Full Press Release Details
DURECT Corporation Announces Third Quarter 2011 Financial Results and Update of Programs
CUPERTINO, CA, November 3, 2011/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months
ended September 30, 2011. Total revenues were $8.1 million for the three months ended September 30, 2011 and 2010. Net loss for the three months ended September 30, 2011 was $5.0 million, compared to a net loss of $4.6 million for the
same period in 2010.
At September 30, 2011, we had cash and investments of $35.1 million, compared to cash and investments of $37.5
million at June 30, 2011 and $49.6 million at December 31, 2010. We have no debt obligations, other than normal liabilities associated with running our business.
We completed enrollment in our pivotal Phase III trial for
POSIDUR (BESST) in the third quarter, expect to have
top-line data in the fourth quarter of this year and, assuming positive data, we expect to submit the New Drug Application in the first half of 2012, stated James E. Brown, D.V.M., President and CEO of DURECT. In July, as a culmination
of a multi-year feasibility effort with Zogenix, DURECT added an antipsychotic development program to our pipeline. In addition, we continue to support an experienced team at Pfizer in resolving the remaining issues related to REMOXY .
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.
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.
ELADUR is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from a
single application. ELADUR demonstrated a positive efficacy trend in a Phase 2a study for post-herpetic neuralgia (PHN); a poster describing this study was presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and is accessible on DURECT s website
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 third quarter 2011 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on November 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 a specialty pharmaceutical company developing innovative drugs for pain and 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 authorities.
DURECT Forward-Looking Statement
The statements in this press release the anticipated timing of the receipt of top-line data from BESST, and assuming the data are positive, the submission of the NDA for POSIDUR, anticipated initiation of
clinical studies for Relday in early 2012 and potential milestone payments and royalties receivable from Zogenix, the potential benefits and uses of our drug candidates and our expectations as to cash consumption in 2011 and 2012 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 risk of adverse decisions by
regulatory agencies, including product non-approval, delays and additional costs due to requirements imposed by regulatory agencies, potential adverse effects arising from the testing or use of our drug candidates, the potential failure of our
clinical trials to meet their intended endpoints, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and 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, or ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing
process development of the referenced product candidates, 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 August 5, 2011 under the heading Risk
STATEMENT OF OPERATIONS DATA
(in thousands, except per share amounts)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||
| Collaborative research and development and other revenue | $ | 5,206 | $ | 5,689 | $ | 15,906 | $ | 14,162 | ||||||||
| Product revenue, net | 2,909 | 2,427 | 8,646 | 8,933 | ||||||||||||
| Total revenues | 8,115 | 8,116 | 24,552 | 23,095 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of revenues (1) | 1,300 | 859 | 3,786 | 3,098 | ||||||||||||
| Research and development (1) | 8,452 | 8,142 | 27,040 | 26,767 | ||||||||||||
| Selling, general and administrative (1) | 3,377 | 3,806 | 10,420 | 10,892 | ||||||||||||
| Total operating expenses | 13,129 | 12,807 | 41,246 | 40,757 | ||||||||||||
| Loss from operations | (5,014 | ) | (4,691 | ) | (16,694 | ) | (17,662 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income | 31 | 46 | 109 | 105 | ||||||||||||
| Interest and other expense | (42 | ) | (2 | ) | (42 | ) | (25 | ) | ||||||||
| Net other income (expense) | (11 | ) | 44 | 67 | 80 | |||||||||||
| Net loss | $ | (5,025 | ) | $ | (4,647 | ) | $ | (16,627 | ) | $ | (17,582 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.06 | ) | $ | (0.05 | ) | $ | (0.19 | ) | $ | (0.20 | ) | ||||
| Shares used in computing basic and diluted net loss per share | 87,450 | 86,892 | 87,375 | 86,832 |
| Cost of revenues | $ | 80 | $ | 83 | $ | 247 | $ | 253 | ||||||||
| Research and development | 1,078 | 1,151 | 3,277 | 3,718 | ||||||||||||
| Selling, general and administrative | 592 | 691 | 1,743 | 2,023 | ||||||||||||
| Total stock-based compensation | $ | 1,750 | $ | 1,925 | $ | 5,267 | $ | 5,994 |
CONDENSED BALANCE SHEETS
| As of September 30, 2011 | As of December 31, 2010 (1) | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,031 | $ | 10,437 | ||||
| Short-term investments | 25,428 | 35,005 | ||||||
| Short-term restricted investments | 66 | |||||||
| Accounts receivable | 3,045 | 3,716 | ||||||
| Inventories | 3,134 | 2,836 | ||||||
| Prepaid expenses and other current assets | 1,771 | 2,785 | ||||||
| Total current assets | 40,409 | 54,845 | ||||||
| Property and equipment, net | 3,412 | 1,776 | ||||||
| Goodwill | 6,399 | 6,399 | ||||||
| Intangible assets, net | 58 | 71 | ||||||
| Long-term investments | 1,799 | 3,197 | ||||||
| Long-term restricted Investments | 867 | 867 | ||||||
| Other long-term assets | 305 | 405 | ||||||
| Total assets | $ | 53,249 | $ | 67,560 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,243 | $ | 981 | ||||
| Accrued liabilities | 5,147 | 6,524 | ||||||
| Contract research liability | 2,360 | 2,109 | ||||||
| Deferred revenue, current portion | 7,372 | 8,079 | ||||||
| Other short-term liabilities | 280 | 216 | ||||||
| Total current liabilities | 16,402 | 17,909 | ||||||
| Deferred revenue, noncurrent portion | 31,932 | 34,849 | ||||||
| Other long-term liabilities | 796 | 315 | ||||||
| Stockholders equity | 4,119 | 14,487 | ||||||
| Total liabilities and stockholders equity | $ | 53,249 | $ | 67,560 |
SOURCE: DURECT Corporation
CONTACT: Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936