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

FORM 10-Q

(Mark One)

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

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 000-23143

PROGENICS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

DELAWARE   13-3379479  
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)
 

777 Old Saw Mill River Road
Tarrytown, New York 10591
(Address of principal executive offices)
(Zip Code)

(914) 789-2800
(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   No 

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

As of November 12, 2003 there were 13,258,747 shares of common stock, par value $.0013 per share, of the registrant outstanding.

 


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PROGENICS PHARMACEUTICALS, INC.

INDEX

                                                                                                                             

      Page No.
     
PART I – FINANCIAL INFORMATION    
Item 1. Financial Statements (unaudited)    
  Condensed Balance Sheets at September 30, 2003 and December 31, 2002 3
  Condensed Statements of Operations for the Three Months ended September 30, 2003 and 2002 and the Nine Months ended September 30, 2003 and 2002 4
  Condensed Statement of Stockholders’ Equity and Comprehensive Loss for the Nine Months ended September 30, 2003 5
  Condensed Statements of Cash Flows for the Nine Months ended September 30, 2003 and 2002 6
  Notes to Condensed Financial Statements 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 13
Item 3. Quantitative and Qualitative Disclosures about Market Risk 27
Item 4. Controls and Procedures 27
     
PART II – OTHER INFORMATION    
Items 5. Other Information 28
Item 6. Exhibits and Reports on Form 8-K 28

 


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PROGENICS PHARMACEUTICALS, INC
CONDENSED BALANCE SHEETS
AT SEPTEMBER 30, 2003 AND DECEMBER 31, 2002
(Unaudited)

     September 30,
2003
  December 31,
2002
 
   

 

 
ASSETS:              
Current assets:              
Cash and cash equivalents
  $      11,549,215   $      9,446,982  
Marketable securities
    9,811,883     27,753,984  
Accounts receivable
    203,048     334,006  
Other current assets
    938,342     1,573,815  
   

 

 
Total current assets
    22,502,488     39,108,787  
Marketable securities
    1,090,000     5,172,808  
Fixed assets, at cost, net of accumulated
depreciation and amortization
    3,675,030     3,705,531  
Investment in joint venture
    362,402        
Deferred stock offering costs
    475,000        
Restricted cash
    530,686     130,795  
   

 

 
Total assets
  $      28,635,606   $      48,117,921  
   

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY:              
Current Liabilities:            
Accounts payable and accrued liabilities
  $ 2,646,732   $ 2,892,901  
Investment deficiency in joint venture
          7,127  
   

 

 
Total current liabilities
    2,646,732     2,900,028  
   

 

 
               
Deferred lease liability     49,885     71,264  
   

 

 
Total liabilities
    2,696,617     2,971,292  
   

 

 
Commitments and contingencies              
Stockholders’ equity:              
Preferred stock, $.001 par value, 20,000,000
authorized; none issued and outstanding
             
               
Common stock – $.0013 par value, 40,000,000 shares
authorized; issued and outstanding – 13,178,518
in 2003 and 12,681,585 in 2002
    17,132     16,486  
Additional paid-in capital
    93,479,230     91,332,106  
Accumulated deficit
    (67,575,735 )   (46,307,642 )
Accumulated other comprehensive income
    18,362     105,679  
   

 

 
Total stockholders’ equity
    25,938,989     45,146,629  
   

 

 
Total liabilities and stockholders’ equity
  $      28,635,606   $      48,117,921  
   

 

 

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

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PROGENICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

    For the three months ended
September 30,
  For the nine months ended
September 30,
 
   




 




 
    2003   2002   2003   2003  
 

 

 

 

 
Revenues:                          
Contract research and development from joint venture   $ 828,375   $ 1,817,042   $ 2,730,988   $ 3,901,298  
Other contract research and development                       193,734  
Research grants     1,065,249     916,029     3,230,782     3,642,650  
Product sales     10,055     8,921     96,946     28,260  
   

 

 

 

