OPNT Opiant Pharmaceuticals Inc.

9.3
-0.12  -1%
Previous Close 9.42
Open 9.45
52 Week Low 8.05
52 Week High 18.23
Market Cap $39,600,377
Shares 4,258,105
Float 4,086,660
Enterprise Value $8,544,749
Volume 85,774
Av. Daily Volume 84,285
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Upcoming Catalysts

Drug Stage Catalyst Date
OPNT003
Opioid Overdose
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
OPNT002
Alcohol Use Disorder
Phase 2
Phase 2
Phase 2 recruitment has been delayed due to COVID-19 - noted March 25, 2020.
OPNT001
Bulimia Nervosa
Phase 2
Phase 2
Phase 2 data released February 21, 2019. Endpoints not met.
NARCAN (naloxone HCl) Nasal Spray
Opioid Overdose Reversal
Approved
Approved
FDA approved November 2015.

Latest News

  1. SANTA MONICA, Calif., June 05, 2020 (GLOBE NEWSWIRE) -- Today, the U.S. District Court for the District of New Jersey entered a decision in the patent litigation regarding NARCAN® (naloxone HCl) Nasal Spray 4mg/spray product. The Court ruled in favor of the Defendants, Teva Pharmaceuticals Industries Ltd. Opiant's commercial partner Emergent BioSolutions, intends to appeal the decision to the Court of Appeals for the Federal Circuit.

    "While we are disappointed by the decision today, we are mindful of the important role NARCAN® Nasal Spray plays across the United States in helping our communities save lives from opioid overdose," said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. "With our pipeline and strong financial…

    SANTA MONICA, Calif., June 05, 2020 (GLOBE NEWSWIRE) -- Today, the U.S. District Court for the District of New Jersey entered a decision in the patent litigation regarding NARCAN® (naloxone HCl) Nasal Spray 4mg/spray product. The Court ruled in favor of the Defendants, Teva Pharmaceuticals Industries Ltd. Opiant's commercial partner Emergent BioSolutions, intends to appeal the decision to the Court of Appeals for the Federal Circuit.

    "While we are disappointed by the decision today, we are mindful of the important role NARCAN® Nasal Spray plays across the United States in helping our communities save lives from opioid overdose," said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. "With our pipeline and strong financial position, we remain committed to develop best-in-class medicines for addiction and overdose."

    About Opiant Pharmaceuticals, Inc.

    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

    For more information visit: www.opiant.com.

    Investor Relations Contacts:

    Ben Atkins

    VP of Corporate Communications and Investor Relations



    (310) 598-5410

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

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  2. SANTA MONICA, Calif., May 26, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, announced today that its Chief Executive Officer, Dr. Roger Crystal, will present a company overview at the Jefferies Virtual Healthcare Conference. The presentation will take place on Thursday June 4, 2020, at 2:30 pm EDT. This meeting is being held virtually, and a live webcast of the presentation will be available by visiting the "Investors" section of the company's website: www.opiant.com. A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

    About Opiant Pharmaceuticals, Inc.
    Opiant…

    SANTA MONICA, Calif., May 26, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines for addictions and drug overdose, announced today that its Chief Executive Officer, Dr. Roger Crystal, will present a company overview at the Jefferies Virtual Healthcare Conference. The presentation will take place on Thursday June 4, 2020, at 2:30 pm EDT. This meeting is being held virtually, and a live webcast of the presentation will be available by visiting the "Investors" section of the company's website: www.opiant.com. A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

    About Opiant Pharmaceuticals, Inc.
    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

    For more information visit: www.opiant.com.

    Investor Relations Contacts:

    Ben Atkins
    VP of Corporate Communications and Investor Relations

    (310) 598-5410

    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Source: Opiant Pharmaceuticals, Inc.

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  3. SANTA MONICA, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, announced today that it is changing the format of its 2020 annual meeting of shareholders (the "2020 Annual Meeting") from an in-person meeting to a virtual one due to public health concerns surrounding the outbreak of the novel coronavirus (COVID-19) and to prioritize the health and well-being of its employees, shareholders and other community members. The original date and time of the 2020 Annual Meeting, as well as the matters to be voted on at the 2020 Annual Meeting, remain unchanged.

