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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 March 31, 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 April 30, 2003, there were 50,532,873 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 months ended March 31, 2003 and 2002 (unaudited)

  

3

    

Condensed Consolidated Balance Sheets

As of March 31, 2003 (unaudited) and December 31, 2002

  

4

    

Condensed Consolidated Statements of Cash Flows

For the three months ended March 31, 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

  

36

Item 2.

  

Changes in Securities and Use of Proceeds

  

36

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

  

37

    

(a)    Exhibits

  

37

    

(b)    Reports on Form 8-K

  

37

Signatures

  

37

Certifications

  

38

 

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 March 31,


 
    

2003


    

2002


 

Product revenue, net

  

$

1,507

 

  

$

1,613

 

Collaborative research and development and other revenue

  

 

1,074

 

  

 

11

 

    


  


Total revenues

  

 

2,581

 

  

 

1,624

 

Operating expenses:

                 

Cost of revenues

  

 

595

 

  

 

750

 

Research and development

  

 

5,572

 

  

 

7,995

 

Selling, general and administrative

  

 

2,243

 

  

 

2,323

 

Amortization of intangible assets

  

 

335

 

  

 

335

 

Stock-based compensation(1)

  

 

(154

)

  

 

598

 

    


  


Total operating expenses

  

 

8,591

 

  

 

12,001

 

    


  


Loss from operations

  

 

(6,010

)

  

 

(10,377

)

Other income (expense):

                 

Interest income

  

 

241

 

  

 

711

 

Interest expense

  

 

(124

)

  

 

(83

)

    


  


Net other income

  

 

117

 

  

 

628

 

    


  


Net loss

  

$

(5,893

)

  

$

(9,749

)

    


  


Net loss per common share, basic and diluted

  

$

(0.12

)

  

$

(0.20

)

    


  


Shares used in computing basic and diluted net loss per share

  

 

50,123

 

  

 

47,782

 

    


  



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

                 

Cost of revenues

  

$

8

 

  

$

29

 

Research and development

  

 

(236

)

  

 

394

 

Selling, general and administrative

  

 

74

 

  

 

175

 

    


  


    

$

(154

)

  

$

598

 

    


  


 

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

 

3


Table of Contents

DURECT CORPORATION

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

 

    

March 31, 2003


    

December 31, 2002


 
    

(unaudited)

    

(Note 1)

 

ASSETS

                 

Current assets:

                 

Cash and cash equivalents

  

$

16,211

 

  

$

14,089

 

Short-term investments

  

 

21,049

 

  

 

28,711

 

Accounts receivable, net of allowances of $205 and $207, respectively

  

 

1,407

 

  

 

944

 

Inventories

  

 

1,669

 

  

 

1,707

 

Prepaid expenses and other current assets

  

 

1,613

 

  

 

1,590

 

    


  


Total current assets

  

 

41,949

 

  

 

47,041

 

Property and equipment, net

  

 

10,869

 

  

 

11,625

 

Goodwill

  

 

4,716

 

  

 

4,716

 

Intangible assets, net

  

 

3,786

 

  

 

4,121

 

Long-term investments

  

 

2,159

 

  

 

2,578

 

Restricted investments

  

 

3,750

 

  

 

2,890

 

    


  


Total assets

  

$

67,229

 

  

$

72,971

 

    


  


LIABILITIES AND STOCKHOLDERS’ EQUITY

                 

Current liabilities:

                 

Accounts payable

  

$

486

 

  

$

352

 

Accrued liabilities

  

 

2,179

 

  

 

2,140

 

Contract research liability

  

 

1,275

 

  

 

1,128

 

Deferred revenue

  

 

680

 

  

 

948

 

Equipment financing obligations, current portion

  

 

283

 

  

 

447

 

Bonds payable, current portion

  

 

170

 

  

 

170

 

    


  


Total current liabilities

  

 

5,073

 

  

 

5,185

 

Equipment financing obligations, noncurrent portion

  

 

519

 

  

 

134

 

Bonds payable, noncurrent portion

  

 

1,245

 

  

 

1,245

 

Other long-term liabilities

  

 

238

 

  

 

225

 

Commitments

                 

Stockholders’ equity:

                 

Common stock, $0.0001 par value: 110,000 shares authorized at March 31, 2003 and December 31, 2002 respectively; 50,415 and 50,443 shares issued and outstanding at March 31, 2003 and December 31, 2002, respectively

  

 

5

 

  

 

5

 

Additional paid-in capital

  

 

193,823

 

  

 

194,312

 

Notes receivable from stockholders

  

 

(338

)

  

 

(469

)

Deferred compensation

  

 

(446

)

  

 

(732

)

Deferred royalties and commercial rights

  

 

(13,480

)

  

 

(13,480

)

Accumulated other comprehensive income

  

 

39

 

  

 

102

 

Accumulated deficit

  

 

(119,449

)

  

 

(113,556

)

    


  


Stockholders’ equity

  

 

60,154

 

  

 

66,182

 

    


  


Total liabilities and stockholders’ equity

  

$

67,229

 

  

$

72,971

 

    


  


 

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

 

4


Table of Contents

DURECT CORPORATION

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

    

Three months ended

March 31,


 
    

2003


    

2002


 

Cash flows from operating activities

                 

Net loss

  

$

(5,893

)

  

$

(9,749

)

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

                 

Depreciation and amortization

  

 

1,184

 

  

 

870

 

Noncash charges related to stock-based compensation

  

 

(154

)

  

 

598

 

Changes in assets and liabilities:

                 

Accounts receivable

  

 

(463

)

  

 

48

 

Inventories

  

 

38

 

  

 

188

 

Prepaid expenses and other assets

  

 

(23

)

  

 

364

 

Accounts payable

  

 

134

 

  

 

(210

)

Accrued liabilities and other long-term liabilities

  

 

52

 

  

 

(276

)

Contract research liability

  

 

147

 

  

 

113