Notes to Unaudited Condensed Consolidated Financial Statements
Note 1. 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. 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.
Note 2. 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, 2020 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 June 30, 2021 and December 31, 2020, results of operations for the three and six months ended June 30, 2021 and 2020, and cash flows for the three and six months ended June 30, 2021 and 2020. The interim results are not necessarily indicative of the results for any future interim period or for the entire year.
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, 2020 included in the Company's Annual Report on Form 10-K filed with the SEC on March 4, 2021.
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 $33.4 million and $48.3 million at June 30, 2021 and December 31, 2020, respectively. The Company maintains cash balances at financial institutions insured up to $250 thousand by the Federal Deposit Insurance Corporation. Balances in the UK are insured up to £85 thousand by the Financial Services
Compensation Scheme (UK Equivalent). Although the Company’s cash balances exceeded these insured amounts at various times during the six months ended June 30, 2021, the Company has not experienced any losses on its deposits of cash and cash equivalents for the periods presented.
Earnings (Loss) Per Share
Basic and diluted earnings (loss) per share is computed by dividing loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period.
Basic earnings (loss) per share is computed by dividing the net income (loss) available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the respective period presented in the Company’s accompanying condensed consolidated financial statements. Fully-diluted earnings (loss) per share is computed similarly to basic income (loss) per share except that the denominator is increased to include the number of Common Stock equivalents (primarily outstanding options and warrants).
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(in thousands, except per share data)
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For the Three Months Ended June 30,
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For the Six Months Ended June 30,
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Numerator:
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2021
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2020
|
2021
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2020
|
Net Income (loss)
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$
|
1,684
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$
|
(216)
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$
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(1,161)
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$
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(1,901)
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Denominator:
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Denominator for basic income (loss)
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per share - weighted average shares
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4,332,601
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4,258,105
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4,308,027
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4,241,423
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Effect of dilutive securities:
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Equity incentive plans
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|
1,095,230
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—
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—
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—
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Denominator for diluted income (loss) per share
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5,427,831
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4,258,105
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4,308,027
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4,241,423
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Income (loss) per share - Basic
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0.39
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(0.05)
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(0.27)
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(0.45)
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Income (loss) per share - Diluted
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0.31
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(0.05)
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(0.27)
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(0.45)
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The Company excluded the following securities from the calculation of basic and diluted net loss per share as the effect would have been antidilutive.
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For the Three Months Ended June 30,
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For the Six Months Ended June 30,
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2021
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2020
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2021
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2020
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Options to purchase common stock
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476,580
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3,115,650
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3,126,446
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3,115,650
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Warrants to purchase common stock
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—
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278,800
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278,800
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278,800
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Unvested restricted stock
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102,741
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39,600
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102,741
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63,100
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Convertible Debt
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509,165
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—
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509,165
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—
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Total
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1,088,486
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3,434,050
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4,017,152
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3,457,550
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Foreign Currency Translation
The functional currency of the Company's wholly-owned subsidiary, Opiant UK is the British Pound, its local currency. Consequently, its assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency exchange rates for the period. Adjustments resulting from the translation of the financial statements of Opiant Pharmaceuticals UK Limited (“Opiant UK”), into U.S. dollars, the reporting currency, are excluded from the determination of net loss and are recorded in accumulated other comprehensive loss, a separate component of equity. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of income.
Recently Adopted Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, ("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.
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.
Note 3. Marketable Securities
The Company invests in debt securities and has the intent and ability to hold until maturity. Therefore, the Company's Securities are classified as held-to-maturity. The Company's debt securities are all U.S. Treasury securities. The investments in debt securities are carried at either amortized cost or fair value. As of June 30, 2021, the Company had a total of $15.1 million of total marketable securities, all invested in U.S. Treasury's of which is classified as a short term asset as the maturity is greater than three months, but less than one year. Any debt securities with original maturities of three months or less are classified as cash equivalents.
Note 4. Accounts Receivable
As of June 30, 2021 and December 31, 2020, the Company had accounts receivable of $9.7 million and $8.9 million respectively, which primarily relates to royalty revenue from sales of NARCAN®.
