assignment of the European patents and $6 million upon receipt of regulatory approval in Japan for the Japanese patents.

Other R&D commitments

As of Juneat September 30, 2005, the Company had commitments of $9.7$14.5 million on achievement of specified milestones.milestones of which $1.4 million is committed to be paid in 2005 and $8.1 million is expected to be paid in 2006.

Clinical testing

As at September 30, 2005, the Company had committed to pay approximately $13.0 million to contract vendors for administering and executing clinical trials. The timing of payments is not reasonably certain as payments are dependent

58






upon actual services performed by the organizations as determined by patient enrollment levels and related activities. However, the Company expects to pay for these commitments throughout 2005 and into 2006 as ongoing trials are completed.

Contract manufacturing

As at September 30, 2005, the Company had committed to pay approximately $16.8 million in respect of contract manufacturing over the next 12 months.

TKT acquisition

Appraisal rights

In connection with the merger,acquisition, as at September 30, 2005, the holders of 12,318,765approximately 11.7 million shares of TKT common stock had submitted written demands for appraisal of their shares and, have, as a result, elected not to accept the $37.00$37 per share merger consideration. On October 10, 2005, at the request of one of the petitioners to tender 365,000 shares at the merger price of $37 per share, TKT filed a motion to dismiss the petitioner’s demand. On October 12, 2005, the Delaware Court of Chancery granted this motion, and the petitioner tendered the shares at the merger consideration of $37 per share. Therefore, as at October 28, 2005, the holders of approximately 11.3 million shares of TKT common stock maintain their written demands for appraisal of their shares and have elected not to accept the $37 per share merger consideration. To the extent that these demands were validly asserted in accordance with the applicable requirements of Delaware law and these holders perfect their rights thereunder, such holders will be entitled to receive the fair value of their shares as determined by the Delaware Court of Chancery. The determination of fair value of the TKT shares 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 $37.00$37 per share and may award interest on the amount determined in the appraisal process. TKT shareholders who have asserted appraisal rights may within 60 days after the effective time of the Merger withdraw their demand for appraisal and accept the $37.00 per share Merger consideration in cash.

Total consideration, including amounts payable in respect of stock options and convertible securities, is approximately $1.6 billion at the Mergerconsideration price of $37.00$37 per share. This could change if Shire is required to pay a different amount of consideration in respect of the 12,318,765 TKT shareholders whoapproximately 11.3 million shares for which holders have exercised appraisal rights. The consideration paid by Shire to TKT shareholders at completion who did not exercise appraisal rights was funded from Shire’s existing cash resources. For every $1 increase/decrease in the merger consideration applicable to those TKT shareholders who have asserted appraisal rights, the total estimated purchase price would increase/decrease by approximately $11.3 million.

ITEM 3. Quantitative and Qualitative Disclosures about Market Risk

There have been no material changes in the Company’sGroup’s interest rate or market risk of investments exposure since December 31, 2004. The acquisition of TKT has increased the Group’s exposure to foreign exchange market risk due to an increase in the amount of non US Dollar net assets and earnings. This is being managed in line with the Company’s existing treasury policies. Item 7A of the Company’sGroup’s Annual Report on Form 10-K for the year toended December 31, 2004 contains a detailed discussion of the Company’sGroup’s market risk exposure in relation to interest rate market risk and foreign exchange market risk.

ITEM 4. Controls and Procedures

As of JuneSeptember 30, 2005, 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.

59






During the period covered by this quarterly report, the Company concluded the acquisition of Transkaryotic Therapies, Inc. or TKT. Significant material weaknesses in TKT’s internal control over financial reporting were identified with respect to its sales and marketing subsidiary, TKT Europe A.B. (formerly TKT Europe-5S A.B.), or TKT Europe, as at December 31, 2004 as described in TKT’s Annual Report on Form 10-K for 2004. These material weaknesses at TKT Europe included both entity-control weaknesses, and weaknesses in process, transaction and application controls as defined in the Committee of Sponsoring Organizations of the Treadway Commission inInternal Control-Integrated Framework. As a result of these material weaknesses in TKT Europe’s internal control over financial reporting, TKT’s management, including the Chief Executive Officer and the Chief Financial Officer, concluded that, as at December 31, 2004, TKT’s internal control over financial reporting was not effective. An initial review of these material weaknesses has been undertaken and the Company is progressing remediation activities. Testing of the internal control over financial reporting at TKT Europe is currently scheduled for the final quarter of 2005 in connection with Management's assessment of the effectiveness of the Company's internal control over financial reporting.

