Full Press Release Details
DURECT Corporation Announces Fourth Quarter and Year End 2009 Financial Results
CA, February 24, 2010/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months and year ended December 31, 2009. Total revenues were $4.9 million for the three months ended
December 31, 2009 and $7.7 million for the three months ended December 31, 2008. Net loss for the three months ended December 31, 2009 was $9.0 million, compared to a net loss of $18.4 million for the same period in 2008 which
included a $13.5 million non-cash write-down associated with a research and development program (Chronogesic ) that we are no longer actively pursuing.
For the fiscal year ended December 31, 2009, total revenues were $24.3 million, compared to $27.1 million for the same period in 2008. Net loss for the year ended December 31, 2009 was $30.7
million, compared to a net loss of $43.9 million for the same period in 2008 (including the $13.5 million write-down described above).
December 31, 2009, we had cash and investments of $41.6 million, compared to cash and investments of $52.7 million at December 31, 2008.
We advanced our late stage pipeline in 2009, most notably through the recent initiation of BESST, our pivotal U.S. Phase III clinical study for POSIDUR , and through work by King Pharmaceuticals to prepare the NDA resubmission
for REMOXY , stated James E. Brown, D.V.M., President and CEO of DURECT. Our goals for 2010 include enrolling patients in POSIDUR s Phase III program, assisting King with aspects of the REMOXY NDA resubmission, advancing our
other development programs, and establishing favorable licensing collaborations.
Highlights for DURECT in Fiscal Year 2009 and Major
Potential Milestones over the Next 12-18 Months:
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.
(SABER -Bupivacaine) Post-Operative Pain Relief Depot. In December 2009, we reported positive top-line results from our Phase IIb clinical study in shoulder surgery of 60 patients. In addition, Nycomed continued enrollment in a Phase IIb
study in hysterectomy patients and a Phase IIb study in shoulder surgery patients.
In January 2010, we announced that we had commenced our U.S. pivotal
Phase III clinical study known as BESST (Bupivacaine Effectiveness and Safety in SABERTM Trial). We expect to complete enrollment of BESST, comprising approximately 300 patients, in the first half of 2011. In Europe, we expect to have top-line data in 2010 from the Phase IIb hysterectomy
study being conducted by Nycomed and, depending on the pace of enrollment, potentially from the Phase IIb study in shoulder surgery.
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
other defined countries, and we have retained commercialization rights in the U.S., Canada, Japan and all other countries. In February 2010, we amended our agreement with Nycomed to separate funding and control of the U.S. and European clinical
programs and to expand the territory licensed to Nycomed. The parties are not altering the final decision making authority and financial responsibility for the remainder of the development activities, such as the non-clinical and CMC (Chemistry,
Manufacturing and Control) activities, which will continue to be jointly managed and funded by Nycomed and us. We are in active discussions with multiple potential partners regarding licensing of the U.S./Canadian and Japanese rights to this
ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from a single 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
webcast of a conference call to discuss 2009 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on February 24 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
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 DURINTM 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 anticipated net cash consumption, the anticipated resubmission of the REMOXY NDA, anticipated clinical trials (including timing and results) for POSIDUR,
TRANSDUR-Sufentanil, ELADUR, ORADUR-ADHD and our other drug candidates, the potential benefits and uses of our drug candidates and potential collaborations with third parties 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, 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 on November 2, 2009 under the heading Risk Factors.
CONDENSED STATEMENTS OF OPERATIONS
except per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Collaborative research and development and other revenue | $ | 2,802 | $ | 5,859 | $ | 12,180 | $ | 18,336 | ||||||||
| Product revenue, net | 2,076 | 1,867 | 12,113 | 8,765 | ||||||||||||
| Total revenues | 4,878 | 7,726 | 24,293 | 27,101 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 848 | 691 | 5,343 | 3,365 | ||||||||||||
| Research and development (1) | 9,546 | 8,456 | 34,913 | 39,411 | ||||||||||||
| Selling, general and administrative (1) | 3,548 | 3,697 | 15,136 | 15,510 | ||||||||||||
| Write down of deferred royalties and commercial rights | 13,480 | 13,480 | ||||||||||||||
| Total operating expenses | 13,942 | 26,324 | 55,392 | 71,766 | ||||||||||||
| Loss from operations | (9,064 | ) | (18,598 | ) | (31,099 | ) | (44,665 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 53 | 262 | 420 | 1,547 | ||||||||||||
| Interest and other expense | (5 | ) | (16 | ) | (36 | ) | (789 | ) | ||||||||
| Net other income | 48 | 246 | 384 | 758 | ||||||||||||
| Net loss | $ | (9,016 | ) | $ | (18,352 | ) | $ | (30,715 | ) | $ | (43,907 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.10 | ) | $ | (0.22 | ) | $ | (0.37 | ) | $ | (0.56 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 86,720 | 81,927 | 83,427 | 78,332 | ||||||||||||
| (1) Includes stock-based compensation related to the following: | ||||||||||||||||
| Cost of revenues | $ | 96 | $ | 25 | $ | 382 | $ | 135 | ||||||||
| Research and development | 1,104 | 1,308 | 6,377 | 5,575 | ||||||||||||
| Selling, general and administrative | 656 | 722 | 3,476 | 2,790 | ||||||||||||
| Total stock-based compensation | $ | 1,856 | $ | 2,055 | $ | 10,235 | $ | 8,500 |
CONDENSED BALANCE SHEETS
| As of December 31, 2009 | As of December 31, 2008 (1) | |||||
| (unaudited) | ||||||
| ASSETS | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 8,287 | $ | 29,445 | ||
| Short-term investments | 32,834 | 20,836 | ||||
| Short-term restricted investments | 624 | |||||
| Accounts receivable | 1,700 | 4,055 | ||||
| Inventories | 2,799 | 3,474 | ||||
| Prepaid expenses and other current assets | 1,433 | 1,850 | ||||
| Total current assets | 47,053 | 60,284 | ||||
| Property and equipment, net | 3,808 | 5,971 | ||||
| Goodwill | 6,399 | 6,399 | ||||
| Intangible assets, net | 108 | 157 | ||||
| Long-term investments | 1,362 | |||||
| Long-term restricted Investments | 431 | 425 | ||||
| Other long-term assets | 352 | 276 | ||||
| Total assets | $ | 58,151 | $ | 74,874 | ||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,019 | $ | 1,018 | ||
| Accrued liabilities | 5,764 | 5,204 | ||||
| Contract research liability | 990 | 995 | ||||
| Deferred revenue, current portion | 4,703 | 9,235 | ||||
| Other short-term liabilities | 208 | 431 | ||||
| Total current liabilities | 12,684 | 16,883 | ||||
| Deferred revenue, noncurrent portion | 17,543 | 19,771 | ||||
| Other long-term liabilities | 508 | 656 | ||||
| Stockholders equity | 27,416 | 37,564 | ||||
| Total liabilities and stockholders equity | $ | 58,151 | $ | 74,874 |