 
Total revenues
    1,903,679     2,741,992     6,058,716     7,765,942  
   

 

 

 

 
Expenses:                          
Research and development     6,197,426     6,656,787     18,169,356     17,089,313  
General and administrative     2,095,259     1,598,831     6,022,708     4,608,020  
Loss in joint venture     714,871     999,932     2,680,471     2,108,357  
Depreciation and amortization     342,051     288,898     955,526     738,196  
   

 

 

 

 
Total expenses
    9,349,607     9,544,448     27,828,061     24,543,886  
   

 

 

 

 
Operating loss
    (7,445,928 )   (6,802,456 )   (21,769,345 )   (16,777,944 )
                           
Other income (expense):                          
Interest income     123,581     390,162     505,772     1,409,509  
Interest expense                 (4,520 )      
Payment from insurance settlement                       1,600,000  
   

 

 

 

 
Total other income
    123,581     390,162     501,252     3,009,509  
   

 

 

 

 
Net loss
  $ (7,322,347 ) $ (6,412,294 ) $ (21,268,093 ) $ (13,768,435 )
   

 

 

 

 
Net loss per share – basic and diluted   $ (0.56 ) $ (0.51 ) $ (1.65 ) $ (1.10 )
   

 

 

 

 

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

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PROGENICS PHARMACEUTICALS, INC.
CONDENSED STATEMENT OF STOCKHOLDERS’ EQUITY AND COMPREHENSIVE LOSS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2003 (Unaudited)

    COMMON STOCK  
ADDITIONAL
PAID-IN
CAPITAL
  ACCUMULATED
DEFICIT
  ACCUMULATED
OTHER COMPREHENSIVE
INCOME
  TOTAL
STOCKHOLDERS’
EQUITY
  COMPREHENSIVE
LOSS
 
   



    SHARES     AMOUNT
   
 

 

 

 

 

 

 
Balance at December 31, 2002   12,681,585   $ 16,486   $ 91,332,106   $ (46,307,642 ) $ 105,679   $ 45,146,629      
Issuance of compensatory stock options
              186,715                 186,715      
                                         
Sale of Common Stock under employee stock purchase plans and exercise of stock options
  496,933     646     1,960,409                 1,961,055      
Net loss                     (21,268,093 )         (21,268,093 ) $ (21,268,093 )
Change in unrealized gain on marketable securities
                          (87,317 )   (87,317 )   (87,317 )
   


















Balance at September 30, 2003   13,178,518   $ 17,132   $ 93,479,230   $ (67,575,735 ) $ 18,362   $ 25,938,989   $ (21,355,410 )
   


















                                         
                                         

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

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PROGENICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

    Nine months ended September 30,  


      2003     2002  




Cash flows from operating activities:              
Net loss
  $      (21,268,093 ) $      (13,768,435 )
   

 

 
Adjustments to reconcile net loss to net cash used in
operating activities:
             
Depreciation and amortization
    955,526     738,196  
Amortization of discounts, net of premiums, on
marketable securities
    515,287     927,184  
Loss in joint venture
    2,680,471     2,108,357  
Noncash expenses incurred in connection with issuance of
common stock and stock options
    186,715     255,729  
Changes in assets and liabilities:
             
Decrease in accounts receivable
    130,958     136,346  
Decrease in other current assets
    635,473     60,648  
Decrease in accounts payable and accrued expenses
    (468,362 )   (1,425,172 )
Increase in investment in joint venture
    (3,050,000 )   (2,300,000 )
(Decrease) increase in deferred lease liability
    (21,379 )   24,350  
   

 

 
Total adjustments
    1,564,689     525,638  
   

 

 
Net cash used in operating activities
    (19,703,404 )   (13,242,797 )
   

 

 
Cash flows from investing activities:              
Capital expenditures
    (925,025 )   (1,175,415 )
Purchase of certificate of deposit
          (1,750,000 )
Increase in restricted cash
    (399,891 )   (121,284 )
Sale of marketable securities
    24,374,000     22,095,000  
Purchase of marketable securities
    (2,951,695 )   (10,510,586 )
   