Although Shire is continuing to assess the impact of the acquisition and integration of TKT on the internal control over financial reporting of the enlarged group, Management does not believe that the material weaknesses identified at TKT Europe are likely to be material to the Shire group as a whole.

60






PART II. OTHER INFORMATION


ITEM 1. Legal Proceedings
LEGAL PROCEEDINGS

There are various legal proceedings brought by and against the CompanyShire that are discussed in the Company’sShire’s Annual Report on Form 10-K for the year to December 31, 2004. Material updates to the proceedings discussed in the Company’sShire’s Annual Report on Form 10-K are described below. On July 27, 2005, Shire completed its acquisition of TKT. In addition to the disclosures in Shire’s Annual Report on Form 10-K for the year to December 31, 2004 (as updated in Shire’s subsequent filings with the SEC), there are various legal proceedings brought by and against TKT which are described below. There is no assurance that the Companyenlarged Group will be successful in any of these proceedings and if it is not, there may be a material impact on the Company’senlarged Group’s results and financial position.

46






ADDERALL XR

(a)(i) Barr Laboratories, Inc.

Shire’s extended release "once daily" version of ADDERALL, ADDERALL XR is covered by US patent No. 6,322,819 (the ‘819 Patent) and US patent No. 6,605,300 (the ‘300 Patent). In January 2003 the Company was notified that Barr had submitted an Abbreviated New Drug Application (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 (Barr’s ANDA products) prior to the expiration date of the Company’s ‘819 Patent, and alleging that the ‘819 Patent is not infringed by Barr's ANDA products. In August 2003 Shire was notified that Barr also was seeking permission to market its ANDA products prior to the expiration date of the ‘300 Patent and alleging that the ‘300 Patent is invalid. Shire Laboratories Inc (Shire Laboratories) filed suit against Barr for infringement of the ‘819 Patent in February 2003 and for infringement of the ‘300 Patent in September 2003. The schedules for the lawsuits against Barr with respect to the ‘819 and ‘300 Patents were consolidated in December 2003 and a trial date is scheduled for January 2006. The Company is seeking a ruling that Barr’s ANDA and ANDA products infringe the ‘819 and ‘300 Patents and its ANDA should not be approved before the expiration date of the patents. The Company is also seeking injunctions to prevent Barr from commercializing its ANDA products before the expiration of the ‘819 and ‘300 Patents, damages in the event that Barr should engage in such commercialization, and its attorneys’ fees and costs. On September 27, 2004 Barr filed an amended Answer, Affirmative Defense and Counterclaim in which Barr added the following counterclaims: invalidity of the ‘819 patent, non-infringement of the ‘300 Patent and unenforceability of the ‘819 and ‘300 Patents due to inequitable conduct. Shire has asserted affirmative defenses, alleging, among other things, that Barr has waived its right to assert the counterclaims set forth in its September 27, 2004 amended answers. Under the Court’s schedule summary judgment motions were to be filed and fully briefed by October 14, 2005. Neither Shire nor Barr filed summary judgment motions. Trial in this action is scheduled for January 2006.

On October 19, 2005 Shire brought another lawsuit against Barr in the Southern District of New York alleging infringement of recently issued U.S. Patent No. 6,913,768 (the ‘768 patent). The Company is seeking injunctions to prevent Barr from infringing the ‘768 patent, damages in the event that Barr should commercialize its ANDA products, attorneys’ fees and costs.

(b)(ii) Impax Laboratories, Inc.

In November 2003, Shire was notified that Impax had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic version of the 30mg strength of ADDERALL XR (Impax’s ANDA product) prior to the expiration date of the ‘819 and ‘300 Patents. In December 2003, Shire Laboratories filed suit against Impax for infringement of the ‘819 and ‘300 Patents. The Company is seeking a ruling that Impax’s ANDA product infringes the ‘819 and ‘300 Patents and that its ANDA should not be approved before the expiration date of the ‘819 and ‘300 Patents. The Company is also seeking injunctions to prevent Impax from commercializing its ANDA product before the expiration of the ‘819 and ‘300 Patents, damages in the event that Impax should engage in such commercialization, and its attorneys’ fees and costs. Impax’s affirmative defenses include non-infringement and invalidity of both the ‘819 and ‘300 Patents.