    Although shareholders will not be able to attend…

    SANTA MONICA, Calif., May 21, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, announced today that it is changing the format of its 2020 annual meeting of shareholders (the "2020 Annual Meeting") from an in-person meeting to a virtual one due to public health concerns surrounding the outbreak of the novel coronavirus (COVID-19) and to prioritize the health and well-being of its employees, shareholders and other community members. The original date and time of the 2020 Annual Meeting, as well as the matters to be voted on at the 2020 Annual Meeting, remain unchanged.

    Although shareholders will not be able to attend the 2020 Annual Meeting in person, they will be able to join the virtual meeting as set forth below:

    Virtual Meeting Date: Monday, June 15, 2020
    Virtual Meeting Time: 9:00 a.m. (PDT)
    Virtual Meeting Link: Zoom Meeting
    https://zoom.us/j/96404059308

    Meeting ID: 964 0405 9308

    Join by telephone only

    877 369 0926 US Toll-free
    877 853 5247 US Toll-free
    Meeting ID: 964 0405 9308

    Find your local number: https://zoom.us/u/aO3gNgQ4J

    Shareholders of record at the close of business on April 15, 2020, the record date for the 2020 Annual Meeting, are entitled to participate in the virtual meeting and will need their assigned 16-digit control number to vote shares electronically. Additionally, these shareholders can submit questions related to the matters to be voted on at the 2020 Annual Meeting during the live webcast of the meeting by using the instructions on the virtual meeting website. The control number can be found on the proxy card, voting instruction form, or other previously received notices. Those without a control number may attend the virtual meeting as guests, but will not have the option to vote or ask questions. Technical assistance will be available for attendees who experience an issue accessing the virtual meeting. Contact information for technical support will appear on the virtual meeting website prior to the start of the 2020 Annual Meeting.

    Whether or not shareholders plan to attend the 2020 Annual Meeting, all shareholders are encouraged to vote their shares and submit their proxy in advance of the meeting by one of the methods described in the previously distributed proxy materials for the 2020 Annual Meeting. The proxy card included with the previously distributed proxy materials will not be updated to reflect the change to a virtual meeting format and may continue to be used to vote shares in connection with the 2020 Annual Meeting. Shareholders who have already voted their shares do not need to vote them again because of this change in meeting format. Any shareholder who has not voted prior to the day of the 2020 Annual Meeting may do so by following the applicable voting instructions on the virtual meeting website.

    A list of shareholders entitled to vote at the 2020 Annual Meeting will be available for review by interested shareholders at the offices of the Company, 233 Wilshire Blvd., Suite 280, Santa Monica, CA 90401, beginning on June 5, 2020. Please contact the Company's Investor Relations by sending an e-mail to , if you wish to inspect the list prior to the meeting.

    About Opiant Pharmaceuticals, Inc.
    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.
    For more information visit: www.opiant.com.

    Investor Relations Contacts:
    Ben Atkins
    VP of Corporate Communications and Investor Relations

    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576 

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  4. SANTA MONICA, Calif., May 12, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended March 31, 2020, and provided a corporate update. Recent highlights include:

    • Strong financial position:
       
      -  Q1 2020 revenues of $4.3 million driven by NARCAN® Nasal Spray ("NARCAN®") royalties of $4.2 million, an increase of 12 percent year-over-year
      -  Projected royalties for the full-year 2020 of approximately $26.2 million, reiterated based on Emergent BioSolutions Inc. ("EBS") revenue guidance for NARCAN®
      -  Cash and cash equivalents of $32.2 million and no debt as of March 31, 2020

    SANTA MONICA, Calif., May 12, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended March 31, 2020, and provided a corporate update. Recent highlights include:

    • Strong financial position:
       
      -  Q1 2020 revenues of $4.3 million driven by NARCAN® Nasal Spray ("NARCAN®") royalties of $4.2 million, an increase of 12 percent year-over-year
      -  Projected royalties for the full-year 2020 of approximately $26.2 million, reiterated based on Emergent BioSolutions Inc. ("EBS") revenue guidance for NARCAN®
      -  Cash and cash equivalents of $32.2 million and no debt as of March 31, 2020
       
    • Update on submission of a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for Opiant's lead development program, OPNT003, nasal nalmefene, for opioid overdose:
       
      -  FDA removed its clinical hold on OPNT003, allowing Opiant to proceed with pharmacokinetic ("PK") study
      -  Reached agreement with the FDA on the design of a pharmacodynamic ("PD") study in healthy volunteers to support the OPNT003 NDA application
      -  OPNT003 development program impacted by prolonged COVID-19 related travel restrictions on manufacturing equipment engineers in Europe
      -  Opiant now expects to file an NDA in early 2021
       
