Alkermes Inc.
Table of Contents

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q/A
AMENDMENT NO. 1

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

For the quarterly period ended June 30, 2002

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

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)
  (I.R.S. Employer
Identification No.)
     
88 Sidney Street, Cambridge, MA   02139-4136

 
(Address of principal executive offices)   (Zip Code)
       
Registrant’s telephone number including area code:   (617) 494-0171
   

64 Sidney Street, Cambridge, MA 02139-4136


(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. Yes  box   No  box

         Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

         
Class   Shares Outstanding as of August 7, 2002

 
Common Stock, par value $.01
    64,312,182  
Non-Voting Common Stock, par value $.01
    382,632  

 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. CONSOLIDATED FINANCIAL STATEMENTS:
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF CASH FLOWS
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Item 6. Exhibits and Reports on Form 8-K
SIGNATURES
CERTIFICATIONS
Exhibit Index
Ex-99.1 Certification of Chief Executive Officer
Ex-99.1 Certification of Chief Financial Officer


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ALKERMES, INC. AND SUBSIDIARIES

INDEX

             
        Page No.
       
PART I — FINANCIAL INFORMATION
       
 
Item 1. Consolidated Financial Statements
       
 
            Consolidated Balance Sheets - June 30, 2002 and March 31, 2002
    3  
 
            Consolidated Statements of Operations - Three months ended June 30, 2002 and 2001
    4  
 
            Consolidated Statements of Cash Flows - Three months ended June 30, 2002 and 2001
    5  
 
            Notes to Consolidated Financial Statements
    6  
 
Item 6. Exhibits and Reports on Form 8-K
    9  
SIGNATURES
    10  
CERTIFICATIONS
    10  
EXHIBIT INDEX
    11  

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Explanatory Note

     The Registrant is filing this Amendment No. 1 to its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2002 to include summarized financial information with regard to a fifty percent or less owned person accounted for by the equity method by the Registrant in the notes to its financial statements. Accordingly, in this Form 10-Q/A, the Registrant is amending Note 4 to its Notes to Consolidated Financial Statements included in Item 1 to reflect such summarized financial information. This Form 10-Q/A does not reflect events occurring after the filing of the original Form 10-Q, or modify or update the disclosures therein in any way other than as required to reflect the amendment described above.


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PART I. FINANCIAL INFORMATION

Item 1. Consolidated Financial Statements:

ALKERMES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
(Unaudited)

                         
            June 30,   March 31,
            2002   2002
           
 
       
ASSETS
               
Current Assets:
               
 
Cash and cash equivalents
  $ 9,488,795     $ 16,023,074  
 
Short-term investments
    100,338,942       136,323,768  
 
Receivables from collaborative arrangements
    19,501,908       19,039,706  
 
Prepaid expenses and other current assets
    5,647,655       5,249,797  
 
 
   
     
 
       
Total current assets
    134,977,300       176,636,345  
 
 
   
     
 
Property, Plant and Equipment:
               
 
Land
    235,000       235,000  
 
Building
    5,076,961       5,058,936  
 
Furniture, fixtures and equipment
    51,274,335       49,558,745  
 
Leasehold improvements
    15,108,993       15,016,553  
 
Construction in progress
    41,245,053       26,497,064  
 
 
   
     
 
 
    112,940,342       96,366,298  
       
Less accumulated depreciation and amortization
    (36,745,946 )     (34,530,467 )
 
 
   
     
 
 
    76,194,396       61,835,831  
 
 
   
     
 
Investments
    8,823,556       9,126,093  
 
 
   
     
 
Investment in Reliant Pharmaceuticals, LLC
    70,383,636       94,596,536  
 
 
   
     
 
Other Assets
    7,224,197       8,155,472  
 
 
   
     
 
       
Total Assets
  $ 297,603,085     $ 350,350,277  
 
 
   
     
 
   
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Current Liabilities:
               
