Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 01, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
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 | false | ||
Entity Shell Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction | false | ||
Entity Public Float | $ 82.7 | ||
Entity Common Stock, Shares Outstanding | 73,301,201 | ||
Entity Central Index Key | 0001398733 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Firm ID | 185 |
Auditor Name | KPMG LLP |
Auditor Location | Short Hills, New Jersey |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 23,872 | $ 27,273 |
Trade and other receivables, net | 8,471 | 4,704 |
Inventories, net | 6,769 | 5,780 |
Prepaid expenses and other current assets | 1,854 | 2,131 |
Total current assets | 40,966 | 39,888 |
Property and equipment, net | 4,179 | 4,085 |
Right-of-use assets, net | 5,557 | 5,211 |
Intangible assets, net | 1,278 | 1,435 |
Other non-current assets | 5,438 | 6,451 |
Total assets | 57,418 | 57,070 |
Current liabilities: | ||
Accounts payable | 8,926 | 9,946 |
Accrued expenses | 6,497 | 7,967 |
Lease liabilities, current | 390 | 255 |
Deferred revenue | 1,551 | 1,513 |
Liability related to the sale of future revenue, current | 922 | 1,147 |
Notes payable, current | 22 | 18,700 |
Total current liabilities | 18,308 | 39,528 |
Notes payable, net | 27,508 | 33,448 |
Royalty obligations, net | 14,761 | 0 |
Liability related to the sale of future revenue, net | 63,568 | 64,112 |
Lease liabilities | 5,399 | 5,085 |
Deferred revenue, net of current portion | 32,345 | 31,417 |
Other non-current liabilities | 2,016 | 2,034 |
Total liabilities | 163,905 | 175,624 |
Contingencies (Note 22) | ||
Stockholders’ deficit: | ||
Common stock, 0.001 par value. Authorized 250,000,000 shares; 68,533,085 and 54,827,734 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 69 | 55 |
Additional paid-in capital | 212,521 | 192,598 |
Accumulated deficit | (319,077) | (311,207) |
Total stockholders’ deficit | (106,487) | (118,554) |
Total liabilities and stockholders’ deficit | $ 57,418 | $ 57,070 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
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) | 68,533,085 | 54,827,734 |
Common stock, shares outstanding (in shares) | 68,533,085 | 54,827,734 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Revenues | $ 50,583 | $ 47,680 |
Costs and expenses: | ||
Manufacture and supply | 20,831 | 19,386 |
Research and development | 13,104 | 17,481 |
Selling, general and administrative | 31,750 | 52,879 |
Total costs and expenses | 65,685 | 89,746 |
Loss from operations | (15,102) | (42,066) |
Other income (expenses): | ||
Interest expense | (6,337) | (6,552) |
Interest expense related to royalty obligations, net | (905) | 0 |
Interest expense related to the sale of future revenue | (220) | (5,891) |
Interest income and other income, net | 16,321 | 99 |
Loss on the extinguishment of debt | (1,382) | 0 |
Net loss before income taxes | (7,625) | (54,410) |
Income taxes | (245) | 0 |
Net loss | (7,870) | (54,410) |
Comprehensive loss | $ (7,870) | $ (54,410) |
Net loss per share – basic and diluted | ||
Basic (in dollars per share) | $ (0.13) | $ (1.12) |
Diluted (in dollars per share) | $ (0.13) | $ (1.12) |
Weighted-average number of common shares outstanding - basic and diluted | ||
Basic (in shares) | 61,255,864 | 48,734,377 |
Diluted (in shares) | 61,255,864 | 48,734,377 |
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, 2021 | 41,228,736 | ||||||
Beginning 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) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Common stock issued under equity offering (in shares) | 4,958,341 | ||||||
Common stock issued under equity offering | 9,464 | $ 5 | 9,459 | ||||
Cost of common stock issued under equity offering | (552) | (552) | |||||
Common stock issued upon warrant exercises (in shares) | 8,689,452 | ||||||
Common Stock issued upon warrant exercises | 8,342 | $ 9 | 8,333 | ||||
Costs of common stock issued under private equity offering | (35) | (35) | |||||
Shares issued under employee stock purchase plan (in shares) | 36,168 | ||||||
Shares issued under employee stock purchase plan | 66 | 66 | |||||
Vested restricted stock units (in shares) | 19,515 | ||||||
Vested restricted stock units | (11) | (11) | |||||
Share-based compensation expense | 2,662 | 2,662 | |||||
Options, exercises (in shares) | 1,875 | ||||||
Options exercised | 1 | 1 | |||||
Other | 0 | 0 | 0 | ||||
Net loss | (7,870) | (7,870) | |||||
Balance (in shares) at Dec. 31, 2023 | 68,533,085 | ||||||
Ending balance at Dec. 31, 2023 | $ (106,487) | $ 69 | $ 212,521 | $ (319,077) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (7,870) | $ (54,410) |
Adjustments to reconcile net loss to net cash used for operating activities: | ||
Depreciation, amortization, and impairment | 1,345 | 2,387 |
Share-based compensation | 2,689 | 4,381 |
Amortization of debt issuance costs and discounts | 1,972 | 215 |
Interest expense related to the sale of future revenue | 0 | 5,683 |
Loss on the extinguishment of debt | 1,029 | 0 |
Other, net | (204) | (52) |
Changes in operating assets and liabilities: | ||
Trade receivables and other receivables, net | (3,073) | 7,352 |
Inventories | (989) | (1,743) |
Prepaid expenses and other assets | 1,290 | 1,399 |
Accounts payable | (1,020) | 1,633 |
Accrued expenses and other liabilities | (2,515) | (2,382) |
Deferred revenue | 966 | 25,043 |
Notes Payable | 0 | 675 |
Net cash used for operating activities | (6,380) | (9,819) |
Cash flows from investing activities: | ||
Capital expenditures | (995) | (1,024) |
Additions to intangible assets | 0 | (1,500) |
Net cash used for investing activities | (995) | (2,524) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under public equity offering, net | 8,912 | 3,907 |
Proceeds from common stock and warrants issued under private equity offering, net | 0 | 9,679 |
Proceeds from exercise of warrants, net | 8,307 | 0 |
Proceeds from shares issued under employee stock purchase plan | 39 | 34 |
Proceeds from exercise of stock options | 1 | 0 |
Proceeds from issuance of debt | 31,144 | 0 |
Proceeds from issuance of Royalty Rights Agreements | 13,856 | 0 |
Debt repayments | (51,529) | 0 |
Payments for financing costs | (4,643) | 0 |
Premium paid to retire debt | (2,102) | (2,025) |
Payments for taxes on share-based compensation | (11) | (3) |
Net cash provided by financing activities | 3,974 | 11,592 |
Net decrease in cash and cash equivalents | (3,401) | (751) |
Cash and cash equivalents: | ||
Beginning of period | 27,273 | 28,024 |
End of period | 23,872 | 27,273 |
Supplemental disclosures of cash flow information: | ||
Cash payments for interest | $ 4,602 | $ 6,436 |
Company Overview and Equity Tra
Company Overview and Equity Transactions | 12 Months Ended |
Dec. 31, 2023 | |
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 subsidiaries, “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 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 ATM facility pursuant to which the Company may offer up to $25,000 worth of shares of 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 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, 2023, the Company sold 4,958,341 shares which provided net proceeds of approximately $8,962 after deducting commissions and other transaction costs of $502. This ATM facility has approximately $23,952 available at December 31, 2023. 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. On April 12, 2022, the Company entered into the Lincoln Park Purchase Agreement, which provides that, upon the terms and subject to the conditions and limitations under 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 the Company's 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%, which is equivalent to 6,486,623 shares at December 31, 2023. 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 our Common Stock. For the year ended December 31, 2023, the Company did not sell shares in connection with the Lincoln Park Purchase Agreement. For the year ended December 31, 2022, the Company sold 1,600,000 shares in addition to issuing 236,491 commitment shares, which provided proceeds of approximately $1,987 in connection with the Lincoln Park Purchase Agreement. On June 6, 2022, the Company entered into the Securities Purchase Agreements which 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 used the net proceeds from the offering for general corporate purposes. The pre-funded warrants were fully exercised in 2022. On June 14, 2023, warrants to purchase 3,689,452 shares of Common Stock issued pursuant to the Securities Purchase Agreements were exercised with proceeds paid to the Company thereon of approximately $3,542. On August 1, 2023, the Company entered into the Letter Agreement with a holder (the “Exercising Holder”) of 5,000,000 of the remaining Common Stock Warrants. Pursuant to the Letter Agreement, the Exercising Holder and the Company agreed that the Exercising Holder would exercise all of its Common Stock Warrants for shares of Common Stock lying thereunder at $0.96 per share of Common Stock, the exercise price of the Common Stock Warrants. Pursuant to the Letter Agreement, in consideration of the Exercising Holder exercising the 5,000,000 Common Stock Warrants, the Company issued New Warrants to the Exercising Holder to purchase up to an aggregate of 2,750,000 shares of Common Stock to the Exercising Holder. The New Warrants are exercisable after February 2, 2024, expire on February 2, 2029 and are issuable only for cash, subject to exception if exercise of the New Warrants is not registered in accordance with the terms of the Letter Agreement, in which case the New Warrants may also be exercised, in whole or in part, at such time by means of a "cashless exercise". The New Warrants have an exercise price of $2.60 per share. On August 2, 2023, 5,000,000 of the Common Stock Warrants were exercised pursuant to the Securities Purchase Agreement with the Exercising Holder, with the Company receiving gross proceeds therefrom of $4,800. In total, warrants to exercise 8,689,452 shares of Common Stock issued pursuant to the Securities Purchase Agreements, with proceeds of approximately $8,342 paid to the Company thereon, were exercised during the year ended December 31, 2023. The Company incurred $35 in relation to this transaction. |
Basis of Presentation and Princ
Basis of Presentation and Principles of Consolidation | 12 Months Ended |
Dec. 31, 2023 | |
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 GAAP in the United States of America, and in accordance with the rules and regulations of the 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 year presentation. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and ASU of FASB. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
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 prior to out-licensing to Assertio, allowances for sales returns, the useful lives of fixed assets and the valuations of warrants issued, royalty obligations, sale of future revenues, 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, 2023 and 2022, cash and cash equivalents consisted of cash in bank accounts. Concentration of Credit Risk Cash and cash equivalents 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, 2023 and 2022 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 its 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 $14 and $40 as of December 31, 2023 and 2022, 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 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. The impairment charge of $216 was recognized for the year ended December 31, 2023. No impairment was recognized for the year ended December 31, 2022. 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 nor 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 the Company's 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 its 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 are 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. During the year ended December 31, 2023, the Company recognized a lease supporting its manufacturing facilities as a finance lease. Commitments under finance leases are not significant, and are included in Property and equipment, net; Notes Payable, current and Notes Payable, net on the Consolidated Balance Sheets. Royalty Obligations, net In connection with the issuance of the 13.5% Notes, the Company entered into a Royalty Rights Agreement with each of the Note Holders granting the Note Holders a tiered royalty between 1.0% and 2.0% of annual worldwide net sales of Anaphylm (epinephrine) Sublingual Film for a period of eight eight Long-Term Debt , to its consolidated financial statements. 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 its current estimates of future royalties expected to be paid over the life of the arrangement. The Company periodically assesses the expected royalty payments using a combination of internal projections and forecasts from external resources. To the extent its future estimates of royalty payments are greater or less than previous estimates or the timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related interest expense. Amortization of debt is reflected as interest expense related to the sale of future revenue in the Consolidated Statements of Operations and Comprehensive Loss. For further discussion of the sale of the future revenue, see Note 16, 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 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 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, net 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 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. CROs activities include preclinical laboratory experiments and clinical studies. Other activity expenses include regulatory consulting and other costs. The activities undertaken by regulatory consultants that were classified as R&D expense include assisting, communicating with, and advise its 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 its 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 CROs 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 CROs. Estimated CROs 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 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. The Company’s estimates of the fair value of options at their grant dates are 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, if any, and • risk-free interest rate. The Company’s estimates of the fair value of RSUs at their grant or valuation dates vary based on whether the awards' vesting conditions are based on market conditions or service conditions. For awards with the vesting based on market conditions, the Company uses a Monte Carlo simulation that considers various variables and assumptions, including: • simulated 30-day average at the end of the requisite service period, • discount period based on the vesting term of the awards • an estimate of stock price volatility based on that of an industry peer group, • expected dividends, if any, 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 RSUs and stock option awards over the requisite service period of the awards. All excess tax benefits, taxes and tax deficiencies from stock-based compensation are included in the provision for income taxes in the Company's Consolidated Statements of Operations and Comprehensive Loss. 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, 2023 and 2022, 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 accounts 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 the 12.5% Notes in connection with its debt repayment and debt refinancing. The Company also issued pre-funded warrants and warrants in 2022 and warrants in 2023 to purchase shares of Common Stock 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 15, Warrants for further information on these warrants. The Company's 12.5% Notes contained a repurchase offer or put option which gave 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 14, Long-Term Debt for further discussion. In connection with the issuance of the 13.5% Notes on November 1, 2023, the Company and the Note Holders entered into the Royalty Right Agreements. The Royalty Right Agreements were valued based on Level 3 inputs, and their fair value is estimated by applying probability-weighted cash flows for future sales, which are then discounted to present value. Changes to fair value of the Royalty Rights Agreements can result from changes to one or a number of the aforementioned inputs. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the Royalty Right Agreements liability. During the remainder of 2023, there were no material changes to the significant unobservable inputs used to recognize the Royalty Right Agreements liability. See Note 14, Long-Term Debt 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 The Company complies with new or revised accounting standards by the relevant dates on which adoption of such standards is required for smaller reporting 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: 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. In September 2022, the FASB issued ASU 2022-04, Liabilities-Supplier Finance Programs (Topic 405-50) Disclosure of Supplier Finance Program Obligations , to increase the transparency of supplier finance programs regarding the use of such programs by the buyer party (that is, the disclosing entity) and the programs’ effects on an entity’s working capital, liquidity, and cash flows. ASU 2022-04 is effective for all entities for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The requirement on rollforward information is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Adopted as of December |
Risks and Uncertainties
Risks and Uncertainties | 12 Months Ended |
Dec. 31, 2023 | |
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 2024 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, 2023, the Company had $23,872 of cash and cash equivalents. The Company has experienced a history of net losses. The Company’s accumulated deficit totaled $319,077 as of December 31, 2023. 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 13.5% Notes. The Company began utilizing its ATM facility in November 2020. Since inception to December 31, 2023, the Company sold 15,300,298 shares of Common Stock which generated net cash proceeds of approximately 48,703, net of commissions and other transaction costs of 2,555. For the year ended December 31, 2023, the Company sold 4,958,341 shares which provided net proceeds of approximately $8,962 after deducting commissions and other transaction costs of $502. This ATM facility has approximately $23,952 available at December 31, 2023. 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 cash equivalents, expense management activities, including, but not limited to the ceasing of R&D activities, as well as access to the equity capital markets through its ATM facility (see Note 23 , Subsequent Events) 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, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenues and Trade Receivables, Net | Revenues and Trade Receivables, Net The Company’s revenue was comprised of the following: Year Ended December 31, 2023 2022 Manufacture and supply revenue $ 43,805 $ 36,378 License and royalty revenue 5,376 2,351 Co-development and research fees 1,402 1,293 Proprietary product sales, net — 7,658 Revenues $ 50,583 $ 47,680 Disaggregation of Revenue The following table provides disaggregated net revenue by geographic area: Year Ended December 31, 2023 2022 United States $ 37,104 $ 40,792 Ex-United States 13,479 6,888 Revenues $ 50,583 $ 47,680 Trade and other receivable, net consist of the following: December 31, 2023 2022 Accounts receivable $ 5,570 $ 3,274 Contract and other receivables 2,915 2,139 Less: allowance for bad debt (14) (40) Less: sales-related allowances — (669) Trade and other receivables, net $ 8,471 $ 4,704 Contract and other receivables totaled $2,915 and $2,139 as of December 31, 2023 and 2022, 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. Sales-related allowances as of December 31, 2022 were 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. The following table presents the changes in the allowance for doubtful accounts: December 31, 2023 2022 Allowance for doubtful accounts at beginning of the period $ 40 $ 40 Allowance expense (reduction) (26) — Write-downs charged against the allowance — — Allowance for doubtful accounts at end of the period $ 14 $ 40 The allowance for doubtful accounts was $14 and $40 for each of the years ending December 31, 2023 and 2022. There was a reduction of $26 to th e allowance for doubtful accounts for the year ended December 31, 2023. There were no additions to or write-downs for the year ended December 31, 2022. The following table presents the changes in sales-related allowances: December 31, 2023 2022 Beginning Balance $ 669 $ 605 Provision related to sales in 2022 — 1,365 Credits and payments (87) (1,301) Reclassifications $ (582) $ — Ending Balance $ — $ 669 Total reductions of gross product sales from sales-related allowances and accruals were $0 the year ended December 31, 2023 due to the outlicensing of Sympazan. Accruals for returns allowances and prompt pay discounts are reflected as a direct reduction of trade receivables and accruals for wholesaler service fees, co-pay support redemptions and rebates as current liabilities. The accrued balances relative to these provisions included in Trade and other receivables, net and Accrued expenses were $0 and $645, respectively, as of December 31, 2023, and $669 and $1,012, respectively, as of December 31, 2022. See Note 13, Accrued Expenses. 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, 2023, Indivor represented approximately 80% of total revenue. As of December 31, 2023, Indivor and Zevra Therapeutics, Inc. represented 65% and 13%, respectively, of total trade and other receivables. For the year ended December 31, 2022, Indivor represented approximately 76% of total revenue. As of December 31, 2022, Indivior represented 80% of total trade and other receivables. |
Material Agreements
Material Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Material Agreements | Material Agreements Commercial Exploitation Agreement with Indivior In August 2008, the Company entered into the Indivior License Agreement (with subsequent amendments) with Reckitt Benckiser Pharmaceuticals, Inc. who was later succeeded to in interest by Indivior. 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 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 an agreed upon purchase price per unit until January 1, 2025 and, thereafter, that is subject to annual adjustments based on changes in an agreed upon price index. 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 renewed for successive one Effective as of March 2, 2023, the Company and Indivior entered into 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 covered under the Indivior License Agreement; and (ii) agreeing to transfer pricing and payment terms for supplied product under the Indivior License 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. As of December 31, 2023, the $5,482 price increase has been fully recognized in Manufacture and supply revenue and $6,000 is included in Interest income and other income, net on the Consolidated Statements of Operations and Comprehensive Loss . 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 Indivior Supplemental 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. No further payments are due to the Company under the Indivior Supplemental Agreement. See Note 22, 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, due on the earlier of: (a) the first day of product availability at a pharmacy in the United States; or (b) within six months of FDA approval of the product. 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. Effective March 16, 2020, the Company entered into 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 .unless earlier terminated under the termination provisions contained therein. 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. 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 have been received to date. With the Monetization Agreement (defined below) entered into on November 3, 2020 relating to KYNMOBI as described in the paragraph below, the Company is no longer entitled to receive any payments under the Sunovion License Agreement. Purchase and Sale Agreement with an affiliate of Marathon On November 3, 2020, the Company entered into the Monetization Agreement with Marathon. Under the terms of the Monetization Agreement, the Company sold to Marathon all of its contractual rights to receive royalties and milestone payments due under the Sunovion License Agreement related to Sunovion’s apomorphine product, KYNMOBI. In exchange for the sale of these rights, the Company received an upfront payment from Marathon 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, 2023 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. In June 2023, Sunovion announced that it has voluntarily withdrawn KYNMOBI from the U.S. and Canadian markets, therefore, the Company likely will not receive any of the additional contingent payments under the Monetization agreement. See Note 16, 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 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 or their derivatives. During the year ended December 31, 2023, the Company has recognized $1,500 as milestone revenues for Zevra. Licensing and Supply Agreement with Haisco for Exservan™ (Riluzole Oral Film) for ALS Treatment in China The Company entered into the Haisco Agreement, pursuant to which Aquestive granted Haisco, a Chinese limited company listed on the Shenzhen Stock Exchange, an exclusive license to develop and commercialize Exservan (riluzole oral film) for the treatment of ALS 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 in September 2022, and will receive regulatory milestone payments and 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 (the “Termination Agreement”). In connection with his departure, Mr. Kendall and the Company entered into a Separation Agreement, including a Consulting 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. Under the Separation Agreement, Mr. Kendall received the following principal severance benefits 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-months severance which 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 of time from the Separation Date to December 31, 2022. For these services, Mr. Kendall received a consulting fee of $10 per month. As of December 31, 2023, all obligations related to Mr. Kendall have been completed. Licensing and Supply Agreement with Atnahs Pharma UK Limited The Company entered into the Pharmanovia Agreement, effective as of September 26, 2022, 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 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 upon the occurrence of certain conditions set forth in the Pharmanovia Agreement will receive additional milestone payments and profit shares, as well as manufacturing fees and royalty fees through the expiration of the Pharmanovia Agreement. Effective March 27, 2023, the Company amended the Pharmanovia Agreement to expand the scope of territory for the license of Libervant to cover the rest of the world, excluding the U.S., Canada and China. Under the Pharmanovia Amendment, Pharmanovia will be responsible for seeking applicable 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 execution of the Pharmanovia Amendment. Licensing Agreement with Assertio Holdings, Inc. Effective as of October 26, 2022, the Company entered into the Assertio Agreement to license Sympazan (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox‐Gastaut syndrome in patients aged two years of age and older. Under the terms of the Assertio Agreement, the Company granted to Assertio an exclusive, worldwide license of its intellectual property for Sympazan to Assertio during the term of the Assertio License Agreement for an upfront payment of $9,000. In addition, Aquestive received a $6,000 milestone payment subsequent to Aquestive’s receipt of a notice of allowance from the PTO of the Company’s patent application U.S. Serial No. 16/561,573, and payment by the Company of the related allowance fee. The Company received the notice of allowance from the PTO and paid the related allowance fee on October 27, 2022. Further, under the Assertio Agreement, the Company will receive royalties from Assertio for the sale of the product through the expiration of the Assertio Agreement. The Company also entered into a long-term supply agreement with Assertio for Sympazan pursuant to which the Company is the exclusive sole worldwide manufacturer and supplier of the product and will receive manufacturing fees from Assertio for the product through the expiration of such supply agreement. |
Financial Instruments _ Fair Va
Financial Instruments – Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Financial Instruments – Fair Value Measurements | Financial Instruments – Fair Value Measurements Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1 — Observable quoted prices in active markets for identical assets or liabilities. • Level 2 — Observable prices that are based on inputs not quoted on active markets but corroborated by market data. • Level 3 — Unobservable inputs that are supported by little or no market activity, such as pricing models, discounted cash flow methodologies and similar techniques. The carrying amounts reported in the balance sheets for trade and other receivables, prepaid and other current assets, accounts payable and accrued expenses, and deferred revenue approximate their fair values based on the short-term maturity of these assets and liabilities. The Company granted warrants to certain noteholders in connection with its debt repayment and debt refinancing during 2020 and 2019, respectively. Those warrants were valued based on Level 3 inputs and their fair value was based primarily on an independent third-party appraisal prepared as of the grant date consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation. See Note 15 , Warrants for further information on these warrants. The Company’s 12.5% Senior Secured Notes contained a repurchase offer or put option which gives holders of the option the right, but not the obligation, to require the Company to redeem the 12.5% Notes up to a capped portion of milestone payments resulting from the Monetization Agreement. This put option was valued based on Level 3 inputs and its fair value was based primarily on an independent third-party appraisal consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants Accounting and Valuation Guide. See Note 14, Long-Term Debt for further discussion. In June 2022, the Company issued pre-funded warrants to purchase up to 4,000,000 shares of Common Stock and Common Stock Warrants to purchase up to 8,850,000 shares of Common Stock in connection with its Securities Purchase Agreements with certain purchasers. Those warrants were valued based on Level 3 inputs and their fair value was based primarily on an independent third-party appraisal prepared as of the grant date consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide. See Note 15 , Warrants for further information on these warrants. On August 1, 2023, the Company entered into the Letter Agreement with the Exercising Holder of the remaining warrants to purchase 5,000,000 of the shares of Common Stock. Pursuant to the Letter Agreement, the Exercising Holder and the Company agreed that the Exercising Holder would exercise all of its Existing Warrants for shares of Common Stock underlying the Existing Warrants at $0.96 per share of Common Stock, the current exercise price of the Existing Warrants. Under the Letter Agreement, in consideration of the Exercising Holder exercising the Existing Warrants, the Company issued to the Exercising Holder new warrants to purchase up to an aggregate of 2,750,000 shares of New Warrants at $2.60 per share. Those warrants were valued based on Level 3 inputs and their fair value was based primarily on an independent third-party appraisal prepared as of the grant date consistent with generally accepted valuation methods of the Uniform Standards of Professional Appraisal Practice, the American Society of Appraisers and the American Institute of Certified Public Accountants’ Accounting and Valuation Guide. See Note 15 , Warrants for further information on these warrants. On November 1, 2023, in connection with the issuance of the 13.5% Notes, the Company and the Note Holders entered into the Royalty Right Agreements dated as of November 1, 2023, which provides the Note Holders: a. a tiered royalty between 1.0% and 2.0% of annual worldwide net sales of Anaphylm (epinephrine) Sublingual Film for a period of eight years from the first sale of Anaphylm on a global basis, and b. a tiered royalty between 1.0% to 2.0% of annual worldwide net sales of Libervant (diazepam) Buccal Film until the earlier of (1) the first sale of Anaphylm and (2) eight years from the first sale of Libervant. Those Royalty Agreements were valued based on Level 3 inputs and their fair value was based primarily on internal management estimates developed based on third-party data and reflect management’s judgements, current market conditions, and forecasts. The initial fair value measurement of the Royalty Right Agreements was determined based on significant unobservable inputs, including the discount rate, estimated probabilities of success, and the estimated amount of future sales of Anaphylm and Libervant. See Note 14, Long-Term Debt for further discussion. |
Inventories, Net
Inventories, Net | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories, Net | Inventories, Net Inventory consists of the following: December 31, 2023 2022 Raw material $ 2,118 $ 1,899 Packaging material 3,028 2,914 Finished goods 1,623 967 Total inventory $ 6,769 $ 5,780 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net December 31, Useful Lives 2023 2022 Machinery 3 - 15 years $ 20,248 $ 19,810 Furniture and fixtures 3 - 15 years 769 769 Leasehold improvements (a) 21,386 21,375 Computer, network equipment and software 3 - 7 years 2,627 2,627 Construction in progress 2,033 1,467 47,063 46,048 Less: accumulated depreciation and amortization (42,884) (41,963) Total property and equipment, net $ 4,179 $ 4,085 (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 was $1,153 and $2,270 for the years ended December 31, 2023 and 2022, respectively. For the year ended December 31, 2023 the Company recognized a $216 impairment of an asset held in Construction in progress account that was assessed by management as no longer usable. Such impairment charge is included in the Manufacture and supply expenses |
Right-of-Use Assets and Lease O
Right-of-Use Assets and Lease Obligations | 12 Months Ended |
Dec. 31, 2023 | |
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 4.25 years and 9.80 years, including renewal options expected to be exercised to extend the lease periods. See Part II, Properties for details. During the year ended December 31, 2023, the Company recognized a lease supporting its manufacturing facilities as a finance lease. Commitments under finance leases are not significant, and are included in Property and equipment, net, Notes Payable, current and Notes Payable, net on the Consolidated Balance Sheets. 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 15.6% 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, 2023 and 2022, total operating lease expenses totaled $1,745 and $1,753, respectively, including variable lease expenses such as common area maintenance and operating costs of $447 and $449, 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 2024 $ 1,230 2025 1,266 2026 1,300 2027 1,328 2028 1,162 2029-2033 3,828 Total lease payments 10,114 Less: imputed interest (4,306) Total operating lease liabilities $ 5,808 |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | Intangible Assets, Net The following table provides the components of identifiable intangible assets, all of which are finite lived. December 31, 2023 2022 Purchased intangible $ 3,858 $ 3,858 Purchased patent 509 509 4,367 4,367 Less: accumulated amortization (3,089) (2,932) Intangible assets, net 1,278 1,435 Amortization expense was $157 and $116 for each of the years ended December 31, 2023 and 2022, respectively. During the remaining life of the purchased intangible, estimated annual amortization expense is $157 for the year ending 2024 and beyond. As of December 31, 2023, the remaining weighted-average life of all intangible assets subject to amortization is 8.1 years. The estimated aggregate amortization expense for each of the following fiscal years ending December 31 is presented below: Amount 2024 $ 157 2025 157 2026 157 2027 157 2028 157 2029-2032 493 Total estimated amortization expenses 1,278 |
Other Non-Current Assets
Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Non-Current Assets | Other Non-Current Assets The following table provides the components of other non-current assets: December 31, 2023 2022 Royalty receivable $ 4,000 $ 5,000 Other 1,438 1,451 Total other non-current assets $ 5,438 $ 6,451 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 eight $1,000 annual minimum guaranteed royalty payments that are due to the Company. 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 it was not transferred. Royalty receivable consists of five annual minimum payments due from Sunovion, the last of which is due in March, 2028. The current portion of the royalty receivable is included in Trade and other receivables, net. See Note 16 . Sale of Future Revenue |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: December 31, 2023 2022 Accrued compensation $ 4,202 $ 6,389 Real estate and personal property taxes 337 322 Accrued distribution expenses 645 1,012 Interest payable 1,013 183 Other 300 61 Total accrued expenses $ 6,497 $ 7,967 The reduction in Accrued compensation is mostly related to payments of accrued severance costs and accrued commission expenses during the year ended December 31, 2023. The increase in Interest payable is due to the timing of interest payments on the 13.5% Senior Notes that were due on January 2nd, 2024. See Note 6, Material Agreements, for a discussion of the Termination agreement with certain officers and related severance accrued expenses recorded in Accrued compensation as of December 31, 2022. See Note 14, Long-Term Debt, for discussion of 13.5% Notes and related interest payable. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt 12.5% Senior Secured Notes On July 15, 2019, the Company completed the private placement of up to $100,000 aggregate principal of its 12.5% Notes due 2025 and issued Warrants to purchase 2,000,000 shares of Common Stock, at $0.001 par value per share. Upon closing of the Base Indenture, the Company issued $70,000 of the 12.5% (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 remained 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 contained 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 was capped at 30% of the cash proceeds received by the Company as the contingent milestones were 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 was deemed to be a derivative under ASC 815 Derivatives and Hedging , which required the recording of the embedded put option at fair value 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 the Company's 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. 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, subject to the full approval of Libervant by the FDA for sale in the United States, which full approval included U.S. market access for Libervant. Because full FDA approval was not obtained by March 31, 2023, the Company's option to access the re-openers expired on such 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 principal 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. As of December 31, 2022, the Company recorded the remaining Consent Fee to be paid of $675 as Notes payable, current, on its Consolidated Balance Sheet. The payment was made in February 2023. The 12.5% Notes provided 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 due as Notes Payable, current and Notes Payable, net on its Consolidated Balance Sheet. The Company could have elected, 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 included change of control provisions under which the Company may have been required to redeem the 12.5% Notes at 101% of the remaining principal plus accrued interest at the election of the noteholders. Collateral for the loan under the 12.5% Notes consisted of a first priority lien on substantially all property and assets, including intellectual property, of the Company. This secured obligation provided 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. 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 and fees. Such partial redemptions occurred in January and February 2023, respectively. The Company also paid $353 in a prepayment premium as a result of the early retirement of debt which was reflected as a loss on extinguishment of debt in Loss on the Extinguishment of Debt in the Company’s Consolidated Statements of Operations and Comprehensive Loss. Further, during 2023 the Company made three scheduled principal payments totaling $11,463. Amortization expense arising from deferred debt issuance costs and debt discounts related to the 12.5% Notes for the years ended December 31, 2023 and December 31, 2022 was $13 and $16, respectively. Unamortized deferred debt issuance costs and deferred debt discounts related to the 12.5% Notes were $0 and $27 as of December 31, 2023 and December 31, 2022, respectively. On November 1, 2023, the Company issued the 13.5% Notes, as described below, and used the proceeds from the issuance to repay the outstanding principal balance under the 12.5% Notes of $36,014, including accrued and unpaid interest and a redemption fee. The Company accounted for this transaction as an extinguishment of debt and recognized a debt extinguishment charge of $1,029 for the year ended December 31, 2023. The debt extinguishment charge is included in Loss on the extinguishment of debt in the Company’s Consolidated Statements of Operations and Comprehensive Loss. 13.5% Senior Secured Notes On November 1, 2023, the Company entered into an Indenture Agreement with certain institutional investors (the “Note Holders”) and issued $45,000 aggregate principal amount of its 13.5% Notes due 2028. The Company received net proceeds of approximately $4,326 from this transaction after the repayment of the 12.5% Notes and deduction of debt discount, and debt issuance costs. The 13.5% Notes are senior secured obligations of the Company and mature on November 1, 2028. The 13.5% Notes bear interest at a fixed rate of 13.5% per year, payable quarterly commencing on December 30, 2023 with the first interest payment due on January 2, 2024. On each payment date commencing on June 30, 2026, the Company will pay an installment of principal of the 13.5% Notes pursuant to a fixed amortization schedule, along with the applicable Exit Fee. The Exit Fee totals $2,000. The Company may, at its option, redeem the 13.5% Notes in full or in part: a. if such redemption occurs prior to November 1, 2025, at a redemption price equal to 100% of the principal amount plus accrued and unpaid interest, plus the applicable Exit Fee, plus an Applicable Premium which is the greater of i. 1.0% of the principal redeemed; and ii. the amount, if any, by which the present value of the principal to be redeemed on November 1, 2025, plus all required interest due on such date, computed using a discount rate equal to the Treasury Rate, plus 100 basis points, exceeds the amount of principal to be redeemed; and b. if such redemption occurs after November 1, 2025, the redemption price is equal to 108.50% of the principal amount plus accrued and unpaid interest, plus the applicable Exit Fee. If the Company undergoes a change of control, the Note Holders may require the Company to repurchase for cash all or any portion of the 13.5% Notes at a change of control repurchase price equal at 108.5% plus the Exit Fee of the remaining principal, plus accrued interest at the election of the Note Holders. The Indenture permits the Company, upon the continuing satisfaction of certain conditions, including that the Company (on a consolidated basis) has at least $100,000 of net revenues for the most recently completed twelve calendar month period, to enter into an asset-based borrowing facility not to exceed $10,000 (the “ABL Facility”). The ABL Facility may be collateralized only by assets of the Company constituting inventory, accounts receivable, and the proceeds thereof. In connection with the issuance of 13.5% Notes, the Company and the Note Holders entered into the Royalty Right Agreements dated as of November 1, 2023, which provides Note Holders: a. a tiered royalty between 1.0% and 2.0% of annual worldwide net sales of Anaphylm (epinephrine) Sublingual Film for a period of eight years from the first sale of Anaphylm on a global basis, and b. a tiered royalty between 1.0% to 2.0% of annual worldwide net sales of Libervant (diazepam) Buccal Film until the earlier of (1) the first sale of Anaphylm and (2) eight years from the first sale of Libervant. Both, the 13.5% Notes and Royalty Right Agreements, represent freestanding instruments which were issued in conjunction with each other. They are classified as debt within the scope of ASC 470, Debt and are subsequently measured on an amortized cost basis. The initial fair value measurement of the Royalty Right Agreements was determined based on significant unobservable inputs, including the discount rate, estimated probabilities of success, and the estimated amount of future sales of Anaphylm and Libervant. These inputs are derived using internal management estimates developed based on third-party data and reflect management’s judgements, current market conditions, and forecasts. The Royalty Right Agreements fair value is estimated by applying probability-weighted cash flows for future sales, which are then discounted to present value. Changes to fair value of the Royalty Rights Agreements can result from changes to one or a number of the aforementioned inputs. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the Royalty Right Agreements liability. During the remainder of 2023, there were no material changes to the significant unobservable inputs used to recognize the Royalty Right Agreements liability. The following table summarizes the significant unobservable inputs used in the initial fair value measurement of the Royalty Right Agreements as of December 31, 2023: Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable) Discount Rate 15% Royalty Right Agreements Probability weighted Probability of Success 75% Projected Years of Payments 2025 - 2033 Since the Royalty Right Agreements were issued in connection with the 13.5% Notes, the Company allocated the proceeds to the two instruments based on their relative fair values. The Company allocated approximately $13,856 to the Royalty Right Agreements. The Company determined the allocated fair value by calculating the present value of estimated future royalties to be paid to Note Holders over the life of the arrangement. The excess of future estimated royalty payments of $56,926 over the $13,856 of allocated fair value is recognized as a discount related to the Royalty Right Agreements and is amortized as interest expense using the effective interest method. Consequently, the Company calculated an imputed rate of interest on the unamortized portion of the Royalty Right Agreements liability, which was approximately 9.68% as of December 31, 2023. The allocated amounts of $13,856 when combined with the Exit Fee of $2,000, original issue discount of $1,125 and debt issuance costs of $3,517, resulted in debt discount of $20,498. The debt discount is being amortized over the term of 13.5% Notes using the effective interest method. Amortization expense arising from the discounts related to the 13.5% Notes and Royalty Right Agreements for the year ended December 31, 2023 was $833 and $905, respectively. Unamortized discounts totaled $17,665 for the 13.5% Notes and $42,165 for Royalty obligations as of December 31, 2023. Long-term notes and unamortized debt discount balances are as follows: December 31, 2023 2022 Total outstanding notes $ 45,000 $ 51,500 Unamortized discount, including Exit Fee (17,665) (27) Current portion of long-term debt — (18,025) Notes payable, long-term $ 27,335 $ 33,448 Finance lease 173 — Notes payable, net $ 27,508 $ 33,448 December 31, 2023 Royalty obligations $ 56,926 Unamortized discount (42,165) Royalty obligations, net $ 14,761 Scheduled principal payments on the 13.5% Notes as of December 31, 2023 are as follows: 2024 $ — 2025 — 2026 9,540 2027 14,535 2028 20,925 Total $ 45,000 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 and December 31, 2022, respectively. Warrants to purchase a total of 1,714,429 shares of Common Stock with exercise prices of $4.25 and $5.38 for 1,571,429 warrants and 143,000 warrants, respectively, remain outstanding as of December 31, 2023 and December 31, 2022. See Note 14. Long-Term Debt. Warrants Issued Under Securities Purchase Agreements In June 2022, the Company issued pre-funded warrants and Common Stock Warrants to certain purchasers in connection with the Securities Purchase Agreements. The pre-funded warrants entitled purchasers to purchase up to 4,000,000 shares of Common Stock and were exercised in full during the year ended as of December 31, 2022. The Common Stock Warrants expire on June 8, 2027 and entitle the purchasers to purchase up to 8,850,000 shares of Common Stock at a price ranging from $0.96 to $1.09 per share. Management estimated the fair value of the pre-funded warrants and Common Stock warrants to be $5,874 based on an assessment by an independent third-party appraiser. The fair value of the pre-funded and Common Stock warrants is treated as equity and is presented in Additional Paid-in Capital in the Company’s Consolidated Balance Sheet. On June 14, 2023, 3,689,452 Common Stock warrants issued pursuant to the Securities Purchase Agreements were exercised with proceeds of approximately $3,542. On August 1, 2023, the Company entered into the Letter Agreement with the Exercising Holder of 5,000,000 of the remaining Common Stock Warrants. Pursuant to the Letter Agreement, the Exercising Holder and the Company agreed that the Exercising Holder would exercise all of its Existing Warrants for shares of Common Stock underlying the Existing Warrants at $0.96 per share of Common Stock, the current exercise price of the Existing Warrants. Under the Letter Agreement, in consideration of the Exercising Holder exercising the Existing Warrants, the Company issued to the Exercising Holder New Warrants to purchase up to an aggregate of 2,750,000 shares of Common Stock. The New Warrants are exercisable after February 2, 2024, expire on February 2, 2029 and are issuable only for cash, subject to exception if the shares of Common Stock underlying the New Warrants are not registered in accordance with the terms of the Letter Agreement, in which case the New Warrants may also be exercised, in whole or in part, at such time by means of a "cashless exercise". The New Warrants have an exercise price of $2.60 per share. Management estimated the fair value of the warrants to be $4,671 based on an assessment by an independent third-party appraiser. The fair value of the New warrants is treated as equity and is presented in Additional Paid-in Capital in the Company’s Consolidated Balance Sheet. On August 2, 2023, 5,000,000 of the Existing Warrants were exercised pursuant to the Securities Purchase Agreement with the Exercising Holder, with the Company receiving gross proceeds therefrom of $4,800. In total, 8,689,452 Common Stock warrants issued pursuant to the Securities Purchase Agreements with proceeds of approximately $8,307 were exercised during the year ended December 31, 2023. The Company incurred $35 in relation to this transaction. |
