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United States

Securities and Exchange Commission

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

(Mark One)

 

x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 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: 000-26727

 


 

BIOMARIN PHARMACEUTICAL INC.

(Exact name of registrant issuer as specified in its charter)

 


 

Delaware   68-0397820

(State of other jurisdiction of

Incorporation or organization)

 

(I.R.S. Employer

Identification No.)

371 Bel Marin Keys Blvd., #210, Novato,

California

  94949
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number: (415) 506-6700

(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 ¨

 

APPLICABLE ONLY TO CORPORATE ISSUERS

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 64,497,636 shares common stock, par value $0.001, outstanding as of November 3, 2004.

 



Table of Contents

BIOMARIN PHARMACEUTICAL INC.

 

TABLE OF CONTENTS

 

            Page

PART I.

    

FINANCIAL INFORMATION

    

Item 1.

    

Consolidated Financial Statements (Unaudited)

   3
      

Consolidated Balance Sheets

   3
      

Consolidated Statements of Operations

   4
      

Consolidated Statements of Cash Flows

   5
      

Notes to Consolidated Financial Statements (Unaudited)

   6

Item 2.

    

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

   14

Item 3.

    

Quantitative and Qualitative Disclosure about Market Risk

   37

Item 4.

    

Controls and Procedures

   37

PART II.

    

OTHER INFORMATION

    

Item 1.

    

Legal Proceedings

   38

Item 2.

    

Unregistered Sales of Equity Securities and Use of Proceeds

   38

Item 3.

    

Defaults Upon Senior Securities

   38

Item 4.

    

Submission of Matters to a Vote of Security Holders

   38

Item 5.

    

Other Information

   38

Item 6.

    

Exhibits

   38

SIGNATURE

   39

 

2


Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1. Consolidated Financial Statements (Unaudited)

 

BioMarin Pharmaceutical Inc. and Subsidiaries

 

Consolidated Balance Sheets

(In thousands, except share and per share data)

 

     December 31,
2003 (1)


    September 30,
2004


 
           (unaudited)  

Assets

                

Current assets:

                

Cash and cash equivalents

   $ 121,406     $ 34,981  

Short-term investments

     84,951       51,570  

Restricted cash

     —         25,198  

Accounts receivable

     —         119  

Inventory

     —         3,090  

Investment in and advances to BioMarin/Genzyme LLC

     16,058       22,650  

Other current assets

     2,854       3,079  
    


 


Total current assets

     225,269       140,687  

Property and equipment, net

     25,154       35,620  

Acquired intangible assets, net

     —         99,123  

Goodwill

     —         32,250  

Other assets

     5,917       4,550  
    


 


Total assets

   $ 256,340     $ 312,230  
    


 


Liabilities and Stockholders’ Equity

                

Current liabilities:

                

Accounts payable and accrued liabilities

   $ 10,098     $ 24,541  

Current portion of acquisition obligation, net of discount

     —         48,747  

Other current liabilities

     2,717       2,427  
    


 


Total current liabilities

     12,815       75,715  

Convertible debt

     125,000       125,000  

Equipment and facility loan

     —         6,986  

Long-term portion of acquisition obligation, net of discount

     —         90,076  

Other long-term liabilities

     672       290  
    


 


Total liabilities

     138,487       298,067  
    


 


Stockholders’ equity:

                

Common stock, $0.001 par value: 150,000,000 shares authorized; 64,156,285 and 64,388,138 shares issued and outstanding December 31, 2003 and September 30, 2004, respectively

     64       64  

Additional paid-in capital

     414,110       420,758  

Warrants

     5,219       —    

Deferred compensation

     (145 )     —    

Accumulated other comprehensive loss

     (17 )     (260 )

Accumulated deficit

     (301,378 )     (406,399 )
    


 


Total stockholders’ equity

     117,853       14,163  
    


 


Total liabilities and stockholders’ equity

   $ 256,340     $ 312,230  
    


 



(1) December 31, 2003 balances were derived from the audited consolidated financial statements.

 

See accompanying notes to consolidated financial statements.

