Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 02, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | OPIANT PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001385508 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Trading Symbol | OPNT | |
Entity Common Stock, Shares Outstanding | 3,995,361 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 23,768 | $ 24,614 |
Accounts receivable | 1,956 | 4,489 |
Prepaid and other current assets | 522 | 267 |
Total current assets | 26,246 | 29,370 |
Other assets | ||
Patents and patent applications - net of accumulated amortization | 15 | 16 |
Total assets | 26,261 | 29,386 |
Current liabilities | ||
Accounts payable and accrued expenses | 1,482 | 1,133 |
License fees | 6,300 | 5,400 |
Accrued salaries and wages | 618 | 1,084 |
Royalty payable | 314 | 998 |
Deferred revenue | 757 | 1,212 |
Total current liabilities | 9,471 | 9,827 |
Long-term liabilities | ||
License fees | 0 | 2,700 |
Total long-term liabilities | 0 | 2,700 |
Total liabilities | 9,471 | 12,527 |
Stockholders' equity | ||
Common stock; par value $0.001; 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 | 92,943 | 91,276 |
Accumulated deficit | (76,157) | (74,421) |
Total stockholders' equity | 16,790 | 16,859 |
Total liabilities and stockholders' equity | $ 26,261 | $ 29,386 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Statement of Financial Position [Abstract] | ||
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock issued (in shares) | 3,925,361 | 3,845,361 |
Common stock outstanding (in shares) | 3,925,361 | 3,845,361 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues | ||
Royalty and licensing revenue | $ 3,746 | $ 1,649 |
Treatment investment revenue | 80 | 54 |
Grant and contract revenue | 1,609 | 0 |
Total revenue | 5,435 | 1,703 |
Operating expenses | ||
General and administrative | 3,696 | 2,965 |
Research and development | 3,567 | 2,421 |
License fees | 0 | 5,625 |
Total operating expenses | 7,263 | 11,011 |
Loss from operations | (1,828) | (9,308) |
Other income (expense) | ||
Interest income, net | 122 | 5 |
Loss on foreign exchange | (30) | (8) |
Total other income (expense) | 92 | (3) |
Loss before provision for income taxes | (1,736) | (9,311) |
Provision for income taxes | 0 | 33 |
Net loss | $ (1,736) | $ (9,344) |
Net loss per share of common stock: | ||
Basic and Diluted (in dollars per share) | $ (0.44) | $ (3.68) |
Weighted average shares outstanding used to compute net loss per share: | ||
Basic and Diluted (in shares) | 3,909,702 | 2,542,084 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid In Capital | Accumulated Deficit |
Beginning Balance (in shares) at Dec. 31, 2017 | 2,535,766 | |||
Beginning Balance at Dec. 31, 2017 | $ 13,000 | $ 2 | $ 66,223 | $ (53,225) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of warrants (in shares) | 2,400 | |||
Exercise of warrants | 24 | 24 | ||
Issuance of common stock for cash, net of issuance costs (in shares) | 48,634 | |||
Issuance of common stock, net of issuance costs | 642 | $ 0 | 641 | |
Stock based compensation from issuance of stock options | 1,609 | 1,609 | ||
Net loss | (9,344) | (9,344) | ||
Ending Balance (in shares) at Mar. 31, 2018 | 2,586,800 | |||
Ending Balance at Mar. 31, 2018 | 5,931 | $ 3 | 68,497 | (62,569) |
Beginning Balance (in shares) at Dec. 31, 2018 | 3,845,361 | |||
Beginning Balance at Dec. 31, 2018 | 16,859 | $ 4 | 91,276 | (74,421) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Exercise of stock options (in shares) | 80,000 | |||
Exercise of stock options | 601 | 601 | ||
Issuance of common stock for cash, net of issuance costs (in shares) | 80,000 | |||
Stock based compensation from issuance of stock options | 1,066 | 1,066 | ||
Net loss | (1,736) | (1,736) | ||
Ending Balance (in shares) at Mar. 31, 2019 | 3,925,361 | |||
Ending Balance at Mar. 31, 2019 | $ 16,790 | $ 4 | $ 92,943 | $ (76,157) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cash flows from operating activities | ||
Net loss | $ (1,736) | $ (9,344) |
Adjustments to reconcile net loss to net cash from operating activities: | ||
Depreciation and amortization | 0 | 1 |
Stock based compensation from issuance of options | 1,066 | 1,609 |
Change in assets and liabilities: | ||
Accounts receivable | 2,533 | 10,048 |
Prepaid and other current assets | (254) | (4) |
Accounts payable and accrued liabilities | 349 | 221 |
Accrued salaries and wages | (466) | (277) |
Royalty payable | (684) | 0 |
Deferred revenue | (455) | (54) |
License fees | (1,800) | 0 |
Net cash provided by (used in) operating activities | (1,447) | 2,200 |
Cash flows provided by financing activities | ||
Proceeds from issuance of warrants | 0 | 24 |
Proceeds from issuance of common shares | 0 | 1,006 |
Proceeds from stock option exercises | 601 | 0 |
Net cash provided by financing activities | 601 | 1,030 |
Net increase (decrease) in cash and cash equivalents | (846) | 3,230 |
Cash and cash equivalents, beginning of period | 24,614 | 8,116 |
Cash and cash equivalents, end of period | 23,768 | 11,346 |
Non-Cash Transactions | ||
Offset of deferred financing costs against APIC | 0 | 365 |
Deferred financing costs in accounts payable | $ 0 | $ 155 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Company Opiant is a specialty pharmaceutical company developing medicines for addiction and drug overdose. The Company developed NARCAN® (naloxone hydrochloride) Nasal Spray (“NARCAN®”), a treatment to reverse opioid overdose. This product was conceived and developed by the Company, licensed to Adapt Pharma Operations Limited (“Adapt”), an Ireland based pharmaceutical company in December 2014 and approved by the U.S. Food and Drug Administration (“FDA”) in November 2015. It is marketed by Adapt. In October 2018, Emergent BioSolutions, Inc. ("EBS") completed its acquisition of Adapt. The Company's current pipeline includes medicines in development for Opioid Overdose Reversal (“OOR”), Alcohol Use Disorder (“AUD”), Opioid Use Disorder (“OUD”), and Acute Cannabinoid Overdose (“ACO”). The Company is also pursuing other treatment opportunities within the addiction and drug overdose field. The Company has not had a bankruptcy, receivership or similar proceeding. The Company is required to comply with all regulations, rules and directives of governmental authorities and agencies applicable to the clinical testing and manufacturing and sale of pharmaceutical products. |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and the applicable rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the Company's financial position as of March 31, 2019 and December 31, 2018, results of its operations for the three months ended March 31, 2019 and cash flows for the three months ended March 31, 2019 and 2018. The interim results are not necessarily indicative of the results for any future interim period or for the entire year. Certain prior period amounts have been reclassified to conform to current period presentation. These classifications have no effect on the previously reported net loss or loss per share. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited, a company incorporated on November 4, 2016 under the England and Wales Companies Act of 2006. Intercompany balances and transactions are eliminated upon consolidation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in the Company's Annual Report on Form 10-K filed with the SEC on March 21, 2019. Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the financial statements and accompanying notes. Actual results could differ from those estimates. Key estimates included in the financial statements include the valuation of: deferred income tax assets, equity instruments, stock-based compensation, acquired intangibles, and allowances for accounts receivable. Cash and Cash Equivalents The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents were approximately $23.8 million and $24.6 million at March 31, 2019 and December 31, 2018, respectively. The Company maintains cash balances at financial institutions insured up to $250 thousand by the Federal Deposit Insurance Corporation. Balances in the UK are insured up to £85 thousand by the Financial Services Compensation Scheme (UK Equivalent). Although the Company’s cash balances exceeded these insured amounts at various times during the three months ended March 31, 2019, the Company has not experienced any losses on its deposits of cash and cash equivalents for the periods presented. Earnings (Loss) Per Share Basic and diluted loss per share is computed by dividing loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted weighted average shares outstanding for the three months ended March 31, 2019 and 2018 excludes 3.6 million and 3.7 million shares, underlying stock options and warrants, respectively, because the effects would be anti-dilutive. Accordingly, basic and diluted loss per share is the same. Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, " Leases" (Topic 842) The new standard requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. The new standard establishes a right-of-use ("ROU") model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The standard is effective on January 1, 2019, with early adoption permitted. The Company adopted the new standard on January 1, 2019 using the modified retrospective method. As part of the adoption, the Company elected to utilize the package of practical expedients included in this guidance, which permitted the Company to not reassess (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and (iii) the initial direct costs for existing leases. In conjunction with the adoption of the new lease standard, the Company adopted the following policy; an election not to recognize short-term leases (i.e., a lease that is less than 12 months and contains no purchase option) within the unaudited Condensed Consolidated Balance Sheets, with the expense related to these short-term leases recorded within total operating expenses within the unaudited Condensed Consolidated Statements of Operations. As the Company's current operating leases are less than 12 months the Company has concluded there is no impact on its consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, "Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting," ("ASU 2018-07"), which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. ASU 2018-07 is effective for financial statements issued for annual periods beginning after December 15, 2018, and for the interim periods therein. The Company adopted this ASU effective January 1, 2019 and has concluded it did not have a material impact on its consolidated financial statements. In 2018, the FASB issued ASU No. 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This new standard permits entities to reclassify to retained earnings the tax effects stranded in accumulated other comprehensive income ("AOCI") as a result of U.S. tax reform. Th amendments in this update are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company adopted this ASU effective January 1, 2019 and has concluded it did not have a material impact on its consolidated financial statements. Recent accounting pronouncements pending adoption In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 . This standard resolves the diversity in practice concerning whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Accounting Standards Codification 606, Revenue from Contracts with Customers (“Topic 606”). This standard specifies when a participant is a customer in a collaboration, adds unit of account guidance to align with Topic 606 and provides presentation guidance for collaborative arrangements. This guidance is effective for public entities for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the timing of the adoption and its impact on the Company’s consolidated financial statements. The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its consolidated financial statements. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2019 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets As of March 31, 2019 , the Company had approximately $ 522 thousand recorded as prepaid expenses and other current assets. The Company's prepaid amounts are primarily for insurance, advance research and development payments, software licenses, prepaid rent, and other amounts paid that relate to future periods of service. Other current assets are primarily items such as security deposits and other receivables. |
Accounts Receivable
Accounts Receivable | 3 Months Ended |
Mar. 31, 2019 | |
Receivables [Abstract] | |
Accounts Receivable | Accounts Receivable As of March 31, 2019, the Company had accounts receivable of $ 1,956 thousand of which $1,946 thousand relates to royalty revenue from the sales of NARCAN®. As of December 31, 2018 the Company had accounts receivable of $4.5 million , which relates to royalty revenue from the sales of NARCAN®. |
Deferred Revenue
Deferred Revenue | 3 Months Ended |
Mar. 31, 2019 | |
Revenue Recognition [Abstract] | |
Deferred Revenue | Deferred Revenue On December 17, 2013, the Company entered into an agreement with an investor, Potomac, and subsequently received additional funding totaling $250 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the Company’s BED treatment product (the “BED Treatment Product”) and pay the investor 0.5% of the BED Net Profit in perpetuity (the “2013 0.5% Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by December 17, 2016, the investor would have a 60 -day option to exchange its entire 0.5% Investor Interest for 31,250 shares of Common Stock of the Company. On February 17, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in February 2017. The Company recognized approximately $14.4 thousand of revenue relating to the agreement for each of the three month periods ended March 31, 2019 and 2018. On September 17, 2014, the Company entered into an agreement with an investor, Potomac, and subsequently received funding totaling $500 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 1.0% interest in the Company’s BED Treatment Product and pay the investor 1.0% of the BED Net Profit generated from the BED Treatment Product in perpetuity (the “ 1.0% Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by September 17, 2017, the investor would have a 60 -day option to exchange its entire 1.0% Investor Interest for 62,500 shares of Common Stock of the Company. On November 15, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in November 2017. The Company continues to assess the BED Treatment Product research and development progress and is currently recognizing revenue on a straight line basis through December 31, 2020. During the three months ended March 31, 2019 and 2018, the Company recognized revenue of approximately $39.2 thousand in each period related to this agreement. On July 20, 2015, the Company entered into an agreement with an investor, Potomac, and subsequently received funding from an individual investor in the amount of $250 thousand for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a 0.5% interest in the BED Net Profit (the “2015 0.5% Investor Interest”) generated from the BED Treatment Product in perpetuity. The investor also has rights with respect to the 2015 0.5% Investor Interest if the BED Treatment Product is sold or the Company is sold. If the product is not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed by July 20, 2018, the investor will have a 60 -day option to exchange the 2015 0.5% Investor Interest for 25,000 shares of Common Stock of the Company. During the three months ended March 31, 2019 and 2018, the Company recognized revenue of approximately $26.8 thousand and zero , respectively related to this agreement. On April 17, 2018, the Company was awarded a grant of approximately $7.4 million from the National Institutes of Health’s National Institute on Drug Abuse, (NIDA). The grant provides the Company with additional resources for the ongoing development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The grant includes approximately $2.6 million to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years, subject to available funds and satisfactory progress on the development of OPNT003. Government grants are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. The Company recognized revenues from grants in the period during which the related costs were incurred, provided that the conditions under which the grants were provided had been met and only perfunctory obligations