In December 2004, Shire received an additional notification from Impax advising of the filing of an amendment to its ANDA for a generic version of the 5mg, 10mg, 15mg, 20mg and 25mg strengths of ADDERALL XR in addition to the 30mg strength, the subject of Impax’s initial ANDA. In January 2005, Shire Laboratories filed suit against Impax for infringement of the ‘819 and ‘300 Patents. The Company is seeking a ruling that Impax’s amended ANDA infringes the ‘819 and ‘300 patents and should not be approved before the expiration dates of the ‘819 and ‘300 Patents. The Company is also seeking an injunction to prevent Impax from commercializing its amended ANDA products before the expiration of the ‘819 and ‘300 Patents, damages in the event that Impax should engage in such commercialization, as well as its attorneys’ fees and costs. Impax’s affirmative defenses include non-infringement, invalidity and unenforceability of both the ‘819 and ‘300 Patents. Impax is also requesting that costs be assessed against the Company.

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The Delaware District Court had set an October 11, 2005 trial date for the first Impax case. Following a scheduling conference with the same Court in the second case, a consolidated February 23, 2006 trial date has now been set for both cases. Impax has also filed for summary judgment of noninfringement with respect to the ‘819 and ‘300 patents. The Delaware District Court has not yet ruled on Impax’s motion.

As part of the October 19, 2005 lawsuit against Barr, Shire also brought suit in the Southern District of New York against Impax for infringing the ‘768 patent. The Company is seeking injunctions to prevent Impax from infringing the ‘768 patent, damages in the event that Impax should commercialize its ANDA products, attorneys’ fees and costs.

(c)(iii) Colony Pharmaceuticals Inc.

In December 2004, Shire was notified that Colony 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 date of the Company’s ‘819 and ‘300 Patents. Shire has chosen not to sue Colony.

(d)(iv) Teva Pharmaceuticals USA, Inc.

In February 2005, Shire was notified that Teva had submitted an ANDA under the Hatch-Waxman Act seeking permission to market its generic versions of the 10mg and 30mg strengths of ADDERALL XR prior to the expiration date of the Company’s ‘819 and ‘300 Patents. In June 2005, Shire was notified that Teva had amended it'sits ANDA to seek permission to market additional strengths of 5mg, 15mg and 20mg of ADDERALL XR prior to the expiration of the '819 and '300 Patents. Shire has chosen not to sue Teva.



None of Barr, Impax, Colony or Teva may launch their generic versions of ADDERALL XR before they receive final FDA approval of their respective ANDAs. In respect of Barr’s and Impax’s ANDAs, the lawsuits triggered stays of final FDA approval of up to 30 months from the date of the Company’s receipt of, respectively, Barr’s and Impax’s notice letters. Even if Barr and/or Impax receive tentative FDA approval of their ANDAs, neither of them can lawfully launch their generic versions of ADDERALL XR before the earlier of the expiration of the respective stays (Barr - February 2006; Impax - May 2006 in the case of the 30mg strength and June 2007 in the case of the 5mg, 10mg,15mg, 20mg and 25mg strengths) or a district court decision in its favor. In the event that the Company does not prevail in the Barr suit, Barr could be in a position to market its ANDA products upon FDA final approval of its ANDA. In the event the Company does not prevail in the Impax suit, Impax could be in a position to market its ANDA product upon FDA final approval of its ANDA and upon expiry of any exclusivity that Barr may hold. The FDA may grant 180 days of generic market exclusivity to the “first to file”.

Neither Colony nor Teva may market their ANDA products until FDA final approval of their ANDAs and upon the expiration of the first to file’s exclusivity rights.

The Hatch-Waxman exclusivity period for ADDERALL XR expired on April 11, 2005.

CARBATROL

In August 2003 the Company was notified that 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 Laboratories 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 Company was seeking a ruling that Nostrum’s ANDA infringes the ‘013 and ‘570 Patents and should not be approved before the expiration date of the ‘013 and ‘570 Patents. The Company was also seeking an injunction to prevent Nostrum from commercializing its ANDA product before the expiration of the ‘013 and ‘570 Patents, damages in the event that Nostrum should engage in such commercialization, as well as its attorneys’ fees and costs. On January 23, 2004 the Company amended the complaint to delete the allegations with respect to the ‘013 Patent while maintaining the suit with respect to the ‘570 Patent. By way of counterclaims Nostrum is seeking a declaration that the ‘570 and ‘013 Patents are not infringed by Nostrum’s ANDA product. Nostrum also was seeking actual and punitive damages for alleged abuse of process by Shire. On July 12, 2004 the Court dismissed Nostrum’s abuse of process counterclaim for failure to state a claim upon which relief can be granted. On December 10, 2004 Nostrum filed a summary judgment motion seeking a declaration of non-infringement of the ‘570 Patent. Shire’s opposition to this motion was filed on January 14, 2005. Summary judgment arguments were presented to the Court on July 15, 2005. The Court ruled duringAt the conclusion of the hearing thatthe Court denied Nostrum's motion for summary judgment was denied.judgment. Expert discovery will now continue. The Court will also set a new discoverycontinue and pretrial schedule.is scheduled to be completed by December 31, 2005. No trial date has been set.

