UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
Form 10-Q(Mark One)
   
(Mark One)
þ
 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2008
  For the quarterly period ended December 31, 2007
o
 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from          to          
For the transition period from            to
Commission file number 1-14131
ALKERMES, INC.
(Exact name of registrant as specified in its charter)
   
PENNSYLVANIA
23-2472830
(State or other jurisdiction of
incorporation or organization)
 23-2472830
(I.R.S. Employer
Identification No.)
incorporation or organization)Identification No.)
88 Sidney Street, Cambridge, MA
02139-4234
(Address of principal executive offices) 02139-4234
(Zip Code)
Registrant’s telephone number including area code:
(617) 494-0171

(Former name, former address, and former fiscal year, if changed since last report)
     
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 (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yesþ Noo
     
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a non-accelerated filer.smaller reporting company. See definitionthe definitions of “large accelerated filer,” “accelerated filerfiler” and large accelerated filer”“smaller reporting company” inRule 12b-2 of the Exchange Act. (Check one):
Large accelerated filerþ Accelerated filero     Non-accelerated fileroNon-accelerated filer  o
(Do not check if a smaller reporting company)
Smaller reporting companyo
     
Indicate by check mark whether the registrant is a shell company (as defined inRule 12b-2 of the Exchange Act.): Yeso Noþ
     
The number of shares outstanding of each of the issuer’s classes of common stock was:
     
  As of February 6,
Class
 November 5, 2008
Common Stock, $.01 par value  99,699,95494,932,052 
Non-Voting Common Stock, $.01 par value  382,632 
 


 

ALKERMES, INC. AND SUBSIDIARIES
INDEX
     
    Page No.
 
Condensed Consolidated Financial Statements:  
    
Item 1.3
 3
   4
   5
   6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations13
 14
Item 3.27
Item 4.28
  25 
 Controls and Procedures26
 Legal Proceedings27 
   
Item 1.29
Item 1A.29
Item 2. 2729
Item 5.  30
Item 6.30
Signatures  2831
ExhibitsExhibit Index  28
29
3032
 EX-10.1 Employment Agreement (Richard F. Pops)31.1 Rule 13a-14(a)/15d-14(a) Certification
 EX-10.2 Employment Agreement (David A. Broecker)31.2 Rule 13a-14(a)/15d-14(a) Certification
 EX-10.3 Form of Employment Agreement
EX-31.132.1 Certification pursuant to 18 U.S.C. Section 302 Certification of CEO
EX-31.2 Section 302 Certification of CFO
EX-32 Section 906 Certification of CEO & CFO1350


2


PART 1. FINANCIAL INFORMATION
Item 1.Condensed Consolidated Financial Statements:
ALKERMES, INC. AND SUBSIDIARIES
(unaudited)
         
  December 31,
  March 31,
 
  2007  2007 
  (In thousands, except share and per share amounts) 
 
ASSETS
CURRENT ASSETS:        
Cash and cash equivalents $320,931  $80,500 
Investments  190,535   271,082 
Receivables  40,256   56,049 
Inventory  23,054   18,190 
Prepaid expenses and other current assets  7,088   7,054 
         
Total current assets  581,864   432,875 
         
PROPERTY, PLANT AND EQUIPMENT:        
Land  301   301 
Building and improvements  32,602   25,717 
Furniture, fixtures and equipment  67,783   64,203 
Equipment under capital lease  463   464 
Leasehold improvements  33,349   32,345 
Construction in progress  47,705   42,442 
         
   182,203   165,472 
Less: accumulated depreciation  (50,687)  (41,877)
         
Total property, plant and equipment — net  131,516   123,595 
         
RESTRICTED INVESTMENTS  5,146   5,144 
OTHER ASSETS  11,958   7,007 
         
TOTAL ASSETS $730,484  $568,621 
         
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:        
Accounts payable and accrued expenses $29,958  $45,855 
Accrued interest  2,975   2,976 
Unearned milestone revenue — current portion  5,820   11,450 
Deferred revenue — current portion     200 
Long-term debt — current portion  651   1,579 
         
Total current liabilities  39,404   62,060 
         
NON-RECOURSE RISPERDAL CONSTA SECURED 7% NOTES  159,430   156,851 
UNEARNED MILESTONE REVENUE — LONG-TERM PORTION  113,393   117,300 
DEFERRED REVENUE — LONG-TERM PORTION  27,837   22,153 
OTHER LONG-TERM LIABILITIES  5,774   6,796 
         
TOTAL LIABILITIES  345,838   365,160 
         
COMMITMENTS AND CONTINGENCIES (Notes 9 and 10)         
SHAREHOLDERS’ EQUITY:        
Capital stock, par value, $0.01 per share; 4,550,000 shares authorized (includes 3,000,000 shares of preferred stock); none issued and outstanding      
Common stock, par value, $0.01 per share; 160,000,000 shares authorized; 102,797,809 and 101,550,673 shares issued; 99,969,036 and 100,726,996 shares outstanding at December 31, 2007 and March 31, 2007, respectively  1,028   1,015 
Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized; 382,632 shares issued and outstanding at December 31, 2007 and March 31, 2007  4   4 
Treasury stock, at cost (2,828,773 and 823,677 shares at December 31, 2007 and March 31, 2007, respectively)  (41,599)  (12,492)
Additional paid-in capital  864,362   837,727 
Accumulated other comprehensive (loss) income  (929)  753 
Accumulated deficit  (438,220)  (623,546)
         
TOTAL SHAREHOLDERS’ EQUITY  384,646   203,461 
         
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $730,484  $568,621 
         
         
  September 30,  March 31, 
  2008  2008 
  (In thousands, except share 
  and per share amounts) 
ASSETS
        
CURRENT ASSETS:        
Cash and cash equivalents $68,525  $101,241 
Investments — short-term  263,913   240,064 
Receivables  36,047   47,249 
Inventory  15,721   18,884 
Prepaid expenses and other current assets  15,354   5,720 
       
Total current assets  399,560   413,158 
       
PROPERTY, PLANT AND EQUIPMENT:        
Land  301   301 
Building and improvements  36,371   35,003 
Furniture, fixtures and equipment  65,293   63,364 
Equipment under capital lease  464   464 
Leasehold improvements  33,614   33,387 
Construction in progress  40,686   42,859 
       
   176,729   175,378 
Less: accumulated depreciation  ( 67,922)  ( 62,839)
       
Total property, plant and equipment — net  108,807   112,539 
       
INVESTMENTS — LONG-TERM  93,395   119,056 
OTHER ASSETS  3,256   11,558 
       
TOTAL ASSETS $605,018  $656,311 
       
         
LIABILITIES AND SHAREHOLDERS’ EQUITY
        
CURRENT LIABILITIES:        
Accounts payable and accrued expenses $23,623  $36,046 
Unearned milestone revenue — current portion  5,728   5,927 
Deferred revenue — current portion  298    
Long-term debt — current portion     47 
Non-recourse RISPERDAL CONSTA secured 7% notes — current portion  15,835    
       
Total current liabilities  45,484   42,020 
       
NON-RECOURSE RISPERDAL CONSTA SECURED 7% NOTES  76,054   160,324 
UNEARNED MILESTONE REVENUE — LONG-TERM PORTION  108,890   111,730 
DEFERRED REVENUE — LONG-TERM PORTION  28,397   27,837 
OTHER LONG-TERM LIABILITIES  7,228   9,086 
       
TOTAL LIABILITIES  266,053   350,997 
       
COMMITMENTS AND CONTINGENCIES (Note 12)        
SHAREHOLDERS’ EQUITY:        
Capital stock, par value, $0.01 per share; 4,550,000 shares authorized (includes 3,000,000 shares of preferred stock); none issued and outstanding      
Common stock, par value, $0.01 per share; 160,000,000 shares authorized; 103,912,534 and 102,977,348 shares issued; 94,912,489 and 95,099,166 shares outstanding at September 30, 2008 and March 31, 2008, respectively  1,039   1,030 
Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized; 382,632 shares issued and outstanding at September 30, 2008 and March 31, 2008  4   4 
Treasury stock, at cost (9,000,045 and 7,878,182 shares at September 30, 2008 and March 31, 2008, respectively)  ( 120,970)  ( 107,322)
Additional paid-in capital  885,259   869,695 
Accumulated other comprehensive loss  ( 1,185)  ( 1,526)
Accumulated deficit  ( 425,182)  ( 456,567)
       
TOTAL SHAREHOLDERS’ EQUITY  338,965   305,314 
       
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $605,018  $656,311 
       
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


3


ALKERMES, INC. AND SUBSIDIARIES
(unaudited)
                 
  Three Months Ended
  Nine Months Ended
 
  December 31,  December 31, 
  2007  2006  2007  2006 
  (In thousands, except per share amounts) 
 
REVENUES:                
Manufacturing revenues $14,275  $28,763  $69,929  $77,078 
Royalty revenues  7,384   5,673   21,714   16,625 
Research and development revenue under collaborative arrangements  23,985   19,532   68,641   51,620 
Net collaborative profit  5,127   8,445   18,025   29,798 
                 
Total revenues  50,771   62,413   178,309   175,121 
                 
EXPENSES:                
Cost of goods manufactured  7,499   12,989   26,862   34,149 
Research and development  30,395   29,908   91,331   85,588 
Selling, general and administrative  15,249   16,365   45,136   48,572 
                 
Total expenses  53,143   59,262   163,329   168,309 
                 
OPERATING (LOSS) INCOME  (2,372)  3,151   14,980   6,812 
                 
OTHER INCOME (EXPENSE):                
Gain on sale of investment in Reliant Pharmaceuticals, Inc.   174,631      174,631    
Interest income  4,292   4,260   12,940   13,329 
Interest expense  (4,088)  (4,141)  (12,238)  (13,648)
Other (expense) income, net  (393)  89   784   212 
                 
Total other income (expense)  174,442   208   176,117   (107)
                 
INCOME BEFORE INCOME TAXES  172,070   3,359   191,097   6,705 
INCOME TAXES  3,189   426   5,771   761 
                 
NET INCOME $168,881  $2,933  $185,326  $5,944 
                 
EARNINGS PER COMMON SHARE:                
BASIC $1.66  $0.03  $1.82  $0.06 
                 
DILUTED $1.63  $0.03  $1.78  $0.06 
                 
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:                
BASIC  101,703   100,896   101,676   98,690 
                 
DILUTED  103,914   104,746   104,097   103,156 
                 
                 
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
  2008  2007  2008  2007 
  (In thousands, except per share amounts) 
REVENUES:                
Manufacturing revenues $33,039  $24,137  $71,649  $55,654 
Royalty revenues  8,439   7,348   17,020   14,330 
Research and development revenue under collaborative arrangements  5,252   21,206   36,702   44,656 
Net collaborative profit  581   5,909   1,932   12,898 
             
Total revenues  47,311   58,600   127,303   127,538 
             
EXPENSES:                
Cost of goods manufactured  12,071   9,218   26,385   19,363 
Research and development  19,710   28,317   41,971   60,936 
Selling, general and administrative  11,679   14,487   23,605   29,887 
             
Total expenses  43,460   52,022   91,961   110,186 
             
OPERATING INCOME  3,851   6,578   35,342   17,352 
             
OTHER (EXPENSE) INCOME:                
Interest income  2,693   4,246   6,309   8,648 
Interest expense  (4,243)  (4,077)  (8,469)  (8,150)
Other (expense) income  (666)  1,151   (830)  1,177 
             
Total other (expense) income  (2,216)  1,320   (2,990)  1,675 
             
INCOME BEFORE INCOME TAXES  1,635   7,898   32,352   19,027 
INCOME TAX (BENEFIT) PROVISION  (63)  200   967   2,582 
             
NET INCOME $1,698  $7,698  $31,385  $16,445 
             
EARNINGS PER COMMON SHARE:                
BASIC $0.02  $0.08  $0.33  $0.16 
             
DILUTED $0.02  $0.07  $0.32  $0.16 
             
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:                
BASIC  95,637   101,595   95,211   101,663 
             
DILUTED  97,356   104,315   96,729   104,446 
             
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


4


ALKERMES, INC. AND SUBSIDIARIES
(unaudited)
         
  Nine Months Ended
 
  December 31, 
  2007  2006 
  (In thousands) 
 
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net income $185,326  $5,944 
Adjustments to reconcile net income to cash flows from operating activities:        
Share-based compensation  15,477   22,218 
Depreciation  9,380   8,838 
Other non-cash charges  3,580   2,645 
Change in fair value of warrants  (1,425)  510 
Gain on sale of investment in Reliant Pharmaceuticals, Inc.   (174,631)   
Loss on disposal of equipment  645    
Changes in assets and liabilities:        
Receivables  14,368   (11,079)
Inventory, prepaid expenses and other assets  (7,904)  (10,040)
Accounts payable, accrued expenses and accrued interest  (14,004)  (11,598)
Unearned milestone revenue  (9,537)  58,760 
Deferred revenue  6,909   18,516 
Other liabilities  (180)  202 
         
Cash flows from operating activities  28,004   84,916 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Additions to property, plant and equipment  (17,618)  (24,728)
Proceeds from the sale of equipment     159 
Purchases of investments  (371,342)  (217,453)
Sales and maturities of investments  453,403   214,193 
Proceeds from the sale of investment in Reliant Pharmaceuticals, Inc.   166,865    
         
Cash flows from investing activities  231,308   (27,829)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock  9,510   5,868 
Excess tax benefit from stock options  211    
Payment of debt  (975)  (817)
Purchase of treasury stock  (27,627)  (12,492)
         
Cash flows from financing activities  (18,881)  (7,441)
         
NET INCREASE IN CASH AND CASH EQUIVALENTS  240,431   49,646 
CASH AND CASH EQUIVALENTS — Beginning of period  80,500   33,578 
         
CASH AND CASH EQUIVALENTS — End of period $320,931  $83,224 
         
SUPPLEMENTAL CASH FLOW DISCLOSURE:        
Cash paid for interest $9,004  $10,647 
Cash paid for income taxes $980  $896 
Non-cash investing and financing activities:        
Conversion of 2.5% convertible subordinated notes into common stock $  $125,000 
Redemption of redeemable convertible preferred stock $  $15,000 
Purchased capital expenditures included in accounts payable and accrued expenses $328  $ 
Net share exercise of warrants into common stock of the issuer $2,994  $ 
Receipt of Alkermes shares for the purchase of stock options or as payment to satisfy minimum withholding tax obligations related to employee stock awards $1,480  $ 
Funds held in escrow from the sale of investment in Reliant Pharmaceuticals, Inc.  $7,766  $ 
         
  Six Months Ended 
  September 30, 
  2008  2007 
  (In thousands) 
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net income $31,385  $16,445 
Adjustments to reconcile net income to cash flows from operating activities:        
Share-based compensation  8,309   10,295 
Depreciation  4,901   6,114 
Other non-cash charges  2,564   2,187 
Loss on the purchase of the 7% Notes  1,989    
Change in fair value of warrants     (1,426)
Changes in assets and liabilities:        
Receivables  2,251   10,939 
Inventory, prepaid expenses and other assets  890   (8,116)
Accounts payable and accrued expenses  (10,785)  (20,707)
Unearned milestone revenue  (3,039)  (8,101)
Deferred revenue  2,092   2,086 
Other liabilities  (1,363)  (155)
       
Cash flows from operating activities  39,194   9,561 
       
CASH FLOWS FROM INVESTING ACTIVITIES:        
Purchases of property, plant and equipment  (3,567)  (14,609)
Sales of property, plant and equipment  7,717    
Purchases of investments  (462,412)  (291,480)
Sales and maturities of investments  463,959   293,861 
       
Cash flows from investing activities  5,697   (12,228)
       
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from issuance of common stock  7,221   9,122 
Excess tax benefit from stock options  74   108 
Payment of debt  (47)  (644)
Purchase of non-recourse RISPERDAL CONSTA secured 7% notes  (71,775)   
Purchase of treasury stock  (13,080)   
       
Cash flows from financing activities  (77,607)  8,586 
       
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS  (32,716)  5,919 
CASH AND CASH EQUIVALENTS — Beginning of period  101,241   80,500 
       
CASH AND CASH EQUIVALENTS — End of period $68,525  $86,419 
       
SUPPLEMENTAL CASH FLOW DISCLOSURE:        
Cash paid for interest $6,662  $5,999 
Cash paid for income taxes $435  $980 
Non-cash investing and financing activities:        
Purchased capital expenditures included in accounts payable and accrued expenses $233  $246 
Net share exercise of warrants into common stock of the issuer $  $2,994 
Receipt of Alkermes shares for the purchase of stock options or as payment to satisfy minimum withholding tax obligations related to stock based awards $568  $924 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.


5


ALKERMES, INC. AND SUBSIDIARIES
1.  1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESSUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
     
The accompanying condensed consolidated financial statements of Alkermes, Inc. (the “Company” or “Alkermes”) for the three and ninesix months ended December 31,September 30, 2008 and 2007 and 2006 are unaudited and have been prepared on a basis substantially consistent with the audited financial statements for the year ended March 31, 2007.2008. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America (commonly referred to as “GAAP”). In the opinion of management, the condensed consolidated financial statements include all adjustments, which are of a normal recurring nature, that are necessary to present fairly the results of operations for the reported periods.
     
These financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto which are contained in the Company’s Annual Report onForm 10-K for the year ended March 31, 2007,2008, as filed with the Securities and Exchange Commission (“SEC”).
     
The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for a full fiscal year.
     
Principles of Consolidation— The condensed consolidated financial statements include the accounts of Alkermes, Inc. and its wholly-owned subsidiaries: Alkermes Controlled Therapeutics, Inc.; Alkermes Europe, Ltd. and RC Royalty Sub LLC (“Royalty Sub”). The assets of Royalty Sub are not available to satisfy obligations of Alkermes and its subsidiaries, other than the obligations of Royalty Sub, including Royalty Sub’s non-recourse RISPERDAL® CONSTA® secured 7% notes (the “Non-Recourse 7%“7% Notes”). Intercompany accounts and transactions have been eliminated.
     
Use of Estimates— The preparation of the Company’s condensed consolidated financial statements in conformity with GAAP necessarily requires management to make estimates and assumptions that affect the following: (1) reported amounts of assets and liabilities; (2) disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements; and (3) the reported amounts of revenues and expenses during the reporting period. Actual results could differ from these estimates.
Income TaxesNew Accounting Pronouncements
     
Effective April 1,In November 2007, the Company adoptedEmerging Issues Task Force (“EITF”) of the Financial Accounting Standards Board (“FASB”) Interpretationreached a final consensus on EITF Issue No. 48,07-1,“Accounting for Uncertainty in Income Taxes”Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property”(“FINEITF No. 48”07-1”). FINEITF No. 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109,“Accounting for Income Taxes”.FIN No. 48 also prescribes a recognition threshold and measurement attribute07-1 is effective for the financial statement recognition and measurementCompany’s fiscal year beginning April 1, 2009. Adoption is on a retrospective basis to all prior periods presented for all collaborative arrangements existing as of each tax position taken or expected to be taken in a tax return, and provides guidancethe effective date. The Company is currently evaluating the impact of the adoption of EITF No. 07-1 on derecognition, classification, interest and penalties, accounting in interim periods, disclosures and transition. See Note 9, Income Taxes, to the condensedits consolidated financial statements for a discussion of the Company’s accounting for uncertain tax positions.statements.
     
New Accounting Pronouncements
In September 2006,March 2008, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 157,161,Fair Value Measurements”Disclosures about Derivative Instruments and Hedging Activities”(“SFAS No. 157”161”), which establishes a framework for measuring fair value in GAAP and expands disclosures about the use of fair value to measure assets and liabilities in interim and annual reporting periods subsequent to initial recognition. Prior to. SFAS No. 157, which emphasizes that fair value161 is intended to improve financial reporting about derivative instruments and hedging activities by requiring enhanced disclosures to enable investors to better understand their effects on an entity’s financial position, financial performance and cash flows. SFAS No. 161 is effective for the Company’s fiscal year beginning April 1, 2009, and the Company does not expect the adoption of this standard to have a market-based measurement and not an entity-specific measurement, there were different definitionsmaterial impact on its consolidated financial statements.


6


ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
2. COMPREHENSIVE INCOME
     
of fair value and limited guidance for applying those definitions in GAAP. SFAS No. 157 is effective for the Company for the reporting period beginning April 1, 2008. The Company is in the process of evaluating the impact of the adoption of SFAS No. 157 on its consolidated financial statements.
In February 2007, the FASB issued SFAS No. 159,“The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of FASB Statement No. 115”(“SFAS No. 159”). SFAS No. 159 permits entities to elect to measure selected financial instruments and certain other items at fair value. Unrealized gains and losses on items for which the fair value option has been elected are recognized in earnings in each reporting period. SFAS No. 159 is effective for the Company for the reporting period beginning April 1, 2008. The Company is in the process of evaluating the impact of the adoption of SFAS No. 159 on its consolidated financial statements.
In June 2007, the Emerging Issues Task Force (“EITF”) of the FASB reached a consensus on IssueNo. 07-03,“Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development Activities,” (“EITFNo. 07-03”), which addresses the diversity that exists with respect to the accounting for the non-refundable portion of a payment made by a research and development entity for future research and development activities. Under EITFNo. 07-03, an entity would defer and capitalize non-refundable advance payments made for research and development activities until the related goods are delivered or the related services are performed. EITFNo. 07-03 is effective for the Company for the reporting period beginning April 1, 2008. The Company does not expect the adoption of EITFNo. 07-03 to have a significant impact on its consolidated financial statements.
In November 2007, the EITF of the FASB reached a consensus on IssueNo. 07-01,“Accounting for Collaborative Arrangements,”(“EITFNo. 07-01”). EITFNo. 07-01 defines a collaborative arrangement as a contractual arrangement in which the parties are: (1) active participants to the arrangement; and (2) exposed to significant risks and rewards that depend upon the commercial success of the endeavor. The issue also addresses the appropriate income statement presentation for activities and payments between the participants in a collaborative arrangement as well as for costs incurred and revenue generated from transactions with third parties. EITFNo. 07-01 is effective for the Company for the reporting period beginning April 1, 2009. The Company is in the process of evaluating the impact of the adoption of EITFNo. 07-01 on its consolidated financial statements.
2.  COMPREHENSIVE INCOME
Comprehensive income for the three and ninesix months ended December 31,September 30, 2008 and 2007 and 2006 is as follows:
                 
  Three Months
  Nine Months
 
  Ended
  Ended
 
  December 31,  December 31, 
(In thousands) 2007  2006  2007  2006 
 
Net income $168,881  $2,933  $185,326  $5,944 
Unrealized losses on available for sale securities:                
Holding losses  (1,469)  (1,152)  (2,019)  (699)
Reclassification of unrealized loss to realized loss on available for sale securities during the period  337      337    
                 
Unrealized losses on available for sale securities  (1,132)  (1,152)  (1,682)  (699)
                 
Comprehensive income $167,749  $1,781  $183,644  $5,245 
                 


7


                 
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In thousands) 2008  2007  2008  2007 
Net income $1,698  $7,698  $31,385  $16,445 
Unrealized gains (losses) on available-for-sale securities:                
Holding losses  (61)  (25)  (266)  (550)
Reclassification of unrealized losses to realized losses on available-for-sale securities  559      607    
             
Unrealized gains (losses) on available-for-sale securities  498   (25)  341   (550)
             
Comprehensive income $2,196  $7,673  $31,726  $15,895 
             
ALKERMES, INC. AND SUBSIDIARIES
3. EARNINGS PER COMMON SHARE
     
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
3.  EARNINGS PER COMMON SHARE
Basic earnings per common share is calculated based upon net income available to holders of common shares divided by the weighted average number of shares outstanding. For the calculation of diluted earnings per common share, the Company uses the weighted average number of common shares outstanding, as adjusted for the effect of potential outstanding shares, including stock options and stock awards, redeemable convertible preferred stock and convertible debt.awards.
     
Basic and diluted earnings per common share are calculated as follows:
                
 Three Months
 Nine Months
                 
 Ended
 Ended
  Three Months Ended Six Months Ended 
 December 31, December 31,  September 30, September 30, 
(In thousands) 2007 2006 2007 2006  2008 2007 2008 2007 
Numerator:                 
Net income $168,881  $2,933  $185,326  $5,944  $1,698 $7,698 $31,385 $16,445 
                  
Denominator:                 
Weighted average number of common shares outstanding  101,703   100,896   101,676   98,690  95,637 101,595 95,211 101,663 
Effect of dilutive securities:                 
Stock options  2,159   2,723   2,354   3,633  1,479 2,371 1,329 2,451 
Restricted stock awards  52   291   67   244  240 349 189 332 
Redeemable convertible preferred stock     836      589 
                  
Dilutive common share equivalents  2,211   3,850   2,421   4,466  1,719 2,720 1,518 2,783 
                  
Shares used in calculating diluted earnings per common share  103,914   104,746   104,097   103,156  97,356 104,315 96,729 104,446 
                  
     
The following amounts areStock options of 13.4 million and 10.3 million for the three months ended September 30, 2008 and 2007, respectively, and 13.9 million and 11.8 million for the six months ended September 30, 2008 and 2007, respectively, were not included in the calculation of net income per common share because their effects are anti-dilutive:anti-dilutive. There were 0.1 million and no restricted stock units excluded from the calculation of net income per common share for the three and months ended September 30, 2008 and 2007, respectively, and none for the six months ended September 30, 2008 and 2007 because their effects are anti-dilutive.
4. INVESTMENTS
     At September 30, 2008 and March 31, 2008, the Company held investments of $352.6 million and $354.5 million, respectively, of which $88.7 million and $114.4 million are long-term, respectively, which were classified as available-for-sale and are carried at fair value in the Company’s condensed consolidated balance sheets. These investments include United States (“U.S.”) government debt securities, U.S. agency debt securities, municipal debt securities, investment grade corporate debt securities, including asset backed debt securities, student loan backed auction rate securities and strategic equity investments.
                 
  Three Months
  Nine Months
 
  Ended
  Ended
 
  December 31,  December 31, 
(In thousands) 2007  2006  2007  2006 
 
Stock options  11,899   12,053   11,919   9,540 
2.5% convertible subordinated notes           2,461 
3.75% convertible subordinated notes     10      10 
                 
Total  11,899   12,063   11,919   12,011 
                 
     At September 30, 2008 and March 31, 2008, the Company held investments of $4.7 million, which were classified as long-term, held-to-maturity securities and were carried at amortized cost. These investments include


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ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
4.  SHARE-BASED COMPENSATION
Share-based compensation expense for the three and nine months ended December 31, 2007 and 2006 is as follows:
                 
  Three Months
  Nine Months
 
  Ended
  Ended
 
  December 31,  December 31, 
(In thousands) 2007  2006  2007  2006 
 
Cost of goods manufactured $319  $931  $1,279  $2,094 
Research and development  2,055   1,897   5,691   6,965 
Selling, general and administrative  2,808   4,672   8,507   13,159 
                 
Total $5,182  $7,500  $15,477  $22,218 
                 
As of December 31, 2007 and March 31, 2007, $0.5 million and $0.6 million, respectively, of share-based compensation cost was capitalized and recorded under the caption “Inventory” in the condensed consolidated balance sheets.
5.  INVESTMENTS
As of December 31, 2007 and March 31, 2007, Investments of $190.5 million and $271.1 million, respectively, consist of investments in U.S. government obligations,debt securities and corporate debt obligationssecurities that are restricted and marketable equity securitiesheld as collateral under certain letters of publicly traded companies thatcredit related to certain of the Company’s lease agreements.
     At September 30, 2008, the Company collaborates with that are classified as available-for-sale and recorded at fair value. Fair value is generally based on quoted market prices. If quoted market prices are not available, fair values are estimated based on dealer quotes or quoted prices for instruments with similar characteristics. As of December 31, 2007,had gross unrealized gains and losses on the investments were $1.0of $2.3 million and $1.9gross unrealized losses of $3.5 million respectively.on its available-for-sale investments. The Company believes that the gross unrealized losses on these investments are temporary, and the Company has the intent and ability to hold these securities to recovery, which may be at maturity. For the six months ended September 30, 2008, the Company recognized $0.6 million in charges for other-than-temporary losses on its strategic equity investments.
     At September 30, 2008, the Company had $10.0 million in investments in auction rate securities with an unrealized loss of $0.7 million. The securities represent the Company’s investment in taxable student loan revenue bonds issued by state higher education authorities which service student loans under the Federal Family Education Loan Program. The bonds were triple A rated at the date of purchase and are collateralized by student loans purchased by the authorities, which are guaranteed by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity for these securities is typically provided by an auction process that resets the applicable interest rate at pre-determined intervals. Each of these securities had been subject to auction processes for which there had been insufficient bidders on the scheduled auction dates and the auctions subsequently failed. The Company is not able to liquidate its investments in auction rate securities until future auctions are successful, a buyer is found outside of the auction process or the bonds are redeemed by the issuer. The securities continue to pay interest at predetermined interest rates during the periods in which the auctions have failed. At September 30, 2008, the Company determined that the securities were temporarily impaired due to the length of time each security was in an unrealized loss position, the extent to which fair value was less than cost, the financial condition and near term prospects of the issuers and the guarantee agencies, and the Company’s intent and ability to hold each security for a period of time sufficient to allow for any anticipated recovery in fair value.
As     At September 30, 2008, the Company had $8.2 million in investments in asset backed debt securities with an unrealized loss of December 31, 2007$0.9 million. The securities represent the Company’s investment in investment grade medium term floating rate notes (“MTN”) of Aleutian Investments, LLC (“Aleutian”) and Meridian Funding Company, LLC (“Meridian”), which are qualified special purpose entities (“QSPE’s”) of Ambac Financial Group, Inc. (“Ambac”) and MBIA, Inc. (“MBIA”), respectively. Ambac and MBIA are guarantors of financial obligations and are referred to as monoline financial guarantee insurance companies. The QSPE’s, which purchase pools of assets or securities and fund the purchase through the issuance of MTN’s, have been established to provide a vehicle to access the capital markets for asset backed debt securities and corporate borrowers. The MTN’s include sinking fund redemption features which match-fund the terms of redemptions to the maturity dates of the underlying pools of assets or securities in order to mitigate potential liquidity risk to the QSPE’s. At September 30, 2008, a substantial portion of the Company’s initial investment in the Meridian MTN’s had been redeemed by MBIA though scheduled sinking fund redemptions at par value, and the first sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
     The liquidity and fair value of these securities has been negatively impacted by the uncertainty in the credit markets, and the exposure of these securities to the financial condition of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac had its triple A rating reduced to Aa3 by Moody’s and double A by Standard and Poor’s (“S&P”), and MBIA was downgraded from triple A to A2 by Moody’s and double A by S&P. Both downgrades were due to Ambac’s and MBIA’s inability to maintain triple A capital levels. In August 2008, S&P affirmed its double A ratings of Ambac and MBIA with negative outlook. In September 2008, Moody’s placed Ambac and MBIA on review for possible downgrade. In November 2008, Moody’s announced that it had downgraded Ambac’s rating to Baa1 with a developing outlook.
     The Company may not be able to liquidate its investment in these securities before the scheduled redemptions or until trading in the securities resumes in the credit markets, which may not occur. At September 30, 2008, the Company determined that the securities had been temporarily impaired due to the length of time each security was in an unrealized loss position, the extent to which fair value was less than cost, the financial condition and near term prospects of the issuers, current redemptions made by one of the issuers and the Company’s intent and ability to hold each security for a period of time sufficient to allow for any anticipated recovery in fair value or until scheduled redemption.
     The Company also has warrants to purchase securities of certain publicly held companies included in its portfolio of strategic equity investments. These warrants are considered to be derivative instruments and at September 30, 2008 and March 31, 2007, Restricted Investments2008, the warrants had carrying values of $5.1 million consistsless than $0.1 million.

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ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
5. FAIR VALUE MEASUREMENTS
     Effective April 1, 2008, the Company implemented SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”) for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period. The adoption of SFAS No. 157 did not have a material impact on the Company’s financial position and results of operations. In accordance with the provisions of FASB Staff Position FAS 157-2, “Effective Date of FASB Statement No. 157” (“FSP FAS 157-2”) the Company has elected to defer implementation of SFAS No. 157 as it relates to non-financial assets and non-financial liabilities that are recognized and disclosed at fair value in the financial statements on a nonrecurring basis until April 1, 2009. The Company is evaluating the impact, if any, this standard will have on its non-financial assets and liabilities.
     SFAS No. 157 provides a framework for measuring fair value and requires expanded disclosures regarding fair value measurements. SFAS No. 157 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, SFAS No. 157 permits the use of various valuation approaches, including market, income and cost approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. In October 2008, the FASB issued FASB Staff Position FAS 157-3“Determining the Fair Value of a Financial Asset When the Market for that Asset is not Active”(“FSP FAS 157-3”). FSP FAS 157-3 clarifies the application of SFAS No. 157 in a market that is not active and provides an example to illustrate key considerations in determining the fair value of a financial asset when the market for that financial asset is not active. FSP FAS 157-3 is effective for the Company’s condensed consolidated financial statements for the three and six months ended September 30, 2008. The adoption of this standard did not have a material impact on the consolidated financial statements.
     The fair value hierarchy is broken down into three levels based on the reliability of inputs. The Company has categorized its cash, cash equivalents and investments within the hierarchy as follows:
Level 1— These valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 1 inputs include investments in money market funds, U.S. government debt securities, U.S. agency debt securities, municipal debt securities, bank deposits and exchange-traded equity securities of certain publicly held companies;
Level 2— These valuations are based on a market approach using quoted prices obtained from brokers or dealers for similar securities or for securities for which we have limited visibility into their trading volumes. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 2 inputs consist of investments in corporate debt securities;
Level 3— These valuations are based on an income approach using certain inputs that are unobservable and are significant to the overall fair value measurement. Valuations of these products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of investments in auction rate securities and asset backed debt securities that are not currently trading. In addition, the Company holds warrants in certain publicly held companies that are classified using Level 3 inputs. The carrying balance of these warrants was immaterial at September 30, 2008 and March 31, 2008.

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ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
     The following table presents information about the Company’s assets and liabilities that are measured at fair value on a recurring basis at September 30, 2008, and indicates the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value:
                 
          Significant    
          Other  Significant 
      Quoted Prices in  Observable  Unobservable 
  September 30,  Active Markets  Inputs  Inputs 
(In thousands) 2008  (Level 1)  (Level 2)  (Level 3) 
Assets:
                
Cash equivalents $7,025  $7,025  $  $ 
U.S. government and agency and municipal debt securities  250,231   250,231       
Corporate debt securities  89,107   4,240   84,867    
Asset backed debt securities  7,283         7,283 
Auction rate securities  9,272         9,272 
Strategic equity investments  1,414   1,414       
             
Total $364,332  $262,910  $84,867  $16,555 
             
     The fair values of the Company’s cash equivalents and investments in U.S. government obligationsand agency and municipal debt securities, and corporate debt obligations thatsecurities are restricted and classified as long-term held-to-maturity securities and are recorded at amortized cost.determined through observable market sources. The Company’s strategic equity investments are held as collateral underinvestments in certain letters of credit related to the Company’s lease agreements.
As of December 31, 2007 and March 31, 2007, the Company held investments of $0.2 million and $0.7 million, respectively, in marketable equity securities of publicly traded companies whose fair value is readily determinable.
     The fair values of the Company’s investments in asset backed debt securities and auction rate securities are determined using certain inputs that are unobservable and significant to the overall fair value measurement. Typically, auction rate securities trade at their par value due to the short interest rate reset period and the availability of buyers or sellers of the securities at recurring auctions. However, since the security auctions have failed and fair value cannot be derived from quoted prices, the Company collaboratesused a discounted cash flow model to determine the estimated fair value of its investments in auction rate securities at September 30, 2008. The Company also used a discounted cash flow model to determine the estimated fair value of its investments in asset backed debt securities at September 30, 2008, as the asset backed debt securities are not actively trading. The assumptions used in the discounted cash flow models used to determine the estimated fair value of these securities include estimates for interest rates, timing of cash flows, expected holding periods and risk adjusted discount rates, which include a provision for default and liquidity risk. The Company’s valuation analyses consider, among other items, assumptions that market participants would use in their estimates of fair value, such as the collateral underlying the security, the inability to sell the investment in an active market, the creditworthiness of the issuer and any associated guarantees, the timing of expected future cash flows, and the expectation of the next time the security will have a successful auction or when callability features may be exercised by the issuer. These securities were also compared, where possible, to other observable market data with that are classified as long-term available-for-salesimilar characteristics.
     The following table is a rollforward of the fair value of the Company’s investments in asset backed debt securities and are recordedauction rate securities whose fair value is determined using Level 3 inputs:
     
  Fair Value 
(In thousands)    
Balance, April 1, 2008 $18,612 
Total unrealized losses included in earnings   
Total unrealized losses included in comprehensive income  (468)
Redemptions  (1,589)
    
Balance, September 30, 2008 $16,555 
    
     In February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for Financial Assets and Financial Liabilities Including an Amendment of FASB Statement No. 115” (“SFAS No. 159”). SFAS No. 159 permits, but does not require, entities to elect to measure selected financial instruments and certain other items at fair value. Unrealized gains and losses on items for which the fair value under “Other Assets”option has been elected are recognized in earnings at each reporting period. The Company adopted the provisions of SFAS No. 159 on April 1, 2008 and did not elect to

10


ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
measure any new assets or liabilities at their respective fair values and, therefore, the adoption of SFAS No. 159 did not have an impact on its results of operations and financial position.
     The carrying amounts reflected in the Company’s condensed consolidated balance sheets.sheets for cash and cash equivalents, receivables, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term durations.
6. INVENTORY
     
6.  INVENTORY
Inventory is stated at the lower of cost or market value. Cost is determined using thefirst-in, first-out method. Inventory consists of the following:
         
  December 31,
  March 31,
 
(In thousands) 2007  2007 
 
Raw materials $8,995  $7,238 
Work in process  6,895   4,291 
Finished goods  7,164   6,661 
         
Total $23,054  $18,190 
         


9


         
  September 30,  March 31, 
(In thousands) 2008  2008 
Raw materials $8,338  $8,373 
Work in process  2,215   3,060 
Finished goods  5,168   7,451 
       
Total $15,721  $18,884 
       
ALKERMES, INC.7. ACCOUNTS PAYABLE AND SUBSIDIARIES
ACCRUED EXPENSES
     
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
7.  ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
         
  September 30,  March 31, 
(In thousands) 2008  2008 
Accounts payable $5,019  $7,042 
Accrued compensation  8,255   11,245 
Accrued interest  1,750   2,975 
Accrued restructuring — current portion  804   4,037 
Accrued other  7,795   10,747 
       
Total $23,623  $36,046 
       
         
  December 31,
  March 31,
 
(In thousands) 2007  2007 
 
Accounts payable $9,127  $12,097 
Accrued expenses related to collaborative arrangements  747   16,155 
Accrued compensation  9,385   10,917 
Accrued other  10,699   6,686 
         
Total $29,958  $45,855 
         
8. RESTRUCTURING
     In March 2008, the Company announced the decision by Eli Lilly and Company to discontinue the AIR® Insulin development program. As a result, the Company terminated approximately 150 employees and closed its commercial manufacturing facility in Chelsea, MA (the “2008 Restructuring”). In connection with the 2008 Restructuring, the Company recorded net restructuring charges of $6.9 million in the year ended March 31, 2008. At September 30, 2008, the Company had paid in cash approximately $3.5 million in connection with the 2008 Restructuring.
     Restructuring activity during the six months ended September 30, 2008 for the 2008 Restructuring is as follows:
                 
          Other    
  Facility      Contract    
(In thousands) Closure  Severance  Losses  Total 
Balance, April 1, 2008 $4,930  $2,881  $37  $7,848 
Additions     78   70   148 
Payments  (490)  (2,952)  (107)  (3,549)
Other adjustments  99         99 
             
Balance, September 30, 2008 (1) $4,539  $7  $  $4,546 
             
8.  (1)SALE OF INVESTMENT IN RELIANT PHARMACEUTICALS, INC.The restructuring liability at September 30, 2008 consists of $0.8 million classified as current and $3.7 million classified as long-term in the accompanying condensed consolidated balance sheet.
     In June 2004, the Company and its former collaborative partner Genentech, Inc. announced the decision to discontinue commercialization of NUTROPIN DEPOT® (the “2004 Restructuring”). In connection with the 2004

11


ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
Restructuring, the Company recorded charges of $11.5 million in the year ended March 31, 2005. During the six months ended September 30, 2008, the Company paid $0.1 million in facility closure costs and recorded an adjustment of $0.1 million to reduce the restructuring charges accrued in connection with the 2004 Restructuring to zero. As of September 30, 2008, the 2004 Restructuring was complete.
9. SHARE-BASED COMPENSATION
     Share-based compensation expense for the three and six months ended September 30, 2008 and 2007 is as follows:
                 
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In thousands) 2008  2007  2008  2007 
Cost of goods manufactured $428  $334  $857  $960 
Research and development  1,282   1,785   2,870   3,636 
Selling, general and administrative  2,104   2,429   4,582   5,699 
             
Total $3,814  $4,548  $8,309  $10,295 
             
     At September 30, 2008 and March 31, 2008, $0.5 million and $0.3 million, respectively, of share-based compensation cost was capitalized and recorded as Inventory in the condensed consolidated balance sheets.
10. EXTINGUISHMENT OF DEBT
     During the six months ended September 30, 2008, the Company purchased, in three privately negotiated transactions, $75.0 million in original principal amount of its outstanding 7% Notes for $71.8 million. As a result of the purchases, $95.0 million principal amount of the 7% Notes remains outstanding at September 30, 2008. The Company recorded a loss on the extinguishment of the notes of $2.0 million during the six months ended September 30, 2008, which was recorded as interest expense.
11. INCOME TAXES
     The Company records a deferred tax asset or liability based on the difference between the financial statement and tax bases of assets and liabilities, as measured by enacted tax rates assumed to be in effect when these differences reverse. At September 30, 2008, the Company determined that it is more likely than not that the deferred tax assets may not be realized and a full valuation allowance continues to be recorded.
     The income tax benefit in the amount of $0.1 million and income tax provision of $1.0 million for the three and six months ended September 30, 2008, respectively, and the income tax provision of $0.2 million and $2.6 million for the three and six months ended September 30, 2007, respectively, related to the U.S. alternative minimum tax (“AMT”). Included in the $0.1 million benefit for the three months ended September 30, 2008 is $0.1 million which represents the amount the Company estimates it will benefit from as a result of the recently enactedHousing and Economic Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus depreciation in lieu of a refundable cash credit based on certain qualified asset purchases. The utilization of tax loss carryforwards is limited in the calculation of AMT and, as a result, a federal tax charge was recorded in the three and six months ended September 30, 2008 and 2007. The AMT liability is available as a credit against future tax obligations upon the full utilization or expiration of the Company’s net operating loss carryforward.
12. COMMITMENTS AND CONTINGENCIES
     From time to time, the Company may be subject to legal proceedings and claims in the ordinary course of business. The Company is not aware of any such proceedings or claims that it believes will have, individually or in the aggregate, a material adverse effect on its business, financial condition or results of operations.
In November 2007, Reliant Pharmaceuticals, Inc. (“Reliant”) was acquired by GlaxoSmithKline (“GSK”). Under the terms of the acquisition, Alkermesthe Company received $166.9 million upon the closing of the transaction in December 2007 in exchange for the Company’s investment in Series C convertible, redeemable preferred stock of Reliant. The Company is entitled to receive up to an additional $7.7 million of funds held in escrow subject to the terms of an escrow agreement between GSK and Reliant. The escrowed funds represent the maximum potential amount of future payments that may be payable to GSK under the terms of the escrow agreement, which is effective for a

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ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
period of 15 months following the closing of the transaction. The Company has not recorded a liability related to the indemnification to GSK as the Company currently believes that it is remote that any of the escrowed funds will be needed to indemnify GSK for any losses it might incur related to the representations and warranties made by Reliant in connection with the acquisition.
This transaction was recorded as a non-operating gain on sale of investment in Reliant Pharmaceuticals, Inc. of $174.6 million in the three and nine months ended December 31, 2007. The $7.7 million of funds held in escrow is included within other assets in the condensed consolidated balance sheet as of December 31, 2007. The Company purchased the Series C convertible, redeemable preferred stock of Reliant for $100.0 million in December 2001. The Company’s investment in Reliant had a carrying value of $0 at the time of the sale.
9.  INCOME TAXES
The Company records a deferred tax asset or liability based on the difference between the financial statement and tax bases of assets and liabilities, as measured by enacted tax rates assumed to be in effect when these differences reverse. As of December 31, 2007, the Company determined that it is more likely than not that the deferred tax assets may not be realized and a full valuation allowance continues to be recorded.
The provision for income taxes in the amount of $3.2 million and $5.8 million for the three and nine months ended December 31, 2007, respectively, and $0.4 million and $0.8 million for the three and nine months ended December 31, 2006, respectively, relates to the U.S. alternative minimum tax (“AMT”). The utilization of tax loss carryforwards is limited in the calculation of AMT and as a result, a federal tax charge was recorded in the three and nine months ended December 31, 2007 and 2006. The current AMT liability is available as a credit against future tax obligations upon the full utilization or expiration of the Company’s net operating loss carryforward. The provision for income taxes reflects tax recognition of the portion of the nonrefundable milestone payments the Company received from Cephalon, Inc. (“Cephalon”) under its collaborative arrangement which have not been fully recognized for financial reporting purposes as of December 31, 2007.
The Company adopted FIN No. 48 on April 1, 2007. The implementation of FIN No. 48 did not have a material impact on the Company’s condensed consolidated financial statements. At the adoption date of


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ALKERMES, INC. AND SUBSIDIARIES
13. SEGMENT INFORMATION
     
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
April 1, 2007, and also at December 31, 2007, the Company had no significant unrecognized tax benefits. The tax years 1993 through 2006 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United States (“U.S.”), as carryforward attributes generated in years past may still be adjusted upon examination by the Internal Revenue Service (“IRS”) or state tax authorities if they have or will be used in a future period. The Company is currently in the process of conducting a study of its research and development credit carryforwards. This study may result in an adjustment to the Company’s research and development credit carryforwards, however, until the study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position under FIN No. 48. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the condensed consolidated balance sheet or statement of income if an adjustment were required.
In addition, the Company recently concluded a study of its net operating loss (“NOL”) carryforwards to determine whether such amounts are limited under IRC Sec. 382. The Company does not believe the limitations will significantly impact its ability to offset income with available NOLs.
The Company has elected to include interest and penalties related to uncertain tax positions as a component of its provision for taxes. For the three and nine months ended December 31, 2007, the Company did not recognize any accrued interest and penalties in its condensed consolidated financial statements.
10.  LEGAL MATTERS
On October 10, 2006, a purported shareholder derivative lawsuit, captioned “Thomas Bennett, III vs. Richard Pops et al.” and docketed as CIV-06-3606, was filed ostensibly on the Company’s behalf in Middlesex County Superior Court, Massachusetts. The complaint in that lawsuit alleged, among other things that in connection with certain stock option grants made by the Company, certain of its directors and officers committed violations of state law, including breaches of fiduciary duty. The complaint named the Company as a nominal defendant, but did not seek monetary relief from the Company. The lawsuit sought recovery of damages allegedly caused to the Company as well as certain other relief, including an order requiring the Company to take action to enhance its corporate governance and internal procedures. The defendants moved to dismiss the lawsuit and, following oral argument, the Massachusetts Superior Court issued a decision dated July 10, 2007 granting the defendants’ motion to dismiss the lawsuit in its entirety. The plaintiff did not appeal the Court’s decision and the plaintiff’s time to appeal has expired.
The Company has received four letters, allegedly sent on behalf of owners of its securities, which claim, among other things, that certain of the Company’s officers and directors breached their fiduciary duties to the Company by, among other allegations, allegedly violating the terms of its stock option plans, allegedly violating GAAP by failing to recognize compensation expenses with respect to certain option grants during certain years, and allegedly publishing materially inaccurate financial statements relating to the Company. The letters demand, among other things, that the Company’s Board of Directors take action on its behalf to recover from the current and former officers and directors identified in the letters the damages allegedly sustained by the Company as a result of their alleged conduct, among other amounts. The letters do not seek any monetary recovery from the Company. The Company’s Board of Directors appointed a special independent committee of the Board of Directors to investigate, assess and evaluate the allegations contained in these and any other demand letters relating to the Company’s stock option granting practices and to report its findings, conclusions and recommendations to the Company’s Board of Directors. The special independent committee was assisted by independent outside legal counsel. In November 2006, based on the results of its investigation, the special independent committee of the Company’s Board of Directors concluded that the assertions contained in the demand letters lacked merit, that nothing had come to its attention that would cause it to believe that there are any instances where management of the Company or the Compensation Committee of the Company had retroactively selected a date for the grant of stock options during the 1995 through 2006 period, and that it


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ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)
would not be in the Company’s best interests or the best interests of the Company’s shareholders to commence litigation against its current or former officers or directors as demanded in the letters. The findings and conclusions of the special independent committee of the Company’s Board of Directors have been presented to and adopted by the Company’s Board of Directors.
From time to time, the Company may be subject to other legal proceedings and claims in the ordinary course of business. The Company is not aware of any such proceedings or claims that it believes will have, individually or in the aggregate, a material adverse effect on its business, financial condition or results of operations.
11.  SEGMENT INFORMATION
The Company operates as one business segment, which is the business of developing, manufacturing and commercializing innovative medicines designed to yield better therapeutic outcomes and improve the lives of patients with serious disease. The Company’s chief decision maker, the Chief Executive Officer, reviews the Company’s operating results on an aggregate basis and manages the Company’s operations as a single operating unit.
12.  TREASURY STOCK
During the nine months ended December 31, 2007, in connection with the Company’s publicly announced share repurchase program, the Company repurchased 1,919,327 shares of treasury stock for $27.6 million. In addition, the Company executed three broker-assisted trades to purchase 358,867 shares of treasury stock at an aggregate cost of $5.7 million in December 2007 that were not settled until January 2008 and have not been reflected in the Company’s condensed consolidated financial statements.
13.  SUBSEQUENT EVENTS
On February 7, 2008, the Company entered into an agreement for an Accelerated Share Repurchase Transaction (the “ASR”) with Morgan Stanley & Co. Incorporated (“Morgan Stanley”) pursuant to which the Company will repurchase $60.0 million of its outstanding common stock from Morgan Stanley. The Company is acquiring these shares as part of a previously announced share repurchase program of up to $175.0 million approved by the Company’s Board of Directors. Under the ASR, the final price of shares repurchased will be determined based on a discount to the volume weighted average trading price of the Company’s common stock over a period not to exceed three months. Depending on the final price and number of shares being repurchased, Morgan Stanley may deliver additional shares to the Company at the completion of the transaction, or the Company may, at its option, deliver to Morgan Stanley either cash or shares. The Company expects that Morgan Stanley will purchase shares of the Company’s common stock from time to time in the open market in connection with the ASR and may also sell shares in the open market from time to time.


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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
     
Alkermes, Inc. (“Alkermes” or the “Company” as(as used in this section, together with our subsidiaries, “us”, “we”, “our” or “our”the “Company”) is a biotechnology company that uses proprietary technologies and know-howcommitted to createdeveloping innovative medicines designed to yield better therapeutic outcomes for patients with serious disease. Alkermes manufacturesimprove patients’ lives. We manufacture RISPERDAL® CONSTA®, marketed by divisions of Johnson & Johnson, for schizophrenia and developed and manufacturesmanufacture VIVITROL®, marketed in the U.S. primarily by Cephalon, Inc. (“Cephalon”). The company’s for alcohol dependence. Our pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Alkermes is headquarteredHeadquartered in Cambridge, Massachusetts, withwe have research and manufacturing facilities in Massachusetts and Ohio.
     
