CUPERTINO, Calif., Aug 03, 2009 /PRNewswire-FirstCall via COMTEX/ —
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2009. Total revenues were $4.9 million for the three months ended June 30, 2009, compared to $6.3 million for the same period in 2008. Net loss for the three months ended June 30, 2009 was $7.5 million, compared to a net loss of $8.6 million for the same period in 2008.
At June 30, 2009, DURECT had cash and investments of $41.9 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at June 30, 2009 and $1.0 million at December 31, 2008.
“Our senior management team was strengthened during the second quarter through the hiring of Joe Stauffer as our Chief Medical Officer, a former anesthesiologist and FDA reviewer with directly relevant experience covering all aspects of developing pain medications,” stated James E. Brown, D.V.M., President and CEO of DURECT. “It is also noteworthy that we signed four new feasibility projects in the quarter with pharmaceutical companies to apply our SABER(TM) depot and DURIN(TM) injectable technologies to address specific drug delivery challenges for both small molecule and biologic agents. Shortly after the end of the quarter, we were pleased to learn that King Pharmaceuticals met with the FDA regarding Remoxy(R) and believes that they have a clear path forward that could allow them to resubmit the Remoxy NDA in mid-2010.”
— Remoxy. Pain Therapeutics, our licensee, received a Complete Response
Letter from the FDA in December 2008 indicating that the NDA is not
approved in its present form. King Pharmaceuticals, the
commercialization partner of Pain Therapeutics for Remoxy, assumed
responsibility for further development of Remoxy from Pain
Therapeutics in March 2009 and met with the Food and Drug
Administration (FDA) on July 2, 2009 to discuss the Complete Response
Letter. According to King Pharmaceuticals and Pain Therapeutics, the
outcome of that meeting provided King with a clear path forward to
resubmit the REMOXY NDA and to address all FDA comments in the
Complete Response Letter. According to the King Pharmaceuticals /
Pain Therapeutics press release, King now anticipates the
resubmission of the NDA could occur mid-year 2010. King has stated
that it remains committed to the development and commercialization of
REMOXY and looks forward to working closely with the FDA toward
approval of the product.
REMOXY, an investigational drug, is a long acting oral formulation of
oxycodone intended to treat moderate to severe pain. Based on DURECT’s
ORADUR(R) 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(TM) (SABER(TM)-Bupivacaine). During the quarter, DURECT continued
enrollment in our approximately 60 patient Phase IIb clinical study in
shoulder surgery. In addition, Nycomed continued enrollment in a
Phase IIb study in hysterectomy patients and a Phase IIb study in
shoulder surgery patients. We are in active discussions with multiple
potential partners regarding licensing of the U.S./Canada and Asian
rights to this program.
POSIDUR is our investigational 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 select other
countries, and we have retained commercialization rights in the US,
Canada and Asia.
— ELADUR(TM) (TRANSDUR(TM)-Bupivacaine). In October 2008, worldwide rights to
this program were licensed to Alpharma, which was acquired by King
Pharmaceuticals in December 2008. During the second quarter, we
continued to interact with the King team on details associated with
next steps in the clinical program, which King expects to initiate
ELADUR is our proprietary transdermal patch intended to provide
bupivacaine for a period of up to three days from a single
— TRANSDUR-Sufentanil. A successful end-of-Phase II meeting with the
FDA has been conducted for this program that laid out a potential
regulatory pathway for the Phase III program and approval. We are in
active discussions with multiple 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
provide sufentanil to chronic pain sufferers for a period of up to
seven days from a single application.
— Feasibility Projects. During the second quarter, we signed four new
feasibility projects with pharmaceutical and biotechnology companies
whereby we will apply our SABER and DURIN technologies to both small
molecule and biologic agents of interest to our collaborator. We
undertake these feasibility projects as a means of demonstrating that
our technologies can achieve the drug delivery objectives set forth by
our collaborators and are worthy of further development. These
feasibility projects entail anticipated revenue to DURECT of
approximately $1.4 million in total during 2009.