 

 
Net cash provided by investing activities     20,097,389     8,537,715  
   

 

 
Cash flows from financing activities:              
Proceeds from the sale of common stock under employee stock
purchase plans and the exercise of stock options
     1,961,055      1,116,242  
Increase in deferred offering costs
    (252,807 )      
   

 

 
Net cash provided by financing activities     1,708,248     1,116,242  
   

 

 
Net increase (decrease) in cash and cash equivalents     2,102,233     (3,588,840 )
   

 

 
Cash and cash equivalents at beginning of period     9,446,982     10,759,636  
   

 

 
Cash and cash equivalents at end of period   $      11,549,215   $      7,170,796  
   

 

 
Supplemental disclosure of noncash investing and financing activities:              
Fixed assets included in accounts payable and accrued expenses
        $      650,896  
Deferred stock offering costs in accrued expenses
  $      222,193        

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

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PROGENICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

1. Interim Financial Statements

Progenics Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. The Company applies its expertise in clinical medicine, immunology and molecular biology to develop biopharmaceuticals to fight viral diseases, such as human immunodeficiency virus (HIV) infection, and cancers, including malignant melanoma and prostate cancer, as well as to enhance symptom management and supportive care. The Company was incorporated in Delaware on December 1, 1986. All of the Company’s operations are located in New York. The Company operates in a single segment.

The Company believes that its existing capital resources together with revenue from currently approved government grants and contracts and revenue from its services agreement with PSMA Development Company LLC should be sufficient to fund operations for at least the next 12 months. There could be changes that would consume the Company’s assets before such time. The Company will require substantial funds to conduct research and development activities, preclinical studies, clinical trials and other related general and administrative activities. In addition, the Company’s cash requirements may vary materially from those now planned because of results of research and development and product testing, changes in existing relationships with, or new relationships with, licensees, licensors or other collaborators, changes in the focus and direction of the Company’s research and development programs, competitive and technological advances, the cost of filing, prosecuting, defending and enforcing patent claims, the regulatory approval process, manufacturing and marketing and other costs associated with the commercialization of products following receipt of regulatory approvals and other factors. Other than currently approved grants and research contracts, the Company has no committed external sources of capital and expects no significant product revenues for a number of years as it will take at least that much time, if ever, to bring the Company’s products to the commercial marketing stage. During the third quarter ended September 30, 2003, the Company filed with the U.S. Securities and Exchange Commission a Registration Statement for the public offering of common stock from time to time. See footnote 13. To fund operations beyond 12 months, the Company may sell its common stock pursuant to this Registration Statement and may seek additional financing, such as through other offerings of equity or debt securities or agreements with corporate partners and collaborators with respect to the development of its technology. There can be no assurance, however, that the Company will be able to obtain additional funds on acceptable terms, if at all.

The interim Condensed Financial Statements of the Company included in this report have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles. In the opinion of management, these financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for such periods. The results of operations for interim periods are not necessarily indicative of the results for the full year. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002, as amended.

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PROGENICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (cont.)

2. Stock-Based Employee Compensation

The accompanying financial position and results of operations of the Company have been prepared in accordance with APB Opinion No. 25, “Accounting for Stock Issued to Employees” (APB No. 25). Under APB No. 25, compensation expense is generally not recognized in connection with the awarding of stock option grants to employees, provided that, as of the grant date, all terms associated with the award are fixed and the quoted market price of the Company’s stock as of the grant date is equal to or less than the option exercise price.

In accordance with Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (SFAS No. 123), as amended by Statement of Financial Accounting Standards No. 148, “Accounting for Stock-Based Compensation Transition and Disclosure, an amendment of SFAS 123” (SFAS No. 148), pro forma operating results have been determined as if the Company had prepared its financial statements in accordance with the fair value-based method of accounting. The following table illustrates the effect on net loss and net loss per share as if the Company had applied the fair value-based method of accounting to compute compensation expense for all stock based awards. Since option grants awarded during 2003 and 2002 vest over several years and additional awards are expected to be issued in the future, the pro forma results shown below are not likely to be representative of the effects on future years of the application of the fair value-based method.

    Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
   










 
      2003     2002     2003     2002  
                           
Net loss, as reported   $ (7,322,347 ) $ (6,412,294 ) $ (21,268,093 ) $ (13,768,435 )
Add:   Stock-based employee compensation
          expense included in reported net loss
    69,863           69,863        
Deduct:   Total stock-based employee
                compensation expense
                determined under fair value-
                based method for all awards
    (4,273,700 )   (2,116,376 )   (8,447,406 )   (5,320,353 )
   










 
Pro forma net loss   $ (11,526,184 ) $ (8,528,670 ) $ (29,645,636 ) $ (19,088,788 )
   










 
Net loss per share amounts, basic and diluted:                          
As reported
  $ (0.56 ) $ (0.51 ) $ (1.65 ) $ (1.10 )
Pro forma
  $ (0.88 ) $ (0.68 ) $ (2.30 ) $ (1.52 )

For the purpose of the above pro forma calculation, the fair value of each option granted was estimated on the date of grant using the Black-Scholes option pricing model. The following assumptions were used in computing the fair value of options granted:  expected volatility of 75% in 2003 and 2002, expected lives of five years (six months for the employee stock purchase plan), zero dividend yield, and weighted-average risk-free interest rate of 2.48% in 2003, and 3.99% in 2002.

The fair value of options and warrants granted to non-employees for goods or services is expensed as the goods are utilized or the services performed.

In July 2003, the Company’s Chief Executive Officer was granted 225,000 non-qualified stock options under the Company’s 1996 Amended Stock Option Plan at an exercise price equal to the fair market value on the date of grant. Vesting of one-half of those options will occur nine years and eleven months from the date of grant unless accelerated upon the achievement of defined clinical, financial and operational performance milestones. On September 30, 2003, a performance milestone was achieved, resulting in the vesting of 33,750 options. The Company recognized compensation expense of $69,863 in connection with the vesting of those options, which represents the intrinsic value of those options on the date the performance milestone was achieved. Vesting upon the achievement of additional performance milestones could result in future compensation charges.

 

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PROGENICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS (cont.)

3. Accounts Payable and Accrued Expenses

     Accounts payable and accrued expenses as of September 30, 2003 and December 31, 2002 consist of the following:

    September 30,
2003
  December 31,
2002
 
   

 

 
Accounts payable   $ 571,158   $ 1,199,998  
Accrued consulting and clinical trial costs     1,070,430     557,113  
Accrued payroll and related costs     511,452     568,358  
Accrued professional fees     493,692     567,432  
   

 

 
    $ 2,646,732   $ 2,892,901  
   

 

 
4. Net Loss Per Share

The Company’s basic net loss per share amounts have been computed by dividing net loss by the weighted average number of common shares outstanding during the respective periods. For the three and nine months ended September 30, 2003 and 2002, the Company reported net losses and, therefore, no potentially dilutive securities were included in the computation of diluted per share amounts.

      Net Loss
(Numerator)
  Shares
(Denominator)
  Per Share
Amount
 
     

 
 

 
2003:                    
Three months ended September 30, 2003:                    
Basic and Diluted:     $ (7,322,347 ) 13,079,251   $ (0.56 )
     

 
 

 
                     
Nine months ended September 30, 2003:                    
Basic and Diluted:     $ (21,268,093 ) 12,894,258   $ (1.65 )
     

 
 

 
                     
2002:                    
Three months ended September 30, 2002:                    
Basic and Diluted:     $ (6,412,294 ) 12,572,519   $ (0.51 )
     

 
 

 
                     
Nine months ended September 30, 2002:                    
Basic and Diluted:     $ (13,768,435 ) 12,521,322   $ (1.10 )