Navigation Links
DURECT Corporation Announces Third Quarter 2010 Financial Results

CUPERTINO, Calif., Nov. 3, 2010 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2010. Total revenues were $8.1 million for the three months ended September 30, 2010 compared to $8.4 million for the three months ended September 30, 2009; revenues in the 2009 period included $3.0 million recognized from the sale of certain excipients used in REMOXY® to King Pharmaceuticals in prior periods. Net loss for the three months ended September 30, 2010 was $4.6 million, compared to a net loss of $5.5 million for the same period in 2009.



At September 30, 2010, we had cash and investments of $53.0 million, compared to cash and investments of $41.6 million at December 31, 2009.

"Our pipeline of product candidates continued to advance during the third quarter while we maintained a modest burn rate," stated James E. Brown, D.V.M., President and CEO of DURECT.  "King Pharmaceuticals is preparing the NDA resubmission for REMOXY by year-end. King continues to enroll chronic low back pain patients in a Phase IIb clinical study of our proprietary bupivacaine patch, ELADUR™; we currently anticipate receiving top-line data from that study in the first half of 2011. Should Pfizer complete its acquisition of King, we believe that Pfizer will bring added development and commercialization strength to REMOXY, the other ORADUR-based opioids in our collaboration as well as ELADUR. During the quarter, we also continued to enroll patients in BESST, our pivotal U.S. Phase III clinical study for POSIDUR™. Our cash burn rate in the quarter declined to $4.2 million from $6.1 million in the previous quarter, reflecting the first full quarter of our collaboration with Hospira covering the development and commercialization of POSIDUR in the U.S. and Canada, and we anticipate that we will be cash flow positive for all of 2010 by approximately $6 million."Business Highlights:•

REMOXY.  Our understanding is that King anticipates that in the fourth quarter of 2010 it will resubmit the NDA for REMOXY intended to address all FDA comments in the Complete Response Letter.  In July 2009, King met with the FDA to discuss the Complete Response Letter received in December 2008 regarding the REMOXY NDA.  Assuming Pfizer completes its acquisition of King, Pfizer will assume the development and commercialization rights and obligations to REMOXY.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.•

POSIDUR (SABER™-Bupivacaine) Post-Operative Pain Relief Depot.  In June 2010, we entered into an agreement with Hospira covering the development and commercialization of POSIDUR in the U.S. and Canada.  Under terms of the agreement, Hospira made an upfront payment to us of $27.5 million, with the potential for up to an additional $185 million in performance based milestone payments based on the successful development, approval and commercialization of POSIDUR.  For the U.S. and Canada, the two companies will jointly direct and equally fund the remaining development costs for POSIDUR, while Hospira will have exclusive commercialization rights with sole funding responsibility for commercialization activities.  In addition, if commercialized, Hospira will pay DURECT a royalty on product sales.In the third quarter of 2010, we continued to enroll patients in our U.S. pivotal Phase III clinical study known as BESST (Bupivacaine Effectiveness and Safety in SABER Trial).  We expect to complete enrollment of BESST, comprising approximately 300 patients, in the first half of 2011.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 (TRANSDUR™-Bupivacaine).  In October 2008, worldwide rights to this program were licensed to Alpharma, which was acquired by King Pharmaceuticals in December 2008.  In April 2010, King Pharmaceuticals initiated a Phase IIb trial evaluating the safety and efficacy of ELADUR in patients with chronic low back pain.  King expects to enroll approximately 260 patients in this study and we expect to receive top-line results from that study in the first half of 2011.  Assuming Pfizer completes its acquisition of King, Pfizer will assume the development and commercialization rights and obligations to ELADUR.ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from each application.•

TRANSDUR-Sufentanil.  In February 2009, a successful end-of-Phase II meeting with the FDA was conducted for this program outlining a potential regulatory pathway for the Phase III program and NDA submission. During 2009, we transitioned the program back to our control.  We are in discussions with 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 deliver sufentanil to chronic pain sufferers for a period of up to seven days from a single application.•

ORADUR-ADHD Program.  In July 2010, we commenced a Phase I clinical trial in this program with multiple formulations. ORADUR-ADHD applies our proprietary ORADUR technology to a leading active pharmaceutical ingredient for the treatment of attention deficit disorder (ADHD). Under an agreement with Orient Pharma, we are collaborating to perform a clinical development program through a Phase II study intended to produce a data package that will support later stage development of the drug candidate and subsequent licensing by DURECT. We are responsible for formulation and study design of the pre-defined clinical program, which Orient Pharma will fund and execute.•

