At September 30, 2009, DURECT had cash and investments of $47.2 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at September 30, 2009 and $1.0 million at December 31, 2008.
"Since our last earnings report, we have continued to advance our development programs and business activities, including completing enrollment in our POSIDUR(TM) Phase II shoulder study, entering into a new collaboration with Orient Pharma that will allow us to generate Phase II data for a new drug candidate for the Attention Deficit Hyperactivity Disorder market (ORADUR(R)-ADHD) and a long term excipient supply agreement with King Pharmaceuticals with respect to REMOXY," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we enhanced our cash position with a $10 million sale of common stock to affiliates of Venrock, a highly respected institutional investor."
-- Remoxy. According to a King Pharmaceuticals / Pain Therapeutics press release, King anticipates the resubmission of the NDA for REMOXY intended to address all FDA comments in the Complete Response Letter 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. During the third quarter, DURECT and King signed an exclusive long term excipient supply agreement with respect to REMOXY. This agreement stipulates the terms and conditions under which DURECT will supply to King, based on DURECT's manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of REMOXY.
REMOXY is an investigational 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(TM) (SABER(TM)-Bupivacaine). DURECT recently completed enrollment in our Phase IIb clinical study in shoulder surgery of approximately 60 patients and we expect to have top line data analysis completed in December. In addition, Nycomed continues enrollment in a Phase IIb study in hysterectomy patients and a Phase IIb study in shoulder surgery patients. At the American College of Surgeons 95th Annual Clinical Congress on October 12, 2009, we presented a scientific poster regarding our Phase IIb hernia study; this poster can be accessed through www.durect.com under "About DURECT" and "Publications." We are in active discussions with multiple potential partners regarding licensing of the U.S./Canadian and Asian rights to this program.
POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology intended 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. We continue to interact with the King team on details associated with next steps in the clinical program, which King expects to initiate in the first half of next year.
ELADUR is our proprietary transdermal patch intended to provide bupivacaine to treat pain for a period of up to three days from a single application.
-- 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 NDA submission. 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.
-- License Agreement for ADHD Drug Candidate. During the third quarter, we
signed a development and license agreement with Orient Pharma Co., Ltd.
under which DURECT has granted to Orient Pharma development and
commercialization rights in selected Asian and South Pacific countries
to a drug candidate based on DURECT's ORADUR Technology and one
specified active pharmaceutical ingredient for the treatment of
attention deficit hyperactivity disorder (ADHD). This drug candidate
(ORADUR-ADHD) is intended to provide once-a-day dosing with added
tamper-resistant characteristics to address common methods of abuse and
misuse of these types of drugs. North American, European, Japanese and
select other countries' rights to this drug candidate are retained by
DURECT. Under this agreement, the parties will collaborate 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 by DURECT as well as Orient Pharma in their respective
territories. DURECT will be responsible for formulation and study design
of the pre-defined clinical program which Orient Pharma will fund and
-- Financing. In September, DURECT entered into a privately negotiated transaction to sell 4,444,444 shares of common stock to affiliates of Venrock at a price of $2.25 per share, raising proceeds to DURECT of approximately $10 million.
Earnings Conference Call
A live audio webcast of a conference call to discuss third quarter 2009 results will be broadcast over the internet at 4:30 p.m. Eastern Time on October 29 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(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.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, TRANSDUR-Sufentanil and ORADUR-ADHD 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 expectation that we will have top line data from our Phase IIb shoulder study in December, the expectation that King will commence additional clinical studies in the first half of next year with ELADUR, our plan to generate Phase II data with our ORADUR-ADHD program, our possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, and potential agreements with third parties to license the development and commercialization 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 take longer to achieve than expected and 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 August 4, 2009 under the heading "Risk Factors."
DURECT CORPORATION CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) (unaudited) Three months ended Year ended ------------ ---------- September 30, September 30, --------------- --------------- 2009 2008 2009 2008 ---- ---- ---- ---- Collaborative research and development revenue $3,027 $4,341 $9,378 $12,477 Product revenue, net 5,351 2,293 10,037 6,898 ----- ----- ------ ----- Total revenues 8,378 6,634 19,415 19,375 ----- ----- ------ ------ Operating expenses: Cost of revenues (1) 2,834 870 4,495 2,674 Research and development (1) 7,598 11,423 25,367 30,955 Selling, general and administrative (1) 3,554 3,837 11,588 11,813 ----- ----- ------ ------ Total operating expenses 13,986 16,130 41,450 45,442 ------ ------ ------ ------ Loss from operations (5,608) (9,496) (22,035) (26,067) Other income (expense): Interest and other income 82 349 367 1,285 Interest expense (9) (14) (31) (773) --- --- --- ---- Net other income 73 335 336 512 ------- ------- -------- -------- Net loss $(5,535) $(9,161) $(21,699) $(25,555) ======= ======= ======== ======== Net loss per share, basic and diluted $(0.07) $(0.11) $(0.26) $(0.33) ====== ====== ====== ====== Shares used in computing basic and diluted net loss per share 82,781 81,779 82,317 77,124 ====== ====== ====== ====== (1) Includes stock-based compensation related to the following: Cost of revenues $91 $44 $286 $110 Research and development 1,665 1,300 5,273 4,267 Selling, general and administrative 785 619 2,820 2,068 --- --- ----- ----- Total stock-based compensation $2,541 $1,963 $8,379 $6,445 ====== ====== ====== ====== DURECT CORPORATION CONDENSED BALANCE SHEET (in thousands) As of As of September December 30, 2009 31, 2008 (1) --------- ------------- (unaudited) ASSETS Current assets: Cash and cash equivalents $17,933 $29,445 Short-term investments 27,483 20,836 Short-term restricted investments 372 624 Accounts receivable 2,947 4,055 Inventories 2,882 3,474 Prepaid expenses and other current assets 1,020 1,850 ----- ----- Total current assets 52,637 60,284 Property and equipment, net 4,516 5,971 Goodwill 6,399 6,399 Intangible assets, net 121 157 Long-term investments 1,000 1,362 Long-term restricted Investments 431 425 Other long-term assets 360 276 --- --- Total assets $65,464 $74,874 ======= ======= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $498 $1,018 Accrued liabilities 5,271 5,204 Contract research liability 797 995 Deferred revenue, current portion 5,073 9,235 Other short-term liabilities 435 431 --- --- Total current liabilities 12,074 16,883 Deferred revenue, noncurrent portion 18,366 19,771 Other long-term liabilities 561 656 Stockholders' equity 34,463 37,564 ------ ------ Total liabilities and stockholders' equity $65,464 $74,874 ======= ======= (1) Derived from audited financial statements.
SOURCE DURECT Corporation