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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)

þ    QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2005

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 0-19635

GENTA INCORPORATED
(Exact name of Registrant as specified in its charter)

Delaware   33-0326866
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification Number)
     
Two Connell Drive
Berkeley Heights, NJ
  07922
(Address of principal executive offices)   (Zip Code)

(908) 286-9800
(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 þ No o

     Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).

Yes þ No o

As of April 29, 2005, the registrant had 95,358,215 shares of common stock outstanding.



 

Genta Incorporated
INDEX TO FORM 10-Q

PART I. FINANCIAL INFORMATION          
       
Item 1. Financial Statements:    
       
      Consolidated Balance Sheets at March 31, 2005    
         and December 31, 2004       3  
       
      Consolidated Statements of Operations for the    
         Three Months Ended March 31, 2005 and 2004       4  
       
      Consolidated Statements of Cash Flows for the    
         Three Months Ended March 31, 2005 and 2004       5  
             
      Notes to Consolidated Financial Statements       6  
       
Item 2. Management’s Discussion and Analysis of Financial Condition    
  and Results of Operations       14  
             
Item 3. Quantitative and Qualitative Disclosures about Market Risk       20  
             
Item 4.  Controls and Procedures       20  
       
PART II.  OTHER INFORMATION    
             
Item 1.  Legal Proceedings       22  
             
Item 6.  Exhibits       22  
             
SIGNATURES       24  
             
CERTIFICATIONS       26  

2


 

Table of Contents

PART I. FINANCIAL INFORMATION
   
Item 1. Financial Statements:
   
      Consolidated Balance Sheets at March 31, 2005
         and December 31, 2004
   
      Consolidated Statements of Operations for the
         Three Months Ended March 31, 2005 and 2004
   
      Consolidated Statements of Cash Flows for the
         Three Months Ended March 31, 2005 and 2004
   
      Notes to Consolidated 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 6.  Exhibits
   
SIGNATURES
   
CERTIFICATIONS
 
31.1 Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2 Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1 Certification by Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2 Certification by Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 


 

GENTA INCORPORATED
CONSOLIDATED BALANCE SHEETS

(In thousands, except par value data)            
ASSETS     March 31,
2005
  December 31,
2004
 
     
 
 
      (Unaudited)        
Current assets:                
   Cash and cash equivalents     $ 15,522   $ 36,489  
   Marketable securities (Note 3)       15,693     5,758  
   Inventory (Note 4)       339     354  
   Prepaid expenses and other current assets       1,326     1,910  
     
 
 
Total current assets       32,880     44,511  
Property and equipment, net (Note 5)       2,335     2,847  
Intangibles, net (Note 6)       142     286  
Prepaid royalties       1,268     1,268  
Other assets       1,626     1,620  
     
 
 
Total assets     $ 38,251   $ 50,532  
     
 
 
     
LIABILITIES AND STOCKHOLDERS’ EQUITY    
     
Current liabilities:    
   Accounts payable and accrued expenses     $ 10,277   $ 14,424  
   Deferred revenues, current portion       7,790     26,228  
   Notes payable       289     816  
   Short term debt (Note 7)       4,114     7,312  
     
 
 
Total current liabilities and total liabilities       22,470     48,780  
     
 
 
Commitments and contingencies (Note 11)    
     
Stockholders’ equity:    
   Series A convertible preferred stock, $.001 par value;                
        5,000 shares authorized, 10 shares issued and outstanding,                
       liquidation value of $485 at March 31, 2005 and December 31, 2004            
   Common stock, $.001 par value; 150,000 shares authorized,    
       95,358 shares issued and outstanding at March 31, 2005    
       and December 31, 2004       95     95  
   Additional paid-in capital       357,714     357,714  
   Accumulated deficit       (341,959 )   (355,984 )
   Deferred compensation       (30 )   (41 )
   Accumulated other comprehensive loss       (39 )   (32 )
     
 
 
Total stockholders’ equity       15,781     1,752  
     
 
 
Total liabilities and stockholders’ equity     $ 38,251   $ 50,532  
     
 
 

See accompanying notes to consolidated financial statements.

3


 

GENTA INCORPORATED
CONSOLIDATED STATEMENTS OF OPERATIONS

      Three Months Ended March 31,  
(In thousands, except per share data)     2005   2004  
     
 
 
      (Unaudited)  
Revenues:                
   License fees and royalties     $ 3,684   $ 261  
   Development funding       14,754     1,049  
   Product sales - net       76     372  
     
 
 
Total revenues       18,514     1,682  
                 
Cost of goods sold       15     93  
     
 
 
Gross margin       18,499     1,589  
     
Costs and expenses:    
   Research and development (including non-cash compensation expense    
        related to certain stock options issued in 1999 and 2000 of $52    
         for the three months ended March 31, 2004)       3,870     12,353  
     
   Selling, general and administrative (including non-cash compensation    
        expense related to certain stock options issued in 1999 and 2000    
        of $11 and $18 for the three months ended March 31, 2005    
        and March 31, 2004, respectively)       3,986     9,224  
     
 
 
Total costs and expenses - gross       7,856     21,577  
   Aventis reimbursement       (3,252 )   (7,433 )
     
 
 
Total costs and expenses - net       4,604     14,144  
                 
Other income       130     23  
     
 
 
Net income/(loss)       14,025     (12,532 )
     
 
 
                 
Net income/(loss) per basic and diluted share (Note 9)     $ 0.15   $ (0.16 )
     
 
 
Shares used in computing net income/(loss) per    
  basic and diluted share       95,358     76,859  
     
 
 

See accompanying notes to consolidated financial statements.

