Opiant Pharmaceuticals, Inc. Reports Fiscal Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update

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| Source: Opiant Pharmaceuticals, Inc.

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.

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