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DURECT Corporation Announces First Quarter 2010 Financial Results CUPERTINO, CA

Key Takeaway: DURECT Corporation Announces First Quarter 2010 Financial Results CUPERTINO, CA, May 10, 2010/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2010. Total revenues were $7.7 million for the three mont

Full Press Release Details

DURECT Corporation Announces First Quarter 2010 Financial Results
CUPERTINO, CA, May 10, 2010/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months
ended March 31, 2010. Total revenues were $7.7 million for the three months ended March 31, 2010 and $6.2 million for the three months ended March 31, 2009. Net loss for the three months ended March 31, 2010 was $6.6 million,
compared to a net loss of $8.7 million for the same period in 2009.
At March 31, 2010, we had cash and investments of $35.8 million,
compared to cash and investments of $41.6 million at December 31, 2009.
Our late stage pipeline continues to advance in 2010. Of
note, BESST, our pivotal U.S. Phase III clinical study for POSIDUR , is well underway. With respect to our partnered programs, King Pharmaceuticals is preparing the NDA resubmission for REMOXY by year end and has initiated a Phase IIb
clinical study of ELADUR in chronic low back pain, stated James E. Brown, D.V.M., President and CEO of DURECT.
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 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 Nycomed for commercialization in Europe and other defined countries, and we have retained commercialization rights in the U.S., Canada, Japan and all other countries. In February 2010, we
amended our agreement with Nycomed to separate funding and control of the U.S. and European clinical programs and to expand the territory licensed to Nycomed. The parties are not altering the final decision making authority and financial
responsibility for the remainder of the development activities, such as the non-clinical and CMC (Chemistry, Manufacturing and Control) activities, which will continue to be jointly managed and funded by Nycomed and us. We are in discussions with
potential partners regarding licensing of the U.S./Canadian and Japanese rights to this program.
ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days
from a single application.
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 Call
A live audio webcast of a conference call to discuss first quarter 2010 results will be broadcast live over the internet at 4:30 p.m. Eastern
Time on May 10 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 Corporation
DURECT is an emerging 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 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
DURECT Forward-Looking Statement
The statements in this press release regarding the anticipated resubmission of the REMOXY NDA, our U.S. pivotal Phase III clinical trial (BESST) for
POSIDUR and Phase IIb trial for ELADUR including anticipated patient enrollment numbers and timing thereof, 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 on our drug candidates, unexpected results and adverse events from clinical trials for our drug candidates, 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 our growth, operations and expenses. Further information regarding these and other risks is included in DURECT s Form 10-K
on March 4, 2010 under the heading Risk Factors.
STATEMENT OF OPERATIONS DATA
(in thousands, except per share amounts)
Three months ended March 31,
2010 2009
Collaborative research and development and other revenue $ 3,816 $ 3,745
Product revenue, net 3,850 2,415
Total revenues 7,666 6,160
Operating expenses:
Cost of product revenues (1) 1,378 824
Research and development (1) 9,421 9,903
Selling, general and administrative (1) 3,502 4,257
Total operating expenses 14,301 14,984
Loss from operations (6,635 ) (8,824 )
Other income (expense):
Interest and other income 11 179
Interest and other expense (2 ) (11 )
Net other income 9 168
Net loss $ (6,626 ) $ (8,656 )
Net loss per share, basic and diluted $ (0.08 ) $ (0.11 )
Shares used in computing basic and diluted net loss per share 86,756 82,023
(1) Includes stock-based compensation related to the following:
Cost of product revenues $ 84 $ 78
Research and development 1,277 2,281
Selling, general and administrative 669 1,171
Total stock-based compensation $ 2,030 $ 3,530
CONDENSED BALANCE SHEETS
As of March 31, 2010 As of December 31, 2009 (1)
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 3,529 $ 8,287
Short-term investments 31,827 32,834
Short-term restricted investments 66
Accounts receivable 3,603 1,700
Inventories 2,651 2,799
Prepaid expenses and other current assets 1,712 1,433
Total current assets 43,388 47,053
Property and equipment, net 3,158 3,808
Goodwill 6,399 6,399
Intangible assets, net 96 108
Long-term restricted Investments 366 431
Other long-term assets 344 352
Total assets $ 53,751 $ 58,151
LIABILITIES AND STOCKHOLDERS EQUITY
Current liabilities:
Accounts payable $ 1,018 $ 1,019
Accrued liabilities 5,246 5,337
Contract research liability 1,421 990
Deferred revenue, current portion 4,530 4,703
Other short-term liabilities 220 208
Total current liabilities 12,435 12,257
Deferred revenue, noncurrent portion 16,430 17,543
Other long-term liabilities 447 508
Stockholders equity 24,439 27,843
Total liabilities and stockholders equity $ 53,751 $ 58,151
Last updated: May 10, 2010