Full Press Release Details
DURECT Corporation Announces First Quarter 2009 Financial Results
CUPERTINO, Calif., May 6, 2009/PRNewswire-FirstCall/ DURECT
Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2009. Total revenues were $6.2 million for the three months ended March 31, 2009, compared to $6.4 million for the same period in 2008. Net
loss for the three months ended March 31, 2009 was $8.7 million, compared to a net loss of $7.8 million for the same period in 2008.
March 31, 2009, DURECT had cash and investments of $47.0 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at March 31, 2009 and $1.0 million
at December 31, 2008.
The most significant events for DURECT during the first quarter
were interactions with the U.S. Food & Drug Administration (FDA), stated James E. Brown, D.V.M., President and CEO of DURECT. A successful end-of-Phase II meeting with the FDA was conducted for TRANSDUR -Sufentanil, and we
also recently received FDA feedback on our POSIDUR program, enabling us to construct our Phase III development plans. In addition, we are awaiting a mid-year meeting by King Pharmaceuticals with the FDA to clarify the status of the REMOXY New Drug Application (NDA).
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 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 and Asia.
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 single application.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2009 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on May 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 our possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, our
collaborators anticipated meeting with the FDA regarding REMOXY, our intended dose, target label and anticipated total patient exposures, our and Nycomed s clinical development plans including tQTc and other clinical studies, potential
timing of completion of our Phase IIb clinical trial and Phase III program for POSIDUR 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, 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-K filed on March 10, 2009 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
| Three months ended March 31, | ||||||||
| 2009 | 2008 | |||||||
| Collaborative research and development revenue | $ | 3,745 | $ | 4,269 | ||||
| Product revenue, net | 2,415 | 2,169 | ||||||
| Total revenues | 6,160 | 6,438 | ||||||
| Operating expenses: | ||||||||
| Cost of revenues (1) | 824 | 822 | ||||||
| Research and development (1) | 9,903 | 9,634 | ||||||
| Selling, general and administrative (1) | 4,257 | 3,890 | ||||||
| Total operating expenses | 14,984 | 14,346 | ||||||
| Loss from operations | (8,824 | ) | (7,908 | ) | ||||
| Other income (expense): | ||||||||
| Interest and other income | 179 | 568 | ||||||
| Interest expense | (11 | ) | (455 | ) | ||||
| Net other income | 168 | 113 | ||||||
| Net loss | $ | (8,656 | ) | $ | (7,795 | ) | ||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.11 | ) | ||
| Shares used in computing basic and diluted net loss per share | 82,023 | 74,113 | ||||||
| (1) Includes stock-based compensation related to the following: | ||||||||
| Cost of revenues | $ | 78 | $ | 35 | ||||
| Research and development | 2,281 | 1,607 | ||||||
| Selling, general and administrative | 1,171 | 775 | ||||||
| Total stock-based compensation | $ | 3,530 | $ | 2,417 |
CONDENSED BALANCE SHEETS
| As of March 31, 2009 | As of December 31, 2008 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 23,463 | $ | 29,445 | ||
| Short-term investments | 18,191 | 20,836 | ||||
| Short-term restricted investments | 371 | 624 | ||||
| Accounts receivable | 3,392 | 4,055 | ||||
| Inventories | 2,639 | 3,474 | ||||
| Prepaid expenses and other current assets | 3,153 | 1,850 | ||||
| Total current assets | 51,209 | 60,284 | ||||
| Property and equipment, net | 5,435 | 5,971 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 145 | 157 | ||||
| Long-term investments | 4,520 | 1,362 | ||||
| Long-term restricted Investments | 429 | 425 | ||||
| Other long-term assets | 270 | 276 | ||||
| Total assets | $ | 68,407 | $ | 74,874 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 712 | $ | 1,018 | ||
| Accrued liabilities | 4,785 | 5,204 | ||||
| Contract research liability | 645 | 995 | ||||
| Deferred revenue, current portion | 8,826 | 9,235 | ||||
| Other short-term liabilities | 408 | 431 | ||||
| Total current liabilities | 15,376 | 16,883 | ||||
| Deferred revenue, noncurrent portion | 19,903 | 19,771 | ||||
| Other long-term liabilities | 667 | 656 | ||||
| Stockholders equity | 32,461 | 37,564 | ||||
| Total liabilities and stockholders equity | $ | 68,407 | $ | 74,874 |