Full Press Release Details
DURECT Corporation Announces Second Quarter 2008 Financial Results
CUPERTINO, Calif., August 5, 2008/PRNewswire-FirstCall/
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2008. Total revenues were $6.3 million for the three months ended June 30, 2008, compared to $13.4 million for the same period in 2007.
Net loss for the three months ended June 30, 2008 was $8.6 million, compared to a net loss of $0.5 million for the same period in 2007. Revenues and net loss were favorably impacted in the second quarter of 2007 by the achievement of an $8.0
million milestone under our Nycomed collaboration related to the clinical development of POSIDUR .
At June 30, 2008, DURECT had cash and
investments of $47.6 million, compared to cash and investments of $62.0 million at December 31, 2007; these figures include restricted investments of $1.0 million at June 30, 2008 and at December 31, 2007.
The major event for us since the end of the first quarter was the filing of the New Drug Application (NDA) for Remoxy , which represents the first NDA filing
for a product candidate based on one of DURECT s platform technologies, stated James E. Brown, D.V.M., President and CEO of DURECT. We also continued to make progress in our dialogue with the FDA with respect to POSIDUR and,
relevant to ELADUR , received orphan drug designation for bupivacaine for post-herpetic neuralgia. In addition, our balance sheet has been strengthened by the elimination of all of our $23.6 million of convertible debt which was exchanged into
common stock per the original terms of our indenture.
Remoxy, an investigational drug, is a long acting oral
formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT s ORADUR technology, which is covered by issued and pending applications owned by DURECT, Remoxy is designed to resist common methods of prescription drug
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 they have stated that they expect 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,
ELADUR is our proprietary transdermal patch intended to provide bupivacaine for a period
of up to three days from a single application. We retain worldwide 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
Earnings Conference Call
A live audio webcast of a conference call to discuss second quarter 2008 results will be broadcast live over the internet at 9:00 a.m. Eastern Time on
August 6 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 , POSIDUR , ELADUR , and TRANSDUR -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 , SABER , ORADUR , TRANSDUR , and
ELADUR 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 the anticipated acceptance by the FDA of the NDA for Remoxy, the possibility of a priority review designation for the
Remoxy NDA, the potential FDA approval or benefits of Remoxy, the anticipated Phase II trial data and End-of-Phase II meeting for TRANSDUR-Sufentanil, the potential of ELADUR to receive seven years of market exclusivity as an orphan drug, our
possible entry into future collaborative agreements as well as other statements regarding DURECT s products in development, product development plans, product designs and benefits, 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, avoid infringing patents
held by other parties and securing and defending 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 on May 8,
2008 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2008 | 2007 | 2008 | 2007 | |||||||||||||
| Collaborative research and development and other revenue | $ | 3,867 | $ | 11,408 | $ | 8,136 | $ | 14,866 | ||||||||
| Product revenue, net | 2,436 | 2,024 | 4,605 | 4,292 | ||||||||||||
| Total revenues | 6,303 | 13,432 | 12,741 | 19,158 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 982 | 778 | 1,804 | 1,638 | ||||||||||||
| Research and development (1) | 9,898 | 9,630 | 19,532 | 19,982 | ||||||||||||
| Selling, general and administrative (1) | 4,074 | 3,683 | 7,953 | 7,221 | ||||||||||||
| Amortization of intangible assets | 12 | 8 | 23 | 15 | ||||||||||||
| Total operating expenses | 14,966 | 14,099 | 29,312 | 28,856 | ||||||||||||
| Loss from operations | (8,663 | ) | (667 | ) | (16,571 | ) | (9,698 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 368 | 908 | 936 | 1,886 | ||||||||||||
| Interest and other expense | (304 | ) | (720 | ) | (759 | ) | (1,434 | ) | ||||||||
| Net other income (expense) | 64 | 188 | 177 | 452 | ||||||||||||
| Net loss | $ | (8,599 | ) | $ | (479 | ) | $ | (16,394 | ) | $ | (9,246 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.01 | ) | $ | (0.22 | ) | $ | (0.13 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 75,430 | 69,364 | 74,772 | 69,298 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of revenues | $ | 31 | $ | 33 | $ | 66 | $ | 67 | ||||||||
| Research and development | 1,360 | 1,097 | 2,967 | 2,253 | ||||||||||||
| Selling, general and administrative | 674 | 555 | 1,449 | 1,223 | ||||||||||||
| Total stock-based compensation | $ | 2,065 | $ | 1,685 | $ | 4,482 | $ | 3,543 |
CONDENSED BALANCE SHEETS
| As of June 30, 2008 | As of December 31, 2007 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 31,445 | $ | 37,589 | ||
| Short-term investments | 10,859 | 19,710 | ||||
| Accounts receivable (net of allowances of $47 and $49, respectively) | 3,080 | 3,622 | ||||
| Inventories | 2,653 | 1,963 | ||||
| Prepaid expenses and other current assets | 1,723 | 1,904 | ||||
| Total current assets | 49,760 | 64,788 | ||||
| Property and equipment, net | 6,988 | 7,658 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 182 | 180 | ||||
| Long-term investments | 4,259 | 3,697 | ||||
| Restricted Investments | 1,018 | 1,020 | ||||
| Other long-term assets | 274 | 278 | ||||
| Total assets | $ | 68,880 | $ | 84,020 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 749 | $ | 1,834 | ||
| Accrued liabilities | 6,812 | 5,499 | ||||
| Contract research liability | 678 | 1,946 | ||||
| Deferred revenue, current portion | 5,768 | 5,728 | ||||
| Convertible subordinated notes | 23,599 | |||||
| Other short-term liabilities | 425 | 482 | ||||
| Total current liabilities | 14,432 | 39,088 | ||||
| Deferred revenue, non-current portion | 6,649 | 9,268 | ||||
| Other long-term liabilities | 982 | 1,083 | ||||
| Stockholders equity | 46,817 | 34,581 | ||||
| Total liabilities and stockholders equity | $ | 68,880 | $ | 84,020 |
SOURCE DURECT Corporation
Matthew J. Hogan, Chief Financial Officer, DURECT
Corporation, +1-408-777-4936