Note 5. Prepaid Expenses and Other Current Assets
As of June 30, 2021, the Company had prepaid expenses and other current assets of approximately $2.3 million. The Company's prepaid expenses are primarily for advance research and development payments, insurance, software licenses, prepaid rent, and other amounts that relate to future periods of service. Other current assets primarily consist of such items as other receivables and security deposits.
Note 6. Leases
On January 1, 2019, the Company adopted a new accounting standard, Topic 842, that amends the guidance for the accounting and reporting of leases. Leases with terms of 12 months or less are expensed on a straight-line basis over the term and are not recorded in the Company's Condensed Consolidated Balance Sheets.
The Company has entered into operating leases with terms greater than 12 months during the six months ended June 30, 2021. In accordance with the guidance of Topic 842, the leases which are classified as operating leases are included in the Company's Condensed Consolidated Balance Sheets. The Company's operating leases do not include options to renew, do not contain residual value guarantees, do not have variable lease components, or impose significant restrictions or covenants.
Right of use assets, "ROU assets", represent the right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments over the respective lease term, with the ROU asset adjusted for deferred rent liability. The ROU asset is recognized as lease expense on a straight line basis over the lease term. As the implicit rate on the leases is not determinable, the Company uses judgement to estimate the incremental borrowing rate which is used as the discount rate to determine the present value of lease payments. The weighted average discount rate used was 8.8% and the weighted average remaining lease term is 4.53 years.
The ROU asset and corresponding operating lease liability recognized at lease inception during the three months ended June 30, 2021 was $1.09 million.
The following table summarizes information related to the Company's operating leases and are included in the Company's Balance Sheet as of June 30, 2021.
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Balance Sheet descriptions
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June 30, 2021
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Assets:
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(in thousands)
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Right of use assets - operating leases
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$
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1,119
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Liabilities:
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Operating leases - current
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339
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Operating leases - long term
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781
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Total lease liabilities:
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$
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1,120
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The following table summarizes the components of operating lease cost for the three and six months ended June 30, 2021:
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Lease costs, (in thousands)
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Three months ended June 30, 2021
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Six months ended June 30, 2021
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Operating expenses lease costs
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$
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152
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$
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300
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As of June 30, 2021, future minimum operating leases payments related to the Company’s operating lease liabilities were as follows:
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(in thousands)
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June 30, 2021
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2021 (six months remaining)
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$
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234
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2022
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257
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2023
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236
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2024
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247
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2025
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276
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2026
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115
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Total lease payments
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1,365
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Less imputed interest
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(245)
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Present value of operating lease liabilities
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$
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1,120
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Note 7. Other Non-Current Assets
As of June 30, 2021 and December 31, 2020, the Company had non-current prepaid expenses of zero and approximately $1.1 million, respectively. The Company's non-current prepaid expenses are for advance research and development payments which will be issued for projects that have estimated completion dates of more than one year. As of June 30, 2021 all prepaid research and development expenses is classified as current as the services are expected to be provided prior to June 30, 2022.
Note 8. Revenue
The Company's primary source of revenue is from royalty and milestone payments received from NARCAN® net sales by EBS. During the three and six months ended June 30, 2021 the Company recorded revenue of $9.3 million and $13.6 million, respectively, related to its agreement with EBS.
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 $8.1 million and cover activities related to a potential New Drug Application submission for OPTN003 with the Food and Drug Administration. BARDA has awarded approximately $6.5 million of the contract through September 30, 2022, with the balance expected to be funded, subject to satisfactory project progress, availability of funds and certain other conditions. During the three and six months ended June 30, 2021 the Company recognized revenue of $1.0 million and $2.4 million, respectively related to this contract.
Deferred revenue
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. The Company has been awarded the entire $7.4 million through the period ending March 31, 2022. 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 and six months ended June 30, 2021, the Company recognized revenue of $1.0 million and $1.6 million, respectively related to this grant.
