SANTA MONICA, Calif., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB:OPNT), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders, today reported financial results for the fiscal fourth quarter and year ended July 31, 2016.
“The fourth quarter was one of continued progress and development at the company,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “In 2017, we look forward to increased demand for NARCAN® Nasal Spray, adding to our intellectual property portfolio and developing treatments, including for Binge Eating Disorder and Bulimia Nervosa.”
Fourth Quarter 2016 and Recent Highlights
- A study published in The Journal of Clinical Pharmacology confirmed NARCAN® Nasal Spray’s (NARCAN) concentrated formulation rapidly delivers an effective naloxone dose.
- Health Canada granted approval to NARCAN.
- Opiant’s commercial partner, Adapt Pharma Limited (“Adapt”), announced NARCAN’s coverage with California’s Medi-Cal program.
- U.S. Food and Drug Administration (FDA) Joint Meeting endorsed commitment to higher doses and broader access for naloxone to help in fight against opioid overdose.
- Filed a second NARCAN patent for listing in the FDA Orange Book to offer product exclusivity until 2035.
- Opiant licensed a heroin vaccine from Walter Reed Army Institute of Research and National Institute on Drug Abuse, a division of the National Institutes of Health.
Clinical Program Update
Opiant develops treatments for substance abuse, addictive and eating disorders. Opiant expects to achieve the following milestones in fiscal year 2017:
- 1H17: Report top-line results of the Phase II study in patients with Cocaine Use Disorder.
- 1H17: Collaborate with other parties and initiate a study in developing a treatment for patients with Binge Eating Disorder.
- 1Q17: Evaluate use of a nasal opioid antagonist and initiate a study for patients with Bulimia Nervosa.
Financial Results
Year ended July 31, 2016 compared to year ended July 31, 2015
For the year ended July 31, 2016, Opiant reported a net loss of $7.814 million, or $4.09 per basic and fully-diluted share, compared to a net loss of $7.038 million, or $3.88 per basic and fully-diluted share, for the year ended July 31, 2015. The increased net loss was due primarily to the increase in general and administrative expenses, particularly stock-based compensation. The increase was offset by an increase in revenues and a decrease in research and development expenses during the year ended July 31, 2016.
Research and development expense in the year ended July 31, 2016, was $1.747 million compared to $2.415 million for the year ended July 31, 2015. General and administrative expense was $15.571 million in the year ended July 31, 2016, compared to $6.035 million for the year ended July 31, 2015. The decrease in research and development expenses was primarily due to decreased spending for Opiant’s opioid overdose reversal treatment product, now known as NARCAN. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation, partially offset by decreases in professional fees, consulting costs and non-stock based officer’s compensation.
For the year ended July 31, 2016, Opiant reported revenue of $9.898 million, compared to $1.55 million for the year ended July 31, 2015. The increase in revenue during the year ended July 31, 2016 was in part the result of recognizing $4.8 million of revenue from the sale of net profit interests with respect to the Company’s opioid overdose reversal treatment, now known as NARCAN. The revenue from these sales was recognized during the year ended July 31, 2016 because either the investments in net profit interests did not contain an option to exchange the net profit interests for shares of the Company’s common stock or the product was approved by the FDA and marketed, which negated each relevant investor’s option to exchange its net profit interests for shares of common stock of the Company, and the research and development work related to the product was completed as of July 31, 2016. The Company also recognized $5.097 million of revenue derived from its license agreement with Adapt during the year ended July 31, 2016, which included a $2 million milestone payment received as a result of the FDA’s approval of NARCAN for the emergency treatment of known or suspected opioid overdose and a $2.5 million milestone payment received as a result of the first commercial sale of NARCAN, both of which are milestones set forth in the Company’s license agreement with Adapt.
About Opiant Pharmaceuticals, Inc.
Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Its first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. by the company’s partner, Adapt Pharma Limited. Currently, Opiant is developing opioid antagonists for the treatment of substance use, addictive and eating disorders, with a near term focus on Cocaine Use Disorder and Binge Eating Disorder. For more information please visit: www.opiant.com.
