DURECT Corporation Announces Fourth Quarter and Year End 2009 Financial Results

CUPERTINO, Calif., Feb. 24 /PRNewswire-FirstCall/ -- DURECT Corporation announced today financial results for the three months and year ended December 31, 2009. Total revenues were $4.9 million for the three months ended December 31, 2009 and $7.7 million for the three months ended December 31, 2008. Net loss for the three months ended December 31, 2009 was $9.0 million, compared to a net loss of $18.4 million for the same period in 2008 which included a $13.5 million non-cash write-down associated with a research and development program (Chronogesic(R)) that we are no longer actively pursuing.

For the fiscal year ended December 31, 2009, total revenues were $24.3 million, compared to $27.1 million for the same period in 2008. Net loss for the year ended December 31, 2009 was $30.7 million, compared to a net loss of $43.9 million for the same period in 2008 (including the $13.5 million write-down described above).

“We advanced our late stage pipeline in 2009, most notably through the recent initiation of BESST, our pivotal U.S. Phase III clinical study for POSIDUR(TM), and through work by King Pharmaceuticals to prepare the NDA resubmission for REMOXY(TM),” stated James E. Brown, D.V.M., President and CEO of DURECT. “Our goals for 2010 include enrolling patients in POSIDUR’s Phase III program, assisting King with aspects of the REMOXY NDA resubmission, advancing our other development programs, and establishing favorable licensing collaborations.”

About DURECT Corporation

NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), ELADUR(TM), and DURIN(TM) 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 U.S. Food and Drug Administration or other health authorities.

The statements in this press release regarding our anticipated net cash consumption, the anticipated resubmission of the REMOXY NDA, anticipated clinical trials (including timing and results) for POSIDUR, TRANSDUR-Sufentanil, ELADUR, ORADUR-ADHD and our other drug candidates, the potential benefits and uses of our drug candidates and potential collaborations with third parties 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, delays and additional costs due to requirements imposed by regulatory agencies, 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 on November 2, 2009 under the heading “Risk Factors.”

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