The following is a summary of the Company’s deferred revenue activity as of June 30, 2021:
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(in thousands)
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NIDA Grant
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Total
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Balance as of December 31, 2020
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$
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355
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$
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355
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|
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Additions to deferred revenue
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1,187
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|
|
1,187
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Recognized as revenue
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|
(1,542)
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|
|
(1,542)
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Balance as of June 30, 2021
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$
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—
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$
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—
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Note 9. 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 NARCAN®. In exchange for this funding, the Company agreed to provide investors with interest in the net profit generated from NARCAN® sales by EBS into perpetuity. As of June 30, 2021 and December 31, 2020, the Company recorded a royalty payable of $2.1 million and $1.9 million, respectively.
Note 10. Long Term Debt
As of June 30, 2021 and December 31, 2020 the Company had long term debt of $18.8 million and $18.7 million, respectively. There have been no changes to the maturity or other conditions of the debt for the six months ended June 30, 2021.
Note 11. Stockholders' Equity
Common Stock
During the six months ended June 30, 2021, the Company issued 71,592 shares of Common Stock as a result of stock option exercises, and received net cash proceeds of approximately $0.6 million.
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 Company's Board of Directors (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, but can also be one year, from the vesting date. The contractual term of an option is no longer than 10 years. The 2017 Plan also allows the Company to issue restricted stock units.
As provided in the 2017 Plan, on January 1, 2021 the number of shares available for issuance was increased by 4% of the outstanding stock as of December 31, 2020, which represents an increase of 170,234 shares. As of June 30, 2021, the Company had 116,513 shares available for future issuance under the 2017 Plan.
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, 2020, the Company had outstanding Pre-2017 Non-Qualified Stock Options to purchase, in the aggregate, 2,465,500 shares of the Company's Common Stock. During the six months ended June 30, 2021, the Company did not grant any Pre-2017 Non-Qualified Stock Options.
Stock option activity for the Pre-2017 Non-Qualified Stock Options for the six months ended June 30, 2021 is presented in the table below:
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Number of Shares
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Weighted- average Exercise Price
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Weighted- average Remaining Contractual Term (years)
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Aggregate Intrinsic Value
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Outstanding at December 31, 2020
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2,465,500
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$
|
6.99
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|
|
4.09
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$
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2,773,190
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Exercised
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(71,592)
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|
|
8.61
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Forfeited
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(23,332)
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|
|
10.00
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|
|
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|
|
Outstanding at June 30, 2021
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2,370,576
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|
|
$
|
6.91
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|
|
3.72
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|
$
|
15,303,270
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A summary of the status of the Company’s non-vested Pre-2017 Non-Qualified Stock Options as of June 30, 2021 is presented below:
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Number of Options
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Weighted Average Grant Date Fair Value
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|
|
|
|
Vested at June 30, 2021
|
2,358,910
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|
|
$
|
6.90
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|
Non-vested at Non-vested at June 30, 2021
|
11,666
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|
|
$
|
10.00
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|
During the six months ended June 30, 2021 and 2020, the Company recognized zero and $1 thousand, respectively, of non-cash expense related to Pre-2017 Non-Qualified Stock Options granted in prior periods. As of June 30, 2021, there was no further compensation expense to be recognized for the Pre-2017 Non-Qualified Stock Options.
The 2017 Plan
During the six months ended June 30, 2021, the Company granted options to a number of employees and non-employees to purchase 147,110 shares of the Company’s Common Stock at exercise prices from $8.20 to $13.30 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. Option grants to existing employees vest as follows: 1/48th of the option shares vest each month through the fourth anniversary of the grant date. Option grants to new employees vest as follows: 25% of the option shares vest on the one year anniversary of the grant date, and then 1/48th of the option shares vest on such date each month thereafter through the fourth anniversary of the grant date. The Company valued these options using the Black-Scholes option pricing model and estimated the aggregate fair value of the option grants to be $1.3 million.
