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UNITED STATES
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 September 30, 2003

or

     
o   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:

000-50425


Genitope Corporation

(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
      77-0436313
(I.R.S. Employer Identification No.)
    525 Penobscot Drive
Redwood City, CA 94063

(Address of principal executive offices, including zip code)

(650) 482-2000
(Registrant’s telephone number, including area code)
   


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 o

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

On November 30, 2003, there were 16,820,191 shares of common stock, par value $.001 per share, of Genitope Corporation outstanding.


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
ITEM I. FINANCIAL STATEMENTS
CONDENSED BALANCE SHEETS
CONDENSED STATEMENTS OF OPERATIONS
CONDENSED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED FINANCIAL STATEMENTS
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 4. CONTROLS AND PROCEDURES
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
ITEM 5. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
SIGNATURES
EXHIBIT INDEX
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1


Table of Contents

GENITOPE CORPORATION

FORM 10-Q
QUARTER ENDED SEPTEMBER 30, 2003

TABLE OF CONTENTS

           
PART I. FINANCIAL INFORMATION     3
Item 1.   Condensed Financial Statements (unaudited)     3
    Condensed Balance Sheets as of December 31, 2002 and September 30, 2003     3
    Condensed Statements of Operations for the Three and Nine Month Periods Ended September 30, 2002 and September 30, 2003     4
    Condensed Statements of Cash Flows for the Nine Month Periods Ended September 30, 2002 and September 30, 2003     5
    Notes to Condensed Financial Statements     6
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations     10
Item 3.   Quantitative and Qualitative Disclosure About Market Risk     26
Item 4.   Controls and Procedures     26
PART II. OTHER INFORMATION     27
Item 1.   Legal Proceedings     27
Item 2.   Changes in Securities and Use of Proceeds     27
Item 3.   Defaults upon Senior Securities     28
Item 4.   Submission of Matters to a Vote of Security Holders     28
Item 5.   Other Information     29
Item 6.   Exhibits and Reports on Form 8-K     29
SIGNATURES     30

     The terms “Genitope,” “we,” “us” and “our” as used in this report refer to Genitope Corporation.

     Genitope, Hi-GET, our logo and MyVax are our trademarks. In addition to Hi-GET, we have applied to register Genitope, MyVax and our logo with the United States Patent and Trademark Office. Other service marks, trademarks and trade names referred to in this report, such as Rituxan are the property of their respective owners.

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PART I. FINANCIAL INFORMATION

ITEM I. FINANCIAL STATEMENTS

GENITOPE CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED BALANCE SHEETS
(in thousands, except share and per share data)
(unaudited)

                       
          December 31,   September 30,
          2002   2003
         
 
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 9,422     $ 9,222  
 
Deferred costs on lines of credit
          1,295  
 
Prepaid expenses and other current assets
    54       55  
 
 
   
     
 
   
Total current assets
    9,476       10,572  
Property and equipment, net
    2,279       2,027  
Deferred initial public offering costs
          631  
Other assets
    231       266  
 
 
   
     
 
   
Total assets
  $ 11,986     $ 13,496  
 
 
   
     
 
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND
               
 
STOCKHOLDERS’ DEFICIT
               
Current liabilities:
               
 
Accounts payable
  $ 1,116     $ 1,939  
 
Accrued and other current liabilities
    431       977  
 
Borrowings under lines of credit
          8,000  
 
 
   
     
 
   
Total current liabilities
    1,547       10,916  
 
 
   
     
 
   
Total liabilities
    1,547       10,916  
 
 
   
     
 
Convertible preferred stock; $0.001 par value:
               
 
Authorized: 26,608,974 shares at December 31, 2002 and 57,921,079 shares at September 30, 2003; Issued and outstanding: 6,810,396 shares at December 31, 2002 and 31,858,224 shares at September 30, 2003
    46,853       53,436  
 
 
   
     
 
Stockholders’ deficit:
               
 
Common stock; $0.001 par value:
               
 
Authorized: 34,500,000 shares at December 31, 2002 and 66,600,000 shares at September 30, 2003; Issued and outstanding: 1,912,821 shares at December 31,2002 and 2,004,027 shares at September 30, 2003
    2       2  
 
Notes receivable from stockholders
    (60 )     (60 )
 
Deferred stock compensation
    (1,072 )     (3,480 )
 
Additional paid-in capital
    3,609       32,145  
 
Deficit accumulated during the development stage
    (38,893 )     (79,463 )
 
 
   
     
 
   
Total stockholders’ deficit
    (36,414 )     (50,856 )
 
 
   
     
 
     
Total liabilities, convertible preferred stock and stockholders’ deficit
  $ 11,986     $ 13,496  
 
 
   
     
 

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Table of Contents

GENITOPE CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)

                                             
                                        Cumulative
                                        Period from
                                        August 15, 1996
        Three Months Ended   Nine Months Ended   (date of inception)
        September 30,   September 30,   to September 30,
       
 
 
