SANTA MONICA, Calif., Dec. 16, 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 first quarter ended October 31, 2016.
“The milestones we’ve achieved during our fiscal first quarter will provide momentum for our company in the new calendar year,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “During the last quarter, we’ve in-licensed a heroin vaccine from the Walter Reed Research Institute and listed a second patent for NARCAN® Nasal Spray with the U.S. Food and Drug Administration (FDA). In 2017, we anticipate increasing demand for NARCAN® Nasal Spray, and aim to advance developing treatments for bulimia nervosa, cocaine use disorder, and a new area to be announced.”
First Quarter 2017 and Recent Highlights
- Signed a definitive agreement with SWK Holdings Corporation (“SWK”), in which SWK will acquire rights to certain royalties and milestone payments related to the sales of NARCAN® Nasal Spray for the treatment of opioid overdose for up to $17.5 million. Opiant received $13.7 million at closing and is eligible to receive an additional $3.75 million contingent on the achievement of certain future net sales milestones.
- Announced that marketing partner, Adapt Pharma Limited (“Adapt”), was granted approval by Health Canada to treat opioid overdose with NARCAN® Nasal Spray.
- Announced that a second Opiant patent for NARCAN® Nasal Spray was listed in the FDA’s Orange Book, offering product exclusivity until 2035.
- Announced the licensing of a heroin vaccine from Walter Reed Army Institute of Research and National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health. Opiant plans to work with Walter Reed scientists on clinical research with the vaccine.
- Appointed Thomas T. Thomas, the former corporate treasurer of Genentech, Inc., to Opiant’s board of directors.
Clinical Program Update
Opiant develops treatments for substance abuse, addictive and eating disorders. Opiant expects the following events to occur in the next fiscal year:
- 1H17: Evaluate use of a nasal opioid antagonist and initiate a study for patients with bulimia nervosa.
- 1H17: Announce a new program with a 505(b)(2) regulatory pathway.
- FY17: Continue progress with the heroin vaccine to determine viability in humans.
Financial Results
Quarter ended October 31, 2016 compared to quarter ended October 31, 2015
For the quarter ended October 31, 2016, Opiant reported a net loss of $601 thousand, or $0.30 per basic and fully-diluted share, compared to a net loss of $11.1 million, or $6.00 per basic and fully-diluted share, for the same period in 2015. The net loss also decreased due to an increase in revenues.
Research and development expense in the quarter ended October 31, 2016, was $442 thousand compared to $429 thousand for the quarter ended October 31, 2015. General and administrative expense was $1.2 million in the quarter ended October 31, 2016, compared to $10.8 million for the quarter ended October 31, 2015. The $9.6 million decrease in general and administrative expense was primarily due to a decrease in stock-based compensation.
For the quarter ended October 31, 2016, Opiant generated revenue of $1.1 million, compared to $120 thousand for the quarter ended October 31, 2015. Opiant reported $1.1 million of revenue from Adapt during the quarter, of which $621 thousand is royalty revenue and $500 thousand is milestone revenue received as a result of the Health Canada approval of NARCAN® Nasal Spray. During the three month period ended October 31, 2015, Opiant recorded $120 thousand of revenue from Adapt.
Selling expenses were $42 thousand in the quarter ended October 31, 2016. Opiant incurred no selling expenses for revenue earned in the quarter ended October 31, 2015.