were outstanding. During the three months ended March 31, 2019 the Company recognized revenue of $1,575 thousand related to this grant. On September 19, 2018, the Company entered into a contract with the Biomedical Advanced Research and Development Authority (“BARDA”), which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate the Company’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose. The contract will provide potential funding up to a maximum of approximately $4.6 million and cover activities related to a potential New Drug Application submission for OPTN003 with the Food and Drug Administration. The Contract will provide approximately $611,000 for the project through September 30, 2019, with the balance to be funded over the following two years, subject to satisfactory project progress, availability of funds and certain other conditions. During the three months ended March 31, 2019 the Company recognized revenue of $34,329 related to this contract. As of March 31, 2019 the Company had recorded all of its deferred revenue as a current liability because the Company expects to recognize all such deferred revenue as revenue during the next 12 months. The following is a summary of the Company’s deferred revenue activity as of March 31, 2019: (in thousands) BED Grants Total Balance as of December 31, 2018 $ 644 $ 568 $ 1,212 Additions to deferred revenue — 1,200 1,200 Recognized as revenue (80 ) (1,575 ) (1,655 ) Balance as of March 31, 2019 $ 564 $ 193 $ 757 |
License Fee Payable
License Fee Payable | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
License Fee Payable | License Fee Payable On February 28, 2018, the Company was notified that Adapt, now a subsidiary of Emergent BioSolutions ("EBS"), had entered into a license agreement with a Third Party (as defined in the License Agreement) with regard to one or more patents pursuant to which Adapt invoked its right under Section 5.5 of the License Agreement, dated as of December 15, 2014, by and between the Company and Adapt, as amended (the "License Agreement"), to offset 50% of certain payments paid to such Third Party from the amounts payable by Adapt to the Company under the License Agreement, and SWK under the SWK Purchase Agreement. On March 1, 2018, the Company received net milestone payments of $6.1 million , which was net of 50% of a license fee payment Adapt made to the Third Party. The portion of the milestone payment that the Company would have otherwise received was reduced by $5.6 million . As provided in Amendment No. 2 to the License Agreement, which the parties entered into on March 18, 2019, Adapt has made and will in the future make payments to the Third Party Licensee (as defined in Amendment No. 2) and will be allowed to reduce the royalties and milestones that the Company would be due under the License Agreement by a maximum of $9.0 million in relation to such payments. Under the SWK Purchase Agreement, the Company retains 90% of the royalties payable under the License Agreement, with SWK entitled to 10% . The maximum amount payable by the Company is therefore $8.1 million (90% of $9 million), of which the Company recorded $5.4 million as a current liability and $2.7 million as a long-term liability at December 31, 2018. As provided in Amendment No. 2, Adapt will be allowed to reduce the royalties and milestones that the Company would be due under the License Agreement during the year ending December 31, 2019 by a maximum of $1.8 million each quarter. As provided in the License Agreement, if Net NARCAN® Sales (as defined in the License Agreement) exceed $200 million in any calendar year, the Company and SWK will be due a milestone of $15.0 million . Under Amendment No. 2, if this $15.0 million milestone becomes payable to the Company and SWK, Adapt may deduct $2.7 million from the $13.5 million (90% of $15.0 million) milestone payable to the Company. As of March 31, 2019, the Company has recorded $6.3 million as a current liability, as it expects the remaining amounts to be paid, by a reduction of the royalties or milestones payable, within twelve months of March 31, 2019. |
Royalty Payable
Royalty Payable | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Royalty Payable | Royalty Payable The Company entered into various agreements and subsequently received funding from investors for use by the Company for the research and development of its Opioid Overdose Reversal Treatment Product ("OORTP"). In exchange for this funding, the Company agreed to provide investors with interest in the OORTP Net Profit generated from its OORTP in perpetuity. As of December 31, 2018, the Company determined an OORTP Net Profit as a result of NARCAN® sales by Adapt and recorded a royalty payable of $998 thousand . As of March 31, 2019 , the Company has a royalty payable of approximately $314 thousand . |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock During the three months ended March 31, 2019, the Company issued 80,000 shares of Common Stock as a result of employee stock option exercises, and received net cash proceeds of $601 thousand . Stock Options On September 8, 2017, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”), at which time the 2017 Long-Term Incentive Plan ("2017 Plan") was approved by stockholder vote. The 2017 Plan allows the Company to grant both incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”) to purchase a maximum of 400,000 shares of the Company's Common Stock. Under the terms of the 2017 Plan, ISOs may only be granted to Company employees and directors, while NSOs may be granted to employees, directors, advisors, and consultants. The Board has the authority to determine to whom options will be granted, the number of options, the term, and the exercise price. Options are to be granted at an exercise price not less than fair value for an ISO or an NSO. The vesting period is normally over a period of four years from the vesting date. The contractual term of an option is no longer than ten years . As provided in the 2017 Plan, on January 1, 2019 the number of options available for issuance was increased by 4% of the outstanding stock as of December 31, 2018, which represents an increase of 153,814 options. Prior to adopting the 2017 Plan, the Company did not have a formal long-term incentive stock plan. Prior to the implementation of the 2017 Plan, the Company had discretion to provide designated employees of the Company and its affiliates, certain consultants, and advisors who perform services for the Company and its affiliates, and non-employee members of the Board and its affiliates with the opportunity to receive grants of non-qualified stock options (the "Pre-2017 Non-Qualified Stock Options"). All of the Pre-2017 Non-Qualified Stock Option Grants were intended to qualify as non-qualified stock options. There were no Pre-2017 Non-Qualified Stock Option Grants that were intended to qualify as incentive stock options. Pre-2017 Non-Qualified Stock Options As of December 31, 2018, the Company had outstanding Pre-2017 Non-Qualified Stock Options to purchase, in the aggregate, 2,885,500 shares of the Company's Common Stock. During the three months ended March 31, 2019, the Company did no t grant any Pre-2017 Non-Qualified Stock Options. Stock option activity for the Pre-2017 Non-Qualified Stock Options for the three months ended March 31, 2019 is presented in the table below: Number of Shares Weighted- average Exercise Price Weighted- average Remaining Contractual Term (years) Aggregate Intrinsic Value (in Thousands) Outstanding at December 31, 2018 2,885,500 $ 7.30 6.04 $ 20,633,100 Exercised (80,000 ) 7.52 Forfeited (4,865 ) 10.00 Outstanding at March 31, 2019 2,800,635 $ 7.29 5.77 $ 16,358,456 Exercisable at March 31, 2019 2,695,766 $ 7.21 5.76 $ 15,932,550 A summary of the status of the Company’s non-vested Pre-2017 Non-Qualified Stock Options as of March 31, 2019 is presented below: Number of Options Weighted Average Grant Date Fair Value Non-vested at March 31, 2019 109,734 $ 7.76 During the three months ended March 31, 2019 and 2018, the Company recognized approximately $50 thousand and $290 thousand , respectively, of non-cash expense related to Pre-2017 Non-Qualified Stock Options granted in prior periods. As of March 31, 