Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 23, 2023 | Jun. 30, 2022 | |
Entity Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-37977 | ||
Entity Registrant Name | AVADEL PHARMACEUTICALS PLC | ||
Entity Incorporation, State or Country Code | L2 | ||
Entity Tax Identification Number | 98-1341933 | ||
Entity Address, Address Line One | 10 Earlsfort Terrace | ||
Entity Address, City or Town | Dublin 2 | ||
Entity Address, Country | IE | ||
Entity Address, Postal Zip Code | D02 T380 | ||
Country Region | 353 | ||
City Area Code | 1 | ||
Local Phone Number | 901-5201 | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 142,179,000 | ||
Entity Common Stock, Shares Outstanding | 64,477,508 | ||
Documents Incorporated by Reference | Portions of either (a) a definitive proxy statement involving the election of directors or (b) an amendment to this Form 10-K, either of which will be filed within 120 days after December 31, 2022, are incorporated by reference into Part III of this Form 10-K. | ||
Entity Central Index Key | 0001012477 | ||
Amendment Flag | false | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
American Depositary Shares | |||
Entity Information [Line Items] | |||
Title of 12(b) Security | American Depositary Shares* | ||
Trading Symbol | AVDL | ||
Security Exchange Name | NASDAQ | ||
Ordinary Share, Nominal Value $0.01 Per Share | |||
Entity Information [Line Items] | |||
Title of 12(b) Security | Ordinary Shares, nominal value $0.01 per share** | ||
Trading Symbol | AVDL | ||
Security Exchange Name | NASDAQ |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | Deloitte and Touche LLP |
Auditor Location | St. Louis, Missouri |
Auditor Firm ID | 34 |
Consolidated Statements of Loss
Consolidated Statements of Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development expenses | $ 20,700 | $ 17,104 |
Selling, general and administrative expenses | 74,516 | 68,495 |
Restructuring expense (income) | 3,345 | (53) |
Total operating expenses | 98,561 | 85,546 |
Operating loss | (98,561) | (85,546) |
Investment and other (expense) income, net | (536) | 2,343 |
Interest expense | (12,342) | (9,942) |
Loss before income taxes | (111,439) | (93,145) |
Income tax provision (benefit) | 26,025 | (15,816) |
Net loss | $ (137,464) | $ (77,329) |
Net loss per share | ||
Net loss per share - basic (in usd per share) | $ (2.29) | $ (1.32) |
Net loss per share - diluted (in usd per share) | $ (2.29) | $ (1.32) |
Weighted average number of shares outstanding | ||
Weighted average number of shares outstanding - basic (in shares) | 60,094 | 58,535 |
Weighted average number of shares outstanding - diluted (in shares) | 60,094 | 58,535 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (137,464) | $ (77,329) |
Other comprehensive loss, net of tax: | ||
Foreign currency translation loss | (597) | (1,228) |
Net other comprehensive loss, net of income tax benefit of $— and $214, respectively | (1,804) | (1,661) |
Total other comprehensive loss, net of tax | (2,401) | (2,889) |
Total comprehensive loss | $ (139,865) | $ (80,218) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Unrealized gain (loss) on marketable securities, tax | $ 0 | $ 214 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 73,981 | $ 50,708 |
Marketable securities | 22,518 | 106,513 |
Research and development tax credit receivable | 2,248 | 2,443 |
Prepaid expenses and other current assets | 2,096 | 32,826 |
Total current assets | 100,843 | 192,490 |
Property and equipment, net | 839 | 285 |
Operating lease right-of-use assets | 1,713 | 2,652 |
Goodwill | 16,836 | 16,836 |
Research and development tax credit receivable | 1,232 | 1,225 |
Other non-current assets | 11,322 | 33,777 |
Total assets | 132,785 | 247,265 |
Current liabilities: | ||
Current portion of long-term debt | 37,668 | 0 |
Current portion of operating lease liability | 960 | 900 |
Accounts payable | 7,890 | 7,679 |
Accrued expenses | 7,334 | 7,151 |
Other current liabilities | 1,941 | 5,270 |
Total current liabilities | 55,793 | 21,000 |
Long-term debt | 91,614 | 142,397 |
Long-term operating lease liability | 780 | 1,707 |
Other non-current liabilities | 5,743 | 3,917 |
Total liabilities | 153,930 | 169,021 |
Shareholders’ (deficit) equity: | ||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at December 31, 2022 and 2021, respectively | 5 | 5 |
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 62,878 and 58,620 issued and outstanding at December 31, 2022 and 2021, respectively | 628 | 586 |
Additional paid-in capital | 589,783 | 549,349 |
Accumulated deficit | (585,220) | (447,756) |
Accumulated other comprehensive loss | (26,341) | (23,940) |
Total shareholders’ (deficit) equity | (21,145) | 78,244 |
Total liabilities and shareholders’ (deficit) equity | $ 132,785 | $ 247,265 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 |
Preferred shares, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Preferred shares, shares issued (in shares) | 488,000 | 488,000 |
Preferred shares, shares outstanding (in shares) | 488,000 | 488,000 |
Ordinary shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Ordinary shares, shares issued (in shares) | 62,878,000 | 58,620,000 |
Ordinary shares, shares outstanding (in shares) | 62,878,000 | 58,620,000 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' (Deficit) Equity - USD ($) shares in Thousands, $ in Thousands | Total | Cumulative Effect, Period of Adoption, Adjustment | Ordinary shares | Preferred shares | Additional paid-in capital | Additional paid-in capital Cumulative Effect, Period of Adoption, Adjustment | Accumulated deficit | Accumulated deficit Cumulative Effect, Period of Adoption, Adjustment | Accumulated other comprehensive loss |
Beginning balance (in shares) at Dec. 31, 2020 | 58,396 | 488 | (384,187) | ||||||
Beginning balance at Dec. 31, 2020 | $ 162,266 | $ (12,939) | $ 583 | $ 5 | $ 566,916 | $ (26,699) | $ 13,760 | $ (21,051) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (77,329) | $ (77,329) | |||||||
Other comprehensive loss | (2,889) | (2,889) | |||||||
Exercise of stock options (in shares) | 48 | ||||||||
Exercise of stock options | 169 | $ 1 | 168 | ||||||
Vesting of restricted shares (in shares) | 159 | ||||||||
Vesting of restricted shares | 0 | $ 2 | (2) | ||||||
Employee share purchase plan share issuance (in shares) | 17 | ||||||||
Employee share purchase plan share issuance | 94 | 94 | |||||||
Share-based compensation expense | 8,872 | 8,872 | |||||||
Ending balance (in shares) at Dec. 31, 2021 | 58,620 | 488 | |||||||
Ending balance at Dec. 31, 2021 | 78,244 | $ 586 | $ 5 | 549,349 | (447,756) | (23,940) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Net loss | (137,464) | (137,464) | |||||||
Other comprehensive loss | (2,401) | (2,401) | |||||||
Change in fair value of October 2023 Notes conversion feature | 5,508 | 5,508 | |||||||
Issuance of common stock under at-the-market offering program, net of issuance costs (in shares) | 3,588 | ||||||||
Issuance of common stock under at-the-market offering program, net of issuance costs | 25,318 | $ 36 | 25,282 | ||||||
Amortization of deferred issuance costs | $ (45) | (45) | |||||||
Exercise of stock options (in shares) | 450 | 451 | |||||||
Exercise of stock options | $ 2,460 | $ 4 | 2,456 | ||||||
Vesting of restricted shares (in shares) | 144 | ||||||||
Vesting of restricted shares | 0 | $ 1 | (1) | ||||||
Employee share purchase plan share issuance (in shares) | 75 | ||||||||
Employee share purchase plan share issuance | 222 | $ 1 | 221 | ||||||
Share-based compensation expense | 7,013 | 7,013 | |||||||
Ending balance (in shares) at Dec. 31, 2022 | 62,878 | 488 | |||||||
Ending balance at Dec. 31, 2022 | $ (21,145) | $ 628 | $ 5 | $ 589,783 | $ (585,220) | $ (26,341) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (137,464) | $ (77,329) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,493 | 815 |
Amortization of debt discount and debt issuance costs | 6,052 | 1,248 |
Changes in deferred tax | 26,025 | (15,666) |
Share-based compensation expense | 7,013 | 8,872 |
Other adjustments | 2,042 | 1,055 |
Net changes in assets and liabilities | ||
Prepaid expenses and other current assets | 30,815 | (439) |
Research and development tax credit receivable | 30 | 2,796 |
Accounts payable & other current liabilities | (3,108) | 4,232 |
Accrued expenses | 227 | 895 |
Other assets and liabilities | (3,429) | (3,789) |
Net cash used in operating activities | (70,304) | (77,310) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (716) | (26) |
Proceeds from the disposition of the Hospital Products | 0 | 16,500 |
Proceeds from sales of marketable securities | 83,828 | 102,224 |
Purchases of marketable securities | (3,414) | (61,769) |
Net cash provided by investing activities | 79,698 | 56,929 |
Cash flows from financing activities: | ||
Payments for debt issuance costs | (4,804) | 0 |
Payments for extinguishment of February 2023 Notes | (8,653) | 0 |
Proceeds from stock option exercises and employee share purchase plan | 2,682 | 263 |
Proceeds from issuance of shares off the at-the-market offering program | 25,318 | 0 |
Net cash provided by financing activities | 14,543 | 263 |
Effect of foreign currency exchange rate changes on cash and cash equivalents | (664) | (896) |
Net change in cash and cash equivalents | 23,273 | (21,014) |
Cash and cash equivalents at January 1 | 50,708 | 71,722 |
Cash and cash equivalents at December 31 | 73,981 | 50,708 |
Supplemental disclosures of cash flow information: | ||
Income taxes (refunded) paid, net | (29,058) | 76 |
Interest paid | $ 9,660 | $ 6,469 |
Consolidated Statements of Sh_2
Consolidated Statements of Shareholders' (Deficit) Equity (Parenthetical) | 12 Months Ended |
Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | |
Accounting Standards Update [Extensible Enumeration] | Accounting Standards Update 2020-06 [Member] |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a biopharmaceutical company. The Company is registered as an Irish public limited company. The Company’s headquarters are in Dublin, Ireland with operations in Dublin, Ireland and St. Louis, Missouri, United States (“U.S”). The Company’s lead product candidate, LUMRYZ, also known as FT218, is an investigational once-at-bedtime, extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy. On July 18, 2022, the U.S. Food and Drug Administration (“FDA”) granted tentative approval to LUMRYZ for this indication. Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. On March 1, 2023, the Company submitted an amendment to the FDA requesting final approval of the LUMRYZ new drug application (“NDA”) and is currently awaiting a final approval decision from the FDA. The Company cannot legally market LUMRYZ in the U.S. until final approval is granted by the FDA. Outside of the Company’s lead product candidate, the Company continues to evaluate opportunities to expand its product portfolio. As of the date of this Annual Report, the Company does not have any commercialized products in its portfolio. Liquidity and Going Concern The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has a recent history of generating losses and negative cash flows from operations, an accumulated shareholders’ deficit as of the date of these audited consolidated financial statements and approximately $73,981 of cash and cash equivalents and $22,518 of marketable securities available for use to fund its operations, debt service and capital requirements. The Company’s ability to generate revenue is expected to start following the launch of LUMRYZ, which is dependent, in part, on final approval of LUMRYZ by the FDA. As of December 31, 2022, the Company had $17,500 aggregate principal amount of its 4.50% exchangeable senior notes due February 2023 (the “February 2023 Notes”) and $117,375 aggregate principal amount of its 4.50% exchangeable senior notes due October 2023 (the “October 2023 Notes”) (together, the “2023 Notes”). Avadel Finance Cayman Limited, a Cayman Islands exempted company and an indirect wholly-owned subsidiary of Avadel Pharmaceuticals plc (the “Issuer”), repaid, with cash on hand, the remaining $17,500 aggregate principal amount of its February 2023 Notes on the maturity date of February 1, 2023. On March 29, 2023, the Issuer executed an agreement to exchange $96,188 of its $117,375 October 2023 Notes for a new series of 6.0% exchangeable notes due April 2027 (the “April 2027 Notes”) (the “2023 Exchange Transaction”). The remaining $21,187 aggregate principal amount of the October 2023 Notes will maintain a maturity date of October 2, 2023. On March 29, 2023, the Company executed a royalty purchase agreement with RTW Investments, L.P. that could provide the Company up to $75,000 of royalty financing. The $75,000 of royalty financing will be accessible following achievement of certain regulatory and financial milestones, including final FDA approval and commercial launch of LUMRYZ. In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern , the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. The Company has concluded that it does not currently have sufficient liquidity to meet its operating, debt service and capital requirements for the next twelve months following the date of this Annual Report, which include repayment of the $21,187 aggregate principal amount of the October 2023 Notes. These conditions and events raised substantial doubt about the Company’s a bility to continue as a going concern within one year after the date that these audited consolidated financial statements are issued. In response to these conditions and events, the Company is evaluating various financing strategies to obtain sufficient additional liquidity to meet its operating, debt service and capital requirements for the next twelve months following the date of this Annual Report. The potential sources of financing that the Company is evaluating include one or any combination of royalty financing (as described above), secured or unsecur ed debt, convertible debt and equity. The Company also currently has authorized and available the use of its at-the-market offering program (“ATM Program”), described in more detail within Note 13: Equity Instruments and Transactions , which could provide the Company up to approximately $93,200, net of commissions, if fully utilized. While the Company has the ability to utilize the ATM Program, it intends to pursue the other financing strategies described above. Based on the Company’s ability to raise funds through the ATM Program and its cash, cash equivalents and marketable securities as of December 31, 2022, the Company has concluded that it is probable that such proceeds would provide sufficient additional capital to meet the Company’s operating, debt service and capital requirements for the next twelve months following the date of this Annual Report. As a result, the Company has concluded that management’s plans are probable of being achieved to alleviate the substantial doubt about the Company’s ability to continue as a going concern. The sources of financing described above that could be available to the Company and the timing and probability of obtaining sufficient capital depends, in part, on obtaining final FDA approval of LUMRYZ, resolving any legal and regulatory matters that could preclude the Company from launching LUMRYZ and future capital market conditions. If the Company’s current assumptions regarding timing of potential final approval, the timing of the launch of LUMRYZ or if there are any other changes or differences in current assumptions that negatively impact our financing strategy, the Company may have to further reduce expenditures or significantly delay, scale back or discontinue the development or commercialization of LUMRYZ in order to extend its cash resources. Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. Reclassifications Certain reclassifications are made to prior year amounts whenever necessary to conform with the current year presentation. Certain reclassifications have been made to the Consolidated Statement of Loss and the Consolidated Statements of Cash Flows for the fiscal year ended December 31, 2021 to condense line items of the same nature into a single line. This change does not affect previously reported net loss in the Consolidated Statement of Loss and or net cash flows used in operating activities in the Consolidated Statements of Cash Flows. Research and Development (“R&D”). R&D expenses consist primarily of costs related to outside services, personnel expenses, clinical studies and other R&D expenses. Outside services and clinical studies costs relate primarily to services performed by clinical research organizations and related clinical or development manufacturing costs, materials and supplies, filing fees, regulatory support, and other third-party fees. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Other R&D expenses primarily include overhead allocations consisting of various support and facilities-related costs. R&D expenditures are charged to operations as incurred. Raw materials used in the production of pre-clinical and clinical products are expensed as R&D costs. The Company recognizes refundable R&D tax credits received for spending on innovative R&D as an offset of R&D expenses. Advertising Expenses. The Company expenses the costs of advertising as incurred. Branded advertising expenses were immaterial for the years ended December 31, 2022 and 2021, respectively. Share-based Compensation. The Company accounts for share-based compensation based on the estimated grant-date fair value. The fair value of stock options is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Scholes model, estimates are made of the underlying volatility of Avadel stock, a risk-free rate and an expected term of the option or warrant. The Company estimates the expected term using a simplified method, as the Company does not have enough historical exercise data for a majority of such options upon which to estimate an expected term. The Company recognizes compensation cost, net of an estimated forfeiture rate, using the accelerated method over the requisite service period of the award. Income Taxes. The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2022, the Company's cumulative loss position was significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets. Given the weight of objectively verifiable historical losses from operations, the Company recorded a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company records uncertain tax positions on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits in the income tax expense line in the consolidated statements of loss. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months. Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in shareholders’ (deficit) equity, with the exception of unrealized gains and losses on equity instruments and allowances for expected credit losses, if any, which are reported in earnings in the current period. The cost of securities sold is based upon the specific identification method. For available-for-sale debt securities in an unrealized loss position, the Company assesses whether it intends to sell or if it is more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis. If either of the criteria regarding intent or requirement to sell is met, the security’s amortized cost basis is written down to fair value. If the criteria are not met, the Company evaluates whether the decline in fair value has resulted from a credit loss or other factors. In making this assessment, management considers, among other factors, the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and adverse conditions specifically related to the security. If this assessment indicates that a credit loss exists, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of the cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses is recorded for the credit loss, limited by the amount that the fair value is less than the amortized costs basis. Allowance for Credit Losses. Amounts owed to the Company are presented net of an allowance that includes as assessment of expected credit losses. An allowance for credit losses is established based on expected losses. Expected losses are estimated by reviewing individual accounts, considering aging, financial condition of the debtor, payment history, current and forecast economic conditions and other relevant factors. To the extent that the Company identifies that any individual customer's credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics of that customer. The Company makes concerted efforts to collect all outstanding balances due from customers; however, amounts are written off against the allowance when the related balances are no longer deemed collectible. Property and Equipment. Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. The Company has determined that it operates in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. The Company tests goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. The Company determined that no impairment of goodwill existed at December 31, 2022 and 2021. Long-Lived Assets. Long-lived assets include fixed assets and right of use assets at contract manufacturing organizations. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market-based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. Certain long-lived assets are amortized using the straight-line method over a five year useful life. Total amortization expense of long-lived assets for the year ended December 31, 2022 and 2021 was $391 and $0, respectively. Lease Obligations. The Company determines if a contract is a lease at the inception of the arrangement. Right-of-use assets and operating lease liabilities are recognized at commencement date based on the present value of remaining lease payments over the lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. Short term leases with an initial term of 12 months or less are not recorded on the balance sheet and the associated lease payments are recognized in the consolidated statements of loss on a straight-line basis over the lease term. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. The Company’s lease agreements may contain variable costs such as common area maintenance, insurance, real estate taxes or other costs. Variable lease costs are expensed as incurred on the consolidated statements of loss. |
Newly Issued Accounting Standar
Newly Issued Accounting Standards | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
Newly Issued Accounting Standards | Newly Issued Accounting Standards Previously Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. The FASB’s amendments primarily impact ASC 740, Income Taxes , and may impact both interim and annual reporting periods. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years and early adoption is permitted. The Company adopted the provisions of ASU 2019-12 on January 1, 2021. Adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40) , to reduce the complexity associated with applying U.S. GAAP principles for certain financial instruments with characteristics of liabilities and equity. The amendments in this ASU reduce the number of accounting models for convertible instruments and expand the existing disclosure requirements over earnings per share as it relates to convertible instruments. Convertible debt will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The update also requires the if-converted method to be used for convertible instruments and the effect of potential share settlement be included in the diluted earnings per share calculation when an instrument may be settled in cash or shares. This ASU will be effective for the Company’s fiscal year beginning January 1, 2022 and interim periods therein. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The amendments may be adopted through either a modified retrospective method, or a fully retrospective method. The Company elected to early adopt ASU 2020-06 as of January 1, 2021 using a modified retrospective method. The Company’s 4.50% exchangeable senior notes due 2023 (the “2023 Notes”) are a convertible instrument with a cash-conversion feature that is accounted for within the scope of Subtopic 470-20. The Company calculated the cumulative-effect adjustment as of January 1, 2021 by comparing (i) the historical amortization schedule for the 2023 Notes through December 31, 2020 and (ii) an updated amortization schedule wherein the conversion feature within the 2023 Notes would not be separated as an equity |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company is required to measure certain assets and liabilities at fair value, either upon initial recognition or for subsequent accounting or reporting. For example, the Company uses fair value extensively when accounting for and reporting certain financial instruments, when measuring certain contingent consideration liabilities and in the initial recognition of net assets acquired in a business combination. Fair value is estimated by applying the hierarchy described below, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest level of input that is available and significant to the fair value measurement. ASC 820, Fair Value Measurements and Disclosures , defines fair value as a market-based measurement that should be determined based on the assumptions that marketplace participants would use in pricing an asset or liability. When estimating fair value, depending on the nature and complexity of the asset or liability, the Company may generally use one or each of the following techniques: • Income approach, which is based on the present value of a future stream of net cash flows. • Market approach, which is based on market prices and other information from market transactions involving identical or comparable assets or liabilities. As a basis for considering the assumptions used in these techniques, the standard establishes a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows: • Level 1 - Quoted prices for identical assets or liabilities in active markets. • Level 2 - Quoted prices for similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are directly or indirectly observable, or inputs that are derived principally from, or corroborated by, observable market data by correlation or other means. • Level 3 - Unobservable inputs that reflect estimates and assumptions. The following table summarizes the financial instruments measured at fair value on a recurring basis classified in the fair value hierarchy (Level 1, 2 or 3) based on the inputs used for valuation in the accompanying consolidated balance sheets: As of December 31, 2022 As of December 31, 2021 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 4) Mutual and money market funds $ 22,518 $ — $ — $ 78,098 $ — $ — Corporate bonds — — — — 16,479 — Government securities - U.S. — — — — 9,471 — Other fixed-income securities — — — — 2,465 — Total assets $ 22,518 $ — $ — $ 78,098 $ 28,415 $ — A review of fair value hierarchy classifications is conducted on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification for certain financial assets or liabilities. During the fiscal year ended December 31, 2022, there were no transfers in and out of Level 1, 2, or 3. During the twelve months ended December 31, 2022 and 2021, the Company did not recognize any allowances for credit losses. Some of the Company’s financial instruments, such as cash and cash equivalents and accounts payable, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature. Debt The Company estimates the fair value of its $17,500 aggregate principal amount of its February 2023 Notes and its $117,375 aggregate principal amount of its October 2023 Notes based on interest rates that would be currently available to the Company for issuance of similar types of debt instruments with similar terms and remaining maturities or recent trading prices obtained from brokers (a Level 2 input). The estimated fair values of the February 2023 Notes and October 2023 Notes at December 31, 2022 are $16,975 and $112,973, respectively. See Note 8: Long-Term Debt for additional information regarding the Company’s debt obligations. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The Company had investments in available-for-sale debt securities that are recorded at fair market value. The change in the fair value of available-for-sale debt investments is recorded as accumulated other comprehensive loss in shareholders’ (deficit) equity, net of income tax effects. As of December 31, 2022, the Company considered any decreases in fair value on its marketable securities to be driven by factors other than credit risk, including market risk. The following tables show the Company’s available-for-sale securities’ adjusted cost, gross unrealized gains, gross unrealized losses and fair value by significant investment category as of December 31, 2022 and 2021, respectively: 2022 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 24,407 $ — $ (1,889) $ 22,518 Total $ 24,407 $ — $ (1,889) $ 22,518 2021 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 78,331 $ 813 $ (1,046) $ 78,098 Corporate bonds 16,478 94 (93) 16,479 Government securities - U.S. 9,530 39 (98) 9,471 Other fixed-income securities 2,473 2 (10) 2,465 Total $ 106,812 $ 948 $ (1,247) $ 106,513 The Company determines realized gains or losses on the sale of marketable securities on a specific identification method. The Company reflects these gains and losses as a component of investment and other income in the accompanying consolidated statements of loss. The Company recognized gross realized gains of $584 and $174 for the twelve months ended December 31, 2022 and 2021, respectively. These realized gains were offset by realized losses of $2,338 and $275 for the twelve-months ended December 31, 2022 and 2021, respectively. The Company has classified its investment in available-for-sale marketable securities as current assets in the consolidated balance sheets as the securities need to be available for use, if required, to fund current operations. There are no restrictions on the sale of any securities in the Company’s investment portfolio. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net The principal categories of property and equipment, net at December 31, 2022 and 2021, respectively, are as follows: Property and Equipment, net: 2022 2021 Software, office and computer equipment $ 832 $ 448 Furniture, fixtures and fittings 634 302 Less - accumulated depreciation (627) (465) Total $ 839 $ 285 |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill | Goodwill The Company’s goodwill is $16,836 at December 31, 2022 and 2021. No impairment loss related to goodwill was recognized during the years ended December 31, 2022 or 2021. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company leases office space and a production suite. All leased facilities are classified as operating leases with remaining lease terms between one The components of lease costs, which are included in selling, general and administrative expenses in the consolidated statements of loss of years ended December 31, 2022 and 2021 were as follows: Lease cost: 2022 2021 Operating lease costs (1) $ 1,028 $ 821 Sublease income (2) (116) (110) Total lease cost $ 912 $ 711 (1) Variable lease costs were immaterial for the years ended December 31, 2022 and 2021. (2) Represents sublease income received for office subleases. During the years ended December 31, 2022 and 2021, the Company reduced its operating lease liabilities by $963 and $578 for cash paid. As of December 31, 2022, the Company’s operating leases have a weighted-average remaining lease term of 2.0 years and a weighted-average discount rate of 5.0%. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. Maturities of the Company’s operating lease liabilities were as follows: Maturities: Operating Leases 2023 $ 1,013 2024 614 2025 206 2026 — 2027 — Thereafter — Total lease payments 1,833 Less: interest 93 Present value of lease liabilities $ 1,740 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt Long-term debt is summarized as follows: December 31, 2022 December 31, 2021 Principal amount of 4.50% exchangeable senior notes due February 2023 $ 17,500 $ 143,750 Principal amount of 4.50% exchangeable senior notes due October 2023 117,375 — Less: unamortized debt discount and issuance costs, net (5,593) (1,353) Net carrying amount of liability component 129,282 142,397 Less: current maturities 37,668 — Long-term debt $ 91,614 $ 142,397 For the years ended December 31, 2022 and 2021, the total interest expense was $12,342 and $9,942, respectively, with coupon interest expense of $6,405 and $6,469 for each period, respectively, and the amortization of debt issuance costs and debt discount of $6,052 and $1,248 for each period, respectively. On November 4, 2022, the Company repurchased $8,875 of its February 2023 Notes for $8,653 of cash consideration through an open market purchase. The Company recorded a $203 net gain on the early extinguishment that is included as a reduction to current period interest expense. For the years ended December 31, 2022 and 2021, interest expense also included $88 and $2,225, respectively, of additional interest expense owed as a result of not removing a restrictive legend from the 2023 Notes 365 days following original issuance of the 2023 Notes on February 16, 2018. The additional interest was paid to the trustee on March 10, 2022. Additionally, on March 14, 2022, the restrictive legend on the 2023 Notes was removed and the Company is not subject to any additional interest after that date. This interest will not be applicable to future periods. On February 16, 2018, Avadel Finance Cayman Limited, a Cayman Islands exempted company and an indirect wholly-owned subsidiary of the Company (the “Issuer”), issued $125,000 aggregate principal amount of its February 2023 Notes in a private placement (the “Offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act. In connection with the Offering, the Issuer granted the initial purchasers of the February 2023 Notes a 30-day option to purchase up to an additional $18,750 aggregate principal amount of the February 2023 Notes, which was fully exercised on February 16, 2018. Net proceeds received by the Company, after issuance costs and discounts, were approximately $137,560. The February 2023 Notes are the Company’s senior unsecured obligations and rank equally in right of payment with all of the Company’s existing and future senior unsecured indebtedness and effectively junior to any of the Company’s existing and future secured indebtedness, to the extent of the value of the assets securing such indebtedness. On April 5, 2022, the Issuer completed the exchange of $117,375 of its February 2023 Notes for a new series of its October 2023 Notes (the “Exchange Transaction”). The remaining $26,375 aggregate principal amount of the February 2023 Notes were not exchanged and maintained a maturity date of February 1, 2023. On November 4, 2022, the Company repurchased $8,875 of its February 2023 Notes and on the maturity date of February 1, 2023, the Company repaid, with cash on hand, the remaining $17,500 aggregate principal amount of its February 2023 Notes. The Company accounted for the October 2023 Notes as a modification to the February 2023 Notes. The Company paid $4,804 in fees to note holders of the October 2023 Notes that are amortized over the remaining term of the October 2023 Notes. The Company paid approximately $5,450 in fees to third parties that were expensed as part of the completed Exchange Transaction. Additionally, the fair value of the unseparated, embedded conversion feature increased by $5,508, which reduced the carrying amount of the convertible debt instrument as an unamortized debt discount, with a corresponding increase in additional paid-in capital. The $5,508 are amortized over the remaining term of the October 2023 Notes as a component of interest expense. On March 29, 2023, the Issuer executed an agreement to exchange $96,188 of its $117,375 October 2023 Notes for a new series of 6.0% exchangeable notes due April 2027 (the “April 2027 Notes”) (the “2023 Exchange Transaction”). The remaining $21,187 aggregate principal amount of the October 2023 Notes will maintain a maturity date of October 2, 2023. Due to the 2023 Exchange Transaction, the $96,188 principal amount of the October 2023 Notes is classified as long-term debt, net of unamortized debt discount and issuance costs, as of December 31, 2022. The 2023 Notes are exchangeable at the option of the holders at an initial exchange rate of 92.6956 ADSs per $1 principal amount of 2023 Notes, which is equivalent to an initial exchange price of approximately $10.79 per ADS. Such initial exchange price represents a premium of approximately 20% to the $8.99 per ADS closing price on The Nasdaq Global Market on February 13, 2018. Upon the exchange of any 2023 Notes, the Issuer will pay or cause to be delivered, as the case may be, cash, ADSs or a combination of cash and ADSs, at the Issuer’s election. October 2023 Notes Holders of the October 2023 Notes may convert their October 2023 Notes, at their option, only under the following circumstances prior to the close of business on the business day immediately preceding May 1, 2023, under the circumstances and during the periods set forth below and regardless of the conditions described below, on or after May 1, 2023 and prior to the close of business on the business day immediately preceding the maturity date: • Prior to the close of business on the business day immediately preceding May 1, 2023, a holder of the October 2023 Notes may surrender all or any portion of its October 2023 Notes for exchange at any time during the five five • If a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs prior to the close of business on the business day immediately preceding May 1, 2023, regardless of whether a holder of the October 2023 Notes has the right to require the Company to repurchase the October 2023 Notes, or if Avadel is a party to a merger event that occurs prior to the close of business on the business day immediately preceding May 1, 2023, all or any portion of a the holder’s October 2023 Notes may be surrendered for exchange at any time from or after the date that is 95 scheduled trading days prior to the anticipated effective date of the transaction (or, if later, the earlier of (x) the business day after the Company gives notice of such transaction and (y) the actual effective date of such transaction) until 35 trading days after the actual effective date of such transaction or, if such transaction also constitutes a fundamental change, until the related fundamental change repurchase date. • Prior to the close of business on the business day immediately preceding May 1, 2023, a holder of the October 2023 Notes may surrender all or any portion of its October 2023 Notes for exchange at any time during any calendar quarter commencing after the calendar quarter ending on March 31, 2022 (and only during such calendar quarter), if the last reported sale price of the ADSs for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the exchange price on each applicable trading day. • If the Company calls the October 2023 Notes for redemption pursuant to Article 16 to the Indenture prior to the close of business on the business day immediately preceding May 1, 2023, then a holder of the October 2023 Notes may surrender all or any portion of its October 2023 Notes for exchange at any time prior to the close of business on the second business day prior to the redemption date, even if the October 2023 Notes are not otherwise exchangeable at such time. After that time, the right to exchange shall expire, unless the Company defaults in the payment of the redemption price, in which case a holder of the October 2023 Notes may exchange its October 2023 Notes until the redemption price has been paid or duly provided for. The Company considered the guidance in ASC 815-15, Embedded Derivatives , to determine if this instrument contains an embedded feature that should be separately accounted for as a derivative. ASC 815 provides for an exception to this rule when convertible notes, as host instruments, are deemed to be conventional, as defined by ASC 815-40. The Company determined that this exception applies due, in part, to its ability to settle the 2023 Notes in cash, ADSs or a combination of cash and ADSs, at the Company’s option. The Company have therefore applied the guidance provided by ASC 470-20, Debt with Conversion and Other Options, |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of (loss) income before income taxes for the years ended twelve months ended December 31, are as follows: (Loss) Income Before Income Taxes: 2022 2021 Ireland $ (53,717) $ (36,631) U.S. (57,755) (56,687) France 33 173 Total loss before income taxes $ (111,439) $ (93,145) The income tax provision (benefit) consists of the following for the years ended December 31: Income Tax Provision (Benefit): 2022 2021 Current: U.S. - State $ — $ 60 Total current — 60 Deferred: U.S. - Federal 25,896 (15,876) U.S. - State 129 — Total deferred 26,025 (15,876) Income tax provision (benefit) $ 26,025 $ (15,816) The reconciliation between income taxes at the statutory rate and the Company’s provision (benefit) for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2022 2021 Income tax provision (benefit) - at statutory tax rate $ (13,916) $ (11,642) Differences in international tax rates (9,921) (8,950) Change in valuation allowances 48,734 4,296 Nondeductible share-based compensation 1,424 645 Unrealized tax benefits 258 239 State and local taxes (net of federal) (4,467) 60 Nondeductible interest expense 4,239 2,173 Orphan drug and R&D tax credit — (1,524) Other (326) (1,113) Income tax provision (benefit) - at effective income tax rate $ 26,025 $ (15,816) In 2022, the income tax provision was $26,025, a change of $41,841 from income tax benefit of $15,816. The change in the effective tax rate for the year ended December 31, 2022 is primarily driven by the valuation allowances recorded against our deferred tax assets during the period. The effective tax rate for 2021 was impacted by the geographic mix of earnings. Unrecognized Tax Benefits The Company or one of its subsidiaries files income tax returns in Ireland, France, U.S. and various states. The Company is no longer subject to Irish, French, U.S. Federal, and state and local examinations for years before 2018. The following table summarizes the activity related to the Company’s unrecognized tax benefits for the twelve months ended December 31: Unrecognized Tax Benefit Activity 2022 2021 Balance at January 1: $ 3,143 $ 3,143 Increases for tax positions of prior years — — Statute of limitations expiration — — Settlements — — Balance at December 31: $ 3,143 $ 3,143 The Company expects that within the next twelve months the unrecognized tax benefits could decrease by an immaterial amount and the interest could increase by an immaterial amount. At December 31, 2022 and 2021, there are $3,143 and $2,483 of unrecognized tax benefits that if recognized would affect the annual effective tax rate. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax provision. During the years ended December 31, 2022 and 2021, the Company recognized approximately $258 and $239 in interest and penalties. The Company had approximately $2,103 and $1,777 for the payment of interest and penalties accrued at December 31, 2022 and 2021, respectively. Deferred Tax Assets (Liabilities) Deferred income tax provisions reflect the effect of temporary differences between consolidated financial statement and tax reporting of income and expense items. The net deferred tax assets (liabilities) at December 31, 2022 and 2021 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 53,393 $ 34,399 Share-based compensation 4,684 4,108 Amortization 3,541 3,429 Orphan drug and R&D tax credit 4,964 4,964 Capitalized research costs 2,108 — Other 1,521 662 Interest expense carryforward 1,216 1,591 Gross deferred tax assets 71,427 49,153 Deferred tax liabilities: Prepaid expenses (86) (75) Other — (925) Gross deferred tax liabilities (86) (1,000) Less: valuation allowances (71,341) (24,025) Net deferred tax assets $ — $ 24,128 At December 31, 2022, the Company had $147,240 of net operating losses in Ireland that do not have an expiration date and $124,443 of net operating losses and $5,032 163(j) credits in the U.S. Of the $124,443 of net operating losses in the U.S., $10,365 were acquired due to the acquisition of FSC Therapeutics and FSC Laboratories, Inc., (collectively “FSC”) and $114,078 are due to the losses at US Holdings, of which $3,494 are state net operating losses. The portion due to the acquisition of FSC will expire in 2034 through 2035. A valuation allowance is recorded if, based on the weight of available evidence, it is more likely than not that a deferred tax asset will not be realized. This assessment is based on an evaluation of the level of historical taxable income and projections for future taxable income. For the year ended December 31, 2022, the Company recorded an additional valuation allowances related to Irish current year net operating losses of $5,547. The U.S. net operating losses are subject to an annual limitation as a result of the FSC acquisition under Internal Revenue Code Section 382 and will not be fully utilized before they expire. The Company's cumulative loss position was significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets in the U.S. Given the weight of objectively verifiable historical losses from operations, the Company recorded a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company recorded a valuation allowance against all of its net operating losses in Ireland, France and the U.S. as of December 31, 2022 and recorded a valuation allowance against all of its net operating losses in Ireland and France as of December 31, 2021. The Company intends to continue maintaining a full valuation allowance on the Irish and U.S. net operating losses until there is sufficient evidence to support the reversal of all or some portion of these allowances. At December 31, 2022, the Company has unremitted earnings of $3,967 outside of Ireland as measured on a U.S. GAAP basis. Whereas the measure of earnings for purposes of taxation of a distribution may be different for tax purposes, these earnings, which are considered to be invested indefinitely, would become subject to income tax if they were remitted as dividends or if the Company were to sell its stock in the subsidiaries, net of any prior income taxes paid. It is not practicable to estimate the amount of deferred tax liability on such earnings, if any. R&D Tax Credits Receivable The French and Irish governments provide tax credits to companies for spending on innovative R&D. These credits are recorded as an offset of R&D expenses and are credited against income taxes payable in years after being incurred or, if not so utilized, are recoverable in cash after a specified period of time, which may differ depending on the tax credit regime. As of December 31, 2022, the Company’s net research tax credit receivable amounts to $3,480 and represents a French gross research tax credit of $2,912 and an Irish gross research tax credit of $568. As of December 31, 2021, the Company’s net research tax credit receivable amounts to $3,668 and represents a French gross research tax credit of $3,139 and an Irish gross research tax credit of $529. 2020 CARES Act The CARES Act, enacted on March 27, 2020, includes significant business tax provisions. In particular, the CARES Act modified the rules associated with net operating losses. Under the temporary provisions of the CARES Act, net operating loss carryforwards and carrybacks may offset 100% of taxable income for taxable years beginning before 2021. In addition, net operating losses arising in 2018, 2019 and 2020 taxable years may be carried back to each of the preceding five years to generate a refund. The Company filed refund claims for $18,753 associated with the carryback of 2019 tax losses and a $10,273 refund claim associated with the carryback of 2020 tax losses. During the year ended December 31, 2022, the Company collected all of the outstanding receivables due to the Company related to net operating loss carrybacks. |
Other Assets and Liabilities
Other Assets and Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities Disclosure [Abstract] | |
Other Assets and Liabilities | Other Assets and Liabilities Various other assets and liabilities are summarized for the years ended December 31, as follows: Prepaid Expenses and Other Current Assets: 2022 2021 Prepaid and other expenses $ 1,523 $ 3,179 Guarantee from Armistice 276 279 Other 228 271 Income tax receivable 69 29,097 Total $ 2,096 $ 32,826 Other Non-Current Assets: 2022 2021 Right of use assets at contract manufacturing organizations $ 10,686 $ 8,549 Guarantee from Armistice 495 771 Other 141 329 Deferred tax assets — 24,128 Total $ 11,322 $ 33,777 Accrued Expenses: 2022 2021 Accrued professional fees $ 4,040 $ 2,678 Accrued compensation 1,613 3,167 Accrued outsourced contract manufacturing costs 1,208 1,048 Accrued restructuring (see Note 12 ) 473 41 Customer allowances — 217 Total $ 7,334 $ 7,151 Other Current Liabilities: 2022 2021 Accrued interest $ 1,649 $ 4,920 Guarantee to Deerfield 277 280 Other 15 70 Total $ 1,941 $ 5,270 Other Non-Current Liabilities: 2022 2021 Tax liabilities $ 5,246 $ 3,143 Guarantee to Deerfield 497 774 Total $ 5,743 $ 3,917 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingent Liabilities and Commitments | Contingent Liabilities and Commitments Litigation The Company is subject to potential liabilities generally incidental to its business arising out of present and future lawsuits and claims related to product liability, personal injury, contract, commercial, intellectual property, tax, employment, compliance and other matters that arise in the ordinary course of business. The Company accrues for potential liabilities when it is probable that future costs (including legal fees and expenses) will be incurred and such costs can be reasonably estimated. At December 31, 2022 and 2021, there were no contingent liabilities with respect to any litigation, arbitration or administrative or other proceeding that are reasonably likely to have a material adverse effect on the Company’s consolidated financial position, results of operations, cash flows or liquidity. First Jazz Complaint On May 12, 2021, Jazz Pharmaceuticals, Inc. (“Jazz”) filed a formal complaint (the “First Complaint”) initiating a lawsuit in the United States District Court for the District of Delaware (the “Court”) against Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Management Corporation, Avadel Legacy Pharmaceuticals, LLC, Avadel Specialty Pharmaceuticals, LLC, and Avadel CNS Pharmaceuticals, LLC (collectively, the “Avadel Parties”). In the First Complaint, Jazz alleges the sodium oxybate product (“Proposed Product”) described in the NDA owned by Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”) will infringe at least one claim of U.S. Patent No. 8731963, 10758488, 10813885, 10959956 and/or 10966931 (collectively, the “patents-in-suit”). The First Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On June 3, 2021, the Avadel Parties timely filed their Answer and Counterclaims (the “Avadel Answer”) with the Court in response to the First Complaint. The Avadel Answer generally denies the allegations set forth in the First Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patents-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of each patent-in-suit, and ii) a declaratory judgment of invalidity of each patent-in-suit. On June 18, 2021, Jazz filed its Answer (“Jazz Answer”) with the Court in response to the Avadel Answer. The Jazz Answer generally denies the allegations set forth in the Avadel Answer and sets forth a single affirmative defense asserting that Avadel has failed to state a claim for which relief can be granted. On June 21, 2021, the Court issued an oral order requiring the parties to i) confer regarding proposed dates to be included in the Court’s scheduling order for the case, and ii) submit a proposed order, including a proposal for the length and timing of trial, to the Court by no later than July 21, 2021. On July 30, 2021, the Court issued a scheduling order establishing timing for litigation events including i) a claim construction hearing date of August 2, 2022, and ii) a trial date of October 30, 2023. On October 18, 2021, consistent with the scheduling order, Jazz filed a status update with the Court indicating that Jazz did not intend to file a preliminary injunction with the Court at this time. Jazz further indicated that it would provide the Court with an update regarding whether preliminary injunction proceedings may be necessary after receiving further information regarding the FDA’s action on Avadel CNS’s NDA. On January 4, 2022, the Court entered an agreed order dismissing this case with respect to Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Specialty Pharmaceuticals, LLC, Avadel Legacy Pharmaceuticals, LLC, and Avadel Management Corporation. A corresponding order was entered in the two below cases on the same day. On February 25, 2022, Jazz filed an amended Answer to the Avadel Parties’ Counterclaims (“the Jazz First Amended Answer”). The Jazz First Amended Answer is substantially similar to the Jazz Answer except insofar as it adds an affirmative defense for judicial estoppel and unclean hands. Corresponding amended answers were filed in the two below cases on the same day. On June 23, 2022, Avadel CNS filed a Renewed Motion for Judgment on the Pleadings, with respect to its counterclaim against Jazz seeking to have U.S. Patent No. 8731963 (the “REMS Patent”) delisted from the Orange Book and seeking to have the motion resolved concurrent with the parties’ Markman hearing on August 31, 2022. On July 7, 2022, Jazz filed a response it styled as Objections to Avadel CNS’ Motion for Judgment on the Pleadings. On July 14, 2022, Avadel CNS replied to Jazz’s response, and on July 21, 2022, Avadel CNS requested oral argument on its delisting motion simultaneous with the Markman hearing. On August 24, 2022, the Court ordered Jazz to respond substantively to Avadel CNS’ motion, which Jazz did on August 26, 2022. Avadel CNS filed its reply on August 28, 2022. On August 23, 2022, the Markman hearing was postponed. On September 7, 2022, the case was reassigned to a new judge, and the Markman hearing was held on October 25, 2022. At the Markman hearing, Avadel CNS reiterated its request for an expedited hearing on the Renewed Motion for Judgment on the Pleadings for the delisting of the REMS Patent. On October 28, 2022, the Court granted Avadel CNS’ request and scheduled the hearing for November 15, 2022. The Court held the Markman hearing on November 15, 2022 and issued a claim construction ruling on November 18, 2022. Also on November 18, 2022 the Court granted Avadel’s Renewed Motion for Judgment on the Pleadings and ordered Jazz to request delisting of the REMS Patent from the Orange Book. On November 22, 2022, Jazz appealed that decision and on December 14, 2022, the Federal Circuit issued a stay of the delisting order until further notice. Oral argument was held February 14, 2023. On February 24, 2023, the United States Court of Appeals for the Federal Court affirmed the previous ruling from the Court, ordering the delisting of the REMS Patent from the Orange Book, which has since occurred. On March 7, 2023, in response to a joint stipulation filed by the parties, the Court issued an order dismissing Jazz’s infringement claims against the Avadel Parties relating to the REMS Patent as well as Avadel Parties’ noninfringement and invalidity counterclaims relating to the REMS Patent. Second Jazz Complaint On August 4, 2021, Jazz filed another formal complaint (the “Second Complaint”) initiating a lawsuit in the Court against the Avadel Parties. In the Second Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of U.S. Patent No. 11077079. The Second Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On September 9, 2021, the Avadel Parties timely filed their Answer and Counterclaims (the “Second Avadel Answer”) with the Court in response to the Second Complaint. The Second Avadel Answer generally denies the allegations set forth in the Second Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of the patent-in-suit, and ii) a declaratory judgment of invalidity of the patent-in-suit. On October 22, 2021, the Court issued an oral order stating that this case should proceed on the same schedule as the case filed on May 12, 2021. On September 7, 2022, the case was reassigned to a new judge. Third Jazz Complaint On November 10, 2021, Jazz filed another formal complaint (the “Third Complaint”) initiating a lawsuit in the Court against the Avadel Parties. In the Third Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of U.S. Patent No. 11147782. The Third Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. This case will proceed on the same schedule as the cases associated with the First and Second Complaints above. On December 21, 2021, the Court entered a revised schedule for the First, Second and Third Complaints, setting a new claim construction date of August 31, 2022. On January 7, 2022, Avadel CNS timely filed its Answer and Counterclaims (the “Third Avadel Answer”) with the Court in response to the Third Complaint. The Third Avadel Answer generally denies the allegations set forth in the Third Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of the patent-in-suit, and ii) a declaratory judgment of invalidity/unenforceability of the patent-in-suit. On September 7, 2022, the case was reassigned to a new judge. Fourth Jazz Complaint On July 15, 2022, Jazz filed another formal complaint (the “Fourth Complaint”) initiating a lawsuit in the Court against Avadel CNS. In the Fourth Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of the REMS Patent, which was asserted in the First Complaint. The FDA required Avadel CNS to file a Paragraph IV certification against the REMS Patent, which Avadel CNS did under protest, consistent with its Renewed Motion for Judgment on the Pleadings for the delisting of the REMS Patent from the Orange Book, which was later ordered to be delisted in the above First Jazz Complaint action. Avadel CNS provided the required notice of its Paragraph IV certification to Jazz, and Jazz reasserted the REMS Patent in a separate action following receipt of that notice. The Fourth Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On September 7, 2022, the case was reassigned to a new judge. On September 21, 2022, Jazz served the Fourth Complaint. On October 21, 2022, Avadel CNS timely filed its Answer and Counterclaims (the “Fourth Avadel Answer”) with the Court in response to the Fourth Complaint. The Fourth Avadel Answer generally denies the allegations set forth in the Fourth Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims for i) a declaratory judgment of non-infringement of the patent-in-suit, ii) a declaratory judgment of invalidity/unenforceability of the patent-in-suit, iii) delisting of the patent-in-suit from the Orange Book; iv) monopolization under the Sherman Antitrust Act of 1890 (the “Sherman Act”); and v) attempted monopolization under the Sherman Act. On December 9, 2022, Jazz filed a Motion to Dismiss Avadel’s Antitrust Counterclaims. Avadel filed its opposition brief on December 27, 2022, and Jazz filed its reply brief on January 6, 2022. On January 11, 2023, Avadel filed a request for oral argument on the motion, which is still pending. On March 6, 2023, the parties filed a stipulation of dismissal, dismissing Jazz’s claims with respect to the REMS Patent and Avadel’s related non-infringement and invalidity counterclaims. The Court entered that stipulation on March 7, 2023. Avadel Complaint On April 14, 2022, Avadel CNS and Avadel Pharmaceuticals plc (collectively the “Avadel Plaintiffs”) filed a formal complaint (the “Avadel Complaint”) initiating a lawsuit in the Court against Jazz and Jazz Pharmaceuticals Ireland Ltd. (collectively, the “Jazz Parties”). In the Avadel Complaint, the Avadel Plaintiffs allege that the Jazz Parties breached certain confidential disclosure agreements and misappropriated certain of the Avadel Plaintiffs’ trade secrets. The Avadel Complaint further includes typical relief requests such as injunctive relief, monetary damages and attorneys’ fees, costs and expenses, as well as seeking correction of inventorship of certain Jazz patents, for which the Jazz Parties claim ownership, to include former Avadel Plaintiffs’ scientists. On June 2, 2022, Jazz answered the Avadel Complaint. The Answer generally denies the allegations set forth in the Avadel Complaint and includes various affirmative defenses. On July 8, 2022, Jazz filed a Motion for Judgment on the Pleadings seeking to have all Counts dismissed for failure to state a claim upon which relief can be granted. The Avadel Plaintiffs’ response to that Motion was filed with the Court on July 29, 2022. Jazz’s reply was filed with the Court on August 5, 2022. On February 2, 2023, the Court held a hearing on Jazz’s Motion for Judgment on the Pleadings. On September 7, 2022, the case was reassigned to a new judge. On February 2, 2023, the Court held a hearing on Jazz’s Motion for Judgment on the Pleadings. Administrative Procedure Act Complaint On July 21, 2022, Avadel CNS filed an Administrative Procedure Act suit against the FDA, the U.S. Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs (the “Federal Defendants”) in the United States District Court for the District of Columbia (the “DC Court”) related to the NDA for LUMRYZ (sodium oxybate). This suit alleges that the FDA’s decision requiring Avadel CNS to file a patent certification concerning the REMS Patent was arbitrary, capricious and contrary to law and asks the DC Court to vacate the FDA’s decision and order the FDA to take final action on the LUMRYZ NDA. On July 28, 2022, the DC Court granted Jazz’s unopposed motion to intervene in the case to defend the FDA’s decision. The DC Court also entered an expedited briefing schedule governing Avadel CNS’s motion for preliminary injunction or, in the alternative, summary judgment, and the Federal Defendant’s and Jazz’s oppositions to that motion and anticipated cross-motions for summary judgment. On August 19, 2022, the Federal Defendants and Jazz filed their combined oppositions to Avadel CNS’s motion for preliminary injunction or, in the alternative, summary judgment, and cross-motions for summary judgment. On September 2, 2022, Avadel CNS filed its combined reply in support of its motion for preliminary injunction or, in the alternative, summary judgment, and opposition to the cross-motions for summary judgment. On September 14, 2022, the Federal Defendants and Jazz filed their replies in support of their cross-motions for summary judgment. On October 7, 2022, the DC Court heard oral arguments of Avadel CNS’s motion and the Federal Defendants and Jazz’s cross-motions. On November 3, 2022, the DC Court issued its opinion determining that Avadel CNS is not entitled to seek relief under the APA because of the availability of adequate alternative relief in the Court, specifically, in the form of its counterclaim to have the REMS Patent delisted from the FDA’s Orange Book described above in the section regarding the First Jazz Complaint. Material Commitments The Company has a commitment with a contract manufacturer of approximately $2,400 to $3,000 per year. If LUMRYZ is approved by the FDA and the contract manufacturer is subsequently approved, the annual commitment could be up to $4,200 per year. Guarantees The fair values of the Company’s guarantee to Deerfield Capital L.P. (“Deerfield”) and the guarantee received by the Company from Armistice Capital Master Fund, Ltd. largely offset and when combined are not material. Deerfield Guarantee In connection with the Company’s February 2018 divestiture of its pediatric assets, including four pediatric commercial stage assets – Karbinal™ ER, Cefaclor, Flexichamber™ and AcipHex® Sprinkle™ (“FSC products”), to Cerecor, Inc. (“Cerecor”), the Company guaranteed to Deerfield a quarterly royalty payment of 15% on net sales of the FSC products through February 6, 2026 (“FSC Product Royalties”), in an aggregate amount of up to approximately $10,300. Given the Company’s explicit guarantee to Deerfield, the Company recorded the guarantee in accordance with ASC 460. The balance of this guarantee liability was $774 at December 31, 2022. This liability is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield. Armistice Guarantee In connection with the Company’s February 2018 divestiture of the pediatric assets, Armistice Capital Master Fund, Ltd., the majority shareholder of Cerecor, guaranteed to the Company the FSC Product Royalties. The Company recorded the guarantee in accordance with ASC 460. The balance of this guarantee asset was $771 at December 31, 2022. This asset is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield noted above. |
Restructuring Costs
Restructuring Costs | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring Costs 2022 Corporate Restructuring Plan In June 2022, the Company announced a plan to optimize its cost structure to reduce total quarterly cash operating expenses, excluding inventory purchases. The Company’s cost structure optimization efforts included a nearly 50% reduction in its workforce that was completed at the end of August 2022 (the “2022 Corporate Restructuring Plan”). Restructuring expense of $3,345, comprised primarily of severance related costs, was recorded for the year ended December 31, 2022. The following table sets forth activities for the Company’s 2022 Corporate Restructuring Plan obligations as of December 31, 2022: 2022 Corporate Restructuring Plan Obligation: 2022 Balance of 2022 Corporate Restructuring Plan accrual at January 1, $ — Charges for employee severance, benefits and other costs 3,592 Payments (2,910) Other adjustments (247) Balance of 2022 Corporate Restructuring Plan accrual at December 31, $ 435 The 2022 Corporate Restructuring Plan liabilities of $435 are included in the consolidated balance sheet in accrued expenses at December 31, 2022. 2019 French Restructuring During the second quarter of 2019, the Company initiated a plan to discontinue all French business activities, which resulted in the redundancy and reduction of its entire workforce at its Vénissieux, France site and the cessation of all business activities there (“2019 French Restructuring”). This reduction was part of an effort to align the Company’s cost structure with its ongoing and future planned projects. The discontinuation of business activities and elimination of the workforce in France was completed during the year ended December 31, 2020. Restructuring charges associated with this plan recognized during the years ended December 31, 2022 and 2021 were immaterial. The Company does not expect to incur any additional expenses related to the 2019 French Restructuring. The following table sets forth activities for the Company’s cost reduction plan obligations for the years ended December 31, 2022 and 2021: 2019 French Restructuring Obligation: 2022 2021 Balance of restructuring accrual at January 1, $ 41 $ 248 (Benefit) charges for employee severance, benefits and other costs — (122) Payments — (77) Foreign currency impact (3) (8) Balance of restructuring accrual at December 31, $ 38 $ 41 The 2019 French Restructuring liability of $38 is included in the consolidated balance sheet in accrued expenses at December 31, 2022. |
Equity Instruments and Transact
Equity Instruments and Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Equity Instruments and Transactions | Equity Instruments and Transactions Capital Shares The Company has 500,000 shares of authorized ordinary shares with a nominal value of $0.01 per ordinary share. As of December 31, 2022, the Company had 62,878 ordinary shares issued and outstanding, respectively. The Board of Directors is authorized to issue preferred shares in series, and with respect to each series, to fix its designation, relative rights (including voting, dividend, conversion, sinking fund, and redemption rights), preferences (including dividends and liquidation) and limitations. The Company has 50,000 shares of authorized preferred shares, $0.01 nominal value, of which 488 are currently issued and outstanding as of December 31, 2022. Shelf Registration Statement on Form S-3 In February 2020, the Company filed with the SEC a new shelf registration statement on Form S-3 (the “2020 Shelf Registration Statement”) (File No. 333-236258) that allows issuance and sale by the Company, from time to time, of: a. up to $250,000 in aggregate of ordinary shares, nominal value US$0.01 per share (the “Ordinary Shares”), each of which may be represented by American Depositary Shares (“ADSs”), preferred shares, nominal value US$0.01 per share (the “Preferred Shares”), debt securities (the “Debt Securities”), warrants to purchase Ordinary Shares, ADSs, Preferred Shares and/or Debt Securities (the “Warrants”), and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2020 Shelf Registration Statement, the base prospectus contained in the 2020 Shelf Registration Statement (the “2020 Base Prospectus”), and any amendments or supplements thereto; including b. up to $50,000 of ADSs that may be issued and sold from time to time pursuant to the terms of an Open Market Sale Agreement SM , entered into with Jefferies LLC (“Jefferies”) on February 4, 2020 (the “Sales Agreement”), the 2020 Shelf Registration Statement, the 2020 Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement. The Company agreed to pay Jefferies a commission up to 3.0% of the aggregate gross sales proceeds of such ADSs. As of December 31, 2022, the Company had issued and sold 3,588 ADSs, resulting in net proceeds to the Company of approximately $25,318, pursuant to the Sales Agreement. The transaction costs associated with the 2020 Shelf Registration Statement totaled $428, of which $169 remain recorded within prepaid expenses and other current assets at December 31, 2022. In August 2022, the Company filed with the SEC a new shelf registration statement on Form S-3 (the “2022 Shelf Registration Statement”) (File No. 333-267198) that allows issuance and sale by the Company, from time to time, of: a. up to $500,000 in aggregate of Ordinary Shares, each of which may be represented by ADSs, Preferred Shares, Debt Securities, Warrants, and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2022 Shelf Registration Statement, the base prospectus contained in the 2022 Shelf Registration Statement (the “2022 Base Prospectus”), and any amendments or supplements thereto; including b. up to $100,000 of ADSs that may be issued and sold from time to time pursuant to the Sales Agreement, the 2022 Shelf Registration Statement, the 2022 Base Prospectus and the terms of the sales agreement prospectus contained in the 2022 Shelf Registration Statement. At December 31, 2022, the Company had up to $123,899 of ADSs available for sale under the ATM Program pursuant to the Sales Agreement. The transactions costs associated with the 2022 Shelf Registration Statement totaled $192, which are recorded within prepaid expenses and other current assets at December 31, 2022. February 2020 Private Placement On February 21, 2020, the Company announced that it entered into a definitive agreement for the sale of its ADSs and Series A Non-Voting Convertible Preferred Shares (“Series A Preferred”) in a private placement to a group of institutional accredited investors. The private placement resulted in gross proceeds of approximately $65,000 before deducting placement agent and other offering expenses, which resulted in net proceeds of $60,570. Pursuant to the terms of the private placement, the Company issued 8,680 ADSs and 488 shares of Series A Preferred at a price of $7.09 per share, priced at-the-market under Nasdaq rules. Each share of non-voting Series A Preferred is convertible into one ADS, provided that conversion will be prohibited if, as a result, the holder and its affiliates would own more than 9.99% of the total number of Avadel ADSs outstanding. The closing of the private placement occurred on February 25, 2020. Issuance costs of $4,430 have been recorded as a reduction of additional paid-in capital. May 2020 Public Offering In connection with the shelf registration statement described above, on April 28, 2020, the Company announced the pricing of an underwritten public offering of 11,630 Ordinary Shares, in the form of ADSs at a price to the public of $10.75 per ADS. Each ADS represents the right to receive one Ordinary Share. All of the ADSs were offered by the Company and the gross proceeds to the Company from the offering were approximately $125,000, before deducting underwriting discounts and commissions and offering expenses, which resulted in net proceeds of $116,924. The offering closed on May 1, 2020. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation Compensation expense included in the Company’s consolidated statements of loss for all share-based compensation arrangements was as follows for the periods ended December 31, 2022 and 2021, respectively: Share-based Compensation Expense: 2022 2021 Research and development $ 169 $ 758 Selling, general and administrative 6,844 8,114 Total share-based compensation expense $ 7,013 $ 8,872 As of December 31, 2022, the Company expects $9,040 of unrecognized expense related to granted, but non-vested share-based compensation arrangements to be incurred in future periods. This expense is expected to be recognized over a weighted average period of 2.54 years. In 2022, the Company granted options with performance conditions to employees of which 50% vest upon the achievement of certain commercial milestones related to LUMRYZ and the other 50% vest one year following achievement of those milestones (“2022 Performance Options”). At December 31, 2022, achievement of these milestones was not considered probable and the Company has not yet recognized any share-based compensation on the 2022 Performance Options. In the event the performance conditions are met, $8,027 of share-based compensation expense is expected to be recognized. The excess tax benefit related to share-based compensation recorded by the Company was not material for the years ended December 31, 2022 and 2021. Upon exercise of stock options, or upon the issuance of restricted share awards or performance share unit awards, the Company issues new shares. At December 31, 2022, there were 752 shares authorized for stock option grants, restricted share award grants, and performance share unit award grants in subsequent periods. Inducement Plan In November 2021, the Board of Directors approved the Avadel Pharmaceuticals plc 2021 Inducement Plan (the “Inducement Plan”), which allows the Company to grant equity awards to induce highly-qualified prospective officers and employees who are not currently employed by the Company to accept employment and provide them with a proprietary interest in the Company. The maximum number of shares reserved and available for issuance under the Plan is 1,500 shares. As of December 31, 2022, the Company had 1,278 shares available for issuance under this Inducement Plan in subsequent periods. Determining the Fair Value of Stock Options The Company measures the total fair value of stock options on the grant date using the Black-Scholes option-pricing model and recognizes each grant’s fair value as compensation expense over the period that the option vests. Other than the 2022 Performance Options described above, options are granted to employees of the Company and become exercisable ratably over four years following the grant date and expire ten years after the grant date. Prior to 2021, the Company issued stock options to its Board of Directors as compensation for services rendered that are exercisable ratably over three years following the grant date, and expire ten years after the grant date. Beginning in 2021, the Company issued stock options to its Board of Directors as compensation for services rendered and are exercisable one year following the grant date and expire ten years after the grant date. The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2022 and 2021 are as follows: Stock Option Assumptions: 2022 2021 Stock option grants: Expected term (years) 6.09 6.20 Expected volatility 93.41 % 73.91 % Risk-free interest rate 2.73 % 1.10 % Expected dividend yield — — Expected term : The expected term of the options represents the period of time between the grant date and the time the options are either exercised or forfeited, including an estimate of future forfeitures for outstanding options. Given the limited historical data, the simplified method has been used to calculate the expected life. Expected volatility : The expected volatility is calculated based on an average of the historical volatility of the Company’s stock price for a period approximating the expected term. Risk-free interest rate : The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant and a maturity that approximates the expected term. Expected dividend yield : The Company has not distributed any dividends since its inception and have no plan to distribute dividends in the foreseeable future. Stock Options A summary of the combined stock option activity and other data for the Company’s stock option plans for the year ended December 31, 2022 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2022 8,403 $ 7.39 Granted 3,268 5.29 Exercised (450) 5.46 Forfeited (1,496) 7.24 Expired (421) 9.65 Stock options outstanding, December 31, 2022 9,304 $ 6.67 7.78 years $ 8,710 Stock options exercisable, December 31, 2022 4,059 $ 7.40 6.33 years $ 6,859 The aggregate intrinsic value of options exercised during the year ended December 31, 2022 and 2021 was $877 and $249, respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2022 and 2021 was $4.02 and $5.36 per share, respectively. Restricted Share Awards Restricted share awards represent Company shares issued free of charge to employees of the Company as compensation for services rendered. The Company measures the total fair value of restricted share awards on the grant date using the Company’s stock price at the time of the grant. Restricted share awards granted from 2017-2020 vest over a three-year period; two-thirds (2/3) vesting on the second anniversary of the grant date and the remaining one-third (1/3) vesting on the third anniversary of the grant date. In 2021, restricted share awards granted to employees vest over a four-year period; one-fourth (1/4) on each anniversary of the grant date. In 2018, the Company issued restricted share awards to its Board of Directors vesting over a three-year period; one-third (1/3) vesting on each of the three anniversaries of the grant date. Compensation expense for such awards granted during and after 2017 is recognized over the applicable vesting period. A summary of the Company’s restricted share awards as of December 31, 2022, and changes during the year then ended, is reflected in the table below. Restricted Share Activity and Other Data: Number of Restricted Share Awards Weighted Average Grant Date Non-vested restricted share awards outstanding, January 1, 2022 274 $ 7.14 Granted — — Vested (144) 6.37 Forfeited (74) 8.04 Non-vested restricted share awards outstanding, December 31, 2022 56 $ 7.95 No restricted share awards were granted during the year ended December 31, 2022. The weighted average grant date fair value of restricted share awards granted during the year ended December 31, 2021 was $8.22 per share. Performance Share Units Awards Performance share units awards (“PSUs”) represent Company shares issued free of charge to employees of the Company as compensation for achieving various results. The Company measures the total fair value of performance share unit awards on the grant date using the Company’s stock price at the time of the grant. In 2020, the Company granted performance share awards, of which 50% vest upon the achievement of certain regulatory milestones related to LUMRYZ and the other 50% vest one year following achievement of those milestones (“2020 PSU awards”). The regulatory milestones were not met and the 2020 PSU awards were forfeited in 2022. The Company did not recognize any share-based compensation expense related to the 2020 PSU awards as of December 31, 2022. In 2021, the Company granted performance share awards of which 50% vest upon achievement of certain corporate objectives and the second 50% vests one year following achievement of those objectives (“2021 PSU awards”). The objectives of the 2021 PSU awards were not met and the 2021 PSU awards were forfeited in 2022. The Company did not recognize any share-based compensation expense related to the 2021 PSU awards as of December 31, 2022. A summary of the Company’s performance share units awards as of December 31, 2022, and changes during the year then ended, is reflected in the table below. Performance Unit Share Activity and Other Data Number of Performance Share Awards Weighted Average Grant Date Non-vested performance share awards outstanding, January 1, 2022 535 $ 7.71 Granted — — Vested — — Forfeited (535) 7.71 Non-vested performance share awards outstanding, December 31, 2022 — $ — There were no performance share awards granted during the year ended December 31, 2022. The weighted average grant date fair value of performance share awards granted during the years ended December 31, 2021 was $8.20 per share. Employee Share Purchase Plan In 2017, the Board of Directors approved the Avadel Pharmaceuticals plc 2017 Avadel Employee Share Purchase Plan (“ESPP”). The total number of Company ordinary shares, nominal value $0.01 per share, or ADSs representing such ordinary shares (collectively, “Shares”) which may be issued under the ESPP is 1,000. The purchase price at which a share will be issued or sold for a given offering period will be established by the Compensation Committee of the Board (“Committee”) (and may differ among participants, as determined by the Committee in its sole discretion) but will in no event be less than 85% of the lesser of: (a) the fair market value of a Share on the offering date; or (b) the fair market value of a Share on the purchase date. During the years ended December 31, 2022 and 2021, the Company issued 75 and 17 ordinary shares to employees, respectively. Expense related to the ESPP for the years ended December 31, 2022 and 2021 was immaterial. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during each period. Diluted net loss per share is calculated by dividing net loss - diluted by the diluted number of shares outstanding during each period. Except where the result would be anti-dilutive to net loss, diluted net loss per share would be calculated assuming the impact of the conversion of the 2023 Notes, the conversion of the Company’s preferred shares, the exercise of outstanding equity compensation awards, and ordinary shares expected to be issued under the Company’s ESPP. The Company has a choice to settle the conversion obligation under the 2023 Notes in cash, shares or any combination of the two. The Company utilizes the if-converted method to reflect the impact of the conversion of the 2023 Notes, unless the result is anti-dilutive. This method assumes the conversion of the 2023 Notes into shares of the Company’s ordinary shares and reflects the elimination of the interest expense related to the 2023 Notes. The dilutive effect of the stock options, restricted stock units, preferred shares and ordinary shares expected to be issued under the Company’s ESPP has been calculated using the treasury stock method. A reconciliation of basic and diluted net loss per share, together with the related shares outstanding in thousands for the years ended December 31, 2022 and 2021, is as follows: Net Loss Per Share: 2022 2021 Net loss $ (137,464) $ (77,329) Weighted average shares: Basic shares 60,094 58,535 Effect of dilutive securities—employee and director equity awards outstanding — — Diluted shares 60,094 58,535 Net loss per share - basic $ (2.29) $ (1.32) Net loss per share - diluted $ (2.29) $ (1.32) |
Comprehensive Loss
Comprehensive Loss | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Comprehensive Loss | Comprehensive Loss The following table shows the components of accumulated other comprehensive loss for the year ended December 31, net of immaterial tax effects: Accumulated Other Comprehensive Loss: 2022 2021 Foreign currency translation adjustment: Beginning balance $ (23,855) $ (22,627) Net other comprehensive loss (597) (1,228) Balance at December 31, $ (24,452) $ (23,855) Unrealized (loss) gain on marketable securities, net Beginning balance $ (85) $ 1,576 Net other comprehensive loss, net of income tax benefit of $— and $214, respectively (1,804) (1,661) Balance at December 31, $ (1,889) $ (85) Accumulated other comprehensive loss at December 31, $ (26,341) $ (23,940) |
Company Operations by Product,
Company Operations by Product, Customer and Geographic Area | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting [Abstract] | |
Company Operations by Product, Customer and Geographic Area | Company Operations by Product, Customer and Geographic Area The Company has determined that it operates in one segment, the development and commercialization of pharmaceutical products, including controlled-release therapeutic products based on its proprietary polymer based technology. The Company’s Chief Operating Decision Maker is the Chief Executive Officer (“CEO”). The CEO reviews profit and loss information on a consolidated basis to assess performance and make overall operating decisions as well as resource allocations. All products are included in one segment because the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. The Company had no revenue during the years ended December 31, 2022 and 2021. Currently, the Company is working with contract manufacturing organizations for the manufacture of LUMRYZ. Additionally, the Company purchases raw materials used in LUMRYZ from a limited number of suppliers, including a single supplier for certain key ingredients. Non-monetary long-lived assets primarily consist of property and equipment, goodwill, intangible assets and operating right-of use-assets. The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2022 and 2021: Long-lived Assets by Geographic Region: 2022 2021 U.S. $ 19,414 $ 19,605 Ireland 11,296 9,817 Total $ 30,710 $ 29,422 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Avadel Finance Cayman Limited, a Cayman Islands exempted company and an indirect wholly-owned subsidiary of Avadel Pharmaceuticals plc, repaid, with cash on hand, the remaining $17,500 aggregate principal amount of its February 2023 Notes on the maturity date of February 1, 2023. On March 29, 2023, the Issuer executed an agreement to exchange $96,188 of its $117,375 October 2023 Notes for a new series of 6.0% exchangeable notes due April 2027 (the “April 2027 Notes”) (the “2023 Exchange Transaction”). The remaining $21,187 aggregate principal amount of the October 2023 Notes will maintain a maturity date of October 2, 2023. On March 29, 2023, the Company executed a royalty purchase agreement with RTW Investments, L.P. that could provide the Company up to $75,000 of royalty financing. The $75,000 of royalty financing will be accessible following achievement of certain regulatory and financial milestones, including final FDA approval and commercial launch of LUMRYZ. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2022 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II Valuation and Qualifying Accounts | Schedule II Valuation and Qualifying Accounts (In thousands) Deferred Tax Asset Valuation Allowance: Balance, Additions Deductions Other Changes Balance, 2022 $ 24,025 $ 48,734 $ — $ (1,418) $ 71,341 2021 $ 21,624 $ 4,235 $ (51) $ (1,783) $ 24,025 2020 $ 17,037 $ 2,805 $ — $ 1,782 $ 21,624 a. Additions to the deferred tax asset valuation allowance relate to movements on certain French, Irish and U.S. deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal. b. Deductions to the deferred tax asset valuation allowance include movements relating to utilization of net operating losses and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns. c. Other changes to the deferred tax asset valuation allowance including currency translation adjustments recorded directly in equity, account method changes and the impact of corporate restructuring. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Nature of Operations | Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a biopharmaceutical company. The Company is registered as an Irish public limited company. The Company’s headquarters are in Dublin, Ireland with operations in Dublin, Ireland and St. Louis, Missouri, United States (“U.S”). The Company’s lead product candidate, LUMRYZ, also known as FT218, is an investigational once-at-bedtime, extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy. On July 18, 2022, the U.S. Food and Drug Administration (“FDA”) granted tentative approval to LUMRYZ for this indication. Tentative approval indicates that LUMRYZ has met all required quality, safety, and efficacy standards necessary for approval in the U.S. On March 1, 2023, the Company submitted an amendment to the FDA requesting final approval of the LUMRYZ new drug application (“NDA”) and is currently awaiting a final approval decision from the FDA. The Company cannot legally market LUMRYZ in the U.S. until final approval is granted by the FDA. Outside of the Company’s lead product candidate, the Company continues to evaluate opportunities to expand its product portfolio. As of the date of this Annual Report, the Company does not have any commercialized products in its portfolio. |
Liquidity and Going Concern | Liquidity and Going Concern The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. |
Basis of Presentation | Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. |
Reclassifications | Reclassifications Certain reclassifications are made to prior year amounts whenever necessary to conform with the current year presentation. Certain reclassifications have been made to the Consolidated Statement of Loss and the Consolidated Statements of Cash Flows for the fiscal year ended December 31, 2021 to condense line items of the same nature into a single line. This change does not affect previously reported net loss in the Consolidated Statement of Loss and or net cash flows used in operating activities in the Consolidated Statements of Cash Flows. |
Research and Development (“R&D”) | Research and Development (“R&D”). R&D expenses consist primarily of costs related to outside services, personnel expenses, clinical studies and other R&D expenses. Outside services and clinical studies costs relate primarily to services performed by clinical research organizations and related clinical or development manufacturing costs, materials and supplies, filing fees, regulatory support, and other third-party fees. Personnel expenses relate primarily to salaries, benefits and share-based compensation. Other R&D expenses primarily include overhead allocations consisting of various support and facilities-related costs. R&D expenditures are charged to operations as incurred. Raw materials used in the production of pre-clinical and clinical products are expensed as R&D costs. |
Advertising Expenses | Advertising Expenses. The Company expenses the costs of advertising as incurred. Branded advertising expenses were immaterial for the years ended December 31, 2022 and 2021, respectively. |
Stock-based Compensation | Share-based Compensation. The Company accounts for share-based compensation based on the estimated grant-date fair value. The fair value of stock options is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Scholes model, estimates are made of the underlying volatility of Avadel stock, a risk-free rate and an expected term of the option or warrant. The Company estimates the expected term using a simplified method, as the Company does not have enough historical exercise data for a majority of such options upon which to estimate an expected term. The Company recognizes compensation cost, net of an estimated forfeiture rate, using the accelerated method over the requisite service period of the award. |
Income Taxes | Income Taxes. The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2022, the Company's cumulative loss position was significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets. Given the weight of objectively verifiable historical losses from operations, the Company recorded a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company records uncertain tax positions on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits in the income tax expense line in the consolidated statements of loss. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months. |
Marketable Securities | Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in shareholders’ (deficit) equity, with the exception of unrealized gains and losses on equity instruments and allowances for expected credit losses, if any, which are reported in earnings in the current period. The cost of securities sold is based upon the specific identification method. |
Allowance for Credit Losses | Allowance for Credit Losses. Amounts owed to the Company are presented net of an allowance that includes as assessment of expected credit losses. An allowance for credit losses is established based on expected losses. Expected losses are estimated by reviewing individual accounts, considering aging, financial condition of the debtor, payment history, current and forecast economic conditions and other relevant factors. To the extent that the Company identifies that any individual customer's credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics of that customer. The Company makes concerted efforts to collect all outstanding balances due from customers; however, amounts are written off against the allowance when the related balances are no longer deemed collectible. |
Property and Equipment | Property and Equipment. Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years |
Goodwill | Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. The Company has determined that it operates in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. The Company tests goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. The Company determined that no impairment of goodwill existed at December 31, 2022 and 2021. |
Long-Lived Assets | Long-Lived Assets. Long-lived assets include fixed assets and right of use assets at contract manufacturing organizations. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market-based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. Certain long-lived assets are amortized using the straight-line method over a five year useful life. Total amortization expense of long-lived assets for the year ended December 31, 2022 and 2021 was $391 and $0, respectively. |
Lease Obligations | Lease Obligations. The Company determines if a contract is a lease at the inception of the arrangement. Right-of-use assets and operating lease liabilities are recognized at commencement date based on the present value of remaining lease payments over the lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. Short term leases with an initial term of 12 months or less are not recorded on the balance sheet and the associated lease payments are recognized in the consolidated statements of loss on a straight-line basis over the lease term. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. The Company’s lease agreements may contain variable costs such as common area maintenance, insurance, real estate taxes or other costs. Variable lease costs are expensed as incurred on the consolidated statements of loss. |
Use of Estimates | Use of Estimates. The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including marketable securities and contingent liabilities at the date of the consolidated financial statements and the reported amounts of sales and expenses during the periods presented. These estimates and assumptions are based on the best information available to management at the balance sheet dates and depending on the nature of the estimate can require significant judgments. Changes to these estimates and judgments can have and have had a material impact on the Company’s consolidated statements of loss and balance sheets. Actual results could differ from those estimates under different assumptions or conditions. |
Previously Adopted Accounting Guidance | Previously Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. The FASB’s amendments primarily impact ASC 740, Income Taxes , and may impact both interim and annual reporting periods. ASU 2019-12 is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years and early adoption is permitted. The Company adopted the provisions of ASU 2019-12 on January 1, 2021. Adoption of ASU 2019-12 did not have any impact on the Company’s consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging- Contracts in Entity’s Own Equity (Subtopic 815-40) , to reduce the complexity associated with applying U.S. GAAP principles for certain financial instruments with characteristics of liabilities and equity. The amendments in this ASU reduce the number of accounting models for convertible instruments and expand the existing disclosure requirements over earnings per share as it relates to convertible instruments. Convertible debt will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The update also requires the if-converted method to be used for convertible instruments and the effect of potential share settlement be included in the diluted earnings per share calculation when an instrument may be settled in cash or shares. This ASU will be effective for the Company’s fiscal year beginning January 1, 2022 and interim periods therein. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. The amendments may be adopted through either a modified retrospective method, or a fully retrospective method. The Company elected to early adopt ASU 2020-06 as of January 1, 2021 using a modified retrospective method. The Company’s 4.50% exchangeable senior notes due 2023 (the “2023 Notes”) are a convertible instrument with a cash-conversion feature that is accounted for within the scope of Subtopic 470-20. The Company calculated the cumulative-effect adjustment as of January 1, 2021 by comparing (i) the historical amortization schedule for the 2023 Notes through December 31, 2020 and (ii) an updated amortization schedule wherein the conversion feature within the 2023 Notes would not be separated as an equity |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Useful Life | Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years The principal categories of property and equipment, net at December 31, 2022 and 2021, respectively, are as follows: Property and Equipment, net: 2022 2021 Software, office and computer equipment $ 832 $ 448 Furniture, fixtures and fittings 634 302 Less - accumulated depreciation (627) (465) Total $ 839 $ 285 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Instruments Measured at Fair Value on a Recurring Basis | The following table summarizes the financial instruments measured at fair value on a recurring basis classified in the fair value hierarchy (Level 1, 2 or 3) based on the inputs used for valuation in the accompanying consolidated balance sheets: As of December 31, 2022 As of December 31, 2021 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 4) Mutual and money market funds $ 22,518 $ — $ — $ 78,098 $ — $ — Corporate bonds — — — — 16,479 — Government securities - U.S. — — — — 9,471 — Other fixed-income securities — — — — 2,465 — Total assets $ 22,518 $ — $ — $ 78,098 $ 28,415 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Available-for-sale Securities | The following tables show the Company’s available-for-sale securities’ adjusted cost, gross unrealized gains, gross unrealized losses and fair value by significant investment category as of December 31, 2022 and 2021, respectively: 2022 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 24,407 $ — $ (1,889) $ 22,518 Total $ 24,407 $ — $ (1,889) $ 22,518 2021 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 78,331 $ 813 $ (1,046) $ 78,098 Corporate bonds 16,478 94 (93) 16,479 Government securities - U.S. 9,530 39 (98) 9,471 Other fixed-income securities 2,473 2 (10) 2,465 Total $ 106,812 $ 948 $ (1,247) $ 106,513 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years The principal categories of property and equipment, net at December 31, 2022 and 2021, respectively, are as follows: Property and Equipment, net: 2022 2021 Software, office and computer equipment $ 832 $ 448 Furniture, fixtures and fittings 634 302 Less - accumulated depreciation (627) (465) Total $ 839 $ 285 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Components of Lease Costs | The components of lease costs, which are included in selling, general and administrative expenses in the consolidated statements of loss of years ended December 31, 2022 and 2021 were as follows: Lease cost: 2022 2021 Operating lease costs (1) $ 1,028 $ 821 Sublease income (2) (116) (110) Total lease cost $ 912 $ 711 (1) Variable lease costs were immaterial for the years ended December 31, 2022 and 2021. (2) Represents sublease income received for office subleases. |
Maturities of Operating Lease Liabilities | Maturities of the Company’s operating lease liabilities were as follows: Maturities: Operating Leases 2023 $ 1,013 2024 614 2025 206 2026 — 2027 — Thereafter — Total lease payments 1,833 Less: interest 93 Present value of lease liabilities $ 1,740 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-term debt is summarized as follows: December 31, 2022 December 31, 2021 Principal amount of 4.50% exchangeable senior notes due February 2023 $ 17,500 $ 143,750 Principal amount of 4.50% exchangeable senior notes due October 2023 117,375 — Less: unamortized debt discount and issuance costs, net (5,593) (1,353) Net carrying amount of liability component 129,282 142,397 Less: current maturities 37,668 — Long-term debt $ 91,614 $ 142,397 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule Of Components Of (Loss) Income Before Income Tax | The components of (loss) income before income taxes for the years ended twelve months ended December 31, are as follows: (Loss) Income Before Income Taxes: 2022 2021 Ireland $ (53,717) $ (36,631) U.S. (57,755) (56,687) France 33 173 Total loss before income taxes $ (111,439) $ (93,145) |
Schedule Of Income Tax Provision (Benefit) | The income tax provision (benefit) consists of the following for the years ended December 31: Income Tax Provision (Benefit): 2022 2021 Current: U.S. - State $ — $ 60 Total current — 60 Deferred: U.S. - Federal 25,896 (15,876) U.S. - State 129 — Total deferred 26,025 (15,876) Income tax provision (benefit) $ 26,025 $ (15,816) |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between income taxes at the statutory rate and the Company’s provision (benefit) for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2022 2021 Income tax provision (benefit) - at statutory tax rate $ (13,916) $ (11,642) Differences in international tax rates (9,921) (8,950) Change in valuation allowances 48,734 4,296 Nondeductible share-based compensation 1,424 645 Unrealized tax benefits 258 239 State and local taxes (net of federal) (4,467) 60 Nondeductible interest expense 4,239 2,173 Orphan drug and R&D tax credit — (1,524) Other (326) (1,113) Income tax provision (benefit) - at effective income tax rate $ 26,025 $ (15,816) |
Summary of Unrecognized Tax Benefits | The following table summarizes the activity related to the Company’s unrecognized tax benefits for the twelve months ended December 31: Unrecognized Tax Benefit Activity 2022 2021 Balance at January 1: $ 3,143 $ 3,143 Increases for tax positions of prior years — — Statute of limitations expiration — — Settlements — — Balance at December 31: $ 3,143 $ 3,143 |
Schedule of Deferred Tax Assets and Liabilities | The net deferred tax assets (liabilities) at December 31, 2022 and 2021 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2022 2021 Deferred tax assets: Net operating loss carryforwards $ 53,393 $ 34,399 Share-based compensation 4,684 4,108 Amortization 3,541 3,429 Orphan drug and R&D tax credit 4,964 4,964 Capitalized research costs 2,108 — Other 1,521 662 Interest expense carryforward 1,216 1,591 Gross deferred tax assets 71,427 49,153 Deferred tax liabilities: Prepaid expenses (86) (75) Other — (925) Gross deferred tax liabilities (86) (1,000) Less: valuation allowances (71,341) (24,025) Net deferred tax assets $ — $ 24,128 |
Other Assets and Liabilities (T
Other Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Various other assets and liabilities are summarized for the years ended December 31, as follows: Prepaid Expenses and Other Current Assets: 2022 2021 Prepaid and other expenses $ 1,523 $ 3,179 Guarantee from Armistice 276 279 Other 228 271 Income tax receivable 69 29,097 Total $ 2,096 $ 32,826 |
Schedule of Other Non-Current Assets | Other Non-Current Assets: 2022 2021 Right of use assets at contract manufacturing organizations $ 10,686 $ 8,549 Guarantee from Armistice 495 771 Other 141 329 Deferred tax assets — 24,128 Total $ 11,322 $ 33,777 |
Schedule of Accrued Expenses | Accrued Expenses: 2022 2021 Accrued professional fees $ 4,040 $ 2,678 Accrued compensation 1,613 3,167 Accrued outsourced contract manufacturing costs 1,208 1,048 Accrued restructuring (see Note 12 ) 473 41 Customer allowances — 217 Total $ 7,334 $ 7,151 |
Schedule of Other Current Liabilities | Other Current Liabilities: 2022 2021 Accrued interest $ 1,649 $ 4,920 Guarantee to Deerfield 277 280 Other 15 70 Total $ 1,941 $ 5,270 |
Schedule of Other Non-Current Liabilities | Other Non-Current Liabilities: 2022 2021 Tax liabilities $ 5,246 $ 3,143 Guarantee to Deerfield 497 774 Total $ 5,743 $ 3,917 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table sets forth activities for the Company’s 2022 Corporate Restructuring Plan obligations as of December 31, 2022: 2022 Corporate Restructuring Plan Obligation: 2022 Balance of 2022 Corporate Restructuring Plan accrual at January 1, $ — Charges for employee severance, benefits and other costs 3,592 Payments (2,910) Other adjustments (247) Balance of 2022 Corporate Restructuring Plan accrual at December 31, $ 435 2019 French Restructuring Obligation: 2022 2021 Balance of restructuring accrual at January 1, $ 41 $ 248 (Benefit) charges for employee severance, benefits and other costs — (122) Payments — (77) Foreign currency impact (3) (8) Balance of restructuring accrual at December 31, $ 38 $ 41 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Compensation Expense for Share-Based Compensation Arrangements | Compensation expense included in the Company’s consolidated statements of loss for all share-based compensation arrangements was as follows for the periods ended December 31, 2022 and 2021, respectively: Share-based Compensation Expense: 2022 2021 Research and development $ 169 $ 758 Selling, general and administrative 6,844 8,114 Total share-based compensation expense $ 7,013 $ 8,872 |
Schedule of Weighted-Average Assumptions | The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2022 and 2021 are as follows: Stock Option Assumptions: 2022 2021 Stock option grants: Expected term (years) 6.09 6.20 Expected volatility 93.41 % 73.91 % Risk-free interest rate 2.73 % 1.10 % Expected dividend yield — — |
Summary of Stock Option Activity | A summary of the combined stock option activity and other data for the Company’s stock option plans for the year ended December 31, 2022 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2022 8,403 $ 7.39 Granted 3,268 5.29 Exercised (450) 5.46 Forfeited (1,496) 7.24 Expired (421) 9.65 Stock options outstanding, December 31, 2022 9,304 $ 6.67 7.78 years $ 8,710 Stock options exercisable, December 31, 2022 4,059 $ 7.40 6.33 years $ 6,859 |
Summary of Restricted Share Awards and Performance Share Unit Awards | A summary of the Company’s restricted share awards as of December 31, 2022, and changes during the year then ended, is reflected in the table below. Restricted Share Activity and Other Data: Number of Restricted Share Awards Weighted Average Grant Date Non-vested restricted share awards outstanding, January 1, 2022 274 $ 7.14 Granted — — Vested (144) 6.37 Forfeited (74) 8.04 Non-vested restricted share awards outstanding, December 31, 2022 56 $ 7.95 A summary of the Company’s performance share units awards as of December 31, 2022, and changes during the year then ended, is reflected in the table below. Performance Unit Share Activity and Other Data Number of Performance Share Awards Weighted Average Grant Date Non-vested performance share awards outstanding, January 1, 2022 535 $ 7.71 Granted — — Vested — — Forfeited (535) 7.71 Non-vested performance share awards outstanding, December 31, 2022 — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Reconciliation of Basic and Diluted Net Loss Per Share | A reconciliation of basic and diluted net loss per share, together with the related shares outstanding in thousands for the years ended December 31, 2022 and 2021, is as follows: Net Loss Per Share: 2022 2021 Net loss $ (137,464) $ (77,329) Weighted average shares: Basic shares 60,094 58,535 Effect of dilutive securities—employee and director equity awards outstanding — — Diluted shares 60,094 58,535 Net loss per share - basic $ (2.29) $ (1.32) Net loss per share - diluted $ (2.29) $ (1.32) |
Comprehensive Loss (Tables)
Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Accumulated Other Comprehensive Loss | The following table shows the components of accumulated other comprehensive loss for the year ended December 31, net of immaterial tax effects: Accumulated Other Comprehensive Loss: 2022 2021 Foreign currency translation adjustment: Beginning balance $ (23,855) $ (22,627) Net other comprehensive loss (597) (1,228) Balance at December 31, $ (24,452) $ (23,855) Unrealized (loss) gain on marketable securities, net Beginning balance $ (85) $ 1,576 Net other comprehensive loss, net of income tax benefit of $— and $214, respectively (1,804) (1,661) Balance at December 31, $ (1,889) $ (85) Accumulated other comprehensive loss at December 31, $ (26,341) $ (23,940) |
Company Operations by Product_2
Company Operations by Product, Customer and Geographic Area (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Segment Reporting [Abstract] | |
Long-lived Assets by Geographic Areas | The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2022 and 2021: Long-lived Assets by Geographic Region: 2022 2021 U.S. $ 19,414 $ 19,605 Ireland 11,296 9,817 Total $ 30,710 $ 29,422 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 12 Months Ended | ||
Mar. 28, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||
Cash and cash equivalents | $ 73,981,000 | $ 50,708,000 | |
Marketable securities | 22,518,000 | 106,513,000 | |
Goodwill impairment loss | 0 | 0 | |
At-The-Market Offering Program | |||
Class of Stock [Line Items] | |||
Approximate remaining authorized aggregate offering price under shelf registration | $ 93,200 | ||
Subsequent event | Maximum | Forecast | |||
Class of Stock [Line Items] | |||
Royalty financing | $ 75,000,000 | ||
4.50% Exchangeable Senior Notes Due February 2023 | |||
Class of Stock [Line Items] | |||
Interest rate | 4.50% | ||
4.50% Exchangeable Senior Notes Due February 2023 | Senior Notes | |||
Class of Stock [Line Items] | |||
Principal amount | $ 17,500,000 | 143,750,000 | |
4.50% Exchangeable Senior Notes Due October 2023 | |||
Class of Stock [Line Items] | |||
Interest rate | 4.50% | ||
4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | |||
Class of Stock [Line Items] | |||
Principal amount | $ 117,375,000 | $ 0 | |
4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | Subsequent event | |||
Class of Stock [Line Items] | |||
Principal amount | 21,187,000 | ||
Debt exchanged | $ 96,188,000 | ||
April 2027 Notes | Subsequent event | |||
Class of Stock [Line Items] | |||
Interest rate | 6% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment Useful Lives (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Software, office and computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life (in years) | 3 years | |
Leasehold improvements, furniture, fixtures and fittings | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life (in years) | 2 years | |
Leasehold improvements, furniture, fixtures and fittings | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life (in years) | 10 years | |
Fixed Assets and Right Of Use Assets, Contract Manufacturing Organizations | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment, useful life (in years) | 5 years | |
Amortization | $ 391 | $ 0 |
Newly Issued Accounting Stand_2
Newly Issued Accounting Standards (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | $ (21,145) | $ 78,244 | $ 162,266 |
Additional paid-in capital | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | 589,783 | 549,349 | 566,916 |
Accumulated deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | (585,220) | (447,756) | |
Cumulative Effect, Period of Adoption, Adjustment | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | (12,939) | ||
Long-term debt | 12,939 | ||
Cumulative Effect, Period of Adoption, Adjustment | Additional paid-in capital | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | (26,699) | ||
Cumulative Effect, Period of Adoption, Adjustment | Accumulated deficit | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Total shareholders’ (deficit) equity | $ 13,760 | ||
Senior Notes | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Long-term debt | $ 129,282 | $ 142,397 | |
4.50 Percent Exchangeable Senior Notes Due 2023 | Senior Notes | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Interest rate | 4.50% |
Fair Value Measurements - Measu
Fair Value Measurements - Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 22,518 | $ 106,513 |
Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 22,518 | 78,098 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 16,479 | |
Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 9,471 | |
Other fixed-income securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,465 | |
Fair Value Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 22,518 | 78,098 |
Fair Value Measurements, Recurring | Level 1 | Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 22,518 | 78,098 |
Fair Value Measurements, Recurring | Level 1 | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 1 | Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 1 | Other fixed-income securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 28,415 |
Fair Value Measurements, Recurring | Level 2 | Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 2 | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 16,479 |
Fair Value Measurements, Recurring | Level 2 | Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 9,471 |
Fair Value Measurements, Recurring | Level 2 | Other fixed-income securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 2,465 |
Fair Value Measurements, Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Fair Value Measurements, Recurring | Level 3 | Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 3 | Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 3 | Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 0 | 0 |
Fair Value Measurements, Recurring | Level 3 | Other fixed-income securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) - Senior Notes - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | $ 129,282 | $ 142,397 |
4.50% Exchangeable Senior Notes Due February 2023 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt, gross | 17,500 | 143,750 |
4.50% Exchangeable Senior Notes Due February 2023 | Estimate of Fair Value Measurement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 16,975 | |
4.50% Exchangeable Senior Notes Due October 2023 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt, gross | 117,375 | $ 0 |
4.50% Exchangeable Senior Notes Due October 2023 | Estimate of Fair Value Measurement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | $ 112,973 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | $ 24,407 | $ 106,812 |
Unrealized Gains | 0 | 948 |
Unrealized Losses | (1,889) | (1,247) |
Fair Value | 22,518 | 106,513 |
Mutual and money market funds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 24,407 | 78,331 |
Unrealized Gains | 0 | 813 |
Unrealized Losses | (1,889) | (1,046) |
Fair Value | $ 22,518 | 78,098 |
Corporate bonds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 16,478 | |
Unrealized Gains | 94 | |
Unrealized Losses | (93) | |
Fair Value | 16,479 | |
Government securities - U.S. | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 9,530 | |
Unrealized Gains | 39 | |
Unrealized Losses | (98) | |
Fair Value | 9,471 | |
Other fixed-income securities | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 2,473 | |
Unrealized Gains | 2 | |
Unrealized Losses | (10) | |
Fair Value | $ 2,465 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | ||
Marketable securities, realized gains | $ 584 | $ 174 |
Marketable securities, realized loss | $ 2,338 | $ 275 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Less - accumulated depreciation | $ (627) | $ (465) |
Property and equipment, net | 839 | 285 |
Depreciation | 162 | 97 |
Software, office and computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 832 | 448 |
Furniture, fixtures and fittings | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 634 | $ 302 |
Goodwill - Narrative (Details)
Goodwill - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill | $ 16,836,000 | $ 16,836,000 |
Impairment loss related to goodwill | $ 0 | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease, payments | $ 963 | $ 578 |
Operating lease, weighted average remaining lease term (in years) | 2 years | |
Operating lease, weighted average discount rate, percent | 5% | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 1 year | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 3 years |
Leases - Components of lease co
Leases - Components of lease costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | ||
Operating lease costs | $ 1,028 | $ 821 |
Sublease income | (116) | (110) |
Total lease cost | $ 912 | $ 711 |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Leases [Abstract] | |
2023 | $ 1,013 |
2024 | 614 |
2025 | 206 |
2026 | 0 |
2027 | 0 |
Thereafter | 0 |
Total lease payments | 1,833 |
Less: interest | 93 |
Present value of lease liabilities | $ 1,740 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Current portion of long-term debt | $ 37,668 | $ 0 |
Long-term debt | $ 91,614 | 142,397 |
4.50% Exchangeable Senior Notes Due February 2023 | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.50% | |
4.50% Exchangeable Senior Notes Due October 2023 | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.50% | |
Senior Notes | ||
Debt Instrument [Line Items] | ||
Less: unamortized debt discount and issuance costs, net | $ (5,593) | (1,353) |
Total | 129,282 | 142,397 |
Senior Notes | 4.50% Exchangeable Senior Notes Due February 2023 | ||
Debt Instrument [Line Items] | ||
Principal amount | 17,500 | 143,750 |
Senior Notes | 4.50% Exchangeable Senior Notes Due October 2023 | ||
Debt Instrument [Line Items] | ||
Principal amount | $ 117,375 | $ 0 |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Mar. 28, 2023 USD ($) | Apr. 05, 2022 USD ($) day | Feb. 16, 2018 USD ($) day $ / shares Rate | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 04, 2022 USD ($) | |
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Interest expense, debt | $ 12,342 | $ 9,942 | ||||
Coupon interest expense | 6,405 | 6,469 | ||||
Amortization of debt discount and debt issuance costs | 6,052 | 1,248 | ||||
Gain on early extinguishment of debt | 203 | |||||
Payments of debt issuance costs | 4,804 | 0 | ||||
Increase in embedded conversion feature | $ 5,508 | |||||
Change in fair value of October 2023 Notes conversion feature | 5,508 | 5,508 | ||||
ADSs, conversion ratio | Rate | 9,269.56% | |||||
Senior Notes | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Amortization of debt discount and debt issuance costs | $ 6,052 | 1,248 | ||||
4.50% Exchangeable Senior Notes Due February 2023 | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Interest rate | 4.50% | |||||
4.50% Exchangeable Senior Notes Due February 2023 | Senior Notes | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Additional interest expense | $ 88 | 2,225 | ||||
Long-term debt, gross | $ 17,500 | 143,750 | ||||
4.50% Exchangeable Senior Notes Due February 2023 | Convertible Debt | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Repurchase of debt | $ 8,875 | |||||
Cash consideration for debt repurchased | $ 8,653 | |||||
Aggregate principal amount | 26,375 | $ 125,000 | ||||
Option to increase aggregate principal amount | 18,750 | |||||
Proceeds from loans or conditional grants | $ 137,560 | |||||
ADS, option price per share (in dollars per share) | $ / shares | $ 10.79 | |||||
ADS premium percentage | 20% | |||||
ADS purchased, price per share (in dollars per share) | $ / shares | $ 8.99 | |||||
4.50% Exchangeable Senior Notes Due February 2023 | Convertible Debt | Period one | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Number of business days | 5 days | |||||
Consecutive business days | 5 days | |||||
Percentage of product of the last reported sale price of the American Depositary Shares and the exchange rate on each such trading day | 98% | |||||
4.50% Exchangeable Senior Notes Due February 2023 | Convertible Debt | Period two | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Scheduled threshold trading days | 95 days | |||||
Threshold trading days | day | 35 | |||||
4.50% Exchangeable Senior Notes Due February 2023 | Convertible Debt | Period three | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Threshold trading days | day | 20 | |||||
Consecutive trading days | day | 30 | |||||
Threshold percentage of stock price trigger | 130% | |||||
4.50 Percent Exchangeable Senior Notes Due October 2023 | Senior Notes | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Payments of debt issuance costs | 4,804 | |||||
4.50 Percent Exchangeable Senior Notes Due October 2023 | Senior Notes | Third Party | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Payments of debt issuance costs | 5,450 | |||||
4.50 Percent Exchangeable Senior Notes Due October 2023 | Convertible Debt | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Amount exchanged | $ 117,375 | |||||
4.50 Percent Exchangeable Senior Notes Due October 2023 | Convertible Debt | Period three | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Threshold trading days | day | 20 | |||||
Consecutive trading days | day | 30 | |||||
Threshold percentage of stock price trigger | 130% | |||||
4.50% Exchangeable Senior Notes Due October 2023 | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Interest rate | 4.50% | |||||
4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Long-term debt, gross | $ 117,375 | $ 0 | ||||
4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | Subsequent event | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Long-term debt, gross | $ 21,187 | |||||
Debt exchanged | $ 96,188 | |||||
April 2027 Notes | Subsequent event | ||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||
Interest rate | 6% |
Income Taxes - Income (Loss) Be
Income Taxes - Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | ||
Total loss before income taxes | $ (111,439) | $ (93,145) |
Ireland | ||
Income Taxes [Line Items] | ||
Total loss before income taxes | (53,717) | (36,631) |
U.S. | ||
Income Taxes [Line Items] | ||
Total loss before income taxes | (57,755) | (56,687) |
France | ||
Income Taxes [Line Items] | ||
Total loss before income taxes | $ 33 | $ 173 |
Income Taxes - Income Tax Benef
Income Taxes - Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | ||
U.S. - State | $ 0 | $ 60 |
Total current | 0 | 60 |
Deferred: | ||
U.S. - Federal | 25,896 | (15,876) |
U.S. - State | 129 | 0 |
Total deferred | 26,025 | (15,876) |
Income tax provision (benefit) | $ 26,025 | $ (15,816) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
Income tax provision (benefit) - at statutory tax rate | $ (13,916) | $ (11,642) |
Differences in international tax rates | (9,921) | (8,950) |
Change in valuation allowances | 48,734 | 4,296 |
Nondeductible share-based compensation | 1,424 | 645 |
Unrealized tax benefits | 258 | 239 |
State and local taxes (net of federal) | (4,467) | 60 |
Nondeductible interest expense | 4,239 | 2,173 |
Orphan drug and R&D tax credit | 0 | (1,524) |
Other | (326) | (1,113) |
Income tax provision (benefit) | $ 26,025 | $ (15,816) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Line Items] | |||
Income tax provision (benefit) | $ 26,025 | $ (15,816) | |
Increase (decrease) in income tax benefit | 41,841 | ||
Unrecognized tax benefits | 3,143 | 2,483 | |
Income tax penalties and interest expense | 258 | 239 | |
Income tax penalties and interest accrued | 2,103 | 1,777 | |
Unremitted earnings | 3,967 | ||
Deferred tax assets, tax credit carryforwards, research | 3,480 | 3,668 | |
Tax Year 2019 | |||
Income Taxes [Line Items] | |||
CARES Act, cash refund claims | $ 18,753 | ||
Tax Year 2020 | |||
Income Taxes [Line Items] | |||
CARES Act, cash refund claims | $ 10,273 | ||
Ireland | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 147,240 | ||
Operating loss carryforwards, valuation allowance (decrease) | 5,547 | ||
Gross research tax credit | 568 | 529 | |
U.S. | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 124,443 | ||
U.S. | 163(j) Credits | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | 5,032 | ||
France | |||
Income Taxes [Line Items] | |||
Gross research tax credit | 2,912 | $ 3,139 | |
FSC | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 10,365 | ||
U.S. Holdings | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 114,078 | ||
U.S. Holdings | State | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 3,494 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Unrecognized Tax Benefit Activity [Roll Forward] | ||
Beginning balance | $ 3,143 | $ 3,143 |
Increases for tax positions of prior years | 0 | 0 |
Statute of limitations expiration | 0 | 0 |
Settlements | 0 | 0 |
Ending balance | $ 3,143 | $ 3,143 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 53,393 | $ 34,399 |
Share-based compensation | 4,684 | 4,108 |
Amortization | 3,541 | 3,429 |
Orphan drug and R&D tax credit | 4,964 | 4,964 |
Capitalized research costs | 2,108 | 0 |
Other | 1,521 | 662 |
Interest expense carryforward | 1,216 | 1,591 |
