-----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, At9G6CK57Op/0vUkj1MLtKG8G4/NmmtVV99MFKLWZXMAJyESLTLP642QL7X4hN69 NST9if5eKXTMxiw5AoD+pQ== 0001193125-07-232519.txt : 20071101 0001193125-07-232519.hdr.sgml : 20071101 20071101161736 ACCESSION NUMBER: 0001193125-07-232519 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071101 DATE AS OF CHANGE: 20071101 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: 071207149 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

November 1, 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 November 1, 2007, DURECT Corporation, a Delaware corporation (“DURECT”), announced its third 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 November 1, 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: November 1, 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 November 1, 2007
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

DURECT Corporation Announces Third Quarter 2007 Financial Results

CUPERTINO, Calif., November 1, 2007/PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2007. Total revenues were $4.9 million for the three months ended September 30, 2007, compared to $5.1 million for the same period in 2006. Net loss for the three months ended September 30, 2007 was $7.9 million, compared to a net loss of $8.6 million for the same period in 2006. Cash used in operating activities was $1.0 million for the three months ended September 30, 2007, compared to $3.1 million in the three months ended September 30, 2006. At September 30, 2007, we had cash and investments of $66.6 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 third quarter of 2007 and the cash and investments balance at September 30, 2007 reflect the $8.0 million POSIDUR milestone payment from Nycomed that was recognized as revenue in the second quarter but was received in the third quarter.

“Our third quarter efforts focused on advancing our product development pipeline and improving our balance sheet. Toward that end, we recently reported positive results from our POSIDUR Phase IIb hernia study, King Pharmaceuticals and Pain Therapeutics completed enrollment in the Remoxy pivotal Phase III trial and Endo initiated their Phase II program with our TRANSDUR-Sufentanil patch,” stated James E. Brown, D.V.M., President and CEO of DURECT. “In addition, we took proactive steps to generate early conversions of our convertible notes to decrease our outstanding debt and to meter out the issuance of the underlying shares.”

Recent Company Highlights:

 

 

POSIDUR. In July 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. 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 held an end-of-Phase II meeting with the U.S. Food & Drug Administration (FDA) and are in dialogue with the FDA regarding the Phase III program. Hospira, our manufacturer of POSIDUR, has produced supplies for ICH stability, validation and Phase III clinical trials.

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 our licensee, Pain Therapeutics, and its sublicensee, King Pharmaceuticals, the Remoxy Phase III pivotal study is fully enrolled and top-line results of this study are expected in the fourth quarter of 2007. This pivotal Phase III trial is being conducted in accordance with a Special Protocol Assessment (SPA) with the FDA.


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

 

 

TRANSDUR-Sufentanil. According to its public disclosures, Endo Pharmaceuticals, our licensee for commercialization in the US and Canada, 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.

 

 

ELADUR (TRANSDUR-Bupivacaine). We have completed enrollment of patients and expect to report results 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.

 

 

Reduction in Convertible Notes. We reduced the balance of our outstanding convertible notes from $37.3 million at June 30, 2007 to $23.6 million as of October 31, 2007 ($33.1 million at September 30, 2007) by paying a small premium over the future interest payments due on these notes in order to induce early conversion.

 

 

Inclusion in New NASDAQ® Index. Effective September 25, 2007, we were selected as an inaugural member in the NASDAQ NeuroInsights® Neurotech Index (ticker: NERV). The Neurotech Index tracks the stock performance of 32 companies which meet certain minimum market criteria and were identified by NeuroInsights as being significantly involved in researching, developing, manufacturing and marketing pharmaceuticals, biologics, medical devices and diagnostics for the brain and nervous system.

Earnings Conference Call

A live audio webcast of a conference call to discuss third 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, anticipated data announcements from the ELADUR Phase IIa trial and the Remoxy pivotal Phase III trial, discussions with the FDA and other anticipated regulatory, clinical and development milestones and timing thereof, future clinical trial results and our intended 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, 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 August 8, 2007 under the heading “Risk Factors.”


DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2007     2006     2007     2006  

Collaborative research and development revenue

   $ 2,992     $ 3,158     $ 9,858     $ 10,264  

Milestone revenue

     —         —         8,000       —    

Product revenue, net

     1,940       1,976       6,232       6,189  
                                

Total revenues

     4,932       5,134       24,090       16,453  
                                

Operating expenses:

        

Cost of revenues (1)

     780       666       2,418       2,265  

Research and development (1)

     8,858       9,930       28,840       25,643  

Selling, general and administrative (1)

     3,135       3,346       10,356       9,540  

Amortization of intangible assets

     8       22       23       416  
                                

Total operating expenses

     12,781       13,964       41,637       37,864  
                                

Loss from operations

     (7,849 )     (8,830 )     (17,547 )     (21,411 )

Other income (expense):

        

Interest and other income

     906       957       2,792       2,841  

Interest expense

     (716 )     (710 )     (2,150 )     (2,719 )

Debt conversion expense

     (223 )     —         (223 )     (2,287 )
                                

Net other income (expense)

     (33 )     247       419       (2,165 )
                                

Net loss

   $ (7,882 )   $ (8,583 )   $ (17,128 )   $ (23,576 )
                                

Net loss per share, basic and diluted

   $ (0.11 )   $ (0.12 )   $ (0.25 )   $ (0.36 )
                                

Shares used in computing basic and diluted net loss per share

     69,655       68,688       69,414       64,943  
                                

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

        

Cost of revenues

     31     $ 20     $ 98     $ 47  

Research and development

     1,038       774       3,291       2,084  

Selling, general and administrative

     497       368       1,720       1,011  
                                

Total stock-based compensation

   $ 1,566     $ 1,162     $ 5,109     $ 3,142  
                                


DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

 

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

ASSETS

     

Current assets:

     

Cash and cash equivalents

   $ 36,030    $ 41,554

Short-term investments

     27,314      28,297

Accounts receivable

     5,437      2,152

Inventories

     2,027      2,052

Prepaid expenses and other current assets

     1,989      1,744
             

Total current assets

     72,797      75,799

Property and equipment, net

     7,918      7,451

Goodwill

     6,399      6,399

Intangible assets, net

     88      111

Long-term investments

     1,983      10,472

Restricted Investments

     1,283      1,284

Other non-current assets

     280      969
             

Total assets

   $ 90,748    $ 102,485
             

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities:

     

Accounts payable

   $ 606    $ 864

Accrued liabilities

     7,051      4,522

Contract research liability

     1,536      1,624

Interest payable on convertible notes

     604      97

Deferred revenue, current portion

     5,239      5,348

Equipment financing obligations, current portion

     37      34

Bonds payable, current portion

     210      210

Other short-term liabilities

     149      —  

Convertible subordinated notes due 2008

     33,145      —  
             

Total current liabilities

     48,577      12,699

Bond payable and equipment financing obligations, noncurrent portion

     578      606

Convertible subordinated notes due 2008

     —        37,337

Deferred revenue, noncurrent portion

     10,578      14,507

Other long-term liabilities

     780      304

Stockholders’ equity

     30,235      37,032
             

Total liabilities and stockholders’ equity

   $ 90,748    $ 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

-----END PRIVACY-ENHANCED MESSAGE-----