Therapeutic Discovery Tax Grant.  In October 2010, DURECT was notified that we have been awarded grants totaling $733,438 under the Patient Protection and Affordable Care Act of 2010 for three qualifying therapeutic discovery projects; we expect to receive this funding in the fourth quarter of 2010.Earnings Conference CallA live audio webcast of a conference call to discuss third quarter 2010 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on November 3 and is available by accessing DURECT's homepage at 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 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

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 our projected financial results including annual cash burn, the anticipated resubmission of the REMOXY NDA, the potential acquisition of King Pharmaceuticals by Pfizer, our U.S. pivotal Phase III clinical trial (BESST) for POSIDUR including the anticipated timing of completion of the trial and patient enrollment numbers, potential milestone payments and royalties receivable from Hospira, Phase IIb trial for ELADUR including anticipated patient enrollment numbers and timing thereof, our intention to enter into collaborations with respect to TRANSDUR-Sufentanil and our ORADUR-ADHD Phase I trial, 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, delays and additional costs due to requirements imposed by regulatory agencies on our drug candidates, unexpected results and adverse events from clinical trials for our drug candidates, our failure to achieve the performance milestones or commercial sales that trigger the referenced payments or royalties under our collaborative agreements, our (and that of our third party collaborators where applicable) difficulty or failure to obtain approvals from regulatory agencies with respect to development activities and products, design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the referenced drug candidates, consummate collaborative agreements relating to our drug candidates and technologies, manufacture and commercialize the referenced drug candidates, obtain marketplace acceptance of the referenced drug candidates, avoid infringing patents held by other parties and secure and defend patents of our own, and manage and obtain capital to fund our growth, operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q on August 5, 2010 under the heading "Risk Factors."DURECT CORPORATIONSTATEMENT OF OPERATIONS DATA(in thousands, except per share amounts)(Unaudited)Three months ended Nine months ended September 30, September 30, 2010200920102009Collaborative research and development and other revenue

9,545Product revenue, net

2,4275,3518,93310,037Total revenues

8,1168,37823,09519,582Operating expenses:Cost of product revenues (1)

8592,8343,0984,495Research and development (1)

8,1427,59826,76725,534Selling, general and administrative (1)

3,8063,55410,89211,588Total operating expenses

12,80713,98640,75741,617Loss from operations

(4,691)(5,608)(17,662)(22,035)Other income (expense):Interest and other income

4682105367Interest and other expense

(2)(9)(25)(31)Net other income 447380336Net loss$
(21,699)Net loss per share, basic and diluted

(0.26)Shares used in computing basic and diluted net loss per share

86,89282,78186,83282,317(1) Includes stock-based compensation related to the following:Cost of product revenues

286Research and development

1,1511,6653,7185,273Selling, general and administrative

6917852,0232,820Total stock-based compensation

8,379DURECT CORPORATIONCONDENSED BALANCE SHEETS (in thousands)As ofAs ofSeptember 30, 2010December 31, 2009 (1)(unaudited)ASSETSCurrent assets:Cash and cash equivalents$
8,287Short-term investments34,51832,834Short-term restricted investments66-Accounts receivable3,3111,700Inventories2,9642,799Prepaid expenses and other current assets1,6761,433Total current assets54,67347,053Property and equipment, net2,1143,808Goodwill6,3996,399Intangible assets, net76108Long-term investments 5,908-Long-term restricted Investments367431Other long-term assets288352Total assets$
58,151LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:Accounts payable$
,019Accrued liabilities4,7095,337Contract research liability1,310990Deferred revenue, current portion8,0794,703Other short-term liabilities218208Total current liabilities14,91512,257Deferred revenue, noncurrent portion36,86817,543Other long-term liabilities344508Stockholders' equity17,69827,843Total liabilities and stockholders' equity$
58,151(1)  Derived from audited financial statements.

Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. DURECT Corporation Invites You to Join Its Second Quarter 2010 Earnings Conference Call
2. DURECT to Present at the BMO Capital Markets Focus on Healthcare Conference
3. DURECT Corporation Secures $50 Million Committed Equity Financing Facility
4. DURECT Reports Data From European Phase IIb Hysterectomy Study of POSIDUR(TM) (SABER(TM)-Bupivacaine)
5. DURECT to Present at the Jefferies Global Life Sciences Conference
6. DURECT to Present at the Rodman & Renshaw Global Healthcare Conference
7. DURECT Corporation Invites You to Join Its First Quarter 2010 Earnings Conference Call
8. DURECT to Present at the Barclays Capital Global Healthcare Conference
9. DURECT to Present at the Cowen and Company Healthcare Conference
10. DURECT Corporation Announces Fourth Quarter and Year End 2009 Financial Results
11. DURECT and Nycomed Amend POSIDUR(TM) License Agreement to Separate Funding and Control of U.S. and E.U. Clinical Programs and to Expand Territory
Post Your Comments:
(Date:10/9/2015)... 9, 2015 India ... --> India along ... announces addition of 3 divalproex sodium market ... for global markets as well as individually for ... with analysis of major players. ...
(Date:10/9/2015)... Oct. 9, 2015  The Centers for Disease ... Emerging and Zoonotic Infectious Diseases, Office of Advanced ... into a research collaboration to evaluate the performance ... of this research collaboration is to evaluate the ... public health and infectious disease applications. This collaboration ...
(Date:10/9/2015)... -- ClinicalKey Nursing debuts at ...   Elsevier , a world-leading provider of scientific, ... ClinicalKey for Nursing , a new clinical reference platform that ... needs of nursing professionals. Attendees of the ANCC National ... 7-9, will have the opportunity to demo ClinicalKey Nursing at ...
Breaking Medicine Technology:
... NEW YORK, Oct. 5, 2011 ... research report is available in its ... Drug Market: Strategic Assessments of Leading ... This report provides ...
... 2011 announces that a ... in its catalogue: ... Leading Suppliers ... provides industry executives with strategically significant ...
Cached Medicine Technology:
(Date:10/10/2015)... ... October 10, 2015 , ... The Bank of America 500 NASCAR Sprint ... Saturday, October 10th, defending race winner, Kevin Harvick, will battle it out for ... Jr., and all of the stars of the NASCAR Sprint Cup Series. As ...
(Date:10/10/2015)... ... October 10, 2015 , ... Attending ... the health of men, women and children. Depending on the school, the exact ... to the medical field. , Students in a medical school must complete undergraduate ...
(Date:10/10/2015)... Philadelphia, PA (PRWEB) , ... October 10, 2015 ... ... Newman, Wigrizer, Brecher & Miller is pleased to be recognized by The National ... Lawyers. This list acknowledges the 50 law firms across the United States who ...
(Date:10/9/2015)... ... October 09, 2015 , ... Doctors on Liens ... Fresno , to provide highly needed medical care to personal injury victims. When ... providers to diagnose, document and treat the variety of conditions ailing them. With ...
(Date:10/9/2015)... ... October 09, 2015 , ... Each year, over ... the pre-eminent organization in global health: the World Health Organization (WHO). At its ... These internships are a mechanism for WHO to help build public health capacity ...
Breaking Medicine News(10 mins):
... A new $10 million research project which aims at ... launched by the Preventative Health //Flagship, a CSIRO program ... on the early detection of Alzheimer's disease, which currently ... researchers will be using Positron Emission Tomography (PET scans) ...
... screening appears to be increasing among Veterans Affairs patients, ... screening procedures// , according to a report. A second ... with other illnesses and reduced life expectancies may not ... harmed, but continue to be screened at high rates. ...
... have come up with incriminating evidence that warns non-vegetarians who ... study has pointed out that eating more than one and ... developing hormone related breast cancer and another study that ... heart from heart diseases except for vitamin C which seems ...
... the remedy of choice for treatment of influenza is causing ... side effects, regulators said today. ,The U.S. FDA has ... and mental disorientation were reported from Japan by people who ... reports concerned children. ,The new label approved by ...
... patients will adhere more closely to their medication regimens ... care program that includes patient education, specially packaged medications, ... ,The “Federal Study of Adherence to Medications in the ... Health-System Pharmacists (ASHP) Research and Education Foundation, followed 200 ...
... onset of diabetes today is linked to high stress levels. ... diet, hypertension and lack of physical exercise. The number of ... crores and about 7.2 lakh lives are claimed by this ... realize consequences of this deadly disease. , ,Because ...
Cached Medicine News:
Rotating 360 degrees, 3 mm x 7 mm bite....
45 degree, forward 3 mm, 4 mm x 5 mm cup, length of shaft 140 mm, overall length 8.3 inches....
20 mm. Plastic, methylmethacrylate. Supplied sterile....
Small right. Teflon orbital plates....
Medicine Products: