Full Press Release Details
DURECT Corporation Announces Second Quarter 2015 Financial Results and Update of Programs
CUPERTINO, CA, August 3, 2015/PRNewswire-FirstCall/ DURECT Corporation (Nasdaq: DRRX) announced today financial results for the second quarter of
2015. Total revenues were $4.4 million and net loss was $5.5 million for the three months ended June 30, 2015 as compared to total revenues of $4.6 million and net loss of $5.5 million for the three months ended June 30, 2014.
At June 30, 2015, we had cash and investments of $37.8 million, compared to cash and investments of $34.9 million at December 31, 2014. At
June 30, 2015, we had $19.9 million in long term debt.
The second quarter marked significant progress on multiple fronts, stated James
E. Brown, D.V.M., President and CEO of DURECT. We are excited to have received feedback from the FDA on the outline of the new POSIDUR Phase 3 clinical trial which is intended to provide the data necessary for a robust NDA resubmission.
For DUR-928, we completed a positive Phase 1 multiple-ascending-dose study with our oral formulation program, are preparing to start Phase 1 studies with our injectable formulation program and today we are reporting positive data from an animal
stroke model. Regarding REMOXY , Pain Therapeutics has stated that they have substantially completed the transition of REMOXY from Pfizer and that they expect to resubmit the REMOXY NDA in the
first quarter of 2016. Also, our sublicensee, Orient Pharma, has initiated their ORADUR-ADHD Phase 3 study in Taiwan.
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, while at the same time we are evaluating whether to commercialize POSIDUR on our own in the U.S. in the event that we determine that is the preferred route of commercialization.
Earnings Conference Call
A live audio webcast of a conference call to discuss second quarter 2015 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on
August 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 biopharmaceutical company with expertise in drug discovery, drug delivery and drug development, applying those skills primarily to therapeutics in
the fields of pain management, CNS disorders, acute organ injury and metabolic diseases. DURECT s proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes
such as improved abuse deterrence, convenience, adherence, efficacy and safety for small molecule and biologic drugs. Late stage development programs of this nature include POSIDUR and REMOXY. DURECT s Epigenomic Regulator Program includes the
lead molecule DUR-928 in Phase 1 clinical testing. DUR-928 is an endogenous small molecule that is an epigenomic modulator of cellular activities involved in lipid homeostasis, metabolic disease, inflammation and cell survival. For more information,
please visit www.durect.com.
NOTE: POSIDUR , SABER , ORADUR , and TRANSDUR are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR,
ELADUR, ORADUR-Methylphenidate, Relday and DUR-928 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 regarding regulatory matters, including anticipated meetings and submissions for POSIDUR, REMOXY and Relday and potential FDA approval of our product candidates, anticipated clinical trials (including timing and results) for POSIDUR,
DUR-928, Relday, ORADUR-Methylphenidate and our other drug candidates, potential royalties from Pain Therapeutics, the potential benefits and uses of our drug candidates, potential markets for our product candidates, the potential license of
POSIDUR, DUR-928, ORADUR-ADHD and other products and other potential business development 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 the clinical trial of POSIDUR will take longer to conduct than anticipated or result in data that will not support a successful resubmission, development of REMOXY may be significantly delayed and adversely affected by
Pfizer s discontinuation of its development, the risk that Pain Therapeutics 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, REMOXY or other NDA submissions, delays and additional costs due to requirements imposed by regulatory agencies, additional time and resources that may be required for
development, testing and regulatory approval of our Epigenomic Regulatory Program, 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 Form 10-Q for the quarter ending March 31, 2015
filed with the Securities and Exchange Commission on May 1, 2015, under the heading Risk Factors.
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands, except per share amounts)
| Three months ended | Six months ended | |||||||||||||||
| June 30 | June 30 | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Collaborative research and development and other revenue | $ | 1,778 | $ | 1,735 | $ | 3,516 | $ | 5,247 | ||||||||
| Product revenue, net | 2,663 | 2,846 | 5,698 | 5,627 | ||||||||||||
| Total revenues | 4,441 | 4,581 | 9,214 | 10,874 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product revenues | 1,022 | 1,091 | 2,028 | 2,154 | ||||||||||||
| Research and development | 5,638 | 6,088 | 11,005 | 11,557 | ||||||||||||
| Selling, general and administrative | 2,724 | 2,850 | 5,544 | 6,213 | ||||||||||||
| Total operating expenses | 9,384 | 10,029 | 18,577 | 19,924 | ||||||||||||
| Income (loss) from operations | (4,943 | ) | (5,448 | ) | (9,363 | ) | (9,050 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income (expenses) | 23 | 3 | 151 | 6 | ||||||||||||
| Interest expense | (558 | ) | (33 | ) | (1,119 | ) | (34 | ) | ||||||||
| Net other income (expense) | (535 | ) | (30 | ) | (968 | ) | (28 | ) | ||||||||
| Net loss | $ | (5,478 | ) | $ | (5,478 | ) | $ | (10,331 | ) | $ | (9,078 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.05 | ) | $ | (0.05 | ) | $ | (0.09 | ) | $ | (0.08 | ) | ||||
| Diluted | $ | (0.05 | ) | $ | (0.05 | ) | $ | (0.09 | ) | $ | (0.08 | ) | ||||
| Weighted-average shares used in computing net loss per share | ||||||||||||||||
| Basic | 118,804 | 110,570 | 116,313 | 110,519 | ||||||||||||
| Diluted | 118,804 | 110,570 | 116,313 | 110,519 | ||||||||||||
| Total comprehensive loss | $ | (5,482 | ) | $ | (5,481 | ) | $ | (10,420 | ) | $ | (9,077 | ) |
CONDENSED BALANCE SHEETS
| As of | As of | |||||||
| June 30, 2015 | December 31, 2014 (1) | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,990 | $ | 2,680 | ||||
| Short-term investments | 31,606 | 30,016 | ||||||
| Accounts receivable | 1,901 | 2,122 | ||||||
| Inventories | 3,929 | 3,642 | ||||||
| Prepaid expenses and other current assets | 1,170 | 1,034 | ||||||
| Total current assets | 44,596 | 39,494 | ||||||
| Property and equipment, net | 1,543 | 1,749 | ||||||
| Goodwill | 6,399 | 6,399 | ||||||
| Long-term investments | 1,804 | |||||||
| Long-term restricted Investments | 250 | 350 | ||||||
| Other long-term assets | 288 | 288 | ||||||
| Total assets | $ | 53,076 | $ | 50,084 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 654 | $ | 1,021 | ||||
| Accrued liabilities | 3,770 | 5,051 | ||||||
| Contract research liability | 404 | 358 | ||||||
| Deferred revenue, current portion | 776 | 538 | ||||||
| Total current liabilities | 5,604 | 6,968 | ||||||
| Deferred revenue, noncurrent portion | 2,473 | 2,742 | ||||||
| Long-term debt, net | 19,862 | 19,824 | ||||||
| Other long-term liabilities | 2,275 | 2,035 | ||||||
| Stockholders equity | 22,862 | 18,515 | ||||||
| Total liabilities and stockholders equity | $ | 53,076 | $ | 50,084 |
SOURCE: DURECT Corporation
CONTACT: Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936