Sale of Future Revenue
Sale of Future Revenue | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 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. In June 2023, Sunovion announced that it has voluntarily withdrawn KYNMOBI from the U.S. and Canadian markets, therefore, the Company likely will not receive any of the additional contingent payments under the Monetization agreement. Further, 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, 2023: Liability related to the sale of future revenue, net at December 31, 2022 $ 65,259 Royalties related to the sale of future revenue (989) Amortization of issuance costs 220 Interest expense related to the sale of future revenue — Liability related to the sale of future revenue, net (includes current portion of $922) $ 64,490 |
Other Non-Current Liabilities
Other Non-Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Asset Retirement Obligation Disclosure [Abstract] | |
Other Non-Current Liabilities | Other Non-Current Liabilities The Company’s other non-current liabilities at December 31, 2023 consisted of AROs of $2,016, and the fair value of the put option on the 12.5% Notes of $0. The Company’s other non-current liabilities at December 31, 2022 consisted of AROs of $1,989 and the long-term portion of fair value of the put option on the 12.5% Notes of $45. See Note 14, Long-Term Debt for discussion of 12.5% Notes. 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, 2023 and 2022 were $7 and $25, respectively. Below is a schedule of activity in the Company’s liability for AROs for the year ended December 31, 2023 and 2022. Balance at December 31, 2021 $ 1,712 Additions 110 Accretion 167 Balance at December 31, 2022 1,989 Additions — Accretion 27 Balance at December 31, 2023 $ 2,016 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
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 years ended December 31, 2023 and 2022, 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, 2023 Year Ended December 31, 2022 Numerator: Net loss $ (7,870) $ (54,410) Denominator: Weighted-average number of common shares – basic and diluted 61,255,864 48,734,377 Loss per common share – basic and diluted $ (0.13) $ (1.12) (a) For the years ended December 31, 2023 and 2022, outstanding stock options of 5,733,064 and 6,027,997 to purchase shares of Common Stock, respectively, were anti-dilutive. (b) For the years ended December 31, 2023 and 2022, outstanding restricted stock units of 3,280,313 and 161,750 to purchase shares of Common Stock, respectively were anti-dilutive. (c) For the years ended December 31, 2023 and 2022, outstanding warrants of 4,624,977 and 10,564,429 to purchase shares of Common Stock, respectively, were anti-dilutive. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
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. The service-based restricted stock units and stock options that have been awarded are subject to graded vesting over a service period, which is typically three years. The restricted stock units with vesting based on market conditions were awarded in 2023 and vest in three years on the anniversary of the first tranche award. Compensation cost is recognized for restricted stock units, both service-based awards and market conditions vesting-based awards, on a straight line basis over the requisite service period for each award granted. Compensation cost for stock option awards is recognized based on a pro-rata basis over the requisite period for each award granted. At December 31, 2023, there were approximately 1.8 million shares available for grant. The Company recognized share-based compensation in its Consolidated Statements of Operations and Comprehensive Loss during the periods presented as follows: Expense classification: Year Ended December 31, 2023 Year Ended December 31, 2022 Manufacture and supply $ 191 $ 203 Research and development 456 672 Selling, general and administrative 2,042 3,506 Total share-based compensation expenses $ 2,689 $ 4,381 Share-based compensation from: Restricted Stock Units 993 127 Stock Options 1,669 4,244 Employee Stock Purchase Plan 27 10 Total share-based compensation expenses $ 2,689 $ 4,381 The following tables provide information about the Company’s restricted stock unit and stock option activity during the year ended December 31, 2023 and 2022. Restricted Stock Units The following tables summarize the Company’s awards of service-based and market conditions vesting-based restricted stock units for the years 2023 and 2022: Restricted Stock Unit Awards (RSUs) - Service-based: Number Weighted Average (In thousands) Unvested, December 31, 2021 — $ — Granted 192 2.37 Forfeited (20) 2.21 Vested (10) 2.55 Unvested, December 31, 2022 162 $ 2.38 Granted 1,874 0.91 Forfeited (31) 2.33 Vested (57) 2.03 Unvested, December 31, 2023 1,948 $ 0.97 The Company granted 1,874,300 service-based restricted stock units during 2023. The Company granted 192,000 service-based restricted stock units during 2022. During 2023, the total grant date fair market value of shares vested was $72. As of December 31, 2023, $1,278 of total unrecognized compensation expenses related to unvested service-based restricted stock units are expected to be recognized over a weighted average period of 2.18 years from the date of grant. The service-based restricted stock units granted to employees are subject to a three 2022 Inducement Equity Incentive Plan The Company adopted the 2022 Equity Inducement Plan approved by the Compensation Committee of the Board of Directors of the Company effective as of July 29, 2022 pursuant to which the Compensation Committee of the Board of Directors may make inducement grants in accordance with Nasdaq Listing Rule 5635(c)(4). There were 150,000 awards granted and outstanding under this Plan as of December 31, 2023 and included in the service-based restricted stock units granted as described in the table above. Restricted Stock Unit Awards (RSUs) - Market conditions vesting-based: Number Weighted Average (In thousands) Unvested, December 31, 2022 — $ — Granted 1,332 2.40 Forfeited — — Vested — — Unvested, December 31, 2023 1,332 $ 2.40 The Company granted 1,332,000 market conditions vesting-based restricted stock units during 2023. There were no market conditions vesting-based restricted stock units granted in 2022. As of December 31, 2023, $2,314 of total unrecognized compensation expenses related to unvested market conditions vesting-based restricted stock units are expected to be recognized over a weighted average period of 2.34 years from the date of grant. The market conditions vesting-based restricted stock units vest based on a Performance Price measured as the 30-day average of the closing prices of the Company’s common stock as reported on the Nasdaq Stock Market immediately prior to and including the last calendar day of the three is $1.75, the Vesting Percentage will be 50%. To the extent the Performance Price is $1.76 or greater, but less than $2.50, the Vesting Percentage will be a prorated amount between 50.01% and 99.99%, based on straight-line interpolation. To the extent the Performance Price is $2.50, the Vesting Percentage will be 100%. To the extent the Performance Price is $2.51 or greater, but less than $3.25, the Vesting Percentage will be a prorated amount between 100.01% and 149.99%, based on straight-line interpolation. To the extent the Performance Price is $3.25 or greater, the Vesting Percentage will be 150%. In no event will the Vesting Percentage exceed 150%. The Company’s estimates of the fair value of market conditions vesting-based awards at their grant or valuation dates were based on a Monte Carlo simulation and considered various variables and assumptions, including a simulated 30-day average at the end of the Performance period including the following assumptions: Year Ended December 31, 2023 Expected dividend yield 0% Expected volatility 92% - 95% Expected term (years) 2.74 - 3.00 Risk-free interest rate 3.6% - 4.4% Stock price at grant date $2.01 - $2.04 Stock option awards The following table summarizes the Company’s stock option activity for the years during 2023 and 2022: (in 000s, except share price data) Number Weighted Weighted Aggregate Outstanding at December 31, 2021 4,146 $ 7.28 7.88 $ 1,423 Granted 2,015 $ 1.83 Forfeited and Expired (133) $ 7.81 Outstanding at December 31, 2022 6,028 $ 5.48 7.50 $ 38 Granted 150 2.02 Exercised (1) $ 0.88 Forfeited and Expired (444) $ 2.27 Outstanding at December 31, 2023 5,733 $ 5.58 6.41 $ 1,082 Vested and expected to vest at December 31, 2023 5,674 $ 5.62 6.32 $ 1,050 Exercisable at December 31, 2023 4,324 $ 6.59 5.98 $ 596 The weighted average grant date fair value of stock options granted during 2023 and 2022 was $1.50 and $1.46, respectively. During the year ended December 31, 2023, 150,000 stock options were granted with an exercise price of $2.02 and accordingly, given the Company’s share price of $2.02 at December 31, 2023, the intrinsic value provided by certain shares granted during this period was de minimis. The fair values of stock options granted were estimated using the Black-Scholes model based on the following assumptions: Year Ended December 31, 2023 2022 Expected dividend yield 0% 0% Expected volatility 100% 100% Expected term (years) 5.50 5.50 - 6.13 Risk-free interest rate 4.0% 2.0% - 4.3% Exercise prices $2.02 $0.71 - $2.55 The Company anticipates 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 an estimate of stock price volatility based on the historical trading data of comparable public companies at the time of grant given the lack of sufficient history for the Company's 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, 2023, $1,421 of total unrecognized compensation expenses related to non-vested stock options is expected to be recognized over a weighted average period of 1.06 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 6.41 years. Options granted to senior management and key employees are subject to a 3-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. 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 the year ended 2023 and 2022, 36,168 and 45,304 shares were purchased and issued through the ESPP at total discounts of $27 and $10, respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | Employee Benefit Plans The 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, 2023 and 2022 were $761 and $815, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of the provision for income taxes are as follows: Expense classification: Year Ended December 31, 2023 2022 Current Federal $ 245 $ — State — — Total 245 — Deferred Federal — — State — — Total — — Provision for Income Tax $ 245 $ — 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, 2023 and 2022 are as follows: December 31, 2023 2022 Deferred tax assets: Accounts receivable $ 4 $ 177 Inventory 345 449 Accrued expenses 73 1,063 NOL carryforwards 27,120 32,197 Interest limitation imposed by the TJCA 9,880 10,667 Stock Compensation 6,529 5,813 Deferred Revenue 7,662 2,326 Royalty Monetization 16,750 17,139 Property and equipment 2,756 2,576 Orphan Drug and R&D Tax Credits 4,805 5,625 Accrued debt fees — 697 Intangible Assets 154 1,731 Section 174 R&D Capitalization 5,039 3,770 Royalty Obligations 3,520 — Other 58 82 84,695 84,312 Deferred tax liabilities: 481(a) adjustment (193) — Prepaid expenses (449) (524) (642) (524) Valuation Allowance (84,053) (83,788) Net deferred tax asset/(liability) $ — $ — At December 31, 2023 and 2022, the Company had federal net operating loss carryforwards of $101,029 and $123,922, respectively, a significant portion of which carryforward for an indefinite period. At December 31, 2023 and 2022, the Company also had state net operating loss carryforwards of $104,478 and $104,238, 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, 2023, 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 the Company refers 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 the Company 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 $84,053, and $83,788 have been established at December 31, 2023 and 2022, 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 TCJA requires taxpayers to capitalize and amortize R&D expenditures under section 174 for tax years beginning after December 31, 2021. For the years ended December 31, 2023 and 2022, the capitalized R&D costs were $12.6 million and $16.6 million, respectively. 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, 2023 and 2022. 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, 2023 and 2022, respectively, as follows: Year Ended December 31, 2023 2022 Income taxes at statutory rate 21.00 % 21.00 % Increase (decrease) resulting from: State income tax 4.00 4.23 Permanent differences (0.43) (0.20) Tax credits — 0.20 Valuation allowance (26.53) (20.69) Return to provision (3.28) 0.11 State rate change (1.78) (4.67) FDII Deductions 3.80 — Effective tax rate (3.22) % (0.02) % The Company received an ERTC refund of $1,250. It is included in Interest income and other income, net on the December 31, 2023 Company's Consolidated Statements of Operations and Comprehensive Loss. |
Contingencies
Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingencies | 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, securities, civil tort, and commercial litigation, and environmental or other regulatory matters. Patent-Related Litigation Indivior Inc., Indivior UK Ltd., and Aquestive Therapeutics, Inc. v. Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. , On February 7, 2018, the Company and Indivior Inc. and Indivior UK Ltd. (collectively, “Indivior”) initiated a lawsuit against Dr. Reddy’s Laboratories S.A. and Dr. Reddy’s Laboratories, Inc. (collectively, “Dr. Reddy’s”) asserting infringement of U.S. Patent No. 9,855,221 (the "221 patent”). On April 3, 2018, the Company and Indivior initiated a separate lawsuit against Dr. Reddy’s asserting infringement of U.S. Patent No. 9,931,305 (the “’305 patent”). On May 29, 2018, the lawsuits regarding the ’221 and ’305 patents were consolidated which was originally initiated by Indivior against Dr. Reddy’s asserting infringement of U.S. Patent No. 9,687,454 (the “’454 patent”). On February 19, 2019, the Court granted the parties’ agreed stipulation to drop the ’221 patent from the case. On January 8, 2020, the Court entered a stipulated order of non-infringement of the ’305 patent based on the Court’s claim construction ruling, and the Company and Indivior preserved its 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). On January 31, 2024, 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. 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. On November 9, 2023, 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. Patent Litigation Settlement with 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 is included in Interest income and other income, net on the Company's Consolidated Statements of Operations and Comprehensive Loss. Kentucky Litigation - Humana Humana Inc. v. Indivior Inc, Indivior Solutions Inc., Indivior PLC, Reckitt Benckiser Group plc, Reckitt Benckiser Healthcare (UK) Ltd., and Aquestive Therapeutics, Inc. On August 20, 2021, Humana filed a complaint in state court in Kentucky, alleging conspiracy to violate the RICO Act, fraud under state law, unfair and deceptive trade practices under state law, insurance fraud, and unjust enrichment against the Company relating to Indivior’s launch of Suboxone Sublingual Film in 2010. The Humana action was stayed pending related litigation, and the stay was lifted on October 30, 2023. No schedule has been set in the action and there is no trial date set. 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 the Company 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 $156 and ordering Neurelis to pay the fees within 60 days of June 17, 2022. The Court denied the Company’s demurrer and the parties proceeded with discovery on the claims in the Second Amended Complaint. The plaintiff filed a motion to file a third amended complaint. which the Court granted on November 17, 2023. The Third Amended Complaint alleges additional facts but includes the same claims as the Second Amended Complaint. Trial in this matter is scheduled for October 25, 2024. 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 for 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. On March 14, 2023, the Court entered an order granting Defendants’ motion to dismiss without prejudice and permitting plaintiffs leave to file a final, Second Amended Complaint by April 14, 2023. On April 7, 2023, the parties filed a Stipulation of Voluntary Dismissal stating that plaintiffs determined not to file an amended complaint and agreed to dismiss the action as to them with prejudice. On April 10, 2023, the Court so-ordered the stipulation and terminated the lawsuit. Shareholder Derivative Litigation Loreen Niewenhuis v. Keith Kendall, et al. On December 15, 2021, a purported Aquestive shareholder instituted a derivative action captioned Loreen Niewenhuis v. Keith Kendall, et al. in the United States District Court for the District of New Jersey, purportedly on behalf of the Company, against certain current and former officers and directors of the Company. The case was designated as related to the pending federal securities class action Deanna Lewakowski v. Aquestive Therapeutics, Inc., referenced above, and accepted by the same judge presiding over the securities class action. The complaint in this matter alleges claims for breach of fiduciary duty and contribution. The factual allegations that form the basis of these claims are similar to the disclosure-related allegations asserted in the class action. On April 4, 2022, the plaintiff filed an amended complaint asserting the same claims against the same defendants. The Company filed a motion to dismiss the amended complaint on April 25, 2022, which became fully briefed as of June 27, 2022. On April 20, 2023, the parties filed a Stipulation of Voluntary Dismissal stating that plaintiff agreed to dismiss the action as to her with prejudice. On April 21, 2023, the Court so-ordered the stipulation and terminated the lawsuit. Commercial Agreements Amendment to the Indivior Commercial Exploitation Agreement Effective as of March 2, 2023, the Company and Indivior entered into Indivior Amendment 11. The Indivior Amendment 11 was entered into for the primary purpose of amending the Indivior License Agreement, dates as of August 15, 2008 as follows: (i) extending the term of the Indivior License 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 Indivior License Agreement, and providing that the Indivior License 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 Invidior License 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 $5,482 payment is included in Manufacture and supply revenue and $6,000 is included in Interest income and other income, net on the Company's Consolidated Statements of Operations and Comprehensive Loss. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Continued Utilization of the At-The-Market Facility The Company continued utilization of its ATM facility from January 1 through March 4, 2024 and sold 4,557,220 shares which generated net proceeds of approximately $12,014. Product Liability Litigation |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net loss | $ (7,870) | $ (54,410) |
Insider Trading Arrangements
Insider Trading Arrangements shares in Thousands | 3 Months Ended |
Dec. 31, 2023 shares | |
Trading Arrangements, by Individual | |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Mark Schobel [Member] | |
Trading Arrangements, by Individual | |
Material Terms of Trading Arrangement | On December 7, 2023, Mark Schobel, Chief Innovation & Technology Officer of the Company, adopted a written sales plan intended to satisfy the affirmative defense conditions of Rule 10b5-1 of the Securities Exchange Act of 1934, as amended, for trading 175,000 shares. The plan commenced on December 6, 2023 and will expire on December 4, 2024. |
Name | Mark Schobel |
Title | Chief Innovation & Technology Officer |
Rule 10b5-1 Arrangement Adopted | true |
Adoption Date | December 7, 2023 |
Arrangement Duration | 364 days |
Aggregate Available | 175 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | 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 prior to out-licensing to Assertio, allowances for sales returns, the useful lives of fixed assets and the valuations of warrants issued, royalty obligations, sale of future revenues, share-based compensation, and contingencies. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Concentration of Credit Risk | Concentration of Credit Risk |
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 its 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. 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 |
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 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. The impairment charge of $216 was recognized for the year ended December 31, 2023. No impairment was recognized for the year ended December 31, 2022. |
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 nor 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 the Company's 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 its 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 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 its current estimates of future royalties expected to be paid over the life of the arrangement. The Company periodically assesses the expected royalty payments using a combination of internal projections and forecasts from external resources. To the extent its future estimates of royalty payments are greater or less than previous estimates or the timing of such payments is materially different than its previous estimates, the Company will prospectively recognize related interest expense. Amortization of debt is reflected as interest expense related to the sale of future revenue in the Consolidated Statements of Operations and Comprehensive Loss. For further discussion of the sale of the future revenue, see Note 16, Sale of Future Revenue. |
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 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 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, net 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 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. CROs activities include preclinical laboratory experiments and clinical studies. Other activity expenses include regulatory consulting and other costs. The activities undertaken by regulatory consultants that were classified as R&D expense include assisting, communicating with, and advise its 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 its 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 CROs 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 CROs. Estimated CROs 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 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. The Company’s estimates of the fair value of options at their grant dates are 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, if any, and • risk-free interest rate. The Company’s estimates of the fair value of RSUs at their grant or valuation dates vary based on whether the awards' vesting conditions are based on market conditions or service conditions. For awards with the vesting based on market conditions, the Company uses a Monte Carlo simulation that considers various variables and assumptions, including: • simulated 30-day average at the end of the requisite service period, • discount period based on the vesting term of the awards • an estimate of stock price volatility based on that of an industry peer group, • expected dividends, if any, 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 RSUs and stock option awards over the requisite service period of the awards. All excess tax benefits, taxes and tax deficiencies from stock-based compensation are included in the provision for income taxes in the Company's Consolidated Statements of Operations and Comprehensive Loss. |
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 Loss |
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 accounts 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 the 12.5% Notes in connection with its debt repayment and debt refinancing. The Company also issued pre-funded warrants and warrants in 2022 and warrants in 2023 to purchase shares of Common Stock 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 15, Warrants for further information on these warrants. The Company's 12.5% Notes contained a repurchase offer or put option which gave 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 14, Long-Term Debt for further discussion. In connection with the issuance of the 13.5% Notes on November 1, 2023, the Company and the Note Holders entered into the Royalty Right Agreements. The Royalty Right Agreements were valued based on Level 3 inputs, and their fair value is estimated by applying probability-weighted cash flows for future sales, which are then discounted to present value. Changes to fair value of the Royalty Rights Agreements can result from changes to one or a number of the aforementioned inputs. A significant change in unobservable inputs could result in a material increase or decrease to the effective interest rate of the Royalty Right Agreements liability. During the remainder of 2023, there were no material changes to the significant unobservable inputs used to recognize the Royalty Right Agreements liability. See Note 14, Long-Term Debt for further discussion. |
Segment Information | 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 | Recent Accounting Pronouncements The Company complies with new or revised accounting standards by the relevant dates on which adoption of such standards is required for smaller reporting 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: 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. In September 2022, the FASB issued ASU 2022-04, Liabilities-Supplier Finance Programs (Topic 405-50) Disclosure of Supplier Finance Program Obligations , to increase the transparency of supplier finance programs regarding the use of such programs by the buyer party (that is, the disclosing entity) and the programs’ effects on an entity’s working capital, liquidity, and cash flows. ASU 2022-04 is effective for all entities for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The requirement on rollforward information is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements. Recent Accounting Pronouncements Not Adopted as of December 31, 2023: 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 but does not expect to have a material impact on the Company’s 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 2020-03 on its consolidated financial statements but does not expect to have a material impact on the Company’s consolidated financial statements. In December 2023, the FASB issued ASU 2023-09— Income Taxes (Topic 740)—Improvements to Income Tax Disclosures. This Accounting Standards Update was issued to enhance the transparency and decision usefulness of income tax disclosures. The ASU requires that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It further requires discloses on an annual basis of the following information about income taxes paid: 1. The amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes 2. The amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5 percent of total income taxes paid (net of refunds received). Additionally, it requires the following information disclosure: 1. Income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign 2. Income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. The ASU eliminates certain current disclosure requirements. These disclosure requirements will be effective for the Company beginning January 1, 2025, with early adoption of the amendments permitted. The Company is currently evaluating the impact from the adoption of ASU 2023-09 on disclosures to its consolidated financial statements. |
Revenues and Trade Receivable_2
Revenues and Trade Receivables, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenue | The Company’s revenue was comprised of the following: Year Ended December 31, 2023 2022 Manufacture and supply revenue $ 43,805 $ 36,378 License and royalty revenue 5,376 2,351 Co-development and research fees 1,402 1,293 Proprietary product sales, net — 7,658 Revenues $ 50,583 $ 47,680 |
Disaggregation of Revenue | The following table provides disaggregated net revenue by geographic area: Year Ended December 31, 2023 2022 United States $ 37,104 $ 40,792 Ex-United States 13,479 6,888 Revenues $ 50,583 $ 47,680 |
Summary of Accounts Receivable, Net | Trade and other receivable, net consist of the following: December 31, 2023 2022 Accounts receivable $ 5,570 $ 3,274 Contract and other receivables 2,915 2,139 Less: allowance for bad debt (14) (40) Less: sales-related allowances — (669) Trade and other receivables, net $ 8,471 $ 4,704 |
Accounts Receivable, Allowance for Credit Loss | The following table presents the changes in the allowance for doubtful accounts: December 31, 2023 2022 Allowance for doubtful accounts at beginning of the period $ 40 $ 40 Allowance expense (reduction) (26) — Write-downs charged against the allowance — — Allowance for doubtful accounts at end of the period $ 14 $ 40 |
Summary of Sales-related Allowances | The following table presents the changes in sales-related allowances: December 31, 2023 2022 Beginning Balance $ 669 $ 605 Provision related to sales in 2022 — 1,365 Credits and payments (87) (1,301) Reclassifications $ (582) $ — Ending Balance $ — $ 669 |
Inventories, Net (Tables)
Inventories, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory, net | Inventory consists of the following: December 31, 2023 2022 Raw material $ 2,118 $ 1,899 Packaging material 3,028 2,914 Finished goods 1,623 967 Total inventory $ 6,769 $ 5,780 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | December 31, Useful Lives 2023 2022 Machinery 3 - 15 years $ 20,248 $ 19,810 Furniture and fixtures 3 - 15 years 769 769 Leasehold improvements (a) 21,386 21,375 Computer, network equipment and software 3 - 7 years 2,627 2,627 Construction in progress 2,033 1,467 47,063 46,048 Less: accumulated depreciation and amortization (42,884) (41,963) Total property and equipment, net $ 4,179 $ 4,085 (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, 2023 | |
Leases [Abstract] | |
Schedule of Operating Lease Liabilities Maturities | The Company’s payments due under its operating leases are as follows: Amount 2024 $ 1,230 2025 1,266 2026 1,300 2027 1,328 2028 1,162 2029-2033 3,828 Total lease payments 10,114 Less: imputed interest (4,306) Total operating lease liabilities $ 5,808 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite Lived - Intangible Assets | The following table provides the components of identifiable intangible assets, all of which are finite lived. December 31, 2023 2022 Purchased intangible $ 3,858 $ 3,858 Purchased patent 509 509 4,367 4,367 Less: accumulated amortization (3,089) (2,932) Intangible assets, net 1,278 1,435 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The estimated aggregate amortization expense for each of the following fiscal years ending December 31 is presented below: Amount 2024 $ 157 2025 157 2026 157 2027 157 2028 157 2029-2032 493 Total estimated amortization expenses 1,278 |
Other Non-Current Assets (Table
Other Non-Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Assets, Noncurrent | The following table provides the components of other non-current assets: December 31, 2023 2022 Royalty receivable $ 4,000 $ 5,000 Other 1,438 1,451 Total other non-current assets $ 5,438 $ 6,451 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued expenses consisted of the following: December 31, 2023 2022 Accrued compensation $ 4,202 $ 6,389 Real estate and personal property taxes 337 322 Accrued distribution expenses 645 1,012 Interest payable 1,013 183 Other 300 61 Total accrued expenses $ 6,497 $ 7,967 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Significant Unobservable Inputs Used In The Initial Fair Value Measurement Of The Royalty Right Agreement | The following table summarizes the significant unobservable inputs used in the initial fair value measurement of the Royalty Right Agreements as of December 31, 2023: Valuation Methodology Significant Unobservable Input Weighted Average (range, if applicable) Discount Rate 15% Royalty Right Agreements Probability weighted Probability of Success 75% Projected Years of Payments 2025 - 2033 |
Schedule of Debt | Long-term notes and unamortized debt discount balances are as follows: December 31, 2023 2022 Total outstanding notes $ 45,000 $ 51,500 Unamortized discount, including Exit Fee (17,665) (27) Current portion of long-term debt — (18,025) Notes payable, long-term $ 27,335 $ 33,448 Finance lease 173 — Notes payable, net $ 27,508 $ 33,448 December 31, 2023 Royalty obligations $ 56,926 Unamortized discount (42,165) Royalty obligations, net $ 14,761 |