        2002   2003   2002   2003   2003
       
 
 
 
 
Operating expenses:
                                       
 
Research and development
  $ 4,245     $ 5,108     $ 11,749     $ 14,124     $ 46,580  
 
Sales and marketing
    349       351       986       989       2,327  
 
General and administrative
    584       850       2,215       2,071       8,723  
 
 
   
     
     
     
     
 
   
Total operating expenses
    5,178       6,309       14,950       17,184       57,630  
 
 
   
     
     
     
     
 
Loss from operations
    (5,178 )     (6,309 )     (14,950 )     (17,184 )     (57,630 )
 
Loss on extinguishment of convertible notes and cancellation of Series E convertible preferred stock warrants
          (3,509 )           (3,509 )     (3,509 )
Interest expense
          (695 )           (1,530 )     (1,663 )
Interest and other income, net
    68       18       168       60       1,746  
 
 
   
     
     
     
     
 
Net loss
    (5,110 )     (10,495 )     (14,782 )     (22,163 )     (61,056 )
Dividend related to issuance of convertible preferred shares and the beneficial conversion feature of preferred stock
                      (18,407 )     (18,407 )
 
 
   
     
     
     
     
 
Net loss attributable to common stockholders
  $ (5,110 )   $ (10,495 )   $ (14,782 )   $ (40,570 )   $ (79,463 )
 
 
   
     
     
     
     
 
Net loss per share attributable to common stockholders, basic and diluted
  $ (2.96 )   $ (5.62 )   $ (8.70 )   $ (22.27 )        
 
 
   
     
     
     
       
Shares used in computing net loss per share attributable to common stockholders, basic and diluted
    1,726       1,866       1,699       1,822          
 
 
   
     
     
     
       

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

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GENITOPE CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)

                                 
                            Cumulative
                            Period from
                            August 15, 1996
            Nine Months Ended   (date of inception)
            September 30,   to September 30,
           
 
            2002   2003   2003
           
 
 
Cash flows from operating activities:
                       
 
Net loss
  $ (14,782 )   $ (22,163 )   $ (61,056 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
                       
     
Depreciation and amortization
    1,503       534       3,473  
     
Loss on disposal of assets
    24       5       29  
     
Stock-based compensation expense
    1,029       1,339       3,162  
     
Loss on extinguishment of convertible notes and cancellation of convertible preferred stock warrants
          3,509       3,509  
     
Amortization of warrant issued to guarantor of the lines of credit
          638       638  
     
Interest expense on convertible notes
          892       892  
     
Common stock issued for services
          29       45  
     
Changes in assets and liabilities:
                       
       
Prepaids and other assets
    83       (36 )     (154 )
       
Accounts payable
    146       823       1,939  
       
Accrued and other current liabilities
    (123 )     546       977  
       
Other long term liabilities
    (38 )            
 
   
     
     
 
       
Net cash used in operating activities
    (12,158 )     (13,884 )     (46,546 )
 
   
     
     
 
Cash flows from investing activities:
                       
   
Purchase of property and equipment
    (370 )     (287 )     (5,529 )
   
Long term cash deposits
                (167 )
 
   
     
     
 
       
Net cash used in investing activities
    (370 )     (287 )     (5,696 )
 
   
     
     
 
Cash flows from financing activities:
                       
 
Proceeds from issuance of convertible preferred stock, net of issuance costs
    20,690       2,182       47,393  
 
Borrowings under lines of credit
          8,000       8,786  
 
Proceeds from issuance of convertible notes and warrants
          4,280       6,060  
 
Deferred initial public offering costs
          (631 )     (631 )
 
Repayment of borrowings under lines of credit
                (786 )
 
Proceeds from issuance of common stock
    190       158       630  
 
Repurchase of unvested common stock
    (11 )     (18 )     (32 )
 
Proceeds from note receivable from stockholder
                44  
 
   
     
     
 
       
Net cash provided by financing activities
    20,869       13,971       61,464  
 
   
     
     
 
Net increase (decrease) in cash and cash equivalents
    8,341       (200 )     9,222  
Cash and cash equivalents, beginning of period
    6,080       9,422        
 
   
     
     
 
Cash and cash equivalents, end of period
  $ 14,421     $ 9,222     $ 9,222  
 
   
     
     
 
Supplemental schedule of noncash investing and financing activities:
                       
 
Conversion of notes payable to convertible preferred stock
  $     $     $ 1,780  
 
Convertible preferred stock issued in exchange for note receivable from stockholder
  $     $     $ 5  
 
Warrants issued in connection with services related to convertible preferred stock
  $     $     $ 144  
 
Dividend related to issuance of convertible preferred shares and the beneficial conversion feature of preferred stock
  $     $ 18,407     $ 18,407  
 
Discount on convertible notes payable relating to warrants and beneficial conversion feature of preferred stock
  $     $ 4,280     $ 4,280  
 
Conversion of convertible notes into convertible preferred stock
  $     $ (4,280 )   $ (4,280 )
 