We have funded our operations primarily with funds generated by our business operations and through public offerings and private placements of debt and equity securities, bank loans, term loans, equipment financing arrangements and payments received under research and development agreements and other agreements with collaborators. We expect to incur significant additional research and development and other costs in connection with certain collaborative arrangements and as we expand the development of our proprietary product candidates, including costs related to preclinical studies, clinical trials and facilities expansion. Our costs, including research and development costs for our product candidates and selling, marketing and promotion expenses for any future products to be marketed by us or our collaborators, if any, may exceed revenues in the future, which may result in losses from operations.
Forward-Looking Statements
     
Any statements herein or otherwise made in writing or orally by us with regard to our expectations as to financial results and other aspects of our business may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning future operating results, the achievement of certain business and operating goals, including those related to commercialization of our products, manufacturing revenues, royalty revenues, research and development revenues under collaborative arrangements, net collaborative profit, research and development activities and spending, plans for clinical trials and regulatory approvals, spending relating to selling and marketing income taxes,and clinical development activities, financial goals and projections of capital expenditures, recognition of revenues, and future financings. These statements relate to our future plans, objectives, expectations and intentions and may be identified by words like “believe,” “expect,” “designed,” “may,” “will,” “should,” “seek,” or “anticipate,” and similar expressions.
     
Although we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our business and operations, the forward-looking statements contained in this document are neither promises nor guarantees;guarantees, and our business is subject to significant risk and uncertainties and there can be no assurance that our actual results will not differ materially from our expectations. These forward looking statements include, but are not limited to, statements concerning: the achievement of certain business and operating milestones and future operating results and profitability; continued revenue growth from RISPERDAL CONSTA; the commercialization of VIVITROL in the U.S. by Cephalon and in Russia and countries in the Commonwealth of Independent States by Cilag GmbH International (“Cilag”), a subsidiary of Johnson & Johnson; recognition of milestone payments from our partners related to the future sales of VIVITROL; the successful continuation of development activities for our programs, including exenatide once weekly; the successful manufacture of our products and product candidates, including RISPERDAL CONSTA and VIVITROL at a commercial scale, and the successful manufacture of exenatide once weekly by Amylin Pharmaceuticals, Inc. (“Amylin”); and the building of a selling and marketing infrastructure for VIVITROL. Factors which could cause actual results to differ materially from our expectations set forth in our forward-looking statements include, among others: (i) manufacturing and royalty revenues forfrom RISPERDAL CONSTA may not continue to grow, or even decline, particularly because we rely on our partner, Janssen Pharmaceutica, Inc., a division of Johnson & Johnson,Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International (together, “Janssen”), to forecast and market this product; (ii) we may be unable to manufacture RISPERDAL CONSTA and VIVITROL in sufficient quantities and with sufficient yields to meet Janssen’sour partners’ requirements or to add additional production capacity for RISPERDAL CONSTA and VIVITROL, or unexpected events could interrupt manufacturing operations at our RISPERDAL CONSTA and VIVITROL manufacturing facility, which is the sole source of supply for that product;these products; (iii) manufacturing and other revenues for VIVITROL may not grow, or even decline; (iv) we may be unable to manufacturedevelop the selling and marketing capabilities, and/or infrastructure, necessary to successfully commercialize VIVITROL; (iv) Cilag may be unable to receive approval for VIVITROL for the treatment of opioid dependence in sufficient quantitiesRussia and with sufficient yieldsfor the treatment of alcohol and opioid dependence in the other countries in the CIS; (v) Cilag may be unable to meet commercial requirements,successfully commercialize VIVITROL; (vi) third party payors may not cover or unexpected events could interrupt manufacturing operations at our VIVITROL facility, which is the sole source of supply for that product; (v)reimburse VIVITROL; (vii) we may be unable toscale-up and manufacture our product candidates including AIR Insulin, ALKS 27commercially or

14


economically; (viii) we may not be able to source raw materials for our production processes from third parties; (ix) we may not be able to successfully transfer manufacturing technology and ALKS 29 commercially or economically; (vi)related systems for exenatide once weekly to Amylin, and Amylin may not be able to successfully operate the manufacturing facility for exenatide once weekly; (x) our product candidates, if approved for marketing, may not be launched successfully in one or all indications for which marketing is approved and, if launched, may not produce significant revenues; (vii)(xi) we rely on our partners to determine the regulatory and marketing strategies for RISPERDAL CONSTA and our other partnered, non-proprietary programs; (xii) RISPERDAL CONSTA, VIVITROL and our product candidates in commercial use may have unintended side effects, adverse reactions or incidents of misuse and the U.S. Food and Drug Administration (“FDA”) or other health authorities could require post approval studies or require removal of our products from the market; (xiii) our collaborators could elect to terminate or delay programs at any time and disputes with collaborators or failure to negotiate acceptable new collaborative arrangements for our technologies could occur; (xiv) clinical trials may take more time or consume more resources than initially envisioned; (viii)(xv) results of earlier clinical trials may not necessarily be predictive of the safety and efficacy results in larger clinical trials; (ix)(xvi) our product candidates could be ineffective or unsafe during preclinical studies and clinical trials, and we and our collaborators may not be permitted by regulatory authorities to


13


undertake new or additional clinical trials for product candidates incorporating our technologies, or clinical trials could be delayed or terminated; (x)(xvii) after the completion of clinical trials for our product candidates and the submission for marketing approval, the U.S. Food and Drug Administration (“FDA”)FDA or foreign regulatoryother health authorities could refuse to accept such filings or could request additional preclinical or clinical studies be conducted, each of which could result in significant delays or the failure of such product to receive marketing approval; (xi)(xviii) even if our product candidates appear promising at an early stage of development, product candidates could fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical, fail to achieve market acceptance, be precluded from commercialization by proprietary rights of third parties or experience substantial competition in the marketplace; (xii)(xix) technological change in the biotechnology or pharmaceutical industries could render our productsand/or product candidates obsolete or non-competitive; (xiii)(xx) difficulties or set-backs in obtaining and enforcing our patents and difficulties with the patent rights of others could occur; (xiv)(xxi) we may continue to incur losses in the future; (xv)(xxvi) we may need to raise substantial additional funding to continue research and development programs and clinical trials and other operations and could incur difficulties or setbacks in raising such funds; (xvi)(xxii) we may not receive the full amount,be able to liquidate or any, of the proceeds placedotherwise recoup our investments in escrow in connection with the Reliant Pharmaceuticals, Inc. (“Reliant”) transaction due to claims against the escrow account;our asset backed debt securities and (xvii) whether we will purchase up to $175.0 million of our own stock.auction rate securities.
     
The forward-looking statements made in this document are made only as of the date hereof and we do not intend to update any of these factors or to publicly announce the results of any revisions to any of our forward-looking statements other than as required under the federal securities laws.
Our Strategy
     
We leverage our unique formulation expertise and drug development technologies to develop, both with partners and on our own, innovative and competitively advantaged drug products that enhance patient outcomes in major therapeutic areas. We enter into select collaborations with pharmaceutical and biotechnology companies to develop significant new product candidates, based on existing drugs and incorporating our technologies. In addition, we develop our own proprietary therapeutics by applying our innovative formulation expertise and drug development capabilities to create new pharmaceutical products. Each of these approaches is discussed in more detail below.

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Product Developments
RISPERDAL CONSTA
     
UsingRISPERDAL CONSTA is a long-acting formulation of risperidone, a product of Janssen. RISPERDAL CONSTA is the first and only long-acting, atypical antipsychotic to be approved by the FDA. The medication uses our proprietary Medisorb® technology we developed RISPERDAL CONSTA, a long-acting formulation of Janssen’s antipsychotic drug RISPERDAL forto deliver and maintain therapeutic medication levels in the treatment of schizophrenia.body through just one injection every two weeks. Schizophrenia is a brain disorder characterized by disorganized thinking, delusions and hallucinations. Studies have demonstrated that as many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis, which can lead to worsening of symptoms. Clinical data has shown that treatment with RISPERDAL CONSTA may lead to improvements in symptoms, sustained remission and decreases in hospitalization. RISPERDAL CONSTA is administered via intramuscular injection every two weeks, alleviating the need for daily dosing.marketed by Janssen marketsand is exclusively manufactured by us. RISPERDAL CONSTA worldwide. We are the exclusive manufacturer of RISPERDAL CONSTA for Janssen, and we earn both manufacturing fees and royalties from Janssen.
RISPERDAL CONSTA was first approved by regulatory authorities in the United Kingdom (“U.K”U.K.”) and Germany in August 2002 and was approved by the FDA in October 2003. RISPERDAL CONSTA is approved in approximately 8385 countries and marketed in approximately 6360 countries, and Janssen continues to launch the product around the world.
     In April 2008, we announced that our partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (“J&JPRD”), submitted a Supplemental New Drug Application (“sNDA”) for RISPERDAL CONSTA to the FDA seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (“FRBD”). FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor’s care. The condition may affect 10 to 20 percent of the 27 million people with bipolar disorder.
In FebruaryMay 2008, we and Janssen agreed to begin development of a four-week formulation of RISPERDAL CONSTA, which could offer patients and physicians another dosing option.
     In May 2008, the results of a study sponsored by Janssen were presented at the 14th Biennial Winter WorkshopAmerican Psychiatric Association (“APA”) 161st Annual Meeting in Washington D.C. This twenty-four month, open-label, active-controlled, international study investigated whether treatment with Risperidone Long-Acting Injection (“RLAI”), compared with oral quetiapine when tested in a routine care setting within general psychiatric services, had an effect on Schizophrenialong-term efficacy maintenance as measured by time to relapse in patients with schizophrenia. The results demonstrated that the average relapse-free time was significantly longer in patients treated with RLAI (607 days) compared to quetiapine (533 days) (p<0.0001). Furthermore, over the 24 month treatment period, relapse occurred in 16.5 percent of patients treated with RLAI and Bipolar Disorders31.3 percent in Montreux, Switzerland. This one-year, phase 3 trial was the first placebo-controlled studyquetiapine treatment arm.
     In July 2008, we announced that our partner, J&JPRD, submitted a sNDA for RISPERDAL CONSTA to explore the use of a long-acting injectable medicationFDA for approval as monotherapy in the maintenance treatment of frequently relapsing bipolar I disorder (FRBD). FRBD, defined as four or more manic or depressive


14


episodes in the previous year that require a doctor’s care, may affect 20% of the 27 million people with bipolar disorder worldwide. The study found that patients with FRBD had a significantto delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment.occurrence of mood episodes in adults. Bipolar disorder is a brain disorder that causes unusual shifts in a person’s mood, energy and ability to function. Characterized by debilitating mood swings, from extreme highs (mania) to extreme lows (depression), bipolar I disorder affects 5.7 million, or 2.6 percent, of the American adult population in any given year.
     
The study compared patients who received RLAI and standard treatment to those who received standard treatment combined with placebo. The study evaluatedIn October 2008, the time toFDA approved the next mood episode, also knowndeltoid muscle of the arm as a relapse, in FRBD patients receiving RLAI plus standard treatment compared to patients receiving placebo plus standard treatment. For most patients, standard treatment consisted of mood stabilizers, antidepressants, anxiolytics or combinations thereof. The trial showed that time to relapsenew injection site for RISPERDAL CONSTA. RISPERDAL CONSTA was significantly longer in patients receiving RLAI compared with placebo (p=0.004), and the relative risk of relapse was 2.4 times higher with placebo. The relapse rates were 47.8% with placebo and 22.2% with RLAI.
previously approved as a gluteal injection only.
VIVITROL
     
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, for the treatment of alcohol dependence in patients who are able to abstain from drinking in an outpatient setting and are not actively drinking prior to treatment initiation. Alcohol dependence is a serious and chronic brain disease characterized by cravings for alcohol, loss of control over drinking, withdrawal symptoms and an increased tolerance for alcohol. Adherence to medication is particularly challenging with this patient population. In clinical trials, when used in combination with psychosocial support, VIVITROL was shown to reduce the number of drinking days and heavy drinking days and to prolong abstinence in patients who abstained from alcohol the week prior to starting treatment. Each injection of VIVITROL provides medication for one month and alleviates the need for patients to make daily medication dosing decisions. VIVITROL was approved by the FDA in April 2006 and launched in June 2006. Cephalon is primarily responsible for marketing VIVITROL in the U.S. We are the exclusive manufacturer of VIVITROL.

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VIVITROL was approved by the FDA inIn April 2006 and launched in June 2006. In March 2007, we submitted a Marketing Authorization Application (“MAA”) for VIVITROL for the treatment of alcohol dependence to regulatory authorities in the U.K. and Germany. The MAA forGermany based on the single pivotal clinical study used to register VIVITROL was submitted under a decentralized procedure, in whichthe U.S. In July 2008, based on feedback from the U.K. will act ashealth authorities that data from a single study would not be sufficient to register VIVITROL in the Reference Member StateU.K. and Germany, will act aswe withdrew the Concerned Member State for the application. If successful, a filing under the decentralized procedure would result in a simultaneous approval of VIVITROL as a treatment for alcohol dependence in these two countries. The MAA submission reflects the Company’s targeted approach to commercialize VIVITROL in Europe on acountry-by-country basis.MAA.
     
In December 2007, we entered into an exclusive agreement with Cilag GmbH International, a subsidiary of Johnson & Johnson, to commercialize VIVITROL for the treatment of alcohol dependence and opioid dependence in Russia and other countries in the CommonwealthCIS. In August 2008, we announced that Cilag received approval from the Russian regulatory authority to market VIVITROL for the treatment of Independent States (“CIS”). Under the terms of the agreement, Cilag GmbH International has primary responsibility for filing the new drug application for VIVITROL in Russia and other countries in the CIS. The product will be commercialized byalcohol dependence. Janssen-Cilag, an affiliate company of Cilag, GmbH International.will commercialize VIVITROL. We will retain exclusive development and marketing rights to VIVITROL in all markets outside the U.S., Russia and other countries in the CIS. We are responsible for manufacturing VIVITROL and will receive from Cilag GmbH International manufacturing fees and royalties based on product sales in the CIS. Cilag GmbH International paid us $5.0 million upfront and will pay milestone paymentssales.
     In June 2008, we initiated a randomized, multi-center registration study of up to $34.0 million upon regulatory approvalsVIVITROL for the product, certainagreed-upon eventstreatment of opioid dependence. The multi-center study is designed to assess the efficacy and levelssafety of VIVITROL sales. There was no revenue recognized underin approximately 200 patients diagnosed with opioid dependence. The clinical data from this agreement instudy will form the three and nine months ended December 31, 2007.
basis of a sNDA to the FDA for VIVITROL for the treatment of opioid dependence, a chronic brain disease.
AIR InsulinExenatide Once Weekly
     
We are collaborating with Eli Lilly and Company (“Lilly”) to develop inhaled formulationsAmylin on the development of insulin and other potential productsexenatide once weekly for the treatment of diabetes based on our AIR pulmonary technology.type 2 diabetes. Exenatide once weekly is an injectable formulation of Amylin’s BYETTA® (exenatide) which is an injection administered twice daily. Diabetes is a disease in which the body does not produce or properly use insulin. Diabetes can result in serious health complications, including cardiovascular, kidney and nerve disease. Our inhaled insulin formulation, AIR Insulin, is currently in phase 3 clinical development.


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Exenatide Once Weekly
We are collaborating with Amylin Pharmaceuticals, Inc. (“Amylin”) on the development of exenatide once weekly, an injectable formulation of Amylin’s exenatide (“exenatide”) for the treatment of type 2 diabetes. Exenatide injection (trade name BYETTA®) was approved by the FDA in April 2005 as adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not achieved adequate control on metforminand/or sulfonylurea; two commonly used oral diabetes medications. In December 2006, the FDA approved BYETTA as an add-on therapy for people with type 2 diabetes unable to achieve adequate glucose control on thiazolidinedione, a class of diabetes medications. BYETTA is a twice-daily injection. Amylin entered into a collaborationhas an agreement with Eli Lilly and Company (“Lilly”) for the development and commercialization of exenatide, including exenatide once weekly. Exenatide once weekly is being developed with the goal of providing patients with an effective and more patient-friendly treatment option.
     
