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FORM 10-Q

 


 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

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

 

For the quarterly period ended January 31, 2005

 

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 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  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


 

27,932,093 shares


Class   Outstanding at February 28, 2005

 



ALEXION PHARMACEUTICALS, INC.

 

INDEX

 

              Page

PART I.

       FINANCIAL INFORMATION     
    Item 1.    Condensed Consolidated Financial Statements (Unaudited)     
         Condensed Consolidated Balance Sheets as of January 31, 2005 and July 31, 2004    3
         Condensed Consolidated Statements of Operations for the three and six months ended January 31, 2005 and 2004    4
         Condensed Consolidated Statements of Cash Flows for the six months ended January 31, 2005 and 2004    5
         Notes to Condensed Consolidated Financial Statements    6
    Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    11
    Item 3.    Quantitative and Qualitative Disclosures about Market Risk    18
    Item 4.    Controls and Procedures    19

PART II.

   OTHER INFORMATION    20
    Item 2.    Sale of $150 million principal amount of 1.375% Convertible Senior Notes    20
    Item 4.    Submission of Matters to a Vote of Security Holders    20
    Item 6.    Exhibits    20

SIGNATURES

   22

CERTIFICATIONS

    

 

2


ALEXION PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(UNAUDITED)

(amounts in thousands)

 

     January 31, 2005

    July 31, 2004

 
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 177,019     $ 113,224  

Marketable securities

     193,974       153,277  

Milestone receivable

     —         4,000  

Reimbursable contract costs

     823       826  

State tax receivable

     700       1,493  

Prepaid expenses and other current assets

     3,018       3,513  
    


 


Total current assets

     375,534       276,333  

Property, plant and equipment, net

     11,003       11,336  

Property, plant and equipment held for sale (see Note 7)

     —         450  

Goodwill

     19,954       19,954  

Prepaid manufacturing costs (see Note 8)

     12,500       9,500  

Deferred financing costs, net (see Note 3)

     5,965       1,547  

Other assets

     456       455  
    


 


TOTAL ASSETS

   $ 425,412     $ 319,575  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Convertible subordinated notes (see Note 3)

   $ 120,000     $ —    

Note payable (see Note 7)

     —         3,920  

Accounts payable

     1,385       3,973  

Accrued expenses

     13,088       8,123  

Accrued interest

     2,628       2,881  

Deferred revenue

     828       588  

Deferred research and development payments

     188       188  
    


 


Total current liabilities

     138,117       19,673  

Deferred revenue, less current portion included above

     5,882       6,177  

Deferred research and development payments, less current portion included above

     1,110       1,203  

Convertible subordinated notes (see Note 3)

     —         120,000  

Convertible senior notes (see Note 3)

     150,000       —    
    


 


Total liabilities

     295,109       147,053  
    


 


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; 27,958 and 27,557 shares issued at January 31, 2005 and July 31, 2004, respectively

     3       3  

Additional paid-in capital

     514,488       512,827  

Accumulated deficit

     (383,019 )     (339,361 )

Accumulated other comprehensive loss

     (569 )     (347 )

Treasury stock, at cost; 37 shares

     (600 )     (600 )
    


 


Total stockholders’ equity

     130,303       172,522  
    


 


TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

   $ 425,412     $ 319,575  
    


 


 

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

 

3


ALEXION PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(UNAUDITED)

(amounts in thousands, except per share amounts)

 

     Three months ended
January 31,


    Six months ended
January 31,


 
     2005

    2004

    2005

    2004

 

CONTRACT RESEARCH REVENUES

   $ 563     $ 147     $ 710     $ 294  
    


 


 


 


OPERATING EXPENSES:

                                

Research and development

     20,088       14,524       38,751       31,212  

General and administrative

     4,280       3,300       7,959       6,114  
    


 


 


 


Total operating expenses

     24,368       17,824       46,710       37,326  
    


 


 


 


Operating loss

     (23,805 )     (17,677 )     (46,000 )     (37,032 )

OTHER INCOME AND EXPENSE:

                                

Investment income

     1,168       994       2,217       1,995  

Interest expense

     (1,921 )     (1,926 )     (3,829 )     (3,855 )

Gain from extinguishment of debt

     —         —         3,804       —    
    


 


 


 


Loss before state tax benefit

     (24,558 )     (18,609 )     (43,808 )     (38,892 )

State tax benefit

     88       62       150       133  
    


 


 


 


Net loss

   $ (24,470 )   $ (18,547 )   $ (43,658 )   $ (38,759 )
    


 


 


 


BASIC AND DILUTED NET LOSS PER COMMON SHARE

   $ (0.88 )   $ (0.85 )   $ (1.57 )   $ (1.85 )
    


 


 


 


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

     27,838       21,893       27,722       20,924  
    


 


 


 


 

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

 

4


ALEXION PHARMACEUTICALS, INC.

Condensed Consolidated Statements Of Cash Flows

(UNAUDITED)

(amounts in thousands)

 

     Six months ended
January 31,


 
     2005

    2004

 

CASH FLOWS FROM OPERATING ACTIVITIES:

                

Net loss

   $ (43,658 )   $ (38,759 )

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

                

Gain from extinguishment of debt

     (3,804 )     —    

Depreciation and amortization

     1,636       1,737  

Compensation expense related to grant of stock options

     15       57  

Change in assets and liabilities:

                

Milestone receivable and reimbursable contract costs

     4,003       298  

State tax receivable

     793       79  

Prepaid expenses

     495       2  

Prepaid manufacturing costs

     (3,000 )     —    

Other assets

     (1 )     601  

Accounts payable

     (2,588 )     425  

Accrued expenses

     4,965       (1,408 )

Accrued interest

     80       118  

Deferred revenue

     (55 )     (294 )

Deferred research and development payments

     (93 )     1,484  
    


 


Net cash used in operating activities

     (41,212 )     (35,660 )
    


 


CASH FLOWS FROM INVESTING ACTIVITIES:

                

Purchases of marketable securities

     (90,631 )     (72,539 )

Proceeds from maturity or sale of marketable securities

     49,712       49,969  

Investments in patents and licensed technology

     —         (5 )

Purchases of property, plant and equipment

     (1,003 )     (941 )
    


 


Net cash used in investing activities

     (41,922 )     (23,516 )
    


 


CASH FLOWS FROM FINANCING ACTIVITIES:

                

Net proceed from convertible debt offering

     145,283       —    

Net proceeds from issuance of common stock

     1,646       44,864  
    


 


Net cash provided by financing activities

     146,929       44,864  
    


 


NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

     63,795       (14,312 )

CASH AND CASH EQUIVALENTS, beginning of period

     113,224       24,844  
    


 


CASH AND CASH EQUIVALENTS, end of period

   $ 177,019     $ 10,532  
    


 


SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

                

Cash paid for interest

   $ 3,450     $ 3,450  
    


 


 

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

 

5


ALEXION PHARMACEUTICALS, INC.

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Operations -

 

Alexion Pharmaceuticals, Inc. (“Alexion”) was incorporated in 1992 and is engaged in the discovery and development of therapeutic products to treat patients with a wide array of severe disease states, including hematologic and cardiovascular disorders, autoimmune diseases, and cancer.

 

The accompanying condensed 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.

 

The condensed 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. These condensed consolidated 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, 2004. Certain reclassifications have been made to prior period accounts payable balances and accrued expenses to conform to current year classifications. The year-end balance sheet data