4


 

GENTA INCORPORATED
CONSOLIDATED STATEMENTS OF CASH FLOWS

      Three Months Ended March 31,  
(In thousands)     2005   2004  
     
 
 
      (Unaudited)  
Operating activities:                
Net income/(loss)     $ 14,025   $ (12,532 )
Items reflected in net income/(loss) not requiring cash:    
    Depreciation and amortization       663     787  
    Non-cash reimbursement of research & development expense (Note 7)       (3,252 )    
    Amortization of deferred revenues       (18,438 )   (1,309 )
    Compensation expense related to certain stock options issued in 1999 and 2000       11     70  
Changes in operating assets and liabilities:    
         Accounts receivable           7,730  
         Inventory (Note 4)       15     (6,178 )
         Notes receivable           (845 )
         Prepaid expenses and other current assets       584     1,099  
         Accounts payable and accrued expenses       (4,093 )   (3,114 )
         Other assets       (6 )    
     
 
 
Net cash used in operating activities       (10,491 )   (14,292 )
     
 
 
Investing activities:    
    Purchase of marketable securities (Note 3)       (9,942 )   (7,281 )
    Maturities and sales of marketable securities (Note 3)           33,735  
    Purchase of property and equipment       (7 )   (1,409 )
     
 
 
Net cash (used in)/provided by investing activities       (9,949 )   25,045  
     
 
 
Financing activities:    
    Repayments of note payable       (527 )    
    Deferred financing costs           (33 )
    Issuance of common stock upon exercise of warrants and options           276  
     
 
 
Net cash (used in)/provided by financing activities       (527 )   243  
     
 
 
Decrease/(increase) in cash and cash equivalents       (20,967 )   10,996  
Cash and cash equivalents at beginning of period       36,489     25,153  
     
 
 
Cash and cash equivalents at end of period     $ 15,522   $ 36,149  
     
 
 

See accompanying notes to consolidated financial statements

5


 

GENTA INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2005
(Unaudited)

1.   Organization and Business

     Genta Incorporated (“Genta” or the “Company”) is a biopharmaceutical company engaged in pharmaceutical (drug) research and development, its sole reportable segment. The Company is dedicated to the identification, development and commercialization of novel drugs for the treatment of cancer and related diseases.

     The Company has had recurring operating losses since its inception. Management expects that such losses will continue at least until its lead product, Genasense®, receives approval from the U.S. Food and Drug Administration (“FDA”) for commercial sale in one or more indications. Achievement of profitability for the Company is dependent on the timing of Genasense® regulatory approvals in the U.S. and outside the U.S.

     Genta has completed and announced the results of Phase 3 trials of Genasense in combination with chemotherapy in the treatment of malignant melanoma, chronic lymphocytic leukemia (CLL) and multiple myeloma. The Company is currently evaluating possible regulatory filings in the U.S. and/or Europe for approvals of Genasense in combination with chemotherapy for the treatment of CLL and malignant melanoma. In addition to the three Phase 3 trials, the Company is conducting (under its own sponsorship or in conjunction with various cooperative groups) randomized trials in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), acute myeloid leukemia (AML) and prostate cancer. Genta is also conducting a number of non-randomized clinical trials in patients with various types of cancer, either under its own sponsorship or in collaboration with the National Cancer Institute (NCI).

     Genta markets Ganite® (gallium nitrate injection) for the treatment of cancer-related hypercalcemia. In May 2004, the Company eliminated its sales force and significantly reduced its marketing support for Ganite®.

     A significant source of funds during the last several years has been from the Company’s collaboration with Aventis, a member of the sanofi-aventis Group (“Aventis”), regarding the development and commercialization of Genasense®. On November 8, 2004 Aventis gave six-month notice to Genta that it was terminating its collaborative agreements with the Company. Pursuant to those agreements, Aventis continued to fund ongoing development activities through the termination notice period. Although no assurances can be expressed, management believes that at the current rate of spending, the Company should have sufficient cash funds to maintain its present operations through 2005. There are a number of alternatives available to the Company to sustain its operations beyond 2005 should there be a delay in approval of Genasense®.

     The Company may also seek collaborative agreements, equity financing and other financing arrangements with potential corporate partners and other sources. However, there can be no assurance that any such collaborative agreements or other sources of funding will be available on favorable terms, if at all. The Company will need substantial additional funds before it can expect to realize significant product revenue.

