-----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, HfAmQ6d70wnCEo2lKVBvAAE7qkoIAIQpwwr0FeaKuQGLmvtauM5I9m5FVsdHw5eO 5c0NAFRQPnnmy722K+zijA== 0001193125-08-105902.txt : 20080507 0001193125-08-105902.hdr.sgml : 20080507 20080507161719 ACCESSION NUMBER: 0001193125-08-105902 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080507 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080507 DATE AS OF CHANGE: 20080507 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: 08810179 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 7, 2008

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.

On May 7, 2008, DURECT Corporation, a Delaware corporation (“DURECT”), announced its first quarter 2008 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 7, 2008


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 7, 2008     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 7, 2008
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces First Quarter 2008 Financial Results

CUPERTINO, Calif., May 7, 2008/PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2008. Total revenues were $6.4 million for the three months ended March 31, 2008, compared to $5.7 million for the same period in 2007. Net loss for the three months ended March 31, 2008 was $7.8 million, compared to a net loss of $8.8 million for the same period in 2007.

At March 31, 2008, DURECT had cash and investments of $53.4 million, compared to cash and investments of $62.0 million at December 31, 2007; these figures include restricted investments of $1.0 million at March 31, 2008 and at December 31, 2007.

“We continued to make progress towards our product development and corporate objectives during the first quarter,” stated James E. Brown, D.V.M., President and CEO of DURECT. “We continued to advance our POSIDUR, ELADUR, TRANSDUR-Sufentanil and Remoxy programs, including support of Pain Therapeutics and King Pharmaceuticals in their preparation of the New Drug Application (NDA) filing for Remoxy as well as starting commercial production of certain key components that are integral to Remoxy. We also continued to be active in business development and strengthened our intellectual property position by acquiring additional patents that may be strategic to our business.”

Recent Highlights:

 

 

Remoxy and other Abuse-Resistant Opioids. In the first quarter of 2008, DURECT continued to execute on its activities supporting the filing of the Remoxy NDA, and we began to manufacture commercial lots of certain key components that are included in Remoxy to meet the anticipated production requirements of King Pharmaceuticals. Our collaborator, Pain Therapeutics, has stated that they expect to file the NDA for Remoxy in the second quarter of 2008. In 2007, our collaborators King Pharmaceuticals and Pain Therapeutics announced that the pivotal Phase III trial for Remoxy successfully met its primary endpoint (p<0.01) that was prospectively defined by the U.S. Food and Drug Administration (FDA) during the Special Protocol Assessment (SPA) process. In addition, the study achieved statistically significant results in secondary endpoints such as Quality of Analgesia (p<0.01) and Global Assessment (p<0.01). No drug related safety issues were noted in the study.

Remoxy is an abuse-resistant, long-acting form of oxycodone based on our ORADUR technology intended for the treatment of chronic pain.

In addition to Remoxy, there are three other ORADUR-based abuse-resistant opioids covered in our collaboration with Pain Therapeutics. Pain Therapeutics has previously announced positive results from a Phase I clinical trial for one of these drug candidates, and Pain Therapeutics has stated that it expects to file an Investigational New Drug application (IND) for a new abuse-resistant opioid in 2008.

 

 

POSIDUR (SABER-Bupivacaine) Post-Operative Pain Relief Depot. We continue to be in dialogue with the FDA regarding the Phase III program. Upon completion of our discussions with the FDA, we plan to commence that program. As preparation for our Phase III program, we held an investigators meeting on April 25, 2008 with physicians attending the Arthroscopy Association of North America


 

2008 Annual Meeting in Washington. We have also recently conducted a survey, using independent consultants, among providers and insurers/payers to explore coverage and pricing for POSIDUR. In 2007, we announced positive results from a 122 patient Phase IIb clinical trial in which POSIDUR at a dose of 5 mL demonstrated statistically significant reductions in post-operative pain (by approximately 30% versus placebo) and in total consumption of supplemental opioid analgesic medications (approximately 3x less versus placebo) in patients undergoing inguinal hernia repair. A poster (http://www.durect.com/pdf/Posidur_AHS_2008_Poster.pdf) describing this study was presented at a meeting of the American Hernia Society on March 25, 2008.

POSIDUR is our post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine to provide up to three days of pain relief after surgery. POSIDUR is licensed to Nycomed for commercialization in Europe and select other countries, and DURECT has retained commercialization rights in the US, Canada and Asia.

 

 

ELADUR (TRANSDUR-Bupivacaine). In the first quarter of 2008, we continued to conduct manufacturing scale-up and processing to secure Phase II and Phase III supplies, and to develop our clinical and regulatory strategy. We have previously announced positive results from a 60 patient Phase IIa clinical trial of patients suffering from post-herpetic neuralgia. In this study, ELADUR showed improved pain control versus placebo during the 3-day continuous treatment period. In addition, ELADUR appeared to be well tolerated overall, and patients treated with ELADUR and placebo exhibited similar safety profiles. A poster describing this study is being presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and will be accessible shortly thereafter on our website (http://www.durect.com/wt/durect/page_name/Publications).

ELADUR is our proprietary transdermal patch intended to provide bupivacaine for a period of up to three days from a single application. We retain full commercial rights to this drug candidate.

