PALATINE, IL--(Marketwired - November 04, 2015) - Acura Pharmaceuticals, Inc. (
The Company reported a net loss of $2.6 million for the third quarter of 2015 or $0.23 per diluted share, compared to net loss of $2.9 million or $0.30 per diluted share for the same period in 2014. Revenues for the quarter were $210 thousand compared to $145 thousand in the third quarter of 2014.
Research and development expenses associated with product candidates utilizing the Company's LIMITX™, and IMPEDE® Technologies were $0.4 million in the third quarter of 2015, compared to $1.0 million for the same period in 2014. Selling, marketing, general and administrative expenses were $2.0 million in the third quarter of 2015, versus $1.7 million in the same period last year. Selling and marketing expenses primarily consist of advertising and marketing activities for NEXAFED® and NEXAFED® SINUS.
The Company reported a net loss of $4.1 million for the nine months ended September 30, 2015 or $0.39 per diluted share, compared to net loss of $10.5 million or $1.08 per diluted share for the same period in 2014. Revenues for the nine months ended September 30, 2015 were $5.9 million compared to $222 thousand in the same period last year. The 2015 results reflect the $5.0 million payment arising from licensing OXAYDO™ (oxycodone HCI) tablets to Egalet Corporation (
Research and development expenses associated with product candidates utilizing the Company's LIMITX™, and IMPEDE® Technologies were $1.9 million in the nine months ended September 30, 2015, compared to $3.7 million for the same period in 2014 for the Company's LIMITX™, AVERSION® and IMPEDE® Technologies. Selling, marketing, general and administrative expenses were $6.4 million in the nine months ended September 30, 2015, versus $5.9 million in the same period last year. Selling and marketing expenses primarily consisted of advertising and marketing activities for NEXAFED® and NEXAFED® SINUS.
In October 2015, the Company received a $2.5 million milestone payment from Egalet Corporation triggered by the first commercial shipments of OXAYDO™. As of October 30, 2015, our unrestricted cash, cash equivalents and marketable securities, less our compensating balance requirement of $2.5 million, was approximately $14.0 million, and our outstanding loan balance with Oxford Finance LLC was $8.6 million.
In August 2015, the Company effected a 1-for-5 reverse stock split of its common stock. All share amounts and per share data (other than the par value and number of authorized shares) in this earnings release and the accompanying condensed consolidated financial statements have, where applicable, been adjusted retroactively to reflect this reverse stock split. As a result of the reverse stock split, the Company regained compliance with the minimum bid price requirement for continued listing on the NASDAQ Capital Market in September 2015.
Conference Call Information
Acura Pharmaceuticals, Inc. will host a conference call on Thursday, November 5, 2015 at 8:30 a.m. ET to discuss the results.
To participate in the live conference call, please dial 888-572-7034 (U.S. and Canada) five to ten minutes prior to the start of the call. The participant passcode is 402784. A replay of the call will be available beginning November 6, 2015 and ending on November 26, 2015 on the company's website, and by dialing 888-203-1112 (U.S. and Canada). The replay participant code is 402784.
About Acura Pharmaceuticals
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary LIMITX™, AVERSION® and IMPEDE® Technologies. LIMITX contains ingredients that are intended to reduce or limit the rate or extent of opioid release when multiple tablets are ingested. AVERSION contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages if the product is snorted. IMPEDE is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
In June 2011, the U.S. Food and Drug Administration approved OXAYDO™ (oxycodone HCl immediate-release tablets) which incorporates the AVERSION technology. On January 7, 2015, we entered into a Collaboration and License Agreement with Egalet US, Inc. and Egalet Ltd., each a subsidiary of Egalet Corporation, pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize OXAYDO.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Forward-looking statements may include, but are not limited to:
In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "indicates," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in greater detail in our filings with the Securities and Exchange Commission.
ACURA PHARMACEUTICALS, INC. | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
(in thousands) | |||
(unaudited) | (audited) | ||
September 30, | December 31, | ||
2015 | 2014 | ||
Current assets | $16,034 | $13,231 | |
Property, plant and equipment, net | 1,042 | 957 | |
Other assets | 1,865 | 1,845 | |
Total assets | $18,941 | $16,033 | |
Other current liabilities | $1,369 | $881 | |
Current deferred revenue | - | 353 | |
Current maturities of long-term debt | 2,470 | 1,758 | |
Long-term portion of accrued interest | 339 | 190 | |
Long-term debt, net of discount of $220 and $281,and debt issuance costs of $112 and $162 | 6,038 | 7,799 | |
Stockholders' equity | 8,725 | 5,052 | |
Total liabilities and stockholders' equity | $18,941 | $16,033 | |
ACURA PHARMACEUTICALS, INC. | |||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND | |||||||
COMPREHENSIVE INCOME (LOSS) | |||||||
(Unaudited; in thousands, except per share amounts) | |||||||
(unaudited) | (unaudited) | ||||||
Three Months | Nine months | ||||||
Ended September 30, | Ended September 30, | ||||||
2015 | 2014 | 2015 | 2014 | ||||
Revenues: | |||||||
License fee revenue | $ - | $- | $ 5,250 | $ - | |||
Collaboration revenue | 95 | - | 95 | - | |||
Royalty revenue | - | - | - | 4 | |||
Product sales, net | 115 | 145 | 563 | 218 | |||
Total revenues, net | 210 | 145 | 5,908 | 222 | |||
Cost and expenses: | |||||||
Cost of sales (excluding inventory write-down) | 132 | 108 | 554 | 188 | |||
Inventory write-down | 27 | - | 334 | 201 | |||
Research and development | 432 | 955 | 1,907 | 3,674 | |||
Selling, marketing, general and administrative | 2,024 | 1,728 | 6,404 | 5,903 | |||
Total operating expenses | 2,615 | 2,791 | 9,199 | 9,966 | |||
Operating loss | (2,405) | (2,646) | (3,291) | (9,744) | |||
Non-operating income (expense): | |||||||
Investment income | 39 | 46 | 110 | 143 | |||
Interest expense | (283) | (304) | (892) | (907) | |||
Other expense | - | - | - | (5) | |||
Total other expense, net | (244) | (258) | (782) | (769) | |||
Loss before income taxes | (2,649) | (2,904) | (4,073) | (10,513) | |||
Provision for income taxes | - | - | - | - | |||
Net loss | $ (2,649) | $ (2,904) | $ (4,073) | $ (10,513) | |||
Other comprehensive income (loss): | |||||||
Unrealized gains (losses) on securities | 2 | (44) | 2 | 6 | |||
Total other comprehensive (loss) income | 2 | (44) | 2 | 6 | |||
Comprehensive loss | $ (2,647) | $ (2,948) | $ (4,071) | $ (10,507) | |||
Loss per share: | |||||||
Basic | $ (0.23) | $ (0.30) | $ (0.39) | $ (1.08) | |||
Diluted | $ (0.23) | $ (0.30) | $ (0.39) | $ (1.08) | |||
Weighted average shares outstanding: | |||||||
Basic | 11,677 | 9,784 | 10,446 | 9,774 | |||
Diluted | 11,677 | 9,784 | 10,446 | 9,774 |
Contact Information:
Contact:
for Acura Investor Relations