Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 25, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-38599 | |
Entity Registrant Name | Aquestive Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 30 Technology Drive | |
Entity Address, City or Town | Warren | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 07059 | |
Entity Tax Identification Number | 82-3827296 | |
City Area Code | 908 | |
Local Phone Number | 941-1900 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | AQST | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 40,164,028 | |
Entity Central Index Key | 0001398733 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 31,164 | $ 31,807 |
Trade and other receivables, net | 13,643 | 6,955 |
Inventories, net | 2,863 | 2,461 |
Prepaid expenses and other current assets | 2,540 | 3,402 |
Total current assets | 50,210 | 44,625 |
Property and equipment, net | 5,197 | 6,873 |
Right-of-use assets, net | 2,917 | 3,448 |
Intangible assets, net | 64 | 102 |
Other non-current assets | 6,905 | 7,836 |
Total assets | 65,293 | 62,884 |
Current liabilities: | ||
Accounts payable | 6,215 | 7,089 |
Accrued expenses | 7,624 | 8,569 |
Lease liabilities, current | 860 | 728 |
Deferred revenue, current | 767 | 693 |
Liability related to the sale of future revenue, current | 1,848 | 1,450 |
Loans payable, current | 7,725 | 2,575 |
Total current liabilities | 25,039 | 21,104 |
Loans payable, net | 32,673 | 34,329 |
Liability related to the sale of future revenue, net | 56,615 | 47,524 |
Lease liabilities | 2,185 | 2,846 |
Deferred revenue | 7,316 | 3,633 |
Other non-current liabilities | 1,810 | 1,945 |
Total liabilities | 125,638 | 111,381 |
Contingencies (Note 19) | ||
Stockholders’ deficit: | ||
Common stock, $0.001 par value. Authorized 250,000,000 shares; 40,083,245 and 34,569,254 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 40 | 35 |
Additional paid-in capital | 167,466 | 137,725 |
Accumulated deficit | (227,851) | (186,257) |
Total stockholders’ deficit | (60,345) | (48,497) |
Total liabilities and stockholders’ deficit | $ 65,293 | $ 62,884 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Stockholders’ deficit: | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 40,083,245 | 34,569,254 |
Common stock, shares outstanding (in shares) | 40,083,245 | 34,569,254 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | $ 13,287,000 | $ 8,260,000 | $ 39,754,000 | $ 38,700,000 |
Costs and expenses: | ||||
Manufacture and supply | 4,400,000 | 2,978,000 | 11,623,000 | 10,176,000 |
Research and development | 4,726,000 | 7,260,000 | 12,647,000 | 15,461,000 |
Selling, general and administrative | 12,129,000 | 11,803,000 | 38,494,000 | 40,310,000 |
Total costs and expenses | 21,255,000 | 22,041,000 | 62,764,000 | 65,947,000 |
Loss from operations | (7,968,000) | (13,781,000) | (23,010,000) | (27,247,000) |
Other income/(expenses): | ||||
Interest expense | (2,787,000) | (2,778,000) | (8,305,000) | (8,296,000) |
Interest expense related to the sale of future revenue, net | (3,767,000) | 0 | (10,567,000) | 0 |
Interest and other (expense) income, net | (33,000) | 8,000 | 288,000 | 128,000 |
Net loss before income taxes | (14,555,000) | (16,551,000) | (41,594,000) | (35,415,000) |
Income taxes | 0 | 0 | 0 | 0 |
Net loss | (14,555,000) | (16,551,000) | (41,594,000) | (35,415,000) |
Comprehensive loss | $ (14,555,000) | $ (16,551,000) | $ (41,594,000) | $ (35,415,000) |
Net loss per share - basic (in dollars per share) | $ (0.37) | $ (0.49) | $ (1.12) | $ (1.05) |
Net loss per share - diluted (in dollars per share) | $ (0.37) | $ (0.49) | $ (1.12) | $ (1.05) |
Weighted-average number of common shares outstanding - basic (in shares) | 39,224,863 | 33,619,379 | 37,297,892 | 33,592,846 |
Weighted-average number of common shares outstanding - diluted (in shares) | 39,224,863 | 33,619,379 | 37,297,892 | 33,592,846 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2019 | 33,562,885 | |||
Balance at Dec. 31, 2019 | $ (6,122) | $ 34 | $ 124,318 | $ (130,474) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense | 1,860 | 1,860 | ||
Vested restricted stock units (in shares) | 19,811 | |||
Vested restricted stock units | (37) | (37) | ||
Net loss | (16,530) | (16,530) | ||
Balance (in shares) at Mar. 31, 2020 | 33,582,696 | |||
Balance at Mar. 31, 2020 | (20,829) | $ 34 | 126,141 | (147,004) |
Balance (in shares) at Dec. 31, 2019 | 33,562,885 | |||
Balance at Dec. 31, 2019 | $ (6,122) | $ 34 | 124,318 | (130,474) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Shares issued under employee stock purchase plan (in shares) | 14,961 | |||
Net loss | $ (35,415) | |||
Balance (in shares) at Sep. 30, 2020 | 33,619,796 | |||
Balance at Sep. 30, 2020 | (36,519) | $ 34 | 129,336 | (165,889) |
Balance (in shares) at Mar. 31, 2020 | 33,582,696 | |||
Balance at Mar. 31, 2020 | (20,829) | $ 34 | 126,141 | (147,004) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Shares issued under employee stock purchase plan (in shares) | 14,961 | |||
Shares issued under employee stock purchase plan | 73 | 73 | ||
Share-based compensation expense | 1,754 | 1,754 | ||
Vested restricted stock units (in shares) | 18,944 | |||
Vested restricted stock units | (52) | (52) | ||
Net loss | (2,334) | (2,334) | ||
Balance (in shares) at Jun. 30, 2020 | 33,616,601 | |||
Balance at Jun. 30, 2020 | (21,388) | $ 34 | 127,916 | (149,338) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Share-based compensation expense (in shares) | 3,195 | |||
Share-based compensation expense | 1,420 | 1,420 | ||
Net loss | (16,551) | (16,551) | ||
Balance (in shares) at Sep. 30, 2020 | 33,619,796 | |||
Balance at Sep. 30, 2020 | (36,519) | $ 34 | 129,336 | (165,889) |
Balance (in shares) at Dec. 31, 2020 | 34,569,254 | |||
Balance at Dec. 31, 2020 | (48,497) | $ 35 | 137,725 | (186,257) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Common Stock issued under public equity offering (in shares) | 1,672,104 | |||
Common Stock issued under public equity offering | 10,197 | $ 1 | 10,196 | |
Costs of common stock issued under public equity offering | (306) | (306) | ||
Share-based compensation expense | 1,507 | 1,507 | ||
Other | (27) | (27) | ||
Net loss | (14,672) | (14,672) | ||
Balance (in shares) at Mar. 31, 2021 | 36,241,358 | |||
Balance at Mar. 31, 2021 | (51,798) | $ 36 | 149,095 | (200,929) |
Balance (in shares) at Dec. 31, 2020 | 34,569,254 | |||
Balance at Dec. 31, 2020 | $ (48,497) | $ 35 | 137,725 | (186,257) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Shares issued under employee stock purchase plan (in shares) | 19,270 | |||
Net loss | $ (41,594) | |||
Balance (in shares) at Sep. 30, 2021 | 40,083,245 | |||
Balance at Sep. 30, 2021 | (60,345) | $ 40 | 167,466 | (227,851) |
Balance (in shares) at Mar. 31, 2021 | 36,241,358 | |||
Balance at Mar. 31, 2021 | (51,798) | $ 36 | 149,095 | (200,929) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Common Stock issued under public equity offering (in shares) | 2,304,949 | |||
Common Stock issued under public equity offering | 9,241 | $ 3 | 9,238 | |
Costs of common stock issued under public equity offering | (627) | (627) | ||
Shares issued under employee stock purchase plan (in shares) | 19,270 | |||
Shares issued under employee stock purchase plan | 76 | 76 | ||
Share-based compensation expense | 1,710 | 1,710 | ||
Vested restricted stock units (in shares) | 2,665 | |||
Vested restricted stock units | (4) | (4) | ||
Net loss | (12,367) | (12,367) | ||
Balance (in shares) at Jun. 30, 2021 | 38,568,242 | |||
Balance at Jun. 30, 2021 | (53,769) | $ 39 | 159,488 | (213,296) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Common Stock issued under public equity offering (in shares) | 1,509,818 | |||
Common Stock issued under public equity offering | 6,222 | $ 1 | 6,221 | |
Costs of common stock issued under public equity offering | (135) | (135) | ||
Share-based compensation expense | 1,900 | 1,900 | ||
Vested restricted stock units (in shares) | 5,185 | |||
Vested restricted stock units | (9) | (9) | ||
Other | 1 | 1 | ||
Net loss | (14,555) | (14,555) | ||
Balance (in shares) at Sep. 30, 2021 | 40,083,245 | |||
Balance at Sep. 30, 2021 | $ (60,345) | $ 40 | $ 167,466 | $ (227,851) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities: | ||
Net loss | $ (41,594) | $ (35,415) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation, amortization, and impairment | 2,233 | 2,337 |
Share-based compensation | 5,128 | 5,052 |
Amortization of debt issuance costs and discounts | 3,604 | 1,758 |
Interest expense related to the sale of future revenue, net | 10,457 | 0 |
Other, net | (248) | 34 |
Changes in operating assets and liabilities: | ||
Trade and other receivables, net | (6,726) | 5,082 |
Inventories, net | (402) | (383) |
Prepaid expenses and other assets | 1,793 | (7,101) |
Accounts payable | (874) | (3,189) |
Accrued expenses and other liabilities | (2,046) | 616 |
Deferred revenue | 3,757 | (738) |
Net cash used for operating activities | (24,918) | (31,947) |
Investing activities: | ||
Capital expenditures | (380) | (281) |
Net cash used for investing activities | (380) | (281) |
Financing activities: | ||
Proceeds from issuance of common stock, net | 24,592 | 0 |
Proceeds from shares issued under employee stock purchase plan | 76 | 62 |
Payments for taxes on share-based compensation | (13) | (96) |
Net cash provided by/(used for) financing activities | 24,655 | (34) |
Net decrease in cash and cash equivalents | (643) | (32,262) |
Cash and cash equivalents at beginning of period | 31,807 | 49,326 |
Cash and cash equivalents at end of period | 31,164 | 17,064 |
Supplemental disclosures of cash flow information: | ||
Cash payments for interest | $ 4,828 | $ 6,562 |
Company Overview and Basis of P
Company Overview and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Company Overview and Basis of Presentation | Company Overview and Basis of Presentation (A) Company Overview Aquestive Therapeutics, Inc., (together with its subsidiary, “Aquestive” or “the Company”) is a pharmaceutical company focused on identifying, developing and commercializing differentiated products which leverage its proprietary PharmFilm ® technology to meet patients' unmet medical needs and solve patients' therapeutic problems. The Company has five products approved by the U.S. Food and Drug Administration (FDA), both proprietary and out-licensed, as well as a late-stage proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and an earlier stage pipeline including for treatment of severe allergic reactions, including anaphylaxis. The Company's licensees market their products in the U.S. and in some instances outside the U.S. The Company markets its proprietary product in the U.S. The Company believes that its proprietary and licensed products address the needs of these patient populations and the shortcomings of available treatments create opportunities for the development and commercialization of meaningfully differentiated medicines. Production facilities are located in Portage, Indiana, and corporate headquarters, sales and commercialization operations and primary research laboratory facilities are based in Warren, New Jersey. (B) Equity Transactions Equity Offering of Common Stock On September 11, 2019, the Company established an “At-The-Market” (ATM) facility pursuant to which the Company may offer up to $25,000 of shares of common stock. On November 20, 2020, the Company began utilizing the ATM facility and through December 31, 2020 sold 930,993 shares which provided net proceeds of approximately $6,055 after deducting commissions and other transaction costs of $473. On March 26, 2021, the Company filed a prospectus supplement to offer up to an additional $50,000 of shares of common stock under the ATM facility. For the nine months ended September 30, 2021, the Company sold 5,486,871 shares which provided net proceeds of approximately $24,592 after deducting commissions and other transaction costs of $1,068. This ATM facility has approximately $42,812 available at September 30, 2021. Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements were prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and with Article 10 of Regulation S-X for interim financial reporting. In compliance with those rules, certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes for the fiscal year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2021 (the “2020 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet as of December 31, 2020 is derived from the audited consolidated financial statements as of that date. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the results of interim periods have been included. The accompanying financial statements reflect certain reclassifications from previously issued financial statements to conform to the current presentation. The Company has evaluated subsequent events for disclosure through the date of issuance of the accompanying unaudited condensed financial statements. Any reference in these notes to applicable guidance refers to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies (A) Recent Accounting Pronouncements As an emerging growth company, the Company has elected to take advantage of the extended transition period afforded by the Jumpstart Our Business Startups Act for the implementation of new or revised accounting standards and, as a result, the Company will comply with new or revised accounting standards no later than the relevant dates on which adoption of such standards is required for emerging growth companies. The Company believes that the impact of recently issued accounting standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption . Recent Accounting Pronouncements Not Adopted as of September 30, 2021: In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) , amending existing guidance on the accounting for credit losses on financial instruments within its scope. The guidance provides for use of a forward-looking expected loss model for estimating credit losses, replacing the incurred loss model that is based on past events and current conditions. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for the Company beginning after December 15, 2022. The Company is currently evaluating the impact of the adoption of this guidance on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which amends accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard allows exceptions to the use of the incremental approach for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to-date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. The standard will be effective for the Company beginning January 1, 2022, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2019-12 on its consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This Accounting Standards Update was issued to address the complexity in accounting for certain financial instruments with characteristics of liabilities and equity. Among other provisions, the amendments in this ASU significantly change the guidance on the issuer’s accounting for convertible instruments and the guidance on the derivative scope exception for contracts in an entity’s own equity such that fewer conversion features will require separate recognition, and fewer freestanding instruments, like warrants, will require liability treatment. More specifically, the ASU reduces the number of models that may be used to account for convertible instruments from five to three, amends diluted EPS calculations for convertible instruments, modifies the requirements for a contract that may be settled in an entity’s own shares to be classified in equity and requires expanded disclosures intended to increase transparency. These amendments will be effective for the Company beginning January 1, 2024, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2020-06 on its consolidated financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options . The accounting standard update was issued to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The new accounting guidance is effective for the Company beginning after December 15, 2022. Early adoption is permitted. The Company does not expect the new accounting guidance to have a material impact on the Company's consolidated financial statements. |
Risks and Uncertainties
Risks and Uncertainties | 9 Months Ended |
Sep. 30, 2021 | |
Risks and Uncertainties [Abstract] | |
Risks and Uncertainties | Risks and UncertaintiesThe Company assesses liquidity in terms of its ability to generate cash to fund its operating, investing and financing activities. The Company’s cash requirements for 2021 and beyond include expenses related to continuing development and clinical evaluation of its products, manufacture and supply costs, costs of regulatory filings, patent prosecution expenses and litigation expenses, expenses related to commercialization of its products, as well as costs to comply with the requirements of being a public company operating in a highly regulated industry. As of September 30, 2021, the Company had $31,164 of cash and cash equivalents. The Company has experienced a history of net losses. The Company's accumulated deficits totaled $227,851 as of September 30, 2021. The net losses and accumulated deficits were partially offset by gross margins from sales of commercialized licensed and proprietary products, license fees, milestone and royalty payments from commercial licensees and co-development parties. The Company's funding requirements are met by its cash and cash equivalents, as well as its existing equity and debt offerings, including the Senior Secured Notes due 2025 (the "12.5% Notes"). The Company began utilizing its ATM facility in November 2020. Since inception to September 30, 2021, the Company sold 6,417,804 shares which generated net cash proceeds of approximately $30,647, net of commissions and other transaction costs of $1,541. For the nine months ended September 30, 2021, the Company sold 5,486,871 shares which provided net proceeds of approximately $24,592, net of commissions and other transaction costs of $1,068. This ATM facility has approximately $42,812 available at September 30, 2021. While the Company’s ability to execute its business objectives and achieve profitability over the longer term cannot be assured, the Company’s anticipated revenues from licensed and proprietary products, available cash and cash equivalents, expense management initiatives, and access to equity markets, including through its ATM facility, under the shelf registration statement will enable the Company to fund its operating needs for at least the next twelve months as it continues to execute its business strategy. |
Revenues and Trade Receivables,
Revenues and Trade Receivables, Net | 9 Months Ended |
Sep. 30, 2021 | |
Revenues and Trade Receivables, Net [Abstract] | |
Revenues and Trade Receivables, Net | Revenues and Trade Receivables, Net The Company’s revenues include (i) sales of manufactured products pursuant to contracts with commercialization licensees, (ii) sales of its proprietary clobazam-based Sympazan oral film product, (iii) license and royalty revenues and (iv) co-development and research fees generally in the form of milestone payments. The Company recognizes revenue to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To achieve this core principle, a five-step model is applied that includes (1) identifying the contract with a customer, (2) identifying the performance obligation in the contract, (3) determining the transaction price, (4) allocating the transaction price to the performance obligations, and (5) recognizing when, or as, an entity satisfies a performance obligation. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in the current revenue recognition standard. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. At contract inception, the Company assesses the goods promised in its contracts with customers and identify a performance obligation for each promise to transfer to the customer a distinct good. When identifying performance obligations, the Company considers all goods or services promised in a contract regardless of whether explicitly stated in the contract or implied by customary business practice. The Company's performance obligations consist mainly of transferring of goods and services identified in the contracts, purchase orders or invoices. Manufacture and supply revenue – this revenue is derived from products manufactured exclusively for specific customers according to their strictly-defined specifications, subject only to specified quality control inspections. Accordingly, at the point in time when quality control requirements are satisfied, revenue net of related discounts is recorded. Proprietary product sales, net - this net revenue is recognized when product is shipped and title passes to the customer, typically at time of delivery. At the time of sale, estimates for various revenue allowances are recorded based on historical trends and judgmental estimates. For sales of Sympazan, returns allowances and prompt pay discounts are estimated based on contract terms and historical return rates, if available, and these estimates are recorded as a reduction of receivables. Similarly determined estimates are recorded relating to wholesaler service fees, co-pay support redemptions, Medicare, Medicaid and other rebates, and these estimates are reflected as a component of accrued liabilities. Once all related variable considerations are resolved and uncertainties as to collectable amounts are eliminated, estimates are adjusted to actual allowance amounts. Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis. License and Royalty Revenu e – license revenues are determined based on an assessment of whether the license is distinct from any other performance obligations that may be included in the underlying licensing arrangement. If the customer is able to benefit from the license without provision of any other performance obligations by the Company and the license is thereby viewed as a distinct or functional license, the Company then determines whether the customer has acquired a right to use the license or a right to access the license. For functional licenses that do not require further development or other ongoing activities by the Company, the customer is viewed as acquiring the right to use the license as, and when, transferred and revenues are generally recorded at a point in time, subject to contingencies or constraints. For symbolic licenses providing substantial value only in conjunction with other performance obligations to be provided by the Company, revenues are generally recorded over the term of the license agreement. Such other obligations provided by the Company generally include manufactured products, additional development services or other deliverables that are contracted to be provided during the license term. Payments received in excess of amounts ratably or otherwise earned are deferred and recognized over the term of the license or as contingencies or other performance obligations are met. Royalty revenue is estimated and recognized when sales under supply agreements with commercial licensees are recorded, absent any contractual constraints or collectability uncertainties. Co-development and Research Fees – co-development and research fees are earned through performance of specific tasks, activities or completion of stages of development defined within a contractual development or feasibility study agreement with a customer. The nature of these performance obligations, broadly referred to as milestones or deliverables, are usually dependent on the scope and structure of the project as contracted, as well as the complexity of the product and the specific regulatory approval path necessary for that product. Accordingly, the duration of the Company’s research and development projects may range from several months to approximately three years. Although each contractual arrangement is unique, common milestones included in these arrangements include those for the performance of efficacy and other tests, reports of findings, formulation of initial prototypes, production of stability clinical and/or scale-up batches, and stability testing of those batches. Additional milestones may be established and linked to clinical results of the product submission and/or approval of the product by the FDA and the commercial launch of the product. Revenue recognition arising from milestone payments is dependent upon the facts and circumstances surrounding the milestone payments. Milestone payments based on a non-sales metric such as a development-based milestone (e.g., an NDA filing or obtaining regulatory approval) represent variable consideration and are included in the transaction price subject to any constraints. If the milestone payments relate to future development, the timing of recognition depends upon historical experience and the significance a third party has on the outcome. For milestone payments to be received upon the achievement of a sales threshold, the revenue from the milestone payments is recognized at the later of when the actual sales are incurred or the performance obligation to which the sales relate to has been satisfied. Contract Assets - in certain situations, customer contractual payment terms provide for invoicing in arrears. Accordingly, some, or all performance obligations may be completely satisfied before the customer may be invoiced under such agreements. In these situations, billing occurs after revenue recognition, which results in a contract asset supported by the estimated value of the completed portion of the performance obligation. These contract assets are reflected as a component of other receivables within Trade and other receivables within the Condensed Consolidated Balance Sheet. As of September 30, 2021, and December 31, 2020, such contract assets were $2,637 and $3,081, respectively, consisting primarily of products and services provided under specific contracts to customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. Contract Liabilities - in certain situations, customer contractual payment terms are structured to permit invoicing in advance of delivery of a good or service. In such instances, the customer’s cash payment may be received before satisfaction of some, or any, performance obligations that are specified. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. These contract liabilities are reflected as deferred revenue within the Condensed Consolidated Balance Sheet. As remaining performance obligations are satisfied, an appropriate portion of the deferred revenue balance is credited to earnings. As of September 30, 2021, and December 31, 2020, such contract liabilities were $8,083 and $4,326, respectively. The Company’s revenues were comprised of the following: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Manufacture and supply revenue $ 10,447 $ 5,903 $ 27,623 $ 20,078 License and royalty revenue 328 328 5,000 13,682 Co-development and research fees 523 341 1,417 870 Proprietary product sales, net 1,989 1,688 5,714 4,070 Total revenues $ 13,287 $ 8,260 $ 39,754 $ 38,700 Disaggregation of Revenue The following table provides disaggregated net revenue by geographic area: Three Months Ended Nine Months Ended 2021 2020 2021 2020 United States $ 10,530 $ 6,567 $ 33,487 $ 35,496 Ex-United States 2,757 1,693 6,267 3,204 Total revenues $ 13,287 $ 8,260 $ 39,754 $ 38,700 Ex-United States revenues are derived primarily from Indivior for product manufactured for markets outside of the United States. Trade and other receivables, net consist of the following: September 30, December 31, Trade receivables $ 11,500 $ 4,330 Contract and other receivables 2,637 3,081 Less: allowance for doubtful accounts (40) (40) Less: sales-related allowances (454) (416) Trade and other receivables, net $ 13,643 $ 6,955 The following table presents the changes in the allowance for doubtful accounts: September 30, December 31, Allowance for doubtful accounts at beginning of the period $ 40 $ 124 Additions charged to expense — 198 Write-downs charged against the allowance — (282) Allowance for doubtful accounts at end of the period $ 40 $ 40 Sales Related Allowances and Accruals Revenues from sales of products are recorded net of prompt payment discounts, wholesaler service fees, returns allowances, rebates and co-pay support redemptions. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale. The Company includes these estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved. The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis. The following table provides a summary of activity with respect to sales related allowances and accruals for the nine months ended September 30, 2021: Total Sales Related Allowances Balance at December 31, 2020 $ 2,138 Provision 6,769 Payments / credits (5,920) Balance at September 30, 2021 $ 2,987 Total reductions of gross product sales from sales-related allowances and accruals were $6,769 for the nine months ended September 30, 2021. Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction of trade receivables and accruals for wholesaler service fees, co-pay support redemptions and rebates as current liabilities. The accrued balances relative to these provisions included in Trade and other receivables, net and Accounts payable and accrued expenses were $454 and $2,533, respectively, as of September 30, 2021 and $416 and $1,722 , respectively, as of December 31, 2020. Concentration of Major Customers Customers are considered major customers when net revenue exceeds 10% of total revenue for the period or outstanding receivable balances exceed 10% of total receivables. For the nine months ended September 30, 2021, Indivior Inc. ("Indivor") exceeded the 10% threshold for revenue and represented approximately 73% of total revenue. As of September 30, 2021, Indivior exceeded the 10% threshold for outstanding receivables and represented 68% of outstanding receivables. For the nine months ended September 30, 2020, Indivior and Sunovion Pharmaceuticals, Inc. (“Sunovion”) represented approximately 48% and 39%, respectively of total revenue. As of December 31, 2020, Indivior, AmerisourceBergen Corporation, Sunovion, and Cardinal Health Inc. represented 53%, 14%, 13%, and 10%, respectively of outstanding receivables. |
Material Agreements
Material Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Material Agreements [Abstract] | |
Material Agreements | Material Agreements Commercial Exploitation Agreement with Indivior In August 2008, the Company entered into a Commercial Exploitation Agreement with Reckitt Benckiser Pharmaceuticals, Inc. (with subsequent amendments collectively, the “Indivior License Agreement”). Reckitt Benckiser Pharmaceuticals, Inc. was later succeeded to in interest by Indivior Inc. Pursuant to the Indivior License Agreement, the Company agreed to manufacture and supply Indivior’s requirements for Suboxone, a sublingual film formulation, both inside and outside the United States on an exclusive basis. Under the terms of the Indivior License Agreement, the Company is required to manufacture Suboxone in accordance with current Good Manufacturing Practice standards and according to the specifications and processes set forth in the related quality agreements with Indivior. Additionally, the Company is required to obtain active pharmaceutical ingredients ("API") for the manufacture of Suboxone directly from Indivior. The Indivior License Agreement specifies a minimum annual threshold quantity of Suboxone that the Company is obligated to fill and requires Indivior to provide the Company with a forecast of its requirements at various specified times throughout the year. The Indivior License Agreement provides for payment by Indivior of a purchase price per unit that is subject to adjustment based on the Company’s ability to satisfy minimum product thresholds. In addition to the purchase price for the Suboxone supplied, Indivior is required to make certain single digit percentage royalty payments tied to net sales (as provided for in the Indivior License Agreement) in each of the United States and in the rest of the world subject to annual maximum amounts and limited to the life of the related United States or international patents. In 2012, Indivior exercised its right to buy out its future royalty obligations in the United States under the Indivior License Agreement. Indivior remains obligated to pay royalties for all sales outside the United States. The Indivior License Agreement contains customary contractual termination provisions, including with respect to a filing for bankruptcy or corporate dissolution, an invalidation of the intellectual property surrounding Suboxone, and commission of a material breach of the Indivior License Agreement by either party. Additionally, Indivior may terminate the Indivior License Agreement if the FDA or other applicable regulatory authority declares the Company’s manufacturing site to no longer be suitable for the manufacture of Suboxone or Suboxone is no longer suitable to be manufactured due to health