 

 

TRANSDUR-Sufentanil. Endo Pharmaceuticals, our licensee for commercialization in the US and Canada, is continuing to conduct Phase II studies with TRANSDUR-Sufentanil designed to evaluate the conversion of patients on oral opioids to TRANSDUR-Sufentanil.

TRANSDUR-Sufentanil is our proprietary transdermal patch intended to provide sufentanil to chronic pain sufferers for a period of up to seven days from a single application.

 

 

Business Development Activities. We continue to be active on the business development front and have multiple late stage programs that are the subject of partnering discussions with third parties. These include ELADUR (worldwide), TRANSDUR-Sufentanil (ex-US and Canada), POSIDUR (Asia), as well as various other programs, some of which are internally funded and some of which are funded by third parties under feasibility agreements.

 

 

Expansion of patent portfolio. In the first quarter of 2008, we acquired from a third party a portfolio of worldwide patents relating to drug delivery technologies. This portfolio consists of approximately 49 issued and pending U.S. patents and patent applications as well as their international counterparts. Taken together with a similar portfolio acquisition in the fourth quarter of 2007, we have significantly increased our patent estate, which we believe will benefit our business by broadening our drug delivery technology base and strengthening our intellectual property position.


About DURECT Corporation

DURECT Corporation is an emerging specialty pharmaceutical company developing pharmaceutical systems based on its proprietary drug delivery platform technologies. The Company currently has a number of late-stage pharmaceutical products in development addressing large markets in pain management, with a number of research programs underway targeting chronic disease and other therapeutic areas. For more information, please visit www.durect.com.

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

DURECT Forward-Looking Statement

The statements in this press release regarding the anticipated filing of an NDA for Remoxy, our anticipated commencement of the Phase III program for POSIDUR, commercial production of Remoxy, our possible entry into future collaborative agreements as well as other statements regarding DURECT’s products in development, product development plans, anticipated regulatory, clinical and development milestones and timing thereof, future clinical trial results, our business development intentions, the potential benefits to our business from our above referenced acquisition of patents and DURECT’s emergence as a specialty pharmaceutical company 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 obtain approvals from regulatory agencies with respect to its development activities and products, design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the referenced product candidates, consummate collaborative agreements relating to our product candidates and technologies, manufacture and commercialize the referenced product candidates, obtain marketplace acceptance of the referenced product candidates and manage and obtain capital to fund its growth, operations and expenses and the breadth, validity and enforceability of the acquired patents referenced above. Further information regarding these and other risks is included in DURECT’s Form 10-K on March 13, 2008 under the heading “Risk Factors.”


DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three Months Ended March 31,  
     2008     2007  

Collaborative research and development and other revenue

   $ 4,269     $ 3,458  

Product revenue, net

     2,169       2,268  
                

Total revenues

     6,438       5,726  
                

Operating expenses:

    

Cost of revenues (1)

     822       860  

Research and development (1)

     9,634       10,352  

Selling, general and administrative (1)

     3,879       3,538  

Amortization of intangible assets

     11       7  
                

Total operating expenses

     14,346       14,757  
                

Loss from operations

     (7,908 )     (9,031 )

Other income (expense):

    

Interest and other income

     568       978  

Interest expense

     (455 )     (714 )
                

Net other income

     113       264  
                

Net loss

   $ (7,795 )   $ (8,767 )
                

Net loss per share, basic and diluted

   $ (0.11 )   $ (0.13 )
                

Shares used in computing basic and diluted net loss per share

     74,113       69,231  
                

 

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

    

Cost of revenues

   $ 35     $ 34  

Research and development

     1,607       1,156  

Selling, general and administrative

     775       668  
                

Total stock-based compensation

   $ 2,417     $ 1,858  
                


DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

 

     As of
March 31,

2008
   As of
December 31,

2007 (1)
     (unaudited)     

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 33,913    $ 37,589

Short-term investments

     12,979      19,710

Accounts receivable (net of allowances of $60 and $49, respectively)

     3,434      3,622

Inventories

     2,437      1,963

Prepaid expenses and other current assets

     1,824      1,904
             

Total current assets

     54,587      64,788

Property and equipment, net

     7,323      7,658

Goodwill

     6,399      6,399

Intangible assets, net

     194      180

Long-term investments

     5,473      3,697

Restricted Investments

     1,018      1,020

Other long-term assets

     277      278
             

Total assets

   $ 75,271    $ 84,020
             

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 1,210    $ 1,834

Accrued liabilities

     4,946      5,499

Contract research liability

     989      1,946

Deferred revenue, current portion

     5,330      5,728

Convertible subordinated notes

     23,599      23,599

Other short-term liabilities

     841      482
             

Total current liabilities

     36,915      39,088

Deferred revenue, non-current portion

     7,958      9,268

Other long-term liabilities

     1,044      1,083

Stockholders’ equity

     29,354      34,581
             

Total liabilities and stockholders’ equity

   $ 75,271    $ 84,020
             

 

(1) Derived from audited financial statements.

SOURCE DURECT Corporation

CONTACT:

Matt Hogan, Chief Financial Officer, DURECT Corporation, +1-408-777-4936

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