Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 01, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38599 | ||
Entity Registrant Name | Aquestive Therapeutics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 82-3827296 | ||
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 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 Public Float | $ 27.6 | ||
Entity Common Stock, Shares Outstanding | 55,870,556 | ||
Entity Central Index Key | 0001398733 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Firm ID | 185 |
Auditor Name | KPMG LLP |
Auditor Location | New York, New York |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 27,273 | $ 28,024 |
Trade and other receivables, net | 4,704 | 12,120 |
Inventories, net | 5,780 | 4,038 |
Prepaid expenses and other current assets | 2,131 | 3,077 |
Total current assets | 39,888 | 47,259 |
Property and equipment, net | 4,085 | 5,055 |
Right-of-use assets, net | 5,211 | 2,725 |
Intangible assets, net | 1,435 | 51 |
Other non-current assets | 6,451 | 6,903 |
Total assets | 57,070 | 61,993 |
Current liabilities: | ||
Accounts payable | 9,946 | 8,314 |
Accrued expenses | 7,967 | 8,736 |
Lease liabilities, current | 255 | 899 |
Deferred revenue | 1,513 | 765 |
Liability related to the sale of future revenue, current | 1,147 | 1,225 |
Loans payable, current | 18,700 | 2,025 |
Total current liabilities | 39,528 | 21,964 |
Loans payable, net | 33,448 | 51,551 |
Liability related to the sale of future revenue, net | 64,112 | 59,059 |
Lease liabilities | 5,085 | 1,946 |
Deferred revenue, net of current portion | 31,417 | 7,122 |
Other non-current liabilities | 2,034 | 2,485 |
Total liabilities | 175,624 | 144,127 |
Contingencies (Note 20) | ||
Stockholders’ deficit: | ||
Common stock, $0.001 par value. Authorized 250,000,000 shares; 54,827,734 and 41,228,736 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 55 | 41 |
Additional paid-in capital | 192,598 | 174,621 |
Accumulated deficit | (311,207) | (256,796) |
Total stockholders’ deficit | (118,554) | (82,134) |
Total liabilities and stockholders’ deficit | $ 57,070 | $ 61,993 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Common stock, par or stated value per share (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) | 54,827,734 | 41,228,736 |
Common stock, shares outstanding (in shares) | 54,827,734 | 41,228,736 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | ||
Revenues | $ 47,680 | $ 50,832 |
Costs and expenses: | ||
Manufacture and supply | 19,386 | 14,989 |
Research and development | 17,481 | 17,047 |
Selling, general and administrative | 52,879 | 53,475 |
Total costs and expenses | 89,746 | 85,511 |
Loss from operations | (42,066) | (34,679) |
Other income (expenses): | ||
Interest expense | (6,552) | (10,049) |
Interest expense related to the sale of future revenue | (5,891) | (12,412) |
Interest income and other income, net | 99 | 423 |
Loss on the extinguishment of debt | 0 | (13,822) |
Net loss before income taxes | (54,410) | (70,539) |
Income taxes | 0 | 0 |
Net loss | (54,410) | (70,539) |
Comprehensive loss | $ (54,410) | $ (70,539) |
Net loss per share - basic (in usd per share) | $ (1.12) | $ (1.85) |
Net loss per share - diluted (in usd per share) | $ (1.12) | $ (1.85) |
Weighted-average number of common shares outstanding - basic (in shares) | 48,734,377 | 38,077,660 |
Weighted-average number of common shares outstanding - diluted (in shares) | 48,734,377 | 38,077,660 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Deficit - USD ($) $ in Thousands | Total | Private equity | Common Stock | Common Stock Private equity | Additional Paid-in Capital | Additional Paid-in Capital Private equity | Accumulated Deficit |
Balance (in shares) at Dec. 31, 2020 | 34,569,254 | ||||||
Beginning balance at Dec. 31, 2020 | $ (48,497) | $ 35 | $ 137,725 | $ (186,257) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Common stock issued under equity offering (in shares) | 6,550,486 | ||||||
Common stock issued under equity offering | 31,069 | $ 6 | 31,063 | ||||
Cost of common stock issued under equity offering | (1,291) | (1,291) | |||||
Shares issued under employee stock purchase plan (in shares) | 40,146 | ||||||
Shares issued under employee stock purchase plan | 158 | 158 | |||||
Exercise of stock options (in shares) | 61,000 | ||||||
Exercise of stock options | 185 | 185 | |||||
Vested restricted stock units (in shares) | 7,850 | ||||||
Vested restricted stock units | (14) | (14) | |||||
Share-based compensation expense | 6,795 | 6,795 | |||||
Net loss | (70,539) | (70,539) | |||||
Balance (in shares) at Dec. 31, 2021 | 41,228,736 | ||||||
Ending balance at Dec. 31, 2021 | (82,134) | $ 41 | 174,621 | (256,796) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Fair value of warrants issued | 5,874 | 5,874 | |||||
Common stock issued under equity offering (in shares) | 2,860,538 | 6,686,491 | |||||
Common stock issued under equity offering | 4,196 | $ 4,629 | $ 3 | $ 7 | 4,193 | $ 4,622 | |
Cost of common stock issued under equity offering | (289) | $ (824) | (289) | $ (824) | |||
Common stock issued upon warrant exercises (in shares) | 4,000,000 | ||||||
Common Stock issued upon warrant exercises | 0 | $ 4 | (4) | ||||
Shares issued under employee stock purchase plan (in shares) | 45,304 | ||||||
Shares issued under employee stock purchase plan | 34 | 34 | |||||
Vested restricted stock units (in shares) | 6,665 | ||||||
Vested restricted stock units | (3) | (3) | |||||
Share-based compensation expense | 4,371 | 4,371 | |||||
Other | 2 | 3 | (1) | ||||
Net loss | (54,410) | (54,410) | |||||
Balance (in shares) at Dec. 31, 2022 | 54,827,734 | ||||||
Ending balance at Dec. 31, 2022 | $ (118,554) | $ 55 | $ 192,598 | $ (311,207) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (54,410) | $ (70,539) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation, amortization, and impairment | 2,387 | 2,964 |
Share-based compensation | 4,381 | 6,819 |
Amortization of debt issuance costs and discounts | 215 | 3,731 |
Interest expense related to the sale of future revenue | 5,683 | 12,253 |
Loss on the extinguishment of debt | 0 | 13,822 |
Other, net | (52) | (299) |
Changes in operating assets and liabilities: | ||
Trade receivables and other receivables, net | 7,352 | (5,353) |
Inventories | (1,743) | (1,577) |
Prepaid expenses and other assets | 1,399 | 1,258 |
Accounts payable | 1,633 | 1,225 |
Accrued expenses and other liabilities | (2,352) | (844) |
Deferred revenue | 25,043 | 3,561 |
Loans Payable | 675 | 0 |
Net cash used for operating activities | (9,789) | (32,979) |
Cash flows from investing activities: | ||
Capital expenditures | (1,024) | (913) |
Additions to intangible assets | (1,500) | 0 |
Net cash used for investing activities | (2,524) | (913) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under public equity offering, warrants and warrant exercises, net | 9,751 | 29,780 |
Proceeds from common stock issued under private equity offering, net | 3,805 | 0 |
Proceeds from shares issued under employee stock purchase plan | 34 | 158 |
Proceeds from exercise of stock options | 0 | 185 |
Premium paid to retire debt | (2,025) | 0 |
Payments for taxes on share-based compensation | (3) | (14) |
Net cash provided by financing activities | 11,562 | 30,109 |
Net decrease in cash and cash equivalents | (751) | (3,783) |
Cash and cash equivalents: | ||
Beginning of period | 28,024 | 31,807 |
End of period | 27,273 | 28,024 |
Supplemental disclosures of cash flow information: | ||
Cash payments for interest | $ 6,436 | $ 6,438 |
Company Overview and Equity Tra
Company Overview and Equity Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Company Overview and Equity Transactions | Company Overview and Equity Transactions Company Overview Aquestive Therapeutics, Inc. (together with its subsidiary, “Aquestive” or “the Company”) is a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives. The Company is developing pharmaceutical products that deliver complex molecules through alternative administrations to invasive and inconvenient standard of care therapies. The Company has five licensed commercialized products which are marketed by its licensees in the U.S. and around the world. The Company is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. The Company is advancing a product pipeline for the treatment of severe allergic reactions, including anaphylaxis. The Company has also developed a product pipeline focused on treating diseases of the central nervous system, or CNS. The Company's production facilities are located in Portage, Indiana, and its corporate headquarters and primary research laboratory facilities are based in Warren, New Jersey. Equity Transactions On September 11, 2019, the Company established an “At-The-Market” (ATM) facility pursuant to which the Company may offer up to $25,000 worth of shares of common stock, par value $0.001 per share, of the Company (the "Common Stock"). On November 20, 2020, the Company began utilizing the ATM facility. On March 26, 2021, the Company filed a prospectus supplement to offer up to an additional $50,000 worth of shares of Common Stock under the ATM. The 2019 Registration Statement expired under its terms on September 17, 2022. On September 7, 2022, the Company filed a prospectus supplement to register the offer and sale of up to $35,000 worth of shares of Common Stock pursuant to the Amended Equity Distribution Agreement under a shelf registration statement on Form S-3 (Registration Statement No. 333-254775), or the 2021 Registration Statement, that was declared effective by the Securities and Exchange Commission (SEC) on April 5, 2021. The Company discontinued using the 2021 Prospectus upon the filing of the prospectus supplement on September 7, 2022. For the year ended December 31, 2022, the Company sold 2,860,538 shares which provided net proceeds of approximately $3,907 after deducting commissions and other transaction costs of $289. This ATM facility has approximately $33,416 available at December 31, 2022. For the year ended December 31, 2021, the Company sold 6,550,486 shares which provided net proceeds of approximately $29,778 after deducting commissions and other transaction costs of $1,291. On April 12, 2022, the Company entered into a purchase agreement (the "Lincoln Park Purchase Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), which provides that, upon the terms and subject to the conditions and limitations set forth in the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park up to $40,000 worth of shares of Common Stock from time to time over the 36-month term of the Lincoln Park Purchase Agreement. The Lincoln Park Purchase Agreement contains an ownership limitation such that the Company will not issue, and Lincoln Park will not purchase, shares of Common Stock if it would result in Lincoln Park's beneficial ownership of our outstanding Common Stock exceeding 9.99%. Lincoln Park has covenanted under the Lincoln Park Purchase Agreement not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company's Common Stock. For the year ended December 31, 2022, the Company sold 1,600,000 shares in addition to issuing 236,491 commitment shares, which provided gross proceeds of approximately $1,987 in connection with the Lincoln Park Purchase Agreement. On June 6, 2022, the Company entered into securities purchase agreements (the "Securities Purchase Agreements") with certain purchasers. The Securities Purchase Agreements provided for the sale and issuance by the Company of an aggregate of: (i) 4,850,000 shares of Common Stock, (ii) pre-funded warrants to purchase up to 4,000,000 shares of Common Stock and (iii) Common Stock warrants to purchase up to 8,850,000 shares of Common Stock. The Company received net proceeds of approximately $7,796, after deducting placement agent fees and expenses and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes. On June 8, 2022, the Company filed a prospectus supplement in connection with this equity offering. Refer to Note 13, Warrants for further details. Nasdaq Stock Market Notification On December 30, 2022, the Company received a notice from the Nasdaq Stock Market (“Nasdaq”) that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s Common Stock has been below $1.00 per share for 30 consecutive business days (the “Minimum Bid Price Requirement”). The notification of noncompliance has no immediate effect on the listing or trading of the Company’s Common Stock on The Nasdaq Global Market. The Company has 180 calendar days, or until June 28, 2023, to regain compliance with the Minimum Bid Price Requirement. To regain compliance, the minimum bid price of the Company’s Common Stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the Minimum Bid Price Requirement by June 28, 2023, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. If the Company does not regain compliance with the Minimum Bid Price Requirement by the end of the compliance period (or the second compliance period, if applicable), the Company’s Common Stock will become subject to |
Basis of Presentation and Princ
Basis of Presentation and Principles of Consolidation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation These consolidated financial statements have been prepared in accordance with Generally Accepted Accounting Principles ("GAAP") in the United States of America, and in accordance with the rules and regulations of the Securities and Exchange Commission ("SEC"). The accounts of wholly owned subsidiaries are included in the consolidated financial statements. Other than corporate formation activities, no such subsidiaries have conducted any commercial, developmental or operational activities and none have customers or vendors. Certain reclassifications were made to conform to the current presentation. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted principles 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 | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions often involve assessments of matters that are inherently uncertain and accordingly actual results could differ from those estimates. Significant items subject to estimates and assumptions include those related to revenue recognition, inventory costs, allowances for rebates from proprietary product sales, allowances for sales returns, the useful lives of fixed assets, the valuations of warrants issued and of share-based compensation, and contingencies. Cash and Cash Equivalents The Company considers all short-term, highly liquid investments purchased with original maturities of three months or less to be cash equivalents. At December 31, 2022 and 2021, cash and cash equivalents consisted of cash in bank accounts and money market funds. Concentration of Credit Risk Cash and cash equivalents are maintained are held by federally insured financial institutions that management believes are of high credit quality. The Company has not experienced any losses in such accounts and such amounts may exceed federally-insured limits of $250. Concentration of the Company's significant customers as of December 31, 2022 and 2021 is outlined in Note 5, Revenues and Trade Receivables, Net . Trade Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables. The Company’s credit terms generally range from 30 to 60 days, depending on the customer and type of invoice. The Company performs a regular review of our customers' credit risk and payment histories, including payments made subsequent to year-end. The Company evaluates the collectability of accounts receivable based on a combination of factors. In situations where changing circumstances indicate that a specific customer is unable to meet its financial obligations to the Company, a provision to the allowances for doubtful accounts is recorded against amounts due in order to reduce the net recognized receivable to the amount that is reasonably expected to be collected. For all other customers, a provision to the allowances for doubtful accounts is recorded based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. Provisions to the allowances for doubtful accounts are recorded to selling, general and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered. The allowance for doubtful accounts, associated with recoverability of accounts receivable, was $40 and $40 as of December 31, 2022 and 2021, respectively. Inventories Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost, determined by the first-in, first-out method, or net realizable value. The Company regularly reviews its inventories for impairment and reserves are established when necessary. At each balance sheet date, the Company evaluates inventories for excess quantities, obsolescence and shelf life expiration. This evaluation includes analysis of historical sales levels by product, projections of future demand, the risk of competitive obsolescence for products, general market conditions, and a review of the shelf life expiration dates for products. To the extent that management determines there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products, or use them in production, prior to their expiration, the Company records allowances to adjust the carrying value to estimated net realizable value as necessary. The Company expenses inventory related to the Company's research and development activities when the Company purchases or manufactures it. Before the regulatory approval of the Company's product candidates, the Company recognizes research and development expense for the manufacture of drug products that could potentially be available to support the commercial launch of the Company's drug candidates, if approved by regulatory authorities. Property and Equipment Property and equipment are stated at cost net of accumulated depreciation and amortization, which is computed by the straight-line method based on the estimated useful lives of the respective assets, as discussed below. Leasehold improvements are amortized over the shorter of the lease terms or the estimated useful lives of the leased assets. Maintenance and repair costs are charged to expense as incurred, and expenditures for major renewals and improvements are capitalized. Upon disposition of property and equipment, the related cost and accumulated depreciation and amortization are removed from the accounts, and any gain or loss is reflected in the accompanying Consolidated Statements of Operations and Comprehensive Loss. Intangible Assets Intangible assets include the costs of acquired composition and process technologies, the costs of purchased patents used in the manufacture of orally soluble film and the costs of acquired New Drug Application (NDA). The Company amortizes these assets using the straight-line method over the shorter of their legal lives or estimated useful lives. Impairment of Long-Lived Assets Long lived assets, such as property, plant, and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In these circumstances, the Company compares undiscounted cash flows expected to be generated by that asset or asset group to the corresponding carrying amounts. If this comparison is indicative of impairment, an impairment charge is recognized to the extent that the carrying amount exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered most appropriate. Leases Determination if an arrangement is a lease is made at inception. An arrangement is determined to contain a lease if the contract conveys the right to control the use of an identified property and equipment for a period of time in exchange for consideration. If the Company can benefit from the various underlying assets of a lease on their own or together with other resources that are readably available, or if the various underlying assets are neither highly dependent or highly interrelated with underlying assets in the arrangements, they are considered to be a separate lease component. In the event multiple underlying assets are identified, the lease consideration is allocated to the various components based on each on the component's relative fair value. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease arrangement. Operating lease assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, in determining the operating lease liability, the Company uses an estimate of our incremental borrowing rate. The calculation of the operating lease assets includes any lease payments made and excludes any lease incentives. Our lease terms may include options to extend or terminate the lease and are included when it is reasonably certain that the Company will exercise the option. The Company records operating lease assets and lease liabilities in its consolidated balance sheets. Lease expenses for lease payments is recognized on a straight-line bases over the lease term. Short-term leases, or leases that have a lease term of 12 months or less at consummation date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. The Company has not entered into any material short-term lease or financing leases as of December 31, 2022. Liability Related to the Sale of Future Revenue The Company treats the liability related to the sale of future revenue as debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liability related to the sale of future revenue and the related interest expense are based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from third-party manufacturers. To the extent our future estimates of royalty payments are greater or less than previous estimates or the interest timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related interest expense. Royalty revenue related to the sale of future revenue is reflected as royalty revenue, and amortization of debt is reflected as interest expense related to the sale of future revenue in the Consolidated Statement of Operations and Comprehensive Loss. For further discussion of the sale of the future revenue, refer to Note 14, Sale of Future Revenue. Revenue Recognition The Company’s revenues include (i) sales of manufactured products pursuant to contracts with commercialization licensees, (ii) sales of the Company's proprietary clobazam-based Sympazan oral film product used as a treatment for LGS-related seizures prior to its outlicensing to Assertio Holdings, Inc. ("Assertio") in October 2022, (iii) license and royalty revenues and (iv) co-development and research fees generally in the form of milestone payments. See Note 5, Revenues and Trade Receivables, Net for further details. 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. 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 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 . Sale 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 accounts 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 as a reduction of revenue. 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 Revenue – 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. Royalties based on sales of licensed products have been recorded in this manner. 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 Food and Drug Administration ("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 occur 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 Consolidated Balance Sheet. 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 Consolidated Balance Sheets. As remaining performance obligations are satisfied, an appropriate portion of the deferred revenue balance is credited to earnings. Costs to obtain contracts - in certain situations, the Company may incur incremental costs of obtaining a contract with a customer. These costs, if expected to be recovered, are recognized as an asset and reflected as other assets within the Consolidated Balance Sheets. The asset is amortized on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates. Research and Development Research and development, or R&D, expenses are recorded in accordance ASC 730, Research and Development and are expensed as incurred. R&D expenses include R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activities include preclinical laboratory experiments and clinical studies. Other activity expenses include regulatory consulting and other costs. The activities undertaken by a regulatory consultants that were classified as R&D expense include assisting, communicating with, and advise our in-house staff with respect to various FDA submission processes, clinical trial processes and scientific writing matters, including preparing protocols and FDA submissions. These consulting expenses were direct costs associated with preparing, receiving and understanding work for our clinical trials and investigative drugs. Payments made to CROs based on agreed-upon terms, which may include payments in advance of a study start date. The Company expenses non-refundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when goods or services have been received rather than when payment was made. The Company reviews and accrues CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion state of study as provided by CRO's. Estimated CRO costs subject to revisions as such studies progress to completion. The Company charges revisions to expense in the period when the facts that give rise to the revision become known. Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes , or ASC 740, which provides for deferred taxes using an asset and liability approach. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained during an audit. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Uncertain tax positions are accounted for in accordance with the provision of ASC 740. When uncertain tax positions exist, the tax benefit is recognized to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not had any significant uncertain tax positions. Share-Based Compensation The Company records share-based compensation expenses for awards of stock options and restricted stock units (RSUs) under ASC 718, Compensation — Stock Compensation . For awards to non-employees for periods prior to the adoption of ASU 2018-07, Compensation-Stock Compensation: Improvements to Non-employee Share-Based Payment Accounting, on January 1, 2019, the Company had applied ASC 505-50, Equity-based Payments to Non-Employees . ASC 718 establishes guidance for the recognition of expenses arising from the issuance of stock-based compensation awards at their fair value at the grant date. The Company’s stock-based compensation includes grants of stock options and restricted stock units (RSUs) to employees, consultants and non-employee directors. Beginning in 2019, the Company also offered employees an opportunity to participate in an employee stock purchase plan. Expenses arising from these grants are recorded in the accompanying financial statements based on their grant date fair values as ratably earned during their respective vesting periods. The Company’s estimates of the fair value of options at their grant dates is based on the Black-Scholes option valuation model and considers various variables and assumptions, including: • the stock price at the grant date, • exercise price, • both the contractual and estimated expected term of the option, • an estimate of stock price volatility based on that of an industry peer group, • expected dividends, • no dividends for the foreseeable future, and • risk-free interest rate. These assumptions require estimates and judgements and changes in those inputs could impact the amount of expenses that are charged to earnings. The Company recognizes compensation expense for the fair value of RSU and stock option awards over the requisite service period of the award. All excess tax benefits, taxes and tax deficiencies from stock-based compensation are included in the provision for income taxes in the Consolidated Statement of Operations. Per Share Data Basic net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted net income per common share is calculated by dividing net income available to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of Common Stock and dilutive Common Stock outstanding during the period. Potentially dilutive common shares include the shares of Common Stock issuable upon the exercise of outstanding stock options and warrants, the shares of issued but unvested RSUs and the purchase of shares from the Company’s employee stock purchase plan (using the treasury stock method). For all periods presented, potential common shares have been excluded from the calculation of EPS because their effect would be anti-dilutive. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity that may result from transactions and economic events other than those with stockholders, such as unrealized gains or losses on investments. For the periods ended December 31, 2022 and 2021, the Company’s comprehensive loss included only its net loss. 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 — Quoted prices in active markets for identical assets or liabilities. Cash and cash equivalents consisted of cash in bank checking accounts and money market funds which are all Level 1 assets. • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. The Company currently has no Level 2 assets or liabilities. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including 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, accrued expenses and deferred revenue approximate fair value based on the short-term maturity of these assets and liabilities. The Company previously granted warrants to certain holders of the Company's 12.5% Senior Secured Notes due 2025 (the 12.5% Notes") in connection with its debt repayment and debt refinancing. Additionally in 2022, the Company issued pre-funded warrants and Common Stock warrants to certain purchasers in connection with the Securities Purchase Agreements. The warrants were valued based on the Black-Scholes valuation model performed by 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 13, Warrants for further information on these warrants. The Company's 12.5% Notes contain a repurchase offer or put option which gives holders of the option the right, but not the obligation, to receive a specified amount of future royalties up to a capped amount. 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 12, 12.5% Senior Secured Notes and Loans Payable for further discussion. Segment Information Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company manages its operations as a single segment for purposes of assessing performance and making operating decisions. Recent Accounting Pronouncements As a public emerging growth company, the Company has elected to take advantage of the extended transition period afforded by 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 by the relevant dates on which adoption of such standards is required for public emerging growth companies. From time to time, new accounting pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Recently Adopted Accounting Pronouncements: None. Recent Accounting Pronouncements Not Adopted as of December 31, 2022: 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 June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . This Accounting Standards Update was issued to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, and to introduce new disclosure requirements for such equity securities. 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 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 Company adopted the new guidance on January 1, 2023. The adoption of this guidance did not have a material impact on the Company's 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 Company adopted the new guidance on January 1, 2023. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. |
Risks and Uncertainties
Risks and Uncertainties | 12 Months Ended |
Dec. 31, 2022 | |
Risks and Uncertainties [Abstract] | |
Risks and Uncertainties | Risks and Uncertainties The 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 2022 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 December 31, 2022, the Company had $27,273 of cash and cash equivalents. The Company has experienced a history of net losses. The Company's accumulated deficits totaled $311,207 as of December 31, 2022. The net losses and accumulated deficits were partially offset by gross margins from sales of commercialized licensed and proprietary products (prior to the licensing agreement of Sympazan with Assertio), license fees, milestone and royalty payments from commercial licensees and co-development parties. The Company's funding requirements have been met by its cash and cash equivalents, as well as its existing equity and debt offerings, including the 12.5% Notes. The Company began utilizing its ATM facility in November 2020. Since inception to December 31, 2022, the Company sold 10,341,957 shares of Common Stock which generated net cash proceeds of approximately $39,740, net of commissions and other transaction costs of $2,053. For the year ended December 31, 2022, the Company sold 2,860,538 shares which provided net proceeds of approximately $3,907 after deducting commissions and other transaction costs of $289. This ATM facility has approximately $33,416 available at December 31, 2022. As of the filing of this Annual Report on Form 10-K, the Company will be subject to the SEC general instructions of Form S-3 known as the "baby shelf rules." Under these instructions, the amount of funds the Company can raise through primary public offerings of securities in any 12-month period using its registration statement on Form S-3 is limited to one-third of the aggregate market value of the shares of the Company’s Common Stock held by non-affiliates. Therefore, the Company will be limited in the amount of proceeds it is able to raise by selling shares of its Common Stock using its Form S-3, including under the ATM facility and the Lincoln Park Purchase Agreement, until such time as its public float exceeds $75 million. While the Company’s ability to execute its business objectives and achieve profitability over the longer term cannot be assured, the Company's on-going business, existing cash and equivalents, expense management activities, including, but not limited to the ceasing of R&D activities, as well as access to the equity capital markets, including through its ATM facility and under the Lincoln Park Purchase Agreement, provide near term liquidity for 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 | 12 Months Ended |
Dec. 31, 2022 | |
Revenues and Trade Receivables, Net [Abstract] | |
Revenues and Trade Receivables, Net | Revenues and Trade Receivables, Net The Company’s revenue was comprised of the following: Year Ended December 31, 2022 2021 Manufacture and supply revenue $ 36,378 $ 35,312 License and royalty revenue 2,351 5,380 Co-development and research fees 1,293 1,635 Proprietary product sales, net 7,658 8,505 Revenues $ 47,680 $ 50,832 Disaggregation of Revenue The following table provides disaggregated net revenue by geographic area: Year Ended December 31, 2022 2021 United States $ 39,921 $ 42,860 Ex-United States 7,759 7,972 Revenues $ 47,680 $ 50,832 Trade and other receivable, net consist of the following: December 31, 2022 2021 Accounts receivable $ 3,274 $ 9,678 Contract and other receivables 2,139 3,087 Less: allowance for bad debt (40) (40) Less: sales-related allowances (669) (605) Trade and other receivables, net $ 4,704 $ 12,120 Contract and other receivables totaled $2,139 and $3,087 as of December 31, 2022 and 2021, respectively, consisting primarily of contract assets and other receivables. Contract assets consist 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. Sales-related allowances for both periods presented are estimated in relation to revenues recognized for sales of Sympazan prior to the licensing agreement the Company entered into with Assertio in October 2022. See details in Note 6, Material Agreements . There were no additions to or write-downs charged against the allowance for doubtful accounts for the years ended December 31, 2022 and 2021, respectively. The allowance for doubtful accounts was $40 for each of the years ending December 31, 2022 and 2021. The following table presents the changes in sales-related allowances: December 31, 2022 2021 Balance at December 31, 2021 $ 605 $ 416 Provision related to sales in 2022 1,365 1,209 Credits and payments (1,301) (1,020) Balance at December 31, 2022 $ 669 $ 605 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 year ended December 31, 2022, Indivior Inc. ("Indivor") exceeded the 10% threshold for revenue and represented approximately 76% of total revenue. As of December 31, 2022, Indivor exceeded the 10% threshold for outstanding receivables and represented 80% of total trade and other receivables. For the year ended December 31, 2021, Indivor exceeded the 10% threshold for revenue and represented approximately 73% of total revenue. As of December 31, 2021, two customers exceeded the 10% threshold for outstanding receivables which were Indivior and Cardinal Health Inc. which represented 51% and 12%, respectively, of total trade and other receivables. |
