Full Press Release Details
DURECT Corporation Announces Second Quarter 2009 Financial Results
CUPERTINO, Calif., August 3, 2009/PRNewswire-FirstCall/
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2009. Total revenues were $4.9 million for the three months ended June 30, 2009, compared to $6.3 million for the same period in 2008.
Net loss for the three months ended June 30, 2009 was $7.5 million, compared to a net loss of $8.6 million for the same period in 2008.
June 30, 2009, DURECT had cash and investments of $41.9 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at June 30, 2009 and $1.0 million at
Our senior management team was strengthened during the second quarter through the hiring of Joe Stauffer as our Chief
Medical Officer, a former anesthesiologist and FDA reviewer with directly relevant experience covering all aspects of developing pain medications, stated James E. Brown, D.V.M., President and CEO of DURECT. It is also noteworthy that we
signed four new feasibility projects in the quarter with pharmaceutical companies to apply our SABER depot and DURIN injectable technologies to address specific drug delivery challenges for both small molecule and biologic agents.
Shortly after the end of the quarter, we were pleased to learn that King Pharmaceuticals met with the FDA regarding Remoxy and believes that they have a clear path forward that could allow them to resubmit the Remoxy NDA in mid-2010.
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 patents and pending patent applications owned by us, REMOXY is
designed to resist common methods of prescription drug misuse and abuse.
POSIDUR is our investigational 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 we have retained commercialization rights in the US, Canada
ELADUR is our proprietary transdermal patch intended to provide bupivacaine for a period of up to three days from a single application.
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 2009 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on August 3 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 plans by King Pharmaceuticals for resubmission of the REMOXY NDA in mid-2010 and their belief that this resubmission will address all FDA comments in the Complete
Response Letter, the potential of FDA approving the REMOXY NDA, the timing and content of any potential update to be provided by King Pharmaceuticals, as well as the potential royalty and other payments that may be received by DURECT from REMOXY,
our possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, and potential agreements with third parties about licensing and development rights to our product 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, the potential that the REMOXY NDA
resubmission may not adequately address all of FDA s concerns, the potential that FDA may not grant regulatory approval of REMOXY, failure of our clinical trials to produce intended results, possible adverse events associated with the use of
our drug candidates, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of our drug candidates, DURECT s (and that of its third party collaborators where
applicable) difficulty or failure 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 secure and defend 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 filed on May 7, 2009 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three months ended | Year ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Collaborative research and development revenue | $ | 2,606 | $ | 3,867 | $ | 6,351 | $ | 8,136 | ||||||||
| Product revenue, net | 2,271 | 2,436 | 4,686 | 4,605 | ||||||||||||
| Total revenues | 4,877 | 6,303 | 11,037 | 12,741 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 837 | 982 | 1,661 | 1,804 | ||||||||||||
| Research and development (1) | 7,866 | 9,898 | 17,769 | 19,532 | ||||||||||||
| Selling, general and administrative (1) | 3,777 | 4,086 | 8,034 | 7,976 | ||||||||||||
| Total operating expenses | 12,480 | 14,966 | 27,464 | 29,312 | ||||||||||||
| Loss from operations | (7,603 | ) | (8,663 | ) | (16,427 | ) | (16,571 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 106 | 368 | 285 | 936 | ||||||||||||
| Interest expense | (11 | ) | (304 | ) | (22 | ) | (759 | ) | ||||||||
| Net other income | 95 | 64 | 263 | 177 | ||||||||||||
| Net loss | $ | (7,508 | ) | $ | (8,599 | ) | $ | (16,164 | ) | $ | (16,394 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.09 | ) | $ | (0.11 | ) | $ | (0.20 | ) | $ | (0.22 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 82,138 | 75,430 | 82,081 | 74,772 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of revenues | $ | 117 | $ | 31 | $ | 195 | $ | 66 | ||||||||
| Research and development | 1,327 | 1,360 | 3,608 | 2,967 | ||||||||||||
| Selling, general and administrative | 864 | 674 | 2,035 | 1,449 | ||||||||||||
| Total stock-based compensation | $ | 2,308 | $ | 2,065 | $ | 5,838 | $ | 4,482 |
CONDENSED BALANCE SHEETS
| As of June 30, 2009 | As of December 31, 2008 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 10,024 | $ | 29,445 | ||
| Short-term investments | 24,507 | 20,836 | ||||
| Short-term restricted investments | 372 | 624 | ||||
| Accounts receivable | 2,336 | 4,055 | ||||
| Inventories | 2,737 | 3,474 | ||||
| Prepaid expenses and other current assets | 3,037 | 1,850 | ||||
| Total current assets | 43,013 | 60,284 | ||||
| Property and equipment, net | 4,955 | 5,971 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 133 | 157 | ||||
| Long-term investments | 6,528 | 1,362 | ||||
| Long-term restricted Investments | 428 | 425 | ||||
| Other long-term assets | 368 | 276 | ||||
| Total assets | $ | 61,824 | $ | 74,874 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 846 | $ | 1,018 | ||
| Accrued liabilities | 4,135 | 5,204 | ||||
| Contract research liability | 616 | 995 | ||||
| Deferred revenue, current portion | 8,074 | 9,235 | ||||
| Other short-term liabilities | 421 | 431 | ||||
| Total current liabilities | 14,092 | 16,883 | ||||
| Deferred revenue, noncurrent portion | 19,552 | 19,771 | ||||
| Other long-term liabilities | 614 | 656 | ||||
| Stockholders equity | 27,566 | 37,564 | ||||
| Total liabilities and stockholders equity | $ | 61,824 | $ | 74,874 |
SOURCE DURECT Corporation
Matthew J. Hogan, Chief Financial Officer, DURECT
Corporation, +1-408-777-4936