 
Accounts payable and accrued expenses
  $ 22,703,760     $ 20,764,375  
 
Accrued interest
    2,881,226       1,013,521  
 
Deferred revenue
    6,807,177       7,083,516  
 
Long-term obligations — current portion
    3,900,000       14,025,000  
 
 
   
     
 
       
Total current liabilities
    36,292,163       42,886,412  
 
 
   
     
 
Long-Term Obligations
    6,825,000       7,800,000  
 
 
   
     
 
Convertible Subordinated Notes
    200,000,000       200,000,000  
 
 
   
     
 
Shareholders’ Equity:
               
 
Capital stock, par value $.01 per share: authorized, 4,550,000 shares; none issued
               
 
Common stock, par value $.01 per share:
               
     
authorized, 160,000,000 shares; issued, 64,290,178 and 64,225,395 shares at
June 30, 2002 and March 31, 2002, respectively
    642,902       642,254  
 
Non-voting common stock, par value $.01 per share:
               
     
authorized, 450,000 shares; issued, 382,632 at June 30, 2002 and March 31, 2002
    3,826       3,826  
 
Additional paid-in capital
    444,851,926       444,425,742  
 
Deferred compensation
    (2,587,460 )     (3,162,448 )
 
Accumulated other comprehensive income
    692,198       1,619,541  
 
Accumulated deficit
    (389,117,470 )     (343,865,050 )
 
 
   
     
 
       
Total shareholders’ equity
    54,485,922       99,663,865  
 
 
   
     
 
       
Total Liabilities and Shareholders’ Equity
  $ 297,603,085     $ 350,350,277  
 
 
   
     
 

See notes to consolidated financial statements.

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ALKERMES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)

                     
        Three Months   Three Months
        Ended   Ended
        June 30,   June 30,
        2002   2001
       
 
Revenues:
               
 
Research and development revenue under collaborative arrangements
  $ 10,291,391     $ 15,526,675  
 
 
   
     
 
Expenses:
               
 
Research and development
    24,599,673       20,710,031  
 
General and administrative
    6,016,040       5,374,278  
 
 
   
     
 
   
Total expenses
    30,615,713       26,084,309  
 
 
   
     
 
Net operating loss
    (20,324,322 )     (10,557,634 )
 
 
   
     
 
Other income (expense):
               
 
Interest income
    1,365,936       4,525,015  
 
Interest expense
    (2,081,134 )     (2,309,927 )
 
 
   
     
 
   
Total other (expense) income
    (715,198 )     2,215,088  
 
 
   
     
 
Equity in losses of Reliant Pharmaceuticals, LLC
    24,212,900        
 
 
   
     
 
Net loss
    ($45,252,420 )     ($8,342,546 )
 
 
   
     
 
Basic and diluted loss per common share
    ($0.70 )     ($0.13 )
 
 
   
     
 
Weighted average number of common shares outstanding
    64,260,903       63,236,893  
 
 
   
     
 

See notes to consolidated financial statements.

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ALKERMES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

                         
            Three Months   Three Months
            Ended   Ended
            June 30,   June 30,
            2002   2001
           
 
Cash flows from operating activities:
               
   
Net loss
    ($45,252,420 )     ($8,342,546 )
   
Adjustments to reconcile net loss to net cash used by operating activities:
               
     
Depreciation, amortization and other noncash expenses
    3,071,035       2,313,341  
     
Equity in losses of Reliant Pharmaceuticals, LLC
    24,212,900        
     
Noncash interest expense
          138,730  
     
Adjustments to other assets
          250,447  
     
Changes in assets and liabilities:
               
       
Receivables from collaborative arrangements
    (462,201 )     (6,132,254 )
       
Prepaid expenses and other current assets
    (400,779 )     1,011,462  
       
Accounts payable and accrued expenses
    3,823,187       1,818,670  
       
Deferred revenue
    (276,341 )     (579,472 )
   
 
   
     
 
       
Net cash used by operating activities
    (15,284,619 )     (9,521,622 )
   
 
   
     
 
