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 3, 2009

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 3, 2009, DURECT Corporation, a Delaware corporation (“DURECT”), announced its second quarter 2009 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 3, 2009

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 3, 2009	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 3, 2009

EX-99.1

Exhibit 99.1

DURECT Corporation Announces Second Quarter 2009 Financial Results

CUPERTINO, Calif., August 3, 2009/PRNewswire-FirstCall/ — DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2009. Total revenues were $4.9 million for the three months ended June 30, 2009, compared to $6.3 million for the same period in 2008. Net loss for the three months ended June 30, 2009 was $7.5 million, compared to a net loss of $8.6 million for the same period in 2008.

At June 30, 2009, DURECT had cash and investments of $41.9 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at June 30, 2009 and $1.0 million at December 31, 2008.

“Our senior management team was strengthened during the second quarter through the hiring of Joe Stauffer as our Chief Medical Officer, a former anesthesiologist and FDA reviewer with directly relevant experience covering all aspects of developing pain medications,” stated James E. Brown, D.V.M., President and CEO of DURECT. “It is also noteworthy that we signed four new feasibility projects in the quarter with pharmaceutical companies to apply our SABER™ depot and DURIN™ injectable technologies to address specific drug delivery challenges for both small molecule and biologic agents. Shortly after the end of the quarter, we were pleased to learn that King Pharmaceuticals met with the FDA regarding Remoxy® and believes that they have a clear path forward that could allow them to resubmit the Remoxy NDA in mid-2010.”

Recent Highlights:

• Remoxy. Pain Therapeutics, our licensee, received a Complete Response Letter from the FDA in December 2008 indicating that the NDA is not approved in its present form. King Pharmaceuticals, the commercialization partner of Pain Therapeutics for Remoxy, assumed responsibility for further development of Remoxy from Pain Therapeutics in March 2009 and met with the Food and Drug Administration (FDA) on July 2, 2009 to discuss the Complete Response Letter. According to King Pharmaceuticals and Pain Therapeutics, the outcome of that meeting provided King with a clear path forward to resubmit the REMOXY NDA and to address all FDA comments in the Complete Response Letter. According to the King Pharmaceuticals / Pain Therapeutics press release, King now anticipates the resubmission of the NDA could occur mid-year 2010. King has stated that it remains committed to the development and commercialization of REMOXY and looks forward to working closely with the FDA toward approval of the product.

REMOXY, an investigational drug, is a long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT’s ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to resist common methods of prescription drug misuse and abuse.

• POSIDUR™ (SABER™-Bupivacaine). During the quarter, DURECT continued enrollment in our approximately 60 patient Phase IIb clinical study in shoulder surgery. In addition, Nycomed continued enrollment in a Phase IIb study in hysterectomy patients and a Phase IIb study in shoulder surgery patients. We are in active discussions with multiple potential partners regarding licensing of the U.S./Canada and Asian rights to this program.

POSIDUR is our investigational 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 we have retained commercialization rights in the US, Canada and Asia.

• ELADUR™ (TRANSDUR™-Bupivacaine). In October 2008, worldwide rights to this program were licensed to Alpharma, which was acquired by King Pharmaceuticals in December 2008. During the second quarter, we continued to interact with the King team on details associated with next steps in the clinical program, which King expects to initiate this year.

ELADUR is our proprietary transdermal patch intended to provide bupivacaine for a period of up to three days from a single application.

• TRANSDUR-Sufentanil. A successful end-of-Phase II meeting with the FDA has been conducted for this program that laid out a potential regulatory pathway for the Phase III program and approval. We are in active discussions with multiple potential partners regarding licensing development and commercialization rights to this program to which we hold worldwide rights.

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.

• Feasibility Projects. During the second quarter, we signed four new feasibility projects with pharmaceutical and biotechnology companies whereby we will apply our SABER and DURIN technologies to both small molecule and biologic agents of interest to our collaborator. We undertake these feasibility projects as a means of demonstrating that our technologies can achieve the drug delivery objectives set forth by our collaborators and are worthy of further development. These feasibility projects entail anticipated revenue to DURECT of approximately $1.4 million in total during 2009.

