-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JKF1TXJk1pdGlaAvED3vTW1zyyQckgVbwxcizqGkEWWcntj54Pe15wxJ7DLeIbiJ MW0m4YPc5m6P55VSHQkqQQ== 0001193125-06-096767.txt : 20060502 0001193125-06-096767.hdr.sgml : 20060502 20060502161904 ACCESSION NUMBER: 0001193125-06-096767 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060502 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060502 DATE AS OF CHANGE: 20060502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DURECT CORP CENTRAL INDEX KEY: 0001082038 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943297098 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31615 FILM NUMBER: 06799812 BUSINESS ADDRESS: STREET 1: 10240 BUBB RD CITY: CUPERTINO STATE: CA ZIP: 95014 BUSINESS PHONE: 4087771417 MAIL ADDRESS: STREET 1: 10240 BUBB ROAD CITY: CUPERTINO STATE: CA ZIP: 95014 8-K 1 d8k.htm FORM 8-K Form 8-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


Form 8-K

 


Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

May 2, 2006

Date of Report

(Date of earliest event reported)

 


DURECT CORPORATION

(Exact name of Registrant as specified in its charter)

 


 

Delaware   000-31615   94-3297098

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(I.R.S. Employer

Identification No.)

2 Results Way

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

(408) 777-1417

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 



Item 2.02. Results of Operations and Financial Condition.

Item 8.01 Other Events.

On May 2, 2006, DURECT Corporation, a Delaware corporation (“DURECT”), announced its first quarter 2006 financial results. This Current Report is filed to disclose nonpublic information required to be disclosed by Regulation FD. A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

The information concerning financial results in this Form 8-K and in Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information concerning financial results in this Form 8-K and in Exhibit 99.1 shall not be incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

99.1 Press Release of DURECT Corporation dated May 2, 2006


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  DURECT Corporation
Date: May 2, 2006   By:  

/s/ James E. Brown

    James E. Brown
    President and Chief Executive Officer


DURECT CORPORATION

INDEX TO EXHIBITS

 

Exhibit
Number
 

Description

99.1   Press Release of DURECT Corporation dated May 2, 2006
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces First Quarter 2006 Financial Results

CUPERTINO, Calif., May 2, 2006/PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2006.

DURECT’s net loss for the three months ended March 31, 2006 was $6.3 million or 10 cents per share, compared to a net loss of $5.4 million or 10 cents per share for the same period in 2005. DURECT’s results for the three months ended March 31, 2006 included non-cash charges for the amortization of intangible assets and stock-based compensation of $1.2 million, compared to $353,000 for the same period in 2005. Cash used in operating activities was $3.3 million for the three months ended March 31, 2006, compared to $5.2 million for the same period in 2005.

“We continue to drive forward our development programs and carry the momentum from 2005 into the first quarter of 2006. We are pleased with development progress of Remoxy, an abuse-resistant, long-acting, oral pain medication under development by Pain Therapeutics, Inc. and its commercialization sub-licensee King Pharmaceuticals, Inc., based on DURECT’s patented ORADUR™ technology, and the clarification of the pathway to regulatory approval afforded by the Special Protocol Assessment received in February 2006,” said Jim Brown, D.V.M., President and CEO of DURECT.

Dr. Brown continued, “We also continue to advance our post-operative pain relief depot, SABER-Bupivacaine, development program. During 2006, our U.S. IND was accepted by the FDA, we announced results from our Phase II Australian clinical study in hernia patients and we initiated dosing in our first U.S. clinical trial, a Phase II, placebo-controlled trial in hernia patients.”

Total revenues were $5.2 million for the three months ended March 31, 2006, compared to $5.4 million for the same period in 2005. Total collaborative research and development and other revenues were $3.1 million for the three months ended March 31, 2006, compared with $3.6 million for the same period in 2005. The decrease in total revenues is primarily attributable to lower collaborative research and development revenue recognized from our agreements with Voyager Pharmaceutical Corporation and Endo Pharmaceuticals, Inc., offset by higher product revenues from our ALZET product lines.

