CUPERTINO, Calif., May 3, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2012. Excluding the accelerated recognition of deferred revenue described below, DURECT's reported revenues would have been $5.8 million for the three months ended March 31, 2012 (as compared to $8.6 million for the same period in 2011) and reported net loss would have been $4.6 million for the three months ended March 31, 2012 (as compared to a net loss of $6.4 million for the same period in 2011). Total revenues as reported under GAAP were $41.2 million and net income as reported under GAAP was $30.8 million for the three months ended March 31, 2012; these figures include the accelerated recognition of $35.4 million in deferred revenue associated with upfront fees previously received under terminated collaboration agreements. This $35.4 million in revenue is non-recurring and has no cash flow impact for the quarter.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)At March 31, 2012, we had cash and investments of $26.4 million, compared to cash and investments of $30.8 million at December 31, 2011."This quarter was dominated by the POSIDUR™ clinical trial results and partnership terminations. However, we continued to make progress with our development programs and we have recently reinforced the protection of our pipeline through 13 patent issuances and 2 patent allowances involving major and/or partnered programs that extend patent protection in large market jurisdictions to 2025 or beyond," stated James E. Brown, D.V.M., President and CEO of DURECT. "In particular, we now have issued U.S. patents covering REMOXY® and our other ORADUR®-based opioid programs that extend to at least 2025 as well as an issued European patent providing coverage to at least 2023."
Update of Programs:
REMOXY, an investigational drug, is a unique 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 discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.
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. We currently hold worldwide commercialization rights to POSIDUR following the notice given in the first quarter of 2012 by Hospira and Nycomed to terminate their collaborations related to the program.
Earnings Conference CallA live audio webcast of a conference call to discuss first quarter 2012 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 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 CorporationDURECT is a specialty pharmaceutical company 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 studies 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 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-K on March 2, 2012 under the heading "Risk Factors."DURECT CORPORATIONSTATEMENTS OF COMPREHENSIVE INCOME (LOSS) (in thousands, except per share amounts)(Unaudited)Three months ended March 31, 20122011Collaborative research and development and other revenue
$38,328$ 5,512Product revenue, net
41,1858,604Operating expenses:Cost of product revenues
1,4611,401Research and development
5,6349,880Selling, general and administrative
3,2803,716Total operating expenses
10,37514,997Income (loss) from operations
30,810(6,393)Other income (expense):Interest and other income
(2)(4)Net other income
1936Net Income (loss)
$30,829$(6,357)Net income (loss) per shareBasic $ 0.35$ (0.07)Diluted$ 0.35$ (0.07)Weighted-average shares used in computing net income (loss) per shareBasic 87,54787,270Diluted87,56887,270Total comprehensive income (loss)
$30,826$(6,343) DURECT CORPORATIONCONDENSED BALANCE SHEETS (in thousands)As ofAs ofMarch 31, 2012December 31, 2011(1)(unaudited)ASSETSCurrent assets:Cash and cash equivalents
$ 7,537$ 8,896Short-term investments
15,12819,535Short-term restricted investments
3,2333,252Prepaid expenses and other current assets
1,4881,803Total current assets
30,30137,301Property and equipment, net
6,3996,399Intangible assets, net
3,2241,530Long-term restricted Investments
501501Other long-term assets
$ 43,703$ 49,196LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable
$ 615$ 1,274Accrued liabilities
3,7084,884Contract research liability
6651,361Deferred revenue, current portion
3127,372Total current liabilities
5,30014,891Deferred revenue, noncurrent portion
1,71430,090Other long-term liabilities
35,9743,477Total liabilities and stockholders' equity
$ 43,703$ 49,196(1) Derived from audited financial statements.
|SOURCE DURECT Corporation|
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