Gross deferred tax assets | 71,427 | 49,153 |
Deferred tax liabilities: | ||
Prepaid expenses | (86) | (75) |
Other | 0 | (925) |
Gross deferred tax liabilities | (86) | (1,000) |
Less: valuation allowances | (71,341) | (24,025) |
Net deferred tax assets | $ 0 | $ 24,128 |
Other Assets and Liabilities -
Other Assets and Liabilities - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Prepaid and other expenses | $ 1,523 | $ 3,179 |
Guarantee from Armistice | 276 | 279 |
Other | 228 | 271 |
Income tax receivable | 69 | 29,097 |
Total | $ 2,096 | $ 32,826 |
Other Assets and Liabilities _2
Other Assets and Liabilities - Other Non-Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Right of use assets at contract manufacturing organizations | $ 10,686 | $ 8,549 |
Guarantee from Armistice | 495 | 771 |
Other | 141 | 329 |
Deferred tax assets | 0 | 24,128 |
Total | $ 11,322 | $ 33,777 |
Other Assets and Liabilities _3
Other Assets and Liabilities - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Accrued professional fees | $ 4,040 | $ 2,678 |
Accrued compensation | 1,613 | 3,167 |
Accrued outsourced contract manufacturing costs | 1,208 | 1,048 |
Accrued restructuring | 473 | 41 |
Customer allowances | 0 | 217 |
Total | $ 7,334 | $ 7,151 |
Other Assets and Liabilities _4
Other Assets and Liabilities - Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Accrued interest | $ 1,649 | $ 4,920 |
Guarantee to Deerfield | 277 | 280 |
Other | 15 | 70 |
Other current liabilities | $ 1,941 | $ 5,270 |
Other Assets and Liabilities _5
Other Assets and Liabilities - Other Non-Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Other Liabilities Disclosure [Abstract] | ||
Tax liabilities | $ 5,246 | $ 3,143 |
Guarantee to Deerfield | 497 | 774 |
Total | $ 5,743 | $ 3,917 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | ||
Feb. 28, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guarantee to Deerfield | $ 497 | $ 774 | |
Minimum | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Contractual obligation, annual amount | 2,400 | ||
Maximum | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Contractual obligation, annual amount | 3,000 | ||
Annual amount of contractual obligation if LUMRYZ is approved by the FDA | 4,200 | ||
Discontinued Operations, Disposed of by Sale | 2016 MIPA | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guarantee to Deerfield | 774 | ||
Discontinued Operations, Disposed of by Sale | Cerecor | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guaranty assets | $ 771 | ||
FSC | Discontinued Operations, Disposed of by Sale | 2016 MIPA | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Percentage of royalty payable on net sales | 15% | ||
Royalty payable on net sales, maximum | $ 10,300 |
Restructuring Costs - Narrative
Restructuring Costs - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
2022 Corporate Restructuring Plan | |||
Restructuring Cost and Reserve [Line Items] | |||
Percent reduction in workforce | 50% | ||
Restructuring costs | $ 3,345 | ||
Restructuring reserve | 435 | $ 0 | |
2019 French Restructuring Obligation | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring reserve | $ 38 | $ 41 | $ 248 |
Restructuring Costs - Severance
Restructuring Costs - Severance Obligation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
2022 Corporate Restructuring Plan | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance of accrued costs | $ 0 | |
(Benefit) charges for employee severance, benefits and other costs | 3,592 | |
Payments | (2,910) | |
Other adjustments | (247) | |
Ending balance of accrued costs | 435 | $ 0 |
2019 French Restructuring Obligation | ||
Restructuring Reserve [Roll Forward] | ||
Beginning balance of accrued costs | 41 | 248 |
Payments | 0 | (77) |
Foreign currency impact | (3) | (8) |
Ending balance of accrued costs | 38 | 41 |
Employee Severance | 2019 French Restructuring Obligation | ||
Restructuring Reserve [Roll Forward] | ||
(Benefit) charges for employee severance, benefits and other costs | $ 0 | $ (122) |
Equity Instruments and Transa_2
Equity Instruments and Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Apr. 28, 2020 | Feb. 21, 2020 | Feb. 29, 2020 | Dec. 31, 2022 | Aug. 31, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | ||||||
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 | ||||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 | ||||
Ordinary shares, shares issued (in shares) | 62,878,000 | 58,620,000 | ||||
Ordinary shares, shares outstanding (in shares) | 62,878,000 | 58,620,000 | ||||
Preferred shares, shares authorized (in shares) | 50,000,000 | 50,000,000 | ||||
Preferred shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 | ||||
Preferred shares, shares issued (in shares) | 488,000 | 488,000 | ||||
Preferred shares, shares outstanding (in shares) | 488,000 | 488,000 | ||||
Prepaid expenses and other current assets | $ 2,096 | $ 32,826 | ||||
Issuance of common stock under at-the-market offering program, net of issuance costs | 25,318 | |||||
Maximum threshold percentage for trigger of convertible preferred stock | 9.99% | |||||
Issuance costs recorded as a reduction to additional paid-in capital | 45 | |||||
2020 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | |||||
Preferred shares, nominal value (in usd per share) | $ 0.01 | |||||
Maximum aggregate offering price of securities under shelf registration | $ 250 | |||||
Maximum aggregate offering price of ADSs under shelf registration | $ 50 | |||||
Sales agent commission, as a percent of aggregate gross sales proceeds | 3% | |||||
Transaction costs | $ 428 | |||||
2022 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Maximum aggregate offering price of securities under shelf registration | $ 500 | |||||
Maximum aggregate offering price of ADSs under shelf registration | $ 100 | |||||
Securities Purchase Agreement | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock under at-the-market offering program, net of issuance costs | $ 65,000 | |||||
Proceeds from issuance of shares off the at-the-market offering program | $ 60,570 | |||||
Securities Purchase Agreement | American Depositary Receipts | ||||||
Class of Stock [Line Items] | ||||||
Stock issued during period, new issues (in shares) | 8,680,000 | |||||
Securities Purchase Agreement | Series A Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Stock issued during period, new issues (in shares) | 488,000 | |||||
Shares issued, price per share (in dollars per share) | $ 7.09 | |||||
Public Offering | American Depositary Shares | ||||||
Class of Stock [Line Items] | ||||||
Public offering, shares issued (in shares) | 11,630,000 | |||||
Net proceeds from public offering | $ 116,924 | |||||
Public offering, price per share (in dollars per share) | $ 10.75 | |||||
Public offering, proceeds | $ 125,000 | |||||
At-The-Market Offering Program | ||||||
Class of Stock [Line Items] | ||||||
Remaining authorized aggregate offering price under shelf registration | $ 123,899 | |||||
At-The-Market Offering Program | American Depositary Shares | ||||||
Class of Stock [Line Items] | ||||||
Public offering, shares issued (in shares) | 3,588,000 | |||||
Net proceeds from public offering | $ 25,318 | |||||
Additional paid-in capital | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock under at-the-market offering program, net of issuance costs | 25,282 | |||||
Issuance costs recorded as a reduction to additional paid-in capital | $ 4,430 | 45 | ||||
Additional paid-in capital | 2020 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Prepaid expenses and other current assets | 169 | |||||
Additional paid-in capital | 2022 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Prepaid expenses and other current assets | $ 192 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 7,013 | $ 8,872 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 169 | 758 |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 6,844 | $ 8,114 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | 48 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 9,040 | ||||
Weighted average period for unrecognized expense (in years) | 2 years 6 months 14 days | ||||
Aggregate intrinsic value of options exercised | $ 877 | $ 249 | |||
Grant date fair value of options granted (in usd per share) | $ 4.02 | $ 5.36 | |||
Ordinary shares, nominal value (in usd per share) | 0.01 | 0.01 | |||
Performance Shares | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant fair value of free share awards (in usd per share) | $ 0 | $ 8.20 | |||
Granted (in shares) | 0 | ||||
Performance Shares | Share-based Payment Arrangement, Employee | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Granted (in shares) | 75,000 | 17,000 | |||
Stock Option | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period (in years) | 4 years | ||||
Number of shares authorized (in shares) | 752,000 | ||||
Expiration period (in years) | 10 years | ||||
Stock Option | Board of Directors | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period (in years) | 1 year | 3 years | |||
Expiration period (in years) | 10 years | 10 years | |||
Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period (in years) | 3 years | ||||
Weighted average grant fair value of free share awards (in usd per share) | $ 0 | $ 8.22 | |||
Granted (in shares) | 0 | ||||
Restricted Share Awards Granted To Employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period (in years) | 4 years | ||||
Restricted Share Awards, Grants Beginning In 2018 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period (in years) | 3 years | ||||
Inducement Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Maximum number of shares reserved and available for issuance (in shares) | 1,500,000 | ||||
Shares available for issuance (in shares) | 1,278,000 | ||||
2017 Avadel Employee Share Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for issuance (in shares) | 1,000,000 | ||||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | ||||
Purchase price of common stock, percentage | 85% | ||||
Vest Upon The Achievement Of Certain Regulatory Milestones | Performance Shares | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 50% | ||||
Vest One Year Following Achievement Of Milestones | Performance Shares | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense | $ 8,027 | ||||
Vesting percentage | 50% | ||||
Vesting period (in years) | 1 year | ||||
2/3 vesting at second anniversary of grant date | Restricted Share Awards Granted From 2017-2020 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 67% | ||||
1/3 vesting at third anniversary of grant date | Restricted Share Awards Granted From 2017-2020 | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 33% | ||||
1/4 vesting at each anniversary of grant date | Restricted Share Awards Granted To Employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 25% | ||||
1/3 vesting at third anniversary of grant date | Restricted Share Awards Granted To Employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 33% | ||||
Vest Upon Achievement Of Certain Corporate Objectives | Performance Shares | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 50% | ||||
Vest One Year Following Achievement Of Certain Corporate Objectives | Performance Shares | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 50% | ||||
Vesting period (in years) | 1 year |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 2 years 6 months 14 days | |
Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 2 days | 6 years 2 months 12 days |
Expected volatility | 93.41% | 73.91% |
Risk-free interest rate | 2.73% | 1.10% |
Expected dividend yield | 0% | 0% |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Stock Options, Outstanding [Roll Forward] | |
Stock options outstanding, beginning balance (in shares) | shares | 8,403 |
Granted (in shares) | shares | 3,268 |
Exercised (in shares) | shares | (450) |
Forfeited (in shares) | shares | (1,496) |
Expired (in shares) | shares | (421) |
Stock options outstanding, ending balance (in shares) | shares | 9,304 |
Stock options exercisable (in shares) | shares | 4,059 |
Stock Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Stock options outstanding, beginning balance (in usd per share) | $ / shares | $ 7.39 |
Granted (in usd per share) | $ / shares | 5.29 |
Exercised (in usd per share) | $ / shares | 5.46 |
Forfeited (in usd per share) | $ / shares | 7.24 |
Expired (in usd per share) | $ / shares | 9.65 |
Stock options outstanding, ending balance (in usd per share) | $ / shares | 6.67 |
Stock options exercisable (in usd per share) | $ / shares | $ 7.40 |
Stock options outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 9 months 10 days |
Stock options exercisable, Weighted Average Remaining Contractual Life (in years) | 6 years 3 months 29 days |
Stock options outstanding, Aggregate Intrinsic Value | $ | $ 8,710 |
Stock options exercisable, Aggregate Intrinsic Value | $ | $ 6,859 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock and Performance Unit Share Activity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restricted Stock | ||
Free Share Activity and Other Data, Nonvested [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 274,000 | |
Granted (in shares) | 0 | |
Vested (in shares) | (144,000) | |
Forfeited (in shares) | (74,000) | |
Outstanding, ending balance (in shares) | 56,000 | 274,000 |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | ||
Nonvested free share award, beginning balance (in usd per share) | $ 7.14 | |
Granted (in usd per share) | 0 | $ 8.22 |
Vested (in usd per share) | 6.37 | |
Forfeited (in usd per share) | 8.04 | |
Nonvested free share award, ending balance (in usd per share) | $ 7.95 | $ 7.14 |
Performance Shares | ||
Free Share Activity and Other Data, Nonvested [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 535,000 | |
Granted (in shares) | 0 | |
Vested (in shares) | 0 | |
Forfeited (in shares) | (535,000) | |
Outstanding, ending balance (in shares) | 0 | 535,000 |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | ||
Nonvested free share award, beginning balance (in usd per share) | $ 7.71 | |
Granted (in usd per share) | 0 | $ 8.20 |
Vested (in usd per share) | 0 | |
Forfeited (in usd per share) | 7.71 | |
Nonvested free share award, ending balance (in usd per share) | $ 0 | $ 7.71 |
Net Loss Per Share - Reconcilia
Net Loss Per Share - Reconciliation of basic and diluted EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (137,464) | $ (77,329) |
Weighted average shares: | ||
Basic shares (in shares) | 60,094 | 58,535 |
Effect of dilutive securities—employee and director equity awards outstanding (in shares) | 0 | 0 |
Diluted shares (in shares) | 60,094 | 58,535 |
Net loss per share - basic (in usd per share) | $ (2.29) | $ (1.32) |
Net loss per share - diluted (in usd per share) | $ (2.29) | $ (1.32) |
Net Loss Per Share - Narrative
Net Loss Per Share - Narrative (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 17,941 | 15,327 |
Comprehensive Loss (Details)
Comprehensive Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) | ||
Beginning balance | $ 78,244 | $ 162,266 |
Net other comprehensive loss | (139,865) | (80,218) |
Ending balance | (21,145) | 78,244 |
Unrealized gain (loss) on marketable securities, tax | 0 | 214 |
Foreign currency translation adjustment | ||
Accumulated Other Comprehensive Income (Loss) | ||
Beginning balance | (23,855) | (22,627) |
Net other comprehensive loss | (597) | (1,228) |
Ending balance | (24,452) | (23,855) |
Unrealized gain (loss) on marketable securities, net | ||
Accumulated Other Comprehensive Income (Loss) | ||
Beginning balance | (85) | 1,576 |
Net other comprehensive loss | (1,804) | (1,661) |
Ending balance | (1,889) | (85) |
Accumulated other comprehensive loss | ||
Accumulated Other Comprehensive Income (Loss) | ||
Beginning balance | (23,940) | (21,051) |
Ending balance | $ (26,341) | $ (23,940) |
Company Operations by Product_3
Company Operations by Product, Customer and Geographic Area (Details) | 12 Months Ended | |
Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Segment Reporting [Abstract] | ||
Number of operating segments | 1 | |
Number of reportable segments | 1 | |
Product sales | $ | $ 0 | $ 0 |
Company Operations by Product_4
Company Operations by Product, Customer and Geographic Area - Data by Geographic Region (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Long-lived Assets by Geographic Region: | ||
Long-lived assets | $ 30,710 | $ 29,422 |
U.S. | ||
Long-lived Assets by Geographic Region: | ||
Long-lived assets | 19,414 | 19,605 |
Ireland | ||
Long-lived Assets by Geographic Region: | ||
Long-lived assets | $ 11,296 | $ 9,817 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | Mar. 28, 2023 | Feb. 01, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
4.50% Exchangeable Senior Notes Due February 2023 | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 4.50% | |||
4.50% Exchangeable Senior Notes Due February 2023 | Senior Notes | ||||
Subsequent Event [Line Items] | ||||
Long-term debt, gross | $ 17,500 | $ 143,750 | ||
4.50% Exchangeable Senior Notes Due October 2023 | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 4.50% | |||
4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | ||||
Subsequent Event [Line Items] | ||||
Long-term debt, gross | $ 117,375 | $ 0 | ||
Subsequent event | Forecast | Maximum | ||||
Subsequent Event [Line Items] | ||||
Royalty financing | $ 75,000 | |||
Subsequent event | 4.50% Exchangeable Senior Notes Due February 2023 | Senior Notes | ||||
Subsequent Event [Line Items] | ||||
Repayment of debt | $ 17,500 | |||
Subsequent event | 4.50% Exchangeable Senior Notes Due October 2023 | Senior Notes | ||||
Subsequent Event [Line Items] | ||||
Debt exchanged | 96,188 | |||
Long-term debt, gross | $ 21,187 | |||
Subsequent event | April 2027 Notes | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 6% |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | $ 24,025 | $ 21,624 | $ 17,037 |
Additions | 48,734 | 4,235 | 2,805 |
Deductions | 0 | (51) | 0 |
Other Changes | (1,418) | (1,783) | 1,782 |
Balance at end of period | $ 71,341 | $ 24,025 | $ 21,624 |