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SECURITIES AND EXCHANGE
COMMISSION

Washington, D.C. 20549


FORM 10-Q


























(Mark One)
 


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 000-49730




DOV PHARMACEUTICAL, INC.

(Exact Name of Registrant as Specified in its Charter)















Delaware

(State or Other Jurisdiction

of Incorporation or Organization)
  22-3374365

(I.R.S. Employer

Identification No.)


Continental Plaza

433 Hackensack Avenue

Hackensack, New Jersey 07601

(Address of principal executive office)


(201) 968-0980

(Registrant's telephone number, including area code)





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

o 
No
x



On November
4, 2003,


there were outstanding 16,431,965 shares of our common stock, par
value $0.0001 per share, and 354,643 shares of series B nonvoting preferred
stock, par value $1.00 per share, which shares are convertible at any time upon
the vote of the holders of 75% or more of such shares outstanding into 574,521
shares of our common stock.



1





DOV PHARMACEUTICAL,
INC.





Form 10-Q





For the Quarter Ended
September 30, 2003





Table of Contents






















































































































 

 
   

 
  PAGE

NUMBER

PART 1 - FINANCIAL INFORMATION

 
   
Item 1.   Financial Statements (unaudited)    


Consolidated Balance Sheets as of September 30, 2003 and December 31, 2002


 


4


 


 


Consolidated Statements of Operations for the three and nine months ended
September 30, 2003 and 2002


 


5


 


 


Consolidated Statements of Cash Flows for the nine months ended September
30, 2003 and 2002


 


6


 


 


Notes to Unaudited Consolidated Financial Statements


 


7


Item 2.


 


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


 


14


Item 3.


 


Quantitative and Qualitative Disclosures About Market Risk


 


22


Item 4.


 


Controls and Procedures


 


22


PART II-OTHER INFORMATION


 


 


Item 1.


 


Legal Proceedings


 


23


Item 2.


 


Changes in Securities and Use of Proceeds


 


23


Item 4.


 


Submission of Matters to a Vote of Security Holders


 


24


Item 5.


 


Other Information


 


24


Item 6.


 


Exhibits and Reports on Form 8-K


 


32


Signatures


 


34



2





Special Note Regarding
Forward-Looking Statements




        This
Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as
amended, including statements regarding our expectations with respect to the progress of
and level of expenses for our clinical trial programs. You can also identify
forward-looking statements by the following words: may, will, should, expect, intend,
plan, anticipate, believe, estimate, predict, potential, continue or the negative of these
terms or other comparable terminology. We caution you that forward-looking statements are
inherently uncertain and are simply point-in-time estimates based on a combination of
facts and factors currently known by us about which we cannot be certain. Actual results
or events may differ and may differ materially from our forward-looking statements as a
result of many factors, some of which we will surely not be able to predict or may not be
within our control. Such factors may also materially adversely affect our ability to
achieve our objectives and to successfully develop and commercialize our product
candidates, including our ability to:















        You
should refer to the “Part II—Other Information” section of this report
under the subheading “Item 5. Other Information – Risk Factors and Factors
Affecting Forward-Looking Statements” for a detailed discussion of some of the
factors that may cause our actual results to differ materially from our forward-looking
statements. You should also refer to the risks discussed in our other filings with the
Securities and Exchange Commission, including those contained in our Annual Report on Form
10-K. We qualify all our forward-looking statements by these cautionary statements. There
may also be other factors that may materially affect our forward-looking statements and
our future results. As a result of the foregoing, readers should not place undue reliance
on our forward-looking statements. We do not undertake any obligation and do not intend to
update any forward-looking statement.



3








PART I –
FINANCIAL INFORMATION





Item I. Financial Statements





DOV PHARMACEUTICAL,
INC.
CONSOLIDATED BALANCE
SHEETS







































































































































































































































































































































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



4








DOV PHARMACEUTICAL,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS




  December 31, 2002
  September 30, 2003
 
(Unaudited)
Assets                
   Current assets:  
      Cash and cash equivalents     $ 37,859,573   $ 31,045,440  
      Accounts receivable     47,289     --  
      Marketable securities - short-term       21,446,821     32,646,368  
      Investments     1,609,961     --  
      Receivable from DOV Bermuda       3,040,379     --  
      Prepaid expenses and other current assets     710,880     1,252,308  


        Total current assets       64,714,903     64,944,116  
   Marketable securities - long-term     1,039,230     --  
   Property and equipment, net       338,500     374,525  
   Deferred charges, net     57,814     156,323  


