Full Press Release Details
DURECT Corporation Announces Third Quarter 2009 Financial Results
October 29, 2009/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended September 30, 2009. Total revenues were $8.4 million for the three months ended September 30,
2009, compared to $6.6 million for the same period in 2008; revenues in the 2009 period included $3.0 million related to the sale of certain excipients used in REMOXY to King Pharmaceuticals in 2008 and the first quarter of 2009, all of which
was recognized upon the execution of the long term supply agreement between us and King in the third quarter of 2009. Net loss for the three months ended September 30, 2009 was $5.5 million, compared to a net loss of $9.2 million for the same
At September 30, 2009, DURECT had cash and investments of $47.2 million, compared to cash and investments of $52.7
million at December 31, 2008; these figures include restricted investments of $0.8 million at September 30, 2009 and $1.0 million at December 31, 2008.
Since our last earnings report, we have continued to advance our development programs and business activities, including completing enrollment in our POSIDUR Phase II shoulder study, entering into a new collaboration with Orient Pharma that will allow us to generate Phase II data for a new drug candidate for
the Attention Deficit Hyperactivity Disorder market (ORADUR -ADHD) and a long term excipient supply agreement
with King Pharmaceuticals with respect to REMOXY, stated James E. Brown, D.V.M., President and CEO of DURECT. In addition, we enhanced our cash position with a $10 million sale of common stock to affiliates of Venrock, a highly respected
institutional investor.
REMOXY is an investigational 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 intended 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 to treat pain for a period of up to three days from a single
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 third quarter 2009 results will be broadcast over the internet at 4:30 p.m.
Eastern Time on October 29 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, TRANSDUR-Sufentanil and
ORADUR-ADHD 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 expectation that we will
have top line data from our Phase IIb shoulder study in December, the expectation that King will commence additional clinical studies in the first half of next year with ELADUR, our plan to generate Phase II data with our ORADUR-ADHD program, our
possible licensing of development and commercialization rights to POSIDUR and TRANSDUR-Sufentanil to third parties, and potential agreements with third parties to license the development and commercialization 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 take longer to achieve than expected and 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 August 4, 2009 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
except per share amounts)
| Three months ended September 30, | Year ended September 30, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Collaborative research and development revenue | $ | 3,027 | $ | 4,341 | $ | 9,378 | $ | 12,477 | ||||||||
| Product revenue, net | 5,351 | 2,293 | 10,037 | 6,898 | ||||||||||||
| Total revenues | 8,378 | 6,634 | 19,415 | 19,375 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 2,834 | 870 | 4,495 | 2,674 | ||||||||||||
| Research and development (1) | 7,598 | 11,423 | 25,367 | 30,955 | ||||||||||||
| Selling, general and administrative (1) | 3,554 | 3,837 | 11,588 | 11,813 | ||||||||||||
| Total operating expenses | 13,986 | 16,130 | 41,450 | 45,442 | ||||||||||||
| Loss from operations | (5,608 | ) | (9,496 | ) | (22,035 | ) | (26,067 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 82 | 349 | 367 | 1,285 | ||||||||||||
| Interest expense | (9 | ) | (14 | ) | (31 | ) | (773 | ) | ||||||||
| Net other income | 73 | 335 | 336 | 512 | ||||||||||||
| Net loss | $ | (5,535 | ) | $ | (9,161 | ) | $ | (21,699 | ) | $ | (25,555 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.07 | ) | $ | (0.11 | ) | $ | (0.26 | ) | $ | (0.33 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 82,781 | 81,779 | 82,317 | 77,124 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of revenues | $ | 91 | $ | 44 | $ | 286 | $ | 110 | ||||||||
| Research and development | 1,665 | 1,300 | 5,273 | 4,267 | ||||||||||||
| Selling, general and administrative | 785 | 619 | 2,820 | 2,068 | ||||||||||||
| Total stock-based compensation | $ | 2,541 | $ | 1,963 | $ | 8,379 | $ | 6,445 |
CONDENSED BALANCE SHEETS
| As of September 30, 2009 | As of December 31, 2008 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 17,933 | $ | 29,445 | ||
| Short-term investments | 27,483 | 20,836 | ||||
| Short-term restricted investments | 372 | 624 | ||||
| Accounts receivable | 2,947 | 4,055 | ||||
| Inventories | 2,882 | 3,474 | ||||
| Prepaid expenses and other current assets | 1,020 | 1,850 | ||||
| Total current assets | 52,637 | 60,284 | ||||
| Property and equipment, net | 4,516 | 5,971 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 121 | 157 | ||||
| Long-term investments | 1,000 | 1,362 | ||||
| Long-term restricted Investments | 431 | 425 | ||||
| Other long-term assets | 360 | 276 | ||||
| Total assets | $ | 65,464 | $ | 74,874 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 498 | $ | 1,018 | ||
| Accrued liabilities | 5,271 | 5,204 | ||||
| Contract research liability | 797 | 995 | ||||
| Deferred revenue, current portion | 5,073 | 9,235 | ||||
| Other short-term liabilities | 435 | 431 | ||||
| Total current liabilities | 12,074 | 16,883 | ||||
| Deferred revenue, noncurrent portion | 18,366 | 19,771 | ||||
| Other long-term liabilities | 561 | 656 | ||||
| Stockholders equity | 34,463 | 37,564 | ||||
| Total liabilities and stockholders equity | $ | 65,464 | $ | 74,874 |
SOURCE: DURECT Corporation
CONTACT: Matthew J. Hogan, Chief
Financial Officer, DURECT Corporation, 408-777-4936