Opiant Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2017 Financial Results and Provides Corporate Update

Opiant Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2017 Financial Results and Provides Corporate Update

SANTA MONICA, Calif., June 15, 2017 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions and eating disorders, today reported financial results for the fiscal third quarter ended April 30, 2017 and provided an update on recent developments and upcoming milestones.

“In the fiscal third quarter, we have made notable progress on our clinical and corporate goals for 2017. On the clinical side, we initiated a Phase 2 clinical trial evaluating our novel, nasally-delivered opioid antagonist candidate, OPNT001, as a potential treatment for Bulimia Nervosa (BN). Additionally, our Alcohol Use Disorder (AUD) program and our pre-clinical work on a heroin vaccine candidate continue to advance. We also gained insight into the effect of two different dosages of nasal naloxone on opioid receptors using positron emission tomography (PET) imaging,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “On the corporate front, we continue to support our NARCAN® Nasal Spray partner, Adapt Pharma Limited, and continue to improve our intellectual property position. In the last nine months, we have also added depth to our management team and have strengthened our corporate governance by appointing a new director to our Board of Directors and by forming committees of our Board of Directors. We remain committed to creating value for our stockholders by working to fulfill our clinical and corporate goals.”  

Fiscal Third Quarter 2017 Highlights

  • Initiated a Phase 2 randomized, double-blind, placebo-controlled multisite study that will enroll up to 80 patients in the United Kingdom diagnosed with BN. The trial is evaluating OPNT001, Opiant’s novel nasally-delivered opioid antagonist candidate. The study is designed to evaluate OPNT001’s safety and tolerability, as well as its impact on clinical outcomes, including changes in eating behavior. Opiant expects to report topline data from this study in the first half of 2018.
     
  • Generated encouraging Phase 1 data and received supportive U.S. Food and Drug Administration (FDA) feedback on a proposed clinical development plan for OPNT002 for treatment of AUD. 
     
  • Announced the completion of a study conducted in Finland, evaluating two doses of naloxone nasal spray on the occupation of brain opiate receptors using PET imaging. The purpose of the study was to determine the extent and time course of brain mu opioid receptor occupancy following the administration of two doses (four milligrams and two milligrams) in healthy volunteers. This study was the first use of PET imaging to assess nasal naloxone on opioid receptor dynamics. The 4 mg dose resulted in a larger degree of receptor occupancy in the brain than the 2 mg dose, and receptor occupancy was also achieved more rapidly with the 4 mg dose. Nasal naloxone was safe and well tolerated at both dose levels. The study results are expected to be independently published in a scientific journal.
     
  • Strengthened our intellectual property position and enhanced NARCAN® Nasal Spray product exclusivity with the addition of two patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluations publication (commonly referred to as the “Orange Book”). There are now four Orange Book-listed patents covering NARCAN® Nasal Spray.

  • Expanded the leadership team through the appointment of Phil Skolnick, Ph.D., D.Sc. (hon) as Chief Scientific Officer.

Upcoming Corporate and Clinical Goals

  • Further advance OPNT002 for AUD in the second half of 2017.
     
  • Further advance the pre-clinical development of Opiant’s heroin vaccine candidate, which was licensed in October 2016 from the Walter Reed Army Institute of Research and the National Institute on Drug Abuse (NIDA).
     
  • Complete an uplisting to a major stock exchange.
     
  • Reincorporate from a Nevada corporation to a Delaware corporation.

Financial Results

Quarter ended April 30, 2017 compared to quarter ended April 30, 2016

For the quarter ended April 30, 2017, Opiant reported a net loss of approximately $3.1 million, or a net loss of $1.55 per basic share and fully-diluted share, compared to a net profit of approximately $0.4 million, or $0.22 per basic share and $0.15 per fully-diluted share, for the same period in 2016. 

For the quarter ended April 30, 2017, Opiant generated revenue of $18,116, compared to approximately $2.6 million in the corresponding period in 2016. As a result of Opiant’s December 2016 royalty monetization agreement with SWK Holdings Corporation (“SWK”) which generated $13.7 million at closing, SWK acquired rights to certain royalties and milestone payments related to the net sales of NARCAN® Nasal Spray.  Pursuant to the royalty monetization agreement, after SWK has received 1.5 times its investment, Opiant will receive at least 90% of future NARCAN® Nasal Spray royalties and milestone payments.

Research and development expenses were approximately $1.1 million for each of the quarters ended April 30, 2017 and 2016. General and administrative expenses were approximately $2.0 million in the quarter ended April 30, 2017, compared to approximately $1.0 million for the same period in 2016. Selling expenses were approximately $0.1 million for each of the quarters ended April 30, 2017 and 2016.

Nine months ended April 30, 2017 compared to nine months ended April 30, 2016

For the nine months ended April 30, 2017, Opiant reported a net profit of approximately $6.9 million, or $3.45 per basic share and $3.07 per fully-diluted share, compared to a net loss of approximately $6.7 million, or $3.57 per basic and fully-diluted share, for the same period in 2016. 

For the nine months ended April 30, 2017, Opiant generated revenue of approximately $14.7 million, compared to approximately $9.6 million in the corresponding period in 2016.

Research and development expenses were approximately $1.9 million for the nine months ended April 30, 2017 compared to approximately $2.8 million for the same period in 2016. General and administrative expenses were approximately $4.6 million for the nine months ended April 30, 2017, compared to approximately $13.2 million for the same period in 2016. Selling expenses were approximately $1.3 million for the nine months ended April 30, 2017, compared to approximately $0.3 million for the corresponding period in 2016.

Opiant ended the fiscal third quarter 2017 with cash and cash equivalents of approximately $9.7 million.

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for addictions and eating disorders. 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” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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, including those risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Therefore, current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by Opiant or any other person that the objectives and plans of Opiant will be achieved in any specified time frame, if at all. 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.        
Consolidated Balance Sheets         
As of April 30, 2017 (Unaudited) and July 31, 2016        
         
  April 30, 2017   July 31, 2016  
         
Assets        
Current assets        
Cash and cash equivalents $ 9,680,454     $ 1,481,393    
Accounts receivable   -       312,498    
Prepaid expenses   98,911       62,404    
Total current assets   9,779,365       1,856,295    
         
Other assets        
Computer equipment (net of accumulated amortization of $3,842 at April 30, 2017 and $1,016 at July 31, 2016)   3,695       6,521    
Patents and patent applications (net of accumulated amortization of $9,417 at April 30, 2017 and $8,388 at July 31, 2016)   18,033       19,062    
         
Total assets $ 9,801,093     $ 1,881,878    
         
Liabilities and Stockholders' Equity (Deficit)        
Liabilities        
Current liabilities        
Accounts payable and accrued liabilities $ 1,390,780     $ 140,584    
Accrued salaries and wages   1,543,142       3,681,250    
Note payable   -       165,000    
Deferred revenue   194,800       250,000    
Total current liabilities   3,128,722       4,236,834    
         
Deferred revenue   2,387,084       2,350,000    
Total liabilities   5,515,806       6,586,834    
         
Stockholders' equity (deficit)        
Common stock; par value $0.001; 1,000,000,000 shares authorized; 2,020,380 shares issued and outstanding at April 30, 2017 and 1,992,433 shares issued and outstanding at July 31, 2016   2,020       1,992    
Additional paid-in capital   58,549,055       56,478,394    
Accumulated deficit   (54,265,788 )     (61,185,342 )  
Total stockholders' equity (deficit)   4,285,287       (4,704,956 )  
Total liabilities and stockholders' equity (deficit) $ 9,801,093     $ 1,881,878    
         


Opiant Pharmaceuticals, Inc.            
Consolidated Statements of Operations (Unaudited)          
For the three and nine months ended April 30, 2017 and 2016        
             
  For the   For the  
  Three Months Ended   Nine Months Ended  
  April 30, 2017 April 30, 2016   April 30, 2017 April 30, 2016  
             
Revenue            
Royalty and licensing revenue $ -   $ 2,605,097   $ 14,656,142 $ 4,785,097    
Treatment investment revenue   18,116     -     18,116   4,800,000    
Total revenue   18,116     2,605,097     14,674,258   9,585,097    
             
Operating expenses            
General and administrative   1,995,892     1,040,608     4,567,898   13,155,931    
Research and development   1,103,319     1,059,627     1,889,989   2,814,520    
Selling expenses   84,375     93,000     1,322,974   302,251    
Total operating expenses   3,183,586     2,193,235     7,780,861   16,272,702    
             
Income (loss) from operations   (3,165,470 )   411,862     6,893,397   (6,687,605 )  
             
Other income (expense)            
Interest income (expense), net   10,673     -     9,306   (11,319 )  
Income (loss) on foreign exchange   25,189     4,266     16,851   (24,925 )  
Total other income (expense)   35,862     4,266     26,157   (36,244 )  
             
Income (loss) before provision for income taxes   (3,129,608 )   416,128     6,919,554   (6,723,849 )  
             
Provision for income taxes   -     -     -   -    
             
Net income (loss) $ (3,129,608 ) $ 416,128   $ 6,919,554 $ (6,723,849 )  
             
Basic income (loss) per common share $ (1.55 ) $ 0.22   $ 3.45 $ (3.57 )  
Diluted income (loss) per common share $ (1.55 ) $ 0.15   $ 3.07 $ (3.57 )  
             
Basic weighted average common shares outstanding   2,014,141     1,916,554     2,004,143   1,882,088    
Diluted weighted average common shares outstanding   2,014,141     2,734,760     2,251,127   1,882,088    
             


Opiant Pharmaceuticals, Inc.      
Consolidated Statements of Cash Flows (Unaudited)      
For the nine months ended April 30, 2017 and 2016      
       
  For the Nine Months Ended  
  April 30, 2017 April 30, 2016  
       
Cash flows used in operating activities      
Net income (loss) $ 6,919,554   $ (6,723,849 )  
Adjustments to reconcile net income (loss) to net cash provided by operating activities:      
Amortization   3,855     1,187    
Issuance of common stock for services   190,427     1,215,719    
Stock based compensation from issuance of options   889,076     10,183,555    
Stock based compensation from issuance of warrants   229,360     -    
       
Changes in assets and liabilities:      
Increase in prepaid expenses   (36,507 )   (37,233 )  
Decrease in accounts receivable   312,498     -    
Decrease in deferred revenue   (18,116 )   (4,300,000 )  
Increase (decrease) in accounts payable   1,250,196     (108,639 )  
Increase (decrease) in accrued salaries and wages   (1,376,282 )   501,536    
Net cash provided by operating activities   8,364,061     732,276    
       
Cash flows used in investing activities      
Purchase of equipment   -     (6,528 )  
Net cash used in investing activities   -     (6,528 )  
       
Cash flows provided by financing activities      
Proceeds from related parties notes payable   -     151,191    
Repayment of related parties notes payable   -     (281,191 )  
Repayment of notes payable   (165,000 )   -    
Investment received in exchange for royalty agreement   -     1,333,500    
Net cash provided (used) by financing activities   (165,000 )   1,203,500    
       
Net increase in cash and cash equivalents   8,199,061     1,929,248    
Cash and cash equivalents, beginning of period   1,481,393     434,217    
Cash and cash equivalents, end of period $ 9,680,454   $ 2,363,465    
       
Supplemental disclosure      
Interest paid during the period $ 4,828   $ 78,865    
Taxes paid during the period $ -   $ -    
       
Non-Cash Transactions      
Forgiveness of related party debt $ 761,826   $ -    
Cashless exercise of options $ -   $ 15    
       
CONTACT INFORMATION:

Corporate Contact:
Investor.relations@opiant.com

Investors:
Sam MartinArgot Partnerssam@argotpartners.com
212-600-1902

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