Research and development expenses were $7.2 million for the three months ended March 31, 2006, compared to $6.7 million for the same period in 2005. The increase was primarily attributable to the stock-based compensation expense of $614,000 related to research and development personnel recognized under SFAS 123R (Share-based Payments) in the first quarter of 2006.

Selling, general and administrative expenses were $3.0 million for the three months ended March 31, 2006, compared to $2.5 million for the same period in 2005. The increase in the three months ended March 31, 2006 was primarily attributable to the higher product assessment and market research related expenses as well as the stock-based compensation expense of $321,000 related to selling, general and administrative personnel recognized under SFAS 123R in the first quarter of 2006.

Interest and other income was $906,000 for the three months ended March 31, 2006, compared with $485,000 for the same period in 2005. The increase in interest income was primarily the result of higher


yields as well as higher average cash and investment balances during the three months ended March 31, 2006 compared with the same period in 2005. Interest expense was $1.1 million for the three months ended March 31, 2006 and 2005. The interest expense was primarily due to the interest accrued on our convertible notes issued in 2003.

At March 31, 2006, DURECT had cash and investments of $87.9 million, including $1.7 million in restricted investments, compared with cash and investments of $91.0 million at December 31, 2005.

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.

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 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 Annual Report on Form 10-K for the year ended December 31, 2005 filed with the SEC on March 16, 2006 under the heading “Risk Factors.”


DURECT CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

     Three months ended
March 31,
 
     2006     2005  
     (unaudited)     (unaudited)  

Collaborative research and development and other revenue

   $ 3,058     $ 3,597  

Product revenue, net

     2,153       1,757  
                

Total revenues

     5,211       5,354  
                

Operating expenses:

    

Cost of revenues (1)

     829       671  

Research and development (1)

     7,164       6,664  

Selling, general and administrative (1)

     3,005       2,508  

Amortization of intangible assets

     300       303  
                

Total operating expenses

     11,298       10,146  
                

Loss from operations

     (6,087 )     (4,792 )

Other income (expense):

    

Interest and other income

     906       485  

Interest expense

     (1,077 )     (1,120 )
                

Net other loss

     (171 )     (635 )
                

Net loss

   $ (6,258 )   $ (5,427 )
                

Net loss per share, basic and diluted

   $ (0.10 )   $ (0.10 )
                

Shares used in computing basic and diluted net loss per share

     61,837       51,887  
                
___________     

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

    

Cost of revenues

   $ 8     $ —    

Research and development

     614       46  

Selling, general and administrative

     321       4  
                
   $ 943     $ 50  
                

 


DURECT CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     March 31,    December 31,
     2006    2005 (1)

Assets

     

Current assets:

     

Cash and cash equivalents

   $ 44,093    $ 65,542

Short-term investments

     29,731      18,022

Restricted investments

     203      321

Accounts Receivable

     3,164      4,488

Inventories

     1,998      2,047

Prepaid expenses and other current assets

     2,016      3,659
             

Total current assets

     81,205      94,079

Property and equipment, net

     7,580      7,304

Goodwill

     6,399      6,399

Intangible assets, net

     235      536

Long-term investments

     12,330      5,459

Restricted investments

     1,505      1,653

Other non-current assets

     1,825      1,984
             

Total assets

   $ 111,079    $ 117,414
             

Liabilities and stockholders’ equity

     

Current liabilities:

     

Accounts payable, accrued liabilities and deferred revenue

   $ 8,114    $ 9,643

Long-term obligations, current portion

     221      234
             

Total current liabilities

     8,335      9,877

Long-term obligations, noncurrent portion

     63,790      64,185

Stockholders’ equity

     38,954      43,352
             

Total liabilities and stockholders’ equity

   $ 111,079    $ 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

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