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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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 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: 000-30681

 


 

DENDREON CORPORATION

(Exact name of registrant as specified in its charter)

 


 

DELAWARE   22-3203193

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

3005 FIRST AVENUE, SEATTLE, WASHINGTON 98121

(Address of principal executive offices, including zip code)

 

(206) 256-4545

(Registrant’s telephone number, including area code)

 

www.dendreon.com

 


 

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.    x  Yes    ¨  No

 

Indicate by check mark whether the registrant (1) is an accelerated filer (as defined in Rule 12b-2 of the Act).    x  Yes    ¨  No

 

The number of shares of the registrant’s common stock, $.001 par value, outstanding as of October 31, 2004 was 58,994,134.

 



Table of Contents

DENDREON CORPORATION

 

INDEX

 

               PAGE NO.

PART I.

   FINANCIAL INFORMATION     
     Item 1.    Financial Statements     
          a) Consolidated Balance Sheets as of September 30, 2004 (unaudited) and December 31, 2003    2
         

b) Consolidated Statements of Operations for the Three Months and Nine Months Ended September 30, 2004 and 2003 (unaudited)

   3
         

c) Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2004 and 2003 (unaudited)

   4
         

d) Notes to Consolidated Financial Statements (unaudited)

   5
     Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    9
     Item 3.    Qualitative and Quantitative Disclosures About Market Risk    28
     Item 4.    Controls and Procedures    28

PART II.

   OTHER INFORMATION     
     Item 6.    Exhibits    29

SIGNATURES

   30

EXHIBIT INDEX

   31


Table of Contents

PART I—FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

DENDREON CORPORATION

 

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share amounts)

 

     September 30,
2004


    December 31,
2003


 
     (Unaudited)        
ASSETS                 

Current assets:

                

Cash and cash equivalents

   $ 35,104     $ 44,349  

Short-term investments

     154,431       55,692  

Accounts receivable

     5,972       5,689  

Other current assets

     3,389       2,974  
    


 


Total current assets

     198,896       108,704  

Property and equipment, net

     3,792       5,011  

Long-term investments

     22,228       13,150  

Restricted cash

     304       303  

Receivable, net of current portion

     10,601       9,943  

Deposits and other assets

     798       734  
    


 


Total assets

   $ 236,619     $ 137,845  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY                 

Current liabilities:

                

Accounts payable

   $ 3,590     $ 1,221  

Accrued liabilities

     9,568       8,473  

Accrued acquisition-related restructuring liabilities

     1,746       924  

Accrued compensation

     2,569       4,052  

Deferred revenue

     97       107  

Current portion of capital lease obligations

     1,194       1,463  
    


 


Total current liabilities

     18,764       16,240  

Deferred revenue, less current portion

     659       725  

Capital lease obligations, less current portion

     1,758       899  

Deferred foreign tax

     —         994  

Stockholders’ equity:

                

Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued or outstanding

     —         —    

Common stock, $0.001 par value; 80,000,000 shares authorized, 58,439,366 and 44,926,284 shares issued and outstanding at September 30, 2004 and December 31, 2003, respectively

     58       45  

Additional paid-in capital

     411,175       263,610  

Deferred stock-based compensation

     (686 )     (651 )

Accumulated other comprehensive loss

     (456 )     (61 )

Accumulated deficit

     (194,653 )     (143,956 )
    


 


Total stockholders’ equity

     215,438       118,987  
    


 


Total liabilities and stockholders’ equity

   $ 236,619     $ 137,845  
    


 


 

See accompanying notes

 

Page 2


Table of Contents

DENDREON CORPORATION

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

     Three Months Ended
September 30,


    Nine Months Ended
September 30,


 
     2004

    2003

    2004

    2003

 

Revenue

   $ 69     $ 1,777     $ 4,960     $ 5,376  

Operating expenses:

                                

Research and development

     20,240       10,351       46,345       26,505  

Acquired in-process research and development

     —         1,780       —         1,780  

General and administrative

     2,410       3,481       12,012       6,786  

Marketing

     527       125       1,335       426  
    


 


 


 


Total operating expenses

     23,177       15,737       59,692       35,497  
    


 


 


 


Loss from operations

     (23,108 )     (13,960 )     (54,732 )     (30,121 )

Interest income

     1,108       400       2,983       779  

Interest expense

     (50 )     (168 )     (220 )     (353 )

Other expense

     —         —         (290 )     —    
    


 


 


 


Loss before income taxes

     (22,050 )     (13,728 )     (52,259 )     (29,695 )

Foreign tax benefit

     —         —         1,562       —    
    


 


 


 


Net loss

   $ (22,050 )   $ (13,728 )   $ (50,697 )   $ (29,695 )
    


 


 


 


Basic and diluted net loss per share

   $ (0.38 )   $ (0.35 )   $ (0.90 )   $ (0.95 )
    


 


 


 


Shares used in computation of basic and diluted net loss per share

     58,245       39,764       56,513       31,420  
    


 