or safety reasons. The initial term of the Indivior License Agreement was seven years from the commencement date. Thereafter, the Indivior License Agreement automatically renews for successive one-year periods, unless either party provides the other with written notice of its intent not to renew at least one year prior to the expiration of the initial or renewal term. Supplemental Agreement with Indivior On September 24, 2017, the Company entered into an agreement with Indivior (the "Indivior Supplemental Agreement"). Pursuant to the Indivior Supplemental Agreement, the Company conveyed to Indivior all existing and future rights in the settlement of various ongoing patent enforcement legal actions and disputes related to the Suboxone product. The Company also conveyed to Indivior the right to sublicense manufacturing and marketing capabilities to enable an Indivior licensed generic buprenorphine product to be produced and sold by parties unrelated to Indivior or Aquestive. Under the Indivior Supplemental Agreement, the Company is entitled to receive certain payments from Indivior commencing on the date of the agreement through January 1, 2023. Once paid, all payments made under the Indivior Supplemental Agreement are non-refundable. Through February 20, 2019, the at-risk launch date of the competing generic products of Dr. Reddy’s Labs and Alvogen, the Company received an aggregate of $40,750 from Indivior under the Indivior Supplemental Agreement. Further payments under the Indivior Supplemental Agreement are suspended until adjudication of related patent infringement litigation is finalized. If such litigation is successful, in addition to the amounts already received as described in the foregoing, the Company may receive up to an additional $34,250, consisting of (i) up to $33,000 in the aggregate from any combination of (a) performance or event-based milestone payments and (b) single digit percentage royalties on net revenue earned by Indivior on sales of Suboxone and (ii) an additional $1,250 that was earned through the issuance of additional process patent rights to the Company. The aggregate payments under this Indivior Supplemental Agreement are capped at $75,000. All payments made by Indivior to the Company pursuant to the Indivior Supplemental Agreement are in addition to, and not in place of, any amounts owed by Indivior to the Company pursuant to the Indivior License Agreement. Indivior’s payment obligations under the Indivior Supplemental Agreement are subject to certain factors affecting the market for Suboxone and may terminate prior to January 1, 2023 in the event certain contingencies relating to that market occur. License Agreement with Sunovion Pharmaceuticals, Inc. On April 1, 2016, the Company entered into a license agreement with Cynapsus Therapeutics Inc. (which was later succeeded to in interest by Sunovion Pharmaceuticals, Inc.), referred to as the Sunovion License Agreement, pursuant to which Sunovion obtained an exclusive, worldwide license (with the right to sub-license) to certain intellectual property, including existing and future patents and patent applications, covering all oral films containing apomorphine for the treatment of off episodes in Parkinson’s disease patients. Sunovion used this intellectual property to develop its apomorphine product KYNMOBI ® , which was approved by the FDA on May 21, 2020 and commercially launched by Sunovion in September 2020. The FDA approval triggered Sunovion's obligation to remit a payment of $4,000 which was received in September 2020 and was included in License and royalty revenues for the year ended December 31, 2020. In consideration of the rights granted to Sunovion under the Sunovion License Agreement, the Company received aggregate payments totaling $22,000 to date. In addition to the upfront payment of $5,000, the Company has also earned an aggregate of $17,000 in connection with specified regulatory and development milestones in the United States and Europe (the “Initial Milestone Payments”). As a result of the Monetization Agreement, the Company is no longer entitled to receive the remaining contingent royalty or milestone payments related to net sales thresholds of KYNMOBI. . During the second quarter of 2020, the Company recorded minimum royalty revenue of $8,000 for minimum royalties which was reflected in License and royalty revenue. Effective March 16, 2020, the Company entered into a first amendment (the "First Amendment") to the Sunovion License Agreement. The First Amendment provides for the following: (i) inclusion of the United Kingdom and any other country currently in the European Union (EU) that later withdraws as a member country of the EU for purpose of determining the satisfaction of the condition triggering the obligation to pay the third milestone due under the Sunovion License Agreement, (ii) extension of the date after which Sunovion has the right to terminate the Sunovion License Agreement for convenience from December 31 2024 to March 31, 2028, (iii) modification of the effective inception date of the first minimum annual royalty due from Sunovion to the Company from January 1, 2020 to April 1, 2020, and (iv) modification of the termination provisions to reflect the Company's waiver of the right to terminate the Sunovion License Agreement in the event that KYNMOBI was not commercialized by January 1, 2020. The Sunovion License Agreement will continue until terminated by Sunovion in accordance with the termination provisions of the First Amendment. The Sunovion License Agreement continues (on a country-by-country basis) until the expiration of all applicable licensed patents. Upon termination of the Sunovion License Agreement, all rights to intellectual property granted to Sunovion to develop and commercialize apomorphine-based products will revert to the Company. On October 23, 2020, the Company entered into a Second Amendment to the Sunovion License Agreement for the purpose of clarifying the rights and obligations of Sunovion and the Company with respect to the prosecution and maintenance of the patents covered under the Sunovion License Agreement and to provide that, on and after March 31, 2028, in respect of any jurisdiction or jurisdictions covered under the Sunovion License Agreement, Sunovion may terminate its rights to the licensed Patents under the Sunovion License Agreement upon 180 days prior written notice. Effective as of July 23, 2021, the Company entered into a Third Amendment to the Sunovion License Agreement for the purpose of clarifying the definition of the term "Field" and certain sublicense rights and obligations of the parties under the Sunovion License Agreement, including the rights of European sublicensees upon termination of the Sunovion License Agreement. Purchase and Sale Agreement with an affiliate of Marathon Asset Management ("Marathon") On November 3, 2020, the Company entered into a Purchase and Sale Agreement (the "Monetization Agreement") with MAM Pangolin Royalty, LLC, an affiliate of Marathon Asset Management ("Marathon"). Under the terms of the Monetization Agreement, the Company sold all of its contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion's apomorphine product, KYNMOBI. KYNMOBI, an apomorphine film therapy for the treatment of off episodes in Parkinson’s disease patients, received approval from the FDA on May 21, 2020. In exchange for the sale of these rights, the Company received an upfront payment of $40,000 and an additional payment of $10,000 through the achievement of the first milestone. The Company has received an aggregate amount of $50,000 through September 30, 2021 under the Monetization Agreement. Under the Monetization Agreement, additional aggregate contingent payments of up to $75,000 may be due to us upon the achievement of worldwide royalty and other commercial targets within a specified timeframe, which could result in total potential proceeds of $125,000. See Note 15 Sale of Future Revenue for further details on the accounting for the Monetization Agreement. Agreement to Terminate CLA with KemPharm In March 2012, the Company entered into an agreement with KemPharm, Inc. (“KemPharm”), to terminate a Collaboration and License Agreement entered into by the Company and KemPharm in April 2011. Under the termination arrangement, the Company has the right to participate in any and all value that KemPharm may derive from the commercialization or any other monetization of KP-415 and KP-484 compounds or their derivatives. Among these monetization transactions are those related to any business combinations involving KemPharm and collaborations, royalty arrangements, or other transactions from which KemPharm may realize value from these compounds. The Company has received payment of $500 under this arrangement during June 2020 in connection with the FDA's acceptance of a New Drug Application ("NDA") filing for KP-415. On March 2, 2021 KemPharm announced FDA approval of KP 415 (AZTARYS TM ) a new once-daily treatment for ADHD. During the second quarter of 2021, the Company received $2,000 of milestone payments in connection with the FDA approval and other regulatory activities. |
Financial Instruments - Fair Va
Financial Instruments - Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments - Fair Value Measurements | Financial Instruments – Fair Value Measurements Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Observable quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable prices that are based on inputs not quoted on active markets but corroborated by market data. • Level 3 — Unobservable inputs that are supported by little or no market activity, such as pricing models, discounted cash flow methodologies and similar techniques. The carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, accounts payable and accrued expenses, and deferred revenue approximate their fair values based on the short-term maturity of these assets and liabilities. The Company granted warrants to certain note holders in connection with its debt repayment and debt refinancing during 2020 and 2019, respectively. Those warrants were valued based on Level 3 inputs and their fair value was based primarily on an independent third-party appraisal prepared as of the grant date consistent with generally-accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation. See Note 14 Warrants for further information on these warrants. The Company's 12.5% Senior Secured Notes contain a repurchase offer or put option which gives holders of the option the right, but not the obligation, to require the Company to redeem on the Notes up to a capped portion of milestone payments resulting from the Monetization Agreement. This put option was valued based on Level 3 inputs and its fair value was based primarily on an independent third-party appraisal consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants Accounting and Valuation Guide. See Note 13 12.5% Senior Secured Notes and Loans Payable for further discussion. |
Inventories, Net
Inventories, Net | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories, Net | Inventories, Net The components of Inventory, net are as follows: September 30, December 31, Raw material $ 938 $ 789 Packaging material 1,195 1,128 Finished goods 730 544 Total inventory, net $ 2,863 $ 2,461 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net Useful September 30, December 31, Machinery 3-15 years $ 18,900 $ 21,333 Furniture and fixtures 3-15 years 769 1,209 Leasehold improvements (a) 21,265 21,333 Computer, network equipment and software 3-7 years 2,469 2,999 Construction in progress 985 877 44,388 47,751 Less: accumulated depreciation and amortization (39,191) (40,878) Total property and equipment, net $ 5,197 $ 6,873 (a) Leasehold improvements are amortized over the shorter of the lease term or their estimated useful lives. Total depreciation, amortization, and impairment related to property and equipment was $724 and $714 for the three-month periods ended September 30, 2021 and 2020, respectively. For the respective nine-month periods, these expenses totaled $2,195 and $2,127. |
Right-of-Use Assets and Lease O
Right-of-Use Assets and Lease Obligations | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Right-of-Use Assets and Lease Obligations | Right-of-Use Assets and Lease Obligations The Company leases all realty used as its production and warehouse facilities, corporate headquarters, commercialization operations center and research and laboratory facilities. None of its three leases include the characteristics specified in ASC 842, Leases, that require classification as financing leases and, accordingly, these leases are accounted for as operating leases. These leases provide remaining terms between 1.5 and 5.0 years, including renewal options expected to be exercised to extend the lease periods. The Company does not recognize a right-to use asset and lease liability for short-term leases, which have terms of 12 months or less on its consolidated balance sheet. For longer-term lease arrangements that are recognized on the Company's consolidated balance sheet, the right-of-use asset and lease liability is initially measured at the commencement date based upon the present value of the lease payments due under the lease. These payments represent the combination of the fixed lease and fixed non-lease components that are due under the arrangement. The costs of associated with the Company's short-term leases, as well as variable costs relating to the Company's lease arrangements, are not material to the consolidated financial results. The implicit interest rates of the Company's lease arrangements are generally not readily determinable and as such, the Company applies an incremental borrowing rate, which is established based upon the information available at the lease commencement date, to determine the present value of lease payments due under an arrangement. Measurement of the operating lease liability reflects an estimated discount rate of 16.9% applied to minimum lease payments, including expected renewals, based on the incremental borrowing rate experienced in the Company’s collateralized debt refinancing. Right-of-use assets recorded upon adoption of ASC 842 totaled $4,048. The Company's lease costs are recorded manufacture and supply, research and development and selling, general and administrative expenses in its consolidated statements of income. For the three and nine-months ended September 30, 2021, total operating lease expenses totaled $431 and $1,294, respectively, including variable lease expenses such as common area maintenance and operating costs of $117 and $352, respectively. For the three and nine-months ended September 30, 2020, total operating lease expenses totaled $377 and $819, respectively, including variable lease expenses such as common area maintenance and operating costs of $60 and $166, respectively. Maturities of the Company’s operating lease liabilities are as follows: Remainder of 2021 $ 322 2022 1,294 2023 944 2024 565 2025 565 2026 424 Total future lease payments 4,114 Less: imputed interest (1,069) Total operating lease liabilities $ 3,045 |
Intangible Assets, Net
Intangible Assets, Net | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangible Assets, Net The following table provides the components of identifiable intangible assets, all of which are finite lived: September 30, December 31, Purchased technology-based intangible $ 2,358 $ 2,358 Purchased patent 509 509 2,867 2,867 Less: accumulated amortization (2,803) (2,765) Intangible assets, net 64 102 |
Other non-current Assets
Other non-current Assets | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Other non-current Assets | Other non-current AssetsThe following table provides the components of other non-current assets: September 30, December 31, Royalty receivable 6,000 7,000 Other 905 836 Total other non-current assets $ 6,905 $ 7,836 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, Accrued compensation $ 4,596 $ 6,330 Accrued distribution expenses 2,533 1,722 Other 495 517 Total accrued expenses $ 7,624 $ 8,569 |
12.5% Senior Secured Notes and
12.5% Senior Secured Notes and Loans Payable | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
