CUPERTINO, Calif., Oct. 31, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the third quarter of 2016. Total revenues were $3.7 million and net loss was $8.8 million for the three months ended September 30, 2016 as compared to total revenues of $4.7 million and net loss of $6.5 million for the three months ended September 30, 2015.
At September 30, 2016, we had cash and investments of $29.0 million, compared to cash and investments of $29.3 million at December 31, 2015. At September 30, 2016, we had $19.8 million in long term debt.
"We are pleased to have provided a separate update today on our DUR-928 program," stated James E. Brown, D.V.M., President and CEO of DURECT. "Regarding POSIMIR®, we have switched over the majority of our active clinical trial sites in the PERSIST Phase 3 trial from Part 1 to Part 2, in which POSIMIR is compared head-to-head against bupivacaine HCL, and continue to add new sites as enrollment proceeds."
Update of Selected Programs:
Earnings Conference Call
A live audio webcast of a conference call to discuss third quarter 2016 results will be broadcast live over the internet at 4:30 p.m. Eastern Time on October 31 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 actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT's Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury and chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). DURECT's advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage development program in this category is POSIMIR® (SABER®-Bupivacaine), an investigational analgesic product intended to address key unmet needs in postoperative pain management. Another is REMOXY ER (oxycodone), an investigational new drug based on DURECT's ORADUR technology. For more information, please visit www.durect.com.
NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY ER, POSIMIR, DUR-928 and ORADUR-Methylphenidate 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 the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat NASH, other liver disease or kidney disease, the potential use of POSIMIR to treat pain, the potential abuse deterrent properties of REMOXY ER and the potential use of ORADUR-ADHD to treat ADHD, clinical trial plans for DUR-928, POSIMIR and our other product candidates (including timing and potential results), potential regulatory approvals of POSIMIR and REMOXY ER, potential markets for our product candidates, potential plans to commercialize POSIMIR ourselves, collaborations with third parties, including Pain Therapeutics' plans for REMOXY ER, 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 risks that future clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, that the PERSIST clinical trial of POSIMIR will take longer to conduct than anticipated or result in data that will not support a successful NDA resubmission or product approval, that Pain Therapeutics may not be able to adequately address all of FDA's concerns regarding the REMOXY ER NDA or there could be a delay in addressing such concerns and the potential that FDA may not grant regulatory approval of REMOXY ER, the risks of obtaining marketplace acceptance of REMOXY ER, the risk of delays in the commencement, enrollment or completion of other clinical trials, the risk that prior clinical trials (including prior trials of POSIMIR in laparoscopic cholecystectomy patients) will not be confirmed in subsequent trials, the potential failure of clinical trials to meet their intended endpoints, the risk that Pain Therapeutics or Orient Pharma will discontinue development of REMOXY, or ORADUR-Methylphenidate, respectively, or be delayed in development or regulatory submissions, the risk of adverse decisions by regulatory agencies or 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 DUR-928, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 2, 2016 under the heading "Risk Factors."
DURECT CORPORATION | ||||||||
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||
(in thousands, except per share amounts) | ||||||||
(Unaudited) | ||||||||
Three months ended |
Nine months ended | |||||||
September 30 |
September 30 | |||||||
2016 |
2015 |
2016 |
2015 | |||||
Collaborative research and development and other revenue |
$ 352 |
$ 2,052 |
$ 1,142 |
$ 5,568 | ||||
Product revenue, net |
3,391 |
2,691 |
9,366 |
8,389 | ||||
Total revenues |
3,743 |
4,743 |
10,508 |
13,957 | ||||
Operating expenses: |
||||||||
Cost of product revenues |
2,180 |
884 |
4,335 |
2,912 | ||||
Research and development |
6,805 |
6,654 |
21,282 |
17,659 | ||||
Selling, general and administrative |
3,043 |
3,177 |
8,993 |
8,721 | ||||
Total operating expenses |
12,028 |
10,715 |
34,610 |
29,292 | ||||
Loss from operations |
(8,285) |
(5,972) |
(24,102) |
(15,335) | ||||
Other income (expense): |
||||||||
Interest and other income |
45 |
43 |
112 |
194 | ||||
Interest and other expense |
(592) |
(558) |
(1,708) |
(1,677) | ||||
Net other income (expense) |
(547) |
(515) |
(1,596) |
(1,483) | ||||
Net loss |
$ (8,832) |
$ (6,487) |
$(25,698) |
$(16,818) | ||||
Net loss per share |
||||||||
Basic |
$ (0.06) |
$ (0.05) |
$ (0.20) |
$ (0.14) | ||||
Diluted |
$ (0.06) |
$ (0.05) |
$ (0.20) |
$ (0.14) | ||||
Weighted-average shares used in computing net loss per share |
||||||||
Basic |
137,933 |
120,483 |
130,990 |
117,718 | ||||
Diluted |
137,933 |
120,483 |
130,990 |
117,718 | ||||
Total comprehensive loss |
$ (8,836) |
$ (6,481) |
$(25,678) |
$(16,901) |
DURECT CORPORATION | ||||
CONDENSED BALANCE SHEETS | ||||
(in thousands) | ||||
As of |
As of | |||
September 30, 2016 |
December 31, 2015(1) | |||
(unaudited) |
||||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 5,363 |
$ 3,583 | ||
Short-term investments |
22,403 |
25,457 | ||
Short-term restricted Investments |
100 |
- | ||
Accounts receivable |
1,249 |
2,222 | ||
Inventories |
3,641 |
3,917 | ||
Prepaid expenses and other current assets |
1,744 |
3,142 | ||
Total current assets |
34,500 |
38,321 | ||
Property and equipment, net |
1,290 |
1,566 | ||
Goodwill |
6,399 |
6,399 | ||
Long-term investments |
1,000 |
- | ||
Long-term restricted Investments |
150 |
250 | ||
Other long-term assets |
236 |
236 | ||
Total assets |
$ 43,575 |
$ 46,772 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 1,494 |
$ 1,286 | ||
Accrued liabilities |
4,092 |
4,970 | ||
Contract research liability |
555 |
575 | ||
Deferred revenue, current portion |
989 |
616 | ||
Total current liabilities |
7,130 |
7,447 | ||
Deferred revenue, noncurrent portion |
1,988 |
2,269 | ||
Long-term debt, net |
19,838 |
19,684 | ||
Other long-term liabilities |
1,676 |
2,489 | ||
Stockholders' equity |
12,943 |
14,883 | ||
Total liabilities and stockholders' equity |
$ 43,575 |
$ 46,772 | ||
(1) Derived from audited financial statements. |
SOURCE DURECT Corporation