In October 2007,June 2008, we, Amylin and Lilly announced positive results from a 30-week comparator52-week, open-label clinical study that showed the durable efficacy of exenatide once weekly injection and BYETTA taken twice daily inweekly. At 52 weeks, patients with type 2 diabetes. Exenatidetaking exenatide once weekly showed a statistically significant improvement inan average A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for BYETTA. Approximately three out2 percent and an average weight loss of four subjects treated with9.5 pounds. The study also showed that patients who switched from BYETTA injection after 30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma glucose. Seventy-four percent of all patients in the study achieved an endpoint of A1C of 7 percent or less. A1Cless at 52 weeks. Exenatide once weekly was well tolerated, with no major hypoglycemia events regardless of less than 7 percent isbackground therapy and nausea was predominantly mild and transient.
     In November 2008, we announced that Amylin had received feedback from the target for good glucose control as recommended byFDA that the American Diabetes Association. After 30 weeks of treatment, bothdata it submitted from itsin vitro in vivocorrelation studies to demonstrate comparability between exenatide once weekly manufactured by Alkermes in our facility and BYETTA treatment resultedused in an average weight loss of approximately eight pounds. Nearly 90 percent of subjectsprevious clinical studies and exenatide once weekly manufactured on a commercial scale in both groups completed the study, which enrolled patientsAmylin’s Ohio facility did not achieving adequate glucose controlmeet FDA requirements. Amylin is in active discussions with either diet and exercise or with use of oral glucose-lowering agents. The companies anticipate a regulatory submission to the FDA regarding options to enable a New Drug Application, or NDA, submission by the end of the first half of 2009. If Amylin is required to initiate a new clinical study, the timing of the NDA submission would depend on the parameters of the new study, and the submission could be delayed beyond the previously stated filing timeline of by the end of the first half of 2009.
ALKS 29
     
We are developing ALKS 29, an oral compound for the treatment of alcohol dependence, which could offer a new treatment option for people suffering from this disease.dependence. In July 2007, we announced positive preliminary results from a clinical trial of ALKS 29 in alcohol dependent patients. Based on these results, we plan to move forward with a development program for oral product candidates to treat alcohol dependence. The clinical trial for ALKS 29, a phase 1/2 multi-center, randomized, double-blind, placebo-controlled,placebo- controlled, eight-week study that was designed to assess the efficacy and safety of ALKS 29 in approximately 150 alcohol dependent patients. In the study, ALKS 29 was generally well tolerated and led to both a statistically significant increase in the percent of days abstinent and a decrease in drinking compared to placebo when combined with psychosocial therapy. The study endpoints included the percent of daysday’s abstinent, percent of heavy drinking days and number of drinks per day. Heavy drinking was defined as five or more drinks per day for men and four or

17


more drinks per day for women.
We plan to initiate additional clinical studies to support ALKS 29 during calendar year 2008.
ALKS 27
     
Using our AIR pulmonary technology, we are independently developing ALKS 27, an inhaled formulation of trospium chloride, with Indevus Pharmaceuticals, Inc. (“Indevus”),product for the treatment of chronic obstructive pulmonary disease (“COPD”). COPD is a serious, chronic disease characterized by a gradual loss of lung function. Trospium chloride is a muscarinic receptor antagonist that relaxes smooth muscle tissue and has the potential to improve airflow in patients with COPD. Trospium chloride is the active ingredient in SANCTURA®, Indevus’ currently marketed product for overactive bladder.
In September 2007,Last year, we and Indevus announcedreported positive preliminary resultsclinical data from a randomized, double-blind, placebo-controlled, phase 2a clinical study of ALKS 27 in patients with COPD. In the study,showing that single doses of ALKS 27 demonstrated a rapid onset of action and produced a significant improvement in lung function (p<0.0001) over 24 hours compared to placebo. We are manufacturing clinical trial material for a placebo. ALKS 27 was well tolerated, and all enrolled patients completedphase 2 dose ranging study expected to start in the study. No treatment related adverse events were reported in this study. Based on these positive results, we are moving forward to identify a partner for the future development and commercializationfirst quarter of ALKS 27.calendar 2009.


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AIR parathyroid hormoneALKS 33
     
ALKS 33 is a novel opioid modulator, identified from the library of compounds in-licensed from Rensselaer Polytechnic Institute (“RPI”). These compounds represent an opportunity for us to develop important therapeutics for a broad range of diseases and medical conditions, including addiction, pain and other central nervous system disorders. In July 2008, we announced positive preclinical results for three proprietary molecules targeting opioid receptors, including ALKS 33. The study results included efficacy data from an ethanol drinking behavior model in rodents, a well-characterized model for evaluating the effects of potential therapeutics targeting opioid receptors. Results showed that single, oral doses of our novel molecules significantly reduced the ethanol drinking behavior in rodents, with an average reduction from baseline ranging from 35 percent to 50 percent for the proprietary molecules compared to 10 percent for the active control (P less than 0.05). Details from an evaluation of thein vivopharmacology, pharmacokinetics andin vitrometabolism were also presented. Data showed that the molecules have improved metabolic stability compared to the active control when cultured with human hepatocytes (liver cells), suggesting that they are not readily metabolized by the liver. Pharmacokinetic results showed that the oral bioavailability of ALKS 33 was significantly greater than that of the active control. We are on track to file our Investigational New Drug Application (“IND”) and Lilly completedbegin a phase 1 study of inhaled formulations of parathyroid hormone (“PTH”)ALKS 33 in healthy post menopausal women. The data fromvolunteers by the study indicates that additional feasibility and formulation work are required. At this time, we and Lilly are not planning to pursue further developmentend of inhaled formulations of PTH.
calendar 2008.
Critical Accounting Policies
     
A summaryThe discussion and analysis of significantour financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting policiesprinciples generally accepted in the United States of America. The preparation of these financial statements requires us to make estimates and a descriptionassumptions that affect the reported amounts of accounting policies that are considered criticalassets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may be found indiffer from these estimates under different assumptions or conditions. Refer to Part II, Item 7 of our Annual Report onForm 10-K for the year ended March 31, 20072008 in the “Critical Accounting Policies” section. Other than as described below,section for a discussion of our critical accounting policies and estimates are as set forth in theForm 10-K.
Provision for Income Taxes— We record a deferred tax asset or liability based on the difference between the financial statement and tax bases of assets and liabilities, as measured by enacted tax rates assumed to be in effect when these differences reverse. As of December 31, 2007, we determined that it was more likely than not that the deferred tax assets may not be realized and a full valuation allowance continues to be recorded.
We adopted Financial Accounting Standards Board (“FASB”) Interpretation No. 48,“Accounting for Uncertainty in Income Taxes”(“FIN No. 48”) on April 1, 2007. The implementation of FIN No. 48 did not have a material impact on our condensed consolidated financial statements. At the adoption date of April 1, 2007, and also at December 31, 2007, we had no significant unrecognized tax benefits. The tax years 1993 through 2006 remain open to examination by major taxing jurisdictions to which we are subject, which are primarily in the U.S., as carryforward attributes generated in years past may still be adjusted upon examination by the IRS or state tax authorities if they have or will be used in a future period. We are currently in the process of conducting a study of our research and development credit carryforwards. This study may result in an adjustment to our research and development credit carryforwards, however, until the study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position under FIN No. 48. A full valuation allowance has been provided against our research and development credits, and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the condensed consolidated balance sheet or statement of income if an adjustment were required.
In addition, we recently concluded a study of our net operating loss (“NOL”) carryforwards to determine whether such amounts are limited under IRC Sec. 382. We do not believe the limitations will significantly impact our ability to offset income with available NOLs.
We have elected to include interest and penalties related to uncertain tax positions as a component of our provision for taxes. For the three and nine months ended December 31, 2007, we did not recognize any accrued interest and penalties in our condensed consolidated financial statements.
policies.
Results of Operations
     
Net income for the three months ended December 31, 2007September 30, 2008 was $168.9$1.7 million, or $1.66$0.02 per common share — basic and $1.63diluted, as compared to net income of $7.7 million, or $0.08 per common share — basic and $0.07 per common share — diluted, for the three months ended September 30, 2007.
     Net income for the six months ended September 30, 2008 was $31.4 million, or $0.33 per common share — basic and $0.32 per common share — diluted, as compared to net income of $2.9$16.4 million, or $0.03$0.16 per common share — basic and diluted, for the threesix months ended December 31, 2006.
Net income for the nine months ended December 31, 2007 was $185.3 million, or $1.82 per common share — basic and $1.78 per common share — diluted, as compared to net income of $5.9 million, or $0.06 per common share — basic and diluted, for the nine months ended December 31, 2006.
Total manufacturing revenues were $14.3 million and $69.9 million for the three and nine months ended December 31, 2007, respectively, as compared to $28.8 million and $77.1 million for the three and nine months ended December 31, 2006, respectively.
RISPERDAL CONSTA manufacturing revenues were $12.9 million and $66.1 million for the three and nine months ended December 31, 2007, respectively, as compared to $23.6 million and $63.6 million for the three and nine months ended December 31, 2006, respectively. The decrease in RISPERDAL CONSTASeptember 30, 2007.


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Revenues
                         
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In millions) 2008  2007  Change  2008  2007  Change 
Manufacturing revenue:                        
RISPERDAL CONSTA $30.7  $22.9  $7.8  $66.7  $53.1  $13.6 
VIVITROL  2.3   1.2   1.1   5.0   2.5   2.5 
                   
Total manufacturing revenue  33.0   24.1   8.9   71.7   55.6   16.1 
                   
Royalty revenue  8.4   7.4   1.0   17.0   14.3   2.7 
Research and development revenue under collaborative arrangements  5.3   21.2   (15.9)  36.7   44.7   (8.0)
Net collaborative profit  0.6   5.9   (5.3)  1.9   12.9   (11.0)
                   
Total revenues $47.3  $58.6  $(11.3) $127.3  $127.5  $(0.2)
                   
     The increase in RISPERDAL CONSTA manufacturing revenues for the three and six months ended December 31, 2007,September 30, 2008, as compared to the three and six months ended December 31, 2006,September 30, 2007, was primarily due to a decrease25% and 16% increase, respectively, in units of RISPERDAL CONSTA shipped to Janssen, partially offset by an increase in the net sales price of units of RISPERDAL CONSTA shipped to Janssen. The increase in RISPERDAL CONSTA revenues for the nine months ended December 31, 2007, as compared to the nine months ended December 31, 2006,There was due to an increase in the net sales price of units of RISPERDAL CONSTA shipped to Janssen, partially offset byalso a slight decrease in units of RISPERDAL CONSTA shipped to Janssen. The increase in the net sales price of RISPERDAL CONSTA in the three and ninesix months ended December 31, 2007,September 30, 2008, as compared to the three and ninesix months ended December 31, 2006,September 30, 2007, which was due in part to fluctuations in the exchange ratio of the U.S. dollar and the foreign currencies of the countries in which the product was sold. See Part I, Item 3. Quantitative“Quantitative and Qualitative Disclosures about Market RiskRisk” for information on foreign currency exchange rate risk related to RISPERDAL CONSTA revenues. Shipments of RISPERDAL CONSTA were lower in the three and nine months ended December 31, 2007, as compared to the three and nine months ended December 31, 2006, as Janssen manages its levels of product inventory, due in part to increased efficiencies and reliability in our RISPERDAL CONSTA processes. We expect manufacturing revenues related to RISPERDAL CONSTA to increase for the three months ended March 31, 2008, as compared to the three months ended December 31, 2007.
     
Under our manufacturing and supply agreement with Janssen, we earn manufacturing revenues when product is shipped to Janssen, based on a percentage of Janssen’s estimated unit net sales price. Revenues include a quarterly adjustment from Janssen’s estimated unit net sales price to Janssen’s actual unit net sales price for product shipped. ForIn the three and ninesix months ended December 31,September 30, 2008 and 2007, and 2006, our RISPERDAL CONSTA manufacturing revenues were based on an average of 7.5% of Janssen’s unit net sales price of RISPERDAL CONSTA. We anticipate that we will earn manufacturing revenues at 7.5% of Janssen’s unit net sales price of RISPERDAL CONSTA for product shipped in the fiscal year ending March 31, 20082009 and beyond.
VIVITROL manufacturing revenues were $1.4 million and $3.8 million for the three and nine months ended December 31, 2007, respectively, as compared to $5.2 million and $13.5 million for the three and nine months ended December 31, 2006, respectively. Under our agreements with Cephalon, we bill Cephalon for all manufacturing costs related to VIVITROL.
The decrease in     VIVITROL manufacturing revenues for the three and ninesix months ended December 31, 2007, as compared to the threeSeptember 30, 2008 consisted of $1.7 million and nine months ended December 31, 2006, was due to lower manufacturing activity and shipments of VIVITROL. We began shipping VIVITROL to Cephalon for the first time during the quarter ended June 30, 2006, and during that quarter and the remainder of the fiscal year ended March 31, 2007 we shipped quantities sufficient to build inventory to support the commercial launch of the product. We are currently managing our manufacturing volumes of VIVITROL to avoid excess inventory and shipped a small quantity of product to Cephalon during the three and nine months ended December 31, 2007. VIVITROL manufacturing revenues for the three and nine months ended December 31, 2007 included $0 and $2.2$2.8 million, respectively, of billings to Cephalon for idle capacity costs, as comparedfailed batches and $0  and $1.4 million, respectively, for shipments of VIVITROL to $1.5Cephalon and $0.4 million for the three and nine months ended December 31, 2006.shipments of VIVITROL to Janssen-Cilag to support commercialization of VIVITROL in Russia. In addition, VIVITROL manufacturing revenues for the three and ninesix months ended December 31, 2007September 30, 2008 included $0.1$0.2 million and $0.3$0.4 million, respectively, of milestone revenue related to manufacturing profit on VIVITROL under our arrangement with Cephalon, which isequals a 10% markup on VIVITROL cost of goods manufactured as compared to $0.5 million and $1.2 million for the three and nine months ended December 31, 2006, respectively.draws down from unearned milestone revenue from Cephalon.
     
All royaltyVIVITROL manufacturing revenues for the three and ninesix months ended December 31,September 30, 2007 consisted of billings to Cephalon for idle capacity costs and 2006no product was shipped to them during these reporting periods. VIVITROL manufacturing revenues for the three and six months ended September 30, 2007 included $0.1 million and $0.2 million, respectively, of milestone revenue related to the manufacturing profit on VIVITROL under our arrangement with Cephalon, which equals a 10% markup on VIVITROL cost of goods manufactured and draws down from unearned milestone revenue from Cephalon.
     Royalty revenues for the three and six months ended September 30, 2008 and 2007 were related to sales of RISPERDAL CONSTA. Under our license agreements with Janssen, we record royalty revenues equal to 2.5% of Janssen’s net sales of RISPERDAL CONSTA in the period that the product is sold by Janssen. Royalty revenues were $7.4 million for the three and six months ended December 31, 2007,September 30, 2008 were based on RISPERDAL CONSTA sales of $295.1$337.5 million and $21.7$680.7 million, respectively. Royalty revenues for the ninethree and six months ended December 31,September 30, 2007 were based on RISPERDAL CONSTA sales of $867.4 million, as compared to $5.7 million for the three months ended December 31, 2006, based on RISPERDAL CONSTA sales of $226.3$293.6 million and $16.6$572.3 million, for the nine months ended December 31, 2006, based on RISPERDAL CONSTA sales of $663.6 million.respectively. The increase in the net sales of RISPERDAL CONSTA infor the three and ninesix months ended December 31, 2007,September 30, 2008, as compared


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to the three and ninesix months ended September 30, 2006,2007, was due in part to fluctuations in the exchange ratio of the U.S. dollar and the foreign currencies of the countries in which the product was sold. See Part I, Item 3. Quantitative“Quantitative and Qualitative Disclosures about Market RiskRisk” for information on foreign currency exchange rate risk related to RISPERDAL CONSTA revenues.

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ResearchThe decrease in research and development revenue under collaborative arrangements (“R&D revenue”Revenue”) for the three and six months ended September 30, 2008, as compared to the three and six months ended September 30, 2007, was $24.0primarily due to the termination of the AIR Insulin development program in March 2008 and the AIR parathyroid hormone (“AIR PTH”) development program in September 2007, and reductions in revenues under the exenatide once weekly development program. In June 2008, we entered into an agreement with Lilly in connection with their termination of the development and license agreements and supply agreement for the development of AIR Insulin (the “AIR Insulin Termination Agreement”). Under the AIR Insulin Termination Agreement, we received $40.0 million in cash as payment for all services we had performed through the date of the AIR Insulin Termination Agreement. We previously recognized $14.5 million of this payment as R&D revenue in the year ended March 31, 2008 and recognized $25.5 million of this payment as R&D revenue in the three months ended June 30, 2008. Revenues from the AIR Insulin development program totaled $12.0 million and $68.6$25.9 million for the three and ninesix months ended December 31,September 30, 2007, respectively, as compared to $19.5 million and $51.6 million for the three and nine months ended December 31, 2006, respectively. The increase in R&D revenue for the three months ended December 31, 2007, as compared to the three months ended December 31, 2006, was primarily due to the recognition of $5.0 million of revenue related to the application of the proportional performance method we are using for this collaboration with Amylin. We received a $5.0 million payment in December 2007 related to the phase 3 clinical program for exenatide once weekly, and based on the amount of effort that has been expended to date we were able to recognize the full amount as revenue. This increase was partially offset by a decrease in revenues related to the completion of work on the AIR PTH development program. The increase in R&D revenue for the nine months ended December 31, 2007, as compared to the nine months ended December 31, 2006, was primarily due to an increase in revenues on the exenatide once weekly and AIR Insulin development programs.
A component of revenue in the three and nine months ended December 31, 2007 onRevenues from the AIR PTH development program, included recognition of a portion ofwhich was terminated during the $1.0three months ended September 30, 2007, totaled $1.8 million milestone payment we received from Lilly in June 2007 upon first dosingand $4.9 million in the phase 1 clinical trial.three and six months ended September 30, 2007, respectively. We recognized revenuedid not record any revenues under the proportional performance method for theAIR PTH development program.program in the three and six months ended September 30, 2008.
     
