Full Press Release Details
DURECT Corporation Announces Fourth Quarter and Year End 2007 Financial Results
CUPERTINO, CA, February 5, 2008/PRNewswire-FirstCall/
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months and year ended December 31, 2007. Total revenues were $6.6 million for the three months ended December 31, 2007, compared to $5.4 million for
the same period in 2006. Net loss for the three months ended December 31, 2007 was $7.2 million, compared to a net loss of $9.8 million for the same period in 2006.
For the fiscal year ended December 31, 2007, total revenues were $30.7 million, compared to $21.9 million for the same period in 2006. Net loss for the year ended December 31, 2007 was $24.3 million,
compared to a net loss of $33.3 million for the same period in 2006.
At December 31, 2007, DURECT had cash and investments of $62.0 million, compared
with cash and investments of $81.6 million at December 31, 2006; these figures include restricted investments of $1.0 million at December 31, 2007 and $1.3 million at December 31, 2006. DURECT s net decrease in cash during 2007
DURECT s pipeline advanced during 2007, reporting positive clinical trial results for three programs in Phase III or II. We
expect to continue this progress in 2008 as we look forward to the filing of the first New Drug Application (NDA) based on our ORADUR technology and further advancing our late stage programs, stated James E. Brown, D.V.M., President and
CEO of DURECT. Remoxy met the primary endpoint in its pivotal Phase III study conducted under a Special Protocol Assessment (SPA), POSIDUR reported statistically significant improvements in pain control while reducing the use of
narcotics in a Phase IIb hernia study, and ELADUR showed improved pain control versus placebo over the three day treatment period in a Phase IIa study. Each of these programs addresses large market opportunities with product features that
offer clear advantages over existing therapeutics.
Highlights for DURECT in Fiscal Year 2007 include:
Remoxy is an abuse-resistant, long-acting form of oxycodone based on our ORADUR technology intended for the treatment of chronic pain.
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.
Financial Guidance for 2008 and Major Potential Milestones Over the Next 12-18 Months
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 , 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, our
possible entry into future collaborative agreements and our projected financial results 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 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. Further information regarding these and other risks is included in DURECT s Form 10-Q on November 8, 2007 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three months ended December 31, | Year Ended December 31, | |||||||||||||||
| 2007 | 2006 | 2007 | 2006 | |||||||||||||
| Collaborative research and development revenue | $ | 4,559 | $ | 3,522 | $ | 14,417 | $ | 13,786 | ||||||||
| Milestone revenue | 8,000 | |||||||||||||||
| Product revenue, net | 2,026 | 1,919 | 8,258 | 8,108 | ||||||||||||
| Total revenues | 6,585 | 5,441 | 30,675 | 21,894 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 807 | 983 | 3,225 | 3,248 | ||||||||||||
| Research and development (1) | 9,502 | 11,598 | 38,342 | 37,241 | ||||||||||||
| Selling, general and administrative (1) | 3,262 | 2,877 | 13,618 | 12,417 | ||||||||||||
| Amortization of intangible assets | 8 | 8 | 31 | 424 | ||||||||||||
| Total operating expenses | 13,579 | 15,466 | 55,216 | 53,330 | ||||||||||||
| Loss from operations | (6,994 | ) | (10,025 | ) | (24,541 | ) | (31,436 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 753 | 991 | 3,545 | 3,832 | ||||||||||||
| Interest expense | (475 | ) | (717 | ) | (2,625 | ) | (3,436 | ) | ||||||||
| Debt conversion expense | (495 | ) | (718 | ) | (2,287 | ) | ||||||||||
| Net other income (expense) | (217 | ) | 274 | 202 | (1,891 | ) | ||||||||||
| Net loss | $ | (7,211 | ) | $ | (9,751 | ) | $ | (24,339 | ) | $ | (33,327 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.35 | ) | $ | (0.51 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 73,641 | 68,980 | 70,483 | 65,961 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of revenues | $ | 32 | $ | 28 | $ | 130 | $ | 75 | ||||||||
| Research and development | 995 | 801 | 4,286 | 2,885 | ||||||||||||
| Selling, general and administrative | 553 | 420 | 2,273 | 1,431 | ||||||||||||
| Total stock-based compensation | $ | 1,580 | $ | 1,249 | $ | 6,689 | $ | 4,391 |
CONDENSED BALANCE SHEETS
| As of December 31, 2007 | As of December 31, 2006 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 37,589 | $ | 41,554 | ||
| Short-term investments | 19,710 | 28,297 | ||||
| Accounts receivable | 3,622 | 2,152 | ||||
| Inventories | 1,963 | 2,052 | ||||
| Prepaid expenses and other current assets | 1,904 | 1,744 | ||||
| Total current assets | 64,788 | 75,799 | ||||
| Property and equipment, net | 7,658 | 7,451 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 180 | 111 | ||||
| Long-term investments | 3,697 | 10,472 | ||||
| Restricted Investments | 1,020 | 1,284 | ||||
| Other non-current assets | 278 | 969 | ||||
| Total assets | $ | 84,020 | $ | 102,485 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,834 | $ | 864 | ||
| Accrued liabilities | 5,499 | 4,522 | ||||
| Contract research liability | 1,946 | 1,624 | ||||
| Interest payable on convertible notes | 61 | 97 | ||||
| Deferred revenue, current portion | 5,728 | 5,348 | ||||
| Equipment financing obligations, current portion | 38 | 34 | ||||
| Bonds payable, current portion | 225 | 210 | ||||
| Convertible subordinated notes due 2008 | 23,599 | |||||
| Other short-term liabilities | 158 | |||||
| Total current liabilities | 39,088 | 12,699 | ||||
| Bond payable and equipment financing obligations, noncurrent portion | 343 | 606 | ||||
| Convertible subordinated notes due 2008 | 37,337 | |||||
| Deferred revenue, noncurrent portion | 9,268 | 14,507 | ||||
| Other long-term liabilities | 740 | 304 | ||||
| Stockholders equity | 34,581 | 37,032 | ||||
| Total liabilities and stockholders equity | $ | 84,020 | $ | 102,485 |
SOURCE DURECT Corporation
Matt Hogan, Chief Financial Officer, DURECT
Corporation, +1-408-777-4936