-----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, J52xsz1AK+prVgJ1eMRDZ6O6qFFpyQ61Sm9Q9P4/VJhe7d/QEAy065Ml7/rW3k3J 3TGvHFdGH04glKsrUIMVhg== 0001193125-07-173708.txt : 20070807 0001193125-07-173708.hdr.sgml : 20070807 20070807161611 ACCESSION NUMBER: 0001193125-07-173708 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070807 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070807 DATE AS OF CHANGE: 20070807 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: 071031830 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

August 7, 2007

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 August 7, 2007, DURECT Corporation, a Delaware corporation (“DURECT”), announced its second quarter 2007 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 August 7, 2007


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: August 7, 2007     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 August 7, 2007

 

EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces Second Quarter 2007 Financial Results

CUPERTINO, Calif., August 7, 2007/PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2007. Total revenues were $13.4 million for the three months ended June 30, 2007, compared to $6.1 million for the same period in 2006; revenues in the second quarter of 2007 include the earning of an $8.0 million milestone payment under our Nycomed collaboration related to the clinical development of POSIDUR™. Net loss for the three months ended June 30, 2007 was $479,000, compared to a net loss of $8.7 million for the same period in 2006. Cash used in operating activities was $6.1 million for the three months ended June 30, 2007, compared to $10.2 million in the three months ended June 30, 2006. At June 30, 2007, we had cash and investments of $65.8 million, including $1.3 million in restricted investments, compared with cash and investments of $81.6 million at December 31, 2006. Cash flow in the second quarter of 2007 and the reported cash and investments balance at June 30, 2007 do not reflect the $8.0 million milestone payment that had been earned but not received as of June 30, 2007; this payment was received on August 1, 2007.

Based on our financial results in the first half of 2007, the receipt of an $8.0 million milestone payment from Nycomed and a reexamination of anticipated financial results in the second half of 2007, we are now providing revised financial guidance for cash burn in 2007 of approximately $25-27 million as compared to prior guidance of $32-36 million. This reforecast continues to assume no major new collaborations during 2007, although we are pursuing potential collaborations on multiple fronts including ELADUR, TRANSDUR-Sufentanil for Europe and Asia, POSIDUR for Asia, as well as various other programs.

“Our development programs continued to progress in the second quarter of this year, as evidenced by positive results from our POSIDUR Phase IIb hernia study, completion of enrollment in the Remoxy™ pivotal Phase III trial and the initiation by Endo of their Phase II program with our TRANSDUR™-Sufentanil patch,” stated James E. Brown, D.V.M., President and CEO of DURECT. “We expect further clinical developments in the second half of 2007 with respect to POSIDUR, Remoxy and ELADUR.”

Recent Company Highlights:

 

 

POSIDUR. We recently 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. This Phase IIb trial was designed to be the study upon which we and our collaborator Nycomed would base our decision for advancing POSIDUR into Phase III clinical trials. These successful results triggered an $8 million milestone payment by Nycomed to DURECT under the parties’ collaborative agreement. We have scheduled an end-of-Phase II meeting with the U.S. Food & Drug Administration (FDA).

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.

 

 

Remoxy. According to Pain Therapeutics and King Pharmaceuticals, the Remoxy Phase III pivotal study is now fully enrolled and top-line results of this study are expected in the fourth quarter of 2007.


Remoxy, an abuse-resistant long-acting form of oxycodone based on our ORADUR™ technology intended for the treatment of chronic pain, is currently in a pivotal Phase III trial in accordance with a Special Protocol Assessment (SPA) with the FDA. Remoxy is licensed to Pain Therapeutics, which has in turn sublicensed commercialization rights to King Pharmaceuticals.

 

 

TRANSDUR™-Sufentanil. According to its public disclosures, Endo Pharmaceuticals commenced its Phase II program in June 2007.

TRANSDUR-Sufentanil is our proprietary transdermal patch intended to provide sufentanil for a period of up to seven days from a single application for chronic pain sufferers. TRANSDUR-Sufentanil is licensed to Endo for commercialization in the US and Canada, and DURECT has retained commercialization rights for the rest of the world.

 

 

ELADUR™ (TRANSDUR-Bupivacaine). We are enrolling patients and expect to report data in 2007 from a Phase IIa trial designed to assess safety as well as the magnitude, duration and characteristics of analgesic activity of ELADUR in approximately 50 patients with Post-Herpetic Neuralgia (PHN).

