CUPERTINO, Calif., Nov. 5, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2012. Total revenues were $3.8 million for the three months ended September 30, 2012 as compared to $8.1 million for the three months ended September 30, 2011. Net loss for the three months ended September 30, 2012 was $4.8 million, compared to a net loss of $5.0 million for the same period in 2011.
At September 30, 2012, we had cash and investments of $21.0 million, compared to cash and investments of $23.7 million at June 30, 2012 and $30.8 million at December 31, 2011. We have no debt obligations, other than normal liabilities associated with running our business."Following our pre-NDA communications with the FDA this summer, we are preparing to submit a new drug application for POSIDUR in the first quarter of 2013," stated James E. Brown, D.V.M., President and CEO of DURECT. "Pfizer has initiated a confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions, with a data read out expected early in 2013. We also are pleased that Zogenix has been actively enrolling in the Phase I clinical trial for Relday."
Update of Programs:
Earnings Conference CallA live audio webcast of a conference call to discuss third quarter 2012 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on November 5 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 CorporationDURECT is a specialty pharmaceuticalcompany developing innovative drugs for pain and 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, TRANSDUR-Sufentanil and Relday are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement The statements in this press release regarding the potential bioavailability study for REMOXY, potential regulatory meetings and submissions for REMOXY and POSIDUR, anticipated clinical trials (including timing and results) for Relday and our other drug candidates, the potential benefits and uses of our drug candidates, collaborations with third parties and potential business development activities 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 risk that Pfizer will discontinue development of Remoxy, the risk of adverse decisions by regulatory agencies, including rejection of meeting requests, requests for additional information or product non-approval, delays and additional costs due to requirements imposed by regulatory agencies, potential adverse effects arising from the testing or use of our drug candidates, the potential failure of our clinical trials to meet their intended endpoints, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and 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, or ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the referenced product candidates, 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 operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q on August 7, 2012 under the heading "Risk Factors."
STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (in thousands, except per share amounts)(unaudited)Three months ended Nine months ended September 30, September 30, 2012201120122011Collaborative research and development and other revenue
5,906Product revenue, net
3,8288,11549,80824,552Operating expenses:Cost of product revenues
1,0371,3003,6163,786Research and development
4,7458,45215,36127,040Selling, general and administrative
2,8543,3779,18310,420Total operating expenses
8,63613,12928,16041,246Income (loss) from operations
(4,808)(5,014)21,648(16,694)Other income (expense):Interest and other income
(12)(42)(15)(42)Net other income
5(11)5167Net Income (loss)
(5,025)$ 21,699$ (16,627)Net income (loss) per shareBasic
(0.19)Weighted-average shares used in computing net income (loss) per shareBasic
87,67187,45087,72687,375Total comprehensive income (loss)
(5,037)$ 21,700$ (16,622) DURECT CORPORATIONBALANCE SHEET DATA(in thousands)As ofAs ofSeptember 30, 2012December 31, 2011(1)(unaudited)ASSETSCurrent assets:Cash and cash equivalents$
8,896Short-term investments12,19319,535Short-term restricted investments-367Accounts receivable2,0823,448Inventories3,2913,252Prepaid expenses and other current assets9351,803Total current assets24,78637,301Property and equipment, net2,5593,124Goodwill6,3996,399Intangible assets, net4053Long-term investments 2,1411,530Long-term restricted Investments400501Other long-term assets288288Total assets$
49,196LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable$
,274Accrued liabilities3,7604,884Contract research liability4721,361Deferred revenue, current portion3127,372Total current liabilities5,32914,891Deferred revenue, noncurrent portion1,55830,090Other long-term liabilities662738Stockholders' equity29,0643,477Total liabilities and stockholders' equity$
49,196(1) Derived from audited financial statements.
|SOURCE DURECT Corporation|
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