12.5% Senior Secured Notes and Loans Payable | 12.5 % Senior Secured Notes and Loans Payable 12.5% Senior Secured Notes On July 15, 2019, the Company completed the private placement of up to $100,000 aggregate principal of its 12.5% Senior Secured Notes due 2025 (the “12.5% Notes”) and issued warrants for 2,000,000 shares of common stock (the “Warrants”), at $0.001 par value per share. Upon closing of the indenture for the 12.5% Notes (the "Base Indenture"), the Company issued $70,000 of the 12.5% Notes (the “Initial Notes”) along with the Warrants and rights of first offer (the “First Offer Rights”) to the noteholders participating in this transaction. Issuance of the Initial Notes and Warrants provided net proceeds of $66,082. On November 3, 2020, the Company entered into the First Supplemental Indenture (the "First Supplemental Indenture" and, together with all other subsequent supplemental indentures and the Base Indenture, collectively, the "Indenture") by and among the Company and U.S. Bank National Association, as Trustee (the "Trustee") and Collateral Agent thereunder to the Base Indenture, by and between the Company and the Trustee. Under the Second Supplemental Indenture, the Company repaid $22,500 of its $70,000 outstanding 12.5% Notes from the upfront proceeds received under the Monetization Agreement. Further, the Company entered into an additional Purchase Agreement with its lenders whereby the Company issued in aggregate $4,000 of additional 12.5% Notes (the "Additional Notes") in lieu of paying a prepayment premium to two lenders on the early repayment of the 12.5% Notes discussed above. The result of these two transactions reduced the net balance of the Company's 12.5% Senior Notes outstanding in the aggregate to $51,500 at December 31, 2020, and such aggregate principal amount remains outstanding as of September 30, 2021. The $4,000 principal issuance will be repaid proportionally over the same maturities as the other 12.5% Notes. The Company also paid to one of its lenders a $2,250 premium as result of the early retirement of debt. The Company accounted for the $22,500 debt repayment as a debt modification of the 12.5% Notes. The fees paid to lenders inclusive of (i) $2,250 early premium prepayment and (ii) $4,000 issuance of Additional Notes in lieu of paying a prepayment penalty were recorded as additional debt discount, amortized over the remaining life of the 12.5% Notes using the effective interest method. Loan origination costs of $220 associated with the Additional Notes were expensed as incurred. Existing deferred discounts and loan origination fees on the 12.5% Notes are amortized as an adjustment of interest expense over the remaining term of modified debt using the effective interest method. The First Supplemental Indenture contains a provision whereby, as the Company receives any cash proceeds from the Monetization Agreement, each noteholder has the right to require the Company to redeem all or any part of such noteholder's outstanding 12.5% Notes at a repurchase price in cash equal to 112.5% of the principal amount, plus accrued and unpaid interest. This repurchase offer is capped at 30% of the cash proceeds received by the Company as the contingent milestones are attained, if any, up through June 30, 2025. A valuation study was performed by an independent third party appraiser and updated as of September 30, 2021. Based on the valuation study, the put option was valued at $258, of which $111 has been recorded in Accrued expenses and $147 has been recorded in Other non-current liabilities. The embedded put option is deemed to be a derivative under ASC 815 Derivatives and Hedging , which requires the recording of the embedded put option at fair value and subject to remeasurement at each reporting period. In addition, as of the closing of this transaction, the Company issued to the holders of the 12.5% Notes warrants to purchase 143,000 shares of its common stock. On August 6, 2021, pursuant to the Third Supplemental Indenture, the holders of the 12.5% Notes extended to June 30, 2022 from December 31, 2021, the Company's ability to access, at the Company's option, $30,000 of 12.5% Notes re-openers under the Indenture. The first $10,000 of 12.5% Notes represents a commitment of such amount by current holders of 12.5% Notes, at the option of the Company, contingent upon FDA approval of the Company's product candidate Libervant (diazepam) Buccal Film for the management of seizure clusters. A second $20,000 12.5% Notes re-opener represents a right, at the Company's option, to market to current holders of the Company's 12.5% Notes, and or other lenders, additional 12.5% Notes up to such amount, contingent upon FDA approval of Libervant for U.S. market access. If and to the extent that the Company accesses these re-openers, it will grant warrants to purchase up to 714,000 shares of common stock, with the strike price calculated based on the 30-day volume weighted average closing price of the Company's common stock at the warrant grant date. The 12.5% Notes provide a stated fixed interest rate of 12.5%, payable quarterly in arrears, with the initial quarterly principal repayment of 12.5% Notes due on September 30, 2021 and the final quarterly payment due at maturity on June 30, 2025. The Company has recorded $7,725 as Loan Payable, Current to reflect this obligation in its Consolidated Balance Sheet. Principal payments are scheduled to increase annually from 10% of the face amount of the debt then outstanding during the first four quarters to 40% of the 12.5% Notes during the final four quarters. A debt maturity table is presented below: Remainder of 2021 $ 2,575 2022 7,725 2023 12,875 2024 18,025 2025 10,300 Total $ 51,500 The Company may elect, at its option, to redeem the 12.5% Notes at any time at premiums that range from 101.56% of outstanding principal if prepayment occurs on or after the fifth anniversary of the issue date of the Initial Notes to 112.50% if payment occurs during the third year after the issuance of the Notes. The Indenture also includes change of control provisions under which the Company may be required to redeem the 12.5% Notes at 101% of the remaining principal plus accrued interest at the election of the noteholders. On September 30, 2021, the Company entered into a waiver agreement (the “Waiver”) with the holders of the 12.5% Notes pursuant to which the principal payment due under the 12.5% Notes on September 30, 2021 was deferred in order to provide sufficient time for the finalization and execution of the Fourth Supplemental Indenture (the “Fourth Supplemental Indenture”) discussed in Note 20 Subsequent Events. The Fourth Supplemental Indenture was executed by the parties on October 7, 2021. The Company capitalizes legal and other third-party costs incurred in connection with obtaining debt as deferred debt issuance costs and applies the unamortized portion as a reduction of the outstanding face amount of the related loan. Similarly, the Company amortizes debt discounts, such as those represented by warrants issued to its lenders, and offsets those as a direct reduction of its outstanding debt. Amortization expense arising from deferred debt issuance costs and debt discounts related to the 12.5% Notes for the three and nine months ended September 30, 2021 were $1,171 and $3,488, respectively, while comparative amortization expenses for the three and nine months ended September 30, 2020 were $590 and $1,758, |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2021 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants Warrants that were issued in conjunction with the Initial Notes (the “Initial Warrants”) and Additional Notes (the “Additional Warrants”) expire on June 30, 2025 and entitle the noteholders to purchase up to 2,143,000 shares of the Company's common stock at $0.001 per share and included specified registration rights. Management estimated the fair value of the Initial Warrants to be $6,800 and the Additional Warrants to be $735, each based on an assessment by an independent third-party appraiser. The fair value of the respective warrants is treated as a debt discount, amortizable over the term of the respective warrants, with the unamortized 12.5% Notes portion applied to reduce the aggregate principal amount of the 12.5% Notes in the Company’s unaudited condensed balance sheet. Additionally, since the warrants issued do not provide warrant redemption or put rights within the control of the holders that could require the Company to make a payment of cash or other assets to satisfy the obligations under the warrants, except in the case of a “cash change in control”, the fair value attributed to the warrants is presented in Additional Paid-in Capital in Company’s unaudited condensed balance sheet. There were no warrants exercised during the nine-months ended September 30, 2021 or 2020, respectively. |
Sale of Future Revenue
Sale of Future Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Sale of Future Revenue | Sale of Future Revenue On November 3, 2020, the Company entered into the Monetization Agreement with Marathon. Under the terms of the Monetization Agreement, the Company sold all of its contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion's apomorphine product, KYNMOBI®. KYNMOBI, an apomorphine film therapy for the treatment of off episodes in Parkinson’s disease patients, received approval from the FDA on May 21, 2020. In exchange for the sale of these rights, the Company received an upfront payment of $40,000 and an additional payment of $10,000 through the achievement of the first milestone. The Company has received an aggregate amount of $50,000 through September 30, 2021 under the Monetization Agreement. Under the Monetization Agreement, additional aggregate contingent payments of up to $75,000 may be due to the Company upon the achievement of worldwide royalty and other commercial targets within a specified timeframe, which could result in total potential proceeds of $125,000. The Company recorded the upfront proceeds of $40,000 and subsequent first milestone of $10,000, reduced by $2,909 of transaction costs, as a liability related to the sale of future revenue that will be amortized using the effective interest method over the life of the Monetization Agreement. As future contingent payments are received, they will increase the balance of the liability related to the sale of future revenue. Although the Company sold all of its rights to receive royalties and milestones, as a result of ongoing obligations related to the generation of these royalties, the Company will account for these royalties as revenue. Its ongoing obligations include the maintenance and defense of the intellectual property and to provide assistance to Marathon in executing a new license agreement for KYNMOBI in the event Sunovion terminates the Sunovion License Agreement in one or more jurisdictions of the licensed territory under the Sunovion License Agreement. The accounting liabilities, as adjusted over time, resulting from this transaction and any non-cash interest expenses associated to those liabilities do not and will not represent any obligation to pay or any potential future use of cash. During the second quarter of 2020, under the Sunovion License Agreement, the Company recognized $8,000 of royalty revenue and corresponding royalty receivable, related to the $1,000 annual minimum guaranteed royalty that is due in each of the next eight years. In connection with the Monetization Agreement, the Company performed an assessment under ASC 860, Transfer and Servicing to determine whether the existing receivable was transferred to Marathon and concluded that the receivable was not transferred. As royalties are remitted to Marathon from Sunovion, the collection of the royalty receivable and balance of the liability related to the sale of future revenue will be effectively repaid over the life of the agreement. In order to determine the amortization of the liability related to the sale of future revenue, the Company is required to estimate the total amount of future royalty and milestone payments to Marathon over the life of the Monetization Agreement and contingent milestone payments from Marathon to the Company. The sum of future royalty payments less the $50,000 in proceeds received and future contingent payments will be recorded as interest expense over the life of the Monetization Agreement. At execution, the estimate of this total interest expense resulted in an effective annual interest rate of approximately 24.9%. This estimate contains significant assumptions that impact both the amount recorded at execution and the interest expense that will be recognized over the life of the Monetization Agreement. The Company will periodically assess the estimated royalty and milestone payments to Marathon from Sunovion and contingent milestone payments from Marathon to the Company. To the extent the amount or timing of such payments is materially different from the original estimates, an adjustment will be recorded prospectively to increase or decrease interest expense. There are a number of factors that could materially affect the amount and timing of royalty and milestone payments to Marathon from Sunovion, and correspondingly, the amount of interest expense recorded by the Company, most of which are not under the Company's control. Such factors include, but are not limited to, changing standards of care, the initiation of competing products, manufacturing or other delays, generic competition, intellectual property matters, adverse events that result in government health authority imposed restrictions on the use of products, significant changes in foreign exchange rates as the royalties remitted to Marathon are made in U.S. dollars (USD) while a portion of the underlying sales of KYNMOBI will be made in currencies other than USD, and other events or circumstances that are not currently foreseen. Changes to any of these factors could result in increases or decreases to both royalty revenue and interest expense related to the sale of future revenue. The following table shows the activity of the liability related to the sale of future for the nine months ended September 30, 2021 : Liability related to the sale of future revenue, net at December 31, 2020 $ 48,974 Royalties related to the sale of future revenue (1,077) Amortization of issuance costs 110 Interest expense related to the sale of future revenue 10,457 Liability related to the sale of future revenue, net (includes current portion of $1,848) $ 58,464 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares. As a result of the Company’s net loss incurred for the three and nine months ended September 30, 2021 and 2020, all potentially dilutive instruments outstanding would have anti-dilutive effects on per-share calculations for the periods. Therefore, basic and diluted net loss per share were the same for all periods presented as reflected below. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Numerator: Net loss $ (14,555) $ (16,551) $ (41,594) $ (35,415) Denominator: Weighted-average number of common shares – basic 39,224,863 33,619,379 37,297,892 33,592,846 Loss per common share – basic and diluted $ (0.37) $ (0.49) $ (1.12) $ (1.05) As of September 30, 2021 and 2020, respectively, the Company’s potentially dilutive instruments included 4,341,967 and 3,167,192 options to purchase common shares and 0 and 14,233 unvested restricted stock units that were excluded from the computation of diluted weighted average shares outstanding because these securities had an antidilutive impact due to the losses reported. Similarly excluded as of September 30, 2021 and 2020, were potentially dilutive warrants for the purchase of 1,571,429 for both periods. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation The Company recognized share-based compensation in its Condensed Consolidated Statements of Operations and Comprehensive Loss during 2021 and 2020 as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Manufacture and supply $ 88 $ 72 $ 241 $ 135 Research and development 230 183 670 365 Selling, general and administrative 1,582 1,510 4,217 3,125 Total share-based compensation expenses $ 1,900 $ 1,765 $ 5,128 $ 3,625 Share-based compensation from: Restricted stock units $ — $ 309 $ 81 $ 773 Stock options 1,900 1,445 5,036 2,841 Employee stock purchase plan — 11 11 11 Total share-based compensation expenses $ 1,900 $ 1,765 $ 5,128 $ 3,625 Share-Based Compensation Equity Awards The following tables provide information about the Company’s restricted stock unit and stock option activity during the nine-month period ended September 30, 2021: Restricted Stock Unit Awards (RSUs): Number of Weighted (in thousands) Unvested as of December 31, 2020 14 $ 11.38 Granted — — Vested (12) $ 11.14 Forfeited (2) $ 13.00 Unvested as of September 30, 2021 — $ — Grant date fair value of shares vested during the period $ 134 Unrecognized compensation costs as of September 30, 2021 $ — Stock Option Awards: Number of Weighted Average (in thousands) Outstanding as of December 31, 2020 3,259 $ 8.14 Granted 1,211 $ 4.73 Exercised, Forfeited, Expired (128) $ 5.11 Outstanding as of September 30, 2021 4,342 $ 7.28 Vested and expected to vest as of September 30, 2021 4,194 $ 7.37 Exercisable as of September 30, 2021 2,018 $ 10.18 The fair values of stock options granted during the nine months ended September 30, 2021 were estimated using the Black-Scholes pricing model based on the following assumptions: Expected dividend yield — % Expected volatility 95% - 100% Expected term (years) 6.1 Risk-free interest rate 1.0 % The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2021 was $3.61. During the nine-month period ended September 30, 2021, stock options were granted with an exercise price ranging from $3.76 to $5.30 and accordingly, given the Company’s share price of $4.36 at September 30, 2021, certain shares granted during this period provided intrinsic value at that date totaling $159. As of September 30, 2021, $4,691 of unrecognized compensation expense related to non-vested stock options is expected to be recognized over a weighted average period of 1.8 years from the date of grant. The Company did not grant restricted stock units during the nine months ended September 30, 2021. There were no unvested restricted stock units and no unrecognized compensation expense related to restricted stock units at September 30, 2021. Employee Stock Purchase Plan The Company's Employee Stock Purchase Plan ("ESPP"), as amended and restated effective as of January 1, 2019, features two six-month offering periods per year, running from January 1 to June 30 and July 1 to December 31. Under the ESPP, employees may elect to purchase the Company’s common stock at the lower of 85% of the fair value of shares on either the first or last day of the offering period. During the nine-month periods ended September 30, 2021 and 2020, respectively, 19,270 and 14,961 shares were purchased and issued through the ESPP at total discounts of $11 and $11. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company has accounted for income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts and respective tax bases of existing assets and liabilities, as well as net operating loss carryforwards and research and development credits. Valuation allowances are provided if it is more likely than not that some portion or all of the deferred tax asset will not be realized. The Company has considered the impact of the CARES Act in relation to the 2021 income tax provision. However, due to the full valuation allowance and no ability or intent to carryback the 2021 net operating loss, no impact is expected. The Company’s tax provision for interim periods is determined using an estimate of its annual effective tax rate, adjusted for discrete items. For the three months ended September 30, 2021 and 2020, the Company recorded no income tax benefit from its pretax losses of $14,555 and $16,551. Similarly for the nine months ended September 30, 2021 and 2020, the Company recorded no income tax benefit from its pretax loss of $41,594 and $35,415, respectively, due to realization uncertainties. The primary factor impacting the effective tax rate for the three and nine months ended September 30, 2021 is the anticipated full year operating loss which will require full valuation allowances against any associated net deferred tax assets. |
Contingencies
Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | Contingencies Litigation and Contingencies From time to time, the Company has been and may again become involved in legal proceedings arising in the course of its business, including product liability, intellectual property, commercial litigation, or environmental or other regulatory matters. Patent-Related Litigation Indivior Inc., Indivior UK Ltd., and Aquestive Therapeutics, Inc. v. Dr. Reddy’s Labs. S.A. and Dr. Reddy’s Labs., Inc. , On February 7, 2018, the Company and Indivior Inc. and Indivior UK Ltd. (collectively, “Indivior”) initiated a lawsuit against Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”) asserting infringement of U.S. Patent No. 9,855,221 (the "'221 patent”). On April 3, 2018, the Company and Indivior initiated a separate lawsuit against Dr. Reddy’s asserting infringement of U.S. Patent No. 9,931,305 (the "’305 patent”). On May 29, 2018, the lawsuits regarding the ’221 and ’305 patents were consolidated which was originally initiated by Indivior against Dr. Reddy’s asserting infringement of U.S. Patent No. 9,687,454 (the "’454 patent”). On February 19, 2019, the court granted the parties’ agreed stipulation to drop the ’221 patent from the case. On January 8, 2020, the court entered a stipulated order of non-infringement of the ’305 patent based on the court’s claim construction ruling. The Company and Indivior preserved the rights to appeal the claim construction ruling. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or losses, if any, in this matter. Indivior Inc., Indivior UK Ltd., and Aquestive Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc. , On February 7, 2018, the Company and Indivior initiated a lawsuit against Teva Pharmaceuticals USA, Inc. (“Teva”) asserting infringement of the ’221 patent. On April 3, 2018, the Company and Indivior initiated a separate lawsuit against Teva asserting infringement of the ’305 patent. On May 29, 2018, the lawsuits regarding the ’221 and ’305 patents were consolidated which was originally initiated by Indivior against Teva asserting infringement of the ’454 patent. The parties agreed that the case would be governed by the final judgment against Dr. Reddy’s (described above). The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or losses, if any, in this matter. Indivior Inc., Indivior UK Ltd., and Aquestive Therapeutics, Inc. v. Alvogen Pine Brook LLC , On September 14, 2017, Indivior initiated a lawsuit against Alvogen Pine Brook LLC (“Alvogen”) asserting infringement of the ’454 patent. On February 7, 2018, the Company and Indivior filed an Amended Complaint, adding us as a plaintiff and asserting infringement of the ’221 patent. On April 3, 2018, the Company and Indivior initiated a separate lawsuit against Alvogen asserting infringement of the ’305 patent. On May 29, 2018, the cases were consolidated. On February 26, 2019, the court granted the parties’ agreed stipulation to drop the ’221 patent from the case. On January 9, 2020, the court entered a stipulated order of non-infringement of the ’305 patent based on the court’s claim construction ruling. The Company and Indivior preserved the rights to appeal the claim construction ruling. Reckitt Benckiser Pharmaceuticals, Inc. and MonoSol Rx, LLC v. BioDelivery Sciences International, Inc. and Quintiles Commercials US, Inc. , On September 22, 2014, the Company and RB initiated a lawsuit against BioDelivery Sciences International, Inc. ("BDSI") and Quintiles Commercial US, Inc. (“Quintiles”) asserting infringement of U.S. Patent No. 8,765,167 ("the ’167 patent”) in the District of New Jersey (Civil Action No. 3:14-cv-5892). On July 22, 2015, the case was transferred to the Eastern District of North Carolina (Civil Action No. 5:15-cv-00350). BDSI filed requests for inter partes review (“IPR”) of the ’167 patent before the Patent Trial and Appeal Board (“PTAB”), and on May 6, 2016, the court stayed the case pending the outcome and final determination of the IPR proceedings. On March 24, 2016, the PTAB issued final written decisions finding the ’167 patent was not unpatentable, and the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) remanded those decisions for further proceedings before the PTAB. Following the PTAB’s February 7, 2019 decision on remand denying institution, BDSI appealed that decision to the Federal Circuit. The Federal Circuit granted the Company's motion to dismiss the appeal, and denied BDSI’s request for rehearing en banc . BDSI filed a petition for writ of certiorari to the Supreme Court of the United States (“Supreme Court”), which the Supreme Court denied on October 5, 2020. On January 4, 2021, the parties submitted a joint status report to the Eastern District of North Carolina stating their agreement that all proceedings and appeals of the IPR on the ’167 patent are complete and that, as a result, the stay of the matter may be lifted. On April 15, 2021, the court lifted the stay. On April 29, 2021, BDSI filed a renewed motion to dismiss the complaint. In response, the Company and RB filed an amended complaint on May 18, 2021, which, among other things, removed Quintiles as a defendant. On June 3, 2021, BDSI filed a notice withdrawing its motion to dismiss the original complaint. On July 7, 2021, the court entered a scheduling order in the case. Under the current scheduling order, the parties have completed their exchange of preliminary infringement and validity contentions, and are proceeding with fact discovery and claim construction. The parties are engaged in briefing claim construction issues. The court may schedule a claim construction hearing after the briefing is complete, and the remainder of the schedule is dependent on the timing of the court’s ruling on claim construction. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or losses, if any, in this matter. Aquestive Therapeutics, Inc. v. BioDelivery Sciences International, Inc. , On November 11, 2019, the Company initiated a lawsuit against BDSI asserting infringement of the ’167 patent in the Eastern District of North Carolina. On April 1, 2020, the court denied BDSI’s motion to stay and its motion to dismiss the complaint. On April 16, 2020, BDSI filed its Answer and Counterclaims to the complaint, including counterclaims for non-infringement, invalidity, and unenforceability of the ’167 patent. On May 7, 2020, the Company filed a Motion to Dismiss BDSI’s unenforceability counterclaim and a Motion to Strike BDSI’s corresponding affirmative defenses. On May 28, 2020, BDSI amended its counterclaims and filed an Answer and Amended Counterclaims, which included additional allegations in support of BDSI’s unenforceability counterclaim. On June 25, 2020, the Company filed a Motion to Dismiss BDSI’s Amended Counterclaim for unenforceability and a Motion to Strike BDSI’s corresponding affirmative defense of unenforceability. BDSI filed its opposition to the Company's Motion to Dismiss and Strike on July 16, 2020, and the Company filed its Reply on July 30, 2020. On March 16, 2021, the court issued an order granting-in-part and denying-in-part Aquestive’s motion to dismiss BDSI’s counterclaims asserting unenforceability of the ’167 patent. Aquestive filed its answer to the remaining portions of BDSI’s counterclaims on April 6, 2021. BDSI also filed on April 6, 2021 a renewed motion to dismiss Aquestive’s complaint. Aquestive filed its opposition to BDSI’s renewed motion to dismiss on April 27, 2021, and BDSI filed its reply on May 11, 2021. On August 10, 2021, the court entered an order denying BDSI’s motion to dismiss. On July 7, 2021, the court entered a scheduling order in the case, including the same operative dates as the court included in the scheduling order for Civil Action No. 5:15-cv-00350 described above, and the parties are proceeding under that same schedule. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or losses, if any, in this matter. Antitrust Litigation State of Wisconsin, et al. v. Indivior Inc., Reckitt Benckiser Healthcare (UK) Ltd., Indivior PLC, and MonoSol Rx, LLC , On September 22, 2016, forty-one states and the District of Columbia, or the States, brought a lawsuit against Indivior and us in the U.S. District Court for the Eastern District of Pennsylvania alleging violations of federal and state antitrust statutes and state unfair trade and consumer protection laws relating to Indivior’s launch of Suboxone Sublingual Film in 2010 and seeking an injunction, civil penalties, and disgorgement. After filing the lawsuit, the case was consolidated for pre-trial purposes with the In re Suboxone (Buprenorphine Hydrochloride and Naloxone) Antitrust Litigation, MDL No. 2445, or the Suboxone MDL, a multidistrict litigation relating to putative class actions on behalf of various private plaintiffs against Indivior relating to its launch of Suboxone Sublingual Film. While the Company was not named as a defendant in the original Suboxone MDL cases, the action brought by the States alleges that the Company participated in an antitrust conspiracy with Indivior in connection with Indivior’s launch of Suboxone Sublingual Film and engaged in related conduct in violation of federal and state antitrust law. The Company moved to dismiss the States’ conspiracy claims, but by order dated October 30, 2017, the court denied the Company's motion to dismiss. The Company filed an answer denying the States’ claims on November 20, 2017. Daubert motions were filed on September 28, 2020, and oppositions were filed on October 19, 2020. On February 19, 2021, the court issued an order denying all Daubert motions. On March 8, 2021, Aquestive filed a motion for summary judgment. Briefing on summary judgment motions was completed on May 28, 2021. There is no date set for a hearing on the motions for summary judgment and no trial date has yet been set. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter. Humana and Centene Action s Humana Inc. v. Indivior Inc, Indivior Solutions Inc., Indivior PLC, Reckitt Benckiser Healthcare (UK) Ltd., and Aquestive Therapeutics, Inc. , Centene Corporation, Wellcare Health Plans, Inc., New York Quality Healthcare Corporation d/b/a Fidelis Care, and Health Net, LLC v. Indivior Inc, Indivior Solutions Inc., Indivior PLC, Reckitt Benckiser Healthcare (UK) Ltd., and Aquestive Therapeutics, Inc. , On September 18, 2020, Humana, Inc. (“Humana”), a health insurance payor, filed a lawsuit against us and Indivior in the Eastern District of Pennsylvania alleging facts similar to those at issue in the Antitrust Case and the Suboxone MDL described above, which lawsuit was assigned to the same judge that is presiding over Antitrust Case and Suboxone MDL. Humana’s Complaint alleges five causes of action against us, including conspiracy to violate the RICO Act, fraud under state law, unfair and deceptive trade practices under state law, insurance fraud, and unjust enrichment. On September 21, 2020, Centene Corporation (“Centene”) and other related insurance payors filed a similar lawsuit against us and Indivior in the Eastern District of Missouri. On September 21, 2020, the Centene action was provisionally transferred to the Eastern District of Pennsylvania by the United States Judicial Panel on Multidistrict Litigation. On January 15, 2021, the Company filed a motion to dismiss the Centene and Humana complaints. The court held an in-person oral argument on the motions to dismiss on June 9, 2021. The court dismissed all complaints against the defendants in these matters on July 22, 2021. On August 20, 2021, Centene and Humana appealed the decision to the U.S. Appeals Court for the Third Circuit (“Third Circuit”). That state court action is stayed pending resolution of the federal appeal in the Third Circuit. California Litigation Neurelis, Inc. v. Aquestive Therapeutics, Inc. , On December 5, 2019, Neurelis filed a lawsuit against us in the Superior Court of California, County of San Diego alleging the following three causes of action: (1) Unfair Competition under California Business and Professional Code § 17200; (2) Defamation; and (3) Malicious Prosecution. The Company filed a Motion to Strike Neurelis’s Complaint under California’s anti-SLAPP (“strategic lawsuit against public participation”) statute on January 31, 2020, which Neurelis opposed. On August 6, 2020, the court issued an order granting in part and denying in part the Company's anti-SLAPP motion. The Company filed a notice of appeal to the California Court of Appeal on September 1, 2020, and Neurelis filed a notice of cross-appeal on October 5, 2020. The Company filed its opening appeal brief on January 27, 2021, and Neurelis filed its combined opening and responsive appeal brief on March 30, 2021. Aquestive filed its combined response and reply brief on June 1, 2021 and Neurelis filed its final reply brief on July 6, 2021. Oral argument on the appeal was heard on October 14, 2021, and a ruling on the appeal is expected within 90 days of the oral argument. The trial court proceedings remain stayed while the appeal is pending. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter. Neurelis IPR Infringement Litigation In the first quarter of 2019, Aquestive requested institution of three Inter Partes Reviews (“IPRs”) against Neurelis’ Orange Book method of treatment patent, US Patent No. 9,763,876 (‘876 Patent) for nasal administration of benzodiazepines (diazepam). The PTAB denied two of the requests and instituted the third request, which challenged all claims of the Neurelis ‘876 Patent. On August 6, 2020, the PTAB issued its final written decision finding all challenged claims of the ’876 Patent to be unpatentable. Neurelis appealed the decision to the U.S. Court of the Federal Circuit. On October 7, 2021, the Federal Circuit Court issued a per curium decision affirming the PTAB's final decision that the '876 Patent was unpatentable. If no appeal of the Federal Circuit Court ruling is filed by November 7, 2021, the Federal Circuit Court will issue a mandate closing the appeal period and an IPR Certificate will subsequently be issued by the United States Patent and Trademark Office. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter. Stockholder Class Action Deanna Lewakowski v. Aquestive Therapeutics, Inc. On March 1, 2021, a securities class action lawsuit was filed in the United States District Court of the District of New Jersey alleging that the Company and certain of its officers engaged in violations of the federal securities laws relating to public statements made by the Company regarding the FDA approval of Libervant. Following the court’s appointment of a lead plaintiff, an amended complaint was filed by the plaintiffs on July 25, 2021. All dispositive motions were filed with the court on or before November 1, 2021. There is no date set for a hearing on the motions to dismiss and no trial date has yet been set. The Company is not able to determine or predict the ultimate outcome of this proceeding or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Continued Utilization of the At-The-Market Facility The Company continued utilization of its At-The-Market facility from October 1 through October 31, 2021 and sold 80,783 shares which generated net proceeds of approximately $313. 12.5% Senior Secured Notes Fourth Supplemental Indenture |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim unaudited condensed consolidated financial statements were prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and with Article 10 of Regulation S-X for interim financial reporting. In compliance with those rules, certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and related notes for the fiscal year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 9, 2021 (the “2020 Annual Report on Form 10-K”). As included herein, the condensed consolidated balance sheet as of December 31, 2020 is derived from the audited consolidated financial statements as of that date. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of the results of interim periods have been included. The accompanying financial statements reflect certain reclassifications from previously issued financial statements to conform to the current presentation. The Company has evaluated subsequent events for disclosure through the date of issuance of the accompanying unaudited condensed financial statements. Any reference in these notes to applicable guidance refers to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Recent Accounting Pronouncements | Recent Accounting Pronouncements As an emerging growth company, the Company has elected to take advantage of the extended transition period afforded by the Jumpstart Our Business Startups Act for the implementation of new or revised accounting standards and, as a result, the Company will comply with new or revised accounting standards no later than the relevant dates on which adoption of such standards is required for emerging growth companies. The Company believes that the impact of recently issued accounting standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption . Recent Accounting Pronouncements Not Adopted as of September 30, 2021: In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326) , amending existing guidance on the accounting for credit losses on financial instruments within its scope. The guidance provides for use of a forward-looking expected loss model for estimating credit losses, replacing the incurred loss model that is based on past events and current conditions. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for the Company beginning after December 15, 2022. The Company is currently evaluating the impact of the adoption of this guidance on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes, which amends accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard allows exceptions to the use of the incremental approach for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to-date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. The standard will be effective for the Company beginning January 1, 2022, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2019-12 on its consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity . This Accounting Standards Update was issued to address the complexity in accounting for certain financial instruments with characteristics of liabilities and equity. Among other provisions, the amendments in this ASU significantly change the guidance on the issuer’s accounting for convertible instruments and the guidance on the derivative scope exception for contracts in an entity’s own equity such that fewer conversion features will require separate recognition, and fewer freestanding instruments, like warrants, will require liability treatment. More specifically, the ASU reduces the number of models that may be used to account for convertible instruments from five to three, amends diluted EPS calculations for convertible instruments, modifies the requirements for a contract that may be settled in an entity’s own shares to be classified in equity and requires expanded disclosures intended to increase transparency. These amendments will be effective for the Company beginning January 1, 2024, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2020-06 on its consolidated financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options . The accounting standard update was issued to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The new accounting guidance is effective for the Company beginning after December 15, 2022. Early adoption is permitted. The Company does not expect the new accounting guidance to have a material impact on the Company's consolidated financial statements. |
Revenue Recognition and Performance Obligations | The Company’s revenues include (i) sales of manufactured products pursuant to contracts with commercialization licensees, (ii) sales of its proprietary clobazam-based Sympazan oral film product, (iii) license and royalty revenues and (iv) co-development and research fees generally in the form of milestone payments. The Company recognizes revenue to reflect the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To achieve this core principle, a five-step model is applied that includes (1) identifying the contract with a customer, (2) identifying the performance obligation in the contract, (3) determining the transaction price, (4) allocating the transaction price to the performance obligations, and (5) recognizing when, or as, an entity satisfies a performance obligation. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in the current revenue recognition standard. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. At contract inception, the Company assesses the goods promised in its contracts with customers and identify a performance obligation for each promise to transfer to the customer a distinct good. When identifying performance obligations, the Company considers all goods or services promised in a contract regardless of whether explicitly stated in the contract or implied by customary business practice. The Company's performance obligations consist mainly of transferring of goods and services identified in the contracts, purchase orders or invoices. Manufacture and supply revenue – this revenue is derived from products manufactured exclusively for specific customers according to their strictly-defined specifications, subject only to specified quality control inspections. Accordingly, at the point in time when quality control requirements are satisfied, revenue net of related discounts is recorded. Proprietary product sales, net - this net revenue is recognized when product is shipped and title passes to the customer, typically at time of delivery. At the time of sale, estimates for various revenue allowances are recorded based on historical trends and judgmental estimates. For sales of Sympazan, returns allowances and prompt pay discounts are estimated based on contract terms and historical return rates, if available, and these estimates are recorded as a reduction of receivables. Similarly determined estimates are recorded relating to wholesaler service fees, co-pay support redemptions, Medicare, Medicaid and other rebates, and these estimates are reflected as a component of accrued liabilities. Once all related variable considerations are resolved and uncertainties as to collectable amounts are eliminated, estimates are adjusted to actual allowance amounts. Provisions for these estimated amounts are reviewed and adjusted on no less than a quarterly basis. License and Royalty Revenu e – license revenues are determined based on an assessment of whether the license is distinct from any other performance obligations that may be included in the underlying licensing arrangement. If the customer is able to benefit from the license without provision of any other performance obligations by the Company and the license is thereby viewed as a distinct or functional license, the Company then determines whether the customer has acquired a right to use the license or a right to access the license. For functional licenses that do not require further development or other ongoing activities by the Company, the customer is viewed as acquiring the right to use the license as, and when, transferred and revenues are generally recorded at a point in time, subject to contingencies or constraints. For symbolic licenses providing substantial value only in conjunction with other performance obligations to be provided by the Company, revenues are generally recorded over the term of the license agreement. Such other obligations provided by the Company generally include manufactured products, additional development services or other deliverables that are contracted to be provided during the license term. Payments received in excess of amounts ratably or otherwise earned are deferred and recognized over the term of the license or as contingencies or other performance obligations are met. Royalty revenue is estimated and recognized when sales under supply agreements with commercial licensees are recorded, absent any contractual constraints or collectability uncertainties. Co-development and Research Fees – co-development and research fees are earned through performance of specific tasks, activities or completion of stages of development defined within a contractual development or feasibility study agreement with a customer. The nature of these performance obligations, broadly referred to as milestones or deliverables, are usually dependent on the scope and structure of the project as contracted, as well as the complexity of the product and the specific regulatory approval path necessary for that product. Accordingly, the duration of the Company’s research and development projects may range from several months to approximately three years. Although each contractual arrangement is unique, common milestones included in these arrangements include those for the performance of efficacy and other tests, reports of findings, formulation of initial prototypes, production of stability clinical and/or scale-up batches, and stability testing of those batches. Additional milestones may be established and linked to clinical results of the product submission and/or approval of the product by the FDA and the commercial launch of the product. Revenue recognition arising from milestone payments is dependent upon the facts and circumstances surrounding the milestone payments. Milestone payments based on a non-sales metric such as a development-based milestone (e.g., an NDA filing or obtaining regulatory approval) represent variable consideration and are included in the transaction price subject to any constraints. If the milestone payments relate to future development, the timing of recognition depends upon historical experience and the significance a third party has on the outcome. For milestone payments to be received upon the achievement of a sales threshold, the revenue from the milestone payments is recognized at the later of when the actual sales are incurred or the performance obligation to which the sales relate to has been satisfied. Contract Assets - in certain situations, customer contractual payment terms provide for invoicing in arrears. Accordingly, some, or all performance obligations may be completely satisfied before the customer may be invoiced under such agreements. In these situations, billing occurs after revenue recognition, which results in a contract asset supported by the estimated value of the completed portion of the performance obligation. These contract assets are reflected as a component of other receivables within Trade and other receivables within the Condensed Consolidated Balance Sheet. As of September 30, 2021, and December 31, 2020, such contract assets were $2,637 and $3,081, respectively, consisting primarily of products and services provided under specific contracts to customers for which earnings processes have been met prior to shipment of goods or full delivery of completed services. Contract Liabilities - in certain situations, customer contractual payment terms are structured to permit invoicing in advance of delivery of a good or service. In such instances, the customer’s cash payment may be received before satisfaction of some, or any, performance obligations that are specified. In these situations, billing occurs in advance of revenue recognition, which results in contract liabilities. These contract liabilities are reflected as deferred revenue within the Condensed Consolidated Balance Sheet. As remaining performance obligations are satisfied, an appropriate portion of the deferred revenue balance is credited to earnings. As of September 30, 2021, and December 31, 2020, such contract liabilities were $8,083 and $4,326, respectively. |
Revenues and Trade Receivable_2
Revenues and Trade Receivables, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenues and Trade Receivables, Net [Abstract] | |
Revenue | The Company’s revenues were comprised of the following: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Manufacture and supply revenue $ 10,447 $ 5,903 $ 27,623 $ 20,078 License and royalty revenue 328 328 5,000 13,682 Co-development and research fees 523 341 1,417 870 Proprietary product sales, net 1,989 1,688 5,714 4,070 Total revenues $ 13,287 $ 8,260 $ 39,754 $ 38,700 |
Disaggregation of Revenue | The following table provides disaggregated net revenue by geographic area: Three Months Ended Nine Months Ended 2021 2020 2021 2020 United States $ 10,530 $ 6,567 $ 33,487 $ 35,496 Ex-United States 2,757 1,693 6,267 3,204 Total revenues $ 13,287 $ 8,260 $ 39,754 $ 38,700 |
Trade and Other Receivables, Net | Trade and other receivables, net consist of the following: September 30, December 31, Trade receivables $ 11,500 $ 4,330 Contract and other receivables 2,637 3,081 Less: allowance for doubtful accounts (40) (40) Less: sales-related allowances (454) (416) Trade and other receivables, net $ 13,643 $ 6,955 |
Changes in Allowance for Bad Debt | The following table presents the changes in the allowance for doubtful accounts: September 30, December 31, Allowance for doubtful accounts at beginning of the period $ 40 $ 124 Additions charged to expense — 198 Write-downs charged against the allowance — (282) Allowance for doubtful accounts at end of the period $ 40 $ 40 |