Nostrum may not launch a generic version of CARBATROL before it receives final approval of its ANDA from the FDA. The lawsuit triggered a stay of FDA approval of up to 30 months from Shire’s receipt of Nostrum’s notice letter. Even if Nostrum receives tentative approval from the FDA for its ANDA, it cannot lawfully launch its generic version before the earlier of the expiration of the stay (February 2006) or a district court decision in its favor. In the event that the Company

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does not prevail, then Nostrum could be in a position to market its 300mg extended-release carbamazepine product upon FDA final approval of its ANDA.

TKT

ShireTKT
On July 27, 2005, the Company completed its acquisition of TKT. In addition to the above, there are various legal proceedings brought by and against TKT which are described below.

GA-GCB

In January 2005, Genzyme filed suit against TKT in the District Court of Tel-Aviv-Jaffa, Israel, claiming that TKT's Phase 1/2 clinical trial in Israel evaluating GA-GCB for the treatment of Gaucher disease infringes one or more claims of Israeli Patent No. 100,715. In addition, Genzyme filed a motion for preliminary injunction, including a request for an ex parte hearing and relief on the merits, to immediately seize and destroy all GA-GCB being used to treat patients and to prevent TKT from submitting data generated from the clinical trial to regulatory agencies. In March 2005 the District Court refused to grant Genzyme's motion for a preliminary injunction. No trial date has been set.

DYNEPO

In April 1997, Amgen commenced a patent infringement action against TKT and Sanofi-Aventis in the United States District Court of Massachusetts. In January 2001, the United States District Court of Massachusetts concluded that DYNEPO infringed eight of the 18 claims of five patents that Amgen had asserted. Amgen did not seek and was not awarded monetary damages. This decision was subsequently appealed to the United States Court of Appeals for the Federal Circuit.

In January 2003, the United States Court of Appeals for the Federal Circuit issued a decision affirming in part and reversing in part the decision of the United States District Court of Massachusetts, remanded the action to the United States District Court of Massachusetts for further proceedings and instructed the United States District Court of Massachusetts to reconsider the validity of Amgen's patents in the light of potentially invalidating prior art.

In October 2004, the United States District Court of Massachusetts issued a decision on the remanded issues, finding that certain claims related to four patents held by Amgen are infringed by TKT and Sanofi-Aventis. In December 2004, TKT and Sanofi-Aventis filed a notice of appeal of the decision of the United States District Court of Massachusetts to the United States Court of Appeals for the Federal Circuit. TKT and Sanofi-Aventis filed an appeal brief in April 2005.

If TKT and Sanofi-Aventis are not successful in the DYNEPO litigation at the appellate level, TKT and Sanofi-Aventis would be precluded from making, using and selling DYNEPO in the United States until the expiration of the relevant patents. TKT 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. Sanofi-Aventis is entitled to deduct up to 50% of any royalties that Sanofi-Aventis may otherwise owe to TKT with respect to the sale of DYNEPO until Sanofi-Aventis has recouped the full amount of TKT's share of the litigation expenses. TKT has the right to control any other litigation that might arise outside of the United States and is responsible for all litigation expenses incurred in connection with such litigation from and after March 26, 2004.

Gene Activation

In 1996, Applied Research Systems Holding N.V., a wholly-owned subsidiary of Serono S.A. (Serono) and Cell Genesys became involved in a patent interference involving Serono's US Patent No. 5272071 (the "071 patent"), which purportedly covers certain methods of gene activation. In June 2004, the Board of Patent Appeals and Interferences of the US Patent and Trademark Office (PTO) held that both Serono and Cell Genesys were entitled to certain claims in their respective patent and patent application, and Serono and Cell Genesys each appealed the decision of the interference to the US District Court of Massachusetts and the US District Court of the District of Columbia, respectively. TKT was not a party to this interference.

In August 2004, Serono served TKT with an amended complaint in the appeal of the PTO decision that was filed in the US District Court of Massachusetts. The amended complaint alleges that TKT infringes Serono's '071 patent. In August 2005, the US District Court of Massachusetts severed and stayed the infringement action pending resolution of the interference claim at the District Court level.