 

3


Table of Contents

BioMarin Pharmaceutical Inc. and Subsidiaries

 

Consolidated Statements of Operations

For the Three and Nine Months Ended September 30, 2003 and 2004

(In thousands, except per share data, unaudited)

 

    

Three Months Ended

September 30,


   

Nine Months Ended

September 30,


 
     2003

    2004

    2003

    2004

 

Net product sales

   $ —       $ 181     $ —       $ 4,744  

Milestone revenue

     —         —         12,100       —    
    


 


 


 


Total revenue

     —         181       12,100       4,744  
    


 


 


 


Operating expenses:

                                

Cost of sales (excludes amortization of developed product technology)

     —         35       —         648  

Research and development

     14,211       11,806       36,784       37,670  

Selling, general and administrative

     1,956       12,761       9,364       24,304  

Amortization of acquired intangible assets

     —         1,694       —         2,513  

Acquired in-process research and development

     —         —         —         35,444  

Equity in the loss of BioMarin/Genzyme LLC

     4,503       507       16,642       3,965  
    


 


 


 


Total operating expenses

     20,670       26,803       62,790       104,544  
    


 


 


 


Loss from operations

     (20,670 )     (26,622 )     (50,690 )     (99,800 )

Interest income

     781       573       1,787       1,997  

Interest expense

     (1,402 )     (3,429 )     (1,745 )     (7,218 )
    


 


 


 


Net loss from continuing operations

     (21,291 )     (29,478 )     (50,648 )     (105,021 )

Gain on disposal of discontinued operations

     —         —         577       —    
    


 


 


 


Net loss

   $ (21,291 )   $ (29,478 )   $ (50,071 )   $ (105,021 )
    


 


 


 


Net loss per share, basic and diluted:

                                

Net loss from continuing operations

   $ (0.33 )   $ (0.46 )   $ (0.82 )   $ (1.63 )

Gain on disposal of discontinued operations

     —         —         0.01       —    
    


 


 


 


Net loss

   $ (0.33 )   $ (0.46 )   $ (0.81 )   $ (1.63 )
    


 


 


 


Weighted average common shares outstanding, basic and diluted

     63,815       64,384       61,450       64,316  
    


 


 


 


 

See accompanying notes to consolidated financial statements.

 

4


Table of Contents

BioMarin Pharmaceutical Inc. and Subsidiaries

 

Consolidated Statements of Cash Flows

For the Nine Months Ended September 30, 2003 and 2004

(In thousands, unaudited)

 

     Nine Months Ended
September 30,


 
     2003

    2004

 

Cash flows from operating activities:

                

Net loss from continuing operations

   $ (50,648 )   $ (105,021 )

Adjustments to reconcile net loss from continuing operations to net cash used in operating activities:

                

Depreciation and amortization

     7,232       12,680  

Acquired in-process research and development

     —         35,444  

Lease liability reversal

     (2,002 )     —    

Gain on disposals of property and equipment

     —         (104 )

Changes in operating assets and liabilities:

                

Accounts receivable

     —         (119 )

Inventory

     —         (790 )

Investment in and advances to BioMarin/Genzyme LLC

     (5,355 )     (6,592 )

Other current assets

     299       (225 )

Note receivable from officer

     203       917  

Other assets

     (902 )     (172 )

Accounts payable and accrued liabilities

     9,469       8,107  

Other liabilities

     (248 )     199  
    


 


Net cash used in continuing operations

     (41,952 )     (55,676 )

Net cash provided by discontinued operations

     140       —    
    


 


Net cash used in operating activities

     (41,812 )     (55,676 )
    


 


Cash flows from investing activities:

                

Purchase of property and equipment

     (2,637 )     (16,401 )

Proceeds from sale of equipment

     28       —    

Ascent Pediatrics transaction

     —         (14,742 )

Increase in restricted cash

     —         (25,198 )

Sale of short-term investments

     74,056       70,575  

Purchase of short-term investments

     (88,020 )     (37,435 )
    


 


Net cash used in investing activities

     (16,573 )     (23,201 )