Cash flows from investing activities:
               
   
Additions to property, plant and equipment
    (16,626,892 )     (2,441,554 )
   
Purchases of available-for-sale short-term investments
    (35,290,276 )     (69,221,396 )
   
Sales of available-for-sale short-term investments
    71,241,888       66,764,763
   
Purchases of held-to-maturity short-term investments, net
          (19,309,847 )
   
Maturities of long-term investments, net
          38,739,459  
   
Increase in other assets
          (300,000 )
   
 
   
     
 
       
Net cash provided by investing activities
    19,324,720       14,231,425  
   
 
   
     
 
Cash flows from financing activities:
               
   
Proceeds from issuance of common stock
    480,681       1,402,349  
   
Repayment of loan
    (10,000,000 )      
   
Payment of long-term obligations
    (1,100,000 )     (1,350,000 )
   
 
   
     
 
     
Net cash (used by) provided by financing activities
    (10,619,319 )     52,349  
   
 
   
     
 
Effect of exchange rate changes on cash
    44,939       (10,948 )
   
 
   
     
 
Net (decrease) increase in cash and cash equivalents
    (6,534,279 )     4,751,204  
Cash and cash equivalents, beginning of period
    16,023,074       5,923,282  
   
 
   
     
 
Cash and cash equivalents, end of period
  $ 9,488,795     $ 10,674,486  
   
 
   
     
 
Supplementary information:
               
   
Cash paid for interest
  $ 213,428     $ 301,123  
   
 
   
     
 

See notes to consolidated financial statements.

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ALKERMES, INC. AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. BASIS OF PRESENTATION

The consolidated financial statements of Alkermes, Inc. (the “Company”) for the three months ended June 30, 2002 and 2001 are unaudited and include all adjustments which are normal and recurring and, in the opinion of management, are necessary to present fairly the results of operations for the periods then ended. All such adjustments are of a normal recurring nature. These financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended March 31, 2002, which includes consolidated financial statements and notes thereto for the years ended March 31, 2002, 2001 and 2000. In addition, the financial statements include the accounts of Alkermes Controlled Therapeutics, Inc., Alkermes Controlled Therapeutics Inc. II, Advanced Inhalation Research, Inc. (“AIR”), Alkermes Investments, Inc., Alkermes Europe, Ltd. and Alkermes Development Corporation II (“ADC II”), wholly owned subsidiaries of the Company.

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.

The preparation of the Company’s consolidated financial statements in conformity with accounting principles generally accepted in the United States of America necessarily requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

2. COMPREHENSIVE INCOME (LOSS)

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes certain changes in the shareholders’ equity of the Company that are excluded from net income (loss). Specifically, other comprehensive income (loss) includes unrealized holding gains and losses on the Company’s “available-for-sale” securities and changes in cumulative foreign currency translation adjustments.

Comprehensive income (loss) for the three months ended June 30, 2002 and 2001 is as follows:

                 
    Three Months   Three Months
    Ended   Ended
    June 30, 2002   June 30, 2001
   
 
Net loss
    ($45,252,420 )     ($8,342,546 )
Foreign currency translation adjustments
    49,908       (10,575 )
Unrealized (loss) gain on marketable securities
    (977,251 )     9,182  
 
   
     
 
Comprehensive loss
    ($46,179,763 )     ($8,343,939 )
 
   
     
 

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3. NET LOSS PER SHARE

Basic and diluted net loss per share are computed using the weighted average number of common shares outstanding during the period. Basic net loss per share excludes any dilutive effect from stock options and the 3 3/4% Convertible Subordinated Notes due 2007 (the “3 3/4% Notes”). The Company continues to be in a net loss position and, therefore, diluted net loss per share is the same amount as basic net loss per share. Certain securities were not included in the computations of diluted net loss per share for the three months ended June 30, 2002 and 2001 because they would have an antidilutive effect due to net losses for such periods. These securities include (i) outstanding stock options and awards with respect to 11,368,201 and 9,455,725 shares of common stock in the three months ended June 30, 2002 and 2001 and (ii) 2,952,030 shares of common stock issuable upon conversion of the 3 3/4% Notes in the three months ended June 30, 2002 and 2001.