Appraisal Rights

In connection with Shire’s merger with TKT, as at September 30, 2005, the holders of approximately 11.7 million shares of TKT common stock submitted written demands for appraisal of their shares and, as a result, elected not to accept the

63






$37 per share merger consideration. On October 10, 2005, at the request of one of the petitioners to tender 365,000 shares at the merger price of $37 per share, TKT filed a motion to dismiss the petitioner’s demand. On October 12, 2005, the Delaware Court of Chancery granted this motion, and the petitioner tendered the shares at the merger consideration of $37 per share. Therefore, as at October 28, 2005, the holders of approximately 11.3 million shares of TKT common stock maintain their written demands for appraisal of their shares and have elected not to accept the $37 merger consideration. To the extent that the remaining demands were validly asserted in accordance with the applicable requirements of Delaware law and these holders perfect their rights thereunder, such holders will be entitled to receive the fair value of their shares as determined by the Delaware Court of Chancery. The determination of fair value of the TKT shares 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.

Total consideration, including amounts payable in respect of stock options and convertible securities, is approximately $1.6 billion at the merger price of $37 per share. This could change if Shire is required to pay a different amount of consideration in respect of the approximately 11.3 million shares for which holders have exercised appraisal rights. Until such time as the appraisal process is complete the Company is unable to determine the extent of its liability.

Purported Class Action Shareholder Suit

In January and February 2003, various parties filed purported 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. The complaints generally allege securities fraud during the period from January 2001 through January 2003. Each of the complaints asserts claims under Section 10(b) of the Securities Exchange Act of 1934, Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act, and alleges that TKT and its officers made false and misleading statements and failed to disclose material information concerning the status and progress for obtaining United States marketing approval of TKT's REPLAGAL product to treat Fabry disease during that period.

In March 2003, various plaintiffs filed motions to consolidate, to appoint lead plaintiff, and to approve plaintiffs' selections of lead plaintiffs' counsel. In April 2003, various plaintiffs filed a Joint Stipulation and Proposed Order of Lead Plaintiff Applicants to Consolidate Actions, to Appoint Lead Plaintiffs and to Approve Lead Plaintiffs' Selection of Lead Counsel, Executive Committee and Liaison Counsel. In April 2003, the Court endorsed the Proposed Order, thereby consolidating the various matters under one matter: In re Transkaryotic Therapies, Inc., Securities Litigation, C.A. No. 03-10165-RWZ.

In July 27,2003, 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, 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 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 securities fraud during the period from January 4, 2001 through January 10, 2003. 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 that period. The Amended Complaint asserts claims against Dr. Selden and TKT under Section 10(b) of the Exchange Act 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, 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 September 2003, TKT filed a motion to dismiss the Amended Complaint. A hearing of the motion occurred in December 2003. In May 2004, the United States District Court for the District of Massachusetts issued a Memorandum of Decision and Order denying in part and granting in part TKT's motion to dismiss the purported class action lawsuit. In the Memorandum, the Court found several allegations against TKT arose out of forward-looking statements protected by the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 (PSLRA). The Court dismissed those statements as falling within the PSLRA's safe harbor provisions. The Court also dismissed claims based on the public offerings of June 29, 2001 and December 18, 2001 because no plaintiff had standing to bring such claims. The Court allowed all other allegations to remain.

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In June 2004, TKT submitted an unopposed motion seeking clarification from the Court that the Memorandum dismissed claims based on the first two offerings as to all defendants. The Court granted the motion. In July 2004, the plaintiffs voluntarily dismissed all claims based on the third offering because no plaintiff had standing to bring such claims.

The plaintiffs subsequently filed a motion seeking permission to notify certain TKT investors of the dismissal of the claims based on the offerings, and to inform those investors of their opportunity to intervene in the lawsuit. TKT filed an opposition to this motion in July 2004. A hearing on this motion was held in September 2004. The Court denied this motion. TKT filed an answer to the Amended Complaint in July 2004. The plaintiffs then filed a motion for class certification in July 2004. TKT filed an opposition to this motion in March 2005, and the plaintiffs filed a reply in April 2005. A hearing on class certification was held in April 2005. Following that hearing, TKT filed a supplemental brief in opposition to the motion for class certification and the plaintiffs filed a supplemental brief in support of the motion. The court has not yet ruled on this motion.