Earnings Conference Call

A live audio webcast of a conference call to discuss second quarter 2009 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on August 3 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 is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR™, and TRANSDUR™-Sufentanil. DURECT’s proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. 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. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the US Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding plans by King Pharmaceuticals for resubmission of the REMOXY NDA in mid-2010 and their belief that this resubmission will address all FDA comments in the Complete Response Letter, the potential of FDA approving the REMOXY NDA, the timing and content of any potential update to be provided by King Pharmaceuticals, as well as the potential royalty and other payments that may be received by DURECT from REMOXY, our possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, and potential agreements with third parties about licensing and development rights to our product candidates 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, the potential that the REMOXY NDA resubmission may not adequately address all of FDA’s concerns, the potential that FDA may not grant regulatory approval of REMOXY, failure of our clinical trials to produce intended results, possible adverse events associated with the use of our drug candidates, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of our drug candidates, DURECT’s (and that of its third party collaborators where applicable) difficulty or failure 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, avoid infringing patents held by other parties and secure and defend patents of our own, and manage and obtain capital to fund its growth, operations and expenses. Further information regarding these and other risks is included in DURECT’s Form 10-Q filed on May 7, 2009 under the heading “Risk Factors.”

DURECT CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

(unaudited)

	Three months ended						Year ended
	June 30,						June 30,
	2009			2008			2009			2008
Collaborative research and development revenue	$	2,606		$	3,867		$	6,351		$	8,136
Product revenue, net		2,271			2,436			4,686			4,605
Total revenues		4,877			6,303			11,037			12,741
Operating expenses:
Cost of revenues (1)		837			982			1,661			1,804
Research and development (1)		7,866			9,898			17,769			19,532
Selling, general and administrative (1)		3,777			4,086			8,034			7,976
Total operating expenses		12,480			14,966			27,464			29,312
Loss from operations		(7,603	)		(8,663	)		(16,427	)		(16,571	)
Other income (expense):
Interest and other income		106			368			285			936
Interest expense		(11	)		(304	)		(22	)		(759	)
Net other income		95			64			263			177
Net loss	$	(7,508	)	$	(8,599	)	$	(16,164	)	$	(16,394	)
Net loss per share, basic and diluted	$	(0.09	)	$	(0.11	)	$	(0.20	)	$	(0.22	)
Shares used in computing basic and diluted net loss per share		82,138			75,430			82,081			74,772
(1)    Includes stock-based compensation related to the following:
Cost of revenues	$	117		$	31		$	195		$	66
Research and development		1,327			1,360			3,608			2,967
Selling, general and administrative		864			674			2,035			1,449
Total stock-based compensation	$	2,308		$	2,065		$	5,838		$	4,482

DURECT CORPORATION

CONDENSED BALANCE SHEETS

(in thousands)

	As of June 30, 2009		As of December 31, 2008 (1)
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	10,024	$	29,445
Short-term investments		24,507		20,836
Short-term restricted investments		372		624
Accounts receivable		2,336		4,055
Inventories		2,737		3,474
Prepaid expenses and other current assets		3,037		1,850
Total current assets		43,013		60,284
Property and equipment, net		4,955		5,971
Goodwill		6,399		6,399
Intangible assets, net		133		157
Long-term investments		6,528		1,362
Long-term restricted Investments		428		425
Other long-term assets		368		276
Total assets	$	61,824	$	74,874
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	846	$	1,018
Accrued liabilities		4,135		5,204
Contract research liability		616		995
Deferred revenue, current portion		8,074		9,235
Other short-term liabilities		421		431
Total current liabilities		14,092		16,883
Deferred revenue, noncurrent portion		19,552		19,771
Other long-term liabilities		614		656
Stockholders’ equity		27,566		37,564
Total liabilities and stockholders’ equity	$	61,824	$	74,874

(1) Derived from audited financial statements.

SOURCE DURECT Corporation

CONTACT:

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