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Table of Contents

 
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, 2002
 
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 ¨
 
As of November 12, 2002, there were 50,438,193 shares of the registrant’s Common Stock outstanding.
 


Table of Contents
 
INDEX
 
         
Page

PART I.
  
FINANCIAL INFORMATION
    
Item 1.
     
3
    
For the three and nine months ended September 30, 2002 and 2001 (unaudited)
  
3
    
As of September 30, 2002 (unaudited) and December 31, 2001
  
4
    
For the nine months ended September 30, 2002 and 2001 (unaudited)
  
5
       
6
Item 2.
     
10
Item 3.
     
30
Item 4.
     
31
PART II.
  
OTHER INFORMATION
    
Item 1.
     
32
Item 2.
     
32
Item 3.
     
32
Item 4.
     
32
Item 5.
     
32
Item 6.
     
33
       
33
       
33
       
33
       
34
 

2


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
September 30,

    
Nine months ended
September 30,

 
    
2002

    
2001

    
2002

    
2001

 
Revenue, net
  
$
1,783
 
  
$
1,841
 
  
$
5,179
 
  
$
4,928
 
Cost of goods sold(1)
  
 
721
 
  
 
963
 
  
 
2,285
 
  
 
2,548
 
    


  


  


  


Gross profit
  
 
1,062
 
  
 
878
 
  
 
2,894
 
  
 
2,380
 
    


  


  


  


Operating expenses:
                                   
Research and development
  
 
7,571
 
  
 
7,206
 
  
 
23,744
 
  
 
16,680
 
Selling, general and administrative
  
 
2,225
 
  
 
2,305
 
  
 
6,989
 
  
 
6,339
 
Amortization of intangible assets
  
 
335
 
  
 
555
 
  
 
1,005
 
  
 
1,290
 
Stock-based compensation(1)
  
 
338
 
  
 
750
 
  
 
1,375
 
  
 
2,605
 
Acquired in-process research and development
  
 
—  
 
  
 
—  
 
  
 
—  
 
  
 
14,030
 
    


  


  


  


Total operating expenses
  
 
10,469
 
  
 
10,816
 
  
 
33,113
 
  
 
40,944
 
    


  


  


  


Loss from operations
  
 
(9,407
)
  
 
(9,938
)
  
 
(30,219
)
  
 
(38,564
)
Other income (expense):
                                   
Interest income
  
 
428
 
  
 
1,096
 
  
 
1,737
 
  
 
3,960
 
Interest expense
  
 
(71
)
  
 
(92
)
  
 
(232
)
  
 
(238
)
    


  


  


  


Net other income
  
 
357
 
  
 
1,004
 
  
 
1,505
 
  
 
3,722
 
    


  


  


  


Net loss
  
$
(9,050
)
  
$
(8,934
)
  
$
(28,714
)
  
$
(34,842
)
    


  


  


  


Net loss per share, basic and diluted
  
$
(0.19
)
  
$
(0.19
)
  
$
(0.60
)
  
$
(0.76
)
    


  


  


  


Shares used in computing basic and diluted net loss per share
  
 
48,161
 
  
 
46,906
 
  
 
48,006
 
  
 
46,120
 
    


  


  


  


(1) Stock-based compensation related to the following:
                                   
Cost of goods sold
  
$
15
 
  
$
31
 
  
$
61
 
  
$
118
 
Research and development
  
 
219
 
  
 
503
 
  
 
943
 
  
 
1,798
 
Selling, general and administrative
  
 
119
 
  
 
247
 
  
 
432
 
  
 
807
 
    


  


  


  


    
$
353
 
  
$
781
 
  
$
1,436
 
  
$
2,723
 
    


  


  


  


 
See accompanying notes.

3


Table of Contents
DURECT CORPORATION
 
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
 
    
September 30,
2002

    
December 31,
2001

 
    
(unaudited)
 
Assets
                 
Current assets:
                 
Cash and cash equivalents
  
$
18,228
 
  
$
12,596
 
Short-term investments
  
 
27,283
 
  
 
42,608
 
Accounts receivable, net
  
 
901
 
  
 
818
 
Inventories
  
 
1,583
 
  
 
1,864
 
Prepaid expenses and other current assets
  
 
1,430
 
  
 
2,325
 
    


  


Total current assets
  
 
49,425
 
  
 
60,211
 
Property and equipment, net
  
 
12,242
 
  
 
13,136
 
Goodwill
  
 
4,716
 
  
 
4,716
 
Intangible assets, net
  
 
4,456
 
  
 
5,462
 
Long-term investments
  
 
3,635
 
  
 
18,016
 
Restricted investments
  
 
2,879
 
  
 
3,402
 
    


  


Total assets
  
$
77,353
 
  
$
104,943
 
    


  


Liabilities and stockholders’ equity
                 
Current liabilities:
                 
Accounts payable
  
$
691
 
  
$
2,003
 
Accrued liabilities
  
 
3,047
 
  
 
2,140
 
Accrued construction in progress
  
 
—  
 
  
 
342
 
Contract research liability
  
 
1,378
 
  
 
580
 
Equipment financing obligations, current portion
  
 
483
 
  
 
523
 
Bonds payable, current portion
  
 
160
 
  
 
160
 
    


  


Total current liabilities
  
 
5,759
 
  
 
5,748
 
Equipment financing obligations, noncurrent portion
  
 
221
 
  
 
581
 
Bonds payable, noncurrent portion
  
 
1,415
 
  
 
1,415
 
Other long-term liabilities
  
 
212
 
  
 
151
 
Commitments and contingencies
                 
Stockholders’ equity:
                 
Common stock
  
 
4
 
  
 
4
 
Additional paid-in capital
  
 
189,689
 
  
 
189,396
 
Notes receivable from stockholders
  
 
(495
)
  
 
(597
)
Deferred compensation
  
 
(1,055
)
  
 
(2,551
)
Deferred royalties and commercial rights
  
 
(13,480
)
  
 
(13,480
)
Accumulated other comprehensive income
  
 
180
 
  
 
659
 
Accumulated deficit
  
 
(105,097
)
  
 
(76,383
)
    


  


Total stockholders’ equity
  
 
69,746
 
  
 
97,048
 
    


  


Total liabilities and stockholders’ equity
  
$
77,353
 
  
$
104,943
 
    


  


 
See accompanying notes.
 

4


Table of Contents
DURECT CORPORATION
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
 
    
Nine months ended
September 30,

 
    
2002

    
2001

 
Cash flows from operating activities
                 
Net loss
  
$
(28,714
)
  
$
(34,842
)
Adjustments to reconcile net loss to net cash used in operating activities:
                 
Depreciation and amortization
  
 
3,139
 
  
 
2,248
 
Non-cash charges related to stock-based compensation
  
 
1,436
 
  
 
2,723