EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces Third Quarter 2006 Financial Results

CUPERTINO, Calif., November 3, 2006/PRNewswire-FirstCall/ — DURECT Corporation (NASDAQ: DRRX) announced today financial results for the three months ended September 30, 2006. Total revenues were $5.1 million for the three months ended September 30, 2006, compared to $8.6 million for the same period in 2005. Net loss for the three months ended September 30, 2006 was $8.6 million, compared to a net loss of $3.0 million for the same period in 2005. Cash used in operating activities was $3.1 million for the three months ended September 30, 2006, compared to $1.1 million of cash used in operating activities for the same period in 2005.

At September 30, 2006, DURECT had cash and investments of $74.3 million, including $1.5 million in restricted investments, compared with cash and investments of $77.7 million at June 30, 2006 and $91.0 million at December 31, 2005.

“DURECT continued to make solid progress in advancing our pipeline in the third quarter, including entering one new product into Phase I clinical trials,” stated James E. Brown, D.V.M., President and CEO of DURECT.

Recent Corporate Highlights

 

    POSIDUR™ Post-Operative Pain Relief Depot. During the third quarter of 2006, we continued to conduct multiple on-going Phase II clinical trials in a variety of soft-tissue and orthopedic surgeries for the purpose of selecting the optimal dose and the surgical procedures for pivotal Phase III trials. Pending the successful completion of these Phase II trials and approval of regulatory authorities, we will continue into the Phase III program, which we anticipate will occur in 2007.

 

    Remoxy. Phase III clinical trials, conducted according to a Special Protocol Assessment, remain on-going for this abuse-resistant, long-acting, oral pain medication. According to a recent press release by Pain Therapeutics, they believe that they remain on track to announce results of a Phase III trial with Remoxy in the first half of 2007, followed by an NDA filing for this drug candidate three quarters after data release.

 

    2nd ORADUR-based Opioid. In August, our collaborators, Pain Therapeutics and King Pharmaceuticals, announced the initiation of a Phase I clinical trial for a new ORADUR-based opioid drug candidate. This new drug candidate is the second ORADUR-based opioid drug to undergo clinical testing. King Pharmaceuticals is the company that will be commercializing the drug candidate, if approved. Pain Therapeutics, our licensee, has sublicensed rights to the drug candidate and other ORADUR-based products incorporating oxycodone and three other opioid compounds to King Pharmaceuticals. The active pharmaceutical ingredient in the new ORADUR-based opioid drug candidate has not been disclosed.

 

    TRANSDUR Sufentanil Patch. During the third quarter, our main activity under this program involved supply of product for on-going clinical and non-clinical studies conducted by Endo Pharmaceuticals. In addition, we continued our technology transfer to Endo’s contract transdermal patch manufacturer in order to produce additional Phase II supplies, Phase III supplies and then commercial supplies.

 


    Memryte™ Program. Our collaborator, Voyager Pharmaceutical, recently informed DURECT that Voyager is ending its Phase III clinical trials for Memryte™ for the treatment of Alzheimer’s Disease in order to get an early look at potential efficacy.

 

    Management Addition. Matthew J. Hogan has joined us as Chief Financial Officer, bringing with him over 10 years of in-depth knowledge regarding corporate financial transactions as a former investment banker for Merrill Lynch and over 10 years of experience as a chief financial officer of several publicly traded companies, including experience managing commercial product sales.

About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies. The company is developing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time to treat chronic and episodic diseases and conditions. For more information, please visit www.durect.com.

NOTE: POSIDUR™, SABER™, ORADUR™, DURIN™, TRANSDUR™ and MICRODUR™ are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT’s products in development, product development plans and projected financial results are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, DURECT’s (and that of its third party collaborators where applicable) abilities to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT’s Form 10-Q on November 3, 2006 under the heading “Risk Factors.”


DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2006     2005     2006     2005  
     (unaudited)     (unaudited)     (unaudited)     (unaudited)  

Collaborative research and development and other revenue

   $ 3,158     $ 5,369     $ 10,264     $ 15,896  

Product revenue, net

     1,976       1,653       6,189       5,299  

Revenue from sale of intellectual property rights

     —         1,600       —         1,600  
                                

Total revenues

     5,134       8,622       16,453       22,795  
                                

Operating expenses:

        

Cost of revenues (1)

     666       573       2,265       1,933  

Research and development (1)

     9,930       7,024       25,643       21,301  

Selling, general and administrative (1)

     3,346       2,699       9,540       8,362  

Amortization of intangible assets

     22       303       416       909  
                                

Total operating expenses

     13,964       10,599       37,864       32,505  
                                

Loss from operations

     (8,830 )     (1,977 )     (21,411 )     (9,710 )

Other income (expense):

        

Interest and other income

     957       467       2,841       1,359  

Interest expense

     (710 )     (1,095 )     (2,719 )     (3,329 )

Debt conversion expense

     —         (403 )     (2,287 )     (403 )
                                

Net other income (expense)

     247       (1,031 )     (2,165 )     (2,373 )
                                

Loss before income taxes

     (8,583 )     (3,008 )     (23,576 )     (12,083 )

Income tax provision

     —         4       —         4  
                                

Net loss

   $ (8,583 )   $ (3,012 )   $ (23,576 )   $ (12,087 )
                                

Net loss per share, basic and diluted

   $ (0.12 )   $ (0.06 )   $ (0.36 )   $ (0.23 )
                                

Shares used in computing basic and diluted net loss per share

     68,688       52,786       64,943       52,240  
                                

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

        

Cost of revenues

   $ 20     $ —       $ 47     $ —    

Research and development

     774       60       2,084       106  

Selling, general and administrative

     368       —         1,011       347  
                                
   $ 1,162     $ 60     $ 3,142     $ 453  
                                

 


DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

    

September 30,

2006

  

December 31,

2005 (1)

     (unaudited)     

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 37,717    $ 65,542

Short-term investments

     25,099      18,022

Restricted investments

     —        321

Accounts receivable

     3,471      4,488

Inventories

     2,205      2,047

Prepaid expenses and other current assets

     1,611      3,659
             

Total current assets

     70,103      94,079

Property and equipment, net

     7,447      7,304

Goodwill

     6,399      6,399

Intangible assets, net

     119      536

Long-term investments

     9,955      5,459

Restricted investments

     1,508      1,653

Other long-term assets

     1,073      1,984
             

Total assets

   $ 96,604    $ 117,414
             

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 1,121    $ 1,835

Accrued liabilities

     4,042      3,874

Contract research liabilities

     871      1,418

Interest payable on convertible notes

     681      149

Deferred revenue, current portion

     2,412      2,367

Equipment financing obligations and term loan, current portion

     32      34

Bonds payable, current portion

     200      200
             

Total current liabilities

     9,359      9,877

Bonds payable, equipment financing obligations and term loan, noncurrent portion

     825      702

Convertible subordinated notes

     37,337      57,337

Deferred revenue, noncurrent portion

     4,375      6,016

Other long-term liabilities

     279      130

Stockholders’ equity

     44,429      43,352
             

Total liabilities and stockholders’ equity

   $ 96,604    $ 117,414
             

(1) Derived from audited financial statements.

     

SOURCE DURECT Corporation

CONTACT:

Schond L. Greenway, Vice President, Investor Relations and Strategic Planning, DURECT Corporation, +1-408-777-1417