    • Executed a cooperative research and development agreement with the National Center for Advancing Translational Sciences ("NCATS") to formulate OPNT004 for human studies in Acute Cannabinoid Overdose
       
    • Paused initiation of recruitment for planned Phase 2 study of OPNT002 for Alcohol Use Disorder due to ongoing COVID-19 global health pandemic

    "These results highlight our unique position: cash-strong, no debt, and with an increasing royalty stream from sales of NARCAN® supporting our robust pipeline across multiple compelling therapy areas in addiction and overdose," said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. "We also have the financial support and collaboration of multiple government agencies, including the National Institute on Drug Abuse ("NIDA"), NCATS, and the Biomedical Advanced Research and Development Authority ("BARDA")."

    Speaking about OPNT003, Dr. Crystal added: "We are pleased that the FDA has removed its clinical hold on OPNT003 for opioid overdose reversal. As we previously reported in January, the FDA placed our development of OPNT003 on hold as it reviewed certain characteristics of the intranasal delivery device. After reviewing our response, the FDA removed its clinical hold based on our agreement to amend slightly our PK study protocol. Therefore, we can move forward with our study as soon as feasible. Separately, we have agreed with the FDA on the design of a short PD study in healthy volunteers that we believe will enhance the clinical profile of OPNT003. As we progress towards our regulatory filing for OPNT003, we are also having to factor into our timeline the impact of prolonged COVID-19 related travel restrictions on our equipment engineers in Europe. Based on these collective modifications to our OPNT003 development program, our NDA filing is now likely to occur in early 2021."

    David O'Toole, Chief Financial Officer of Opiant, said: "We are well-positioned financially with significant cash, no debt and no need to access government programs in the United States or United Kingdom for COVID-19-related financial assistance or relief. Our pipeline investments and overall financial position continue to benefit from a resilient stream of revenue from the sales of NARCAN®."

    First quarter 2020 results

    For the three months ended March 31, 2020, Opiant recorded approximately $4.3 million in revenue, compared to approximately $5.4 million during the corresponding period of 2019. The first quarter of 2019 included $1.7 million in revenue from the NIDA grant and the contract from BARDA. For the three months ended March 31, 2020, we recorded approximately $4.2 million of revenue from our license agreement with EBS for the sale of NARCAN®, compared to approximately $3.7 million in the same period of 2019. First-quarter 2020 sales of NARCAN® were approximately $72.2 million, as reported by EBS.

    General and administrative expenses for the quarter were approximately $2.6 million, compared to approximately $3.4 million for the same period of 2019. The $0.8 million decrease is primarily attributable to a decrease in stock-based compensation and legal expenses.

    Research and development expenses were approximately $1.4 million, as compared to approximately $3.6 million in the first three months of 2019. The $2.2 million decrease was primarily attributable to a reduction in third-party clinical trial and development expense.

    Sales and marketing expenses were approximately $1.1 million, compared to none during the first three months in 2019. As Opiant continues to advance OPNT003 towards potential market approval, we anticipate that our sales and marketing expenses will increase in several areas to support the development of a commercial platform that would allow Opiant to potentially commercialize OPNT003, as well as future pipeline products.

    Royalty expense for the first quarter was approximately $0.9 million due for payments to Net Profit Partners for the royalties received from the net sales of NARCAN®.

    Net loss for the first quarter was approximately $1.7 million, or a loss of $0.40 per basic and diluted share, compared to a net loss of approximately $1.7 million, or a loss of $0.44 per basic and diluted share, for the comparable period of 2019.

    As of March 31, 2020, Opiant had cash and cash equivalents of $32.2 million, compared to approximately $31 million at December 31, 2019. The current cash balance does not include the full impact of the NIDA grant of approximately $7.4 million or the BARDA contract of approximately $4.6 million.


    Conference Call Details:
    Tuesday, May 12th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time
    Toll Free:   877-407-0792
    International:   201-689-8263
    Conference ID:   13702897
    Webcast:   http://public.viavid.com/index.php?id=139556


    About Opiant Pharmaceuticals, Inc.
    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

    For more information 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, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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 same 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. Additional factors that could materially affect actual results can be found in our filed quarterly reports on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 4, 2020, including under the caption titled "Risk 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.