On September 14, 2005, the plaintiffs filed a Notice of Related Case Pursuant to Local Rule 40.1(G), in which they appeared to seek reassignment of a matter filed on September 1, 2005, entitled Securities and Exchange Commission v. Richard B. Selden, Civil Action No. 05-11805-NMG (D. Mass.) (the SEC Action), to the Court considering this matter. On September 15, 2005, the defendants filed a response to the notice, opposing reassignment of the SEC Action. On October 7, 2005, the plaintiffs filed a memorandum in response to the defendants' response.

Shareholder Derivative Suit

In April 2003, South Shore Gastrointerology UA 6/6/1980 FBO Harold Jacob, and Nancy R. Jacob Ttee filed a Shareholder Derivative Complaint against Dr. Selden; against the following members of TKT's board of directors: Jonathan S. Leff, Walter Gilbert, Wayne P. Yetter, Rodman W. Moorhead, III; against the following former members of TKT's board of directors: James E. Thomas and William Miller; and against TKT as nominal defendant, in Middlesex Superior Court in the Commonwealth of Massachusetts, Civil Action No. 03-1669. On May 29, 2003, the parties moved to transfer venue to the Business Litigation Session in Suffolk Superior Court in the Commonwealth of Massachusetts. The parties' motion was allowed, and in June 2003 the matter was accepted into the Business Litigation Session as Civil Action No. 03-02630-BLS.

The complaint alleges that the individual defendants breached fiduciary duties owed to TKT and its shareholders by disseminating materially false and misleading statements to the market and causing or allowing TKT to conduct its business in an unsafe, imprudent and unlawful manner. The complaint purports to assert derivative claims against the individual defendants for breach of fiduciary duty, and to assert a claim for contribution and indemnification on behalf of TKT for any liability TKT incurs as a result of the individual defendants' alleged misconduct. The complaint seeks declaratory, equitable and monetary relief, an unspecified amount of damages, with interest, and attorneys' fees and costs.

In August 2003, the plaintiff filed its Verified Amended Derivative Complaint (the "Amended Derivative Complaint"). The Amended Derivative Complaint alleges that the individual defendants breached fiduciary duties owed to TKT and its stockholders by causing TKT to issue materially false and misleading statements to the public, by signing TKT's Annual ReportReports on Form 10-K for the year ended December 31,years 2000 and 2001 and by signing a registration statement. The Amended Derivative Complaint also alleges that defendant Dr. Selden sold TKT's stock while in possession of material non-public information. The plaintiff seeks declaratory, equitable and monetary relief, an unspecified amount of damages, with interest, and attorneys' fees and costs.

In September 2003, TKT filed a motion to dismiss the Amended Derivative Complaint. A hearing of the motion was held in January 2004. In May 2004, the Court granted TKT's motion to dismiss. In June 2004, the plaintiff filed a Notice of Appeal appealing the dismissal of the Amended Derivative Complaint to the Massachusetts Court of Appeals.There have been no further developments with respect to this action.

SEC Investigation

In May 2003, TKT received a copy of a formal order of investigation by the Securities and Exchange Commission. The order of investigation relates to TKT's disclosures and public filings with regard to REPLAGAL and the status of the approval process of the FDA for REPLAGAL, as well as transactions in TKT's securities.

In July 2004, TKT and Dr. Selden, its Quarterly Report on Form 10-Qformer Chief Executive Officer, received "Wells" notices from the staff of the SEC, in connection with the SEC investigation. The Wells notices state that the SEC staff has preliminarily determined to recommend that the Commission bring a civil action for possible violations of the three months ended March 31, federal securities laws. In September2005, TKT described certain legal proceedings to whichthe Commission filed a suit against Dr. Selden and is seeking an injunction disgorgement, civil penalties and an order barring Dr. Selden from serving as an officer or director of a public company. Also in September 2005, the SEC staff informed the Company that it is a party.no longer recommending any enforcement action against TKT.

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ITEM 2. Unregistered Sales of Equity Securities and Use of ProceedsUNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.

None

48






ITEM 3. Defaults Upon Senior SecuritiesDEFAULTS UPON SENIOR SECURITIES

NoneNone.

ITEM 4. Submission of Matters to a Vote of Security HoldersSUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

An AnnualExtraordinary General Meeting of Shareholders was held on July 27, 2005.

The meeting considered an ordinary resolution to approve the transaction whereby a wholly-owned subsidiary of Shire Pharmaceuticals Group plc will merge with and into Transkaryotic Therapies, Inc. and pursuant to which Shire Pharmaceuticals Group plc will become the owner of record of all the outstanding capital stock of Transkaryotic Therapies, Inc. (the “Acquisition”) upon the terms and conditions of the Acquisition summarised in the Circular to Shareholders of the Company dated 27th June, 22, 2005. 2005, with any amendments, modifications, variations or revisions thereto which are not of a material nature and that the directors of the Company (or any duly authorised committee thereof) be authorized to do all such things and execute all such agreements and make such arrangements as may seem to them necessary, expedient or appropriate to give effect to the Acquisition.

