Full Press Release Details
DURECT Corporation Announces First Quarter 2014 Financial Results and Update of Programs
CUPERTINO, CA, May 1, 2014/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the first quarter of
2014. Total revenues were $6.3 million and net loss was $3.6 million for the three months ended March 31, 2014 as compared to total revenues of $4.2 million and net loss of $5.2 million for the three months ended March 31, 2013.
At March 31, 2014, we had cash and investments of $21.8 million, compared to cash and investments of $24.4 million at December 31, 2013. We have no
debt obligations, other than normal liabilities associated with running our business.
Next week, we plan to formally request a face-to-face meeting
with the FDA to gain more clarity on the next steps that would be required to address the issues cited in the recent Complete Response Letter for POSIDUR , stated James E. Brown, D.V.M., President and CEO of DURECT. Regarding REMOXY , Pfizer has four studies posted on Clintrials.gov, with one slated for completion in April 2014 and the other three in June 2014. We also are pleased to have established a collaboration with
Impax whereby ELADUR is now back in development for post-herpetic neuralgia (PHN), the indication for which it was originally designed.
REMOXY, an investigational drug, is a unique long
acting oral formulation of oxycodone intended to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Based on DURECT s ORADUR technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to discourage common methods of tampering associated with prescription opioid
analgesic misuse and abuse.
As part of our on-going effort
to communicate to the medical community data that we ve generated in our development program for POSIDUR, DURECT presented four posters on POSIDUR at the 39th Annual American Society of
Regional Anesthetic and Pain Medicine Meeting on April 5.
POSIDUR is our investigational post-operative pain relief depot that
utilizes our patented SABER technology and is intended to deliver bupivacaine to provide up to three days of pain relief after surgery. We are in discussions with potential partners regarding licensing development and commercialization rights to
POSIDUR, for which we hold worldwide rights.
ELADUR, for the treatment of pain associated with post-herpetic neuralgia (PHN), is our proprietary transdermal patch intended to deliver
bupivacaine for a period of up to three days from a single application; existing lidocaine patches for this condition can be worn for 12 hours with a rest period of 12 hours during which time many patients experience breakthrough pain.
Relday is a proprietary, once-monthly subcutaneous injectable formulation of risperidone with immediate onset of action using DURECT s
SABER controlled-release formulation technology. An existing long-acting injectable risperidone product, which achieved $1.3 billion in global net sales in 2013, requires twice-monthly, intramuscular injections and drug reconstitution prior to use.
action, long duration with once-a-day dosing and target pharmacokinetic profile as demonstrated in a Phase 1 trial. In addition, this product candidate utilizes a small capsule size relative to
the leading existing long acting products on the market and incorporates our ORADUR anti-tampering technology. Our licensee, Orient Pharma, has met with the Taiwan Food and Drug Administration (TFDA) to discuss the Phase 3 program in that market and
is developing its plans for further development in the defined Asian and South Pacific countries to which it has rights from us. We retain rights to all other markets in the world, notably including the U.S., Europe and Japan, and are engaged in
licensing discussions with other companies.
Earnings Conference Call
A live audio webcast of a conference call to discuss first quarter 2014 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on
May 1 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.
SABER , ORADUR , TRANSDUR and ELADUR are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.
REMOXY and other ORADUR-based programs, POSIDUR, ELADUR, TRANSDUR-Sufentanil and Relday 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 Statements
The statements in this press release regarding the potential regulatory meetings and discussions and submissions for REMOXY and POSIDUR, potential FDA approval
of REMOXY, POSIDUR, or any of our other product candidates, anticipated studies and clinical trials (including timing and results) for REMOXY, Relday, ORADUR-Methylphenidate and our other drug candidates, potential royalties or milestone payments
from Impax, the potential benefits and uses of our drug candidates, collaborations with third parties and potential business development, licensing and commercialization activities 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 that Pfizer will discontinue development of REMOXY, the risk of adverse
decisions by regulatory agencies, including rejection of meeting requests, requests for additional information or product non-approval or non-acceptance of our POSIDUR or other NDA submissions, 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 clinical trials to meet their intended endpoints, our potential failure to maintain our collaborative agreements with
third parties or consummate new collaborations and risks related to our (and our third party collaborators where applicable) ability to design, enroll, conduct and complete clinical trials, complete the design, development, and manufacturing process
development of product candidates, manufacture and commercialize product candidates, obtain marketplace acceptance of product candidates, avoid infringing patents held by other parties and secure and defend patents of our own, and manage and obtain
capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT s Annual Report on Form 10-K for the fiscal year ending December 31, 2013 under the heading Risk Factors.
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands, except per share amounts)
| Three months ended March 31, | ||||||||
| 2014 | 2013 | |||||||
| Collaborative research and development and other revenue | $ | 3,512 | $ | 913 | ||||
| Product revenue, net | 2,781 | 3,240 | ||||||
| Total revenues | 6,293 | 4,153 | ||||||
| Operating expenses: | ||||||||
| Cost of product revenues | 1,063 | 1,658 | ||||||
| Research and development | 5,469 | 4,789 | ||||||
| Selling, general and administrative | 3,363 | 2,901 | ||||||
| Total operating expenses | 9,895 | 9,348 | ||||||
| Loss from operations | (3,602 | ) | (5,195 | ) | ||||
| Other income (expense): | ||||||||
| Interest and other income (expenses) | 3 | 14 | ||||||
| Interest expense | (1 | ) | (2 | ) | ||||
| Net other income (expense) | 2 | 12 | ||||||
| Net loss | $ | (3,600 | ) | $ | (5,183 | ) | ||
| Net loss per share | ||||||||
| Basic | $ | (0.03 | ) | $ | (0.05 | ) | ||
| Diluted | $ | (0.03 | ) | $ | (0.05 | ) | ||
| Weighted-average shares used in computing net loss per share | ||||||||
| Basic | 110,468 | 101,881 | ||||||
| Diluted | 110,468 | 101,881 | ||||||
| Total comprehensive loss | $ | (3,596 | ) | $ | (5,181 | ) |
CONDENSED BALANCE SHEETS
| As of March 31, 2014 | As of December 31, 2013 (1) | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 1,970 | $ | 7,836 | ||||
| Short-term investments | 15,838 | 12,753 | ||||||
| Accounts receivable | 2,108 | 2,349 | ||||||
| Inventories | 3,510 | 3,502 | ||||||
| Prepaid expenses and other current assets | 2,064 | 1,888 | ||||||
| Total current assets | 25,490 | 28,328 | ||||||
| Property and equipment, net | 1,837 | 1,985 | ||||||
| Goodwill | 6,399 | 6,399 | ||||||
| Intangible assets, net | 13 | 18 | ||||||
| Long-term investments | 3,611 | 3,352 | ||||||
| Long-term restricted Investments | 350 | 450 | ||||||
| Other long-term assets | 288 | 288 | ||||||
| Total assets | $ | 37,988 | $ | 40,820 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,161 | $ | 736 | ||||
| Accrued liabilities | 3,869 | 5,865 | ||||||
| Contract research liability | 202 | 329 | ||||||
| Deferred revenue, current portion | 255 | 255 | ||||||
| Total current liabilities | 5,487 | 7,185 | ||||||
| Deferred revenue, noncurrent portion | 1,232 | 1,296 | ||||||
| Other long-term liabilities | 1,604 | 1,618 | ||||||
| Stockholders equity | 29,665 | 30,721 | ||||||
| Total liabilities and stockholders equity | $ | 37,988 | $ | 40,820 |
| SOURCE: | DURECT Corporation | |
| CONTACT: | Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936 |