4. INVESTMENT IN RELIANT PHARMACEUTICALS, LLC

In December 2001, the Company announced a strategic alliance with Reliant Pharmaceuticals, LLC, a privately held pharmaceutical company marketing branded, prescription pharmaceutical products to primary care physicians in the U.S.

As part of the alliance, in December 2001, the Company purchased approximately 63% of an offering by Reliant of its Series C Convertible Preferred Units, representing approximately 19% of the equity interest in Reliant, for a purchase price of $100 million. The investment is being accounted for under the equity method of accounting because Reliant is organized as a limited liability company which is treated in a manner similar to a partnership. Because, at the time of the Company’s investment, Reliant had an accumulated deficit from operations and a deficit in members capital, under applicable accounting rules, the Company’s share of Reliant’s losses from the date of the investment will be recognized in proportion to the Company’s percentage participation in the Series C financing, and not in proportion to its percentage ownership interest in Reliant. The Company records its equity in the income or losses of Reliant three months in arrears. Reliant is a privately held company over which the Company does not exercise control and it relies on the unaudited financial statements prepared by Reliant and provided to the Company to calculate its share of Reliant’s losses in the Company’s consolidated statements of operations. The Company anticipates that Reliant will have substantial net losses through 2003, and accordingly, recorded its 63% share of such losses in its consolidated financial statements beginning in the quarter ended March 31, 2002.

Summarized financial information related to Reliant for the three-month period ended March 31, 2002 is as follows:

                         
(In thousands)                      
Revenues   $ 58,609  
Costs and expenses     88,461  
Net loss     (29,644 )

In connection with the Company’s $100 million equity investment in Reliant, the Company is in the process of allocating its proportionate share of the assets acquired and liabilities assumed in accordance with the guidance set forth in Statement of Financial Accounting Standards (“SFAS”) No. 141. The Company took a $2.7 million noncash charge for in-process research and development through the income statement under the caption “Equity in losses of Reliant Pharmaceuticals, LLC” in fiscal 2002. The $2.7 million noncash charge is related to management’s current estimate of the amount of the purchase price to be allocated to in-process research and development. This analysis of the purchase price allocation is preliminary and the amount of in-process research and development is subject to future adjustment.

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Termination of Proposed Merger Transaction with Reliant

On March 20, 2002, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Reliant. On August 14, 2002, the Company and Reliant announced the mutual termination of the Merger Agreement. The companies agreed to terminate due to general market conditions. There will be no payments triggered by the mutual termination and each company will bear its own legal and transaction fees.

5. RECENT ACCOUNTING PRONOUNCEMENTS

In August 2002, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 146, “Accounting for Costs Associated with Exit or Disposal Activities.” SFAS No. 146 addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring).” SFAS No. 146 requires that a liability for a cost associated with an exit or disposal activity be recognized when the liability is incurred. The provisions of SFAS No. 146 are effective for exit or disposal activities that are initiated after December 31, 2002. The Company does not believe that the adoption of SFAS No. 146 will have a material impact on its financial statements and result of operations.

6. SUBSEQUENT EVENT

In August, the Company announced the regulatory approval and expected commercial launch of Risperdal Consta™ in Germany and the United Kingdom. Under the Company’s agreements with Janssen and based on the foregoing, certain minimum revenues are to be paid to the Company in minimum annual amounts for up to ten years beginning in calendar 2003. The actual amount of such minimum revenues will be determined by a formula and are currently estimated to aggregate approximately $150 million. The minimum revenue obligation will be satisfied upon receipt by the Company of revenues equalling such aggregate amount of minimum revenues.

