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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 June 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 000-31615

 


 

DURECT CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   94-3297098

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

10240 Bubb Road

Cupertino, California 95014

(Address of principal executive offices, including zip code)

 

(408) 777-1417

(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  ¨

 

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

 

As of July 31, 2003, there were 50,547,385 shares of the registrant’s Common Stock outstanding.


 


Table of Contents

INDEX

 

          Page

     PART I.    FINANCIAL INFORMATION     

Item 1.

   Financial Statements    3
    

Condensed Consolidated Statements of Operations

For the three and six months ended June 30, 2003 and 2002 (unaudited)

   3
    

Condensed Consolidated Balance Sheets

As of June 30, 2003 (unaudited) and December 31, 2002

   4
    

Condensed Consolidated Statements of Cash Flows

For the six months ended June 30, 2003 and 2002 (unaudited)

   5
     Notes to Condensed Consolidated Financial Statements (unaudited)    6

Item 2.

   Management’s Discussion and Analysis of Financial Condition and Results of Operations    12

Item 3.

   Quantitative and Qualitative Disclosures about Market Risk    34

Item 4.

   Controls and Procedures    35
     PART II.    OTHER INFORMATION     

Item 1.

   Legal Proceedings    35

Item 2.

   Changes in Securities and Use of Proceeds    35

Item 3.

   Defaults Upon Senior Securities    36

Item 4.

   Submission of Matters to a Vote of Security Holders    36

Item 5.

   Other Information    36

Item 6.

   Exhibits and Reports on Form 8-K    36
     (a) Exhibits    36
     (b) Reports on Form 8-K    37

Signatures

   38

 

 

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Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

DURECT CORPORATION

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

    

Three months ended

June 30,


   

Six months ended

June 30,


 
     2003

    2002

    2003

    2002

 

Product revenue, net

   $ 1,715     $ 1,677     $ 3,222     $ 3,290  

Collaborative research and development and other revenue

     1,485       95       2,559       106  
    


 


 


 


Total revenues

     3,200       1,772       5,781       3,396  
    


 


 


 


Operating expenses:

                                

Cost of revenue

     534       768       1,129       1,518  

Research and development

     5,282       8,178       10,854       16,173  

Selling, general and administrative

     2,219       2,441       4,462       4,764  

Amortization of intangible assets

     335       335       670       670  

Stock-based compensation(1)

     135       485       (19 )     1,083  
    


 


 


 


Total operating expenses

     8,505       12,207       17,096       24,208  
    


 


 


 


Loss from operations

     (5,305 )     (10,435 )     (11,315 )     (20,812 )

Other income (expense):

                                

Interest income

     368       598       609       1,309  

Interest expense

     (179 )     (78 )     (303 )     (161 )
    


 


 


 


Net other income

     189       520       306       1,148  
    


 


 


 


Net loss

   $ (5,116 )   $ (9,915 )   $ (11,009 )   $ (19,664 )
    


 


 


 


Net loss per share, basic and diluted

   $ (0.10 )   $ (0.21 )   $ (0.22 )   $ (0.41 )
    


 


 


 


Shares used in computing basic and diluted net loss per share

     50,294       48,076       50,209       47,929  
    


 


 


 



                                

(1)    Stock-based compensation related to the following:

                                

Cost of revenues

   $ 3     $ 17     $ 11     $ 46  

Research and development

     (23 )     330       (259 )     724  

Selling, general and administrative

     155       138       229       313  
    


 


 


 


     $ 135     $ 485     $ (19 )   $ 1,083  
    


 


 


 


 

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

 

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Table of Contents

DURECT CORPORATION

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

 

    

June 30,

2003


   

December 31,

2002


 
     (unaudited)     (Note 1)  

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 36,840     $ 14,089  

Short-term investments

     40,223       28,711  

Accounts receivable, net of allowance of $199 and $207, respectively

     1,549       944  

Inventories

     1,698       1,707  

Prepaid expenses and other current assets

     1,360       1,590  
    


 


Total current assets

     81,670       47,041  

Property and equipment, net

     10,259       11,625  

Goodwill

     4,716       4,716  

Intangible assets, net

     3,451       4,121  

Long-term investments

     6,311       2,578  

Restricted investments

     3,305       2,890  

Other long-term assets

     2,826       —    
    


 


Total assets

   $ 112,538     $ 72,971  
    


 


LIABILITIES AND STOCKHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 574     $ 352  

Accrued liabilities

     2,603       2,140  

Contract research liability

     1,004       1,128  

Deferred revenue

     456       948  

Equipment financing obligations, current portion

     283       447  

Bonds payable, current portion

     170       170  
    


 


Total current liabilities

     5,090       5,185  

Equipment financing obligations, noncurrent portion

     449       134  

Bonds payable, noncurrent portion

     1,245       1,245  

Convertible subordinated notes

     50,000       —    

Other long-term liabilities

     247       225  

Commitments and contingencies

                

Stockholders’ equity:

                

Common stock, $0.0001 par value: 110,000 shares authorized at June 30, 2003 and December 31, 2002 respectively; 50,547 and 50,443 shares issued and outstanding at June 30, 2003 and December 31, 2002, respectively

     5       5  

Additional paid-in capital

     194,083       194,312  

Notes receivable from stockholders

     (280 )     (469 )

Deferred compensation

     (267 )     (732 )

Deferred royalties and commercial rights

     (13,480 )     (13,480 )

Accumulated other comprehensive income

     11       102  

Accumulated deficit

     (124,565 )     (113,556 )
    


 


Total stockholders’ equity

     55,507       66,182  
    


 


Total liabilities and stockholders’ equity

   $ 112,538     $ 72,971  
    


 


 

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

 

4


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DURECT CORPORATION

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

    

Six months ended

June 30,


 
     2003

    2002

 

Cash flows from operating activities

                

Net loss

   $ (11,009 )   $ (19,664 )

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

                

Depreciation and amortization

     2,496       1,955  

Non-cash charges related to stock-based compensation

     (19 )     1,083  

Changes in assets and liabilities:

                

Accounts receivable

     (605 )     (75 )

Inventories

     9       313  

Prepaid expenses and other assets

     184       380  

Accounts payable

     222       (1,244 )

Accrued liabilities and other long-term liabilities

     485       (273 )

Contract research liability

     (124 )     639  
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