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Acura Pharmaceuticals Announces Third Quarter 2019 Financial Results
The Company reported an operating income of
The Company reported net income of
For the nine months ended
Research and development expense was
General and administrative expense was
As of
About
LIMITx™ Technology utilizes acid neutralizing ingredients to precisely control gastric acidity, which limits the release of drug from tablets and its subsequent systemic absorption when multiple tablets are ingested. LIMITx™ Technology is useful with products whose side effect risks can be mitigated by limiting exposure to a drug in overdose situations.
AVERSION® Technology, used in the FDA approved drug OXAYDO® (oxycodone HCl) marketed by Zyla Life Sciences, utilizes polymers designed to limit the abuse of the product by nasal snorting and injection. AVERSION® Technology is also licensed to KemPharm for use in certain of their products.
IMPEDE® Technology, used in NEXAFED® (pseudoephedrine HCl) and NEXAFED® Sinus (pseudoephedrine HCl/acetaminophen) marketed by
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:
- our ability to fund or obtain funding for our continuing operations, including the development of our products utilizing our LIMITx™ and IMPEDE® Technologies;
- whether our licensees will terminate licenses prior to commercialization;
- the expected results of clinical studies relating to LTX-03, IMPEDE® or any successor product candidate, the date by which such studies will complete and the results will be available and whether any product candidate will ultimately receive FDA approval;
- the ability of LTX-03 single tablets to achieve bioequivalence or to demonstrate efficacy in a clinical study;
- whether our licensing partners will exercise their options to additional products;
- whether LIMITx™ Technology will retard the release of opioid active ingredients as dose levels increase;
- whether the extent to which products formulated with the LIMITx™ Technology mitigate respiratory depression risk will be determined sufficient by the FDA;
- our and our licensee’s ability to successfully launch and commercialize our products and technologies;
- our and our licensee’s ability to obtain necessary regulatory approvals and commercialize products utilizing our technologies;
- the market acceptance of, timing of commercial launch and competitive environment for any of our products;
- our ability to develop and enter into additional license agreements for our product candidates using our technologies;
- the ability to avoid infringement of patents, trademarks and other proprietary rights of third parties;
- the ability of our patents to protect our products from generic competition and our ability to protect and enforce our patent rights in any paragraph IV patent infringement litigation;
- the adequacy of the development program for our product candidates, including whether additional clinical studies will be required to support an NDA and FDA approval of our product candidates;
- changes in regulatory requirements;
- adverse safety findings relating to our commercialized products or product candidates in development;
- whether or when we are able to obtain FDA approval of labeling for our product candidates for the proposed indications and whether we will be able to promote the features of our technologies; and
- whether our product candidates will ultimately perform as intended in commercial settings.
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.
Contact:
for Acura Investor Relations
investors@acurapharm.com
847-705-7709
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| (unaudited) | ||||||
| 2019 | 2018 | |||||
| Assets - current | $ | 1,015 | $ | 461 | ||
| Property, plant and equipment, net | 555 | 606 | ||||
| Other assets | 896 | 1,085 | ||||
| Total assets | $ | 2,466 | $ | 2,152 | ||
| Liabilities - current | $ | 1,267 | $ | 1,435 | ||
| Accrued interest to related party – non current | 116 | 110 | ||||
| Debt to related party, net – non current | 6,000 | 4,224 | ||||
| Stockholders' deficit | (4,917 | ) | (3,617 | ) | ||
| Total liabilities and stockholders' deficit | $ | 2,466 | $ | 2,152 | ||
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(in thousands, except per share amounts)
| Three Months Ended |
Nine Months Ended |
||||||||||||
| 2019 | 2018 | 2019 | 2018 | ||||||||||
| Revenues: | |||||||||||||
| Royalties | $ | 172 | $ | 73 | $ | 285 | $ | 347 | |||||
| Collaboration | 102 | - | 102 | - | |||||||||
| License fees | 1,050 | - | 1,050 | - | |||||||||
| Total revenues | 1,324 | 73 | 1,437 | 347 | |||||||||
| Expenses: | |||||||||||||
| Research and development | 465 | 549 | 1,040 | 1,676 | |||||||||
| General and administrative | 548 | 543 | 1,391 | 2,332 | |||||||||
| Total expenses | 1,013 | 1,092 | 2,431 | 4,008 | |||||||||
| Operating income (loss) | 311 | (1,019 | ) | (994 | ) | (3,661 | ) | ||||||
| Loss on debt extinguishment | - | - | (2,600 | ) | - | ||||||||
| Interest expense, net | (111 | ) | (76 | ) | (335 | ) | (189 | ) | |||||
| Income (loss) before provision for income taxes | 200 | (1,095 | ) | (3,929 | ) | (3,850 | ) | ||||||
| Provision for income taxes | - | - | - | - | |||||||||
| Net income (loss) | $ | 200 | $ | (1,095 | ) | $ | (3,929 | ) | $ | (3,850 | ) | ||
| Net income (loss) per share: | |||||||||||||
| Basic | $ | 0.00 | $ | (0.05 | ) | $ | (0.16 | ) | $ | (0.18 | ) | ||
| Diluted | $ | 0.00 | $ | (0.05 | ) | $ | (0.16 | ) | $ | (0.18 | ) | ||
| Weighted average number of shares outstanding: | |||||||||||||
| Basic | 31,593 | 21,168 | 25,023 | 21,101 | |||||||||
| Diluted | 31,593 | 21,168 | 25,023 | 21,101 | |||||||||
Source: Acura Pharmaceuticals, Inc.
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