Sales Related Allowances and Accruals | The following table provides a summary of activity with respect to sales related allowances and accruals for the nine months ended September 30, 2021: Total Sales Related Allowances Balance at December 31, 2020 $ 2,138 Provision 6,769 Payments / credits (5,920) Balance at September 30, 2021 $ 2,987 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory, Net | The components of Inventory, net are as follows: September 30, December 31, Raw material $ 938 $ 789 Packaging material 1,195 1,128 Finished goods 730 544 Total inventory, net $ 2,863 $ 2,461 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Useful September 30, December 31, Machinery 3-15 years $ 18,900 $ 21,333 Furniture and fixtures 3-15 years 769 1,209 Leasehold improvements (a) 21,265 21,333 Computer, network equipment and software 3-7 years 2,469 2,999 Construction in progress 985 877 44,388 47,751 Less: accumulated depreciation and amortization (39,191) (40,878) Total property and equipment, net $ 5,197 $ 6,873 (a) Leasehold improvements are amortized over the shorter of the lease term or their estimated useful lives. |
Right-of-Use Assets and Lease_2
Right-of-Use Assets and Lease Obligations (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Operating Lease Liabilities | Maturities of the Company’s operating lease liabilities are as follows: Remainder of 2021 $ 322 2022 1,294 2023 944 2024 565 2025 565 2026 424 Total future lease payments 4,114 Less: imputed interest (1,069) Total operating lease liabilities $ 3,045 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Components of Identifiable Intangible Assets | The following table provides the components of identifiable intangible assets, all of which are finite lived: September 30, December 31, Purchased technology-based intangible $ 2,358 $ 2,358 Purchased patent 509 509 2,867 2,867 Less: accumulated amortization (2,803) (2,765) Intangible assets, net 64 102 |
Other non-current Assets (Table
Other non-current Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Other Non-current Assets | The following table provides the components of other non-current assets: September 30, December 31, Royalty receivable 6,000 7,000 Other 905 836 Total other non-current assets $ 6,905 $ 7,836 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: September 30, December 31, Accrued compensation $ 4,596 $ 6,330 Accrued distribution expenses 2,533 1,722 Other 495 517 Total accrued expenses $ 7,624 $ 8,569 |
12.5% Senior Secured Notes an_2
12.5% Senior Secured Notes and Loans Payable (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Debt Maturity | A debt maturity table is presented below: Remainder of 2021 $ 2,575 2022 7,725 2023 12,875 2024 18,025 2025 10,300 Total $ 51,500 |
Sale of Future Revenue (Tables)
Sale of Future Revenue (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Royalty Obligation Activity | The following table shows the activity of the liability related to the sale of future for the nine months ended September 30, 2021 : Liability related to the sale of future revenue, net at December 31, 2020 $ 48,974 Royalties related to the sale of future revenue (1,077) Amortization of issuance costs 110 Interest expense related to the sale of future revenue 10,457 Liability related to the sale of future revenue, net (includes current portion of $1,848) $ 58,464 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss Per Share | Therefore, basic and diluted net loss per share were the same for all periods presented as reflected below. Three Months Ended Nine Months Ended 2021 2020 2021 2020 Numerator: Net loss $ (14,555) $ (16,551) $ (41,594) $ (35,415) Denominator: Weighted-average number of common shares – basic 39,224,863 33,619,379 37,297,892 33,592,846 Loss per common share – basic and diluted $ (0.37) $ (0.49) $ (1.12) $ (1.05) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-based Compensation Expense | The Company recognized share-based compensation in its Condensed Consolidated Statements of Operations and Comprehensive Loss during 2021 and 2020 as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Manufacture and supply $ 88 $ 72 $ 241 $ 135 Research and development 230 183 670 365 Selling, general and administrative 1,582 1,510 4,217 3,125 Total share-based compensation expenses $ 1,900 $ 1,765 $ 5,128 $ 3,625 Share-based compensation from: Restricted stock units $ — $ 309 $ 81 $ 773 Stock options 1,900 1,445 5,036 2,841 Employee stock purchase plan — 11 11 11 Total share-based compensation expenses $ 1,900 $ 1,765 $ 5,128 $ 3,625 |
Restricted Stock Units Awards | The following tables provide information about the Company’s restricted stock unit and stock option activity during the nine-month period ended September 30, 2021: Restricted Stock Unit Awards (RSUs): Number of Weighted (in thousands) Unvested as of December 31, 2020 14 $ 11.38 Granted — — Vested (12) $ 11.14 Forfeited (2) $ 13.00 Unvested as of September 30, 2021 — $ — Grant date fair value of shares vested during the period $ 134 Unrecognized compensation costs as of September 30, 2021 $ — |
Stock Option Activity | Stock Option Awards: Number of Weighted Average (in thousands) Outstanding as of December 31, 2020 3,259 $ 8.14 Granted 1,211 $ 4.73 Exercised, Forfeited, Expired (128) $ 5.11 Outstanding as of September 30, 2021 4,342 $ 7.28 Vested and expected to vest as of September 30, 2021 4,194 $ 7.37 Exercisable as of September 30, 2021 2,018 $ 10.18 |
Valuation Assumptions for Determination of Fair Value of Options | The fair values of stock options granted during the nine months ended September 30, 2021 were estimated using the Black-Scholes pricing model based on the following assumptions: Expected dividend yield — % Expected volatility 95% - 100% Expected term (years) 6.1 Risk-free interest rate 1.0 % |
Company Overview and Basis of_2
Company Overview and Basis of Presentation (Details) | Sep. 30, 2021USD ($) | Mar. 26, 2021USD ($) | Sep. 11, 2019USD ($) | Dec. 31, 2020USD ($)shares | Sep. 30, 2021USD ($)productshares | Sep. 30, 2021USD ($)shares |
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of products approved by Food and Drug Administration | product | 5 | |||||
Equity Distribution Agreement | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Sale of stock, aggregate offering price | $ 25,000,000 | |||||
Number of shares issued in transaction (in shares) | shares | 930,993 | |||||
Consideration received on sale of stock | $ 6,055,000 | |||||
Payments for stock issuance costs | $ 473,000 | |||||
At-the-Market Offering, Amendment No. 1 | Maximum | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Sale of stock, aggregate offering price | $ 50,000,000 | |||||
At-the-Market Offering | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Number of shares issued in transaction (in shares) | shares | 5,486,871 | 6,417,804 | ||||
Consideration received on sale of stock | $ 24,592,000 | $ 30,647,000 | ||||
Payments for stock issuance costs | $ 1,068,000 | $ 1,541,000 | ||||
Remaining amount available for offering | $ 42,812,000 |
Risks and Uncertainties (Detail
Risks and Uncertainties (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | Jul. 15, 2019 |
Concentration Risk [Line Items] | |||||
Cash and cash equivalents | $ 31,164 | $ 31,164 | $ 31,164 | $ 31,807 | |
Accumulated deficit | 227,851 | $ 227,851 | $ 227,851 | $ 186,257 | |
At-the-Market Offering | |||||
Concentration Risk [Line Items] | |||||
Number of shares issued in transaction (in shares) | 5,486,871 | 6,417,804 | |||
Consideration received on sale of stock | $ 24,592 | $ 30,647 | |||
Payments for stock issuance costs | $ 1,068 | $ 1,541 | |||
Remaining amount available for offering | $ 42,812 | ||||
Senior Secured Notes Due 2025 | |||||
Concentration Risk [Line Items] | |||||
Interest rate | 12.50% | 12.50% | 12.50% | ||
Senior Secured Notes Due 2025 | Senior Notes | |||||
Concentration Risk [Line Items] | |||||
Interest rate | 12.50% | 12.50% | 12.50% | 12.50% |
Revenues and Trade Receivable_3
Revenues and Trade Receivables, Net, Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Contract with Customer, Contract Asset, Contract Liability, and Receivable [Abstract] | |||||
Contract assets | $ 2,637 | $ 2,637 | $ 3,081 | ||
Contract liabilities | 8,083 | 8,083 | $ 4,326 | ||
Revenue [Abstract] | |||||
Revenues | 13,287 | $ 8,260 | $ 39,754 | $ 38,700 | |
Maximum | |||||
Disaggregation of Revenue [Line Items] | |||||
Research and Development, Project Duration | 3 years | ||||
Manufacture and supply revenue | |||||
Revenue [Abstract] | |||||
Revenues | 10,447 | 5,903 | $ 27,623 | 20,078 | |
License and royalty revenue | |||||
Revenue [Abstract] | |||||
Revenues | 328 | 328 | 5,000 | 13,682 | |
Co-development and research fees | |||||
Revenue [Abstract] | |||||
Revenues | 523 | 341 | 1,417 | 870 | |
Proprietary product sales, net | |||||
Revenue [Abstract] | |||||
Revenues | $ 1,989 | $ 1,688 | $ 5,714 | $ 4,070 |
Revenues and Trade Receivable_4
Revenues and Trade Receivables, Net, Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Geographic Areas, Revenues from External Customers [Abstract] | ||||
Revenues | $ 13,287 | $ 8,260 | $ 39,754 | $ 38,700 |
United States | ||||
Geographic Areas, Revenues from External Customers [Abstract] | ||||
Revenues | 10,530 | 6,567 | 33,487 | 35,496 |
Ex-United States | ||||
Geographic Areas, Revenues from External Customers [Abstract] | ||||
Revenues | $ 2,757 | $ 1,693 | $ 6,267 | $ 3,204 |
Revenues and Trade Receivable_5
Revenues and Trade Receivables, Net, Trade and other receivables, net (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Revenues and Trade Receivables, Net [Abstract] | |||
Trade receivables | $ 11,500 | $ 4,330 | |
Contract and other receivables | 2,637 | 3,081 | |
Less: allowance for doubtful accounts | (40) | (40) | $ (124) |
Less: sales-related allowances | (454) | (416) | |
Trade and other receivables, net | $ 13,643 | $ 6,955 |
Revenues and Trade Receivable_6
Revenues and Trade Receivables, Net, Changes in Allowance for Bad Debt (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Allowance for doubtful accounts at beginning of the period | $ 40 | $ 124 |
Additions charged to expense | 0 | 198 |
Write-downs charged against the allowance | 0 | (282) |
Allowance for doubtful accounts at end of the period | $ 40 | $ 40 |
Revenues and Trade Receivable_7
Revenues and Trade Receivables, Net, Summary of Activity with Sales Related Allowances and Accruals (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2020 | |
Accounts Receivable Allowances and Accruals [Roll Forward] | ||
Balance at December 31, 2020 | $ 2,138 | |
Provision | 6,769 | |
Payments / credits | (5,920) | |
Balance at June 30, 2021 | 2,987 | |
Accrued balances - Trade and other receivables, net | 454 | $ 416 |
Accrued balances - Accounts payable and accrued expense | $ 2,533 | $ 1,722 |
Revenues and Trade Receivable_8
Revenues and Trade Receivables, Net, Concentration of Major Customers (Details) - Customer Concentration Risk | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Revenue | Indivior | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 73.00% | 48.00% | |
Revenue | Sunovion Pharmaceuticals, Inc | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 39.00% | ||
Receivables | Indivior | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 68.00% | 53.00% | |
Receivables | AmerisourceBergen | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 14.00% | ||
Receivables | Sunovion Pharmaceuticals, Inc | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 13.00% | ||
Receivables | Cardinal | |||
Customer Concentration [Abstract] | |||
Concentrations of risk | 10.00% |
Material Agreements (Details)
Material Agreements (Details) - USD ($) $ in Thousands | Nov. 03, 2020 | Apr. 01, 2016 | Nov. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2020 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Dec. 31, 2020 | Feb. 20, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 13,287 | $ 8,260 | $ 39,754 | $ 38,700 | ||||||||||
License and royalty revenue | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | 328 | $ 328 | $ 5,000 | $ 13,682 | ||||||||||
Commercial Exploitation Agreement with Indivior | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
License agreement term | 7 years | |||||||||||||
Automatic renewal period of agreement | 1 year | |||||||||||||
Commercial Exploitation Agreement with Indivior | Minimum | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Notice period of intent not to renew agreement | 1 year | |||||||||||||
Supplemental Agreement with Indivior | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 40,750 | |||||||||||||
Contingent payments receivable in the future | 34,250 | $ 34,250 | $ 34,250 | |||||||||||
Supplemental Agreement with Indivior | Maximum | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Contingent payments receivable in the future | 75,000 | 75,000 | 75,000 | |||||||||||
Supplemental Agreement with Indivior Performance or Event-Based Milestones | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Contingent payments receivable in the future | 33,000 | 33,000 | 33,000 | |||||||||||
Supplemental Agreement with Indivior Additional Process Patent Rights to the Company | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Contingent payments receivable in the future | $ 1,250 | $ 1,250 | 1,250 | |||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 22,000 | |||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | License and royalty revenue | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 8,000 | $ 4,000 | ||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. Upfront | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | 5,000 | |||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc Milestones | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 17,000 | |||||||||||||
Marathon Pangolin Royalty LLC | Monetization Agreement | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Proceeds from sale of future revenue | $ 40,000 | $ 10,000 | $ 50,000 | |||||||||||
Proceeds from debt, contingent on additional milestones | $ 75,000 | |||||||||||||
Marathon Pangolin Royalty LLC | Maximum | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Proceeds from sale of future revenue | $ 125,000 | |||||||||||||
Agreement to Terminate CLA with KemPharm | License and royalty revenue | ||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||||||||
Revenues | $ 500 | $ 2,000 |
Financial Instruments - Fair _2
Financial Instruments - Fair Value Measurements (Details) | Sep. 30, 2021 |
Senior Secured Notes Due 2025 | |
Warrants [Abstract] | |
Interest rate | 12.50% |
Inventories, Net (Details)
Inventories, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 938 | $ 789 |
Packaging material | 1,195 | 1,128 |
Finished goods | 730 | 544 |
Total inventory, net | $ 2,863 | $ 2,461 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 44,388 | $ 44,388 | $ 47,751 | ||
Less: accumulated depreciation and amortization | (39,191) | (39,191) | (40,878) | ||
Total property and equipment, net | 5,197 | 5,197 | 6,873 | ||
Depreciation and amortization | 724 | $ 714 | 2,195 | $ 2,127 | |
Machinery | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 18,900 | $ 18,900 | 21,333 | ||
Machinery | Minimum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 3 years | ||||
Machinery | Maximum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 15 years | ||||
Furniture and fixtures | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 769 | $ 769 | 1,209 | ||
Furniture and fixtures | Minimum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 3 years | ||||
Furniture and fixtures | Maximum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 15 years | ||||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 21,265 | $ 21,265 | 21,333 | ||
Computer, network equipment and software | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 2,469 | $ 2,469 | 2,999 | ||
Computer, network equipment and software | Minimum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 3 years | ||||
Computer, network equipment and software | Maximum | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Lives | 7 years | ||||
Construction in progress | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 985 | $ 985 | $ 877 |
Right-of-Use Assets and Lease_3
Right-of-Use Assets and Lease Obligations - Narrative (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021USD ($)lease | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)lease | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Lessee, Lease, Description [Line Items] | ||||||
Number of leases | lease | 3 | 3 | ||||
Right of use assets | $ 2,917 | $ 2,917 | $ 3,448 | |||
Operating lease expense | 431 | $ 377 | 1,294 | $ 819 | ||