Schedule of Debt Maturities | Scheduled principal payments on the 13.5% Notes as of December 31, 2023 are as follows: 2024 $ — 2025 — 2026 9,540 2027 14,535 2028 20,925 Total $ 45,000 |
Sale of Future Revenues (Tables
Sale of Future Revenues (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023: Liability related to the sale of future revenue, net at December 31, 2022 $ 65,259 Royalties related to the sale of future revenue (989) Amortization of issuance costs 220 Interest expense related to the sale of future revenue — Liability related to the sale of future revenue, net (includes current portion of $922) $ 64,490 |
Other Non-Current Liabilities (
Other Non-Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 and 2022. Balance at December 31, 2021 $ 1,712 Additions 110 Accretion 167 Balance at December 31, 2022 1,989 Additions — Accretion 27 Balance at December 31, 2023 $ 2,016 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 Year Ended December 31, 2022 Numerator: Net loss $ (7,870) $ (54,410) Denominator: Weighted-average number of common shares – basic and diluted 61,255,864 48,734,377 Loss per common share – basic and diluted $ (0.13) $ (1.12) (a) For the years ended December 31, 2023 and 2022, outstanding stock options of 5,733,064 and 6,027,997 to purchase shares of Common Stock, respectively, were anti-dilutive. (b) For the years ended December 31, 2023 and 2022, outstanding restricted stock units of 3,280,313 and 161,750 to purchase shares of Common Stock, respectively were anti-dilutive. (c) For the years ended December 31, 2023 and 2022, outstanding warrants of 4,624,977 and 10,564,429 to purchase shares of Common Stock, respectively, were anti-dilutive. |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense | The Company recognized share-based compensation in its Consolidated Statements of Operations and Comprehensive Loss during the periods presented as follows: Expense classification: Year Ended December 31, 2023 Year Ended December 31, 2022 Manufacture and supply $ 191 $ 203 Research and development 456 672 Selling, general and administrative 2,042 3,506 Total share-based compensation expenses $ 2,689 $ 4,381 Share-based compensation from: Restricted Stock Units 993 127 Stock Options 1,669 4,244 Employee Stock Purchase Plan 27 10 Total share-based compensation expenses $ 2,689 $ 4,381 |
Summary of Restricted Stock Units | The following tables summarize the Company’s awards of service-based and market conditions vesting-based restricted stock units for the years 2023 and 2022: Restricted Stock Unit Awards (RSUs) - Service-based: Number Weighted Average (In thousands) Unvested, December 31, 2021 — $ — Granted 192 2.37 Forfeited (20) 2.21 Vested (10) 2.55 Unvested, December 31, 2022 162 $ 2.38 Granted 1,874 0.91 Forfeited (31) 2.33 Vested (57) 2.03 Unvested, December 31, 2023 1,948 $ 0.97 |
Summary of Stock Option Activity | Restricted Stock Unit Awards (RSUs) - Market conditions vesting-based: Number Weighted Average (In thousands) Unvested, December 31, 2022 — $ — Granted 1,332 2.40 Forfeited — — Vested — — Unvested, December 31, 2023 1,332 $ 2.40 The following table summarizes the Company’s stock option activity for the years during 2023 and 2022: (in 000s, except share price data) Number Weighted Weighted Aggregate Outstanding at December 31, 2021 4,146 $ 7.28 7.88 $ 1,423 Granted 2,015 $ 1.83 Forfeited and Expired (133) $ 7.81 Outstanding at December 31, 2022 6,028 $ 5.48 7.50 $ 38 Granted 150 2.02 Exercised (1) $ 0.88 Forfeited and Expired (444) $ 2.27 Outstanding at December 31, 2023 5,733 $ 5.58 6.41 $ 1,082 Vested and expected to vest at December 31, 2023 5,674 $ 5.62 6.32 $ 1,050 Exercisable at December 31, 2023 4,324 $ 6.59 5.98 $ 596 |
Summary of Stock Option Valuation Assumptions | The Company’s estimates of the fair value of market conditions vesting-based awards at their grant or valuation dates were based on a Monte Carlo simulation and considered various variables and assumptions, including a simulated 30-day average at the end of the Performance period including the following assumptions: Year Ended December 31, 2023 Expected dividend yield 0% Expected volatility 92% - 95% Expected term (years) 2.74 - 3.00 Risk-free interest rate 3.6% - 4.4% Stock price at grant date $2.01 - $2.04 The fair values of stock options granted were estimated using the Black-Scholes model based on the following assumptions: Year Ended December 31, 2023 2022 Expected dividend yield 0% 0% Expected volatility 100% 100% Expected term (years) 5.50 5.50 - 6.13 Risk-free interest rate 4.0% 2.0% - 4.3% Exercise prices $2.02 $0.71 - $2.55 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of the provision for income taxes are as follows: Expense classification: Year Ended December 31, 2023 2022 Current Federal $ 245 $ — State — — Total 245 — Deferred Federal — — State — — Total — — Provision for Income Tax $ 245 $ — |
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, 2023 and 2022 are as follows: December 31, 2023 2022 Deferred tax assets: Accounts receivable $ 4 $ 177 Inventory 345 449 Accrued expenses 73 1,063 NOL carryforwards 27,120 32,197 Interest limitation imposed by the TJCA 9,880 10,667 Stock Compensation 6,529 5,813 Deferred Revenue 7,662 2,326 Royalty Monetization 16,750 17,139 Property and equipment 2,756 2,576 Orphan Drug and R&D Tax Credits 4,805 5,625 Accrued debt fees — 697 Intangible Assets 154 1,731 Section 174 R&D Capitalization 5,039 3,770 Royalty Obligations 3,520 — Other 58 82 84,695 84,312 Deferred tax liabilities: 481(a) adjustment (193) — Prepaid expenses (449) (524) (642) (524) Valuation Allowance (84,053) (83,788) 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, 2023 and 2022, respectively, as follows: Year Ended December 31, 2023 2022 Income taxes at statutory rate 21.00 % 21.00 % Increase (decrease) resulting from: State income tax 4.00 4.23 Permanent differences (0.43) (0.20) Tax credits — 0.20 Valuation allowance (26.53) (20.69) Return to provision (3.28) 0.11 State rate change (1.78) (4.67) FDII Deductions 3.80 — Effective tax rate (3.22) % (0.02) % |
Company Overview and Equity T_2
Company Overview and Equity Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | 38 Months Ended | ||||||||
Aug. 02, 2023 | Jun. 14, 2023 | Jun. 06, 2022 | Apr. 12, 2022 | Sep. 11, 2019 | Jun. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Aug. 01, 2023 | Jul. 15, 2019 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock, shares outstanding (in shares) | 68,533,085 | 54,827,734 | 68,533,085 | ||||||||
Exercise price of warrants (in usd per share) | $ 0.001 | ||||||||||
Warrants issued (in shares) | 2,000,000 | ||||||||||
Common Stock Warrants | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Warrants issued to purchase common stock (in shares) | 3,689,452 | ||||||||||
Proceeds from warrant exercises | $ 4,800 | $ 3,542 | $ 8,342 | ||||||||
Warrants issued (in shares) | 8,850,000 | ||||||||||
Costs of common stock issued under private equity offering | $ 35 | ||||||||||
Existing Warrants | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Class of warrant or right, outstanding (in shares) | 5,000,000 | ||||||||||
Exercise price of warrants (in usd per share) | $ 0.96 | ||||||||||
Stock issued during period, conversion of convertible securities (in shares) | 5,000,000 | 8,689,452 | |||||||||
New Warrants | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Warrants issued to purchase common stock (in shares) | 160,548 | ||||||||||
Exercise price of warrants (in usd per share) | $ 1.09 | $ 2.60 | |||||||||
Warrants issued (in shares) | 2,750,000 | ||||||||||
Maximum | Common Stock Warrants | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Exercise price of warrants (in usd per share) | $ 1.09 | ||||||||||
Equity Distribution Agreement | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, aggregate offering price | $ 25,000 | ||||||||||
Number of shares issued in transaction (in shares) | 4,958,341 | 2,860,538 | |||||||||
Consideration received on sale of stock | $ 8,962 | $ 3,907 | |||||||||
Equity Distribution Agreement | Maximum | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, aggregate offering price | 35,000 | ||||||||||
At The Market Offering, Amendment One | Maximum | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Sale of stock, aggregate offering price | $ 50,000 | ||||||||||
At The Market Offering | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued in transaction (in shares) | 15,300,298 | ||||||||||
Consideration received on sale of stock | $ 48,703 | ||||||||||
Payments of stock issuance costs | 502 | $ 289 | $ 2,555 | ||||||||
Remaining amount available for offering | $ 23,952 | ||||||||||
Lincoln Park Agreement | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued in transaction (in shares) | 1,600,000 | ||||||||||
Consideration received on sale of stock | $ 1,987 | ||||||||||
Right to sell common stock, value | $ 40 | ||||||||||
Agreement term (in months) | 36 months | ||||||||||
Lincoln Park Agreement | Maximum | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Subsidiary or equity method investee, cumulative percentage ownership limitation after all transactions | 9.99% | ||||||||||
Subsidiary or equity method investee, cumulative percentage ownership limitation after all transactions, shares | 6,486,623 | 6,486,623 | |||||||||
Securities Purchase Agreement | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Common stock, shares outstanding (in shares) | 4,850,000 | ||||||||||
Common stock entitled to purchasers by pre-funded warrants (in shares) | 4,000,000 | 4,000,000 | |||||||||
Stock to be purchased by common stock warrants (in shares) | 8,850,000 | 8,850,000 | |||||||||
Net proceeds after placement agent fees, expenses, and offering expenses payable | $ 7,796 | ||||||||||
Lincoln Park Agreement, Commitment Share | |||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||
Number of shares issued in transaction (in shares) | 236,491 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Trade Accounts Receivable (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Allowance for doubtful accounts | $ 14 | $ 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 - Impairment of Long-Lived Assets (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | ||
Impairment, long-lived asset | $ 216,000 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Royalty Obligations, net (Details) $ in Thousands | Nov. 01, 2023 USD ($) |
Debt Instrument [Line Items] | |
Royalty payment term | 8 years |
Minimum | |
Debt Instrument [Line Items] | |
Royalty interest percent interest | 1% |
Maximum | |
Debt Instrument [Line Items] | |
Royalty interest percent interest | 2% |
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | |
Debt Instrument [Line Items] | |
Interest rate | 13.50% |
Principal amount | $ 45,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Revenue from Contracts with Customers (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Research and development project duration | 3 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Share Based Compensation (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period | 30 days |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Nov. 01, 2023 | 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% | |
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Interest rate | 13.50% | ||
Fair Value, Inputs, Level 2 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Liabilities, fair value disclosure | $ 0 |
Risks and Uncertainties - Narra
Risks and Uncertainties - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | 38 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Nov. 01, 2023 | Dec. 31, 2021 | |
Unusual Risk or Uncertainty [Line Items] | |||||
Cash and cash equivalents | $ 23,872 | $ 27,273 | $ 23,872 | $ 28,024 | |
Accumulated deficit | (319,077) | (311,207) | $ (319,077) | ||
At The Market Offering | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Number of shares issued in transaction (in shares) | 15,300,298 | ||||
Consideration received on sale of stock | $ 48,703 | ||||
Payments of stock issuance costs | 502 | $ 289 | $ 2,555 | ||
Remaining amount available for offering | $ 23,952 | ||||
Equity Distribution Agreement | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Number of shares issued in transaction (in shares) | 4,958,341 | 2,860,538 | |||
Consideration received on sale of stock | $ 8,962 | $ 3,907 | |||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | |||||
Unusual Risk or Uncertainty [Line Items] | |||||
Interest rate | 13.50% |
Revenues and Trade Receivable_3
Revenues and Trade Receivables, Net - Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 50,583 | $ 47,680 |
Manufacture and supply revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 43,805 | 36,378 |
License and royalty revenue | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 5,376 | 2,351 |
Co-development and research fees | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 1,402 | 1,293 |
Proprietary product sales, net | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 0 | $ 7,658 |
Revenues and Trade Receivable_4
Revenues and Trade Receivables, Net - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 50,583 | $ 47,680 |
United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 37,104 | 40,792 |
Ex-United States | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 13,479 | $ 6,888 |
Revenues and Trade Receivable_5
Revenues and Trade Receivables, Net - Accounts Receivable, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Revenue from Contract with Customer [Abstract] | |||
Accounts receivable | $ 5,570 | $ 3,274 | |
Contract and other receivables | 2,915 | 2,139 | |
Less: allowance for bad debt | (14) | (40) | $ (40) |
Less: sales-related allowances | 0 | (669) | |
Trade and other receivables, net | $ 8,471 | $ 4,704 |
Revenues and Trade Receivable_6
Revenues and Trade Receivables, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Concentration Risk [Line Items] | |||
Contract and other receivables | $ 2,915 | $ 2,139 | |
Allowance for doubtful accounts | 14 | 40 | $ 40 |
Allowance expense (reduction) | (26) | 0 | |
Provision (reversal) related to sales | 0 | ||
Accounts receivable allowances and accruals | 0 | 669 | $ 605 |
Accrued distribution expenses | $ 645 | $ 1,012 | |
Commercial Exploitation Agreement with Indivior | Revenue | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentrations of risk | 80% | 76% | |
Commercial Exploitation Agreement with Indivior | Receivables | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentrations of risk | 65% | 80% | |
Commercial Exploitation Agreement with Zevra | Receivables | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentrations of risk | 13% |
Revenues and Trade Receivable_7
Revenues and Trade Receivables, Net - Allowance For Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Allowance for doubtful accounts at beginning of the period | $ 40 | $ 40 |
Allowance expense (reduction) | (26) | 0 |
Write-downs charged against the allowance | 0 | 0 |
Allowance for doubtful accounts at end of the period | $ 14 | $ 40 |
Revenues and Trade Receivable_8
Revenues and Trade Receivables, Net - Changes in Sales-Related Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning Balance | $ 669 | $ 605 |
Provision related to sales | 0 | 1,365 |
Credits and payments | (87) | (1,301) |
Reclassifications | (582) | 0 |
Ending balance | $ 0 | $ 669 |
Material Agreements (Details)
Material Agreements (Details) $ in Thousands | 2 Months Ended | 12 Months Ended | 17 Months Ended | 26 Months Ended | 38 Months Ended | ||||||||||
Oct. 23, 2023 USD ($) | Mar. 27, 2023 USD ($) | Mar. 02, 2023 USD ($) | Oct. 26, 2022 USD ($) | Sep. 26, 2022 USD ($) | May 17, 2022 USD ($) d installment | Nov. 03, 2020 USD ($) | Apr. 01, 2016 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Feb. 20, 2019 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) | Sep. 30, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 50,583 | $ 47,680 | |||||||||||||
Pro rata portion of target bonus | $ 280 | ||||||||||||||
Cash payment representing 90 days of base pay | $ 150 | ||||||||||||||
Days of base pay | d | 90 | ||||||||||||||
Severance costs | $ 263 | ||||||||||||||
Number of installments | installment | 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 | $ 5,376 | $ 2,351 | |||||||||||||
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 | 1 year | |||||||||||||
Revenues | $ 5,482 | ||||||||||||||
Royalty obligations, net | $ 11,482 | ||||||||||||||
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 | $ 22,000 | ||||||||||||||
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 | ||||||||||||||
License Agreement with Sunovion Pharmaceuticals, Inc. Upfront | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 5,000 | ||||||||||||||
Marathon Pangolin Royalty LLC | Maximum | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from sale of future revenues, net | $ 125,000 | ||||||||||||||