2019, there was approximately $139 thousand of unrecognized compensation costs related to non-vested Pre-2017 Non-Qualified Stock Options. The 2017 Plan During January 2019, the Company granted options to a number of employees to purchase 89,700 shares of the Company’s Common Stock at an exercise prices of $13.61 and $14.62 per share, which represents the closing price of the Company’s Common Stock on the date of the grants. These options were issued under the Company’s 2017 Plan and have ten -year terms. The options vest as follows: 1/48 th of the options shares vest on such date every month through the fourth anniversary of the grant date. The Company valued these options using the Black-Scholes option pricing model and estimated the fair value on the date of grant to be $1.1 million . The assumptions used in the valuation of options granted under the 2017 Plan during the three months ended March 31, 2019 are as follows: For the Three Months Ended March 31, 2019 Market value of stock on measurement date $13.61 to $14.62 Risk-free interest rate 2.41% to 2.57% Dividend yield — Volatility factor 121% Term 6.25 Years Stock option activity for options granted under the 2017 Plan during the three months ended March 31, 2019 is presented in the table below: Number of Shares Available Number of Options Outstanding Weighted-average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Balance at December 31, 2018 157,881 343,550 $ 28.97 8.95 $ 840 Annual additional options authorized 153,814 — — Granted (89,700 ) 89,700 $ 13.76 Exercised — — — Forfeited 1,836 (1,836 ) $ 16.64 Balance at March 31, 2019 223,831 431,414 $ 25.86 8.92 $ — A summary of the status of the Company’s non-vested options granted under the 2017 Plan as of March 31, 2019 is presented in the following table: Number of Shares Weighted Average Grant Date Fair Value Per Share Balance at March 31, 2019 431,414 $ 25.34 Vested (106,278 ) 30.53 Non-vested at March 31, 2019 325,136 $ 23.64 During the three months ended March 31, 2019 and 2018, the Company recognized approximately $1.0 million and $1.3 million of non-cash expense related to options granted under the 2017 Plan. As of March 31, 2019, there was approximately $3.6 million of unrecognized compensation costs related to non-vested stock options that were granted under the 2017 Plan. Warrants During the three months ended March 31, 2019, the Company did no t issue any warrants. Warrant activity for the three months ended March 31, 2019 is presented in the table below: Number of Shares Weighted- average Exercise Price Weighted- average Remaining Contractual Term (years) Aggregate Intrinsic Value (in Thousands) Outstanding at December 31, 2018 353,610 $ 9.78 4.36 $ 1,181 Exercised — $ — Outstanding at March 31, 2019 353,610 $ 9.78 4.36 $ 1,181 Exercisable at March 31, 2019 353,610 $ 9.78 4.36 $ 1,181 |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments The Company has entered into various agreements related to its business activities. The following is a summary of the Company’s commitments: Torreya Agreement On December 18, 2014, the Company entered into a consulting agreement with Torreya (the "2014 Agreement"), a financial advisory firm, under which Torreya agreed to provide financial advisory services with regard to the License Agreement. The 2014 Agreement also requires the Company to pay an additional fee equivalent to 3.75% of all amounts received by the Company in excess of $3.0 million , in perpetuity. On April 25, 2016, the Company entered into a consulting agreement with Torreya, under which Torreya agreed to provide financial advisory services for financing activities. In exchange for these services, the Company is required to pay a fee on all funding received by the Company as a result of assistance provided by Torreya. Torreya’s fee would be equal to 5% of gross funding received by the Company up to $20 million plus 3.5% of any proceeds received in excess of $20 million . On September 8, 2017, the Company and Torreya entered into the Supplemental Engagement Letter to provide financial advisory services with respect to the licensing of the intellectual property rights to develop and commercialize certain products with Adapt. The revised engagement amends total consideration as follows: (i) an aggregate of $300 thousand in cash payments to be paid by the Company to Torreya in three equal installments over a 16 -month period; (ii) shares of Common Stock, equal to an aggregate value of $300 thousand , to be issued by the Company to Torreya in three equal installments over a 16 -month period; (iii) if the Earn Out Milestone Payment is paid under the SWK Agreement, approximately $140.6 thousand , or 3.75% of the Earn Out Milestone Payment (as defined in the SWK Agreement), shall be paid by the Company to Torreya within 15 days of the date that the Earn Out Milestone (as defined in the SWK Agreement) has been paid to the Company; (iv) once SWK has received the Capped Royalty Amount, if the Earn Out Milestone Payment (as defined in the SWK Agreement) is paid, Torreya shall receive 3.375% of the Total Consideration (as defined in the 2014 Agreement) received thereafter or 3.5625% of the Total Consideration received thereafter if no generic version of NARCAN is commercialized prior to the six th anniversary of the Closing Date (as defined in the SWK Agreement) as per the terms of the SWK Agreement; and (v) once SWK has received the Capped Royalty Amount, if the Earn Out Milestone Payment has not been paid, Torreya shall receive 3.45525% of the Total Consideration received thereafter or 3.602625% of the Total Consideration received thereafter if no generic version of NARCAN is commercialized prior to the six th anniversary of the Closing Date as per the terms of the SWK Agreement. Payments made by the Company in the form of shares of Common Stock will be a defined number of shares calculated based upon the average closing price of the Common Stock for the ten trading days prior to the relevant date for the payment. During the three months ended March 31, 2019 and 2018, the Company recorded $66 thousand and zero , respectively of expense related to Torreya, and has recorded a liability of $66 thousand as of March 31, 2019 related to Torreya. Exclusive License and Collaboration Agreement On November 19, 2015, the Company issued 14,327 shares of unregistered Common Stock upon the execution of a binding letter of intent to agree to negotiate and enter into an exclusive license agreement and collaboration agreement (“LOI”) with a pharmaceutical company with certain desirable proprietary information. The shares issued in this transaction were valued using the stock price at issuance date and amounted to approximately $120.3 thousand . Pursuant to the LOI, the Company is obligated to issue up to an additional 92,634 shares of unregistered Common Stock upon the occurrence of various milestones, of which a total of 66,520 shares with a value of approximately $894.4 thousand have been issued through December 31, 2018. No shares were required to be issued during the three months ended March 31, 2019. Heroin Vaccine License In October 2016, the Company in-licensed a heroin vaccine from the Walter Reed Army Institute of Research ("Walter Reed"). In consideration for the license the Company agreed to pay a royalty of 3% of net sales if the Company commercializes the vaccine, or 4% if the vaccine is sublicensed. In addition, the Company agreed to pay a minimum annual royalty of $10 thousand , as well as fixed payments of up to approximately $715.7 thousand if all of the specified milestones are met. No expense was recorded for the three months ended March 31, 2019. Supply Agreement On June 22, 2017, the Company entered into a license agreement (the "License Agreement") and a related supply agreement (the “Supply Agreement”) with Aegis Therapeutics LLC ("Aegis") pursuant to which the Company was granted an exclusive license (the “License”) to Aegis’ proprietary chemically synthesizable delivery enhancement and stabilization agents, including, but not limited to, Aegis’ Intravail® absorption enhancement agents, ProTek® and HydroGel® (collectively, the “Technology”) to exploit (a) the Compounds (as such are defined in the License Agreement) and (b) a