Full Press Release Details
DURECT Corporation Announces First Quarter 2008 Financial Results
CUPERTINO, Calif., May 7, 2008/PRNewswire-FirstCall/ DURECT
Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2008. Total revenues were $6.4 million for the three months ended March 31, 2008, compared to $5.7 million for the same period in 2007. Net
loss for the three months ended March 31, 2008 was $7.8 million, compared to a net loss of $8.8 million for the same period in 2007.
March 31, 2008, DURECT had cash and investments of $53.4 million, compared to cash and investments of $62.0 million at December 31, 2007; these figures include restricted investments of $1.0 million at March 31, 2008 and at
We continued to make progress towards our product development and
corporate objectives during the first quarter, stated James E. Brown, D.V.M., President and CEO of DURECT. We continued to advance our POSIDUR , ELADUR , TRANSDUR -Sufentanil and Remoxy programs, including support of Pain
Therapeutics and King Pharmaceuticals in their preparation of the New Drug Application (NDA) filing for Remoxy as well as starting commercial production of certain key components that are
integral to Remoxy. We also continued to be active in business development and strengthened our intellectual property position by acquiring additional patents that may be strategic to our business.
Remoxy is an abuse-resistant, long-acting form of oxycodone based on our ORADUR technology intended for the treatment of chronic pain.
In addition to Remoxy,
there are three other ORADUR-based abuse-resistant opioids covered in our collaboration with Pain Therapeutics. Pain Therapeutics has previously announced positive results from a Phase I clinical trial for one of these drug candidates, and Pain
Therapeutics has stated that it expects to file an Investigational New Drug application (IND) for a new abuse-resistant opioid in 2008.
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 select other countries, and
DURECT has retained commercialization rights in the US, Canada and Asia.
ELADUR is our proprietary transdermal patch intended to provide bupivacaine for a period of up to three days from a single application. We retain full
commercial rights to this drug candidate.
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.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company developing pharmaceutical systems based on its proprietary drug delivery platform technologies. The Company currently has a number of late-stage pharmaceutical products in
development addressing large markets in pain management, with a number of research programs underway targeting chronic disease and other therapeutic areas. For more information, please visit www.durect.com.
NOTE: POSIDUR , SABER , ORADUR , DURIN , TRANSDUR , and
ELADUR are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.
DURECT Forward-Looking Statement
The statements in this press release regarding the anticipated filing of an NDA for
Remoxy, our anticipated commencement of the Phase III program for POSIDUR, commercial production of Remoxy, our possible entry into future collaborative agreements as well as other statements regarding DURECT s products in development, product
development plans, anticipated regulatory, clinical and development milestones and timing thereof, future clinical trial results, our business development intentions, the potential benefits to our business from our above referenced acquisition of
patents and DURECT s emergence as a specialty pharmaceutical company 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 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 and manage and obtain capital to fund its growth, operations and expenses and the breadth, validity and
enforceability of the acquired patents referenced above. Further information regarding these and other risks is included in DURECT s Form 10-K on March 13, 2008 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three Months Ended March 31, | ||||||||
| 2008 | 2007 | |||||||
| Collaborative research and development and other revenue | $ | 4,269 | $ | 3,458 | ||||
| Product revenue, net | 2,169 | 2,268 | ||||||
| Total revenues | 6,438 | 5,726 | ||||||
| Operating expenses: | ||||||||
| Cost of revenues (1) | 822 | 860 | ||||||
| Research and development (1) | 9,634 | 10,352 | ||||||
| Selling, general and administrative (1) | 3,879 | 3,538 | ||||||
| Amortization of intangible assets | 11 | 7 | ||||||
| Total operating expenses | 14,346 | 14,757 | ||||||
| Loss from operations | (7,908 | ) | (9,031 | ) | ||||
| Other income (expense): | ||||||||
| Interest and other income | 568 | 978 | ||||||
| Interest expense | (455 | ) | (714 | ) | ||||
| Net other income | 113 | 264 | ||||||
| Net loss | $ | (7,795 | ) | $ | (8,767 | ) | ||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.13 | ) | ||
| Shares used in computing basic and diluted net loss per share | 74,113 | 69,231 | ||||||
| (1) Stock-based compensation related to the following: | ||||||||
| Cost of revenues | $ | 35 | $ | 34 | ||||
| Research and development | 1,607 | 1,156 | ||||||
| Selling, general and administrative | 775 | 668 | ||||||
| Total stock-based compensation | $ | 2,417 | $ | 1,858 |
CONDENSED BALANCE SHEETS
| As of March 31, 2008 | As of December 31, 2007 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 33,913 | $ | 37,589 | ||
| Short-term investments | 12,979 | 19,710 | ||||
| Accounts receivable (net of allowances of $60 and $49, respectively) | 3,434 | 3,622 | ||||
| Inventories | 2,437 | 1,963 | ||||
| Prepaid expenses and other current assets | 1,824 | 1,904 | ||||
| Total current assets | 54,587 | 64,788 | ||||
| Property and equipment, net | 7,323 | 7,658 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 194 | 180 | ||||
| Long-term investments | 5,473 | 3,697 | ||||
| Restricted Investments | 1,018 | 1,020 | ||||
| Other long-term assets | 277 | 278 | ||||
| Total assets | $ | 75,271 | $ | 84,020 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,210 | $ | 1,834 | ||
| Accrued liabilities | 4,946 | 5,499 | ||||
| Contract research liability | 989 | 1,946 | ||||
| Deferred revenue, current portion | 5,330 | 5,728 | ||||
| Convertible subordinated notes | 23,599 | 23,599 | ||||
| Other short-term liabilities | 841 | 482 | ||||
| Total current liabilities | 36,915 | 39,088 | ||||
| Deferred revenue, non-current portion | 7,958 | 9,268 | ||||
| Other long-term liabilities | 1,044 | 1,083 | ||||
| Stockholders equity | 29,354 | 34,581 | ||||
| Total liabilities and stockholders equity | $ | 75,271 | $ | 84,020 |
SOURCE DURECT Corporation
Matt Hogan, Chief Financial Officer, DURECT
Corporation, +1-408-777-4936