Warrants issued to guarantor of the lines of credit
  $     $ 1,933     $ 1,933  
 
Accrued interest converted in convertible preferred stock
  $     $ 121     $ 121  

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

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GENITOPE CORPORATION
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO CONDENSED FINANCIAL STATEMENTS

NOTE 1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

The Company

     Genitope Corporation (the “Company”) is a development stage enterprise focused on the research and development of novel immunotherapies for the treatment of cancer. Immunotherapies are treatments that utilize the immune system to combat diseases. The Company’s lead product candidate, MyVax personalized immunotherapy, is a patient-specific active immunotherapy that is based on the unique genetic makeup of a patient’s tumor and is designed to activate a patient’s immune system to identify and attack cancer cells. MyVax is currently in a pivotal Phase 3 clinical trial and additional Phase 2 clinical trials for the treatment of B-cell non-Hodgkin’s lymphoma. The Company was incorporated in the State of Delaware on August 15, 1996 and has incurred significant losses since its inception.

Basis of Presentation

     The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for the fair presentation of the financial statements, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period. Further, the preparation of condensed financial statements requires management to make estimates and assumptions that affect the recorded amounts reported therein. A change in facts or circumstances surrounding the estimate could result in a change to estimates and impact future operating results.

     The financial statements and related disclosures have been prepared with the presumption that users of the interim financial statements have read or have access to the audited financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s Amendment No. 4 of the registration statement on Form S-1, declared effective by the Securities and Exchange Commission on October 29, 2003.

Liquidity

     To date, the Company has not generated any revenues, and except for the recently completed initial public offering, the Company has financed its operations and internal growth almost exclusively through private placements of common and preferred stock. The Company is a development stage enterprise and has incurred significant operating losses and operating cash flow deficiencies since its inception in 1996 as the Company has devoted substantially all of its efforts to research and development activities, including clinical trials. The Company incurred a net loss attributable to common stockholders of $19,864,000 and negative operating cash flow of $16,583,000 for the year ended December 31, 2002. For the nine months ended September 30, 2003, the Company incurred a net loss attributable to common stockholders of $40,570,000 and negative operating cash flow of $13,884,000. As of September 30, 2003, the Company had an accumulated deficit of $79,463,000.

     The Company anticipates working on a number of long-term development projects which will involve experimental and unproven technology. The projects may require many years and substantial expenditures to complete and may ultimately be unsuccessful. The Company will need operating funds to continue its research and development activities, clinical trials, pursue regulatory approvals and build production, sales and marketing capabilities, as necessary.

     Since 1996, the Company has been successful in completing several rounds of private equity financing. In 2002, the sale of Series E convertible preferred stock (“Series E”) generated $20,702,000 of cash proceeds. In April and May of 2003, the Company raised $6,551,000 through the sale of additional Series E, convertible notes (which converted into Series E during the quarter ended September 30, 2003) and warrants.

     On October 29, 2003, the Company’s registration statement filed with the Securities and Exchange Commission for an initial public offering became effective. The Company’s common stock commenced trading on the NASDAQ National Market on October 30, 2003 under the trading symbol “GTOP”. The Company sold 4,179,860 shares of common stock in the offering, including shares that were issued upon the partial exercise by the underwriters of their over-allotment option, at $9.00 per share, for aggregate gross

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proceeds of $37,619,000. After deducting the underwriters’ commission and offering expenses, the Company received net proceeds of $33,735,000. Upon the closing of the initial public offering, all of the outstanding convertible preferred stock automatically converted into approximately 10,592,000 shares of common stock. Management believes that the net proceeds from the recently completed initial public offering, together with the interest thereon, will be sufficient to meet the Company’s projected operating requirements for the next 18 months.

Stock split

     On October 24, 2003, the Company effected a one for three reverse stock split. All share and per share amounts for all periods presented in the accompanying financial statements have been retroactively adjusted to give effect to the reverse stock split.

Stock-based compensation

     The Company accounts for stock-based employee compensation arrangements in accordance with provisions of Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB No. 25”) and complies with the disclosure provisions of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS No. 123”), as amended by SFAS No. 148, “Accounting for Stock-Based Compensation, Transition and Disclosure.” Under APB No. 25, unearned stock compensation is based on the difference, if any, on the date of grant, between the fair value of the Company’s common stock and the exercise price.

     In July and August 2003, the Company granted options to purchase a total of 554,000 shares of common stock to certain employees at a weighted average exercise price of $2.56 per share. As a result, the Company will recognize $3,564,000 in deferred compensation expense that will be amortized to expense over the vesting period, which is four years.

     All stock compensation is amortized and expensed in accordance with Financial Accounting Standards Board (“FASB”) Interpretation No. 28, an accelerated vesting model. Amortization of stock-based compensation for employees and non-employees is as follows:

                                   
      Three Months Ended   Nine Months Ended
      September 30,   September 30,
     
 
      2002   2003   2002   2003
     
 
 
 
Amortization of stock-based compensation: