PALATINE, IL--(Marketwired - February 29, 2016) - Acura Pharmaceuticals, Inc. (
The Company reported a net loss of $5.0 million or $0.46 per diluted share for 2015 compared to a net loss of $13.2 million or $1.35 per diluted share for 2014. For the fourth quarter ended December 31, 2015 the Company reported a net loss of $0.9 million or $0.08 per diluted share, compared to net loss of $2.7 million or $0.30 per diluted share for the same period in 2014.
For the twelve months ended December 31, 2015, the Company recorded $5.0 million and $2.5 million in license fee revenue and milestone revenue, respectively, derived from the January 7, 2015 Collaboration and License Agreement with Egalet Corporation, pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize OXAYDO®. We recorded $0.2 million in collaboration revenue, some of which arises from the June 15, 2015 License and Development Agreement with Bayer Healthcare pursuant to which we granted Bayer an exclusive worldwide license to our IMPEDE® Technology for use in an undisclosed methamphetamine resistant pseudoephedrine -- containing product and providing for the joint development of such product using our IMPEDE® Technology for the U.S. market. We also recorded other license fee revenue of $0.25 million and $0.7 million in NEXAFED® product line net sales as compared with $0.5 million in license fee revenue and $0.2 million in NEXAFED® product line net sales in the same period in 2014.
Research and development expenses associated with product candidates utilizing the Company's LIMITX™, AVERSION® and IMPEDE® Technologies were $2.6 million in the twelve months ended December 31, 2015, compared to $4.6 million in the same period in 2014, although much of the expense associated with LIMITX was offset by a grant by the National Institute on Drug Abuse of the National Institutes of Health. These expenses were $0.7 million in the fourth quarter 2015, compared to $0.9 million for the same period in 2014.
Selling, marketing, general and administrative expenses were $9.0 million in the twelve months ended December 31, 2015, versus $7.9 million in the same period last year. These expenses were $2.6 million in the fourth quarter 2015, versus $2.0 million in the same period last year. The increases in these expenses in 2015 were primarily associated with additional NEXAFED selling and marketing expenses as well as certain patent litigation costs.
At December 31, 2015, the Company had cash, cash equivalents and marketable securities totaling $13.3 million and $8.0 million in term debt financing (excluding debt discount and debt issuance costs).
Conference Call Information
Acura Pharmaceuticals, Inc. will host a conference call on Tuesday, March 1, 2016 at 8:30 a.m. ET to discuss the results.
To participate in the live conference call, please dial 888-430-8694 (U.S. and Canada) five to ten minutes prior to the start of the call. The participant passcode is 7143401. A replay of the call will be available beginning March 2, 2016 and ending on March 22, 2016 on the company's website, and by dialing 888-203-1112 (U.S. and Canada). The replay participant code is 7143401.
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 Corporation pursuant to which we exclusively licensed to Egalet worldwide rights to manufacture and commercialize OXAYDO. Acura markets NEXAFED® and NEXAFED® Sinus, which are pseudoephedrine containing products that utilize the IMPEDE Technology.
Forward-Looking Statements
Certain statements in this Report 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," "estimates," "indicates", "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) | ||||||||
(audited) | (audited) | |||||||
December 31, | December 31, | |||||||
2015 | 2014 | |||||||
Current assets | $ | 14,135 | $ | 13,231 | ||||
Property, plant and equipment, net | 1,013 | 957 | ||||||
Other assets | 1,813 | 1,845 | ||||||
Total assets | $ | 16,961 | $ | 16,033 | ||||
Accounts payable and other current liabilities | $ | 924 | $ | 881 | ||||
Current deferred revenue | - | 353 | ||||||
Current maturities of long-term debt | 2,320 | 1,758 | ||||||
Long-term debt, net of discount of $193 and $281, and debt issuance costs of $97 and $162 | 5,430 | 7,799 | ||||||
Long-term portion of accrued interest | 387 | 190 | ||||||
Stockholders' equity | 7,900 | 5,052 | ||||||
Total liabilities and stockholders' equity | $ | 16,961 | $ | 16,033 | ||||
ACURA PHARMACEUTICALS, INC. | |||||||||||||||||||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||||||
(in thousands, except per share amounts) | |||||||||||||||||||
(audited) Twelve Months Ended December 31, |
(unaudited) Three Months Ended December 31, |
||||||||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||||||||
Revenues: | |||||||||||||||||||
License fee revenue | $ | 5,250 | $ | 500 | $ | - | $ | 500 | |||||||||||
Milestone revenue | 2,500 | - | 2,500 | - | |||||||||||||||
Collaboration revenue | 170 | - | 75 | - | |||||||||||||||
Royalty revenue | 5 | 4 | 5 | - | |||||||||||||||
Product sales, net | 662 | 247 | 99 | 29 | |||||||||||||||
Total revenues, net | 8,587 | 751 | 2,679 | $ | 529 | ||||||||||||||
Operating expenses: | |||||||||||||||||||
Cost of sales (excluding inventory write-down) | 656 | 227 | 102 | 39 | |||||||||||||||
Inventory write-down (write-up) | 330 | 201 | (4 | ) | - | ||||||||||||||
Research and development | 2,608 | 4,582 | 701 | 908 | |||||||||||||||
Selling, marketing, general and administrative | 8,994 | 7,940 | 2,590 | 2,037 | |||||||||||||||
Total operating expenses | 12,588 | 12,950 | 3,389 | 2,984 | |||||||||||||||
Operating loss | (4,001 | ) | (12,199 | ) | (710 | ) | (2,455 | ) | |||||||||||
Non-operating income (expense): | |||||||||||||||||||
Investment income | 166 | 198 | 56 | 55 | |||||||||||||||
Interest expense | (1,157 | ) | (1,212 | ) | (265 | ) | (305 | ) | |||||||||||
Other income | 3 | 4 | 3 | 9 | |||||||||||||||
Total other expense, net | (988 | ) | (1,010 | ) | (206 | ) | (241 | ) | |||||||||||
Loss before income taxes | (4,989 | ) | (13,209 | ) | (916 | ) | (2,696 | ) | |||||||||||
Provision for income taxes | - | - | - | - | |||||||||||||||
Net loss | $ | (4,989 | ) | $ | (13,209 | ) | $ | (916 | ) | $ | (2,696 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||||||
Unrealized losses on marketable securities | (52 | ) | (32 | ) | (54 | ) | (38 | ) | |||||||||||
Total other comprehensive loss | (52 | ) | (32 | ) | (54 | ) | (38 | ) | |||||||||||
Comprehensive loss | $ | (5,041 | ) | $ | (13,241 | ) | $ | (970 | ) | $ | (2,734 | ) | |||||||
Loss per share: | |||||||||||||||||||
Basic | $ | (0.46 | ) | $ | (1.35 | ) | $ | (0.08 | ) | $ | (0.30 | ) | |||||||
Diluted | $ | (0.46 | ) | $ | (1.35 | ) | $ | (0.08 | ) | $ | (0.30 | ) | |||||||
Weighted average shares outstanding: | |||||||||||||||||||
Basic | 10,796 | 9,779 | 11,836 | 9,792 | |||||||||||||||
Diluted | 10,796 | 9,779 | 11,836 | 9,792 | |||||||||||||||
Contact Information:
Contact:
Acura Investor Relations
(416) 644-2020 or (514) 939-3989
www.renmarkfinancial.com