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. and Canada by the company’s partner, Adapt Pharma Limited. 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. | ||||||||
| Balance Sheets (Unaudited) | ||||||||
| As of October 31, 2016 and July 31, 2016 | ||||||||
| October 31, | July 31, | |||||||
| 2016 | 2016 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 1,184,568 | $ | 1,481,393 | ||||
| Accounts receivable | 699,142 | 312,498 | ||||||
| Prepaid insurance | 69,878 | 62,404 | ||||||
| Total current assets | 1,953,588 | 1,856,295 | ||||||
| Other assets | ||||||||
| Computer equipment (net of accumulated amortization of $1,958 at October 31, 2016 and $1,016 at July 31, 2016) | 5,579 | 6,521 | ||||||
| Patents and patent applications (net of accumulated amortization of $8,731 at October 31, 2016 and $8,388 at July 31, 2016) | 18,719 | 19,062 | ||||||
| Total assets | $ | 1,977,886 | $ | 1,881,878 | ||||
| Liabilities and Stockholders' Deficit | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | 641,454 | $ | 140,584 | ||||
| Accrued salaries and wages | 3,696,049 | 3,681,250 | ||||||
| Note payable | 165,000 | 165,000 | ||||||
| Deferred revenue | 250,000 | 250,000 | ||||||
| Total current liabilities | 4,752,503 | 4,236,834 | ||||||
| Deferred revenue | 2,350,000 | 2,350,000 | ||||||
| Total liabilities | 7,102,503 | 6,586,834 | ||||||
| Stockholders' deficit | ||||||||
| Common stock; par value $0.001; 1,000,000,000 shares authorized; | ||||||||
| 1,992,433 shares issued and outstanding at October 31, 2016 and July 31, 2016 | 1,992 | 1,992 | ||||||
| Additional paid-in capital | 56,659,361 | 56,478,394 | ||||||
| Accumulated deficit | (61,785,970 | ) | (61,185,342 | ) | ||||
| Total stockholders' deficit | (5,124,617 | ) | (4,704,956 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 1,977,886 | $ | 1,881,878 | ||||
| The accompanying notes are an integral part of these unaudited financial statements. | ||||||||
| Opiant Pharmaceuticals, Inc. | ||||||||
| Statements of Operations (Unaudited) | ||||||||
| For the three months ended October 31, 2016 and 2015 | ||||||||
| For the | ||||||||
| Three Months Ended | ||||||||
| October 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenues | ||||||||
| Royalty and licensing revenue | $ | 1,121,142 | $ | 120,000 | ||||
| 1,121,142 | 120,000 | |||||||
| Operating expenses | ||||||||
| General and administrative | 1,216,302 | 10,791,380 | ||||||
| Research and development | 441,834 | 429,450 | ||||||
| Selling expenses | 42,036 | - | ||||||
| Total operating expenses | 1,700,172 | 11,220,830 | ||||||
| Loss from operations | (579,030 | ) | (11,100,830 | ) | ||||
| Other expense | ||||||||
| Interest expense, net | (2,244 | ) | (5,828 | ) | ||||
| Loss on foreign exchange | (19,354 | ) | (3,359 | ) | ||||
| Total other expense | (21,598 | ) | (9,187 | ) | ||||
| Loss before provision for income taxes | (600,628 | ) | (11,110,017 | ) | ||||
| Provision for income taxes | - | - | ||||||
| Net loss | $ | (600,628 | ) | $ | (11,110,017 | ) | ||
| Loss per share of common stock: | ||||||||
| Basic and diluted | $ | (0.30 | ) | $ | (6.00 | ) | ||
| Weighted average common stock outstanding | ||||||||
| Basic and diluted | 1,992,433 | 1,850,182 | ||||||
| The accompanying notes are an integral part of these unaudited financial statements. | ||||||||
| Opiant Pharmaceuticals, Inc. | ||||||||
| Statements of Cash Flows (Unaudited) | ||||||||
| For the three months ended October 31, 2016 and 2015 | ||||||||
| For the | ||||||||
| Three Months Ended | ||||||||
| October 31, | October 31, | |||||||
| 2016 | 2015 | |||||||
| Cash flows used in operating activities | ||||||||
| Net loss | $ | (600,628 | ) | $ | (11,110,017 | ) | ||
| Adjustments to reconcile net loss to net cash used by operating activities: | ||||||||
| Depreciation and amortization | 1,285 | 343 | ||||||
| Issuance of common stock for services | - | 186,652 | ||||||
| Stock based compensation from issuance of options | 180,967 | 10,092,179 | ||||||
| Changes in assets and liabilities: | ||||||||
| Decrease (increase) in prepaid expenses | (7,474 | ) | 15,435 | |||||
| Increase in accounts receivable | (386,644 | ) | - | |||||
| Increase (decrease) in accounts payable | 500,870 | (208,358 | ) | |||||
| Increase in accrued salaries and wages | 14,799 | 275,607 | ||||||
| Net cash used in operating activities | (296,825 | ) | (748,159 | ) | ||||
| Cash flows provided by financing activities | ||||||||
| Payments from related parties on notes payable | - | 151,191 | ||||||
| Investment received in exchange for royalty agreement | - | 618,000 | ||||||
| Net cash provided by financing activities | - | 769,191 | ||||||
| Net increase (decrease) in cash and cash equivalents | (296,825 | ) | 21,032 | |||||
| Cash and cash equivalents, beginning of period | 1,481,393 | 434,217 | ||||||
| Cash and cash equivalents, end of period | $ | 1,184,568 | $ | 455,249 | ||||
| Supplemental disclosure | ||||||||
| Interest paid during the period | $ | - | $ | - | ||||
| Taxes paid during the period | $ | - | $ | - | ||||
| The accompanying notes are an integral part of these unaudited financial statements | ||||||||
CONTACT INFORMATION: Corporate Contact: Investor.relations@opiant.com Media Relations and Investor Relations: Scott Stachowiak Assistant Vice President RussoPartners/LLC Scott.Stachowiak@russopartnersllc.com (646) 942-5630