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Item 6. Exhibits and Reports on Form 8-K

  (a)   Exhibits:
             
    Number   Exhibit
   
 
      3.1     Third Amended and Restated Articles of Incorporation as filed with the Pennsylvania Secretary of State on June 7, 2001. (Incorporated by reference to Exhibit 3.1 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 2001).
             
      3.2     Amended and Restated By-Laws of Alkermes, Inc., effective as of February 11, 2001. (Incorporated by reference to Exhibit 3.2 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 2001).
             
      4.1     Specimen of Common Stock Certificate of Alkermes, Inc. (Incorporated by reference to Exhibit 4 to the Company’s Registration Statement on Form S-1, as amended (File No. 33-40250)).
             
      4.2     Specimen of Non-Voting Common Stock Certificate of Alkermes, Inc. (Incorporated by reference to Exhibit 4.4 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 1999).
             
      4.3     Indenture, dated as of February 18, 2000, between Alkermes, Inc. and State Street Bank and Trust Company, as Trustee. (Incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-3, as amended (File No. 333-31354)).
             
      99.1     Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 by Chief Executive Officer.
             
      99.2     Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 by Chief Financial Officer.

  (b)   During the quarter ended June 30, 2002, the Company filed a Current Report on Form 8-K, dated April 2, 2002, under Items 7 and 9 and a Current Report on Form 8-K, dated June 28, 2002, under Item 5.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused Amendment No. 1 to this report to be signed on its behalf by the undersigned thereunto duly authorized.

         
    ALKERMES, INC.
(Registrant)
         
Date: November 14, 2002   By:   /s/ James M. Frates
       
        James M. Frates
Vice President, Chief
Financial Officer and Treasurer
(Principal Financial and
Accounting Officer)

CERTIFICATIONS

I, Richard F. Pops, certify that:

1.   I have reviewed this amendment no. 1 to the quarterly report on Form 10-Q/A of Alkermes, Inc.;
 
2.   Based on my knowledge, this Amendment No. 1 to the quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Amendment No. 1 to the quarterly report; and
 
3.   Based on my knowledge, the financial statements, and other financial information included in this Amendment No. 1 to the quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Amendment No. 1 to the quarterly report.
 

 

         
Date:   November 14, 2002   /s/ Richard F. Pops

Richard F. Pops
Chief Executive Officer

CERTIFICATIONS

I, James M. Frates, certify that:

1.   I have reviewed this amendment no. 1 to quarterly report on Form 10-Q/A of Alkermes, Inc.;
 
2.   Based on my knowledge, this Amendment No. 1 to the quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Amendment No. 1 to the quarterly report; and
 
3.   Based on my knowledge, the financial statements, and other financial information included in this Amendment No. 1 to the quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this Amendment No. 1 to the quarterly report.
 
         
Date:   November 14, 2002   /s/ James M. Frates

James M. Frates
Chief Financial Officer

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Exhibit Index

             
    Exhibit    
    Number   Description
   
 
      3.1     Third Amended and Restated Articles of Incorporation as filed with the Pennsylvania Secretary of State on June 7, 2001. (Incorporated by reference to Exhibit 3.1 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 2001).
             
      3.2     Amended and Restated By-Laws of Alkermes, Inc., effective as of February 11, 2001. (Incorporated by reference to Exhibit 3.2 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 2001).
             
      4.1     Specimen of Common Stock Certificate of Alkermes, Inc. (Incorporated by reference to Exhibit 4 to the Company’s Registration Statement on Form S-1, as amended (File No. 33-40250)).
             
      4.2     Specimen of Non-Voting Common Stock Certificate of Alkermes, Inc. (Incorporated by reference to Exhibit 4.4 to the Company’s Report on Form 10-K for the fiscal year ended March 31, 1999).
             
      5.3     Indenture, dated as of February 18, 2000, between Alkermes, Inc. and State Street Bank and Trust Company, as Trustee. (Incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-3, as amended (File No. 333-31354)).
             
      99.1     Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 by Chief Executive Officer.
             
      99.2     Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350 by Chief Financial Officer.

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