EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

DURECT Corporation Announces Second Quarter 2005 Financial Results

 

CUPERTINO, Calif., July 22, 2005/PRNewswire-FirstCall/ — DURECT Corporation (NASDAQ: DRRX) announced today financial results for the three months ended June 30, 2005.

 

DURECT’s net loss for the three months ended June 30, 2005 was $3.6 million or 7 cents per share, compared to a net loss of $7.4 million or 14 cents per share for the same period in 2004. DURECT’s results for the three months ended June 30, 2005 included non-cash charges of $646,000 for the amortization of intangible assets and stock-based compensation, compared to $443,000 for the same period in 2004. Cash provided by operating activities was $4.8 million for the three months ended June 30, 2005, compared to $6.3 million cash used for the same period in 2004.

 

“We had a very positive second quarter and executed on our corporate objectives. We announced exciting preliminary results from cohort 2 of the Phase II study for our post-operative pain relief depot, SABER-Bupivacaine. In addition, we advanced this program into the third and last cohort of the Phase II study, which is anticipated to enroll 60 patients. Also, our partner Pain Therapeutics announced the completion of enrollment of their first Phase III study using our ORADUR sustained release oral gel-cap technology, and we look forward to the results from this study,” stated James E. Brown, DVM, President and CEO of DURECT.

 

Dr. Brown added, “We continue to make significant progress on our other development programs, including our collaborations with Voyager with respect to Alzheimer’s disease and ENDO with respect to our seven-day sufentanil patch. Today, we also announced that we have taken the opportunity to retire a portion of our outstanding convertible notes in order to further strengthen our financial position.”

 

Total revenues were $8.8 million for the three months ended June 30, 2005, compared to $3.1 million for the same period in 2004. Total collaborative research and development and other revenues were $6.9 million for the three months ended June 30, 2005, compared with $1.3 million for the same period in 2004. The increase in total revenues was primarily attributable to higher collaborative research and development revenue recognized from our agreements with Endo Pharmaceuticals, Inc. (TRANSDUR-sufentanil), Voyager Pharmaceutical Corporation, and Pain Therapeutics, Inc. and higher product revenues from our ALZET and polymer product lines.

 

Research and development expenses were $7.6 million for the three months ended June 30, 2005, compared to $6.0 million for the same period in 2004. The increase was primarily attributable to the higher development expenses for SABER-Bupivacaine, TRANSDUR-Sufentanil, DURIN-Leuprolide and certain other product candidates.

 

Selling, general and administrative expenses were $2.8 million for the three months ended June 30, 2005, compared to $2.3 million for the same period in 2004. The increase in the three months ended June 30, 2005 was primarily due to higher employee related costs and other external costs to comply with the Sarbanes-Oxley Act.

 

Interest and other income was $407,000 for the three months ended June 30, 2005, compared with $289,000 for the same period in 2004. The increase in interest income was primarily the result of higher yields on cash and investment balances held during the three months ended June 30, 2005 compared with the same period


in 2004. Interest expense was both $1.1 million for the three months ended June 30, 2005 and 2004. The interest expense was primarily the result of the interest accrued on the $60.0 million convertible notes the Company issued in June and July of 2003.

 

At June 30, 2005, DURECT had cash and investments of $60.5 million, including $2.4 million in restricted investments, compared with cash and investments of $61.8 million at December 31, 2004. We anticipate that our December 31, 2005 cash and investments balance to be in the range of $48.0 million to $50.0 million.

 

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 that treat chronic debilitating diseases and enable biotechnology products. These platform technologies include the SABER Delivery System (a patented and versatile depot injectable useful for protein and small molecule delivery), the ORADUR sustained release oral gel-cap technology (an oral sustained release technology with several potential abuse deterrent properties), the DURIN Biodegradable Implant (drug-loaded implant system), the TRANSDUR transdermal technology and the MICRODUR Biodegradable Microparticulates (microspheres injectable system). DURECT also collaborates with pharmaceutical companies to develop and commercialize proprietary and enhanced pharmaceutical products based on its technologies. DURECT has five disclosed on-going development programs of which four are in collaboration with pharmaceutical partners. Additional information about DURECT is available at www.durect.com.

 

NOTE: 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, clinical trials 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 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 Quarterly Report on Form 10-Q for the period ended March 31, 2005 filed with the SEC on May 6, 2005 under the heading “Factors that may affect future results.”


DURECT CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

    

Three months ended

June 30,


   

Six months ended

June 30,


 
     2005

    2004

    2005

    2004

 
     (unaudited)     (unaudited)     (unaudited)     (unaudited)  

Product revenue, net

   $ 1,889     $ 1,760     $ 3,646     $ 3,125  

Collaborative research and development and other revenue

     6,930       1,320       10,527       3,340  
    


 


 


 


Total revenues

     8,819       3,080       14,173       6,465  
    


 


 


 


Operating expenses:

                                

Cost of revenues

     689       867       1,360       1,432  

Research and development

     7,613       6,040       14,231       11,449  

Selling, general and administrative

     2,812       2,339       5,316       4,563  

Amortization of intangible assets

     303       308       606       643  

Stock-based compensation(1)

     343       135       393       170  
    


 


 


 


Total operating expenses

     11,760       9,689       21,906       18,257  
    


 


 


 


Loss from operations

     (2,941 )     (6,609 )     (7,733 )     (11,792 )

Other income (expense):

                                

Interest and other income

     407       289       892       593  

Interest expense

     (1,114 )     (1,113 )     (2,234 )     (2,224 )
    


 


 


 


Net other expense

     (707 )     (824 )     (1,342 )     (1,631 )
    


 


 


 


Net loss

   $ (3,648 )   $ (7,433 )   $ (9,075 )   $ (13,423 )
    


 


 


 


Net loss per common share, basic and diluted

   $ (0.07 )   $ (0.14 )   $ (0.17 )   $ (0.26 )
    


 


 


 


Shares used in computing basic and diluted net loss per share

     52,047       51,396       51,967       51,260  
    


 


 


 



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

                                

Cost of revenues

   $ —       $ (2 )   $ —       $ 1  

Research and development

     —         126       46       153  

Selling, general and administrative

     343       11       347       16  
    


 


 


 


     $ 343     $ 135     $ 393     $ 170  
    


 


 


 



DURECT CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

    

June 30,

2005


   December 31,
2004 (1)


Assets

             

Current assets:

             

Cash and cash equivalents

   $ 30,269    $ 20,032

Short-term investments

     18,918      21,765

Accounts receivable

     6,166      2,481

Inventories

     1,911      1,929

Prepaid expenses and other current assets

     1,139      1,364
    

  

Total current assets

     58,403      47,571

Property and equipment, net

     7,258      7,112

Goodwill

     6,399      6,399

Intangible assets, net

     1,138      1,745

Long-term investments

     8,926      17,218

Restricted investments

     2,425      2,798

Other non-current assets

     2,310      2,625
    

  

Total assets

   $ 86,859    $ 85,468
    

  

Liabilities and stockholders’ equity

             

Current liabilities:

             

Accounts payable, accrued liabilities and deferred revenue

   $ 7,612    $ 5,006

Long-term obligations, current portion

     366      483
    

  

Total current liabilities

     7,978      5,489

Long-term obligations, noncurrent portion

     68,647      61,589

Stockholders’ equity

     10,234      18,390
    

  

Total liabilities and stockholders’ equity

   $ 86,859    $ 85,468
    

  


(1) Derived from audited financial statements.

 

SOURCE DURECT Corporation

 

CONTACT: Schond L. Greenway, Executive Director, Investor Relations and Strategic Planning of DURECT Corporation,

+1-408-777-1417