The resolutions wereresolution was approved on a show of hands at the meeting. Had the resolutionsresolution been put to a poll, the proxy votes whichthat would have been voted at the meeting are described below:

1. Ordinary resolution to receive and consider the report of the directors’ and the accounts for the year ended December 31, 2004.

ForAgainstAbstentionsAgainstAbstentions 
390,982,100652,3403,146,277
383,713,047747,22873,178 

2. Ordinary resolution to re-elect Mr Matthew William Emmens as a Director.

ForAgainstAbstentions
389,563,5783,279,7091,937,430

3. Ordinary resolution to re-elect Mr Ronald Maurice Nordmann as a Director.

ForAgainstAbstentions
387,779,1763,082,6403,918,901

4. Ordinary resolution to elect Dr Barry John Price as a Director.

ForAgainstAbstentions
386,034,1423,946,8654,799,710

ITEM 5. Ordinary resolution to re-appoint Deloitte & Touche LLP as Auditors.OTHER INFORMATION
None.

ForAgainstAbstentions
387,710,4014,642,3372,427,979

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6. Ordinary resolution to authorize the Audit Committee of the Board to determine the remuneration of the Auditors.

ForAgainstAbstentions
392,716,4071,103,374960,936

7. Ordinary resolution to approve the Directors’ remuneration report for the financial year ended December 31, 2004.

ForAgainstAbstentions
379,661,9876,796,9988,321,732


8. Ordinary resolution to generally and unconditionally authorize the directors, in substitution for all existing authorities (save to the extent the same may have been exercised by the issue of relevant securities (within the meaning of Section 80 of the Companies Act 1985 (as amended) (the ‘Act’)) prior to June 22, 2005 or by reason of any offer or agreement made prior to June 22, 2005 which would or might require relevant securities to be allotted on or after June 22, 2005), to exercise all or any of the powers of the Company to allot relevant securities up to an aggregate nominal amount equal to £8,203,026 for a period expiring (unless previously renewed, varied or revoked by the Company in general meeting) on the earlier of twelve months from the date of the passing of this resolution or the conclusion of the Annual General Meeting of the Company to be held in 2006 save that the Company may before such expiry make an offer or agreement which would or might require relevant securities to be allotted after such expiry and the directors may allot relevant securities pursuant to any such offer or agreement as if the authority conferred hereby had not expired.

ForAgainstAbstentions
390,798,5492,930,8011,051,367

ITEM 6.EXHIBITS

9. Special resolution subject to the passing of the previous resolution, and in substitution for all existing authorities, to empower the directors pursuant to Section 95 of the Act to allot equity securities (within the meaning of Section 94(2) of the Act) for cash pursuant to the authority conferred by the passing of the previous resolution and/or where such allotment constitutes an allotment of equity securities by virtue of Section 94(3A) of the Act as if Section 89(1) of the Act did not apply to such allotments provided that this power:

(a)(a)shall expire after the earlier of twelve months from the date of the passing of this resolution or the conclusion of the Annual General Meeting of the Company to be held in 2006, save that the Company may before such expiry make an offer or agreement which would or might require equity securities to be allotted after such expiry and the directors may allot equity securities pursuant to any such offer or agreement as if the power conferred hereby had not expired; andExhibits
  
(b)shall be limited to:
(i) the allotment of equity securities in connection with a rights issue, open offer or other pre- emptive offer to holders of ordinary shares (excluding any shareholder holding shares as treasury shares) and to holders of non-voting exchangeable shares in the capital of Shire Acquisition Inc. (“Exchangeable Shares”) in proportion (as nearly as may be, and on the basis that each Exchangeable Share is equivalent to three ordinary shares) to their existing holdings, or to holders of ordinary shares alone in proportion (as nearly as may be) to their existing holdings of ordinary shares, but subject in each case to the directors having a right to make such exclusions or other arrangements in connection with such offerings as the directors may deem necessary or expedient:
(1)to deal with equity securities representing fractional entitlements;
(2) to deal with ordinary shares represented by depositary receipts; and
(3) to deal with legal or practical problems under the laws of, or requirements of any recognized regulatory body or any stock exchange in, any territory or any other matter whatsoever; and
(ii) the allotment of equity securities for cash otherwise than pursuant to paragraph (b)(i) up to an aggregate nominal amount of £1,230,577.
ForAgainstAbstentions
390,522,1043,182,6771,075,936