        Total assets     $ 66,150,447   $ 65,474,964  


Liabilities and Stockholders' Equity  
   Current liabilities:  
      Accounts payable     $ 1,906,923   $ 2,474,380  
      Accrued expenses     3,839,331     1,282,576  
      Deferred revenue--current       1,979,167     --  
      Accumulated loss in excess of investment in DOV Bermuda     2,875,763     --  


        Total current liabilities       10,601,184     3,756,956  


   Deferred revenue--noncurrent     989,583     --  
   Convertible promissory note       10,506,257     11,064,271  
   Convertible line of credit promissory note     3,294,064     3,545,108  
   Commitments and contingencies    
   Stockholders' equity:  
      Preferred stock--series B, $1.00 par value, 354,643 shares  
        authorized, issued and outstanding at December 31, 2002 and  

        September 30, 2003
     354,643     354,643  

      Common stock, $.0001 par value, 60,000,000 shares authorized,
   

        14,414,038 issued and outstanding at December 31, 2002 and
   
        16,380,476 issued and outstanding at September 30, 2003       1,441     1,638  
      Additional paid-in capital     81,523,234     102,256,218  
      Accumulated other comprehensive loss       (179,091 )   (21,382 )
      Accumulated deficit     (40,665,135 )   (55,409,705 )
      Unearned compensation       (275,733 )   (72,783 )


        Total stockholders' equity     40,759,359     47,108,629  


           Total liabilities and stockholders' equity     $ 66,150,447   $ 65,474,964  










































































































































































































































































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



5








DOV PHARMACEUTICAL,
INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS




 
Three Months Ended

September 30,

 
Nine Months Ended

September 30,

 

2002

2003

2002

2003
(Unaudited) (Unaudited)
Revenue     $ 503,899   $ --   $ 1,847,553   $ 2,968,750  
Operating expenses:    
   Royalty and licensing expense       --     --     --     1,000,000  
   General and administrative expense       807,581     1,480,009     2,793,466     3,985,026  
   Research and development expense       2,628,143     5,146,689     7,229,931     12,513,114  




      Loss from operations       (2,931,825 )   (6,626,698 )   (8,175,844 )   (14,529,390 )
Loss in investment in DOV Bermuda       (150,533 )   --     (659,188 )   --  
Interest income       319,250     243,195     600,222     678,800  
Interest expense       (263,162 )   (1,015,668 )   (1,647,960 )   (2,022,185 )
Other income (expense), net       421,943     520     (388,029 )   1,128,205  




      Net loss     $ (2,604,327 ) $ (7,398,651 ) $ (10,270,799 ) $ (14,744,570 )




Basic and diluted net loss per share     $ (0.18 ) $ (0.45 ) $ (0.98 ) $ (0.97 )




Weighted average shares used in computing     basic and diluted net loss per share       14,414,038     16,322,794     10,438,737     15,165,913  

























































































































































































































































































































































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



6








DOV PHARMACEUTICAL,
INC.
NOTES TO UNAUDITED
CONSOLIDATED FINANCIAL STATEMENTS





1. The Company





Organization



        DOV Pharmaceutical, Inc. (the "Company") was incorporated in May 1995 in New Jersey and reincorporated in
Delaware in November 2000.


        The
Company is a biopharmaceutical company focused on the discovery, in-licensing, development
and commercialization of novel drug candidates for central nervous system and other
disorders, including cardiovascular and urological, that involve alterations in neuronal
processing. The Company has six product candidates in clinical trials targeting insomnia,
anxiety disorders, pain, depression and angina and hypertension. The Company has
established strategic alliances with select partners in part to access their unique
technologies and commercialization capabilities. The Company operates principally in the
United States but also conducts clinical studies in Canada and Europe.





2. Significant
Accounting Policies





Basis of Presentation




        The
financial statements are presented on the basis of accounting principles that are
generally accepted in the United States for interim financial information and in
accordance with the instructions of the Securities and Exchange Commission
(“SEC”) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not
include all the information and footnotes required by accounting principles generally
accepted in the United States for complete financial statements. In the opinion of
management, these financial statements include all adjustments (consisting of normal
recurring adjustments) necessary for a fair presentation of the financial position,
results of operations and cash flows for the periods presented.




