CUPERTINO, Calif., May 5, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2011. Total revenues increased to $8.6 million for the three months ended March 31, 2011 from $7.7 million for the three months ended March 31, 2010. Net loss for the three months ended March 31, 2011 was $6.4 million, compared to a net loss of $6.6 million for the same period in 2010.(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)
At March 31, 2011, we had cash and investments of $41.9 million, compared to cash and investments of $49.6 million at December 31, 2010."We are pleased that an experienced and professional organization such as Pfizer is handling the REMOXY® NDA resubmission, and if approved, the marketing of REMOXY," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, our pivotal Phase III trial for POSIDUR™ (BESST) is approaching completion of enrollment with top-line data anticipated this year. These two most advanced programs are complemented by a diverse pipeline of other product candidates which we are progressing in the pain and ADHD markets."
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 resist common methods of prescription drug misuse and abuse. An abuse liability study was recently published in Pain Medicine, the Official Journal of the American Academy of Pain Medicine. In this study of REMOXY versus Oxycodone ER tested in volunteers with a history of opioid abuse, REMOXY met all prospectively defined primary endpoints. See "The Abuse Potential of Remoxy®, an Extended-Release Formulation of Oxycodone, Compared with Immediate- and Extended-Release Oxycodone" (Pain Medicine 2011; 12; 618-631). This study complements previously published data on the extraction under various conditions of oxycodone from REMOXY; see "Remoxy®: A Novel Formulation of Extended-Release Oxycodone Developed Using the ORADUR® Technology" (The Journal of Applied Research, Vol.10, No.3, 2010) which is accessible on DURECT's website at www.durect.com/wt/durect/page_name/Publications.
In February 2011, we announced results from a shoulder surgery Phase II study conducted in Europe by Nycomed.
At that time, we and Nycomed amended our agreement such that, for an interim period, DURECT will have full control and financial responsibility for non-clinical and CMC activities which had been previously jointly controlled and funded by DURECT and Nycomed. If Nycomed elects to continue European development of POSIDUR after evaluation of BESST data, under the terms of the amendment, DURECT and Nycomed would resume joint control and financial responsibility of the non-clinical and CMC activities for the E.U. and the U.S.
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 Hospira for commercialization in the U.S. and Canada, and to Nycomed for commercialization in Europe and other defined countries. We have retained commercialization rights in Japan and all other countries not subject to the Nycomed and Hospira licenses.
ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from a single application. ELADUR demonstrated a positive efficacy trend in a Phase 2a study for post-herpetic neuralgia (PHN); a poster describing this study was presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and is accessible on DURECT's website at www.durect.com/wt/durect/page_name/Publications.
TRANSDUR-Sufentanil is our proprietary transdermal patch intended to deliver sufentanil to chronic pain sufferers for a period of up to seven days from a single application.
Earnings Conference CallA live audio webcast of a conference call to discuss first quarter 2011 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 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 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®, ELADUR®, and DURIN® 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.
DURECT Forward-Looking StatementThe statements in this press release regarding the potential approval and timing of approval of REMOXY by the FDA and subsequent product launch by Pfizer, anticipated completion of enrollment of BESST and receipt of top-line data for POSIDUR, possible licensing transactions relating to TRANSDUR-Sufentanil, future development activities regarding ELADUR, anticipated commencement of a new Phase I trial for ORADUR-ADHD and our other drug candidates and the potential benefits and uses of our drug 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 risk of adverse decisions by regulatory agencies, including 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 its growth, operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-K on March 3, 2011 under the heading "Risk Factors."DURECT CORPORATIONBALANCE SHEET DATA(in thousands)As ofAs ofMarch 31, 2011December 31, 2010 (1)(unaudited)ASSETSCurrent assets:Cash and cash equivalents$
,437Short-term investments33,54135,005Short-term restricted investments-66Accounts receivable3,8163,716Inventories2,9562,836Prepaid expenses and other current assets2,6502,785Total current assets47,79354,845Property and equipment, net1,7521,776Goodwill6,3996,399Intangible assets, net6771Long-term investments 2,6743,197Long-term restricted Investments867867Other long-term assets393405Total assets$
7,560LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable$
981Accrued liabilities3,9766,524Contract research liability2,9772,109Deferred revenue, current portion8,0868,079Other short-term liabilities214216Total current liabilities16,13217,909Deferred revenue, noncurrent portion32,82934,849Other long-term liabilities324315Stockholders’ equity10,66014,487Total liabilities and stockholders’ equity$
7,560(1) Derived from audited financial statements.DURECT CORPORATIONSTATEMENTS OF OPERATIONS DATA(in thousands, except per share amounts)(unaudited)Three months ended March 31, 20112010Collaborative research and development and other revenue
3,816Product revenue, net
8,6047,666Operating expenses:Cost of revenues (1)
1,4011,378Research and development (1)
9,8809,421Selling, general and administrative (1)
3,7163,502Total operating expenses
14,99714,301Loss from operations
(6,393)(6,635)Other income (expense):Interest and other income
4011Interest and other expense
(4)(2)Net other income 369Net loss$
(6,626)Net loss per share, basic and diluted
(0.08)Shares used in computing basic and diluted net loss per share
87,27086,756(1) Includes stock-based compensation related to the following:Cost of revenues$
84Research and development
1,1271,277Selling, general and administrative
571669Total stock-based compensation
|SOURCE DURECT Corporation|
Copyright©2010 PR Newswire.
All rights reserved