Marathon Pangolin Royalty LLC | Monetization Agreement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from sale of future revenues, net | 40,000 | $ 10,000 | $ 50,000 | $ 50,000 | |||||||||||
Proceeds from debt, contingent on additional milestones | $ 75,000 | ||||||||||||||
Atnahs Pharma UK Limited | License & Supply Agreement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from sale of future revenues, net | $ 3,500 | ||||||||||||||
Agreement to Terminate CLA with KemPharm | License and royalty revenue | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Revenues | $ 1,500 | ||||||||||||||
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 | ||||||||||||||
Atnahs Pharma UK Limited, Amended Agreement | License & Supply Agreement | |||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||
Proceeds from sale of future revenues, net | $ 2,000 |
Financial Instruments _ Fair _2
Financial Instruments – Fair Value Measurements (Details) - $ / shares | 1 Months Ended | ||||||
Nov. 01, 2023 | Jun. 06, 2022 | Jun. 30, 2022 | Dec. 31, 2023 | Aug. 02, 2023 | Aug. 01, 2023 | Jul. 15, 2019 | |
Warrants [Abstract] | |||||||
Exercise price of warrants (in usd per share) | $ 0.001 | ||||||
Warrants issued (in shares) | 2,000,000 | ||||||
Royalty payment term | 8 years | ||||||
Minimum | |||||||
Warrants [Abstract] | |||||||
Royalty interest percent interest | 1% | ||||||
Maximum | |||||||
Warrants [Abstract] | |||||||
Royalty interest percent interest | 2% | ||||||
Existing Warrants | |||||||
Warrants [Abstract] | |||||||
Class of warrant or right, outstanding (in shares) | 5,000,000 | ||||||
Exercise price of warrants (in usd per share) | $ 0.96 | ||||||
New Warrants | |||||||
Warrants [Abstract] | |||||||
Exercise price of warrants (in usd per share) | $ 1.09 | $ 2.60 | |||||
Warrants issued (in shares) | 2,750,000 | ||||||
Securities Purchase Agreement | |||||||
Warrants [Abstract] | |||||||
Common stock entitled to purchasers by pre-funded warrants (in shares) | 4,000,000 | 4,000,000 | |||||
Stock to be purchased by common stock warrants (in shares) | 8,850,000 | 8,850,000 | |||||
Senior Secured Notes Due 2025 | |||||||
Warrants [Abstract] | |||||||
Interest rate | 12.50% | ||||||
Senior Secured Notes Due 2025 | Senior Notes | |||||||
Warrants [Abstract] | |||||||
Interest rate | 12.50% | 12.50% | |||||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | |||||||
Warrants [Abstract] | |||||||
Interest rate | 13.50% |
Inventories, Net (Details)
Inventories, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 2,118 | $ 1,899 |
Packaging material | 3,028 | 2,914 |
Finished goods | 1,623 | 967 |
Total inventory | $ 6,769 | $ 5,780 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 47,063,000 | $ 46,048,000 |
Less: accumulated depreciation and amortization | (42,884,000) | (41,963,000) |
Total property and equipment, net | 4,179,000 | 4,085,000 |
Depreciation and amortization | 1,153,000 | 2,270,000 |
Impairment, long-lived asset | $ 216,000 | 0 |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Manufacture and supply | |
Machinery | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 20,248,000 | 19,810,000 |
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 | $ 769,000 | 769,000 |
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 | $ 21,386,000 | 21,375,000 |
Computer, network equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,627,000 | 2,627,000 |
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 | $ 2,033,000 | $ 1,467,000 |
Right-of-Use Assets and Lease_3
Right-of-Use Assets and Lease Obligations - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) lease | Dec. 31, 2022 USD ($) | |
Lessee, Lease, Description [Line Items] | ||
Number of leases | lease | 3 | |
Lease cost | $ 1,745 | $ 1,753 |
Variable lease expense | $ 447 | $ 449 |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Remaining lease term | 4 years 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 | 9 years 9 months 18 days | |
Discount rate | 15.60% |
Right-of-Use Assets and Lease_4
Right-of-Use Assets and Lease Obligations - Maturities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Leases [Abstract] | |
2024 | $ 1,230 |
2025 | 1,266 |
2026 | 1,300 |
2027 | 1,328 |
2028 | 1,162 |
2029-2033 | 3,828 |
Total lease payments | 10,114 |
Less: imputed interest | (4,306) |
Total operating lease liabilities | $ 5,808 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Finite Lived Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | $ 4,367 | $ 4,367 |
Less: accumulated amortization | (3,089) | (2,932) |
Intangible assets, net | 1,278 | 1,435 |
Purchased intangible | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | 3,858 | 3,858 |
Purchased patent | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets, gross | $ 509 | $ 509 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Amortization expense | $ 157 | $ 116 |
Expected amortization, year one | $ 157 | |
Weighted average useful life | 8 years 1 month 6 days |
Intangible Assets, Net - Sche_2
Intangible Assets, Net - Schedule of Finite-Lived Intangible Assets, Future Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2024 | $ 157 | |
2025 | 157 | |
2026 | 157 | |
2027 | 157 | |
2028 | 157 | |
2029-2032 | 493 | |
Intangible assets, net | $ 1,278 | $ 1,435 |
Other Non-Current Assets Narrat
Other Non-Current Assets Narrative (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Jun. 30, 2022 USD ($) | Jun. 30, 2020 USD ($) | Dec. 31, 2023 USD ($) payment royalty_payment | Dec. 31, 2022 USD ($) | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Revenues | $ 50,583 | $ 47,680 | ||
Number of guaranteed royalty payments | royalty_payment | 8 | |||
License Agreement with Sunovion Pharmaceuticals, Inc. | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Minimum royalty receivable | $ 1,000 | $ 1 | ||
Number of annual royalty payments receivable | payment | 5 | |||
Royalty | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Revenues | $ (989) | |||
Royalty | License Agreement with Sunovion Pharmaceuticals, Inc. | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||||
Revenues | $ 8,000 | $ 8 |
Other Non-Current Assets - Sche
Other Non-Current Assets - Schedule Of Components Of Other Non-Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Royalty receivable | $ 4,000 | $ 5,000 |
Other | 1,438 | 1,451 |
Total other non-current assets | $ 5,438 | $ 6,451 |
Accrued Expenses - Accrued Expe
Accrued Expenses - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 4,202 | $ 6,389 |
Real estate and personal property taxes | 337 | 322 |
Accrued distribution expenses | 645 | 1,012 |
Interest payable | 1,013 | 183 |
Other | 300 | 61 |
Total accrued expenses | $ 6,497 | $ 7,967 |
Accrued Expenses - Narrative (D
Accrued Expenses - Narrative (Details) | Nov. 01, 2023 |
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | |
Line of Credit Facility [Line Items] | |
Interest rate | 13.50% |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) | 1 Months Ended | 10 Months Ended | 12 Months Ended | |||||||||
Nov. 01, 2023 USD ($) | Nov. 03, 2020 USD ($) | Jul. 15, 2019 USD ($) $ / shares shares | Feb. 28, 2023 USD ($) | Feb. 28, 2023 USD ($) | Dec. 31, 2023 USD ($) payment $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 16, 2022 USD ($) notice | Nov. 04, 2022 USD ($) | May 13, 2022 USD ($) | Aug. 06, 2021 USD ($) | 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 | |||||||||||
Retirement of debt | $ 51,529,000 | $ 0 | ||||||||||
Long-term debt | 45,000,000 | |||||||||||
Proceeds from issuance of debt | 31,144,000 | 0 | ||||||||||
Premium on early retirement of debt | 2,250,000 | |||||||||||
Consent fee payment | 2,102,000 | 2,025,000 | ||||||||||
Number of redemption notices | notice | 2 | |||||||||||
Loss on the extinguishment of debt | $ 1,382,000 | 0 | ||||||||||
Number of payments made | payment | 3 | |||||||||||
Amortization of debt issuance costs and discounts | $ 1,972,000 | 215,000 | ||||||||||
Royalty payment term | 8 years | |||||||||||
Royalty payments, fair value, allocated | (13,856,000) | |||||||||||
Royalty obligations | $ 56,926,000 | |||||||||||
Royalty liability interest rate | 9.68% | |||||||||||
Unamortized discount | $ 42,165,000 | |||||||||||
Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Royalty interest percent interest | 2% | |||||||||||
Maximum | Marathon Pangolin Royalty LLC | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Percentage of cash proceeds | 30% | |||||||||||
Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Royalty interest percent interest | 1% | |||||||||||
Senior Notes | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Proceeds from issuance of debt | $ 4,000,000 | |||||||||||
Premium on early retirement of debt | 2,250,000 | |||||||||||
Payments of loan costs | 220,000 | |||||||||||
Senior Notes | US Treasury (UST) Interest Rate | Redemption Scenario 1 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, redemption price, basis points above treasury rate | 1% | |||||||||||
Senior Secured Notes Due 2025 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 12.50% | |||||||||||
Principal amount | $ 70,000 | |||||||||||
Warrants issued to purchase common stock (in shares) | shares | 143,000 | |||||||||||
Additional borrowing capacity | $ 30,000 | |||||||||||
Debt instrument, amount redeemed | $ 1,882,000 | $ 3,765,000 | ||||||||||
Senior Secured Notes Due 2025 | Put Option | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Fair value | $ 0 | 45,000 | ||||||||||
Senior Secured Notes Due 2025 | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Principal amount | $ 100,000 | |||||||||||
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 | ||||||||||
Repurchase price percentage | 112.50% | |||||||||||
Additional borrowing capacity | $ 30,000 | |||||||||||
Consent fee payment | $ 675,000 | $ 2,700,000 | ||||||||||
Redemption percentage of debt under change of control provisions | 101% | |||||||||||
Loss on the extinguishment of debt | $ 353,000 | |||||||||||
Repayments of long-term debt | 11,463,000 | |||||||||||
Amortization of debt issuance costs and discounts | 13,000 | 16,000 | ||||||||||
Unamortized deferred debt issuance cost and deferred debt discounts | 0 | 27,000 | ||||||||||
Extinguishment of debt, amount | $ 36,014,000 | |||||||||||
Senior Secured Notes Due 2025 | Senior Notes | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Elective redemption percentage of debt | 112.50% | |||||||||||
Senior Secured Notes Due 2025 | Senior Notes | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Elective redemption percentage of debt | 101.56% | |||||||||||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Unamortized deferred debt issuance cost and deferred debt discounts | 1,125,000 | |||||||||||
Debt issuance costs gross | 3,517,000 | |||||||||||
Unamortized discount, including Exit Fee | 20,498,000 | |||||||||||
Amortization of debt discount (premium) | 905,000 | |||||||||||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 13.50% | |||||||||||
Principal amount | $ 45,000,000 | |||||||||||
Long-term debt | 45,000,000 | 51,500,000 | ||||||||||
Proceeds from issuance of debt | $ 4,326,000 | |||||||||||
Repurchase price percentage | 108.50% | |||||||||||
Debt instrument, exit fee | 2,000,000 | |||||||||||
Unamortized discount, including Exit Fee | 17,665,000 | $ 27,000 | ||||||||||
Amortization of debt discount (premium) | $ 833,000 | |||||||||||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | Redemption Scenario 1 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Repurchase price percentage | 100% | |||||||||||
Debt instrument, redemption price, percentage of principal amount redeemed | 1% | |||||||||||
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | Redemption Scenario 2 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Repurchase price percentage | 108.50% | |||||||||||
Senior Secured Notes Due 2025 - First Additional Offering | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Warrants issued (in shares) | shares | 1,714,429 | |||||||||||
Exercise price of warrants (in usd per share) | $ / shares | $ 4.25 | $ 5.38 | ||||||||||
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 - First Additional Offering | Senior Notes | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Loss on the extinguishment of debt | $ 1,029,000 | |||||||||||
ABL Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Line of credit facility, accordion feature, net revenue threshold | 100,000 | |||||||||||
Line of credit facility, accordion feature, increase limit | $ 10,000 |
Long-Term Debt - Schedule Of Ro
Long-Term Debt - Schedule Of Royalty Right Agreements (Details) | Dec. 31, 2023 |
Measurement Input, Discount Rate | |
Line of Credit Facility [Line Items] | |
Royalty rights agreement, measurement input | 15% |
Measurement Input, Probability Of Success | |
Line of Credit Facility [Line Items] | |
Royalty rights agreement, measurement input | 75% |
Long-Term Debt - Schedule of Te
Long-Term Debt - Schedule of Term Notes and Unamortized Debt Discount Balances (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Line of Credit Facility [Line Items] | ||
Long-term debt | $ 45,000 | |
Finance lease | 173 | $ 0 |
Notes payable, net | $ 27,508 | 33,448 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Notes payable, net | |
Royalty obligations | $ 56,926 | |
Unamortized discount | (42,165) | |
Royalty obligations, net | 14,761 | |
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | ||
Line of Credit Facility [Line Items] | ||
Unamortized discount, including Exit Fee | (20,498) | |
Thirteen Point Five, Senior Secured Notes due November 1, 2028 | Senior Notes | ||
Line of Credit Facility [Line Items] | ||
Long-term debt | 45,000 | 51,500 |
Unamortized discount, including Exit Fee | (17,665) | (27) |
Current portion of long-term debt | 0 | (18,025) |
Notes payable, long-term | $ 27,335 | $ 33,448 |
Long-Term Debt - Debt Maturitie
Long-Term Debt - Debt Maturities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2024 | $ 0 |
2025 | 0 |
2026 | 9,540 |
2027 | 14,535 |
2028 | 20,925 |
Total outstanding notes | $ 45,000 |
Warrants (Details)
Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Aug. 02, 2023 | Jun. 14, 2023 | Jun. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Aug. 01, 2023 | Jul. 15, 2019 | |
Class of Warrant or Right [Line Items] | |||||||
Warrants issued (in shares) | 2,000,000 | ||||||
Fair value of warrants issued | $ 5,874 | ||||||
Exercise price of warrants (in usd per share) | $ 0.001 | ||||||
Proceeds from exercise of warrants, net | $ 8,307 | $ 0 | |||||
Public equity | |||||||
Class of Warrant or Right [Line Items] | |||||||
Fair value of warrants issued | $ 5,874 | ||||||
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 | ||||||
Warrants issued to purchase common stock (in shares) | 3,689,452 | ||||||
Proceeds from warrant exercises | $ 4,800 | $ 3,542 | 8,342 | ||||
Costs of common stock issued under private equity offering | $ 35 | ||||||
Existing Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in usd per share) | $ 0.96 | ||||||
Class of warrant or right, outstanding (in shares) | 5,000,000 | ||||||
Stock issued during period, conversion of convertible securities (in shares) | 5,000,000 | 8,689,452 | |||||
New Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants issued (in shares) | 2,750,000 | ||||||
Exercise price of warrants (in usd per share) | $ 1.09 | $ 2.60 | |||||
Warrants issued to purchase common stock (in shares) | 160,548 | ||||||
Fair value of warrants | $ 4,671 | ||||||
Minimum | Common Stock Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in usd per share) | $ 0.96 | ||||||
Maximum | Common Stock Warrants | |||||||
Class of Warrant or Right [Line Items] | |||||||
Exercise price of warrants (in usd per share) | $ 1.09 | ||||||
Senior Secured Notes Due 2025 | |||||||
Class of Warrant or Right [Line Items] | |||||||
Interest rate | 12.50% | ||||||
Fair value of warrants issued | $ 6,800 | ||||||
Warrants issued to purchase common stock (in shares) | 143,000 | ||||||
Senior Secured Notes Due 2025 - First Additional Offering | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants issued (in shares) | 1,714,429 | ||||||
Exercise price of warrants (in usd per share) | $ 4.25 | $ 5.38 | |||||
Class of warrant or right, outstanding (in shares) | 1,571,429 | 143,000 | |||||
Senior Secured Notes Due 2025 - First Additional Offering | Maximum | |||||||
Class of Warrant or Right [Line Items] | |||||||
Warrants issued (in shares) | 2,143,000 | ||||||
2020 Additional Notes | |||||||
Class of Warrant or Right [Line Items] | |||||||
Fair value of warrants issued | $ 735 |
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 | 38 Months Ended | |||
Nov. 03, 2020 | Dec. 31, 2020 | Jun. 30, 2022 | Jun. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2023 | |
Disaggregation of Revenue [Line Items] | ||||||||
Payments of financing costs | $ 4,643 | $ 0 | ||||||
Revenues | 50,583 | $ 47,680 | ||||||