product containing a Compound and formulated using the Technology (“Product”), in each case of (a) and (b) for any and all purposes. The License Agreement restricts the Company's ability to manufacture any Aegis excipients included in the Technology (“Excipients”), except for certain instances of supply failure, supply shortage or termination of the Supply Agreement, and the Company shall obtain all supply of such Excipients from Aegis under the Supply Agreement. The License Agreement also restricts Aegis’s ability to compete with the Company worldwide with respect to the Exploitation (as defined in the License Agreement) of any therapeutic containing a Compound or derivative or active metabolite of a Compound without the Company's prior written consent. The effective date of the License Agreement and the Supply Agreement is January 1, 2017. As consideration for the grant of the License, the Company paid Aegis two immaterial upfront payments, of which the Company paid 50% by issuing the Company's Common Stock to Aegis, with the number of shares issued equal to 75% of the average closing price of the Company's Common Stock over the 20 trading days preceding the date of payment. The License Agreement also provides for (A) additional developmental milestone payments for each Product containing a different Compound equal to up to an aggregate of $1.8 million , (B) additional commercialization milestone payments for each Product containing a different Compound equal to up to an aggregate of $5.0 million , and (C) single low digit royalties on the Annual Net Sales (as defined in the License Agreement) of all Products during the Royalty Term (as defined in the License Agreement) according to a tiered royalty rate based on Annual Net Sales of the Products by the Company, the Company's sublicensees and affiliates. The Company shall also pay to Aegis a sublicense fee based on a sublicense rate negotiated in good faith by the parties. The License Agreement contains customary representations and warranties, ownership, patent rights, confidentiality, indemnification and insurance provisions. The License Agreement shall expire upon the expiration of the Company's obligation to pay royalties under such License Agreement; provided, however, that the Company shall have the right to terminate the License granted on a Product-by-Product or country-by-country basis upon 30 days’ prior written notice to Aegis. For the three months ended March 31, 2019, and 2018 the Company recorded $225 thousand and zero of expense associated with the License Agreement. Under the terms of the Supply Agreement, Aegis shall deliver to the Company any preclinical, clinical and commercial supply of the Excipients, which Aegis sources from various contract manufacturers. The Supply Agreement has a term of 20 years but shall terminate automatically in the event of expiration or termination of the License Agreement or at any time upon the written agreement of both parties. The Supply Agreement contains customary provisions relating to pricing for such materials, forecasts, delivery, inspection, indemnification, insurance and representations, warranties and covenants. The Supply Agreement includes technology transfer provisions for the transfer of all materials and know-how specific to the manufacturing of the Excipients that is necessary or useful for the Company to manufacture such Excipients. The Company does not have the right to manufacture such Excipients except in the event that Aegis is unable to supply and sell any portion of the material to the Company (subject to a 60 -day cure period). Research and Development Agreement On July 14, 2017, Renaissance Lakewood, LLC (“Renaissance”) and the Company entered into a Research and Development Agreement (the “Renaissance Agreement”). Under the Renaissance Agreement, Renaissance will perform product development work on a naltrexone multi-dose nasal product for the treatment of alcohol use disorder pursuant to the terms set forth in a proposal agreed upon by the parties. The Company will bear the costs of all development services, including all raw materials and packaging components, in connection with the performance of the development work under the Renaissance Agreement and in accordance with financials agreed upon through the proposal. Renaissance will conduct quality control and testing, including non-stability, stability, in-use, raw material, and packaging component testing as part of the services provided to the Company under the Renaissance Agreement. The Company will own all formulations provided to Renaissance and any formulations developed in connection with the Renaissance Agreement. Renaissance will own all know-how developed in connection with the performance of the services that is not solely related to a product. The Company has the right to seek patent protection on any invention or know-how that relates solely to a product developed under the Renaissance Agreement or any our formulation, excluding general manufacturing or product development know-how of Renaissance. The Renaissance Agreement is effective until terminated by either party in accordance with its terms. The Company or Renaissance may terminate the project under a proposal to the Renaissance Agreement due to unforeseen circumstances in the development. The Renaissance Agreement may be terminated by the Company, with or without cause, upon 45 days ' written notice. There are also mutual customary termination provisions relating to uncured breaches of material provisions. During the three months ended March 31, 2019 and 2018, the Company recorded expense in the amount of $598 thousand and $172 thousand related to the product development work. Facility Leases On May 29, 2017, the Company entered into a Sublease (the “Sublease”) with Standish Management, LLC to sublease office space located at 201 Santa Monica Boulevard, Suite 500, Santa Monica, CA 90401, and this is the Company's headquarters. Per the terms of the Sublease, the original term commenced on August 1, 2017 and ended on August 31, 2018. Effective September 1, 2018 the lease is month-to-month. On April 20, 2017, the Company entered into an Office Service Agreement (the “Office Service Agreement”) with Regus to lease office space at 83 Baker Street, London, England, W1U 6AG. Per the terms of the Office Service Agreement, the first month’s rent is £2,473 with monthly rental payments of £7,521 thereafter. The Company was required to pay a security deposit of £15,042 , which is the equivalent of two months of rent. The Office Service Agreement commenced on May 22, 2017 and effective May 31, 2018 continues on a month-to-month basis with either party being able to terminate the agreement by providing three months ' advance written notice of termination. During the three months ended March 31, 2019 and 2018, the Company incurred approximately $104 thousand and $64 thousand of rent expense, respectively. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events From April 1, 2019 through May 9, 2019 the Company issued 70,000 shares of its Common Stock related to stock option exercises. On May 2, 2019, the Company entered into a 26 -month lease agreement in Santa Monica, California The operating lease commences on July 1, 2019 and ends August 31, 2021. The office space is for general and administrative use. |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and the applicable rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the Company's financial position as of March 31, 2019 and December 31, 2018, results of its operations for the three months ended March 31, 2019 and cash flows for the three months ended March 31, 2019 and 2018. The interim results are not necessarily indicative of the results for any future interim period or for the entire year. Certain prior period amounts have been reclassified to conform to current period presentation. These classifications have no effect on the previously reported net loss or loss per share. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited, a company incorporated on November 4, 2016 under the England and Wales Companies Act of 2006. Intercompany balances and transactions are eliminated upon consolidation. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2018 included in the Company's Annual Report on Form 10-K filed with the SEC on March 21, 2019. |