The assumptions used in the valuation of options granted under the 2017 Plan during the six months ended June 30, 2021 were as follows:
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For the Six Months Ended June 30, 2021
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Market value of stock on measurement date
|
$8.2 to $13.30
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Risk-free interest rate
|
0.5% to 1.11%
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Dividend yield
|
—
|
|
Volatility factor
|
75.92% to 88.79%
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Term
|
5.50 to 6.25 years
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Stock option activity for options granted under the 2017 Plan during the six months ended June 30, 2021 is presented in the table below:
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|
Number of Options Outstanding
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|
Weighted-average Exercise Price
|
|
Weighted-average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value
|
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|
|
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|
Balance at December 31, 2020
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|
|
611,760
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|
|
$
|
21.39
|
|
|
7.85
|
|
$
|
—
|
|
|
|
|
|
|
|
|
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|
Granted
|
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|
147,110
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|
|
$
|
11.79
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Exercised
|
|
|
—
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|
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—
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|
|
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|
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Forfeited
|
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|
(3,000)
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|
|
$
|
8.20
|
|
|
|
|
|
Balance at June 30, 2021
|
|
|
755,870
|
|
|
$
|
19.58
|
|
|
7.78
|
|
$
|
484,626
|
|
A summary of the status of the Company’s vested and non-vested options granted under the 2017 Plan as of June 30, 2021 is presented in the following table:
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|
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|
|
|
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|
|
Number of Shares
|
|
Weighted Average Grant Date Fair Value Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at June 30, 2021
|
439,712
|
|
|
22.69
|
|
Non-vested at June 30, 2021
|
316,158
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|
|
$
|
11.44
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|
During the six months ended June 30, 2021 and 2020, the Company recognized approximately $1.0 million and $1.3 million, respectively of non-cash expense related to options granted under the 2017 Plan. As of June 30, 2021, there was approximately $1.5 million of unrecognized compensation costs related to non-vested stock options that were granted under the 2017 Plan.
Restricted Stock Activity
The following summarizes the restricted stock activity under the Company's 2017 Plan during the six months ended June 30, 2021:
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|
|
|
|
|
|
|
|
Number of Shares
|
Weighted Average Fair Value Per Share
|
Restricted stock outstanding and unvested at December 31, 2020
|
49,600
|
|
$
|
12.00
|
|
Restricted stock granted
|
73,043
|
|
$
|
12.34
|
|
Restricted stock vested
|
(19,902)
|
|
$
|
10.79
|
|
Restricted stock outstanding and unvested at June 30, 2021
|
102,741
|
|
$
|
10.92
|
|
Twenty-five percent (25%) of the restricted stock units will vest on the one year anniversary of the vesting commencement date, and twenty-five percent (25%) will vest annually thereafter on the same day as the vesting commencement date. During the six months ended June 30, 2021, the Company recognized approximately $368 thousand of non-cash expense related to restricted stock units. As of June 30, 2021, there was $0.8 million of total unrecognized compensation cost related to restricted stock units.
Warrants
During the six months ended June 30, 2021, the Company did not issue any warrants.
Warrant activity for the six months ended June 30, 2021 is presented in the table below:
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|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares
|
|
Weighted- average Exercise Price
|
|
Weighted- average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value
|
Outstanding at December 31, 2020
|
278,800
|
|
|
$
|
9.72
|
|
|
3.51
|
|
$
|
1,164,000
|
|
Exercised
|
—
|
|
|
$
|
—
|
|
|
|
|
|
Forfeited
|
—
|
|
|
$
|
—
|
|
|
|
|
|
Outstanding at June 30, 2021
|
278,800
|
|
|
$
|
9.72
|
|
|
3.01
|
|
$
|
1,017,156
|
|
Exercisable at June 30, 2021
|
278,800
|
|
|
$
|
9.72
|
|
|
3.01
|
|
$
|
1,017,156
|
|
Note 12. Commitments and Contingencies
Commitments
The Company has entered into various agreements related to its business activities. The following is a summary of the Company’s commitments:
Aptar Agreement
On October 26, 2020, the Company entered into a Master Services Agreement (“MSA”) with AptarGroup, Inc. (“Aptar”) to provide non-exclusive technology access and co-development services for the development and submission of an opioid antagonist for the treatment of opioid overdose using Aptar’s nasal Unidose device (the “UDS Device”). In addition to the cost of the UDS Devices, the Company expects to spend up to approximately $5.2 million over the course of the development program.
Summit Agreement
On July 22, 2020, the Company the Company entered into a Project Scope Agreement ("PSA") pursuant to a Master Services Agreement ("MSA") with Summit Biosciences, Inc. ("Summit"), to support the development and manufacture of a nasal spray device for opioid overdose, with the ability to expand to additional programs in the future. In accordance with the PSA, Summit will develop and produce certain pre-filled nasal spray products using a device previously evaluated as part of other FDA-approved nasal spray products. The Company will pay Summit estimated costs and fees up to approximately $7.5 million of which a deposit of approximately $1.1 million was paid as of June 30, 2021, which is included in current assets in the condensed consolidated balance sheet.
Torreya Agreement
The Company entered into a consulting agreement with Torreya Partners LLP ("Torreya"), a financial advisory firm, under which Torreya agreed to provide certain financial advisory services. The Company is required to pay fees equivalent to 3.375% of all amounts received by the Company from net sales of NARCAN® into perpetuity.
During the six months ended June 30, 2021 and 2020, the Company recorded $461 thousand and $353 thousand, respectively of expense related to Torreya.
Exclusive License and Collaboration Agreement
On November 19, 2015, the Company entered into an exclusive license agreement and collaboration agreement (“LOI”) with a pharmaceutical company with certain desirable proprietary information. Pursuant to the agreement, the Company is obligated to issue shares of unregistered Common Stock upon the occurrence of various milestones. No shares were required to be issued under this agreement during the six months ended June 30, 2021 and 2020.
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.
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).
Under the License Agreement, the Company will be required to pay Aegis $250 thousand upon the successful NDA filing.
For the six months ended June 30, 2021, and 2020 the Company did not have any expenses associated with the License Agreement.
Contingencies
The Company may be subject to various legal proceedings and claims that arise in the ordinary course of business. The Company records a liability when it is probable that a loss will be incurred and the amount is reasonably estimable. There is significant judgment required in both the probability determination and as to whether an exposure can be reasonably estimated. If any legal matter, were resolved against the Company in a reporting period for amounts in excess of management’s expectations, the Company’s would reflect any potential claim in the consolidated financial statements for that reporting period.
The Company and Emergent BioSolutions Inc., through its Adapt Pharma subsidiaries (collectively, “Plaintiffs”), filed complaints, in 2016 against Teva Pharmaceuticals Industries Ltd. (“Teva”), and in 2018 against Perrigo UK FINCO Limited Partnership (“Perrigo”), relating to Teva’s and Perrigo’s respective abbreviated new drug applications (each, an “ANDA”) seeking to market generic versions of NARCAN® (naloxone hydrochloride) Nasal Spray 4mg/spray.
On February 12, 2020, Plaintiffs and Perrigo entered into a settlement agreement to resolve the ongoing litigation. Under the terms of the settlement, Perrigo has received a non-exclusive license under the Company's patents licensed to Adapt to make, have made and market its generic naloxone hydrochloride nasal spray under its own ANDA. Perrigo’s license will be effective as of January 5, 2033 or earlier under certain circumstances including circumstances related to the outcome of the current litigation against Teva or litigation against future ANDA filers. The Perrigo settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of an order dismissing the litigation by the U.S. District Court for the District of New Jersey.
Closing arguments in the Teva trial were held on February 26, 2020. Plaintiffs also filed a complaint related to Teva’s ANDA seeking to market a generic version of NARCAN® (naloxone hydrochloride) Nasal Spray 2mg/spray.
On June 5, 2020, 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 Teva. The Company's commercial partner Emergent BioSolutions, Inc., has appealed the decision to the Court of Appeals for the Federal Circuit. On August 2, 2021, a panel consisting of three appeals-court judges held a hearing on EBS’s appeal of the New Jersey District Court’s decision. A decision by the Court of Appeals is expected in the second half of 2021 or early 2022.
Note 13. Subsequent Events
On July 8, 2021, the Board of Directors of the Company adopted the 2021 Inducement Equity Incentive Plan (the “Inducement Plan”) and, subject to the adjustment provisions of the Inducement Plan, reserved 100,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan.
In July 2021 the Company issued options to purchase 56,500 shares of common stock, and restricted stock units for 18,200 shares of common stock under the Inducement Plan, and issued options to purchase 6,025 shares of common stock under the 2017 Plan.
In July 2021, 50,076 shares of common stock subject to outstanding options were exercised, and the Company received net cash proceeds of approximately $300,000.