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SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934:

 

For the quarterly period ended April 30, 2004

 

OR

 

¨ 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: 0-27756

 

Alexion Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   13-3648318

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

352 Knotter Drive, Cheshire, Connecticut 06410

(Address of principal executive offices) (Zip Code)

 

203-272-2596

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address, and former fiscal year, if changed)

 

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 x No ¨

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).

 

Yes x No ¨

 

Common Stock, $0.0001 par value


 

22,020,751 shares


Class   Outstanding at June 1, 2004

 



Table of Contents

ALEXION PHARMACEUTICALS, INC.

 

INDEX

 

         Page

PART I.

 

FINANCIAL INFORMATION

    

Item 1.

 

Consolidated Financial Statements (Unaudited)

    
   

Consolidated Balance Sheets as of April 30, 2004 and July 31, 2003

   3
   

Consolidated Statements of Operations for the three and nine months ended April 30, 2004 and 2003

   4
   

Consolidated Statements of Cash Flows for the nine months ended April 30, 2004 and 2003

   5
   

Notes to Consolidated Financial Statements

   6

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   13

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

   23

Item 4.

 

Controls and Procedures

   23

PART II.

 

OTHER INFORMATION

   24

Item 6.

 

Exhibits and Reports on Form 8-K

    

SIGNATURES

   25

 

Page 2


Table of Contents

ALEXION PHARMACEUTICALS, INC.

Consolidated Balance Sheets

(UNAUDITED)

(amounts in thousands)

 

     April 30, 2004

    July 31, 2003

 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 74,560     $ 24,844  

Marketable securities

     129,613       190,566  

Reimbursable contract costs

     64       390  

State tax receivable

     1,121       1,012  

Prepaid expenses and other current assets

     3,444       2,948  
    


 


Total current assets

     208,802       219,760  

Property, plant, and equipment, net

     10,270       12,276  

Assets held for sale

     1,210       —    

Goodwill

     19,954       19,954  

Deferred financing costs, net

     1,690       2,119  

Prepaid manufacturing costs

     10,000       10,000  

Other assets

     1,339       1,968  
    


 


TOTAL ASSETS

   $ 253,265     $ 266,077  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 4,476     $ 7,560  

Accrued expenses

     3,559       4,312  

Accrued interest

     1,098       2,646  

Deferred revenue

     589       589  

Deferred research and development payments

     188       —    

Note payable (see Note 9)

     3,920       —    
    


 


Total current liabilities

     13,830       15,107  

Deferred revenue, less current portion included above

     6,323       6,764  

Deferred research and development payments, less current portion included above

     1,250       —    

Note payable (see Note 9)

     —         3,920  

Convertible subordinated notes

     120,000       120,000  
    


 


Total liabilities

     141,403       145,791  
    


 


Commitments and contingencies (see Note 12)

                

Stockholders’ Equity:

                

Preferred stock $.0001 par value; 5,000 shares authorized; no shares issued or outstanding

     —         —    

Common stock $.0001 par value; 145,000 shares authorized; 22,057 and 18,257 shares issued at April 30, 2004 and July 31, 2003, respectively

     2       2  

Additional paid-in capital

     431,799       385,498  

Accumulated deficit

     (319,238 )     (265,266 )

Other comprehensive income (loss)

     (101 )     652  

Treasury stock, at cost; 37 shares

     (600 )     (600 )
    


 


Total stockholders’ equity

     111,862       120,286  
    


 


TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 253,265     $ 266,077  
    


 


 

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

 

Page 3


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ALEXION PHARMACEUTICALS, INC.

Consolidated Statements of Operations

(UNAUDITED)

(amounts in thousands, except per share amounts)

 

     Three months ended
April 30,


    Nine months ended
April 30,


 
     2004

    2003

    2004

    2003

 

CONTRACT RESEARCH REVENUES

   $ 168     $ 167     $ 462     $ 710  
    


 


 


 


OPERATING EXPENSES

                                

Research and development

     10,792       14,110       42,004       52,454  

General and administrative

     3,569       2,732       9,683       7,727  

Impairment of fixed assets

     —         2,560       —         2,560  
    


 


 


 


Total operating expenses

     14,361       19,402       51,687       62,741  
    


 


 


 


Operating loss

     (14,193 )     (19,235 )     (51,225 )     (62,031 )

OTHER INCOME AND EXPENSE

                                

Investment income

     720       1,191       2,715       4,735  

Interest expense

     (1,926 )     (1,930 )     (5,781 )     (5,783 )
    


 


 


 


Loss before state tax benefit

     (15,399 )     (19,974 )     (54,291 )     (63,079 )

State tax benefit

     186       196       319       196  
    


 


 


 


Net loss

   $ (15,213 )   $ (19,778 )   $ (53,972 )   $ (62,883 )
    


 


 


 


BASIC AND DILUTED NET LOSS PER SHARE

   $ (0.69 )   $ (1.09 )   $ (2.54 )   $ (3.45 )
    


 


 


 


SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS PER COMMON SHARE

     21,969       18,210       21,268       18,207  
    


 


 


 


 

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

 

Page 4


Table of Contents

ALEXION PHARMACEUTICALS, INC.