Use of Estimates | The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the financial statements and accompanying notes. Actual results could differ from those estimates. Key estimates included in the financial statements include the valuation of: deferred income tax assets, equity instruments, stock-based compensation, acquired intangibles, and allowances for accounts receivable. |
Cash and Cash Equivalents | The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents were approximately $23.8 million and $24.6 million at March 31, 2019 and December 31, 2018, respectively. The Company maintains cash balances at financial institutions insured up to $250 thousand by the Federal Deposit Insurance Corporation. Balances in the UK are insured up to £85 thousand by the Financial Services Compensation Scheme (UK Equivalent). Although the Company’s cash balances exceeded these insured amounts at various times during the three months ended March 31, 2019, the Company has not experienced any losses on its deposits of cash and cash equivalents for the periods presented. |
Earnings (Loss) Per Share | Basic and diluted loss per share is computed by dividing loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted weighted average shares outstanding for the three months ended March 31, 2019 and 2018 excludes 3.6 million and 3.7 million shares, underlying stock options and warrants, respectively, because the effects would be anti-dilutive. Accordingly, basic and diluted loss per share is the same. |
Accounting Pronouncements | From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, " Leases" (Topic 842) The new standard requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. The new standard establishes a right-of-use ("ROU") model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The standard is effective on January 1, 2019, with early adoption permitted. The Company adopted the new standard on January 1, 2019 using the modified retrospective method. As part of the adoption, the Company elected to utilize the package of practical expedients included in this guidance, which permitted the Company to not reassess (i) whether any expired or existing contracts contain leases; (ii) the lease classification for any expired or existing leases; and (iii) the initial direct costs for existing leases. In conjunction with the adoption of the new lease standard, the Company adopted the following policy; an election not to recognize short-term leases (i.e., a lease that is less than 12 months and contains no purchase option) within the unaudited Condensed Consolidated Balance Sheets, with the expense related to these short-term leases recorded within total operating expenses within the unaudited Condensed Consolidated Statements of Operations. As the Company's current operating leases are less than 12 months the Company has concluded there is no impact on its consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, "Compensation-Stock Compensation (Topic 718): Improvements to Non-employee Share-Based Payment Accounting," ("ASU 2018-07"), which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. ASU 2018-07 is effective for financial statements issued for annual periods beginning after December 15, 2018, and for the interim periods therein. The Company adopted this ASU effective January 1, 2019 and has concluded it did not have a material impact on its consolidated financial statements. In 2018, the FASB issued ASU No. 2018-02, Income Statement-Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income. This new standard permits entities to reclassify to retained earnings the tax effects stranded in accumulated other comprehensive income ("AOCI") as a result of U.S. tax reform. Th amendments in this update are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. The Company adopted this ASU effective January 1, 2019 and has concluded it did not have a material impact on its consolidated financial statements. Recent accounting pronouncements pending adoption In November 2018, the FASB issued ASU No. 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 . This standard resolves the diversity in practice concerning whether certain transactions between collaborative arrangement participants should be accounted for as revenue under Accounting Standards Codification 606, Revenue from Contracts with Customers (“Topic 606”). This standard specifies when a participant is a customer in a collaboration, adds unit of account guidance to align with Topic 606 and provides presentation guidance for collaborative arrangements. This guidance is effective for public entities for fiscal years beginning after December 15, 2019, and for interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the timing of the adoption and its impact on the Company’s consolidated financial statements. The Company has considered all other recently issued accounting pronouncements and does not believe the adoption of such pronouncements will have a material impact on its consolidated financial statements. |
Deferred Revenue (Tables)
Deferred Revenue (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Revenue Recognition [Abstract] | |
Schedule of Deferred Revenue Activity | The following is a summary of the Company’s deferred revenue activity as of March 31, 2019: (in thousands) BED Grants Total Balance as of December 31, 2018 $ 644 $ 568 $ 1,212 Additions to deferred revenue — 1,200 1,200 Recognized as revenue (80 ) (1,575 ) (1,655 ) Balance as of March 31, 2019 $ 564 $ 193 $ 757 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Share-based Compensation, Stock Options, Activity | Stock option activity for options granted under the 2017 Plan during the three months ended March 31, 2019 is presented in the table below: Number of Shares Available Number of Options Outstanding Weighted-average Exercise Price Weighted-average Remaining Contractual Term (years) Aggregate Intrinsic Value Balance at December 31, 2018 157,881 343,550 $ 28.97 8.95 $ 840 Annual additional options authorized 153,814 — — Granted (89,700 ) 89,700 $ 13.76 Exercised — — — Forfeited 1,836 (1,836 ) $ 16.64 Balance at March 31, 2019 223,831 431,414 $ 25.86 8.92 $ — Stock option activity for the Pre-2017 Non-Qualified Stock Options for the three months ended March 31, 2019 is presented in the table below: Number of Shares Weighted- average Exercise Price Weighted- average Remaining Contractual Term (years) Aggregate Intrinsic Value (in Thousands) Outstanding at December 31, 2018 2,885,500 $ 7.30 6.04 $ 20,633,100 Exercised (80,000 ) 7.52 Forfeited (4,865 ) 10.00 Outstanding at March 31, 2019 2,800,635 $ 7.29 5.77 $ 16,358,456 Exercisable at March 31, 2019 2,695,766 $ 7.21 5.76 $ 15,932,550 Warrant activity for the three months ended March 31, 2019 is presented in the table below: Number of Shares Weighted- average Exercise Price Weighted- average Remaining Contractual Term (years) Aggregate Intrinsic Value (in Thousands) Outstanding at December 31, 2018 353,610 $ 9.78 4.36 $ 1,181 Exercised — $ — Outstanding at March 31, 2019 353,610 $ 9.78 4.36 $ 1,181 Exercisable at March 31, 2019 353,610 $ 9.78 4.36 $ 1,181 |
Schedule of Nonvested Share Activity | A summary of the status of the Company’s non-vested Pre-2017 Non-Qualified Stock Options as of March 31, 2019 is presented below: Number of Options Weighted Average Grant Date Fair Value Non-vested at March 31, 2019 109,734 $ 7.76 A summary of the status of the Company’s non-vested options granted under the 2017 Plan as of March 31, 2019 is presented in the following table: Number of Shares Weighted Average Grant Date Fair Value Per Share Balance at March 31, 2019 431,414 $ 25.34 Vested (106,278 ) 30.53 Non-vested at March 31, 2019 325,136 $ 23.64 |
Schedule of Assumptions Used in the Valuation | The assumptions used in the valuation of options granted under the 2017 Plan during the three months ended March 31, 2019 are as follows: For the Three Months Ended March 31, 2019 Market value of stock on measurement date $13.61 to $14.62 Risk-free interest rate 2.41% to 2.57% Dividend yield — Volatility factor 121% Term 6.25 Years |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands, shares in Millions | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Cash and cash equivalents | $ 23,768 | $ 24,614 | |