Material Agreements
Material Agreements | 12 Months Ended |
Dec. 31, 2022 | |
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 the Company entered into 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 value (as provided for in the Indivior License Agreement) outside of the U.S., subject to annual maximum amounts and limited to the life of the related patents. 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. Effective as of March 2, 2023, the Company entered into Amendment No. 11 (the “Indivior Amendment”) to the Indivior License Agreement. The Indivior Amendment was entered into for the primary purpose of amending the Agreement as follows: (i) extending the term of the Agreement until August 16, 2026 and thereafter providing for automatic renewal terms of successive one year periods unless Indivior delivers notice to the Company, at least twelve months prior to the expiration of the then current term, of Indivior’s intent not to renew, subject to the earlier termination rights of the parties under the Agreement, and providing that the Agreement will not automatically renew for any renewal term beginning after the expiration of the last to expire of the product patents; and (ii) agreeing to transfer pricing and payment terms for supplied product. See Note 21, Subsequent Events for details. Supplemental Agreement with Indivior On September 24, 2017, the Company entered into an agreement with Indivior, or 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 was 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 were suspended until adjudication of related patent infringement litigation is finalized. As a result of the settlement and dismissal of all claims under the lawsuit with Dr. Reddy’s Labs on June 28, 2022, no further payments are due to the Company under the Indivior Supplemental Agreement. See Note 20, Contingencies for details. All payments made by Indivior to the Company pursuant to the Indivior Supplemental Agreement were in addition to, and not in place of, any amounts owed by Indivior to the Company pursuant to the Indivior License Agreement. 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. This approval triggered Sunovion's obligation to remit a payment of $4,000 (the "FDA Approval Milestone Payment") due on the earlier of: (a) the first day of product availability at a pharmacy in the United States; or (b) with six months of the FDA approval. This amount was received as of September 30, 2020 and was included in License and royalty revenues for the twelve months 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”), all of which of which has been received to date. With the Monetization Agreement, we are no longer entitled to receive certain contingent one-time milestone payments of $23,000 related to product availability and regulatory approval in Europe, certain one-time milestone payments based on the achievement of specific annual net sales thresholds of KYNMOBI®, and ongoing mid-single digit percentage royalty payments related to the net sales of KYNMOBI (subject to reduction to low-single digit percentage royalty payments in certain circumstances), subject to certain minimum payments. There are minimum annual guaranteed royalty payments under the contract and during the second quarter of 2020, the Company recorded minimum royalty revenue of $8,000 for minimum royalties, reflected in License and royalty revenues for the twelve months ended December 31, 2020. Effective March 16, 2020, the Company entered into a first amendment (the "First Amendment") to the Sunovion License Agreement. The Amendment was entered into for the primary purpose of amending the Sunovion License Agreement as follows: (i) including the United Kingdom and any other country currently in the European Union (EU) which later withdraws as a member country in 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) extending 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) modifying the effective inception date of the first minimum annual royalty due from Sunovion to the Company form January 1, 2020 to April 1, 2020, and (iv) modifying the termination provision 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. This Sunovion License Agreement will continue until terminated by Sunovion in accordance with the termination provisions of the Amendment to the Sunovion License Agreement. 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 amended the Sunovion License Agreement to clarify the parties' agreement with respect to certain provisions in the Sunovion License Agreement, specifically the date after which Sunovion has the right to terminate the Sunovion License Agreement and the rights and obligations of the parties regarding the prosecution and maintenance of the Company's patents covered under the Sunovion License Agreement. Purchase and Sale Agreement with an affiliate of Marathon Asset Management ("Marathon") On November 3, 2020, we 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, we sold to Marathon all of our contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion's apomorphine product, KYNMOBI, an apomorphine film therapy for the treatment of off episodes in Parkinson’s disease patients, which received approval from the FDA on May 21, 2020. In exchange for the sale of these rights, we received an upfront payment from Marathon of $40,000 and an additional payment of $10,000 through the achievement of the first milestone. We have received an aggregate amount of $50,000 through December 31, 2022 under the Monetization Agreement. Under the Monetization Agreement, additional 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. Based on the current forecast by Sunovion of estimated KYNMOBI sales as of December 31, 2022, the Company may likely not receive any of the additional contingent payments under the Monetization agreement. See Note 14, Sale of Future Revenue for further details on the accounting for the Monetization Agreement. Agreement to Terminate CLA with Zevra Therapeutics, Inc. (formerly KemPharm) In March 2012, the Company entered into an agreement with Zevra Therapeutics, Inc. (formerly KemPharm, Inc.) (“Zevra”), to terminate a Collaboration and License Agreement entered into by the Company and Zevra in April 2011. Under this termination arrangement, the Company has the right to participate in any and all value that Zevra 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 Zevra and collaborations, royalty arrangements, or other transactions from which Zevra may realize value from these compounds. For the year ended December 31, 2021, the Company received payment of $2,000 under this arrangement, which was included in License and royalty revenues. Licensing and Supply Agreement with Haisco for Exservan™ (Riluzole Oral Film) for ALS Treatment in China The Company entered into a License, Development and Supply Agreement with Haisco, a Chinese limited company listed on the Shenzhen Stock Exchange, effective as of March 3, 2022 (the "Haisco Agreement"), pursuant to which Aquestive granted Haisco an exclusive license to develop and commercialize Exservan™ (riluzole oral film) for the treatment of amyotrophic lateral sclerosis, or ALS (“Exservan"), in China. Under the terms of the Haisco Agreement, Aquestive will serve as the exclusive sole manufacturer and supplier for Exservan in China. Under the Haisco Agreement, as amended, the Company received a $7,000 upfront cash payment, and will receive regulatory milestone payments, receive double-digit royalties on net sales of Exservan in China, and earn manufacturing revenue upon the sale of Exservan in China. Compensatory Arrangements of Certain Officers On May 17, 2022, the Company announced that Keith J. Kendall, former President and Chief Executive Officer of the Company, was leaving the Company and the Company's Board of Directors, effective May 17, 2022. In connection with his departure, Mr. Kendall and the Company entered into a Separation Agreement, including a Consulting Agreement (collectively, the “Separation Agreement”) dated as of May 17, 2022. Pursuant to the Separation Agreement, Mr. Kendall’s employment with the Company ceased effective as of May 17, 2022 (the “Termination Date”). Under the Separation Agreement, Mr. Kendall received the following principal severance benefits, the outstanding portions of which are contingent upon Mr. Kendall's compliance with a customary release of claims entered into at the time: (i) a cash payment consisting of the sum of any previously unpaid base salary through the Termination Date and any accrued and unused vacation time for the 2022 calendar year; (ii) a cash payment consisting of his pro-rata portion of his target bonus in the amount of $280; (iii) a cash payment in the amount of $150, representing 90 days of his base pay in lieu of the required notice period under Mr. Kendall’s employment agreement; (iv) severance payments consisting of (a) a cash payment of $263, which represents an acceleration of the first three installments of Mr. Kendall’s 18-month severance he is entitled to under his employment agreement; (b) monthly severance payments of $53 per month for the first through the seventh months following the Termination Date; (c) $70 paid for the eighth month after the Termination Date; and (d) monthly severance payments of $88 for the ninth through eighteenth months following the Termination Date; (v) accelerated vesting of unvested outstanding equity awards, with options remaining exercisable for the duration of the stated term of each award; and (vi) continuing coverage under the Company’s group health and life insurance plans at the same levels and on the same terms and conditions as are provided to similarly-situated executives, for a period of 18 months. Under the terms of the Separation Agreement, Mr. Kendall served as a consultant to the Company, on an as-needed basis providing transition services, strategic planning, financial planning, merger and acquisition advice and consultation, for a period from the Separation Date to December 31, 2022. For these services, Mr. Kendall received a consulting fee of $10 per month. Licensing and Supply Agreement with Atnahs Pharma UK Limited The Company entered into a License and Supply Agreement with Atnahs Pharma UK Limited, a company registered in England and Wales ("Pharmanovia"), effective as of September 26, 2022 (the "Pharmanovia Agreement"), pursuant to which the Company granted Pharmanovia an exclusive license to certain of the Company's intellectual property to develop and commercialize Libervant™ (diazepam) Buccal Film for the treatment of prolonged or acute, convulsive seizures in all ages in certain countries of the European Union, the United Kingdom, Switzerland, Norway and the Middle East and North Africa (the "Territory") during the term of the Pharmanovia Agreement. Under the Pharmanovia Agreement, Pharmanovia will lead the regulatory and commercialization activities for Libervant in the Territory and the Company will serve as the exclusive sole manufacturer and supplier of Libervant in the Territory. Pursuant to the Pharmanovia Agreement, the Company received $3,500 upon agreement execution and will receive additional milestone payments upon the occurrence of certain conditions set forth in the Pharmanovia Agreement, additional milestone payments and profit shares, as well as manufacturing fees and royalty fees through the expiration of the Pharmanovia Agreement. The Company expanded its exclusive license and supply agreement with Pharmanovia in March 2023. See Note 21, Subsequent Events for details. Licensing Agreement with Assertio Holdings, Inc. Effective October 26, 2022, the Company entered into a License Agreement with Otter Pharmaceuticals, LLC, a subsidiary of Assertio, a specialty pharmaceutical company offering differentiated products to patients, to license Sympazan® (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox‐Gastaut syndrome in patients aged two years of age or older (the "Assertio |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following: December 31, 2022 2021 Raw material $ 1,899 $ 1,442 Packaging material 2,914 1,414 Finished goods 967 1,182 Total inventory $ 5,780 $ 4,038 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net December 31, Useful Lives 2022 2021 Machinery 3 - 15 years $ 19,810 $ 19,250 Furniture and fixtures 3 - 15 years 769 769 Leasehold improvements (a) 21,375 21,265 Computer, network equipment and software 3 - 7 years 2,627 2,469 Construction in progress 1,467 1,162 46,048 44,915 Less: accumulated depreciation and amortization (41,963) (39,860) Total property and equipment, net $ 4,085 $ 5,055 (a) Leasehold improvements are amortized over the shorter of the lease term or their estimated useful lives. Total depreciation and amortization related to property and equipment were $2,270 and $2,912 for the years ended December 31, 2022 and 2021, respectively. |
Right-of-Use Assets and Lease O
Right-of-Use Assets and Lease Obligations | 12 Months Ended |
Dec. 31, 2022 | |
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 these 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, as amended, provide remaining terms between 0.25 years and 10.80 years, including renewal options expected to be exercised to extend the lease periods. See Part II Properties for details. 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 a range of an estimated discount rate of 14.8% to 16.9% applied to minimum lease payments, including expected renewals, based on the incremental borrowing rate experienced in the Company’s collateralized debt refinancing. The Company's lease costs are recorded in manufacture and supply, research and development and selling, general and administrative expenses in its Consolidated Statements of Operations and Comprehensive Loss. For the years ended December 31, 2022 and 2021, total operating lease expenses totaled $1,753 and $1,725, respectively, including variable lease expenses such as common area maintenance and operating costs of $449 and $469, respectively. Cash payments arising from the Company's lease arrangements are reflected on its consolidated statement of cash flows as outflows for operating activities. The Company's payments due under its operating leases are as follows: Amount 2023 $ 1,050 2024 1,006 2025 1,034 2026 1,060 2027 1,079 2028-2033 4,927 Total lease payments 10,156 Less: imputed interest (4,816) Total operating lease liabilities $ 5,340 |
Intangible Assets, Net and Othe
Intangible Assets, Net and Other non-current assets | 12 Months Ended |
Dec. 31, 2022 | |
Intangible Assets, Net and Other Assets [Abstract] | |
Intangible Assets, Net and Other non-current assets | Intangible Assets, Net and Other non-current assets The following table provides the components of identifiable intangible assets, all of which are finite lived and other non-current assets: December 31, 2022 2021 Purchased intangible $ 3,858 $ 2,358 Purchased patent 509 509 4,367 2,867 Less: accumulated amortization (2,932) (2,816) Intangible assets, net 1,435 51 Royalty receivable 5,000 6,000 Other 1,451 903 Total other non-current assets $ 6,451 $ 6,903 Amortization expense was $116 and $51 for each of the years ended December 31, 2022 and 2021, respectively. During the remaining life of the purchased intangible, estimated annual amortization expense is $156 for the year ending 2023. Other non-current assets consisted of royalty receivable related to the five $1,000 annual minimum guaranteed royalty that is due in the remaining term of the Monetization Agreement, value-added tax receivable, non-current security deposits, and capitalized cost to obtain revenue contracts. Refer to Note 14, Sale of Future Revenue for detail on the Monetization Agreement royalty receivable. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: December 31, 2022 2021 Accrued compensation $ 6,389 $ 5,965 Real estate and personal property taxes 322 349 Accrued distribution expenses 1,012 2,224 Other 244 198 Total accrued expenses $ 7,967 $ 8,736 |
12.5% Senior Secured Notes and
12.5% Senior Secured Notes and Loans Payable | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
12.5% Senior Secured Notes and Loans Payable | 12.5% Senior Secured Notes and Loans Payable On July 15, 2019, the Company completed the private placement of up to $100,000 aggregate principal of its 12.5% Notes due 2025 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, dated November 20, 2020, 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 noteholders 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 noteholders 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 December 31, 2022. The $4,000 principal issuance would be repaid proportionally over the same maturities as the other 12.5% Notes. The Company also paid to one of its noteholders 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 the noteholders 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 December 31, 2022. Based on the valuation study, the put option was valued at $45 and 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 our Common Stock. On August 6, 2021, pursuant to the Third Supplemental Indenture, the holders of the 12.5% 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. Under the Third Supplemental Indenture, the first $10,000 of 12.5% Notes re-openers represented 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 ("First Additional Securities"). In addition, under the Third Supplemental Indenture, a second $20,000 12.5% Notes re-opener represented a right, at the Company's option, to market to current holders of the Company's 12.5% Notes, and or other noteholders, additional 12.5% Notes up to such amount, contingent upon FDA approval of Libervant for U.S. market access ("Second Additional Securities"). If and to the extent that the Company accesses these re-openers (pursuant to the terms currently in effect, as amended by the Fifth Supplemental Indenture described below), 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 Common Stock at the warrant grant date. On October 7, 2021, the Company entered into the Fourth Supplemental Indenture, pursuant to which the amortization schedule for the 12.5% Notes was amended to provide for the date of the first amortization payment to be extended from September 30, 2021 to March 30, 2023. The Fourth Supplemental Indenture did not change the maturity date of the 12.5% Notes or the interest payment obligation due under the 12.5% Notes. In connection with the Fourth Supplemental Indenture, the Company entered into a Consent Fee Letter with the holders of the 12.5% Notes (the “Consent Fee Letter”), pursuant to which the Company agreed to pay the holders of the 12.5% Notes an additional cash payment ("Consent Fee") of $2,700 in the aggregate, payable in four quarterly payments beginning May 15, 2022. For the year ending December 31, 2021, the Company recognized a loss on the extinguishment of debt of $13,822 for fees and expenses related to the Fourth Supplemental Indenture. As of December 31, 2022, the Company recorded the remaining Consent Fee to be paid of $675 as Loans payable, current, on its Consolidated Balance Sheet. On May 13, 2022, pursuant to the Fifth Supplemental Indenture, the holders of the 12.5% Notes further extended to March 31, 2023 from June 30, 2022, the Company's ability to access, at the Company's option, $30,000 of 12.5% Notes re-openers under the Indenture. The Fifth Supplemental Indenture also provided that the Company's access to the First Additional Securities and Second Additional Securities is subject to the full approval of Libervant by the FDA for sale in the United States, which full approval includes U.S. market access for Libervant prior to March 31, 2023. In addition, the Fifth Supplemental Indenture provides that the holders of 12.5% Notes have the right, but not the obligation, to purchase the First Additional Securities and Second Additional Securities upon the exercise by the Company of the option to access the re-openers. A debt maturity table as of December 31, 2022 is presented below: 2023 $ 18,025 2024 21,888 2025 11,587 Total $ 51,500 The 12.5% Notes provide a stated fixed interest rate of 12.5%, payable quarterly in arrears, with the final quarterly principal repayment of 12.5% Notes due at maturity on June 30, 2025. As of December 31, 2022, the Company recorded its principal payments as Loans payable, current and Loans payable, net on its Consolidated Balance Sheet. 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 November 4, 2022 and December 16, 2022, the Company issued two separate notices of partial redemption pursuant to the Indenture, dated as of July 15, 2021, between the Company and the Trustee and collateral agent governing the 12.5% Notes. Pursuant to each of the notice of partial redemption, the Company gave holders of the 12.5% Notes notice that the Company intended to redeem $3,765 and $1,882, respectively, of its outstanding 12.5% Notes at a redemption price pursuant to the formula set forth in the Indenture governing the 12.5% Notes, plus accrued and unpaid interest. See Note 21, Subsequent Events for details. 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 noteholders, 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 years ended December 31, 2022 and 2021 were $16 and $3,572, respectively. Unamortized deferred debt issuance costs and deferred debt discounts totaled $27 and $43 as of December 31, 2022 and December 31, 2021, respectively. Collateral for the loan under the 12.5% Notes consists of a first priority lien on substantially all property and assets, including intellectual property, of the Company. This secured obligation provides payment rights that are senior to all existing and future subordinated indebtedness of the Company and provides noteholders with perfected security interests in substantially all of the Company’s assets. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | Warrants Warrants Issued to 12.5% Senior Secured Noteholders 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 Common Stock 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 was 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 Consolidated Balance Sheet. Additionally, since the Initial Warrants and Additional 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 the Company’s Consolidated Balance Sheet. There were no warrants exercised as it relates to the Initial Warrants and the Additional Warrants during the year ended December 31, 2022 and December 31, 2021, respectively. Warrants Issued Under Securities Purchase Agreements |
Sale of Future Revenue
Sale of Future Revenue | 12 Months Ended |
Dec. 31, 2022 | |
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, an apomorphine film therapy for the treatment of off episodes in Parkinson’s disease patients, which 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 December 31, 2022 under the Monetization Agreement. Under the Monetization Agreement, additional 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 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. Based on the current forecast by Sunovion of estimated KYNMOBI sales as of December 31, 2022, the Company likely may not receive any of the additional contingent payments under the Monetization Agreement. As a result, the Company discontinued recording interest expense related to the sale of future revenue during the fourth quarter of 2022. The following table shows the activity of the liability related to the sale of future revenue for the year ended December 31, 2022: Liability related to the sale of future revenue, net at December 31, 2021 $ 60,284 Royalties related to the sale of future revenue (916) Amortization of issuance costs 208 Interest expense related to the sale of future revenue 5,683 Liability related to the sale of future revenue, net (includes current portion of $1,147) $ 65,259 |
Other Non-Current Liabilities
Other Non-Current Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Asset Retirement Obligation Disclosure [Abstract] | |
Other Non-Current Liabilities | Other Non-Current Liabilities The Company’s other non-current liabilities at December 31, 2022 consisted of asset retirement obligations ("AROs") of $1,989, and the fair value of the put option on the 12.5% Notes of $45. The Company’s other non-current liabilities at December 31, 2021 consisted of AROs of $1,712, the long term portion of the Consent Fee related to the 12.5% Senior Secured Note of $675 and the long-term portion of fair value of the put option on the 12.5% Notes of $98. AROs consists of estimated future spending related to removing certain leasehold improvements at the Company's facilities in Portage, Indiana and Warren, New Jersey, and returning all facilities to their original condition. Depreciation expense related to the ARO assets included in overall depreciation expense for the periods ended December 31, 2022 and 2021 were $25 and $23, respectively. Below is a schedule of activity in the Company’s liability for AROs for the year ended December 31, 2022 and 2021. Balance at December 31, 2020 $ 1,525 Additions — Accretion 187 Balance at December 31, 2021 1,712 Additions 110 Accretion 167 Balance at December 31, 2022 $ 1,989 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
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 shares of Common Stock. As a result of the Company’s net loss incurred for the year ended December 31, 2022 and 2021, 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 below. Year Ended December 31, 2022 Year Ended December 31, 2021 Numerator: Net loss $ (54,410) $ (70,539) Denominator: Weighted-average number of common shares – basic and diluted 48,734,377 38,077,660 Loss per common share – basic and diluted $ (1.12) $ (1.85) As of December 31, 2022 and 2021, respectively, the Company’s potentially dilutive instruments included 6,028 thousand and 4,146 thousand of options to purchase shares of Common Stock, as well as 162 thousand and zero 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 December 31, 2022 and 2021 were potentially dilutive warrants for the purchase of 10,564 thousand and 1,714 thousand common shares for the respective periods. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation The Company provides certain employees, non-employee directors and consultants with performance incentives under the Aquestive Therapeutics, Inc. Equity Incentive Plan (the Plan), adopted by the Board of Directors on June 15, 2018. Under this Plan, the Company may grant restricted stock units, stock options, or other stock-based awards in order to align the long-term financial interests of selected participants with those of its stockholders, strengthen the commitment of such persons to the Company, and attract and retain competent and dedicated persons whose efforts will enhance long-term growth, profitability and share value. Restricted stock units and stock options that have been awarded are subject to graded vesting over a service period, which is typically three years. Compensation cost is recognized for these awards on a pro-rata basis over the requisite service period for each award granted. At December 31, 2022, there were approximately 0.4 million shares available for grant. The Company recognized share-based compensation in its Consolidated Statements of Operations during the periods presented as follows: Expense classification: Year Ended December 31, 2022 Year Ended December 31, 2021 Manufacture and supply $ 203 $ 313 Research and development 672 881 Selling, general and administrative 3,506 5,625 Total share-based compensation expenses $ 4,381 $ 6,819 Share-based compensation from: Restricted Stock Units 127 81 Stock Options 4,244 6,714 Employee Stock Purchase Plan 10 24 Total share-based compensation expenses $ 4,381 $ 6,819 Restricted Stock Units The following table summarizes the Company’s awards of restricted stock units for the years during 2021 and 2022: Number Weighted Average (In thousands) Unvested, December 31, 2020 14 $ 11.38 Granted — — Forfeited (2) 13.00 Vested (12) 11.14 Unvested, December 31, 2021 — Granted 192 2.37 Forfeited (20) 2.21 Vested (10) 2.55 Unvested, December 31, 2022 162 $ 2.38 The Company granted 192 thousand restricted stock units during 2022. The Company did not grant restricted stock units during 2021. During 2022, the total grant date fair market value of shares vested was $26. As of December 31, 2022, $261 of total unrecognized compensation expenses related to restricted stock units awards is expected to be recognized over a weighted average period of 2.21 years from the date of grant. The restricted stock units previously granted to employees were subject to a three-year graduated vesting schedule and were not subject to performance-based criteria other than continued employment. Stock option awards The following table summarizes the Company’s stock option activity for the years during 2021 and 2022: (in 000s, except share price data) Number Weighted Weighted Aggregate Outstanding at December 31, 2020 3,259 $ 8.14 8.42 $ 2,978 Granted 1,212 $ 4.73 Forfeited and Expired (264) $ 7.52 Exercised (61) Outstanding at December 31, 2021 4,146 $ 7.28 7.88 $ 1,423 Granted 2,015 1.83 Forfeited and Expired (133) $ 7.81 Exercised — $ — Outstanding at December 31, 2022 6,028 $ 5.48 7.50 $ 38 Vested and expected to vest at December 31, 2022 5,877 $ 5.57 7.46 $ 36 Exercisable at December 31, 2022 3,652 $ 7.42 6.57 $ — The weighted average grant date fair value of stock options granted during 2022 and 2021 was $1.46 and $3.61, respectively. During the year ended December 31, 2022, stock options were granted with an exercise price ranging from $0.71 to $2.55 and accordingly, given the Company’s share price of $0.90 at December 30, 2022, the intrinsic value provided by certain shares granted during this period was de minimus. The fair values of stock options granted were estimated using the Black-Scholes model based on the following assumptions: Year Ended December 31, 2022 2021 Expected dividend yield 0% 0% Expected volatility 100% 100% Expected term (years) 5.50 - 6.13 5.50 - 6.00 Risk-free interest rate 2.0% —% 4.3% 0.5% —% 1.5% Exercise prices $0.71 - $2.55 $3.76 - $5.30 We anticipate reinvesting earnings for the foreseeable future in product development and other avenues of share-value growth and therefore used a dividend yield of zero. The estimate of volatility was determined based on the historical trading data of comparable public companies at the time of grant given the lack of sufficient history for our own publicly-traded Common Stock. The expected term of the award was calculated using the simplified method and weighted average was utilized taking into account the vesting periods and contractual life. The risk-free interest rates are derived from the U.S. Treasury yield curve in effect on the date of grant for instruments with a remaining term similar to the expected term of the options. As of December 31, 2022, $3,433 of total unrecognized compensation expenses related to non-vested stock options is expected to be recognized over a weighted average period of 1.84 years from the date of grant. These option grants provided a maximum contract term of 10 years from grant date, with a weighted average remaining contract life of 7.50 years. Options granted to senior management and key employees are subject to a three-year graded vesting schedule while options granted to the board of directors are subject to a one year cliff vesting schedule. These stock options are not subject to performance-based criteria other than continued employment. 2022 Inducement Equity Incentive Plan In accordance with Nasdaq Listing Rule 5635(c)(4), the Company adopted the Aquestive Therapeutics, Inc. 2022 Equity Inducement Plan approved by the Compensation Committee of the Board of Directors of the Company effective as of July 29, 2022. In September 2022, the Company granted a nonqualified option to purchase 100,000 shares of Common Stock to an officer of the Company. Employee Stock Purchase Plan The Company's Employee Stock Purchase Plan (the "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 of the Company 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. Under the ESPP, a total of 250,000 shares of Common Stock were initially reserved for issuance. During 2022 and 2021, 45,304 and 40,146 shares were purchased and issued through the ESPP at total discounts of $10 and $24, respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | Employee Benefit PlansThe Company sponsors a defined-contribution 401(k) plan covering all full-time employees and makes matching employer contributions as defined by the terms of that plan. The Company may also make discretionary contributions. Total contributions made to the plan by the Company for the year ended December 31, 2022 and 2021 were $815 and $706, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe tax effect of temporary differences between the tax bases of assets and liabilities and their financial reporting amounts that give rise to the deferred tax assets and deferred tax liabilities as of December 31, 2022 and 2021 are as follows: December 31, 2022 2021 Deferred tax assets: Accounts receivable $ 177 $ 149 Inventory 449 100 Accrued expenses 1,063 309 NOL carryforwards 32,197 28,722 Interest limitation imposed by the TJCA 10,667 9,022 Stock Compensation 5,813 5,003 Other 2,408 2,122 Sale of Future Revenue 17,139 16,595 Property and equipment 2,576 2,566 Orphan Drug and R&D Tax Credits 5,625 5,490 Accrued debt fees 697 726 Intangible assets 1,731 2,547 Section 174 R&D Capitalization 3,770 — 84,312 73,351 Deferred tax liabilities: 481(a) adjustment — (14) Prepaid expenses (524) (807) (524) (821) Valuation Allowance (83,788) (72,530) Net deferred tax asset/(liability) $ — $ — At December 31, 2022 and 2021, the Company had federal net operating loss carryforwards of $123,922 and $105,722, respectively, a significant portion of which carryforward for an indefinite period. At December 31, 2022 and 2021, the Company also had state net operating loss carryforwards of $104,238 and $93,304, respectively, which begin expiring in 2034. As a result of the December 2017 U.S. Tax Cuts and Jobs Act (“TCJA”), updated regulations under section 163(j) create new limitations on deductible interest expense. For the year ended December 31, 2022, the Company’s interest expense deduction under 163(j) will be limited for tax purposes based on a calculation of 30% of its EBITDA on a tax basis. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act, which we refer to as the "U.S. CARES ACT," was signed into law. The U.S. CARES Act, among other things, includes provisions related to net operating loss carryback periods, modifications to the interest deduction limitation. The U.S. CARES Act increased the adjusted taxable income limitation from 30% to 50% for business interest deductions for tax years beginning in 2019 and 2020. This modification increased the allowable interest expense deduction and resulted in additional net operating loss (NOL) for the year 2019 and lower current taxable income (before NOL utilization) for the Company. Additionally, the U.S. CARES Act allowed us to fully offset 2020 taxable income with prior years' NOL carried forward. The Company has determined, based upon available evidence, that is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax assets. Valuation allowances of $83,788, and $72,530 have been established at December 31, 2022 and 2021, respectively. The Company may also be subject to the net operating loss utilization provisions of Section 382 of the Internal Revenue Code due to ownership changes. As a result, the use of NOL carry forwards from the current and prior periods are subject to annual limitations. The Tax Cuts and Jobs Act (TCJA) requires taxpayers to capitalize and amortize research and experimental (R&D) expenditures under section 174 for tax years beginning after December 31, 2021. This rule became effective for the Company during the year and resulted in the capitalization of R&D costs of $16,560. The Company will amortize these costs for tax purposes over five years if the R&D was performed in the U.S. and over 15 years if the R&D was performed outside the U.S. Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that there were no uncertain positions as of December 31, 2022 and 2021. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for the years ended December 31, 2022 and 2021. The Company’s U.S. federal and state net operating losses have occurred since its election to be treated as a C Corporation in 2017 and. as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. In early 2020, the U.S. Internal Revenue Service began an examination of the Company’s federal income tax return for 2018 which was concluded in 2021 with no significant adjustments required. A reconciliation of income tax benefit and the amount computed by applying the statutory federal income tax rates of 21% to loss before taxes for the year ended December 31, 2022 and 2021, respectively, as follows: Year Ended December 31, 2022 2021 Income taxes at statutory rate 21.00 % 21.00 % Increase (decrease) resulting from: State income tax 4.23 5.28 Permanent differences (0.20) (0.15) Research & development credit 0.20 0.12 Return to provision 0.11 (0.63) Valuation allowance (20.69) (22.37) State rate change (4.67) (2.63) Other — (0.74) Effective tax rate (0.02) % (0.12) % On July 1, 2018, the New Jersey governor signed into law a bill which included significant changes to the New Jersey taxation of corporations. Chiefly, this legislation imposes a 2.5% surtax on taxpayers with allocated net income over $1 million for 2018 and 2019, and a 1.5% surtax for taxpayers with allocated net income over $1 million for 2020 and 2021. Subsequently, on September 29, 2020, Assembly Bill 4721 extended the additional corporation business tax surtax of 2.5% for the tax years 2020 through 2023. In addition, the state is changing its filing requirements from separate entity reporting to combined reporting on a water’s edge basis. In 2023, the Pennsylvania corporate rate will be decreasing by one percentage point to 8.99%, followed by an annual 0.5% reduction through 2031, ending with a corporate tax rate of 4.99%. Further, there are changes to the state’s computation of its dividend received deduction and application of IRC section 163(j). The Company has considered these changes and does not believe this change in law will have a material impact due to availability of significant New Jersey NOL carryforwards to set off against future taxable income and a full valuation allowance against the net deferred tax assets. |
Contingencies
Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
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, we 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, we 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, and the Company and Indivior preserved our rights to appeal the claim construction ruling. On June 28, 2022, pursuant to a settlement agreement between the parties, the Court entered a Stipulation and Order of Dismissal, dismissing all claims and counterclaims with prejudice in the lawsuit. 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 with a suit 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 the Company 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, and the Company and Indivior preserved the right to appeal the claim construction ruling. On November 21, 2019, Alvogen filed an amended answer and counterclaims asserting monopolization, attempted monopolization, and conspiracy to monopolize against the Company and Indivior under federal and New Jersey antitrust laws. The court denied the Company’s motion to dismiss Alvogen’s counterclaims on August 24, 2020. On November 2, 2020, Alvogen filed a second amended answer and counterclaims, removing its allegations of monopolization and attempted monopolization against the Company and asserting only conspiracy to monopolize against the Company. Fact discovery on Alvogen’s antitrust counterclaims concluded on January 29, 2021. Expert discovery concluded on October 8, 2021, and dispositive motions were filed on October 26, 2021. The Court heard oral argument on the dispositive motions on August 29, 2022, and the parties are awaiting a ruling from the Court. There is no trial date 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 losses, if any, in this matter. Reckitt Benckiser Pharmaceuticals, Inc. and MonoSol Rx, LLC v. BioDelivery Sciences International, Inc. and Quintiles Commercials US, Inc. (BDSI 2014 Lawsuit) On September 22, 2014, the Company and Indivior initiated a lawsuit against 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. 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 April 15, 2021, the court lifted the stay of the litigation in the Eastern District of North Carolina. On April 29, 2021, BDSI filed a renewed motion to dismiss the complaint. In response, the Company and Indivior 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, have completed claim construction briefing, and are proceeding with fact discovery. The court may schedule a claim construction hearing, 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, which BDSI opposed. On March 16, 2021, the court issued an order granting-in-part and denying-in-part the Company’s motion to dismiss BDSI’s counterclaims asserting unenforceability of the ’167 patent. The Company 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 the Company’s complaint, which the Company opposed. 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 the BDSI 2014 Lawsuit 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 the Company 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 its 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, and briefing on summary judgment motions was completed on May 28, 2021. The hearing on Aquestive’s motion for summary judgment was held on May 18, 2022 and, on October 19, 2022, the Court entered an order dismissing all claims against the Company in the lawsuit. The order dismissing all claims against the Company could be appealed by the plaintiffs in this case. The Company is not able to determine or predict whether the plaintiffs will appeal the order or 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 Actions 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 the Company 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 the Company, 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 the Company and Indivior in the Eastern District of Missouri. The counsel representing Humana is also representing Centene. 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 in the Eastern District of Pennsylvania 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”). Also, on August 20, 2021, Humana filed a complaint in state court in Kentucky, alleging the same causes of action previously filed in the federal case in the Eastern District of Pennsylvania. That state court action remains stayed pending further action from the court following resolution of the federal appeal in the Third Circuit. On December 15, 2022, the Third Circuit issued an opinion and order affirming the district court’s dismissal of the Centene and Humana actions. The Company is not able to determine or predict the ultimate outcome of the state court action in Kentucky by Humana, or provide a reasonable estimate or range of estimates of the possible outcome or loss, if any, in this matter. California Litigation Neurelis, Inc. v. Aquestive Therapeutics, Inc. On December 5, 2019, Neurelis Inc. 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 (“UCL”); (2) Defamation; and (3) Malicious Prosecution. Neurelis filed a First Amended Complaint on December 9, 2019, alleging the same three causes of action. 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 parties cross-appealed the ruling to the California Court of Appeal. The appeals court held oral argument on the appeal on October 14, 2021, and issued its ruling on November 17, 2021. Under the ruling, the court struck the entirety of the malicious prosecution claim and struck portions of the UCL and defamation claims. On April 12, 2022, Neurelis filed a Second Amended Complaint in response to the Court of Appeal's decision. The Second Amended Complaint also added a cause of action for Trade Libel. On May 3, 2022, the Company filed a "demurrer" challenge to the sufficiency of the allegations of the Second Amended Complaint. Oral argument on the Company’s motion for attorney fees related to the anti-SLAPP motion and on the Second Amended Complaint and demurer challenge was held on June 17, 2022. The Court entered an order granting the Company’s motion for attorney fees, awarding $155,907.50 and ordering Neurelis to pay the fees within 60 days of June 17, 2022. The Court denied the Company’s demurrer and the parties are proceeding with discovery on the claims in the Second Amended Complaint. No trial date has 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. Federal Securities Class Action Deanna Lewakowski v. Aquestive Therapeutics, Inc., et al. 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 June 25, 2021. Defendants filed a motion to dismiss on August 16, 2021, which became fully briefed as of November 1, 2021. There is no date set for a hearing on the motion 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. Shareholder Derivative Litigation Loreen Niewenhuis v. Keith Kendall, et al. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Continued Utilization of the At-The-Market Facility The Company continued utilization of its "at-the-market" (ATM) facility from January 1 through March 7, 2023 and sold 1,078,622 shares which generated net proceeds of approximately $964. Partial Redemption of 12.5% Senior Secured Notes due 2025 On November 4, 2022 and December 16, 2022, the Company issued two separate notices of partial redemption pursuant to the indenture, dated as of July 15, 2021 (the “Indenture”), between the Company and U.S. Bank Trust Company, National Association (as successor in interest to U.S. Bank National Association) as trustee and collateral agent governing its 12.5% Senior Secured Notes due 2025 (the “12.5% Notes”). On January 3, 2023 and February 14, 2023, the Company redeemed $3,765 and $1,882 of its outstanding 12.5% Notes, respectively. In addition to the two principal repayments along with accrued and unpaid interest, the Company also paid $352 in prepayment premium as result of the early retirement of debt, which will be reflected on the Company's Condensed Consolidated Statements of Operations and Comprehensive Loss in the first quarter of 2023. The result of these two prepayments reduced the net balance of the 12.5% Notes outstanding in the aggregate to $45,853. Amendment to the Indivior Commercial Exploitation Agreement Effective as of March 2, 2023, the Company entered into Amendment No. 11 (the “Indivior Amendment”) to the Commercial Exploitation Agreement (the “Indivior Agreement"), dated as of August 15, 2008, with Indivior Inc. (formerly, Reckitt Benckiser Pharmaceuticals Inc., and referred to herein as “Indivior”). The Indivior Amendment was entered into for the primary purpose of amending the Agreement as follows: (i) extending the term of the Agreement until August 16, 2026 and thereafter providing for automatic renewal terms of successive one year periods unless Indivior delivers notice to the Company, at least twelve months prior to the expiration of the then current term, of Indivior’s intent not to renew, subject to the earlier termination rights of the parties under the Agreement, and providing that the Agreement will not automatically renew for any renewal term beginning after the expiration of the last to expire of the product patents; and (ii) agreeing to transfer pricing and payment terms for supplied product. In addition, Indivior agreed to pay the Company reimbursable amounts due to the Company under the Agreement. In consideration of the agreements between the parties, the Company received a payment of $11,482 from Indivior, of which amount $5,482 represents: (a) payment of the portion of a 2022 price increase that had not been previously paid and (b) an estimated payment in 2023 for certain price increases. The payments will be reflected on the Company's Condensed Consolidated Statements of Operations and Comprehensive Loss in 2023. Patent Litigation Settlement with BioDelivery Sciences International, Inc. ("BDSI") The Company reached a settlement effective March 3, 2023 in the patent infringement lawsuits related to the sale of BDSI’s Bunavail and Belbuca drug film products in the United States. Under the terms of the settlement agreement, all pending patent claims have been resolved between BDSI and Aquestive, as well as Indivior Inc., co-plaintiff in the Belbuca lawsuit, in exchange for a one-time, lump-sum payment of $8,500 to the Company. This settlement continues the Company's focus on resolving outstanding litigation matters, where possible and appropriate. The payment will be reflected on the Company's Condensed Consolidated Statements of Operations and Comprehensive Loss in 2023. Expansion of Licensing and Supply Agreement with Pharmanovia Effective March 27, 2023, the Company amended its exclusive license and supply agreement with Pharmanovia ("Pharmanovia Amendment") for its patented diazepam buccal film formulation. The Pharmanovia Amendment expanded the scope of territory to cover the rest of the world, excluding US, Canada and China. Pharmanovia will be responsible for seeking appropriate regulatory approval in the expanded territories, which includes Latin America, Africa and Asia Pacific. Pursuant to the terms of the Pharmanovia Amendment, the Company received a non-refundable payment of $2,000 from Pharmanovia in connection with the Pharmanovia Amendment execution. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | These consolidated financial statements have been prepared in accordance with Generally Accepted Accounting Principles ("GAAP") in the United States of America, and in accordance with the rules and regulations of the Securities and Exchange Commission ("SEC"). The accounts of wholly owned subsidiaries are included in the consolidated financial statements. Other than corporate formation activities, no such subsidiaries have conducted any commercial, developmental or operational activities and none have customers or vendors. Certain reclassifications were made to conform to the current presentation. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Use of Estimates | Use of EstimatesThe preparation of financial statements in conformity with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and assumptions often involve assessments of matters that are inherently uncertain and accordingly actual results could differ from those estimates. Significant items subject to estimates and assumptions include those related to revenue recognition, inventory costs, allowances for rebates from proprietary product sales, allowances for sales returns, the useful lives of fixed assets, the valuations of warrants issued and of share-based compensation, and contingencies. |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company considers all short-term, highly liquid investments purchased with original maturities of three months or less to be cash equivalents. |
Concentration of Credit Risk | Concentration of Credit RiskCash and cash equivalents are maintained are held by federally insured financial institutions that management believes are of high credit quality. The Company has not experienced any losses in such accounts and such amounts may exceed federally-insured limits of $250. |
Trade Accounts Receivable | Trade Accounts Receivable Trade accounts receivable are recorded at the invoiced amount and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables. The Company’s credit terms generally range from 30 to 60 days, depending on the customer and type of invoice. The Company performs a regular review of our customers' credit risk and payment histories, including payments made subsequent to year-end. |
Inventories | Inventories Inventories, consisting of purchased materials, direct labor and manufacturing overhead, are stated at the lower of cost, determined by the first-in, first-out method, or net realizable value. The Company regularly reviews its inventories for impairment and reserves are established when necessary. |
Property and Equipment | Property and EquipmentProperty and equipment are stated at cost net of accumulated depreciation and amortization, which is computed by the straight-line method based on the estimated useful lives of the respective assets, as discussed below. Leasehold improvements are amortized over the shorter of the lease terms or the estimated useful lives of the leased assets. Maintenance and repair costs are charged to expense as incurred, and expenditures for major renewals and improvements are capitalized. Upon disposition of property and equipment, the related cost and accumulated depreciation and amortization are removed from the accounts, and any gain or loss is reflected in the accompanying Consolidated Statements of Operations and Comprehensive Loss. |
Intangible Assets | Intangible Assets Intangible assets include the costs of acquired composition and process technologies, the costs of purchased patents used in the manufacture of orally soluble film and the costs of acquired New Drug Application (NDA). The Company amortizes these assets using the straight-line method over the shorter of their legal lives or estimated useful lives. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long lived assets, such as property, plant, and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. In these circumstances, the Company compares undiscounted cash flows expected to be generated by that asset or asset group to the corresponding carrying amounts. If this comparison is indicative of impairment, an impairment charge is recognized to the extent that the carrying amount exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered most appropriate. |
Leases | Leases Determination if an arrangement is a lease is made at inception. An arrangement is determined to contain a lease if the contract conveys the right to control the use of an identified property and equipment for a period of time in exchange for consideration. If the Company can benefit from the various underlying assets of a lease on their own or together with other resources that are readably available, or if the various underlying assets are neither highly dependent or highly interrelated with underlying assets in the arrangements, they are considered to be a separate lease component. In the event multiple underlying assets are identified, the lease consideration is allocated to the various components based on each on the component's relative fair value. Operating lease assets represent our right to use an underlying asset for the lease term and operating lease liabilities represent an obligation to make lease payments arising from the lease arrangement. Operating lease assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, in determining the operating lease liability, the Company uses an estimate of our incremental borrowing rate. The calculation of the operating lease assets includes any lease payments made and excludes any lease incentives. Our lease terms may include options to extend or terminate the lease and are included when it is reasonably certain that the Company will exercise the option. |
Liability Related to the Sale of Future Revenue | Liability Related to the Sale of Future RevenueThe Company treats the liability related to the sale of future revenue as debt financing, amortized under the effective interest rate method over the estimated life of the related expected royalty stream. The liability related to the sale of future revenue and the related interest expense are based on our current estimates of future royalties expected to be paid over the life of the arrangement. The Company will periodically assess the expected royalty payments using a combination of internal projections and forecasts from third-party manufacturers. To the extent our future estimates of royalty payments are greater or less than previous estimates or the interest timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related interest expense. Royalty revenue related to the sale of future revenue is reflected as royalty revenue, and amortization of debt is reflected as interest expense related to the sale of future revenue in the Consolidated Statement of Operations and Comprehensive Loss. |
Revenue Recognition | Revenue Recognition The Company’s revenues include (i) sales of manufactured products pursuant to contracts with commercialization licensees, (ii) sales of the Company's proprietary clobazam-based Sympazan oral film product used as a treatment for LGS-related seizures prior to its outlicensing to Assertio Holdings, Inc. ("Assertio") in October 2022, (iii) license and royalty revenues and (iv) co-development and research fees generally in the form of milestone payments. See Note 5, Revenues and Trade Receivables, Net for further details. 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. 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 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 . Sale 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 accounts 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 as a reduction of revenue. 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 Revenue – 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. Royalties based on sales of licensed products have been recorded in this manner. 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 Food and Drug Administration ("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 occur 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 Consolidated Balance Sheet. 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 Consolidated Balance Sheets. As remaining performance obligations are satisfied, an appropriate portion of the deferred revenue balance is credited to earnings. Costs to obtain contracts - in certain situations, the Company may incur incremental costs of obtaining a contract with a customer. These costs, if expected to be recovered, are recognized as an asset and reflected as other assets within the Consolidated Balance Sheets. The asset is amortized on a systematic basis that is consistent with the transfer to the customer of the goods or services to which the asset relates. |
Research and Development | Research and Development Research and development, or R&D, expenses are recorded in accordance ASC 730, Research and Development and are expensed as incurred. R&D expenses include R&D activities, services of external contract research organizations, or CROs, costs of their clinical research sites, scale-up and validation costs, and other activities. Internal R&D activity expenses include laboratory supplies, salaries, benefits, and non-cash share-based compensation expenses. CRO activities include preclinical laboratory experiments and clinical studies. Other activity expenses include regulatory consulting and other costs. The activities undertaken by a regulatory consultants that were classified as R&D expense include assisting, communicating with, and advise our in-house staff with respect to various FDA submission processes, clinical trial processes and scientific writing matters, including preparing protocols and FDA submissions. These consulting expenses were direct costs associated with preparing, receiving and understanding work for our clinical trials and investigative drugs. Payments made to CROs based on agreed-upon terms, which may include payments in advance of a study start date. The Company expenses non-refundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when goods or services have been received rather than when payment was made. The Company reviews and accrues CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion state of study as provided by CRO's. Estimated CRO costs subject to revisions as such studies progress to completion. The Company charges revisions to expense in the period when the facts that give rise to the revision become known. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes , or ASC 740, which provides for deferred taxes using an asset and liability approach. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Tax benefits are recognized when it is more likely than not that a tax position will be sustained during an audit. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. Uncertain tax positions are accounted for in accordance with the provision of ASC 740. When uncertain tax positions exist, the tax benefit is recognized to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not had any significant uncertain tax positions. |
Share-Based Compensation | Share-Based Compensation The Company records share-based compensation expenses for awards of stock options and restricted stock units (RSUs) under ASC 718, Compensation — Stock Compensation . For awards to non-employees for periods prior to the adoption of ASU 2018-07, Compensation-Stock Compensation: Improvements to Non-employee Share-Based Payment Accounting, on January 1, 2019, the Company had applied ASC 505-50, Equity-based Payments to Non-Employees . ASC 718 establishes guidance for the recognition of expenses arising from the issuance of stock-based compensation awards at their fair value at the grant date. The Company’s stock-based compensation includes grants of stock options and restricted stock units (RSUs) to employees, consultants and non-employee directors. Beginning in 2019, the Company also offered employees an opportunity to participate in an employee stock purchase plan. Expenses arising from these grants are recorded in the accompanying financial statements based on their grant date fair values as ratably earned during their respective vesting periods. The Company’s estimates of the fair value of options at their grant dates is based on the Black-Scholes option valuation model and considers various variables and assumptions, including: • the stock price at the grant date, • exercise price, • both the contractual and estimated expected term of the option, • an estimate of stock price volatility based on that of an industry peer group, • expected dividends, • no dividends for the foreseeable future, and • risk-free interest rate. |
Per Share Data | Per Share Data Basic net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted net income per common share is calculated by dividing net income available to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of Common Stock and dilutive Common Stock outstanding during the period. Potentially dilutive common shares include the shares of Common Stock issuable upon the exercise of outstanding stock options and warrants, the shares of issued but unvested RSUs and the purchase of shares from the Company’s employee stock purchase plan (using the treasury stock method). For all periods presented, potential common shares have been excluded from the calculation of EPS because their effect would be anti-dilutive. |
Comprehensive Loss | Comprehensive LossComprehensive loss includes net loss as well as other changes in stockholders’ equity that may result from transactions and economic events other than those with stockholders, such as unrealized gains or losses on investments. |
Fair Value Measurements | 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 — Quoted prices in active markets for identical assets or liabilities. Cash and cash equivalents consisted of cash in bank checking accounts and money market funds which are all Level 1 assets. • Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. The Company currently has no Level 2 assets or liabilities. • Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including 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, accrued expenses and deferred revenue approximate fair value based on the short-term maturity of these assets and liabilities. The Company previously granted warrants to certain holders of the Company's 12.5% Senior Secured Notes due 2025 (the 12.5% Notes") in connection with its debt repayment and debt refinancing. Additionally in 2022, the Company issued pre-funded warrants and Common Stock warrants to certain purchasers in connection with the Securities Purchase Agreements. The warrants were valued based on the Black-Scholes valuation model performed by 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 13, Warrants for further information on these warrants. |
Segment Information | Segment InformationOperating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company manages its operations as a single segment for purposes of assessing performance and making operating decisions. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements As a public emerging growth company, the Company has elected to take advantage of the extended transition period afforded by 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 by the relevant dates on which adoption of such standards is required for public emerging growth companies. From time to time, new accounting pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. Recently Adopted Accounting Pronouncements: None. Recent Accounting Pronouncements Not Adopted as of December 31, 2022: 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 June 2022, the FASB issued ASU 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . This Accounting Standards Update was issued to clarify the guidance in Topic 820, Fair Value Measurement, when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security, and to introduce new disclosure requirements for such equity securities. 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 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 Company adopted the new guidance on January 1, 2023. The adoption of this guidance did not have a material impact on the Company's 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 Company adopted the new guidance on January 1, 2023. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements. |
Revenues and Trade Receivable_2
Revenues and Trade Receivables, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenues and Trade Receivables, Net [Abstract] | |
Summary of Revenue | The Company’s revenue was comprised of the following: Year Ended December 31, 2022 2021 Manufacture and supply revenue $ 36,378 $ 35,312 License and royalty revenue 2,351 5,380 Co-development and research fees 1,293 1,635 Proprietary product sales, net 7,658 8,505 Revenues $ 47,680 $ 50,832 |
Disaggregation of Revenue | The following table provides disaggregated net revenue by geographic area: Year Ended December 31, 2022 2021 United States $ 39,921 $ 42,860 Ex-United States 7,759 7,972 Revenues $ 47,680 $ 50,832 |
Summary of Accounts Receivable, Net | Trade and other receivable, net consist of the following: December 31, 2022 2021 Accounts receivable $ 3,274 $ 9,678 Contract and other receivables 2,139 3,087 Less: allowance for bad debt (40) (40) Less: sales-related allowances (669) (605) Trade and other receivables, net $ 4,704 $ 12,120 |
Summary of Sales-related Allowances | The following table presents the changes in sales-related allowances: December 31, 2022 2021 Balance at December 31, 2021 $ 605 $ 416 Provision related to sales in 2022 1,365 1,209 Credits and payments (1,301) (1,020) Balance at December 31, 2022 $ 669 $ 605 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory, net | Inventory consists of the following: December 31, 2022 2021 Raw material $ 1,899 $ 1,442 Packaging material 2,914 1,414 Finished goods 967 1,182 Total inventory $ 5,780 $ 4,038 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | December 31, Useful Lives 2022 2021 Machinery 3 - 15 years $ 19,810 $ 19,250 Furniture and fixtures 3 - 15 years 769 769 Leasehold improvements (a) 21,375 21,265 Computer, network equipment and software 3 - 7 years 2,627 2,469 Construction in progress 1,467 1,162 46,048 44,915 Less: accumulated depreciation and amortization (41,963) (39,860) Total property and equipment, net $ 4,085 $ 5,055 (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) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Schedule of Operating Lease Liabilities Maturities | The Company's payments due under its operating leases are as follows: Amount 2023 $ 1,050 2024 1,006 2025 1,034 2026 1,060 2027 1,079 2028-2033 4,927 Total lease payments 10,156 Less: imputed interest (4,816) Total operating lease liabilities $ 5,340 |
Intangible Assets, Net and Ot_2
Intangible Assets, Net and Other non-current assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Intangible Assets, Net and Other Assets [Abstract] | |
Schedule of Finite Lived - Intangible Assets | The following table provides the components of identifiable intangible assets, all of which are finite lived and other non-current assets: December 31, 2022 2021 Purchased intangible $ 3,858 $ 2,358 Purchased patent 509 509 4,367 2,867 Less: accumulated amortization (2,932) (2,816) Intangible assets, net 1,435 51 Royalty receivable 5,000 6,000 Other 1,451 903 Total other non-current assets $ 6,451 $ 6,903 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: December 31, 2022 2021 Accrued compensation $ 6,389 $ 5,965 Real estate and personal property taxes 322 349 Accrued distribution expenses 1,012 2,224 Other 244 198 Total accrued expenses $ 7,967 $ 8,736 |
12.5% Senior Secured Notes an_2
12.5% Senior Secured Notes and Loans Payable (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt Maturities | A debt maturity table as of December 31, 2022 is presented below: 2023 $ 18,025 2024 21,888 2025 11,587 Total $ 51,500 |
Sale of Future Revenues (Tables
Sale of Future Revenues (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Royalty Obligation Activity | The following table shows the activity of the liability related to the sale of future revenue for the year ended December 31, 2022: Liability related to the sale of future revenue, net at December 31, 2021 $ 60,284 Royalties related to the sale of future revenue (916) Amortization of issuance costs 208 Interest expense related to the sale of future revenue 5,683 Liability related to the sale of future revenue, net (includes current portion of $1,147) $ 65,259 |
Other Non-Current Liabilities (
Other Non-Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Asset Retirement Obligation Disclosure [Abstract] | |
Liability for Asset Retirement Obligations | Below is a schedule of activity in the Company’s liability for AROs for the year ended December 31, 2022 and 2021. Balance at December 31, 2020 $ 1,525 Additions — Accretion 187 Balance at December 31, 2021 1,712 Additions 110 Accretion 167 Balance at December 31, 2022 $ 1,989 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Therefore, basic and diluted net loss per share were the same for all periods presented below. Year Ended December 31, 2022 Year Ended December 31, 2021 Numerator: Net loss $ (54,410) $ (70,539) Denominator: Weighted-average number of common shares – basic and diluted 48,734,377 38,077,660 Loss per common share – basic and diluted $ (1.12) $ (1.85) |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense | The Company recognized share-based compensation in its Consolidated Statements of Operations during the periods presented as follows: Expense classification: Year Ended December 31, 2022 Year Ended December 31, 2021 Manufacture and supply $ 203 $ 313 Research and development 672 881 Selling, general and administrative 3,506 5,625 Total share-based compensation expenses $ 4,381 $ 6,819 Share-based compensation from: Restricted Stock Units 127 81 Stock Options 4,244 6,714 Employee Stock Purchase Plan 10 24 Total share-based compensation expenses $ 4,381 $ 6,819 |