 


 


 

See accompanying notes

 

Page 3


Table of Contents

DENDREON CORPORATION

 

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

     Nine Months Ended
September 30,


 
     2004

    2003

 

OPERATING ACTIVITIES

                

Net loss

   $ (50,697 )   $ (29,695 )

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

                

Acquired in-process research and development

     —         1,780  

Depreciation expense

     1,852       1,583  

Non-cash stock-based compensation expense

     773       378  

Non-cash stock-based consulting expense

     —         447  

Non-cash interest expense

     11       12  

Impairment of fixed assets

     689       —    

Changes in current assets and liabilities:

                

Accounts receivable

     (941 )     1,760  

Other current assets

     (427 )     (219 )

Deposits and other assets

     (64 )     12  

Deferred revenue

     (76 )     (4,072 )

Accounts payable

     2,369       (495 )

Accrued liabilities and compensation

     (560 )     (908 )
    


 


Net cash used in operating activities

     (47,071 )     (29,417 )
    


 


INVESTING ACTIVITIES

                

Purchases of investments

     (237,989 )     (44,474 )

Maturities of investments

     129,777       57,005  

Proceeds from asset disposals

     174       500  

Purchases of property and equipment

     (1,496 )     (1,505 )

Net cash acquired from Corvas International, Inc.

     —         1,052  
    


 


Net cash provided by (used in) investing activities

     (109,534 )     12,578  
    


 


FINANCING ACTIVITIES

                

Payments on long-term debt

     —         (10,000 )

Proceeds from sale-leaseback financing arrangements

     1,705       856  

Payments on capital lease obligations

     (1,114 )     (902 )

Proceeds from sale of equity securities

     140,461       30,709  

Proceeds from exercise of stock options

     5,163       491  

Issuance of common stock under the Employee Stock Purchase Plan

     1,145       552  
    


 


Net cash provided by financing activities

     147,360       21,706  
    


 


NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

     (9,245 )     4,867  

CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR

     44,349       11,263  
    


 


CASH AND CASH EQUIVALENTS AT END OF PERIOD

   $ 35,104     $ 16,130  
    


 


Supplemental Schedule of Noncash Investing and Financing Activities:

                

Equity instruments issued for acquisition

   $ —       $ 62,930  

Stock options assumed in acquisition

   $ —       $ 4,381  

 

See accompanying notes

 

Page 4


Table of Contents

DENDREON CORPORATION

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

 

1. BUSINESS, PRINCIPLES OF CONSOLIDATION AND BASIS OF PRESENTATION

 

Description of Business

 

We were founded in 1992 as a Delaware corporation and we are headquartered in Seattle, Washington. We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio includes product candidates to treat a wide range of cancers using therapeutic vaccines, monoclonal antibodies, and small molecules. Our most advanced product candidate is Provenge®, a therapeutic vaccine for the treatment of prostate cancer.

 

Principles of Consolidation

 

The consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary. All material inter-company transactions and balances have been eliminated in consolidation. On July 30, 2003, we completed the acquisition of Corvas International, Inc., or Corvas (See Note 3 – Significant Events). In accordance with Statement of Financial Accounting Standards (“SFAS”), No. 141, “Business Combinations,” we have included the results of operations of Corvas in our consolidated results since the acquisition on July 30, 2003.

 

Basis of Presentation

 

The accompanying unaudited financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of our financial position, results of operations and cash flows for each period presented in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted from the accompanying statements. These interim financial statements should be read in conjunction with the audited financial statements and related notes thereto, which are included in our Annual Report on Form 10-K for the year ended December 31, 2003. The accompanying financial information as of December 31, 2003 has been derived from audited financial statements. Operating results for the three-month and nine-month periods ended September 30, 2004 are not necessarily indicative of future results that may be expected for the year ending December 31, 2004. Certain prior year items have been reclassified to conform to the current year presentation, including certain operating expenses aggregating approximately $1.2 million and $2.8 million previously reported as general and administrative expenses that have been reclassified to research and development and marketing expenses for the three and nine months ended September 30, 2003, respectively. Items reclassified include certain costs related to human resources, facilities, information technology, finance and accounting.

 

2. RECENT ACCOUNTING PRONOUNCEMENTS

 

In January 2003, the FASB issued FIN No. 46, Consolidation of Variable Interest Entities. “ This interpretation of Accounting Research Bulletin No. 51, “Consolidated Financial Statements,” addresses consolidation of business enterprises of variable interest entities in which: (1) the equity investment at risk is not sufficient to permit the entity to finance its activities without additional subordinated financial support from other parties, which is provided through other interest that will absorb some or all of the expected losses of the entity and (2) the equity investors lack one or more of certain essential characteristics of a controlling interest. FIN No. 46 became effective on January 1, 2004. Adoption of this standard had no material impact on our financial position, results of operations or cash flows.

 

3. SIGNIFICANT EVENTS

 

Page 5