Variable lease expense | $ 117 | $ 60 | $ 352 | $ 166 | ||
Accounting Standards Update 2016-02 | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Estimated discount rate | 16.90% | |||||
Right of use assets | $ 4,048 | |||||
Minimum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Remaining lease term | 1 year 6 months | 1 year 6 months | ||||
Maximum | ||||||
Lessee, Lease, Description [Line Items] | ||||||
Remaining lease term | 5 years | 5 years |
Right of Use Assets and Lease O
Right of Use Assets and Lease Obligations - Maturities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Leases [Abstract] | |
Remainder of 2021 | $ 322 |
2022 | 1,294 |
2023 | 944 |
2024 | 565 |
2025 | 565 |
2026 | 424 |
Total future lease payments | 4,114 |
Less: imputed interest | (1,069) |
Total operating lease liabilities | $ 3,045 |
Intangible Assets, Net (Details
Intangible Assets, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Intangible assets, gross | $ 2,867 | $ 2,867 | $ 2,867 | ||
Less: accumulated amortization | (2,803) | (2,803) | (2,765) | ||
Intangible assets, net | 64 | 64 | 102 | ||
Amortization expense | 13 | $ 13 | 38 | $ 38 | |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | |||||
2021 | 50 | 50 | |||
2022 | 50 | 50 | |||
Purchased technology-based intangible | |||||
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Intangible assets, gross | 2,358 | 2,358 | 2,358 | ||
Purchased patent | |||||
Finite-Lived Intangible Assets, Net [Abstract] | |||||
Intangible assets, gross | $ 509 | $ 509 | $ 509 |
Other non-current Assets (Detai
Other non-current Assets (Details) $ in Thousands | Apr. 01, 2016USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Sep. 30, 2021USD ($)Payment | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) |
Acquired Finite-Lived Intangible Assets [Line Items] | |||||||
Royalty receivable | $ 6,000 | $ 6,000 | $ 7,000 | ||||
Other | 905 | 905 | 836 | ||||
Total other non-current assets | 6,905 | 6,905 | $ 7,836 | ||||
Revenues | 13,287 | $ 8,260 | 39,754 | $ 38,700 | |||
License Agreement with Sunovion Pharmaceuticals, Inc. | |||||||
Acquired Finite-Lived Intangible Assets [Line Items] | |||||||
Revenues | $ 22,000 | ||||||
Minimum annual royalty receivable | $ 1,000 | $ 1,000 | $ 1,000 | ||||
Guaranteed royalty period | 8 years | 8 years | |||||
Number of annual royalty payments receivable | Payment | 7 | ||||||
Royalty | |||||||
Acquired Finite-Lived Intangible Assets [Line Items] | |||||||
Revenues | $ (1,077) | ||||||
Royalty | License Agreement with Sunovion Pharmaceuticals, Inc. | |||||||
Acquired Finite-Lived Intangible Assets [Line Items] | |||||||
Revenues | $ 8,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 4,596 | $ 6,330 |
Accrued distribution expenses | 2,533 | 1,722 |
Other | 495 | 517 |
Total accrued expenses | $ 7,624 | $ 8,569 |
12.5% Senior Secured Notes an_3
12.5% Senior Secured Notes and Loans Payable, 12.5% Senior Secured Notes (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 03, 2020 | Jul. 15, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2025 | Sep. 30, 2022 | Dec. 31, 2020 |
12.5% Senior Secured Notes [Abstract] | |||||||||
Warrants issued (in shares) | 2,000,000 | ||||||||
Warrant exercise price (in dollars per share) | $ 0.001 | ||||||||
Net proceeds from issuance of initial notes, warrants and first offer rights | $ 66,082 | ||||||||
Long-term debt | $ 51,500 | $ 51,500 | |||||||
Premium on early retirement of debt | $ 2,250 | 2,250 | |||||||
Loans payable, current | $ 7,725 | 7,725 | $ 2,575 | ||||||
Amortization expense, deferred debt issuance costs and debt discounts | $ 3,604 | $ 1,758 | |||||||
Forecast | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Principal payments, percentage of face amount | 40.00% | 10.00% | |||||||
Senior Notes | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Proceeds from refinancing of debt | 4,000 | ||||||||
Payments of loan costs | $ 220 | ||||||||
Maximum | Marathon Pangolin Royalty LLC | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Percentage of cash proceeds | 30.00% | ||||||||
Senior Secured Notes Due 2025 | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Interest rate | 12.50% | 12.50% | |||||||
Principal amount | $ 70,000 | ||||||||
Warrants issued (in shares) | 714,000 | ||||||||
Warrants issued to purchase common stock (in shares) | 143,000 | ||||||||
Additional borrowing capacity | $ 30,000 | $ 30,000 | |||||||
Redemption percentage of debt under change of control provisions | 101.00% | ||||||||
Amortization expense, deferred debt issuance costs and debt discounts | 1,171 | $ 590 | $ 3,488 | $ 1,758 | |||||
Unamortized deferred debt issuance cost and deferred debt discounts | 11,110 | 11,110 | 14,596 | ||||||
Senior Secured Notes Due 2025 | Put Option | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Fair value of put option | 258 | 258 | |||||||
Senior Secured Notes Due 2025 | Put Option | Accrued Expenses | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Fair value of put option | 111 | 111 | |||||||
Senior Secured Notes Due 2025 | Put Option | Other Noncurrent Liabilities | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Fair value of put option | $ 147 | $ 147 | |||||||
Senior Secured Notes Due 2025 | Senior Notes | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Interest rate | 12.50% | 12.50% | 12.50% | ||||||
Repayment of debt | $ 22,500 | ||||||||
Long-term debt | $ 70,000 | $ 51,500 | |||||||
Repurchase price percentage | 112.50% | ||||||||
Senior Secured Notes Due 2025 | Minimum | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Elective redemption percentage of debt | 101.56% | ||||||||
Senior Secured Notes Due 2025 | Maximum | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Principal amount | $ 100,000 | ||||||||
Elective redemption percentage of debt | 112.50% | ||||||||
Senior Secured Notes Due 2025 - First Additional Offering | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Warrant exercise price (in dollars per share) | $ 0.001 | $ 0.001 | |||||||
Additional borrowing capacity | $ 10,000 | $ 10,000 | |||||||
Senior Secured Notes Due 2025 - First Additional Offering | Maximum | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Warrants issued (in shares) | 2,143,000 | 2,143,000 | |||||||
Senior Secured Notes Due 2025 - Second Additional Offering | |||||||||
12.5% Senior Secured Notes [Abstract] | |||||||||
Additional borrowing capacity | $ 20,000 | $ 20,000 |
12.5% Senior Secured Notes an_4
12.5% Senior Secured Notes and Loans Payable - Debt Maturities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Debt Disclosure [Abstract] | |
Remainder of 2021 | $ 2,575 |
2022 | 7,725 |
2023 | 12,875 |
2024 | 18,025 |
2025 | 10,300 |
Total | $ 51,500 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Nov. 03, 2020 | Jul. 15, 2019 | |
Class of Warrant or Right [Line Items] | ||||
Warrants issued (in shares) | 2,000,000 | |||
Warrant exercise price (in dollars per share) | $ 0.001 | |||
Exercise of warrants (in shares) | 0 | 0 | ||
Senior Secured Notes Due 2025 - First Additional Offering | ||||
Class of Warrant or Right [Line Items] | ||||
Warrant exercise price (in dollars per share) | $ 0.001 | |||
Fair value of warrants | $ 6,800 | |||
Change in fair value of warrant | $ 735 | |||
Senior Secured Notes Due 2025 - First Additional Offering | Maximum | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants issued (in shares) | 2,143,000 | |||
Senior Secured Notes Due 2025 | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants issued (in shares) | 714,000 | |||
Interest rate | 12.50% |
Sale of Future Revenue (Details
Sale of Future Revenue (Details) - USD ($) $ in Thousands | Nov. 03, 2020 | Apr. 01, 2016 | Nov. 30, 2020 | Dec. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 |
Disaggregation of Revenue [Line Items] | ||||||||||
Payments for loan acquisition costs | $ 2,909 | |||||||||
Revenues | $ 13,287 | $ 8,260 | 39,754 | $ 38,700 | ||||||
Royalty | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Revenues | (1,077) | |||||||||
Marathon Pangolin Royalty LLC | Maximum | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Proceeds from sale of future revenue | $ 125,000 | |||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Revenues | $ 22,000 | |||||||||
Minimum annual royalty receivable | $ 1,000 | $ 1,000 | $ 1,000 | $ 1,000 | ||||||
Guaranteed royalty period | 8 years | 8 years | ||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | Royalty | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Revenues | $ 8,000 | |||||||||
Monetization Agreement | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Effective annual interest rate | 24.90% | |||||||||
Monetization Agreement | Marathon Pangolin Royalty LLC | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Proceeds from sale of future revenue | $ 40,000 | $ 10,000 | $ 50,000 | |||||||
Proceeds from debt, contingent on additional milestones | $ 75,000 |
Sale of Future Revenue - Royalt
Sale of Future Revenue - Royalty Obligation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Sale of Future Revenue [Roll Forward] | ||||
Liability related to the sale of future revenue, net at December 31, 2020 | $ 48,974 | |||
Royalties related to the sale of future revenue | $ 13,287 | $ 8,260 | 39,754 | $ 38,700 |
Amortization of issuance costs | 110 | |||
Interest expense related to the sale of future revenue | 10,457 | $ 0 | ||
Liability related to the sale of future revenue, net (includes current portion of $1,848) | 58,464 | 58,464 | ||
Current portion | $ 1,848 | 1,848 | ||
Royalty | ||||
Sale of Future Revenue [Roll Forward] | ||||
Royalties related to the sale of future revenue | $ (1,077) |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||||||
Net loss | $ (14,555) | $ (12,367) | $ (14,672) | $ (16,551) | $ (2,334) | $ (16,530) | $ (41,594) | $ (35,415) |
Denominator: | ||||||||
Weighted-average number of common shares - basic (in shares) | 39,224,863 | 33,619,379 | 37,297,892 | 33,592,846 | ||||
Loss per common share - basic (in dollars per share) | $ (0.37) | $ (0.49) | $ (1.12) | $ (1.05) | ||||
Loss per common share - diluted (in dollars per share) | $ (0.37) | $ (0.49) | $ (1.12) | $ (1.05) | ||||
Options on Common Shares Outstanding | ||||||||
Denominator: | ||||||||
Total potentially antidilutive derivatives excluded from losses per share (in shares) | 4,341,967 | 3,167,192 | ||||||
Restricted Stock Units Unvested | ||||||||
Denominator: | ||||||||
Total potentially antidilutive derivatives excluded from losses per share (in shares) | 0 | 14,233 | ||||||
Warrants on Common Shares Outstanding | ||||||||
Denominator: | ||||||||
Total potentially antidilutive derivatives excluded from losses per share (in shares) | 1,571,429 | 1,571,429 |
Share-Based Compensation (Detai
Share-Based Compensation (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)offeringPeriod$ / sharesshares | Sep. 30, 2020USD ($)shares | |
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | $ 1,900,000 | $ 1,765,000 | $ 5,128,000 | $ 3,625,000 |
Employee Stock Purchase Plan [Abstract] | ||||
Shares issued under employee stock purchase plan (in shares) | shares | 19,270 | 14,961 | ||
ESPP discount | $ | $ 11,000 | $ 11,000 | ||
Employee Stock Purchase Plan | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | 0 | 11,000 | 11,000 | 11,000 |
Restricted stock units | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | $ 0 | 309,000 | $ 81,000 | 773,000 |
Number of Units | ||||
Unvested, at beginning of period (in shares) | shares | 14,000 | |||
Granted (in shares) | shares | 0 | |||
Vested (in shares) | shares | (12,000) | |||
Forfeited (in shares) | shares | (2,000) | |||
Unvested, at end of period (in shares) | shares | 0 | 0 | ||
Weighted Average Grant Date Fair Value | ||||
Unvested, at beginning of period (in dollars per share) | $ 11.38 | |||
Granted (in dollars per share) | 0 | |||
Vested (in dollars per share) | 11.14 | |||
Forfeited (in dollars per share) | 13 | |||
Unvested, at end of period (in dollars per share) | $ 0 | $ 0 | ||
Grant date fair value of shares vested during the period | $ | $ 134,000 | $ 134,000 | ||
Unrecognized compensation costs of RSU awards | $ | 0 | 0 | ||
Stock options | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | $ 1,900,000 | 1,445,000 | $ 5,036,000 | 2,841,000 |
Number of Options | ||||
Outstanding at beginning of period (in shares) | shares | 3,259,000 | |||
Granted (in shares) | shares | 1,211,000 | |||
Exercised, Forfeited, Expired (in shares) | shares | (128,000) | |||
Outstanding at end of period (in shares) | shares | 4,342,000 | 4,342,000 | ||
Vested or expected to vest at end of period (in shares) | shares | 4,194,000 | 4,194,000 | ||
Exercisable at end of period (in shares) | shares | 2,018,000 | 2,018,000 | ||
Weighted Average Exercise Price | ||||
Outstanding at beginning of period (in dollars per share) | $ 8.14 | |||
Granted (in dollars per share) | 4.73 | |||
Exercised, Forfeited, Expired (in dollars per share) | 5.11 | |||
Outstanding at end of period (In dollars per share) | $ 7.28 | 7.28 | ||
Vested or expected to vest at end of period (in dollars per share) | 7.37 | 7.37 | ||
Exercisable at end of period (in dollars per share) | 10.18 | $ 10.18 | ||
Fair Value Assumptions [Abstract] | ||||
Expected dividend yield | 0.00% | |||
Expected term (years) | 6 years 1 month 6 days | |||
Risk-free interest rate | 1.00% | |||
Weighted average grant date fair value (in dollars per share) | $ 3.61 | |||
Additional Disclosures [Abstract] | ||||
Share price (in dollars per share) | $ 4.36 | $ 4.36 | ||
Intrinsic value of options granted | $ | $ 159,000 | |||
Compensation Cost Not yet Recognized [Abstract] | ||||
Unrecognized compensation expense related to non-vested stock options | $ | $ 4,691,000 | $ 4,691,000 | ||
Unrecognized compensation cost, recognition period | 1 year 9 months 18 days | |||
Stock options | Minimum | ||||
Fair Value Assumptions [Abstract] | ||||
Expected volatility | 95.00% | |||
Additional Disclosures [Abstract] | ||||
Share price (in dollars per share) | $ 3.76 | $ 3.76 | ||
Stock options | Maximum | ||||
Fair Value Assumptions [Abstract] | ||||
Expected volatility | 100.00% | |||
Additional Disclosures [Abstract] | ||||
Share price (in dollars per share) | $ 5.30 | $ 5.30 | ||
Employee Stock | ||||
Employee Stock Purchase Plan [Abstract] | ||||
Number of offering periods | offeringPeriod | 2 | |||
Offering period | 6 months | |||
Purchase price of common stock as percentage of fair market value | 85.00% | |||
Manufacture and supply | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | $ 88,000 | 72,000 | $ 241,000 | 135,000 |
Research and development | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | 230,000 | 183,000 | 670,000 | 365,000 |
Selling, general and administrative | ||||
Share-based Compensation expenses [Abstract] | ||||
Share-based compensation expenses | $ | $ 1,582,000 | $ 1,510,000 | $ 4,217,000 | $ 3,125,000 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | ||||||||
Income taxes | $ 0 | $ 0 | $ 0 | $ 0 | ||||
Net loss | $ 14,555,000 | $ 12,367,000 | $ 14,672,000 | $ 16,551,000 | $ 2,334,000 | $ 16,530,000 | $ 41,594,000 | $ 35,415,000 |
Contingencies (Details)
Contingencies (Details) | 9 Months Ended | |
Sep. 30, 2021cause | Sep. 22, 2016state | |
Loss Contingencies [Line Items] | ||
Number of states in the antitrust litigation | state | 41 | |
Humana and Centene Actions | ||
Loss Contingencies [Line Items] | ||
Number of causes alleged | cause | 5 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Thousands | Oct. 07, 2021USD ($)payment | Oct. 31, 2021USD ($)shares | Dec. 31, 2020USD ($)shares | Sep. 30, 2021 | Jul. 15, 2019 |
Senior Secured Notes Due 2025 | |||||
Subsequent Event [Line Items] | |||||
Interest rate | 12.50% | ||||
Senior Secured Notes Due 2025 | Senior Notes | |||||
Subsequent Event [Line Items] | |||||
Interest rate | 12.50% | 12.50% | |||
Subsequent Event | Senior Secured Notes Due 2025 | Senior Notes | |||||
Subsequent Event [Line Items] | |||||
Prepayment premiums paid | $ 2,700 | ||||
Number of quarterly payments | payment | 4 | ||||
Amount of principal payments deferred | $ 10,300 | ||||
Equity Distribution Agreement | |||||
Subsequent Event [Line Items] | |||||
Number of shares issued in transaction (in shares) | shares | 930,993 | ||||
Consideration received on sale of stock | $ 6,055 | ||||
Equity Distribution Agreement | Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Number of shares issued in transaction (in shares) | shares | 80,783 | ||||
Consideration received on sale of stock | $ 313 |