Summary of Restricted Stock Units | The following table summarizes the Company’s awards of restricted stock units for the years during 2021 and 2022: Number Weighted Average (In thousands) Unvested, December 31, 2020 14 $ 11.38 Granted — — Forfeited (2) 13.00 Vested (12) 11.14 Unvested, December 31, 2021 — Granted 192 2.37 Forfeited (20) 2.21 Vested (10) 2.55 Unvested, December 31, 2022 162 $ 2.38 |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity for the years during 2021 and 2022: (in 000s, except share price data) Number Weighted Weighted Aggregate Outstanding at December 31, 2020 3,259 $ 8.14 8.42 $ 2,978 Granted 1,212 $ 4.73 Forfeited and Expired (264) $ 7.52 Exercised (61) Outstanding at December 31, 2021 4,146 $ 7.28 7.88 $ 1,423 Granted 2,015 1.83 Forfeited and Expired (133) $ 7.81 Exercised — $ — Outstanding at December 31, 2022 6,028 $ 5.48 7.50 $ 38 Vested and expected to vest at December 31, 2022 5,877 $ 5.57 7.46 $ 36 Exercisable at December 31, 2022 3,652 $ 7.42 6.57 $ — |
Summary of Stock Option Valuation Assumptions | The fair values of stock options granted were estimated using the Black-Scholes model based on the following assumptions: Year Ended December 31, 2022 2021 Expected dividend yield 0% 0% Expected volatility 100% 100% Expected term (years) 5.50 - 6.13 5.50 - 6.00 Risk-free interest rate 2.0% —% 4.3% 0.5% —% 1.5% Exercise prices $0.71 - $2.55 $3.76 - $5.30 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effect of temporary differences between the tax bases of assets and liabilities and their financial reporting amounts that give rise to the deferred tax assets and deferred tax liabilities as of December 31, 2022 and 2021 are as follows: December 31, 2022 2021 Deferred tax assets: Accounts receivable $ 177 $ 149 Inventory 449 100 Accrued expenses 1,063 309 NOL carryforwards 32,197 28,722 Interest limitation imposed by the TJCA 10,667 9,022 Stock Compensation 5,813 5,003 Other 2,408 2,122 Sale of Future Revenue 17,139 16,595 Property and equipment 2,576 2,566 Orphan Drug and R&D Tax Credits 5,625 5,490 Accrued debt fees 697 726 Intangible assets 1,731 2,547 Section 174 R&D Capitalization 3,770 — 84,312 73,351 Deferred tax liabilities: 481(a) adjustment — (14) Prepaid expenses (524) (807) (524) (821) Valuation Allowance (83,788) (72,530) Net deferred tax asset/(liability) $ — $ — |
Schedule of Income Tax Benefit Reconciliation | A reconciliation of income tax benefit and the amount computed by applying the statutory federal income tax rates of 21% to loss before taxes for the year ended December 31, 2022 and 2021, respectively, as follows: Year Ended December 31, 2022 2021 Income taxes at statutory rate 21.00 % 21.00 % Increase (decrease) resulting from: State income tax 4.23 5.28 Permanent differences (0.20) (0.15) Research & development credit 0.20 0.12 Return to provision 0.11 (0.63) Valuation allowance (20.69) (22.37) State rate change (4.67) (2.63) Other — (0.74) Effective tax rate (0.02) % (0.12) % |
Company Overview and Equity T_2
Company Overview and Equity Transactions (Details) | 12 Months Ended | 25 Months Ended | ||||||
Sep. 07, 2022 USD ($) | Jun. 06, 2022 USD ($) shares | Mar. 26, 2021 USD ($) | Sep. 11, 2019 USD ($) $ / shares | Dec. 31, 2022 USD ($) licensedCommercializedProduct $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) licensedCommercializedProduct $ / shares shares | Apr. 12, 2022 USD ($) | |
Class of Stock [Line Items] | ||||||||
Number of licensed commercialized products | licensedCommercializedProduct | 5 | 5 | ||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Cost of common stock issued under equity offering | $ (289,000) | $ (1,291,000) | ||||||
Ownership limitation, maximum percent of beneficial ownership | 9.99% | |||||||
Common stock, shares outstanding (in shares) | shares | 54,827,734 | 41,228,736 | 54,827,734 | |||||
Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock issued under equity offering (in shares) | shares | 2,860,538 | 6,550,486 | ||||||
Equity Distribution Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, aggregate offering price | $ 25,000,000 | |||||||
Common stock, par or stated value per share (in dollars per share) | $ / shares | $ 0.001 | |||||||
Equity Distribution Agreement | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, aggregate offering price | $ 35,000 | |||||||
At The Market Offering, Amendment One | Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of stock, aggregate offering price | $ 50,000,000 | |||||||
At The Market Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Consideration received on sale of stock | $ 3,907,000 | $ 29,778,000 | $ 39,740,000 | |||||
Remaining amount available for offering | 33,416,000 | |||||||
Number of shares issued in transaction (in shares) | shares | 10,341,957 | |||||||
Lincoln Park Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Consideration received on sale of stock | $ 1,987,000 | |||||||
Right to sell common stock, value | $ 40,000 | |||||||
Agreement term (in months) | 36 months | |||||||
Number of shares issued in transaction (in shares) | shares | 1,600,000 | |||||||
Commitment shares issued (in shares) | shares | 236,491 | |||||||
Securities Purchase Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares outstanding (in shares) | shares | 4,850,000 | |||||||
Common stock entitled to purchasers by pre-funded warrants (in shares) | shares | 4,000,000 | |||||||
Stock to be purchased by common stock warrants (in shares) | shares | 8,850,000 | |||||||
Net proceeds after placement agent fees, expenses, and offering expenses payable | $ 7,796,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Trade Accounts Receivable (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Allowance for doubtful accounts | $ 40 | $ 40 |
Minimum | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Trade receivables, period for credit term | 30 days | |
Maximum | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Trade receivables, period for credit term | 60 days |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Revenue from Contracts with Customers (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Research and development project duration | 3 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Fair Value Measurements (Details) - USD ($) | Dec. 31, 2022 | Jul. 15, 2019 |
Senior Secured Notes Due 2025 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Interest rate | 12.50% | |
Senior Secured Notes Due 2025 | Senior Notes | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Interest rate | 12.50% | 12.50% |
Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, fair value disclosure | $ 0 | |
Liabilities, fair value disclosure | $ 0 |
Risks and Uncertainties - Narra
Risks and Uncertainties - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | 25 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2020 | Jul. 15, 2019 | |
Unusual Risk or Uncertainty [Line Items] | |||||
Cash and cash equivalents | $ 27,273 | $ 28,024 | $ 27,273 | $ 31,807 | |
Accumulated deficit | 311,207 | 256,796 | $ 311,207 | ||
Cost of common stock issued under equity offering | $ (289) | $ (1,291) | |||
Common Stock | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Common stock issued under equity offering (in shares) | 2,860,538 | 6,550,486 | |||
At The Market Offering | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Number of shares issued in transaction (in shares) | 10,341,957 | ||||
Consideration received on sale of stock | $ 3,907 | $ 29,778 | $ 39,740 | ||
Payments of stock issuance costs | $ 2,053 | ||||
Remaining amount available for offering | $ 33,416 | ||||
Senior Secured Notes Due 2025 | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Interest rate | 12.50% | 12.50% | |||
Senior Secured Notes Due 2025 | Senior Notes | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Interest rate | 12.50% | 12.50% | 12.50% |
Revenues and Trade Receivable_3
Revenues and Trade Receivables, Net - Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 47,680 | $ 50,832 |
Manufacture and supply revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 36,378 | 35,312 |
License and royalty revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 2,351 | 5,380 |
Co-development and research fees | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,293 | 1,635 |
Proprietary product sales, net | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 7,658 | $ 8,505 |
Revenues and Trade Receivable_4
Revenues and Trade Receivables, Net - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 47,680 | $ 50,832 |
United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 39,921 | 42,860 |
Ex-United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 7,759 | $ 7,972 |
Revenues and Trade Receivable_5
Revenues and Trade Receivables, Net - Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Revenues and Trade Receivables, Net [Abstract] | ||
Accounts receivable | $ 3,274 | $ 9,678 |
Contract and other receivables | 2,139 | 3,087 |
Less: allowance for bad debt | (40) | (40) |
Less: sales-related allowances | (669) | (605) |
Trade and other receivables, net | $ 4,704 | $ 12,120 |
Revenues and Trade Receivable_6
Revenues and Trade Receivables, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Concentration Risk [Line Items] | ||
Contract and other receivables | $ 2,139 | $ 3,087 |
Allowance for doubtful accounts | $ 40 | $ 40 |
Commercial Exploitation Agreement with Indivior | Receivables | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Concentrations of risk | 80% | 51% |
Commercial Exploitation Agreement with Indivior | Revenue | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Concentrations of risk | 76% | 73% |
Cardinal | Receivables | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Concentrations of risk | 12% |
Revenues and Trade Receivable_7
Revenues and Trade Receivables, Net - Changes in Sales-Related Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning Balance | $ 605 | $ 416 |
2022 | 1,365 | 1,209 |
Credits and payments | (1,301) | (1,020) |
Ending balance | $ 669 | $ 605 |
Material Agreements (Details)
Material Agreements (Details) $ in Thousands | 2 Months Ended | 3 Months Ended | 12 Months Ended | 17 Months Ended | 26 Months Ended | ||||||||||
Mar. 02, 2023 USD ($) | Nov. 01, 2022 USD ($) | Oct. 26, 2022 USD ($) | Sep. 26, 2022 USD ($) | May 17, 2022 USD ($) vestingPeriod day | Nov. 03, 2020 USD ($) | Apr. 01, 2016 USD ($) | Dec. 31, 2020 USD ($) | Jun. 30, 2020 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Feb. 20, 2019 USD ($) | Dec. 31, 2022 USD ($) | Mar. 03, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 47,680 | $ 50,832 | |||||||||||||
Pro rata portion of target bonus | $ 280 | ||||||||||||||
Cash payment representing 90 days of base pay | $ 150 | ||||||||||||||
Days of base pay | day | 90 | ||||||||||||||
Severance costs | $ 263 | ||||||||||||||
Number of installments | vestingPeriod | 3 | ||||||||||||||
Severance period (in months) | 18 months | ||||||||||||||
Coverage duration | 18 months | ||||||||||||||
Consulting fee | $ 10 | ||||||||||||||
Assertio Holdings, Inc | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from collaborators | $ 9,000 | ||||||||||||||
Contingent consideration, milestone payments | $ 6,000 | ||||||||||||||
First Seven Months | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Severance costs | 53 | ||||||||||||||
Eighth Month | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Severance costs | 70 | ||||||||||||||
Ninth through Eighteenth Month | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Severance costs | $ 88 | ||||||||||||||
License and royalty revenue | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | 2,351 | 5,380 | |||||||||||||
Royalty | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ (916) | ||||||||||||||
Royalty | Minimum | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 8,000 | ||||||||||||||
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 | Subsequent Event | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
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 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 22 | ||||||||||||||
Milestone payment, no longer receivable | 23,000 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | Royalty | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 8,000 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc Milestones | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | 17,000 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc Milestones | License and royalty revenue | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 4,000 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. Upfront | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 5,000 | ||||||||||||||
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 | ||||||||||||||
Atnahs Pharma UK Limited | License & Supply Agreement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from sale of future revenue | $ 3,500 | ||||||||||||||
Haisco Pharmaceutical Group Co., Ltd, Upfront Payment | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Contract with customer, receivable, after allowance for credit loss | $ 7,000 | ||||||||||||||
CLA KemPharm | License and royalty revenue | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 2 | ||||||||||||||
Suboxone Agreements Settlement | Subsequent Event | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 11,482 | ||||||||||||||
Deferred revenue, revenue recognized | $ 5,482 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 1,899 | $ 1,442 |
Packaging material | 2,914 | 1,414 |
Finished goods | 967 | 1,182 |
Total inventory | $ 5,780 | $ 4,038 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 46,048 | $ 44,915 |
Less: accumulated depreciation and amortization | (41,963) | (39,860) |
Total property and equipment, net | 4,085 | 5,055 |
Depreciation and amortization | 2,270 | 2,912 |
Machinery | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 19,810 | 19,250 |
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 |
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 | $ 21,375 | 21,265 |
Computer, network equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,627 | 2,469 |
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 | $ 1,467 | $ 1,162 |
Right-of-Use Assets and Lease_3
Right-of-Use Assets and Lease Obligations - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) lease | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Number of leases | lease | 3 | |
Right-of-use assets, net | $ 5,211 | $ 2,725 |
Lease cost | 1,753 | 1,725 |
Variable lease expense | $ 449 | $ 469 |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Remaining lease term | 3 months | |
Minimum | Accounting Standards Update 2016-02 | ||
Lessee, Lease, Description [Line Items] | ||
Discount rate | 14.80% | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Remaining lease term | 10 years 9 months 18 days | |
Maximum | Accounting Standards Update 2016-02 | ||
Lessee, Lease, Description [Line Items] | ||
Discount rate | 16.90% |
Right-of-Use Assets and Lease_4
Right-of-Use Assets and Lease Obligations - Maturities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Leases [Abstract] | |
2023 | $ 1,050 |
2024 | 1,006 |
2025 | 1,034 |
2026 | 1,060 |
2027 | 1,079 |
2028-2033 | 4,927 |
Total lease payments | 10,156 |
Less: imputed interest | (4,816) |
Total operating lease liabilities | $ 5,340 |
Intangible Assets, Net and Ot_3
Intangible Assets, Net and Other non-current assets - Schedule of Finite Lived Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | $ 4,367 | $ 2,867 |
Less: accumulated amortization | (2,932) | (2,816) |
Intangible assets, net | 1,435 | 51 |
Royalty receivable | 5,000 | 6,000 |
Other | 1,451 | 903 |
Total other non-current assets | 6,451 | 6,903 |
Purchased intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 3,858 | 2,358 |
Purchased patent | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | $ 509 | $ 509 |
Intangible Assets, Net and Ot_4
Intangible Assets, Net and Other non-current assets - Narrative (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Jun. 30, 2020 USD ($) minimumGuaranteedRoyalty | |
Intangible Assets, Net and Other Assets [Abstract] | |||
Amortization expense | $ 116 | $ 51 | |
Estimated amortization expense | $ 156 | ||
Number of $1,000 annual minimum guaranteed royalties | minimumGuaranteedRoyalty | 5 | ||
Minimum royalty receivable | $ 1,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 6,389 | $ 5,965 |
Real estate and personal property taxes | 322 | 349 |
Accrued distribution expenses | 1,012 | 2,224 |
Other | 244 | 198 |
Total accrued expenses | $ 7,967 | $ 8,736 |
12.5% Senior Secured Notes an_3
12.5% Senior Secured Notes and Loans Payable - Narrative (Details) | 12 Months Ended | |||||||||
Oct. 07, 2021 USD ($) | Nov. 03, 2020 USD ($) vestingPeriod shares | Jul. 15, 2019 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 16, 2022 USD ($) | Nov. 04, 2022 USD ($) | May 15, 2022 vestingPeriod | Aug. 06, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | |
Debt Instrument [Line Items] | ||||||||||
Warrants issued (in shares) | shares | 2,000,000 | |||||||||
Exercise price of warrants (in usd per share) | $ / shares | $ 0.001 | |||||||||
Net proceeds from issuance of initial notes, warrants and first offer rights | $ 66,082,000 | |||||||||
Number of transactions | vestingPeriod | 2 | |||||||||
Premium on early retirement of debt | $ 2,250,000 | |||||||||
Consent fee payment | $ 2,025,000 | $ 0 | ||||||||
Loss on the extinguishment of debt | 0 | 13,822,000 | ||||||||
Amortization of debt issuance costs and discounts | $ 215,000 | 3,731,000 | ||||||||
Maximum | Marathon Pangolin Royalty LLC | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of cash proceeds | 30% | |||||||||
Senior Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Proceeds from issuance of debt | 4,000,000 | |||||||||