Antidilutive securities excluded from the computation of earnings per share (in shares) | 3.6 | 3.7 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid expenses and other current assets | $ 522 | $ 267 |
Accounts Receivable (Details)
Accounts Receivable (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 1,956 | $ 4,489 |
Royalty Revenue from Sales of NARCAN | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable | $ 1,946 | $ 4,500 |
Deferred Revenue - Additional I
Deferred Revenue - Additional Information (Details) - USD ($) | Sep. 30, 2018 | Sep. 19, 2018 | Sep. 22, 2015 | Jul. 20, 2015 | Sep. 17, 2014 | Dec. 17, 2013 | Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Apr. 17, 2018 |
Deferred Revenue Arrangement [Line Items] | ||||||||||
Proceeds from funding agreement | $ 250,000 | $ 500,000 | $ 250,000 | |||||||
Interest in asset | 0.50% | 1.00% | 0.50% | |||||||
Number of shares issuable term | 60 days | 60 days | 60 days | |||||||
Number of shares issuable (in shares) | 25,000 | 62,500 | 31,250 | |||||||
Recognized as revenue | $ 1,655,000 | |||||||||
Number of shares per dollar exchange rate (in shares) | 0.1 | |||||||||
Grants receivable | $ 7,400,000 | |||||||||
Grant revenue | 1,575,000 | $ 2,600,000 | ||||||||
BARDA | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Proceeds from funding agreement | $ 611,000 | |||||||||
Period of funding for remaining balance | 2 years | |||||||||
Plan | BARDA | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Proceeds from funding agreement | $ 4,600,000 | |||||||||
Research and Development Arrangement December 17, 2013 | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Recognized as revenue | 14,400 | $ 14,400 | ||||||||
Research and Development Arrangement September 17, 2014 | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Recognized as revenue | 39,200 | 39,200 | ||||||||
Research and Development Arrangement July 20, 2015 | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Recognized as revenue | $ 26,800 | 0 | ||||||||
Research And Development Arrangement September 19, 2018 | ||||||||||
Deferred Revenue Arrangement [Line Items] | ||||||||||
Recognized as revenue | $ 34,329 |
Deferred Revenue - Summary of D
Deferred Revenue - Summary of Deferred Revenue Activity (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Movement in Deferred Revenue [Roll Forward] | |
Balance at beginning of period | $ 1,212 |
Additions to deferred revenue | 1,200 |
Recognized as revenue | (1,655) |
Balance at end of period | 757 |
BED | |
Movement in Deferred Revenue [Roll Forward] | |
Balance at beginning of period | 644 |
Additions to deferred revenue | 0 |
Recognized as revenue | (80) |
Balance at end of period | 564 |
Grants | |
Movement in Deferred Revenue [Roll Forward] | |
Balance at beginning of period | 568 |
Additions to deferred revenue | 1,200 |
Recognized as revenue | (1,575) |
Balance at end of period | $ 193 |
License Fee Payable (Details)
License Fee Payable (Details) - USD ($) | Mar. 18, 2019 | Mar. 01, 2018 | Mar. 31, 2019 | Dec. 31, 2018 | Feb. 28, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Percent of counterparty payable offset by guarantor | 50.00% | ||||
Proceeds from milestone payments | $ 6,100,000 | ||||
License fee payment | $ 5,600,000 | ||||
License fees payable | $ 8,100,000 | ||||
License fees payable, current | 5,400,000 | $ 6,300,000 | $ 5,400,000 | ||
License fees payable, noncurrent | $ 2,700,000 | $ 0 | $ 2,700,000 | ||
License Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Percent of royalties payable under license agreement | 90.00% | ||||
Third Party Licensee | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum reduction in quarterly royalty payable payments in next twelve months | $ 9,000,000 | ||||
Adapt | SWK Purchase Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payment to be received if requirements are met | $ 2,700,000 | ||||
SWK Funding LLC | SWK Purchase Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Percent of royalties payable under license agreement | 10.00% | ||||
EBS | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Maximum reduction in quarterly royalty payable payments in next twelve months | $ 1,800,000 | ||||
Narcan | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Minimum sales requirement for milestone payment | 200,000,000 | ||||
Milestone payment to be received if requirements are met | 15,000,000 | ||||
Narcan | License Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Milestone payment to be received if requirements are met | $ 13,500,000 |
Royalty Payable (Details)
Royalty Payable (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Royalty payable | $ 314 | $ 998 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Proceeds from stock option exercises | $ 601 | $ 0 |
Common Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock newly-issued during the period (in shares) | 80,000 | 48,634 |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Options (Details) - Options to purchase common stock - 2017 Plan - shares | Jan. 01, 2019 | Jan. 31, 2019 | Mar. 31, 2019 | Sep. 08, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum shares authorized (in shares) | 400,000 | |||
Award vesting period | 4 years | |||
Expiration period | 10 years | 10 years | ||
Percentage increase of authorized shares | 4.00% | |||
Annual additional options authorized (in shares) | 153,814 | 153,814 |
Stockholders' Equity - Pre-2017
Stockholders' Equity - Pre-2017 Non-Qualified Stock Options, Additional Information (Details) - Pre-2017 Non-Qualified Stock Options - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options outstanding (in shares) | 2,800,635 | 2,885,500 | |
Options granted (in shares) | 0 | ||
Options to purchase common stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | $ 50 | $ 290 | |
Compensation cost not yet recognized | $ 139 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Pre-2017 Non-Qualified Stock Options Outstanding (Details) - Pre-2017 Non-Qualified Stock Options - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||
Outstanding at beginning of period (in shares) | 2,885,500 | |
Exercised (in shares) | (80,000) | |
Forfeited (in shares) | (4,865) | |
Outstanding at end of period (in shares) | 2,800,635 | 2,885,500 |
Exercisable (in shares) | 2,695,766 | |
Weighted- average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 7.30 | |
Exercised (in dollars per share) | 7.52 | |
Forfeited (in dollars per share) | 10 | |
Outstanding at end of period (in dollars per share) | 7.29 | $ 7.30 |
Exercisable (in dollars per share) | $ 7.21 | |
Weighted- average Remaining Contractual Term (years) | ||
Outstanding | 5 years 9 months 7 days | 6 years 15 days |
Exercisable | 5 years 9 months 4 days | |
Aggregate Intrinsic Value (in Thousands) | ||
Outstanding | $ 16,358,456 | $ 20,633,100 |
Exercisable | $ 15,932,550 |
Stockholders' Equity - Schedu_2
Stockholders' Equity - Schedule of Pre-2017 Non-Qualified Stock Options Nonvested Share Activity (Details) - Pre-2017 Non-Qualified Stock Options | Mar. 31, 2019$ / sharesshares |
Number of Shares | |
Non-vested (in shares) | shares | 109,734 |
Weighted Average Grant Date Fair Value Per Share | |
Non-vested (in dollars per share) | $ / shares | $ 7.76 |
Stockholders' Equity - The 2017
Stockholders' Equity - The 2017 Plan, Additional Information (Details) - 2017 Plan - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted (in shares) | 89,700 | ||
Options granted, exercise price (in dollars per share) | $ 13.76 | ||
Compensation not yet recognized | $ 3.6 | ||
Options to purchase common stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted (in shares) | 89,700 | ||
Expiration period | 10 years | 10 years | |
Vesting percentage | 2.0833% | ||
Fair value of option granted | $ 1.1 | ||
Stock based compensation expense | $ 1 | $ 1.3 | |
Options to purchase common stock | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted, exercise price (in dollars per share) | $ 13.61 | ||
Options to purchase common stock | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted, exercise price (in dollars per share) | $ 14.62 |