License Agreement with Sunovion Pharmaceuticals, Inc. | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Minimum royalty receivable | $ 1,000 | 1 | $ 1 | |||||
Monetization Agreement | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Payments of financing costs | 2,909 | |||||||
Effective annual interest rate | 24.90% | |||||||
Monetization Agreement | Marathon Pangolin Royalty LLC | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Proceeds from sale of future revenues, net | $ 40,000 | $ 10,000 | $ 50,000 | $ 50,000 | ||||
Proceeds from debt, contingent on additional milestones | 75,000 | |||||||
Royalty | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Revenues | $ (989) | |||||||
Royalty | License Agreement with Sunovion Pharmaceuticals, Inc. | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Revenues | $ 8,000 | $ 8 | ||||||
Maximum | Marathon Pangolin Royalty LLC | ||||||||
Disaggregation of Revenue [Line Items] | ||||||||
Proceeds from sale of future revenues, net | $ 125,000 |
Sale of Future Revenue - Royalt
Sale of Future Revenue - Royalty Obligation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Sale of Future Revenue [Roll Forward] | ||
Liability related to the sale of future revenue, net at December 31, 2022 | $ 65,259 | |
Revenues | 50,583 | $ 47,680 |
Amortization of issuance costs | 220 | |
Interest expense related to the sale of future revenue | 0 | 5,683 |
Liability related to the sale of future revenue, net (includes current portion of $922) | 64,490 | $ 65,259 |
Current portion of liability related to sale of future revenue | 922 | |
Royalty | ||
Sale of Future Revenue [Roll Forward] | ||
Revenues | $ (989) |
Other Non-Current Liabilities -
Other Non-Current Liabilities - Narrative (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Jul. 15, 2019 | |
Debt Instrument [Line Items] | ||||
Asset retirement obligation | $ 1,989,000 | $ 1,712,000 | ||
Depreciation expense related to ARO | $ 7,000 | 25,000 | ||
Put Option | ||||
Debt Instrument [Line Items] | ||||
Asset retirement obligation | 2,016,000 | |||
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 | $ 0 | $ 45,000 | ||
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, 2023 | Dec. 31, 2022 | |
Asset Retirement Obligation, Roll Forward Analysis [Roll Forward] | ||
Balance at beginning of period | $ 1,989 | $ 1,712 |
Additions | 0 | 110 |
Accretion | $ 27 | 167 |
Balance at ending of period | $ 1,989 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Undistributed Earnings, Basic [Abstract] | ||
Net loss | $ (7,870) | $ (54,410) |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Basic (in shares) | 61,255,864 | 48,734,377 |
Diluted (in shares) | 61,255,864 | 48,734,377 |
Basic (in dollars per share) | $ (0.13) | $ (1.12) |
Diluted (in dollars per share) | $ (0.13) | $ (1.12) |
Stock Options | ||
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Dilutive securities excluded (in shares) | 5,733,064 | 6,027,997 |
Restricted Stock Units | ||
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Dilutive securities excluded (in shares) | 3,280,313 | 161,750 |
Warrant | ||
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Dilutive securities excluded (in shares) | 4,624,977 | 10,564,429 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares available for grant (in shares) | shares | 1,800,000 | ||
Inducement equity, common stock options outstanding, (in shares) | shares | 150,000 | ||
Inducement equity, common stock options granted, (in shares) | shares | 150,000 | ||
Share price (in dollars per share) | $ 2.02 | ||
Expected dividend yield | 0% | ||
Total share-based compensation expenses | $ | $ 2,689 | $ 4,381 | |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share price (in dollars per share) | $ 2.01 | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share price (in dollars per share) | $ 2.04 | ||
Common Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Shares issued under employee stock purchase plan (in shares) | shares | 36,168 | 45,304 | |
Restricted Stock Units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted (in shares) | shares | 1,874,300 | ||
Grant date fair value | $ | $ 72 | ||
Vesting period | 30 days | ||
Average closing prices period | 30 days | ||
Performance price threshold, vesting percentage limit | 1.50 | ||
Total share-based compensation expenses | $ | $ 993 | $ 127 | |
Restricted Stock Units | Market Condition Range One | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 1.75 | ||
Performance price threshold, vesting percentage | 0 | ||
Restricted Stock Units | Market Condition Range Two | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 1.75 | ||
Performance price threshold, vesting percentage | 0.50 | ||
Restricted Stock Units | Market Condition Range Four | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 2.50 | ||
Performance price threshold, vesting percentage | 1 | ||
Restricted Stock Units | Market Condition Range Six | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 3.25 | ||
Performance price threshold, vesting percentage | 1.50 | ||
Restricted Stock Units | Service Based | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted (in shares) | shares | 1,874,000 | 192,000 | |
Share-based payment arrangement, nonvested award, option, cost not yet r.ecognized, amount | $ | $ 1,278 | ||
Vesting period | 3 years | ||
Equity instruments other than options, nonvested, number (in shares) | shares | 1,948,000 | 162,000 | 0 |
Granted (in dollars per share) | $ 0.91 | $ 2.37 | |
Weighted average recognition period | 2 years 2 months 4 days | ||
Restricted Stock Units | Market Based | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Granted (in shares) | shares | 1,332,000 | ||
Share-based payment arrangement, nonvested award, option, cost not yet r.ecognized, amount | $ | $ 2,314 | ||
Vesting period | 3 years | ||
Equity instruments other than options, nonvested, number (in shares) | shares | 1,332,000 | 0 | |
Granted (in dollars per share) | $ 2.40 | ||
Weighted average recognition period | 2 years 4 months 2 days | ||
Restricted Stock Units | Minimum | Market Condition Range Three | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 1.76 | ||
Performance price threshold, vesting percentage | 0.5001 | ||
Restricted Stock Units | Minimum | Market Condition Range Five | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 2.51 | ||
Performance price threshold, vesting percentage | 1.0001 | ||
Restricted Stock Units | Maximum | Market Condition Range Three | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 2.50 | ||
Performance price threshold, vesting percentage | 0.9999 | ||
Restricted Stock Units | Maximum | Market Condition Range Five | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Performance price threshold, per share (in dollars per share) | $ 3.25 | ||
Performance price threshold, vesting percentage | 1.4999 | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 3 years | ||
Granted (in dollars per share) | $ 1.50 | $ 1.46 | |
Granted (in shares) | shares | 150,000 | 2,015,000 | |
Granted (in dollars per share) | $ 2.02 | $ 1.83 | |
Expected dividend yield | 0% | ||
Cost not yet recognized, amount | $ | $ 1,421 | ||
Weighted average recognition period | 1 year 21 days | ||
Weighted average remaining contract life | 6 years 4 months 28 days | 7 years 6 months | 7 years 10 months 17 days |
Total share-based compensation expenses | $ | $ 1,669 | $ 4,244 | |
Stock Options | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average remaining contract life | 10 years | ||
Stock Options | Key Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Vesting period | 3 years | ||
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Offering period term | 6 months | ||
Employee stock purchase plan, purchase price percentage | 85% | ||
Number of shares reserved for issuance (in shares) | shares | 250,000 | ||
Total share-based compensation expenses | $ | $ 27 | $ 10 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | $ 2,689 | $ 4,381 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 993 | 127 |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 1,669 | 4,244 |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 27 | 10 |
Manufacture and supply | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 191 | 203 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | 456 | 672 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation expenses | $ 2,042 | $ 3,506 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock Units (Details) - Restricted Stock Units - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Units | ||
Granted (in shares) | 1,874,300 | |
Service Based | ||
Number of Units | ||
Unvested, at beginning of period (in shares) | 162,000 | 0 |
Granted (in shares) | 1,874,000 | 192,000 |
Forfeited (in shares) | (31,000) | (20,000) |
Vested (in shares) | (57,000) | (10,000) |
Unvested, at end of period (in shares) | 1,948,000 | 162,000 |
Weighted Average Grant Date Fair Value Per Share | ||
Unvested, balance at beginning of period (in dollars per share) | $ 2.38 | $ 0 |
Granted (in dollars per share) | 0.91 | 2.37 |
Forfeited (in dollars per share) | 2.33 | 2.21 |
Vested (in dollars per share) | 2.03 | 2.55 |
Unvested, balance at end of period (in dollars per share) | $ 0.97 | $ 2.38 |
Market Based | ||
Number of Units | ||
Unvested, at beginning of period (in shares) | 0 | |
Granted (in shares) | 1,332,000 | |
Forfeited (in shares) | 0 | |
Vested (in shares) | 0 | |
Unvested, at end of period (in shares) | 1,332,000 | 0 |
Weighted Average Grant Date Fair Value Per Share | ||
Unvested, balance at beginning of period (in dollars per share) | $ 0 | |
Granted (in dollars per share) | 2.40 | |
Forfeited (in dollars per share) | 0 | |
Vested (in dollars per share) | 0 | |
Unvested, balance at end of period (in dollars per share) | $ 2.40 | $ 0 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) - Stock Options - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Options | |||
Outstanding at beginning of period (in shares) | 6,028,000 | 4,146,000 | |
Granted (in shares) | 150,000 | 2,015,000 | |
Forfeited and Expired (in shares) | (444,000) | (133,000) | |
Exercised (in shares) | (1,000) | ||
Outstanding at end of period (in shares) | 5,733,000 | 6,028,000 | 4,146,000 |
Vested or expected to vest (in shares) | 5,674,000 | ||
Exercisable at end of period (in shares) | 4,324,000 | ||
Weighted Average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 5.48 | $ 7.28 | |
Granted (in dollars per share) | 2.02 | 1.83 | |
Forfeited and Expired (in dollars per share) | 2.27 | 7.81 | |
Exercised (in dollars per share) | 0.88 | ||
Outstanding at end of period (in dollars per share) | 5.58 | $ 5.48 | $ 7.28 |
Vested or expected to vest at end of period (in dollars per share) | 5.62 | ||
Exercisable at end of period (in dollars per share) | $ 6.59 | ||
Weighted Average Remaining Contractual Term in Years | |||
Weighted average remaining contractual term | 6 years 4 months 28 days | 7 years 6 months | 7 years 10 months 17 days |
Weighted average remaining contractual term, vested or expected to vest | 6 years 3 months 25 days | ||
Weighted average remaining contractual term, exercisable | 5 years 11 months 23 days | ||
Aggregate Intrinsic Value | |||
Intrinsic value | $ 1,082 | $ 38 | $ 1,423 |
Intrinsic value, vested or expected to vest at end of period | 1,050 | ||
Intrinsic value, exercisable at end of period | $ 596 |
Share-Based Compensation - Pric
Share-Based Compensation - Pricing Assumptions (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Share price (in dollars per share) | $ 2.02 | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share price (in dollars per share) | 2.01 | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share price (in dollars per share) | $ 2.04 | |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | |
Exercise prices (in dollars per share) | $ 2.02 | $ 1.83 |
Stock Options | Black-Scholes | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Expected volatility | 100% | 100% |
Stock Options | Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 92% | |
Expected term (years) | 2 years 8 months 26 days | |
Risk-free interest rate | 3.60% | |
Stock Options | Minimum | Black-Scholes | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Risk-free interest rate | 4% | 2% |
Exercise prices (in dollars per share) | $ 2.02 | $ 0.71 |
Stock Options | Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 95% | |
Expected term (years) | 3 years | |
Risk-free interest rate | 4.40% | |
Stock Options | Maximum | Black-Scholes | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (years) | 6 years 1 month 17 days | |
Risk-free interest rate | 4.30% | |
Exercise prices (in dollars per share) | $ 2.55 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Employer contributions | $ 761 | $ 815 |
Income Taxes - Provision For In
Income Taxes - Provision For Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current | ||
Federal | $ 245 | $ 0 |
State | 0 | 0 |
Total | 245 | 0 |
Deferred | ||
Federal | 0 | 0 |
State | 0 | 0 |
Total | 0 | 0 |
Provision for Income Tax | $ 245 | $ 0 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Accounts receivable | $ 4 | $ 177 |
Inventory | 345 | 449 |
Accrued expenses | 73 | 1,063 |
NOL carryforwards | 27,120 | 32,197 |
Interest limitation imposed by the TJCA | 9,880 | 10,667 |
Stock Compensation | 6,529 | 5,813 |
Deferred Revenue | 7,662 | 2,326 |
Royalty Monetization | 16,750 | 17,139 |
Property and equipment | 2,756 | 2,576 |
Orphan Drug and R&D Tax Credits | 4,805 | 5,625 |
Accrued debt fees | 0 | 697 |
Intangible Assets | 154 | 1,731 |
Section 174 R&D Capitalization | 5,039 | 3,770 |
Royalty Obligations | 3,520 | 0 |
Other | 58 | 82 |
Deferred tax assets | 84,695 | 84,312 |
Deferred tax liabilities: | ||
481(a) adjustment | (193) | 0 |
Prepaid expenses | (449) | (524) |
Deferred tax liabilities | (642) | (524) |
Valuation Allowance | (84,053) | (83,788) |
Net deferred tax asset/(liability) | $ 0 | $ 0 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) $ in Thousands | Dec. 31, 2023 USD ($) vestingPeriod | Dec. 31, 2022 USD ($) vestingPeriod |
Income Tax Disclosure [Line Items] | ||
Valuation allowance | $ 84,053 | $ 83,788 |
Research and development, costs capitalized | $ 12,600 | $ 16,600 |
Number of uncertain tax positions | vestingPeriod | 0 | 0 |
Employee retention tax credit, refund | $ 1,250 | |
Domestic Tax Authority | ||
Income Tax Disclosure [Line Items] | ||
Operating loss carryforwards | $ 101,029 | $ 123,922 |
Research and development, amortization period (in years) | 5 years | |
State and Local Jurisdiction | ||
Income Tax Disclosure [Line Items] | ||
Operating loss carryforwards | $ 104,478 | $ 104,238 |
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, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income taxes at statutory rate | 21% | 21% |
State income tax | 4% | 4.23% |
Permanent differences | (0.43%) | (0.20%) |
Tax credits | 0% | 0.20% |
Valuation allowance | (26.53%) | (20.69%) |
Return to provision | (3.28%) | 0.11% |
State rate change | (1.78%) | (4.67%) |
FDII Deductions | 3.80% | 0% |
Effective tax rate | (3.22%) | (0.02%) |
Contingencies (Details)
Contingencies (Details) $ in Thousands | 12 Months Ended | |||||
Mar. 03, 2023 USD ($) | Mar. 02, 2023 USD ($) | May 03, 2022 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 05, 2019 cause | |
Loss Contingencies [Line Items] | ||||||
Interest income and other income, net | $ 16,321 | $ 99 | ||||
Revenues | 50,583 | 47,680 | ||||
Manufacture and supply revenue | ||||||
Loss Contingencies [Line Items] | ||||||
Revenues | 43,805 | $ 36,378 | ||||
Patent Litigation Settlement with BDSI | ||||||
Loss Contingencies [Line Items] | ||||||
Gain (loss) related to litigation settlement | $ 8,500 | |||||
Neurelis, Inc. v. Aquestive Therapeutics, Inc. | ||||||
Loss Contingencies [Line Items] | ||||||
Pending claim | cause | 3 | |||||
Litigation settlement, amount awarded from other party | $ 156 | |||||
Indivior Amendment | ||||||
Loss Contingencies [Line Items] | ||||||
Gain (loss) related to litigation settlement | $ 11,482 | |||||
Interest income and other income, net | $ 6,000 | |||||
Indivior Amendment | Manufacture and supply revenue | ||||||
Loss Contingencies [Line Items] | ||||||
Revenues | $ 5,482 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Thousands | 2 Months Ended | 12 Months Ended | ||
Mar. 04, 2024 USD ($) shares | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) shares | Feb. 21, 2024 pendingClaim | |
Equity Distribution Agreement | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued in transaction (in shares) | shares | 4,958,341 | 2,860,538 | ||
Consideration received on sale of stock | $ | $ 8,962 | $ 3,907 | ||
Subsequent Event | Equity Distribution Agreement | ||||
Subsequent Event [Line Items] | ||||
Number of shares issued in transaction (in shares) | shares | 4,557,220,000 | |||
Consideration received on sale of stock | $ | $ 12,014 | |||
Subsequent Event | Product Liability Litigation | ||||
Subsequent Event [Line Items] | ||||
Pending claim | pendingClaim | 40 |