10. Special resolution to generally and unconditionally authorize the directors for the purposes of Section 166 of the Act to make market purchases (within the meaning of Section 163(3) of the Act) of ordinary shares in the capital of the Company, provided that:

(a)the maximum number of ordinary shares authorized to be purchased is 49,223,083 (representing 10% of the Company’s issued share capital at May 4, 2005);
(b)the minimum price, exclusive of any expenses, which may be paid for an ordinary share is 5 pence;
(c)the maximum price, exclusive of any expenses, which may be paid for an ordinary share is an amount equal to 5% above the average of the middle market quotations for an ordinary share in the Company taken from the London Stock Exchange Daily Official List for the five business days immediately preceding the day on which such shares are contracted to be purchased;
(d)the authority hereby conferred shall expire at the conclusion of the next Annual General Meeting of the Company to be held after June 22, 2005 (except that the Company may make a contract to purchase ordinary shares under this authority before the expiry of this authority, which will or may be executed wholly or partly after the expiry of this authority, and may make purchases of ordinary shares in pursuance of any such contract as if such authority had not expired).
ForAgainstAbstentions
393,533,510172,4811,074,726



11.Ordinary resolution to authorize the Company, in accordance with section 347C of the Act:
(a)to make donations to EU political organizations, as defined by Section 347A of the Act, not exceeding £25,000 in total; and
(b)to incur EU political expenditure as defined by Section 347A of the Act not exceeding £25,000 in total,

during the period beginning June 22, 2005 and ending on the earlier of 15 months after the date of this resolution and the conclusion of the Company’s Annual General Meeting to be held in 2006.

ForAgainstAbstentions
384,375,3497,229,2203,176,148

Matthew Emmens, Angus Russell, Dr James Cavanaugh, Dr Barry Price, David Kappler, Robin Buchanan, Ronald Nordmann and the Hon. James Andrews Grant continued in their term of office subsequent to the Annual General Meeting.

ITEM 5. Other Information

The following information is being provided pursuant to Item 1.01 “Entry into a Material Definitive Agreement” and Item 2.03 “Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant” of Form 8-K with respect to Shire’s entry into a Multicurrency Revolving Facilities Agreement (the “Facilities Agreement”) on June 15, 2005. There have been no draw downs under the Facilities Agreement. A full description of the Facilities Agreement is included in Note 9 to the condensed consolidated financial statements in this Form 10-Q.

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ITEM 6. EXHIBITS

(a) Exhibits

2.1Agreement 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)
3.1Articles of Association of Shire Pharmaceuticals Group plc as amended by special resolution on October 28, 2005.
  
10.1Multicurrency Revolving Facilities Agreement by and among Shire Pharmaceuticals Group plc, ABN AMRO Bank N.V., Barclays Bank plc., Citicorp USA, Inc., HSBC Bank plc and The Royal Bank of Scotland plc, dated as of June 15, 2005.(2)
  
10.2Exclusive License Agreement between Shire Pharmaceuticals Group plc and Transkaryotic Therapies, Inc., dated as of April 21,2005.21, 2005.(2)(3)
  
31.1Certification of Matthew Emmens pursuant to Rule 13a – 14 under The Exchange Act.
  
31.2Certification of Angus Russell pursuant to Rule 13a – 14 under The Exchange Act.
  
32.32.1Certification of Matthew Emmens and Angus Russell pursuant to Section 906 of the Sarbanes – Oxley Act of 2002.

(1) Incorporated by reference to Exhibit 99.02 to Shire’s Form 8-K filed on April 25, 2005.
(1)Incorporated by reference to Exhibit 99.02 to Shire’s Form 8-K filed on April 25,(2) Incorporated by reference to Exhibit 10.01 to Shire’s Form 10-Q filed on August 5, 2005.
(2)Incorporated by reference to Exhibit 99.03 to Shire’s Form 8-K filed on April 25, 2005.


(3) Incorporated by reference to Exhibit 99.03 to Shire’s Form 8-K filed on April 25, 2005.

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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 PHARMACEUTICALS GROUP PLC
 (Registrant)
Date: 
Date: August 5,November 9, 2005 
/s/ Matthew Emmens

By:Matthew Emmens
 Chief Executive Officer
Date: 
Date: August 5,November 9, 2005 
/s/ Angus Russell

By:Angus Russell
 Chief Financial Officer