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

Earnings Conference Call

A live audio webcast of a conference call to discuss second quarter 2007 results will be broadcast live over the internet at 4:30 p.m. Eastern Time and is available by accessing DURECT’s homepage at www.durect.com and clicking “Investor Relations.” If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the “Investor Relations” section.

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™, 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 our products in development, product development plans, our intended end-of-Phase II meeting with the FDA and other anticipated regulatory, clinical and development milestones and timing thereof, future clinical trial results, our intended emergence as a specialty pharmaceutical company and anticipated 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, our (and that of our 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, manufacture and commercialize the product candidate and manage and obtain capital to fund our growth, operations and expenses. Further information regarding these and other risks is included in our Form 10-Q filed on May 9, 2007 under the heading “Risk Factors.”


DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three months ended
June 30,
    Six months ended
June 30,
 
     2007     2006     2007     2006  

Collaborative research and development revenue

   $ 3,408     $ 4,048     $ 6,866     $ 7,106  

Milestone revenue

     8,000       —         8,000       —    

Product revenue, net

     2,024       2,060       4,292       4,213  
                                

Total revenues

     13,432       6,108       19,158       11,319  
                                

Operating expenses:

        

Cost of revenues (1)

     778       770       1,638       1,599  

Research and development (1)

     9,630       8,549       19,982       15,713  

Selling, general and administrative (1)

     3,683       3,189       7,221       6,194  

Amortization of intangible assets

     8       94       15       394  
                                

Total operating expenses

     14,099       12,602       28,856       23,900  
                                

Loss from operations

     (667 )     (6,494 )     (9,698 )     (12,581 )

Other income (expense):

        

Interest and other income

     908       978       1,886       1,884  

Interest expense

     (720 )     (932 )     (1,434 )     (2,009 )

Debt conversion expense

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

Net other income (expense)

     188       (2,241 )     452       (2,412 )
                                

Net loss

   $ (479 )   $ (8,735 )   $ (9,246 )   $ (14,993 )
                                

Net loss per share, basic and diluted

   $ (0.01 )   $ (0.14 )   $ (0.13 )   $ (0.24 )
                                

Shares used in computing basic and diluted net loss per share

     69,364       64,207       69,298       63,040  
                                

(1)    Includes stock-based compensation related to the following:

        

Cost of revenues

     33     $ 18     $ 67     $ 26  

Research and development

     1,097       697       2,253       1,311  

Selling, general and administrative

     555       323       1,223       644  
                                

Total stock-based compensation

   $ 1,685     $ 1,038     $ 3,543     $ 1,981  
                                


DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

 

     As of
June 30, 2007
   As of
December 31, 2006 (1)
     (unaudited)     

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 32,231    $ 41,554

Short-term investments

     29,342      28,297

Accounts receivable

     11,658      2,152

Inventories

     2,039      2,052

Prepaid expenses and other current assets

     2,054      1,744
             

Total current assets

     77,324      75,799

Property and equipment, net

     7,769      7,451

Goodwill

     6,399      6,399

Intangible assets, net

     96      111

Long-term investments

     2,947      10,472

Restricted Investments

     1,284      1,284

Other non-current assets

     740      969
             

Total assets

   $ 96,559    $ 102,485
             

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 1,123    $ 864

Accrued liabilities

     5,210      4,522

Contract research liability

     2,168      1,624

Interest payable on convertible notes

     97      97

Deferred revenue, current portion

     5,324      5,348

Equipment financing obligations, current portion

     36      34

Bonds payable, current portion

     210      210

Other short-term liabilities

     141      —  
             

Total current liabilities

     14,309      12,699

Bond payable and equipment financing obligations, noncurrent portion

     587      606

Convertible subordinated notes due 2008

     37,337      37,337

Deferred revenue, noncurrent portion

     11,887      14,507

Other long-term liabilities

     498      304

Stockholders’ equity

     31,941      37,032
             

Total liabilities and stockholders’ equity

   $ 96,559    $ 102,485
             

(1) Derived from audited financial statements

SOURCE DURECT Corporation

CONTACT:

Matthew J. Hogan, Chief Financial Officer, DURECT Corporation, +1-408-777-4936

Media Contact:

Feinstein Kean Healthcare

Jeremiah Hall, Senior Vice President, +415 677-2700, jeremiah.hall@fkhealth.com

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