Forward-Looking Statements
This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.
Financial tables to follow
| Opiant Pharmaceuticals, Inc. | ||||||||
| (formerly Lightlake Therapeutics Inc.) | ||||||||
| Balance Sheets | ||||||||
| As of July 31, 2016 and 2015 | ||||||||
| July 31, | July 31, | |||||||
| 2016 | 2015 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 1,481,393 | $ | 434,217 | ||||
| Accounts receivable | 312,498 | - | ||||||
| Prepaid insurance | 62,404 | 33,143 | ||||||
| Total current assets | 1,856,295 | 467,360 | ||||||
| Other assets | ||||||||
| Computer equipment (net of accumulated amortization of $1,016 at July 31, 2016 and $0 at July 31, 2015) | 6,521 | - | ||||||
| Patents and patent applications (net of accumulated amortization of $8,388 at July 31, 2016 and $7,015 at July 31, 2015) | 19,062 | 20,435 | ||||||
| Total assets | $ | 1,881,878 | $ | 487,795 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 140,584 | $ | 315,460 | ||||
| Accrued salaries and wages | 3,681,250 | 3,129,060 | ||||||
| Note payable | 165,000 | - | ||||||
| Deferred revenue | 250,000 | - | ||||||
| Due to related parties | - | 130,000 | ||||||
| Total current liabilities | 4,236,834 | 3,574,520 | ||||||
| Deferred revenue | 2,350,000 | 5,300,000 | ||||||
| Total liabilities | 6,586,834 | 8,874,520 | ||||||
| Stockholders' deficit | ||||||||
| Common stock; par value $0.001; 1,000,000,000 shares authorized; | ||||||||
| 1,992,433 shares issued and outstanding at July 31, 2016 and 1,841,866 shares issued and outstanding at July 31, 2015 | 1,992 | 1,842 | ||||||
| Additional paid-in capital | 56,478,394 | 44,982,519 | ||||||
| Accumulated deficit | (61,185,342 | ) | (53,371,086 | ) | ||||
| Total stockholders' deficit | (4,704,956 | ) | (8,386,725 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 1,881,878 | $ | 487,795 | ||||
The accompanying notes are an integral part of these financial statements.
| Opiant Pharmaceuticals, Inc. | ||||||||
| (formerly Lightlake Therapeutics Inc.) | ||||||||
| Statements of Operations | ||||||||
| For the years ended July 31, 2016 and 2015 | ||||||||
| For the | ||||||||
| Year Ended | ||||||||
| July 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenues | ||||||||
| Royalty and licensing revenue | $ | 5,097,595 | $ | 800,000 | ||||
| Treatment investment revenue | 4,800,000 | 750,000 | ||||||
| 9,897,595 | 1,550,000 | |||||||
| Operating expenses | ||||||||
| General and administrative | 15,571,080 | 6,034,520 | ||||||
| Research and development | 1,747,077 | 2,414,973 | ||||||
| Selling expenses | 317,917 | - | ||||||
| Total operating expenses | 17,636,074 | 8,449,493 | ||||||
| Loss from operations | (7,738,479 | ) | (6,899,493 | ) | ||||
| Other income (expense) | ||||||||
| Interest expense | (11,890 | ) | (28,232 | ) | ||||
| Loss on foreign exchange | (63,887 | ) | (110,148 | ) | ||||
| Total other income (expense) | (75,777 | ) | (138,380 | ) | ||||
| Loss before provision for income taxes | (7,814,256 | ) | (7,037,873 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (7,814,256 | ) | $ | (7,037,873 | ) | ||
| Loss per share of common stock: | ||||||||
| Basic and diluted | $ | (4.09 | ) | $ | (3.88 | ) | ||
| Weighted average common stock outstanding | ||||||||
| Basic and diluted | 1,910,489 | 1,813,069 | ||||||
The accompanying notes are an integral part of these financial statements.