Net collaborative profit for the three and ninesix months ended December 31, 2007 and 2006 was as follows:September 30 consists of the following:
                 
     Nine Months
 
  Three Months Ended
  Ended
 
  December 31,  December 31, 
(In thousands) 2007  2006  2007  2006 
 
Milestone revenue — cost recovery(a) $  $7,250  $5,256  $50,836 
Milestone revenue — license  1,312   1,195   3,932   3,778 
                 
Total milestone revenue — cost recovery and license  1,312   8,445   9,188   54,614 
Payments to Cephalon to reimburse their net losses up to the cumulative loss cap        (5,223)  (24,816)
Payments from Cephalon to reimburse our expenses incurred after the cumulative loss cap was reached  3,815      14,060    
                 
Net collaborative profit $5,127  $8,445  $18,025  $29,798 
                 
                 
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In millions) 2008  2007  2008  2007 
Milestone revenue — cost recovery $  $  $  $5.3 
Milestone revenue — license  1.3   1.3   2.6   2.6 
             
Total milestone revenue — cost recovery and license  1.3   1.3   2.6   7.9 
Net payments (to) from Cephalon  (0.7)  4.6   (0.7)  5.0 
             
Net collaborative profit $0.6  $5.9  $1.9  $12.9 
             
(a)Through December 31, 2007, the cumulative net losses on VIVITROL were $169.1 million, of which $65.3 million was incurred by us on behalf of the collaboration and $103.8 million was incurred by Cephalon on behalf of the collaboration.
Gross sales of VIVITROL by Cephalon were $5.0 million and $13.7 million for the three and nine months ended December 31, 2007, respectively.
Net collaborative profit was $5.1 million and $18.0 million for the three and nine months ended December 31, 2007, respectively. For the three and nine months ended December 31, 2007, we recognized $0 and $5.3 million of milestone revenue — cost recovery, respectively, to offset net losses on VIVITROL that we funded.     We were responsible to fund the first $124.6 million of cumulative net losses incurred on VIVITROL (the “cumulative net loss cap”). WeVIVITROL reached thisthe cumulative net loss cap in April 2007, at which time Cephalon became responsible to fund all net losses incurred on VIVITROL through December 31, 2007. In addition, during the three and nine months ended December 31, 2007, we recognized $1.3 million and $3.9 million, respectively, of milestone revenue related to the licenses provided to Cephalon to commercialize


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VIVITROL. During the three and nine months ended December 31, 2007, we made payments of $0 and $5.2 million, respectively, to Cephalon to reimburse their net losses on VIVITROL, and we received payments of $3.8 million and $14.1 million, respectively, from Cephalon to reimburse us for our expenses on VIVITROL, which we incurred after the cumulative loss cap was reached. In the aggregate, net collaborative profit of $5.1 million and $18.0 million for the three and nine months ended December 31, 2007, respectively, consisted of $1.3 million and $9.2 million of milestone revenue, respectively, in addition to net payments from Cephalon of $3.8 million and $8.8 million, respectively.
Net collaborative profit was $8.4 million and $29.8 million for the three and nine months ended December 31, 2006, respectively. For the three and nine months ended December 31, 2006, we recognized $7.3 million and $50.8 million of milestone revenue — cost recovery, respectively, to offset net losses on VIVITROL that we funded. In addition, during the three and nine months ended December 31, 2006, following FDA approval of VIVITROL, we recognized $1.2 million and $3.8 million, respectively, of milestone revenue related to the licenses provided to Cephalon to commercialize VIVITROL. During the three and nine months ended December 31, 2006, we made payments of $0 and $24.8 million, respectively, to Cephalon to reimburse their net losses on VIVITROL. In the aggregate, net collaborative profit of $8.4 million and $29.8 million for the three and nine months ended December 31, 2006, respectively, consisted of approximately $8.4 million and $54.6 million of milestone revenue, respectively, partially offset by $0 and $24.8 million, respectively, of payments we made to Cephalon to reimburse their net losses on VIVITROL.
Beginning January 1, 2008, all net profits or losses earned on VIVITROL within the collaboration will be sharedare divided between us and Cephalon.Cephalon in approximately equal shares. The net profits earned or losses incurred on VIVITROL beginning January 1, 2008 will beare dependent upon end-market sales which are difficult to predict at this time, and on the level of expenditures by both us and Cephalon in developing, manufacturing and commercializing VIVITROL, all of which is subject to change.
Cost Gross sales of goods manufactured was $7.5VIVITROL by Cephalon were $4.7 million and $26.9$9.5 million for the three and ninesix months ended December 31, 2007,September 30, 2008, respectively, and $13.0$4.7 million and $34.1$8.8 million for the three and ninesix months ended December 31, 2006,September 30, 2007, respectively. Through September 30, 2008, the cumulative net losses on VIVITROL were $190.7 million, of which $75.9 million was incurred by us on behalf of the collaboration and $114.8 million was incurred by Cephalon on behalf of the collaboration.
     
Cost of goods manufactured for RISPERDAL CONSTA was $5.9 million and $23.0 million forFor the three and ninesix months ended December 31, 2007, respectively, and $8.2 million and $21.8 million forSeptember 30, 2008, we recognized no milestone revenue — cost recovery, as VIVITROL had reached the cumulative loss cap prior to the reporting periods. For the three and ninesix months ended December 31, 2006, respectively.September 30, 2007, we recognized $0 and $5.3 million, respectively, of milestone revenue — cost recovery, respectively, to offset net losses on VIVITROL that we funded under the cumulative loss cap.
     For the three and six months ended September 30, 2008 and 2007, we recognized $1.3 million and $2.6 million, respectively, of milestone revenue related to the licenses provided to Cephalon to commercialize VIVITROL. The decrease inlicense revenue is recognized on a straight-line basis over 10 years.
     During the three and six months ended September 30, 2008, we made net payments of $0.7 million to Cephalon under the product loss sharing terms of the arrangement. During the three and six months ended September 30, 2007, we received net payments of $4.6 and $5.0 million, respectively, from Cephalon under the product loss sharing terms of the arrangement.

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Expenses
                         
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In millions) 2008  2007  Change  2008  2007  Change 
Costs of goods manufactured:                        
RISPERDAL CONSTA $8.1  $8.1  $  $18.9  $17.2  $1.7 
VIVITROL  4.0   1.1   2.9   7.5   2.2   5.3 
                   
Total cost of goods manufactured  12.1   9.2   2.9   26.4   19.4   7.0 
                   
Research and development  19.7   28.3   (8.6)  42.0   60.9   (18.9)
Selling, general and administrative  11.7   14.5   (2.8)  23.6   29.9   (6.3)
                   
Total expenses $43.5  $52.0  $(8.5) $92.0  $110.2  $(18.2)
                   
     RISPERDAL CONSTA cost of goods manufactured for RISPERDAL CONSTA for the three months ended December 31,September 30, 2008 and 2007 was comparable in amount due to a 25% increase in the number of units shipped to Janssen offset by a decrease in the unit cost of RISPERDAL CONSTA shipped. The increase in RISPERDAL CONSTA cost of goods manufactured for the six months ended September 30, 2008, as compared to the threesix months ended December 31, 2006,September 30, 2007, was due to a decrease16% increase in units of RISPERDAL CONSTA shipped to Janssen, partially offset by an increasea decrease in the unit cost of RISPERDAL CONSTA shipped to Janssen. The increase inshipped.
     VIVITROL cost of goods manufactured for RISPERDAL CONSTA for the ninethree months ended December 31, 2007, as comparedSeptember 30, 2008 consisted of $2.6 million related to the nine months ended December 31, 2006, was due to an increase inrestart of the unitVIVITROL manufacturing line following a shutdown of the line, $1.1 million of cost of RISPERDAL CONSTA shipped to Janssen, partially offset by a slight decrease in units of RISPERDAL CONSTA shipped to Janssen. Shipments of RISPERDAL CONSTA were lower in the threefor failed batches and nine months ended December 31, 2007, as compared to the three and nine months ended December 31, 2006, as Janssen manages its levels of product inventory, due in part to increased efficiencies and reliability in our RISPERDAL CONSTA processes.
Cost of goods manufactured for VIVITROL was $1.6 million and $3.9$0.3 million for shipments of VIVITROL to Janssen-Cilag to support the three and nine months ended December 31, 2007, respectively, and $4.8 million and $12.3 million for the three and nine months ended December 31, 2006. The decreasecommercialization of VIVITROL in costRussia. Cost of goods manufactured for VIVITROL for the three and nine months ended December 31,September 30, 2007 as compared to the three and nine months ended December 31, 2006, was due to reduced shipmentsconsisted of VIVITROL to Cephalon. We began shipping VIVITROL to Cephalon for the first time during the quarter ended June 30, 2006, and during this period and the remainder of the fiscal year ended March 31, 2007 we shipped quantities sufficient to build inventory to support the commercial launch of the product. We are currently managing our manufacturing volumes of VIVITROL to avoid excess inventory and shipped a small quantity of product to Cephalon during the three and nine months ended December 31, 2007. VIVITROL cost of goods manufactured for the three and nine months ended December 31, 2007 included idle capacity costs, of $0.5 million and $2.7 million, respectively, as compared to


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$1.5 million for the three and nine months ended December 31, 2006. Idle capacity costs consistwhich consisted of current period manufacturing costs related to underutilized VIVITROL manufacturing capacity.
     
Research and development expenses were $30.4VIVITROL cost of goods manufactured for the six months ended September 30, 2008 consisted of $2.6 million and $91.3related to the restart of the VIVITROL manufacturing line following a shutdown of the line, $3.3 million of cost for failed batches, $1.3 million for shipments of VIVITROL to Cephalon and $0.3 million of shipments to Janssen-Cilag to support the three and ninecommercialization of VIVITROL in Russia. Cost of goods manufactured for VIVITROL for the six months ended December 31,September 30, 2007 respectively, as comparedconsisted entirely of idle capacity costs, which consisted of current period manufacturing costs related to $29.9 million and $85.6 million for the three and nine months ended December 31, 2006, respectively.underutilized VIVITROL manufacturing capacity.
     The increasedecrease in research and development expenses for the three and six months ended December 31, 2007,September 30, 2008, as compared to the three and six months ended December 31, 2006,September 30, 2007, was primarily due to increased costs on the exenatide once weeklytermination of the AIR Insulin development program partially offset byand the closure of our AIR commercial manufacturing facility in March 2008 (the “2008 Restructuring”). As a result, our personnel-related costs, including share-based compensation expense, and our facility related costs, including occupancy and depreciation, decreased costscompared to the three and six months ended September 30, 2007. In addition, the use of raw materials and third party packaging of the clinical drug product used during the development of the AIR Insulin development program decreased in the three and six months ended September 30, 2008, as compared to the three and six months ended September 30, 2007. Also, no expenses were incurred in fiscal 2009 on the AIR PTH development program, due to program completion. The increase in research and development expenses forwhich was terminated during the ninethree months ended December 31, 2007, as compared to the nine months ended December 31, 2006, was primarily due to increased costs on the AIR Insulin and exenatide once weekly development programs, partially offset by decreased external costs related to legacy clinical trials for VIVITROL and decreased share-based compensation costs.September 30, 2007.
     
A significant portion of our research and development expenses (including laboratory supplies, travel, dues and subscriptions, recruiting costs, temporary help costs, consulting costs and allocable costs such as occupancy and depreciation) are not tracked by project as they benefit multiple projects or our technologies in general. Expenses incurred to purchase specific services from third parties to support our collaborative research and development activities are tracked by project and are reimbursed to us by our partners. We generally bill our partners under collaborative arrangements using a singlenegotiated full-time equivalent (“FTE”) or hourly rate. This rate has been established by us taking into considerationbased on our annual budget of employee compensation, employee benefits and the billable non-project-specific costs mentioned above and is generally increased annually based on increases in the consumer price index. Each collaborative partner is billed using a full-time equivalentnegotiated FTE or hourly rate for the hours worked by our employees on a particular project, plus direct external research costs, if any. We account for our research and development expenses on a departmental and functional basis in accordance with our budget and management practices.

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Selling, general and administrative expenses were $15.2 million and $45.1 million for the three and nine months ended December 31, 2007, respectively, as compared to $16.4 million and $48.6 million for the three and nine months ended December 31, 2006, respectively.     The decrease in selling, general and administrative expenses for the three and ninesix months ended December 31, 2007,September 30, 2008, as compared to the three and ninesix months ended December 31, 2006,September 30, 2007, was primarily due to a decrease in professional fees, consisting of legal and consulting fees, decreased personnel related costs, including share-based compensation costs.expense, and decreased taxes.
Other (Expense) Income
Gain on sale of investment in Reliant Pharmaceuticals, Inc. was $174.6 million for the three and nine months ended December 31, 2007, as compared to $0 for the three and nine months ended December 31, 2006. In November 2007, Reliant was acquired by GlaxoSmithKline (“GSK”). Under the terms of the acquisition, we received $166.9 million upon the closing of the transaction in exchange for our investment in Series C convertible, redeemable preferred stock of Reliant, and we are entitled to receive up to an additional $7.7 million of funds held in escrow subject to the terms of an escrow agreement between GSK and Reliant. We purchased the Series C convertible, redeemable preferred stock of Reliant for $100.0 million in December 2001, and our investment in Reliant had a carrying value of $0 at the time of the sale.
                         
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In millions) 2008  2007  Change  2008  2007  Change 
Interest income $2.7  $4.2  $(1.5) $6.3  $8.7  $(2.4)
Interest expense  (4.2)  (4.1)  (0.1)  (8.5)  (8.2)  (0.3)
Other (expense) income  (0.7)  1.2   (1.9)  (0.8)  1.2   (2.0)
                   
Total other (expense) income $(2.2) $1.3  $(3.5) $(3.0) $1.7  $(4.7)
                   
Interest income was $4.3 million and $12.9 million for the three and nine months ended December 31, 2007, respectively, as compared to $4.3 million and $13.3 million for the three and nine months ended December 31, 2006, respectively.     The decrease in interest income for the ninethree and six months ended December 31, 2007,September 30, 2008, as compared to the ninethree and six months ended December 31, 2006,September 30, 2007, was due to lower interest earnings on our investments,rates earned during the comparable periods, partially offset by higher average balances of cash and investment balances held duringinvestments. As our investments in corporate debt securities mature or are called by the period.
Interest expense was $4.1 millionissuers, we have reinvested the proceeds primarily in U.S. treasuries and $12.2 million for the three and nine months ended December 31, 2007, respectively,agency securities. As such, we expect our interest earnings to decrease as compared to $4.1 million and $13.6 million for the three and nine months ended December 31, 2006. The decrease in interest expense for the nine months ended December 31, 2007, as compared to the nine months ended December 31, 2006, was primarily due to the conversion of our 2.5% convertible subordinated notes due 2023 (the “2.5% Subordinated Notes”) in June 2006.prior periods. Interest expense for the three and ninesix months ended December 31, 2006 includedSeptember 30, 2008 and 2007 was comparable in amount due to reduced interest expense as a one-time interest chargeresult of $0.6 million for a payment we made in June 2006 in connection with the conversionpurchase of approximately 44% our non-recourse RISPERDAL CONSTA secured 7% notes (the “7% Notes”), offset by debt extinguishment charges related to the purchases of our 2.5% Subordinated Notes to satisfy7% Notes. During the three-year interest make-whole provisionsix months ended September 30, 2008, we purchased, in three privately negotiated transactions, $75.0 million in original principal amount of our outstanding 7% Notes. We recorded a loss on the note indenture. We incur approximately $4.0 millionextinguishment of


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interest expense each quarter on our Non-Recourse Risperdal Consta secured the 7% Notes (the “Non-Recourse 7% Notes”) throughof $2.0 million during the period until principal repayment begins on April 1, 2009.six months ended September 30, 2008, which was recorded as interest expense.
     
Other (expense) income, net was a net expense of $0.4 million and a net income of $0.8 million for the three and ninesix months ended December 31, 2007, respectively,September 30, 2008 consists primarily of the accretion of discounts related to restructurings and a netasset retirement obligations and an other-than-temporary impairment on the common stock of certain publicly held companies. Other income of $0.1 million and $0.2 million for the three and ninesix months ended December 31, 2006, respectively. Other (expense) income, net consistsSeptember 30, 2007 consisted primarily of income or expense recognized on the changes in the fair value of warrants and realized losses on available for sale securities of publiccertain publicly held companies, heldpartially offset by us in connection with collaboration and licensing arrangements, which are recorded under the caption “Other Assets” in the condensed consolidated balance sheets, and the accretion of discounts related to restructuringrestructurings and asset retirement obligations. The recorded value of warrants we hold can fluctuate significantly basedobligations and an other-than-temporary impairment on fluctuations in the market value of the underlying securities. In September 2007, we exercised warrants to purchase common stock of a collaborative partner, which are considered marketable equity securities under Statement of Financial Accounting Standards (“SFAS”) No. 115,certain publicly held companies.
“Accounting for Certain Investments in Debt and Equity Securities”Income Taxesand are recorded under the caption “Investments” in the accompanying condensed consolidated balance sheet as of December 31, 2007. Future changes in the fair value of this common stock will be recorded in other comprehensive
                         
  Three Months Ended  Six Months Ended 
  September 30,  September 30, 
(In millions) 2008  2007  Change  2008  2007  Change 
Income tax (benefit) provision $(0.1) $0.2  $(0.3) $1.0  $2.6  $(1.6)
                   
     The income until realized. As a result of our September 2007 warrant exercise, future recorded income or expense on changes in the fair value of our remaining holdings of warrants of public companies is expected to be less than the amounts recorded in previous reporting periods.
Income taxes were $3.2 million and $5.8 milliontax benefit for the three and nine months ended December 31, 2007, respectivelySeptember 30, 2008 and $0.4 millionthe income tax provision for the six months ended September 30, 2008 and $0.8 million for the three and ninesix months ended December 31, 2006. The provision for income taxes for the three and nine months ended December 31,September 30, 2007 and 2006 wasall related to the U.S. alternative minimum tax (“AMT”). Included in the $0.1 million benefit for the three months ended September 30, 2008 is $0.1 million which represents the amount that we estimated we will benefit from as a result of the recently enactedHousing and Economic Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus depreciation in lieu of a refundable cash credit based on certain qualified asset purchases. Utilization of tax loss carryforwards is limited in the calculation of AMT. As a result, a federal tax charge was recorded in the three and nine months ended December 31, 2007 and 2006. The current AMT liability is available as a credit against future tax obligations upon the full utilization or expiration of our net operating loss carryforward. The provision for income taxes reflects tax recognition of a portion of the nonrefundable milestone payments we received from Cephalon under our collaborative arrangement which have not been fully recognized for financial reporting purposes as of December 31, 2007.
     
