CUPERTINO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2006. Total revenues were $5.1 million for the three months ended September 30, 2006, compared to $8.6 million for the same period in 2005. Net loss for the three months ended September 30, 2006 was $8.6 million, compared to a net loss of $3.0 million for the same period in 2005. Cash used in operating activities was $3.1 million for the three months ended September 30, 2006, compared to $1.1 million of cash used in operating activities for the same period in 2005.
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At September 30, 2006, DURECT had cash and investments of $74.3 million, including $1.5 million in restricted investments, compared with cash and investments of $77.7 million at June 30, 2006 and $91.0 million at December 31, 2005.
"DURECT continued to make solid progress in advancing our pipeline in the third quarter, including entering one new product into Phase I clinical trials," stated James E. Brown, D.V.M., President and CEO of DURECT.
Recent Corporate Highlights
- POSIDUR(TM) Post-Operative Pain Relief Depot. During the third quarter of 2006, we continued to conduct multiple on-going Phase II clinical trials in a variety of soft-tissue and orthopedic surgeries for the purpose of selecting the optimal dose and the surgical procedures for pivotal Phase III trials. Pending the successful completion of these Phase II trials and approval of regulatory authorities, we will continue into the Phase III program, which we anticipate will occur in 2007.
- Remoxy. Phase III clinical trials, conducted according to a Special Protocol Assessment, remain on-going for this abuse-resistant, long- acting, oral pain medication. According to a recent press release by Pain Therapeutics, they believe that they remain on track to announce results of a Phase III trial with Remoxy in the first half of 2007, followed by an NDA filing for this drug candidate three quarters after data release.
- 2nd ORADUR-based Opioid. In August, our collaborators, Pain Therapeutics and King Pharmaceuticals, announced the initiation of a Phase I clinical trial for a new ORADUR-based opioid drug candidate. This new drug candidate is the second ORADUR-based opioid drug to undergo clinical testing. King Pharmaceuticals is the company that will be commercializing the drug candidate, if approved. Pain Therapeutics, our licensee, has sublicensed rights to the drug candidate and other ORADUR-based products incorporating oxycodone and three other opioid compounds to King Pharmaceuticals. The active pharmaceutical ingredient in the new ORADUR-based opioid drug candidate has not been disclosed.
- TRANSDUR Sufentanil Patch. During the third quarter, our main activity under this program involved supply of product for on-going clinical and non-clinical studies conducted by Endo Pharmaceuticals. In addition, we continued our technology transfer to Endo's contract transdermal patch manufacturer in order to produce additional Phase II supplies, Phase III supplies and then commercial supplies.
- Memryte(TM) Program. Our collaborator, Voyager Pharmaceutical, recently informed DURECT that Voyager is ending its Phase III clinical trials for Memryte(TM) for the treatment of Alzheimer's Disease in order to get an early look at potential efficacy.
- Management Addition. Matthew J. Hogan has joined us as Chief Financial Officer, bringing with him over 10 years of in-depth knowledge regarding corporate financial transactions as a former investment banker for Merrill Lynch and over 10 years of experience as a chief financial officer of several publicly traded companies, including experience managing commercial product sales.
DURECT Corporation is an emerging specialty pharmaceutical company focused on the development of pharmaceutical systems based on its proprietary drug delivery platform technologies. The company is developing pharmaceutical systems to deliver the right drug to the right place in the right amount at the right time to treat chronic and episodic diseases and conditions. For more information, please visit www.durect.com .
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), DURIN(TM), TRANSDUR(TM) and MICRODUR(TM) are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding DURECT's products in development, product development plans and projected financial results 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, DURECT's (and that of its third party collaborators where applicable) abilities to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process development of the product candidate, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize the product candidate, as well as marketplace acceptance of the product candidate. Further information regarding these and other risks is included in DURECT's Form 10-Q on November 3, 2006 under the heading "Risk Factors."
DURECT CORPORATION CONDENSED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Three months ended Nine months ended September 30, September 30, 2006 2005 2006 2005 (unaudited) (unaudited) (unaudited) (unaudited) Collaborative research and development and other revenue $3,158 $5,369 $10,264 $15,896 Product revenue, net 1,976 1,653 6,189 5,299 Revenue from sale of intellectual property rights -- 1,600 -- 1,600 Total revenues 5,134 8,622 16,453 22,795 Operating expenses: Cost of revenues (1) 666 573 2,265 1,933 Research and development (1) 9,930 7,024 25,643 21,301 Selling, general and administrative (1) 3,346 2,699 9,540 8,362 Amortization of intangible assets 22 303 416 909 Total operating expenses 13,964 10,599 37,864 32,505 Loss from operations (8,830) (1,977) (21,411) (9,710) Other income (expense): Interest and other income 957 467 2,841 1,359 Interest expense (710) (1,095) (2,719) (3,329) Debt conversion expense -- (403) (2,287) (403) Net other income (expense) 247 (1,031) (2,165) (2,373) Loss before income taxes (8,583) (3,008) (23,576) (12,083) Income tax provision -- 4 -- 4 Net loss $(8,583) $(3,012) $(23,576) $(12,087) Net loss per share, basic and diluted $(0.12) $(0.06) $(0.36) $(0.23) Shares used in computing basic and diluted net loss per share 68,688 52,786 64,943 52,240 (1) Stock-based compensation related to the following: Cost of revenues $20 $-- $47 $-- Research and development 774 60 2,084 106 Selling, general and administrative 368 -- 1,011 347 $1,162 $60 $3,142 $453 DURECT CORPORATION CONDENSED BALANCE SHEETS (in thousands) September 30, December 31, 2006 2005 (1) (unaudited) ASSETS Current assets: Cash and cash equivalents $37,717 $65,542 Short-term investments 25,099 18,022 Restricted investments -- 321 Accounts receivable 3,471 4,488 Inventories 2,205 2,047 Prepaid expenses and other current assets 1,611 3,659 Total current assets 70,103 94,079 Property and equipment, net 7,447 7,304 Goodwill 6,399 6,399 Intangible assets, net 119 536 Long-term investments 9,955 5,459 Restricted investments 1,508 1,653 Other long-term assets 1,073 1,984 Total assets $96,604 $117,414 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 1,121 $1,835 Accrued liabilities 4,042 3,874 Contract research liabilities 871 1,418 Interest payable on convertible notes 681 149 Deferred revenue, current portion 2,412 2,367 Equipment financing obligations and term loan, current portion 32 34 Bonds payable, current portion 200 200 Total current liabilities 9,359 9,877 Bonds payable, equipment financing obligations and term loan, noncurrent portion 825 702 Convertible subordinated notes 37,337 57,337 Deferred revenue, noncurrent portion 4,375 6,016 Other long-term liabilities 279 130 Stockholders' equity 44,429 43,352 Total liabilities and stockholders' equity $96,604 $117,414 (1) Derived from audited financial statements.
SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Vice President, Investor Relations and Strategic Planning, DURECT Corporation, +1-408-777-1417
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