Full Press Release Details
DURECT Corporation Announces Second Quarter 2010 Financial Results
CUPERTINO, CA, August 4, 2010/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months
ended June 30, 2010. Total revenues were $7.3 million for the three months ended June 30, 2010 compared to $4.9 million for the three months ended June 30, 2009. Net loss for the three months ended June 30, 2010 was $6.3 million,
compared to a net loss of $7.5 million for the same period in 2009.
At June 30, 2010, we had cash and investments of $57.2 million,
compared to cash and investments of $41.6 million at December 31, 2009.
The key event in the second quarter was our entry into a
strategic collaboration with Hospira covering the development and commercialization of POSIDUR in the U.S. and Canada, stated James E. Brown, D.V.M., President and CEO of DURECT. We continue to advance our pipeline of product
candidates. BESST, our pivotal U.S. Phase III clinical study for POSIDUR , continued enrollment during the quarter. King Pharmaceuticals is preparing the NDA resubmission for REMOXY by year-end and initiated a Phase IIb clinical study of
ELADUR in chronic low back pain during the second quarter. Lastly, we recently commenced a Phase I clinical trial in our ORADUR -ADHD program.
Business Highlights:
REMOXY, an investigational drug, is a unique 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.
In the second quarter of 2010, we continued to enroll patients in our U.S. pivotal Phase III clinical study known as BESST (Bupivacaine
Effectiveness and Safety in SABER Trial). We expect to complete enrollment of BESST, comprising approximately 300 patients, in the first half of 2011.
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 Hospira for commercialization in the U.S. and Canada, and to Nycomed for commercialization in Europe and other defined countries. We have
retained commercialization rights in Japan and all other countries not subject to the Nycomed and Hospira licenses.
ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days
from each application.
TRANSDUR-Sufentanil is our proprietary transdermal patch intended to
deliver sufentanil to chronic pain sufferers for a period of up to seven days from a single application.
Earnings Conference Call
A live audio webcast of a conference call to discuss second quarter 2010 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on
August 4 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 , ELADUR , and DURIN 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 U.S. Food and Drug Administration or other health
DURECT Forward-Looking Statement
The statements in this press release regarding the anticipated resubmission of the REMOXY NDA, our U.S. pivotal Phase III clinical trial (BESST) for
POSIDUR including the anticipated timing of completion of the trial and patient enrollment, potential milestone payments and royalties receivable from Hospira, Phase IIb trial for ELADUR including anticipated patient enrollment numbers and timing
thereof, our intention to enter into collaborations with respect to TRANSDUR-Sufentanil and our ORADUR-ADHD Phase I trial, the potential benefits and uses of our drug 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, delays and additional costs due to requirements imposed by regulatory agencies on our
drug candidates, unexpected results and adverse events from clinical trials for our drug candidates, our failure to achieve the performance milestones or commercial sales that trigger the referenced payments or royalties under our collaborative
agreements, our (and that of our third party collaborators where applicable) difficulty or failure to obtain approvals from regulatory agencies with respect to development activities and products, design, enroll, conduct and complete clinical
trials, complete the design, development, and manufacturing process development of the referenced drug candidates, consummate collaborative agreements relating to our drug candidates and technologies, manufacture and commercialize the referenced
drug candidates, obtain marketplace acceptance of the referenced drug candidates, avoid infringing patents held by other parties and secure and defend patents of our own, and manage and obtain capital to fund our growth, operations and expenses.
Further information regarding these and other risks is included in DURECT s Form 10-Q on May 10, 2010 under the heading Risk Factors.
STATEMENT OF OPERATIONS DATA
(in thousands, except per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| Collaborative research and development and other revenue | $ | 4,657 | $ | 2,606 | $ | 8,473 | $ | 6,518 | ||||||||
| Product revenue, net | 2,656 | 2,271 | 6,506 | 4,686 | ||||||||||||
| Total revenues | 7,313 | 4,877 | 14,979 | 11,204 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product revenues (1) | 861 | 837 | 2,239 | 1,661 | ||||||||||||
| Research and development (1) | 9,204 | 7,866 | 18,625 | 17,936 | ||||||||||||
| Selling, general and administrative (1) | 3,584 | 3,777 | 7,086 | 8,034 | ||||||||||||
| Total operating expenses | 13,649 | 12,480 | 27,950 | 27,631 | ||||||||||||
| Loss from operations | (6,336 | ) | (7,603 | ) | (12,971 | ) | (16,427 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 48 | 106 | 59 | 285 | ||||||||||||
| Interest and other expense | (21 | ) | (11 | ) | (23 | ) | (22 | ) | ||||||||
| Net other income | 27 | 95 | 36 | 263 | ||||||||||||
| Net loss | $ | (6,309 | ) | $ | (7,508 | ) | $ | (12,935 | ) | $ | (16,164 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.07 | ) | $ | (0.09 | ) | $ | (0.15 | ) | $ | (0.20 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 86,845 | 82,138 | 86,801 | 82,081 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of product revenues | $ | 86 | $ | 117 | $ | 170 | $ | 195 | ||||||||
| Research and development | 1,290 | 1,327 | 2,567 | 3,608 | ||||||||||||
| Selling, general and administrative | 663 | 864 | 1,332 | 2,035 | ||||||||||||
| Total stock-based compensation | $ | 2,039 | $ | 2,308 | $ | 4,069 | $ | 5,838 |
CONDENSED BALANCE SHEETS
| As of June 30, 2010 | As of December 31, 2009 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 21,273 | $ | 8,287 | ||
| Short-term investments | 32,875 | 32,834 | ||||
| Short-term restricted investments | 66 | |||||
| Accounts receivable | 3,340 | 1,700 | ||||
| Inventories | 2,852 | 2,799 | ||||
| Prepaid expenses and other current assets | 1,773 | 1,433 | ||||
| Total current assets | 62,179 | 47,053 | ||||
| Property and equipment, net | 2,656 | 3,808 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 84 | 108 | ||||
| Long-term investments | 2,591 | |||||
| Long-term restricted Investments | 366 | 431 | ||||
| Other long-term assets | 260 | 352 | ||||
| Total assets | $ | 74,535 | $ | 58,151 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 931 | $ | 1,019 | ||
| Accrued liabilities | 4,117 | 5,337 | ||||
| Contract research liability | 1,370 | 990 | ||||
| Deferred revenue, current portion | 8,220 | 4,703 | ||||
| Other short-term liabilities | 219 | 208 | ||||
| Total current liabilities | 14,857 | 12,257 | ||||
| Deferred revenue, noncurrent portion | 38,888 | 17,543 | ||||
| Other long-term liabilities | 396 | 508 | ||||
| Stockholders equity | 20,394 | 27,843 | ||||
| Total liabilities and stockholders equity | $ | 74,535 | $ | 58,151 |
SOURCE: DURECT Corporation
CONTACT: Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936