We do not believe that inflation and changing prices have had a material impact on our results of operations.

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Financial ConditionLiquidity and Capital Resources
     Our financial condition is summarized as follows:
Cash and cash equivalents and unrestricted investments were $511.5 million and $351.6 million as of December 31, 2007 and March 31, 2007, respectively. Unrestricted investments were $190.5 million and $271.1 million as of December 31, 2007 and March 31, 2007, respectively. During the nine months ended December 31, 2007, combined cash and cash equivalents and unrestricted investments increased by $159.9 million primarily due to the receipt of $166.9 million from the Reliant transaction, cash from our operating activities and the issuance of common stock related to our equity compensation plans, partially offset by the purchase of $27.6 million of treasury stock under our stock repurchase program and the acquisition of fixed assets.
         
  September 30,  March 31, 
(In millions) 2008  2008 
Cash and cash equivalents $68.5  $101.2 
Investments — short-term  263.9   240.1 
Investments — long-term  93.4   119.1 
       
Total cash, cash equivalents and investments $425.8  $460.4 
       
Working capital $354.1  $371.1 
       
Outstanding borrowings — current and long-term $91.9  $160.4 
       
     
We invest in cash equivalents,short-term and long-term investments consisting of U.S. government obligations,debt securities, U.S. agency debt securities, municipal debt securities, investment grade corporate notesdebt securities, including asset backed debt securities, and commercial paper.student loan backed auction rate securities issued by major financial institutions in accordance with our documented corporate policies. Our investment objectives are, first, to assure liquidity and conservation of capital and, second, to obtain investment income. We held approximately $5.1 millionperformed an analysis of U.S. government obligations and corporate debt obligations that are classified as restricted long-term investments as of December 31, 2007 and March 31, 2007, which are pledged as collateral under certain letters of credit and lease agreements. In response to the dislocation in the credit markets beginning in the quarter endedour investment portfolio at September 30, 2007,2008 for impairment and determined that we had a temporary impairment of $3.5 million, attributed primarily to our investments in maturingcorporate debt securities, have been reinvested primarilyincluding asset backed debt securities, student loan backed auction rate securities, and an other-than-temporary impairment of $0.6 million attributed to investments in U.S. government obligations.the common stock of certain collaborative partners. Temporary impairments are unrealized and are recorded in accumulated other comprehensive income, a component of shareholders’ equity, and other-than-temporary impairments are realized and recorded in our condensed consolidated statements of income.
     
AllAt September 30, 2008, we have classified $88.7 million of our available-for-sale investments in debtsecurities with temporary losses of $3.5 million as Investments — Long-Term in the accompanying condensed consolidated balance sheet, as we believe the recovery of the losses will extend beyond one year and equity securities classified as available-for-sale are recorded at fair value. Fair value is generally based on quoted market prices. If quoted market prices are not available, fair values are estimated based on dealer quotes or quoted prices for instruments with similar characteristics. As of


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December 31, 2007, gross unrealized gains and losses on the investments were $1.0 million and $1.9 million, respectively. The Company believes that the gross unrealized losses are temporary, and the Company haswe have the intent and ability to hold these securitiesthe investments to recovery, which may be at maturity.
     On April 1, 2008, we implemented SFAS No. 157, “Fair Value Measurements” (“SFAS No. 157”) for our financial assets and liabilities that are re-measured and reported at fair value at each reporting period. SFAS No. 157 provides a framework for measuring fair value and requires expanded disclosures regarding fair value measurements. SFAS No. 157 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, SFAS No. 157 permits the use of various valuation approaches, including market, income and cost approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available.
Receivables were $40.3 million     The fair value hierarchy is broken down into three levels based on the reliability of inputs. We have categorized its cash, cash equivalents and $56.0 millioninvestments within the hierarchy as follows:
Level 1— These valuations are based on a market approach using quoted prices in active markets for identical assets. Valuations of December 31, 2007these products do not require a significant degree of judgment. Assets utilizing Level 1 inputs include investments in money market funds, U.S. government debt securities, U.S. agency debt securities, municipal debt securities, bank deposits and exchange-traded equity securities of certain publicly held companies;
Level 2— These valuations are based on a market approach using quoted prices obtained from brokers or dealers for similar securities or for securities for which we have limited visibility into their trading volumes. Valuations of these products do not require a significant degree of judgment. Assets utilizing Level 2 inputs consist of investments in corporate debt securities;
Level 3— These valuations are based on an income approach using certain inputs that are unobservable and are significant to the overall fair value measurement. Valuations of these products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of investments in auction rate securities and asset backed debt securities that are not currently trading. In addition, we hold warrants in certain publicly held companies that are classified using Level 3 inputs. The carrying balance of these warrants was immaterial at September 30, 2008 and March 31, 2007, respectively. The decrease of $15.7 million during the nine months ended December 31, 2007 was primarily due to decreases in amounts due from Janssen for RISPERDAL CONSTA product deliveries related to the timing of shipments, invoices and payments.
Inventory was $23.1 million and $18.2 million as of December 31, 2007 and March 31, 2007, respectively. This consisted of RISPERDAL CONSTA inventory of $14.8 million and $11.2 million as of December 31, 2007 and March 31, 2007, respectively, and VIVITROL inventory of $8.3 million and $7.0 million as of December 31, 2007 and March 31, 2007, respectively. The increase in RISPERDAL CONSTA inventory during the nine months ended December 31, 2007 was primarily due to increases in work in process and finished goods inventory due to the timing of manufacturing and shipments to Janssen. The increase in VIVITROL inventory during the nine months ended December 31, 2007 was primarily due to increases in raw materials inventory. As of December 31, 2007 and March 31, 2007, inventory included $0.5 million and $0.6 million of share-based compensation costs, respectively.
Accounts payable and accrued expenses were $30.0 million and $45.9 million as of December 31, 2007 and March 31, 2007, respectively. The decrease during the nine months ended December 31, 2007 was primarily due to decreases in accrued expenses related to our collaborative arrangement with Cephalon and decreases in accounts payable, partially offset by an increase in accrued income taxes payable.
Unearned milestone revenue — current and long-term portions, combined, were $119.2 million and $128.8 million as of December 31, 2007 and March 31, 2007, respectively. The decrease during the nine months ended December 31, 2007 was due to the recognition of approximately $9.2 million and $0.4 million of milestone revenue under the captions “Net collaborative profit” and “Manufacturing revenues”, respectively, in the condensed consolidated statement of income during the nine months ended December 31, 2007.
Deferred revenue — current and long-term portions, combined, were $27.8 million and $22.4 million as of December 31, 2007 and March 31, 2007, respectively. The increase during the nine months ended December 31, 2007 was due to the receipt of an upfront payment of $5.0 million from Cilag GmbH International in December 2007 upon the signing of an agreement to commercialize VIVITROL for the treatment of alcohol and opioid dependence in Russia and other countries in the CIS. The Company also received $2.0 million from Cephalon for the cost of two VIVITROL manufacturing lines currently under construction. These increases were partially offset by the recognition of revenue related to a portion of the upfront and milestone payments we received from Lilly under the AIR PTH program. Because we will operate and maintain the two VIVITROL manufacturing lines currently under construction, and intend to do so for the foreseeable future, the continued payments made by Cephalon are being treated as additional consideration and recorded as deferred revenue.
Cash flows provided by investing activities was $231.3 million for the nine months ended December 31, 2007 due to the receipt of proceeds from the sale of Reliant and the sales and maturities of investments, partially offset by the purchases of investments and the acquisition of property, plant and equipment. For the nine months ended December 31, 2006, cash used by investing activities was $27.8 million and was due primarily to the acquisition of property, plant and equipment.
Cash flows used in financing activities were $18.9 million and $7.4 million for the nine months ended December 31, 2007 and 2006, respectively. For both the nine months ended December 31, 2007 and 2006, cash used by financing activities was primarily due to the purchase of treasury stock under our publicly announced share repurchase programs, partially offset by cash provided by the issuance of common stock related to our equity compensation plans. Item 2, Unregistered Sales of Equity Securities and Use of Proceeds, in Part II of this report onForm 10-Q contains additional information related to our publicly announced share repurchase programs.2008.


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     Our investments in auction rate securities have a cost of $10.0 million and invest in taxable student loan revenue bonds issued by state higher education authorities which service student loans under the Federal Family Education Loan Program. The bonds were triple A rated at the date of purchase and are collateralized by student loans purchased by the authorities which are guaranteed by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity for these securities is typically provided by an auction process that resets the applicable interest rate at pre-determined intervals. Each of these securities had been subject to auction processes for which there had been insufficient bidders on the scheduled auction dates and Capital Resourcesthe auctions subsequently failed. We are not able to liquidate our investments in auction rate securities until future auctions are successful, a buyer is found outside of the auction process or the notes are redeemed by the issuer. The securities continue to pay interest at predetermined interest rates during the periods in which the auctions have failed.
     Typically, auction rate securities trade at their par value due to the short interest rate reset period and the availability of buyers or sellers of the securities at recurring auctions. However, since the security auctions have failed and fair value cannot be derived from quoted prices, we used a discounted cash flow model to determine the estimated fair value of the securities at September 30, 2008. Our valuation analyses consider, among other items, assumptions that market participants would use in their estimates of fair value, such as the collateral underlying the security, the creditworthiness of the issuer and any associated guarantees, the timing of expected future cash flows, and the expectation of the next time the security will have a successful auction or when callability features may be exercised by the issuer. These securities were also compared, where possible, to other observable market data with similar characteristics to the securities held by us. Based upon this methodology, we have recorded an unrealized loss related to our investments in auction rate securities of approximately $0.7 million to accumulated other comprehensive income at September 30, 2008. We believe there are several significant assumptions that are utilized in our valuation analysis, the two most critical of which are the discount rate, which includes a provision for default and liquidity risk, and the average expected term.
     At September 30, 2008, we determined that the securities had been temporarily impaired due to the length of time each security was in an unrealized loss position, the extent to which fair value was less than cost, financial condition and near term prospects of the issuers and our intent and ability to hold each security for a period of time sufficient to allow for any anticipated recovery in fair value. We do not expect the estimated fair value of these securities to decrease significantly in the future unless credit market conditions deteriorate significantly.
     Our investments in asset backed debt securities have a cost of $8.2 million and consist of investment grade medium term floating rate notes (“MTN”) of Aleutian Investments, LLC (“Aleutian”) and Meridian Funding Company, LLC (“Meridian”), which are qualified special purpose entities (“QSPE”) of Ambac Financial Group, Inc. (“Ambac”) and MBIA, Inc. (“MBIA”), respectively. Ambac and MBIA are guarantors of financial obligations and are referred to as monoline financial guarantee insurance companies. The QSPE’s, which purchase pools of assets or securities and fund the purchase through the issuance of MTN’s, have been established to provide a vehicle to access the capital markets for asset backed debt securities and corporate borrowers. The MTN’s include a sinking fund redemption feature which match-fund the terms of redemptions to the maturity dates of the underlying pools of assets or securities in order to mitigate potential liquidity risk to the QSPE’s. At September 30, 2008, a substantial portion of our initial investment in the Meridian MTN’s had been redeemed by MBIA through scheduled sinking fund redemptions at par value, and the first sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
     The liquidity and fair value of these securities has been negatively impacted by the uncertainty in the credit markets, and the exposure of these securities to the financial condition of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac had its triple A rating reduced to Aa3 by Moody’s and double A by Standard and Poor’s (“S&P”), and MBIA was downgraded from triple A to A2 by Moody’s and double A by S&P. Both downgrades were due to Ambac’s and MBIA’s inability to maintain triple A capital levels. In August 2008, S&P affirmed its double A ratings of Ambac and MBIA with negative outlook. In September 2008, Moody’s placed Ambac and MBIA on review for possible downgrade. In November 2008, Moody’s announced that it had downgraded Ambac’s rating to Baa1 with a developing outlook.
     We may not be able to liquidate our investment in the securities before the scheduled redemptions or until trading in the securities resumes in the credit markets, which may not occur. Because the MTN’s are not actively trading in the credit markets and fair value cannot be derived from quoted prices, we used a discounted cash flow model to determine the estimated fair value of the securities at September 30, 2008. Our valuation analyses consider, among other items, assumptions that market participants would use in their estimates of fair value such as the collateral

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underlying the security, the creditworthiness of the issuer and the associated guarantees by Ambac and MBIA, the timing of expected future cash flows, including whether the callability features of these investments may be exercised by the issuer. Based upon this methodology, we have an unrealized loss related to these asset backed debt securities of approximately $0.9 million in accumulated other comprehensive income at September 30, 2008. We believe there are several significant assumptions that are utilized in our valuation analysis, the two most critical of which are the discount rate, which includes a provision for default and liquidity risk, and the average expected term.
     At September 30, 2008, we determined that the securities had been temporarily impaired due to the length of time each security was in an unrealized loss position, the extent to which fair value was less than cost, the financial condition and near term prospects of the issuers, current redemptions made by one of the issuers and our intent and ability to hold each security for a period of time sufficient to allow for any anticipated recovery in fair value or until scheduled redemption. We do not expect the estimated fair value of these securities to decrease significantly in the future unless credit market conditions deteriorate significantly or the credit ratings of the issuers are downgraded.
We have funded our operations primarily with funds generated by our business operations and through public offerings and private placements of debt and equity securities, bank loans, term loans, equipment financing arrangements and payments received under research and development agreements and other agreements with collaborators. We expect to incur significant additional research and development and other costs in connection with collaborative arrangements and as we expand the development of our proprietary product candidates, including costs related to preclinical studies, clinical trials and the expansion of our facilities.facilities expansion. Our costs, including research and development costs for our product candidates and sales, marketing and promotionpromotional expenses for any future products to be marketed by us or our collaborators, if any, may exceed revenues in the future, which may result in losses from operations.
We believe that our current cash and cash equivalents and short-term investments, combined with our unused equipment lease line, anticipated interest income and anticipated revenues will generate sufficient cash flows to meet our anticipated liquidity and capital requirements through at least December 31, 2008.September 30, 2009.
Operating Activities
     Cash provided by operating activities was $39.2 million and $9.6 million in the six months ended September 30, 2008 and 2007, respectively. Cash flows from operating activities in the six months ended September 30, 2008 increased over the six months ended September 30, 2007 due to the $40.0 million we received from Lilly related to the AIR Insulin Termination Agreement, of which $25.5 million was recognized as revenue in the first quarter of fiscal 2009, and changes in other working capital accounts.
Investing Activities
     Cash provided by investing activities was $5.7 million and cash used in investing activities was $12.2 million in the six months ended September 30, 2008 and 2007, respectively. During the six months ended September 30, 2008, we had net sales of investments of $1.5 million and purchased $3.6 million in property, plant and equipment, which was offset by $7.7 million in cash we received on the sale of certain equipment to a collaborative partner. During the six months ended September 30, 2007, we had net sales of investments of $2.4 million and purchased $14.6 million in property, plant and equipment.
Financing Activities
     Cash used in financing activities was $77.6 million and cash provided by financing activities was $8.6 million for the six months ended September 30, 2008 and 2007, respectively. In the six months ended September 30, 2008, we used $71.8 million to repurchase a portion of our outstanding 7% Notes and $13.1 million to repurchase our common stock under our publicly announced stock repurchase program. These cash payments were partially offset by $7.2 million of cash provided from the issuance of common stock in connection with the exercise of employee stock options. In the six months ended September 30, 2007, we received cash of $9.1 million from the issuance of common stock in connection with the exercise of employee stock options, offset by debt payments of $0.7 million.
Borrowings
     At September 30, 2008, our borrowings consisted primarily of our 7% Notes, which had a carrying value of $91.9 million. We are currently making interest payments on the 7% Notes, with principal payments scheduled to begin in April 2009. In June and July 2008, in three separate privately negotiated transactions, we purchased an

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aggregate total of $75.0 million principal amount of the 7% Notes for $71.8 million. We recorded a loss on the extinguishment of the notes of $2.0 million during the six months ended September 30, 2008. As a result of the purchases, $95.0 principal amount of the 7% Notes remains outstanding, and we will save approximately $11.2 million in interest payments over the remaining life of the 7% notes.
Capital Requirements
We may continue to pursue opportunities to obtain additional financing in the future. Such financing may be sought through various sources, including debt and equity offerings, corporate collaborations, bank borrowings, arrangements relating to assets or other financing methods or structures. The source, timing and availability of any financings will depend on market conditions, interest rates and other factors. Our future capital requirements will also depend on many factors, including continued scientific progress in our research and development programs (including our proprietary product candidates), the magnitudesize of these programs, progress with preclinical testing and clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved in filing, prosecuting and enforcing patent claims, competing technological and market developments, the establishment of additional collaborative arrangements, the cost of manufacturing facilities and of commercialization activities and arrangements and the cost of product in-licensing and any possible acquisitions and, for any future proprietary products, the sales, marketing and promotion expenses associated with marketing such products. We may from time to time seek to retire or purchase our outstanding debt through cash purchases and/or exchanges for equity securities, in open market purchases, privately negotiated transactions or otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity requirements, contractual restrictions and other factors. The amounts involved may be material.
     