Payments of loan costs | $ 220,000 | |||||||||
Senior Secured Notes Due 2025 | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 12.50% | |||||||||
Principal amount | $ 70,000,000 | |||||||||
Warrants issued (in shares) | shares | 714,000 | |||||||||
Warrants issued to purchase common stock (in shares) | shares | 143,000,000 | |||||||||
Additional borrowing capacity | $ 30,000,000 | |||||||||
Redemption percentage of debt under change of control provisions | 101% | |||||||||
Debt instrument, amount redeemed | $ 1,882,000 | $ 3,765,000 | ||||||||
Amortization of debt issuance costs and discounts | $ 16,000 | 3,572,000 | ||||||||
Unamortized deferred debt issuance cost and deferred debt discounts | 27,000 | 43,000 | ||||||||
Senior Secured Notes Due 2025 | Put Option | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Fair value | $ 45,000 | |||||||||
Senior Secured Notes Due 2025 | Put Option | Other Noncurrent Liabilities | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Fair value | 98,000 | |||||||||
Senior Secured Notes Due 2025 | Maximum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 100,000,000 | |||||||||
Elective redemption percentage of debt | 112.50% | |||||||||
Senior Secured Notes Due 2025 | Minimum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Elective redemption percentage of debt | 101.56% | |||||||||
Senior Secured Notes Due 2025 | Senior Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest rate | 12.50% | 12.50% | ||||||||
Retirement of debt | $ 22,500,000 | |||||||||
Long-term debt | $ 70,000,000 | $ 51,500,000 | $ 51,500,000 | |||||||
Repurchase price percentage | 112.50% | |||||||||
Consent fee payment | $ 2,700,000 | |||||||||
Number of quarterly payments | vestingPeriod | 4 | |||||||||
Loss on the extinguishment of debt | $ 13,822,000 | |||||||||
Senior Secured Notes Due 2025 - First Additional Offering | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Additional borrowing capacity | 10,000,000 | |||||||||
Senior Secured Notes Due 2025 - First Additional Offering | Maximum | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants issued (in shares) | shares | 2,143,000 | |||||||||
Senior Secured Notes Due 2025 - Second Additional Offering | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Additional borrowing capacity | $ 20,000,000 |
12.5% Senior Secured Notes an_4
12.5% Senior Secured Notes and Loans Payable - Debt Maturities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 18,025 |
2023 | 21,888 |
2024 | $ 11,587 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Aug. 06, 2021 | Jul. 15, 2019 | |
Class of Warrant or Right [Line Items] | |||||
Warrants issued (in shares) | 2,000,000 | ||||
Fair value of warrants issued | $ 5,874 | $ 5,874 | |||
Class of warrant or right, warrants exercised (in shares) | 0 | 0 | |||
Exercise price of warrants (in usd per share) | $ 0.001 | ||||
Pre-Funded Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants issued (in shares) | 4,000,000 | ||||
Common Stock Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants issued (in shares) | 8,850,000 | ||||
Maximum | Common Stock Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants (in usd per share) | $ 1.09 | ||||
Minimum | Common Stock Warrants | |||||
Class of Warrant or Right [Line Items] | |||||
Exercise price of warrants (in usd per share) | $ 0.96 | ||||
Senior Secured Notes Due 2025 | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants issued (in shares) | 714,000 | ||||
Fair value of warrants issued | $ 6,800 | ||||
Interest rate | 12.50% | ||||
Senior Secured Notes Due 2025 | Senior Notes | |||||
Class of Warrant or Right [Line Items] | |||||
Interest rate | 12.50% | 12.50% | |||
2020 Additional Notes | |||||
Class of Warrant or Right [Line Items] | |||||
Fair value of warrants issued | $ 735 | ||||
Senior Secured Notes Due 2025 - First Additional Offering | Maximum | |||||
Class of Warrant or Right [Line Items] | |||||
Warrants issued (in shares) | 2,143,000 |
Sale of Future Revenue - Narrat
Sale of Future Revenue - Narrative (Details) - USD ($) $ in Thousands | 2 Months Ended | 3 Months Ended | 12 Months Ended | 26 Months Ended | ||
Nov. 03, 2020 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||||||
Payments of financing costs | $ 2,909 | |||||
Revenues | $ 47,680 | $ 50,832 | ||||
Minimum royalty receivable | $ 1,000 | |||||
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 | |||||
Royalty | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Revenues | $ (916) | |||||
Royalty | License Agreement with Sunovion Pharmaceuticals, Inc. | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Revenues | $ 8,000 | |||||
Maximum | Marathon Pangolin Royalty LLC | ||||||
Disaggregation of Revenue [Line Items] | ||||||
Proceeds from sale of future revenue | $ 125,000 |
Sale of Future Revenue - Royalt
Sale of Future Revenue - Royalty Obligation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Sale of Future Revenue [Roll Forward] | ||
Liability related to the sale of future revenue, net at December 31, 2021 | $ 60,284 | |
Royalties related to the sale of future revenue | 47,680 | $ 50,832 |
Amortization of issuance costs | 208 | |
Interest expense related to the sale of future revenue | 5,683 | 12,253 |
Liability related to the sale of future revenue, net (includes current portion of $1,147) | 65,259 | $ 60,284 |
Current portion of liability related to sale of future revenue | 1,147 | |
Royalty | ||
Sale of Future Revenue [Roll Forward] | ||
Royalties related to the sale of future revenue | $ (916) |
Other Non-Current Liabilities -
Other Non-Current Liabilities - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 15, 2019 | |
Debt Instrument [Line Items] | ||||
Asset retirement obligation | $ 1,712 | $ 1,525 | ||
Depreciation expense related to ARO | $ 25 | 23 | ||
Put Option | ||||
Debt Instrument [Line Items] | ||||
Asset retirement obligation | $ 1,989 | 675 | ||
Senior Secured Notes Due 2025 | ||||
Debt Instrument [Line Items] | ||||
Interest rate | 12.50% | |||
Senior Secured Notes Due 2025 | Put Option | ||||
Debt Instrument [Line Items] | ||||
Fair value | $ 45 | |||
Senior Secured Notes Due 2025 | Other Noncurrent Liabilities | Put Option | ||||
Debt Instrument [Line Items] | ||||
Fair value | $ 98 | |||
Senior Secured Notes Due 2025 | Senior Notes | ||||
Debt Instrument [Line Items] | ||||
Interest rate | 12.50% | 12.50% |
Other Non-Current Liabilities_2
Other Non-Current Liabilities - Summary of Company's Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Asset Retirement Obligation, Roll Forward Analysis [Roll Forward] | ||
Balance at beginning of period | $ 1,712 | $ 1,525 |
Additions | 110 | 0 |
Accretion | $ 167 | 187 |
Balance at ending of period | $ 1,712 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Numerator: | ||
Net loss | $ (54,410) | $ (70,539) |
Denominator: | ||
Weighted-average number of common shares outstanding - basic (in shares) | 48,734,377 | 38,077,660 |
Weighted-average number of common shares outstanding - diluted (in shares) | 48,734,377 | 38,077,660 |
Net loss per share - basic (in usd per share) | $ (1.12) | $ (1.85) |
Net loss per share - diluted (in usd per share) | $ (1.12) | $ (1.85) |
Stock Options | ||
Denominator: | ||
Dilutive securities excluded (in shares) | 6,028,000 | 4,146,000 |
Unvested Restricted Stock Units | ||
Denominator: | ||
Dilutive securities excluded (in shares) | 162,000 | 0 |
Warrant | ||
Denominator: | ||
Dilutive securities excluded (in shares) | 10,564,000 | 1,714,000 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 USD ($) offeringPeriod $ / shares shares | Dec. 31, 2021 $ / shares shares | Dec. 31, 2020 | Dec. 30, 2022 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares available for grant (in shares) | shares | 400,000 | |||
Granted (in dollars per share) | $ / shares | $ 1.83 | $ 4.73 | ||
Share price (in dollars per share) | $ / shares | $ 0.90 | |||
Weighted average remaining contract life | 7 years 6 months | 7 years 10 months 17 days | 8 years 5 months 1 day | |
Granted (in shares) | shares | 2,015,000 | 1,212,000 | ||
Common Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares issued under employee stock purchase plan (in shares) | shares | 45,304 | 40,146 | ||
Restricted Stock Units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in shares) | shares | 192,000 | 0 | ||
Grant date fair value | $ | $ 26 | |||
Unrecognized compensation costs | $ | $ 261 | |||
Vesting period | 2 years 2 months 15 days | |||
Granted (in dollars per share) | $ / shares | $ 2.37 | $ 0 | ||
Restricted Stock Units | Key Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Unrecognized compensation costs | $ | $ 3,433 | |||
Granted (in dollars per share) | $ / shares | $ 1.46 | $ 3.61 | ||
Expected dividend yield | 0% | 0% | ||
Weighted average recognition period | 1 year 10 months 2 days | |||
Term of award | 10 years | |||
Stock Options | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in dollars per share) | $ / shares | $ 0.71 | $ 3.76 | ||
Stock Options | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in dollars per share) | $ / shares | $ 2.55 | $ 5.30 | ||
Stock Options | Key Employees | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Stock Options | Director | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 1 year | |||
Stock Options | Officer | Common Stock | 2022 Equity Inducement Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in shares) | shares | 100,000 | |||
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of yearly offering periods | offeringPeriod | 2 | |||
Offering period term | 6 months | |||
Employee stock purchase plan, purchase price percentage | 85% | |||
Number of shares reserved for issuance (in shares) | shares | 250,000 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | $ 4,381 | $ 6,819 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 127 | 81 |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 4,244 | 6,714 |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 10 | 24 |
Manufacture and supply | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 203 | 313 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 672 | 881 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | $ 3,506 | $ 5,625 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Units | ||
Unvested, at beginning of period (in shares) | 0 | 14 |
Granted (in shares) | 192 | 0 |
Forfeited (in shares) | (20) | (2) |
Vested (in shares) | (10) | (12) |
Unvested, at end of period (in shares) | 162 | 0 |
Weighted Average Grant Date Fair Value Per Share | ||
Unvested, balance at beginning of period (in dollars per share) | $ 11.38 | |
Granted (in dollars per share) | 2.37 | 0 |
Forfeited (in dollars per share) | 2.21 | 13 |
Vested (in dollars per share) | 2.55 | 11.14 |
Unvested, balance at end of period (in dollars per share) | $ 2.38 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Options | |||
Outstanding at beginning of period (in shares) | 4,146 | 3,259 | |
Granted (in shares) | 2,015 | 1,212 | |
Forfeited and Expired (in shares) | (133) | (264) | |
Exercised (in shares) | 0 | (61) | |
Outstanding at end of period (in shares) | 6,028 | 4,146 | 3,259 |
Vested or expected to vest (in shares) | 5,877 | ||
Exercisable at end of period (in shares) | 3,652 | ||
Weighted Average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 7.28 | $ 8.14 | |
Granted (in dollars per share) | 1.83 | 4.73 | |
Forfeited and Expired (in dollars per share) | 7.81 | 7.52 | |
Exercised (in dollars per share) | 0 | ||
Outstanding at end of period (in dollars per share) | 5.48 | $ 7.28 | $ 8.14 |
Vested or expected to vest at end of period (in dollars per share) | 5.57 | ||
Exercisable at end of period (in dollars per share) | $ 7.42 | ||
Weighted Average Remaining Contractual Term in Years | |||
Weighted average remaining contractual term | 7 years 6 months | 7 years 10 months 17 days | 8 years 5 months 1 day |
Weighted average remaining contractual term, vested or expected to vest | 7 years 5 months 15 days | ||
Weighted average remaining contractual term, exercisable | 6 years 6 months 25 days | ||
Aggregate Intrinsic Value | |||
Intrinsic value | $ 38 | $ 1,423 | $ 2,978 |
Intrinsic value, vested or expected to vest at end of period | 36 | ||
Intrinsic value, exercisable at end of period | $ 0 |
Share-Based Compensation - Pric
Share-Based Compensation - Pricing Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Exercise prices (in dollars per share) | $ 1.83 | $ 4.73 |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Stock Options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 100% | 100% |
Expected term (years) | 5 years 6 months | 5 years 6 months |
Risk-free interest rate | 2% | 0.50% |
Exercise prices (in dollars per share) | $ 0.71 | $ 3.76 |
Stock Options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 6 years 1 month 17 days | 6 years |
Risk-free interest rate | 4.30% | 1.50% |
Exercise prices (in dollars per share) | $ 2.55 | $ 5.30 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | ||
Employer contributions | $ 815 | $ 706 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Accounts receivable | $ 177 | $ 149 |
Inventory | 449 | 100 |
Accrued expenses | 1,063 | 309 |
NOL carryforwards | 32,197 | 28,722 |
Interest limitation imposed by the TJCA | 10,667 | 9,022 |
Stock Compensation | 5,813 | 5,003 |
Other | 2,408 | 2,122 |
Sale of Future Revenue | 17,139 | 16,595 |
Property and equipment | 2,576 | 2,566 |
Orphan Drug and R&D Tax Credits | 5,625 | 5,490 |
Accrued debt fees | 697 | 726 |
Intangible assets | 1,731 | 2,547 |
Section 174 R&D Capitalization | 3,770 | 0 |
Deferred tax assets | 84,312 | 73,351 |
Deferred tax liabilities: | ||
481(a) adjustment | 0 | (14) |
Prepaid expenses | (524) | (807) |
Deferred tax liabilities | (524) | (821) |
Valuation Allowance | (83,788) | (72,530) |
Net deferred tax asset/(liability) | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) | Dec. 31, 2022 USD ($) taxPosition | Dec. 31, 2021 USD ($) taxPosition |
Income Tax Disclosure [Line Items] | ||
Valuation allowance | $ 83,788,000 | $ 72,530,000 |
Number of uncertain tax positions | taxPosition | 0 | 0 |
Unrecognized tax benefits | $ 0 | $ 0 |
Penalties and interest accrued | 0 | 0 |
Research and development, costs capitalized | 16,560,000 | |
Domestic Tax Authority | ||
Income Tax Disclosure [Line Items] | ||
Operating loss carryforwards | $ 123,922,000 | 105,722,000 |
Research and development, amortization period (in years) | 5 years | |
State and Local Jurisdiction | ||
Income Tax Disclosure [Line Items] | ||
Operating loss carryforwards | $ 104,238,000 | $ 93,304,000 |
Foreign Tax Authority | ||
Income Tax Disclosure [Line Items] | ||
Research and development, amortization period (in years) | 15 years |
Income Taxes - Statutory Federa
Income Taxes - Statutory Federal Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Income taxes at statutory rate | 21% | 21% |
State income tax | 4.23% | 5.28% |
Permanent differences | (0.20%) | (0.15%) |
Research & development credit | 0.20% | 0.12% |
Return to provision | 0.11% | (0.63%) |
Valuation allowance | (20.69%) | (22.37%) |
State rate change | (4.67%) | (2.63%) |
Other | 0% | (0.74%) |
Effective tax rate | (0.02%) | (0.12%) |
Contingencies (Details)
Contingencies (Details) | May 03, 2022 USD ($) | Sep. 18, 2020 cause | Dec. 05, 2019 cause | Sep. 22, 2016 state |
Loss Contingencies [Line Items] | ||||
Number of states that brought a lawsuit | state | 41 | |||
Humana Inc. v. Aquestive Therapeutics, Inc. | ||||
Loss Contingencies [Line Items] | ||||
Pending claim | 5 | |||
Neurelis, Inc. v. Aquestive Therapeutics, Inc. | ||||
Loss Contingencies [Line Items] | ||||
Pending claim | 3 | |||
Litigation settlement, amount awarded from other party | $ | $ 155,907.5 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | 1 Months Ended | 2 Months Ended | 12 Months Ended | 25 Months Ended | ||||||||||
Mar. 27, 2023 | Mar. 03, 2023 | Mar. 02, 2023 | Feb. 14, 2023 | Mar. 07, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | Jan. 03, 2023 | Dec. 16, 2022 | Nov. 04, 2022 | Dec. 31, 2020 | Nov. 03, 2020 | Jul. 15, 2019 | |
Subsequent Event [Line Items] | ||||||||||||||
Loss on the extinguishment of debt | $ 0 | $ 13,822 | ||||||||||||
Senior Secured Notes Due 2025 | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Interest rate | 12.50% | 12.50% | ||||||||||||
Debt instrument, amount redeemed | $ 1,882 | $ 3,765 | ||||||||||||
Senior Secured Notes Due 2025 | Senior Notes | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Interest rate | 12.50% | 12.50% | 12.50% | |||||||||||
Loss on the extinguishment of debt | 13,822 | |||||||||||||
Long-term debt | $ 51,500 | $ 51,500 | $ 51,500 | $ 70,000 | ||||||||||
Subsequent Event | Patent Litigation Settlement With BioDelivery Sciences International, Inc | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Litigation settlement, amount awarded from other party | $ 8,500 | |||||||||||||
Subsequent Event | Suboxone Agreements Settlement | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Revenues | $ 11,482 | |||||||||||||
Deferred revenue, revenue recognized | $ 5,482 | |||||||||||||
Subsequent Event | Licensing and Supply Agreement with Pharmanovia | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Revenues | $ 2,000 | |||||||||||||
Subsequent Event | Senior Secured Notes Due 2025 | Senior Notes | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Debt instrument, amount redeemed | $ 1,882 | $ 3,765 | ||||||||||||
Loss on the extinguishment of debt | 352 | |||||||||||||
Long-term debt | $ 45,853 | |||||||||||||
At The Market Offering | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Consideration received on sale of stock | $ 3,907 | $ 29,778 | $ 39,740 | |||||||||||
Number of shares issued in transaction (in shares) | 10,341,957 | |||||||||||||
At The Market Offering | Subsequent Event | ||||||||||||||
Subsequent Event [Line Items] | ||||||||||||||
Consideration received on sale of stock | $ 964 | |||||||||||||
Number of shares issued in transaction (in shares) | 1,078,622 |