Consolidated Statements Of Cash Flows

(UNAUDITED)

(amounts in thousands)

 

     Nine months ended
April 30,


 
     2004

    2003

 

CASH FLOWS FROM OPERATING ACTIVITIES:

                

Net loss

   $ (53,972 )   $ (62,883 )

Adjustments to reconcile net loss to net cash used in operating activities:

                

Impairment of fixed assets

     —         2,560  

Depreciation and amortization

     2,547       2,777  

Compensation expense related to grant of stock options

     115       97  

Change in assets and liabilities:

                

Reimbursable contract costs

     326       (530 )

State tax receivable

     (109 )     —    

Prepaid expenses

     (496 )     (1,069 )

Other assets

     603       (125 )

Prepaid manufacturing costs

     —         (7,250 )

Accounts payable

     (3,084 )     (7,597 )

Accrued expenses

     (753 )     757  

Accrued interest

     (1,548 )     (1,706 )

Deferred revenue

     (441 )     (398 )

Deferred research and development payments

     1,438       —    
    


 


Net cash used in operating activities

     (55,374 )     (75,398 )
    


 


CASH FLOWS FROM INVESTING ACTIVITIES:

                

Purchases of marketable securities

     (122,566 )     (65,327 )

Proceeds from maturity or sale of marketable securities

     182,766       156,226  

Investments in patents and licensed technology

     (5 )     (31 )

Purchases of property, plant and equipment

     (1,291 )     (1,955 )
    


 


Net cash provided by investing activities

     58,904       88,944  
    


 


CASH FLOWS FROM FINANCING ACTIVITIES:

                

Net proceeds from issuance of common stock

     46,186       88  
    


 


Net cash provided by financing activities

     46,186       88  
    


 


NET INCREASE IN CASH AND CASH EQUIVALENTS

     49,716       13,634  

CASH AND CASH EQUIVALENTS, beginning of period

     24,844       47,574  
    


 


CASH AND CASH EQUIVALENTS, end of period

   $ 74,560     $ 61,208  
    


 


SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

                

Cash paid for interest

   $ 6,900     $ 7,076  
    


 


 

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

 

Page 5


Table of Contents

ALEXION PHARMACEUTICALS, INC.

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Operations -

 

Alexion Pharmaceuticals, Inc. (“Alexion”) was organized in 1992 and is engaged in the discovery and development of therapeutic products for the treatment of a wide array of severe disease states, including hematologic, cardiovascular, and autoimmune disorders, inflammation, and cancer.

 

The accompanying consolidated financial statements include Alexion Pharmaceuticals, Inc. and our wholly owned subsidiaries, Alexion Antibody Technologies (“AAT”) and Columbus Farming Corporation (“CFC”). All significant inter-company balances and transactions have been eliminated in consolidation. With the abandonment of our UniGraft xenotransplantation research and development program in fiscal 2003, CFC activities were suspended (see Note 9).

 

The consolidated financial statements included herein have been prepared by us, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and include, in the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of interim period results. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. The results for the interim periods presented are not necessarily indicative of results to be expected for any future period. Certain amounts in the fiscal 2003 financial statements have been reclassified to conform to the fiscal 2004 presentation. These consolidated condensed financial statements should be read in conjunction with the audited financial statements and notes thereto included in our Form 10-K Annual Report for the fiscal year ended July 31, 2003, as amended. The year-end balance sheet data presented does not include all disclosures required by accounting principles generally accepted in the United States of America.

 

2. Accounting for Stock-Based Compensation -

 

As permitted by Statement of Financial Accounting Standards (“SFAS”) No. 148, “Accounting for Stock-Based Compensation - Transition and Disclosure - an amendment of SFAS 123”, we account for our stock-based compensation awards using the intrinsic method and disclose the effect on the net loss per share as if the fair value method had been used.

 

At April 30, 2004, we have two stock-based compensation plans for employees, directors and consultants of Alexion. We account for the plans under the recognition and measurement principles of Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees”, and related interpretations.

 

The following table illustrates the effect on net loss and net loss per share if we had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation for the three and nine months ended April 30, 2004 and 2003 (dollars in thousands, except per share amounts):

 

     Three months ended
April 30,


    Nine months ended
April 30,


 
     2004

    2003

    2004

    2003