Stockholders' Equity - Schedu_3
Stockholders' Equity - Schedule of 2017 Plan Valuation Assumptions (Details) - 2017 Plan - Options to purchase common stock | 3 Months Ended |
Mar. 31, 2019$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Dividend yield | 0.00% |
Volatility factor | 121.00% |
Term | 6 years 3 months |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Market value of stock on measurement date (in dollars per share) | $ 13.61 |
Risk-free interest rate | 2.41% |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Market value of stock on measurement date (in dollars per share) | $ 14.62 |
Risk-free interest rate | 2.57% |
Stockholders' Equity - Schedu_4
Stockholders' Equity - Schedule of 2017 Plan Options Outstanding (Details) - 2017 Plan - USD ($) | Jan. 01, 2019 | Jan. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2018 |
Number of Shares/Number of Options Outstanding | ||||
Outstanding at beginning of period (in shares) | 343,550 | 343,550 | 343,550 | |
Granted (in shares) | 89,700 | |||
Forfeited (in shares) | (1,836) | |||
Outstanding at end of period (in shares) | 431,414 | 343,550 | ||
Weighted- average Exercise Price | ||||
Outstanding (in dollars per share) | $ 25.86 | $ 28.97 | ||
Exercised (in dollars per share) | 13.76 | |||
Forfeited (in dollars per share) | $ 16.64 | |||
Weighted- average Remaining Contractual Term (years) | ||||
Outstanding | 8 years 11 months 1 day | 8 years 11 months 12 days | ||
Aggregate Intrinsic Value (in Thousands) | ||||
Outstanding | $ 0 | $ 840 | ||
Options to purchase common stock | ||||
Number of Shares/Number of Options Outstanding | ||||
Options available (in shares) | 157,881 | 157,881 | 157,881 | |
Annual additional options authorized (in shares) | 153,814 | 153,814 | ||
Granted (in shares) | 89,700 | |||
Options available (in shares) | 223,831 | 157,881 |
Stockholders' Equity - Schedu_5
Stockholders' Equity - Schedule of 2017 Nonvested Share Activity (Details) | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Number of Shares | |
Vested (in shares) | shares | (106,278) |
Weighted Average Grant Date Fair Value Per Share | |
Vested (in dollars per share) | $ / shares | $ 30.53 |
2017 Plan | |
Number of Shares | |
Non-vested, beginning balance (in shares) | shares | 431,414 |
Non-vested, ending balance (in shares) | shares | 325,136 |
Weighted Average Grant Date Fair Value Per Share | |
Non-vested, beginning balance (in dollars per share) | $ / shares | $ 25.34 |
Non-vested, ending balance (in dollars per share) | $ / shares | $ 23.64 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants, Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Class of Warrant or Right [Line Items] | ||
Warrants issued | $ 24,000 | |
Warrants to purchase common stock | ||
Class of Warrant or Right [Line Items] | ||
Warrants issued | $ 0 |
Stockholders' Equity - Schedu_6
Stockholders' Equity - Schedule of Warrants Outstanding (Details) - Warrants to purchase common stock - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Number of Shares | ||
Outstanding at beginning of period (in shares) | 353,610 | |
Exercised (in shares) | 0 | |
Outstanding at end of period (in shares) | 353,610 | 353,610 |
Exercisable (in shares) | 353,610 | |
Weighted- average Exercise Price | ||
Outstanding at beginning of period (in dollars per share) | $ 9.78 | |
Exercised (in dollars per share) | 0 | |
Outstanding at end of period (in dollars per share) | 9.78 | $ 9.78 |
Exercisable (in dollars per share) | $ 9.78 | |
Weighted- average Remaining Contractual Term (years) | ||
Outstanding | 4 years 4 months 10 days | 4 years 4 months 10 days |
Exercisable | 4 years 4 months 10 days | |
Aggregate Intrinsic Value | ||
Outstanding | $ 1,181 | $ 1,181 |
Exercisable | $ 1,181 |
Commitments - Torreya Agreement
Commitments - Torreya Agreement (Details) | Sep. 08, 2017USD ($)trading_daysinstallment | Apr. 25, 2016 | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) | Dec. 18, 2014 |
2014 Consulting Agreement | |||||
Other Commitments [Line Items] | |||||
Additional consultant fee payable, percentage of perpetuity in excess of $3 million | 3.75% | ||||
2016 Consulting Agreement | |||||
Other Commitments [Line Items] | |||||
Percentage of gross funding up to $20 million | 5.00% | ||||
Percentage of gross funding over $20 million | 3.50% | ||||
Advisory Services | |||||
Other Commitments [Line Items] | |||||
Other commitment | $ 300,000 | ||||
Number of installment payments | installment | 3 | ||||
Installment payment period | 16 months | ||||
Stock issued during period for services | $ 300,000 | ||||
Milestone payment | $ 140,600 | ||||
Milestone payment percentage | 3.75% | ||||
Milestone payment period | 15 days | ||||
Milestone payment percentage of total consideration with payment | 3.375% | ||||
Milestone payment percentage of total consideration with payment and additional provision | 3.5625% | ||||
Milestone period | 6 years | ||||
Milestone payment percentage of total consideration without payment | 3.45525% | ||||
Milestone payment percentage of total consideration without payment and with additional provision | 3.60263% | ||||
Threshold trading days | trading_days | 10 | ||||
Sponsor fees | $ 65,686 | $ 0 | |||
Accrued liabilities | $ 66,000 |
Commitments - Exclusive License
Commitments - Exclusive License and Collaboration Agreement (Details) - USD ($) | Nov. 19, 2015 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 |
Other Commitments [Line Items] | ||||
Stock issued during the period | $ 642,000 | |||
Letter of Intent | ||||
Other Commitments [Line Items] | ||||
Stock newly-issued during the period (in shares) | 14,327 | 0 | 66,520 | |
Stock issued during the period | $ 120,300 | $ 894,400 | ||
Additional stock issued during the period, upon milestones (in shares) | 92,634 |
Commitments - Heroin In-License
Commitments - Heroin In-License Vaccine (Details) - License Royalty Commitment - USD ($) | 1 Months Ended | 3 Months Ended |
Oct. 31, 2016 | Mar. 31, 2019 | |
Other Commitments [Line Items] | ||
Percentage of royalty net sales | 3.00% | |
Percentage of royalty sublicensed | 4.00% | |
Payments for minimum annual royalty | $ 10,000 | |
Agreement expense | $ 0 | |
Maximum | ||
Other Commitments [Line Items] | ||
Fixed milestone payments | $ 715,700 |
Commitments - Supply Agreement
Commitments - Supply Agreement (Details) | Jun. 22, 2017USD ($)trading_dayspayment | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
License Agreement | |||
Other Commitments [Line Items] | |||
Upfront payments | payment | 2 | ||
Percent of upfront payments which may be paid by issuing common stock | 50.00% | ||
Percent of average share price | 75.00% | ||
Threshold trading days | trading_days | 20 | ||
Maximum additional product milestone payments | $ 1,800,000 | ||
Maximum additional commercialization milestone payments | $ 5,000,000 | ||
Termination advance notice period | 30 days | ||
Agreement expense | $ 225,000 | $ 0 | |
Supply Agreement | |||
Other Commitments [Line Items] | |||
Other commitment, period | 20 years | ||
Material cure period | 60 days |
Commitments - Research and Deve
Commitments - Research and Development Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Long-term Purchase Commitment [Line Items] | ||
Research and development expense | $ 3,567 | $ 2,421 |
Research and Development Arrangement | ||
Long-term Purchase Commitment [Line Items] | ||
Termination notice period | 45 days | |
Research and development expense | $ 598 | $ 172 |
Commitments - Facility Leases (
Commitments - Facility Leases (Details) $ in Thousands | Apr. 20, 2017GBP (£) | Mar. 31, 2019USD ($) | Mar. 31, 2018USD ($) |
Other Commitments [Line Items] | |||
Rent expense | $ | $ 104 | $ 64 | |
Regus Management Group | |||
Other Commitments [Line Items] | |||
Rent expense | £ 2,473 | ||
Rent expense, monthly | 7,521 | ||
Security deposit | £ 15,042 | ||
Security deposit, period of rent equivalent | 2 months | ||
Advance termination period | 3 months |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Event - shares | May 02, 2019 | May 09, 2019 |
Subsequent Event [Line Items] | ||
Exercise of stock options (in shares) | 70,000 | |
Building | ||
Subsequent Event [Line Items] | ||
Operating lease, term of contract | 26 months |