        The
results of operations for the interim periods shown in this report are not necessarily
indicative of results expected for the full year. The financial statements should be read
in conjunction with the audited financial statements and notes for the year ended December
31, 2002, included in our Annual Report on Form 10-K filed with the SEC.




        In
January 1999, the
Company and Elan Corporation, plc (“Elan”) established a joint venture and
formed DOV (Bermuda), Ltd. formerly known as DOV Newco, Ltd. a holding
company and Bermuda exempted limited company
(“DOV Bermuda”), and Nascime Limited, an operating subsidiary
based in Ireland, to develop controlled release formulations of bicifadine and ocinaplon.
While the Company originally owned 80.1% of the outstanding capital stock of DOV Bermuda
and Elan owned 19.9%, through its wholly-owned subsidiary Elan Pharmaceutical Investments
II, Ltd., as of December 31, 2002, Elan had retained significant minority rights that were
considered “participating rights” as defined in the Emerging Issues Task Force
Consensus No. 96-16 “Investor’s Accounting for an Investee When the
Investor Has a Majority of the Voting Interest but the Minority Shareholder or
Shareholders Have Certain Approval or Veto Rights.” Accordingly, as of December 31,
2002, the Company did not consolidate the financial statements of DOV Bermuda, but instead
accounted for its investment in DOV Bermuda under the equity method of accounting. As
such, the Company recorded its 80.1% interest in the loss in DOV Bermuda as research and
development expense for the portion of the research and development expense incurred by
the Company on behalf of DOV Bermuda and as Loss in Investment in DOV Bermuda for the
Company’s 80.1% interest in the remaining loss of DOV Bermuda prior to December 31,
2002. As Elan’s rights to participate in the management of the joint venture expired
as of January 2003, the Company began to consolidate the results of DOV Bermuda as of
January 1, 2003.  If the Company had consolidated the results of DOV Bermuda as of
January 1, 2002, pro forma consolidated revenue, net loss and net loss per share for the
nine months ended September 30, 2002 would have been substantially the same, namely, $1.8
million, $10.3 million and $0.98, respectively.





Use of Estimates




        The
preparation of financial statements in conformity with generally accepted accounting
principles requires management to make certain estimates and assumptions that affect the
reported assets, liabilities, revenues, earnings, financial position and various
disclosures. Actual results could differ from those estimates.



7








  Nine Months Ended September 30,
 
2002

2003

  (Unaudited)
Cash flows from operating activities                
Net loss     $ (10,270,799 ) $ (14,744,570 )
Adjustments to reconcile net loss to net cash used in operating  
activities:  
      Loss in investment in DOV Bermuda       659,188     --  
      Decrease in non-cash litigation settlement expense     --     (42,651 )
      Net depreciation in investments and marketable securities       349,608     250,782  
      Net loss on sale of investments     --     8,839  
      Non-cash interest expense       1,647,284     2,019,879  
      Depreciation     68,565     119,977  
      Amortization of deferred charges       18,803     65,558  
      Non-cash compensation charges     594,721     257,380  
      Warrants, options and common stock issued for services       96,266     747,619  
        Changes in operating assets and liabilities:  
        Receivable from DOV Bermuda (Elan Portion)       (640,516 )   184,122  
        Accounts receivable     131,536     47,289  
        Prepaid expenses and other current assets       (555,150 )   (541,428 )
        Accounts payable     246,354     574,721  
        Accrued expenses       191,634     241,525  
        Deferred revenue     (1,744,791 )   (2,968,750 )


      Net cash used in operating activities       (9,207,297 )   (13,779,708 )


Cash flows from investing activities  
Investments in DOV Bermuda, net of cash received     (668,405 )   --  
Purchases of marketable securities       (16,141,878 )   (26,098,771 )
Sales of marketable securities     6,250,000     16,096,160  
Sales of investments       --     786,854  
Purchases of property and equipment     (169,818 )   (156,002 )


      Net cash used in investing activities       (10,730,101 )   (9,371,759 )


Cash flows from financing activities  
Net proceeds from sale of common stock       58,977,142     14,753,248  
Repayment of notes payable     (934 )   --  
Proceeds from options and warrants exercised       --     1,575,150  


      Net cash provided by financing activities     58,976,208     16,328,398  


        Net increase (decrease) in cash and cash equivalents       39,038,810     (6,823,069 )
Cash and cash equivalents, beginning of period     13,652,334     37,868,509  


Cash and cash equivalents, end of period     $ 52,691,144   $ 31,045,440