    Investor Relations Contacts:

    Ben Atkins
    VP of Corporate Communications and Investor Relations

    (310) 598-5410

    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Opiant Pharmaceuticals, Inc.
    Condensed Consolidated Balance Sheets
    (in thousands, except shares and per share amounts)
           
      As of March 31,   As of December 31,
        2020       2019  
    Assets (unaudited)    
    Current Assets      
    Cash & cash Equivalents $ 32,198     $ 30,981  
    Accounts receivable   4,205       7,218  
    Prepaid expenses and other current assets   1,023       1,056  
    Total Current Assets   37,426       39,255  
    Other assets      
    Property and equipment, net   199       243  
    Right of use assets - operating leases   628       769  
    Patents and patent applications, net   14       14  
    Total Assets $ 38,267     $ 40,281  
           
    Liabilities and stockholders' equity      
    Current Liabilities      
    Accounts payable and accrued liabilities $ 1,450     $ 1,317  
    Accrued salaries and wages   599       1,238  
    Royalty payable   934       1,620  
    Deferred revenue   843       918  
    Operating leases - current   500       517  
    Total Current Liabilities   4,326       5,610  
    Long-Term Liabilities      
    Operating leases - long term   131       255  
    Total Long-Term Liabilities   131       255  
    Total Liabilities   4,457       5,865  
    Stockholders' equity      
    Common stock, $0.001 par value, 200,000,000 shares      
    authorized, 3,925,361 and 3,845,361 shares      
    issued and outstanding at March 31, 2019      
    and December 31, 2018, respectively   4       4  
    Additional paid-in-capital   98,611       97,240  
    Foreign Currency Translation Adjustment   (293 )     -  
    Accumulated deficit   (64,512 )     (62,828 )
    Total stockholders' equity   33,810       34,416  
    Total liabilities and stockholders' equity $ 38,267     $ 40,281  
           




    Opiant Pharmaceuticals Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except shares and per share amounts)
           
           
      Three months ended   Three months ended
      March 31,   March 31,
        2020       2019  
      (Unaudited)   (Unaudited)
    Revenues      
    Royalty & licensing revenue $ 4,199     $ 3,746  
    Treatment investment income   -       80  
    Grant and contract revenue   84       1,609  
    Total Revenue   4,283       5,435  
    Operating Expenses      
    General and administrative   2,573       3,382  
    Research and development   1,421       3,567  
    Sales & marketing   1,077       -  
    Royalty expense   934       314  
           
    Total expenses   6,005       7,263  
           
    Loss from operations   (1,722 )     (1,828 )
           
    Other income (expense)      
    Interest income, net   76       122  
    Loss on foreign exchange   -       (30 )
    Total other income (expense)   76       92  
    Loss before provision for income taxes   (1,646 )     (1,736 )
    Income tax expense   (39 )     -  
    Net loss $ (1,685 )   $ (1,736 )
           
    Other comprehensive loss:      
    Foreign currency translation loss adjustment   (293 )     -  
    Comprehensive loss $ (1,978 )   $ (1,736 )
           
    Net loss per common share      
    Basic & Diluted $ (0.40 )   $ (0.44 )
           
    Weighted-average common shares outstanding:      
    Basic & Diluted   4,224,555       3,909,702  
           

     

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  5. SANTA MONICA, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced that it will report its financial results for the first quarter ended March 31, 2020, after the market close and host a corporate update conference call and webcast on Tuesday, May 12, at 4:30 p.m. Eastern Time.

    SANTA MONICA, Calif., April 28, 2020 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today announced that it will report its financial results for the first quarter ended March 31, 2020, after the market close and host a corporate update conference call and webcast on Tuesday, May 12, at 4:30 p.m. Eastern Time.

    Conference Call Details:
    Tuesday, May 12th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time
    Toll Free:                                877-407-0792
    International:                          201-689-8263
    Conference ID:                       13702897
    Webcast:                                http://public.viavid.com/index.php?id=139556

    About Opiant Pharmaceuticals, Inc.
    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information, please visit: www.opiant.com.

    CONTACTS:

    For Investor and Media Inquiries:
    Ben Atkins
    Vice President, Communications and Investor Relations
    Opiant Pharmaceuticals, Inc.

    (310) 598-5410

    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Primary Logo

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