Earnings Conference Call
A live audio webcast of a conference call to discuss second quarter 2009 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on August 3 and is available by accessing DURECT’s homepage at www.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(R), POSIDUR(TM), ELADUR(TM), and TRANSDUR(TM)-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.www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(R), TRANSDUR(TM), and ELADUR(TM) 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 US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding plans by King Pharmaceuticals for resubmission of the REMOXY NDA in mid-2010 and their belief that this resubmission will address all FDA comments in the Complete Response Letter, the potential of FDA approving the REMOXY NDA, the timing and content of any potential update to be provided by King Pharmaceuticals, as well as the potential royalty and other payments that may be received by DURECT from REMOXY, our possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, and potential agreements with third parties about licensing and development rights to our product 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 potential that the REMOXY NDA resubmission may not adequately address all of FDA’s concerns, the potential that FDA may not grant regulatory approval of REMOXY, failure of our clinical trials to produce intended results, possible adverse events associated with the use of our drug candidates, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of 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 its growth, operations and expenses. Further information regarding these and other risks is included in DURECT’s Form 10-Q filed on May 7, 2009 under the heading “Risk Factors.”
DURECT CORPORATION CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three months ended Year ended ------------ ---------- June 30, June 30, ---------- ---------- 2009 2008 2009 2008 ---- ---- ---- ---- Collaborative research and development revenue $2,606 $3,867 $6,351 $8,136 Product revenue, net 2,271 2,436 4,686 4,605 ----- ----- ----- ----- Total revenues 4,877 6,303 11,037 12,741 ----- ----- ------ ------ Operating expenses: Cost of revenues (1) 837 982 1,661 1,804 Research and development (1) 7,866 9,898 17,769 19,532 Selling, general and administrative (1) 3,777 4,086 8,034 7,976 Total operating expenses 12,480 14,966 27,464 29,312 ------ ------ ------ ------ Loss from operations (7,603) (8,663) (16,427) (16,571) Other income (expense): Interest and other income 106 368 285 936 Interest expense (11) (304) (22) (759) --- ---- --- ---- Net other income 95 64 263 177 ------- ------- -------- -------- Net loss $(7,508) $(8,599) $(16,164) $(16,394) ======= ======= ======== ======== Net loss per share, basic and diluted $(0.09) $(0.11) $(0.20) $(0.22) ====== ====== ====== ====== Shares used in computing basic and diluted net loss per share 82,138 75,430 82,081 74,772 ====== ====== ====== ====== (1) Includes stock-based compensation related to the following: Cost of revenues $117 $31 $195 $66 Research and development 1,327 1,360 3,608 2,967 Selling, general and administrative 864 674 2,035 1,449 --- --- ----- ----- Total stock-based compensation $2,308 $2,065 $5,838 $4,482 ====== ====== ====== ====== DURECT CORPORATION Condensed Balance Sheet (in thousands) As of As of June 30, December 31, 2009 2008 (1) --------- ------------- (unaudited) ASSETS Current assets: Cash and cash equivalents $10,024 $29,445 Short-term investments 24,507 20,836 Short-term restricted investments 372 624 Accounts receivable 2,336 4,055 Inventories 2,737 3,474 Prepaid expenses and other current assets 3,037 1,850 ----- ----- Total current assets 43,013 60,284 Property and equipment, net 4,955 5,971 Goodwill 6,399 6,399 Intangible assets, net 133 157 Long-term investments 6,528 1,362 Long-term restricted Investments 428 425 Other long-term assets 368 276 --- --- Total assets $61,824 $74,874 ======= ======= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $846 $1,018 Accrued liabilities 4,135 5,204 Contract research liability 616 995 Deferred revenue, current portion 8,074 9,235 Other short-term liabilities 421 431 --- --- Total current liabilities 14,092 16,883 Deferred revenue, noncurrent portion 19,552 19,771 Other long-term liabilities 614 656 Stockholders' equity 27,566 37,564 ------ ------ Total liabilities and stockholders' equity $61,824 $74,874 ======= ======= (1) Derived from audited financial statements.
SOURCE DURECT Corporation