6


 

2.   Summary of Significant Accounting Policies

Basis of Presentation

     The consolidated financial statements are presented on the basis of accounting principles generally accepted in the United States. All professional accounting standards have been considered in preparing the consolidated financial statements. Such financial statements include the accounts of the Company and all majority-owned subsidiaries. The preparation of financial statements in conformity with generally accepted accounting principles requires management to make certain estimates and assumptions that affect reported earnings, financial position and various disclosures. Actual results could differ from those estimates. Certain reclassifications have been made to prior-year amounts to conform to the current-year presentation. The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim financial information 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 consolidated financial statements and the related notes thereto included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2004. Results for interim periods are not necessarily indicative of results for the full year. The Company has experienced significant quarterly fluctuations in operating results and it expects those fluctuations will continue.

Revenue Recognition

     In April 2002, the Company entered into a development and commercialization agreement (“Collaborative Agreement”) with Aventis. Under the terms of the Collaborative Agreement, the Company and Aventis would jointly develop and commercialize Genasense® in the U.S., and Aventis would have exclusive development and marketing rights to the compound in all countries outside of the U.S. Under the Collaborative Agreement, Aventis would pay 75% of U.S. New Drug Application (NDA)-directed development costs incurred by either Genta or Aventis, subsequent to the execution of the Collaborative Agreement, and 100% of all other development, marketing, and sales costs incurred within the U.S. and elsewhere as subject to the Collaborative Agreement. On November 8, 2004 Aventis gave six-month notice to Genta that it was terminating its Collaborative Agreement with the Company. Under the terms of the agreement, Aventis continued to fund ongoing development activities through the termination notice period.

     The Company follows the provisions of the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition and Emerging Issues Task Force (EITF) No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables.

     In accordance with EITF No. 00-21 the Company analyzes its multiple element arrangements to determine whether the elements can be separated and accounted for individually as separate units of accounting. The Company recognizes license payments as revenue if the license has stand-alone value and the fair value of the undelivered items can be determined. If the license is considered to have stand-alone value but the fair value on any of the undelivered items cannot be determined, the license payments are recognized as revenue over the period of performance for such undelivered items or services. The Company’s estimate of the period of performance involves management judgment. Amounts received for milestones are recognized upon achievement of the milestone, as long as the milestone is deemed to be substantive and the Company has no other performance obligations.

     The Company determined that, due to the nature of the ongoing development work related to its Collaborative Agreement with Aventis, the end of the development phase and the fair value of the undelivered elements were not determinable. Accordingly, the Company deferred recognition of the initial licensing fee and up-front development funding received from Aventis and recognized these payments on a straight-line basis over the original estimated useful life of the related first-to-expire patent of 115 months. As a result of the notice of termination of the agreement with Aventis, the Company determined that the period over which the remaining deferred revenue should be recognized will be through May 8, 2005. In accordance with EITF No. 00-21 and SAB No. 104, the Company has reclassified the remaining deferred revenue as current and will recognize such revenue through May 8, 2005.

7


 

     Genta recognizes revenue from product sales when title to product and associated risk of loss has passed to the customer and the Company is reasonably assured of collecting payment for the sale. All revenue from product sales are recorded net of applicable allowances for returns, rebates and other applicable discounts and allowances. The Company allows return of its product for up to twelve months after product expiration. In December 2004, a wholesaler contacted the Company to return a significant portion of its inventory of Ganite®. The Company agreed to the return of this product and recorded a provision for sales returns, as well as provided for potential returns from other wholesalers. In January 2005, the wholesaler returned $0.5 million of Ganite®. At March 31, 2005, the Company’s provision for sales returns was $0.8 million.

Research and Development

     Research and development costs are expensed as incurred, including raw material costs required to manufacture products for clinical trials. Reimbursements for applicable Genasense®-related costs, under the Collaborative Agreement, have been recorded as a reduction to expenses in the Consolidated Statement of Operations.

Cash, Cash Equivalents and Marketable Securities

     The carrying amounts of cash, cash equivalents and marketable securities approximate fair value due to the short-term nature of these instruments. Marketable securities primarily consist of government securities, all of which are classified as available-for-sale marketable securities. Management determines the appropriate classification of securities at the time of purchase and reassesses the classification at each reporting date.

Property and Equipment

     Property and equipment is stated at cost and depreciated on the straight-line method over the estimated useful lives of the assets, ranging from three to five years. Leasehold improvements incurred in the renovation of the Company’s current offices are being amortized over the remaining life of the leases. The Company’s policy is to evaluate the appropriateness of the carrying value of the undepreciated value of long-lived assets. If such evaluation were to indicate an impairment of assets, such impairment would be recognized by a write-down of the applicable assets. Based on the valuation, no impairment was indicated in accordance with Statement of Financial Accounting Standards