We may need to raise substantial additional funds for longer-term product development, including development of our proprietary product candidates, regulatory approvals and manufacturing and sales and marketing activities that we might undertake in the future. There can be no assurance that additional funds will be available on favorable terms, if at all. If adequate funds are not available, we may be required to curtail significantly one or more of our research and development programsand/or obtain funds through arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, product candidates or future products.
     
Our capital expendituresWe have been financed to date primarilyan arrangement with proceeds from bank loans and the sales of debt and equity securities. Under the provisions of our existing loans, General Electric Capital Corporation (“GE”) for an equipment lease line that provides us with the ability to finance up to $18.3 million of new equipment purchases. The equipment financing would be secured by the purchased equipment and Johnson & Johnson Finance Corporation have security interestswill be subject to a financial covenant, and this lease line expires in certain of our capital assets.December 2008. At September 30, 2008, there were no amounts outstanding under this lease line.
     
Capital expenditures are expected in the range from $20.0$4.0 million to $25.0$5.0 million for the year ending March 31, 2008, net2009.
Contractual Obligations
     With the exception of reimbursements from our collaborative partners.
On February 7, 2008, we entered into an Accelerated Share Repurchase Transaction (the “ASR”) with Morgan Stanley & Co. Incorporated (“Morgan Stanley”) pursuant to which we will repurchase $60.0 millionthe repurchases of our outstanding common stock from Morgan Stanley. We are acquiring these shares as part of a previously announced share repurchase program of up7% Notes, discussed above under Borrowings, and in Note 10 to $175.0 million approved by our Board of Directors. In addition, we may continue to make open market purchases of our common stock during the term ofaccompanying Condensed Consolidated Financial Statements, the ASR.
Contractual Obligations
The contractual cash obligations disclosed in our Annual Report onForm 10-K for the year ended March 31, 20072008 have not changed materially since the date of that report.
Off-Balance Sheet Arrangements
     As of September 30, 2008, we were not a party to any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources material to investors.


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Off-Balance Sheet ArrangementsItem 3.Quantitative and Qualitative Disclosures about Market Risk
     
As of December 31, 2007, we do not have any significant relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes, except for as discussed in Note 8, Sale of Investment in Reliant Pharmaceuticals, Inc., in the Notes to Condensed Consolidated Financial Statements in Part I of this report on Form 10 Q which is incorporated into this item by reference.
Item 3.Quantitative and Qualitative Disclosures about Market Risk
We hold financial instruments in our investment portfolio that are sensitive to market risks. Our investment portfolio, excluding marketablewarrants and equity securities and warrants we receivehold in connection with our collaborations and licensing activities, is used to preserve capital until it is required to fund operations. Our held-to-maturity investments are restricted and are held as collateral under certain letters of credit related to our lease agreements. Our short-term and long-term investments consist of U.S. government debt securities, U.S. agency debt securities, municipal debt securities, investment grade corporate debt securities, including asset backed debt securities, and auction rate securities. These debt securities are: (i) classified as available-for-sale; (ii) are recorded at fair value; and (iii) are subject to interest rate risk, and could decline in value if interest rates increase. Fixed rate interest securities may have their market value adversely impacted by a rise in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectation due to a fall in interest rates or we may suffer losses in principal if we are forced to sell securities that decline in the market value due to changes in interest rates. However, because we classify our investments in debt securities as available-for-sale, no gains or losses are recognized due to changes in interest rates unless such securities are sold prior to maturity or declines in fair value are determined to be other-than-temporary. Should interest rates fluctuate by 10%, our interest income would change by approximately $1.3 million over an annual period. Due to the conservative nature of our short-term and long-term investments and our investment policy, we do not believe that we have a material exposure to interest rate risk. Although our investments excluding marketable equity securities and warrants we receive in connection with our collaborations and licensing activities, are subject to credit risk, our investment policies specify credit quality standards for our investments and limit the amount of credit exposure from any single issue, issuer or type of investment.
     
Our unrestricted and restricted long-term investments consist of U.S. government obligations, investment grade corporate notes and commercial paper. Thesethat are subject to the greatest credit risk at this time are our investments in asset backed debt securities are: (i) classified as available-for-sale; (ii)and auction rate securities. Holding all other factors constant, if we were to increase the discount rate utilized in our valuation analysis of the asset backed debt securities and auction rate securities by 50 basis points (one-half of a percentage point), this change would have the effect of reducing the fair value of our investments by approximately $0.1 million and $0.2 million at September 30, 2008, respectively. Similarly, holding all other factors constant, if we were to assume that the expected term of the asset backed debt securities was the full contractual maturity, which could be through the year 2012, this change would have the effect of reducing the fair value of these securities by approximately $0.6 million at September 30, 2008. As it relates to auction rate securities, holding all other factors constant, if we were to increase the average expected term utilized in our fair value analysis by one year, this change would have the effect of reducing the fair value of these securities by approximately $0.1 million at September 30, 2008.
     We also hold warrants to purchase the equity securities of certain publicly held companies that are considered derivative instruments and are recorded at fair value; and (iii) are subject to credit and interest rate risk, and could decline in value if interest rates increase.value. These debt securities are sensitive to changes in interest rates, and interestrates. Interest rate changes would result in a change in the fair value of these financial instrumentswarrants due to the difference between the market interest rate and the rate at the date of purchase of the financial instruments.purchase. A 10% increase or decrease in market interest rates would not have a material impact on the condensedour consolidated financial statements.
     
We hold certain marketable equity securities of publicly traded companies we collaborate with that are classified as available-for-sale and are recorded at fair value under the caption “Investments” in the condensed consolidated balance sheets. We also hold other marketable equity securities, including warrants to purchase the securities of publicly traded companies we collaborate with, that are classified as available-for-sale and are recorded at fair value under the caption “Other assets” in the condensed consolidated balance sheets. These marketable equity securities are sensitive to changes in the market price of the underlying securities. Market price changes would result in a change inAt September 30, 2008, the fair value of these securities due to differences between their market price and purchase price. A 10% increase or decrease in the market price of our marketable equity securities would not have a material impact on the condensed consolidated financial statements.
As of December 31, 2007, the fair value of our Non-Recourse 7% Notes approximated the carrying value. The interest rate on these notes, and our capital lease obligations, are fixed and therefore not subject to interest rate risk.
As of December 31, 2007, we have a term loan in the amount of $0.6 million that bears a floating interest rate equal to the one-month London Interbank Offered Rate (“LIBOR”) plus 5.45 basis points.
Foreign Currency Exchange Rate Risk
     
The manufacturing and royalty revenues we receive on RISPERDAL CONSTA are a percentage of the net sales made by our collaborative partner, Janssen. Some of these sales are made in foreign countries and are denominated in foreign currencies. The manufacturing and royalty payment on these foreign sales is calculated initially in the foreign currency in which the sale is made and is then converted into U.S. dollars to determine the amount that Janssen pays us for manufacturing and royalty revenues. Fluctuations in the exchange ratio of the U.S. dollar and these foreign currencies will have the effect of increasing or decreasing our manufacturing and royalty revenues even if there is a constant amount of sales in foreign currencies. For example, if the U.S. dollar weakens against a foreign currency, then our manufacturing and royalty revenues will increase given a constant amount of sales in such foreign currency.


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The impact on our manufacturing and royalty revenues from foreign currency exchange rate risk is based on a number of factors, including the exchange rate (and the change in the exchange rate from the prior period) between a foreign currency and the U.S. dollar, and the amount of RISPERDAL CONSTA sales by Janssen that are denominated in foreign currencies. For the six months ended September 30, 2008, an average 10% strengthening of the U.S. dollar relative to the currencies in which RISPERDAL CONSTA is sold, our manufacturing and royalty revenues would have been reduced by approximately $4.7 million and $1.1 million, respectively. We do not currently hedge our foreign currency exchange rate risk.
Item 4.Controls and Procedures
Item 4.Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
     
(a)  Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision and the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined inRule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Securities Exchange Act) as of December 31, 2007.at September 30, 2008. Based upon that evaluation, our principal executive officer and principal financial officer concluded that, as of December 31, 2007,at September 30, 2008, our disclosure controls and procedures are effective in providing reasonable assurance that (a) the information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’sSecurities and Exchange Commission’s (“SEC”) rules and forms, and (b) such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
(b) Change in Internal Control over Financial Reporting
(b)  Change in Internal Control over Financial Reporting
     
During the period covered by this report, there have been no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


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PART II. OTHER INFORMATION
Item 1.Legal Proceedings
Note 10, Item 1.Legal Matters, in the Notes to Condensed Consolidated Financial Statements in Part I of this report onForm 10-Q is incorporated into this item by reference.Proceedings
     Please see the Legal Proceedings section of our Annual Report onForm 10-K for the year ended March 31, 20072008 for more information on litigation to which we are a party.
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
Item 1A.Risk Factors
The current credit and financial market conditions may exacerbate certain risks affecting our business.
     Sales of our products are dependent, in large part, on reimbursement from government health administration authorities, private health insurers, distribution partners and other organizations. As a result of the current credit and financial market conditions, these organizations may be unable to satisfy their reimbursement obligations or may delay payment. In addition, federal and state health authorities may reduce Medicare and Medicaid reimbursements, and private insurers may increase their scrutiny of claims. A reduction in the availability or extent of reimbursement could negatively affect our product sales and revenue. Customers may also reduce spending during times of economic uncertainty.
     In addition, we rely on third parties for several important aspects of our business. For example, we depend upon collaborators for both manufacturing and royalty revenue and the clinical development of collaboration products, we use third-party contract research organizations for many of our clinical trials, and we rely upon several single source providers of raw materials for the manufacture of our products. Due to the recent tightening of global credit and the disruption in the financial markets, there may be a disruption or delay in the performance of our third-party contractors, suppliers or collaborators. If such third parties are unable to satisfy their commitments to us, our business would be adversely affected.
Our investment portfolio may become impaired by further deterioration of the capital markets.
     As a result of current adverse financial market conditions, investments in some financial instruments, such as auction rate securities and asset backed debt securities, may pose risks arising from liquidity and credit concerns. We have limited holdings of these investments in our portfolio; however, the current disruptions in the credit and financial markets have negatively affected investments in many industries, including those in which we invest. The current global economic crisis has had, and may continue to have, a negative impact on the market values of the investments in our investment portfolio. We cannot predict future market conditions or market liquidity and there can be no assurance that the markets for these securities will not deteriorate further or that the institutions that these investments are with will be able to meet their debt obligations at the time we may need to liquidate such investments or until such time as the investments mature. Although we currently have no plans to access the equity or debt markets to meet capital or liquidity needs, constriction and volatility in these markets may restrict future flexibility to do so if unforeseen capital or liquidity needs were to arise.
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds
A summary of our stock repurchase activity for the threesix months ended December 31, 2007September 30, 2008 is set forth in the table below:as follows:
                 
              Approximate Dollar 
          Total  Value of Shares 
          Number of Shares  that May Yet 
  Total Number  Average  Purchased as  be Purchased 
  of Shares  Price Paid  Part of a Publicly  Under the Program 
Period Purchased(a)  per Share  Announced Program(a)  (in millions) 
April 1 through April 30    $     $81.6 
May 1 through May 31           81.6 
June 1 through June 30  1,038,455   12.11   1,038,455   109.1 
July 1 through July 31           109.1 
August 1 through August 31           109.1 
September 1 through September 30  38,700   12.89   38,700  $108.6 
              
Total  1,077,155�� $12.14   1,077,155     
              

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           Approximate Dollar
 
        Total
  Value of Shares
 
        Number of Shares
  that May Yet
 
  Total Number
  Average
  Repurchased as
  be Repurchased
 
  of Shares
  Price Paid
  Part of a Publicly
  Under the
 
Period
 Repurchased(a)  per Share  Announced Program(a)  Programs(a) 
  (In thousands, except share and per share amounts) 
 
October 1 through October 31          $2,508 
November 1 through November 30  828,600  $14.09   828,600  $165,833 
December 1 through December 31  1,090,727  $14.62   1,090,727  $149,887 
                 
Total  1,919,327  $14.39   1,919,327     
                 
(a)In September 2005, our Board of Directors authorized a program to repurchase up to $15.0 million of our common stock to be repurchased at the discretion of management from time to time in the open market or through privately negotiated transactions. The repurchase program has no set expiration date and may be suspended or discontinued at any time. We publicly announced the share repurchase program in our press release for the fiscal 2006 second quarter financial results dated November 3, 2005. No shares were purchased under this program during the nine months ended December 31, 2007. No repurchase authorization remains outstanding under this program as of December 31, 2007.
In November 2007, our Boardboard of Directorsdirectors authorized a program to repurchase up to $175.0 million of our common stock to be repurchased at the discretion of management from time to time in the open market or through privately negotiated transactions. The repurchase program has no set expiration date and may be suspended or discontinued at any time. We publicly announced the share repurchase program in our press release dated November 21, 2007. The approximate dollar valueIn June 2008, the board of shares that may yet be purchaseddirectors authorized the expansion of this repurchase program by an additional $40.0 million, bringing the total authorization under this program is $149.9 million asto $215.0 million. We publicly announced the expansion of December 31, 2007.the repurchase program in our press release dated June 16, 2008.
     
In addition to the stock repurchases above, during the ninethree and six months ended December 31, 2007,September 30, 2008, we acquired, by means of net share settlements, 77,094583 and 35,532 shares of Alkermes common stock, at an average price of $17.31$13.01 and $12.70 per share, respectively, related to the vesting of employee stock awards to satisfy withholding tax obligations. In addition, during the ninethree and six months ended December 31, 2007,September 30, 2008, we acquired 8,6759,176 shares of Alkermes common stock, at an average price of $16.77$12.66 per share, tendered by employees as payment of the exercise price of stock options granted under our equity compensation plans.
In December 2007, we executedItem 5.Other Information
     The Company’s policy governing transactions in its securities by its directors, officers and employees permits its officers, directors and employees to enter into trading plans in accordance with Rule 10b5-1 under the Exchange Act. During the three tradesmonths ended September 30, 2008, Mr. James M. Frates, an executive officer of the Company, entered into a trading plan in accordance with Rule 10b5-1 and the Company’s policy governing transactions in its securities by its directors, officers and employees. The Company undertakes no obligation to repurchase 358,867 sharesupdate or revise the information provided herein, including for revision or termination of treasury stock at an aggregate costestablished trading plan.
Item 6.Exhibits
     (a) List of $5.7 million under our publicly announced share repurchase programs. These broker-assisted transactions were not settled until January 2008 and have not been reflected in the condensed consolidated financial statements.Exhibits:
Exhibit
No.
31.1Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
31.2Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
32.1Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).


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Item 4.Submission of Matters to a Vote of Security Holders
We held our annual meeting of shareholders on October 9, 2007. For information on this shareholder meeting please see Item 4 to our quarterly report onform 10-Q for the period ended September 30, 2007, and which information is incorporated herein by reference.
Item 6.Exhibits
(a) List of Exhibits:
     
Exhibit
  
No.
  
 
 10.1 Employment Agreement, dated as of December 12, 2007, by and between Richard F. Pops and the Registrant.
 10.2 Employment Agreement, dated as of December 12, 2007, by and between David A. Broecker and the Registrant.
 10.3 Form of Employment Agreement, dated as of December 12, 2007, by and between the Registrant and each of Kathryn L. Biberstein, Elliot W. Ehrich, M.D., James M. Frates, Michael J. Landine, Gordon G. Pugh.
 31.1 Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
 31.2 Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
 32.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).


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SIGNATURES
     
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ALKERMES, INC.
(Registrant)
ALKERMES, INC.
(Registrant)
 By:  /s/ David A. Broecker
David A. Broecker
President and Chief Executive Officer
(Principal Executive Officer)
David A. Broecker 
President and Chief Executive Officer
(Principal Executive Officer) 
 By:  
/s/ James M. Frates
James M. Frates 
Senior Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) 
James M. Frates
Senior Vice President, Chief Financial Officer and
Treasurer
(Principal Financial and Accounting Officer)
Date: February 11,November 7, 2008


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EXHIBIT INDEX
     
Exhibit
  
No
  
 
 10.1 Employment Agreement, dated as of December 12, 2007, by and between Richard F. Pops and the Registrant.
 10.2 Employment Agreement, dated as of December 12, 2007, by and between David A. Broecker and the Registrant.
 10.3 Form of Employment Agreement, dated as of December 12, 2007, by and between the Registrant and each of Kathryn L. Biberstein, Elliot W. Ehrich, M.D., James M. Frates, Michael J. Landine, Gordon G. Pugh.
 31.1 Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
 31.2 Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
 32.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
Exhibit
No
31.1Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
31.2Rule 13a-14(a)/15d-14(a) Certification (furnished herewith).
32.1Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).


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