Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 11, 2022 | Jun. 30, 2021 | |
Entity Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
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 | ||
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 | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 390,167,685 | ||
Entity Common Stock, Shares Outstanding | 59,032,237 | ||
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, 2021, 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 | 2021 | ||
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 $0.01 per share** | ||
Trading Symbol | AVDL | ||
Security Exchange Name | NASDAQ |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Name | Deloitte and Touche LLP |
Auditor Location | St. Louis, Missouri |
Auditor Firm ID | 34 |
Consolidated Statements of (Los
Consolidated Statements of (Loss) Income - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues [Abstract] | |||
Product sales | $ 0 | $ 22,334,000 | $ 59,215,000 |
Operating expenses: | |||
Cost of products | 0 | 5,742,000 | 12,125,000 |
Research and development expenses | 17,104,000 | 20,442,000 | 32,917,000 |
Selling, general and administrative expenses | 68,495,000 | 32,405,000 | 30,183,000 |
Intangible asset amortization | 0 | 406,000 | 816,000 |
Changes in fair value of contingent consideration | 0 | 3,327,000 | 845,000 |
Gain on sale of Hospital Products | 0 | (45,760,000) | 0 |
Restructuring (income) costs | (53,000) | (43,000) | 6,441,000 |
Total operating expenses | 85,546,000 | 16,519,000 | 83,327,000 |
Operating (loss) income | (85,546,000) | 5,815,000 | (24,112,000) |
Investment and other income (expense), net | 2,126,000 | (832,000) | 1,069,000 |
Interest expense | (9,942,000) | (12,994,000) | (12,483,000) |
Gain from release of certain liabilities | 217,000 | 3,364,000 | 0 |
Loss on deconsolidation of subsidiary | 0 | 0 | (2,678,000) |
Other expense - changes in fair value of contingent consideration payable | 0 | (435,000) | (378,000) |
Loss before income taxes | (93,145,000) | (5,082,000) | (38,582,000) |
Income tax benefit | (15,816,000) | (12,110,000) | (5,356,000) |
Net (loss) income | $ (77,329,000) | $ 7,028,000 | $ (33,226,000) |
Earnings (loss) per share | |||
Net income (loss) per share - basic (in usd per share) | $ (1.32) | $ 0.13 | $ (0.89) |
Net income (loss) per share - diluted (in usd per share) | $ (1.32) | $ 0.13 | $ (0.89) |
Weighted average number of shares outstanding | |||
Weighted average number of shares outstanding - basic (in shares) | 58,535 | 52,996 | 37,403 |
Weighted average number of shares outstanding - diluted (in shares) | 58,535 | 54,941 | 37,403 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Net (loss) income | $ (77,329) | $ 7,028 | $ (33,226) |
Other comprehensive (loss) income, net of tax: | |||
Foreign currency translation (loss) gain | (1,228) | 1,111 | (117) |
Net other comprehensive (loss) income, net of income tax benefit (expense) of $214, $(202), $(43), respectively | (1,661) | 644 | 727 |
Total other comprehensive (loss) income, net of tax | (2,889) | 1,755 | 610 |
Total comprehensive (loss) income | $ (80,218) | $ 8,783 | $ (32,616) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive (Loss) Income (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | |||
Unrealized gain (loss) on marketable securities, tax | $ 214 | $ (202) | $ (43) |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 50,708 | $ 71,722 |
Marketable securities | 106,513 | 149,680 |
Research and development tax credit receivable | 2,443 | 3,326 |
Prepaid expenses and other current assets | 32,826 | 38,726 |
Total current assets | 192,490 | 263,454 |
Property and equipment, net | 285 | 359 |
Operating lease right-of-use assets | 2,652 | 2,604 |
Goodwill | 16,836 | 16,836 |
Research and development tax credit receivable | 1,225 | 3,445 |
Other non-current assets | 33,777 | 24,939 |
Total assets | 247,265 | 311,637 |
Current liabilities: | ||
Current portion of operating lease liability | 900 | 474 |
Accounts payable | 7,679 | 2,934 |
Accrued expenses | 7,151 | 6,501 |
Other current liabilities | 5,270 | 5,200 |
Total current liabilities | 21,000 | 15,109 |
Long-term debt | 142,397 | 128,210 |
Long-term operating lease liability | 1,707 | 1,840 |
Other non-current liabilities | 3,917 | 4,212 |
Total liabilities | 169,021 | 149,371 |
Shareholders’ equity: | ||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at December 31, 2021 and 2020, respectively | 5 | 5 |
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 58,620 and 58,396 issued and outstanding at December 31, 2021 and 2020, respectively | 586 | 583 |
Additional paid-in capital | 549,349 | 566,916 |
Accumulated deficit | (447,756) | (384,187) |
Accumulated other comprehensive loss | (23,940) | (21,051) |
Total shareholders’ equity | 78,244 | 162,266 |
Total liabilities and shareholders’ equity | $ 247,265 | $ 311,637 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 29, 2020 |
Statement of Financial Position [Abstract] | |||
Preferred shares, nominal value (in usd per share) | $ 0.01 | $ 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 | $ 0.01 |
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 | |
Ordinary shares, shares issued (in shares) | 58,620,000 | 58,396,000 | |
Ordinary shares, shares outstanding (in shares) | 58,620,000 | 58,396,000 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' 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 capitalCumulative Effect, Period of Adoption, Adjustment | Accumulated deficit | Accumulated deficitCumulative Effect, Period of Adoption, Adjustment | Accumulated other comprehensive loss | Treasury Shares |
Beginning balance (in shares) at Dec. 31, 2018 | 42,720 | 0 | 5,407 | |||||||
Beginning balance at Dec. 31, 2018 | $ 2,780 | $ 427 | $ 0 | $ 433,756 | $ (357,989) | $ (23,416) | $ (49,998) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Net (loss) income | (33,226) | (33,226) | ||||||||
Other comprehensive income (loss) | 610 | 610 | ||||||||
Vesting of restricted shares (in shares) | 153 | |||||||||
Vesting of restricted shares | 0 | $ 2 | (2) | |||||||
Employee share purchase plan share issuance (in shares) | 54 | |||||||||
Employee share purchase plan share issuance | 118 | 118 | ||||||||
Share-based compensation expense | 519 | 519 | ||||||||
Ending balance (in shares) at Dec. 31, 2019 | 42,927 | 0 | 5,407 | |||||||
Ending balance at Dec. 31, 2019 | $ (29,199) | $ 429 | $ 0 | 434,391 | (391,215) | (22,806) | $ (49,998) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Accounting Standards Update [Extensible Enumeration] | Accounting Standards Update 2020-06 [Member] | |||||||||
Net (loss) income | $ 7,028 | 7,028 | ||||||||
Other comprehensive income (loss) | 1,755 | 1,755 | ||||||||
Exercise of stock options (in shares) | 403 | |||||||||
Exercise of stock options | 2,045 | $ 4 | 2,041 | |||||||
February 2020 private placement (in shares) | 8,680 | 488 | ||||||||
February 2020 private placement | 60,570 | $ 87 | $ 5 | 60,478 | ||||||
May 2020 public offering (in shares) | 11,630 | |||||||||
May 2020 public offering | 116,924 | $ 116 | 116,808 | |||||||
Vesting of restricted shares (in shares) | 114 | |||||||||
Vesting of restricted shares | 0 | $ 1 | (1) | |||||||
Employee share purchase plan share issuance (in shares) | 49 | |||||||||
Employee share purchase plan share issuance | 144 | 144 | ||||||||
Share-based compensation expense | 2,999 | 2,999 | ||||||||
Retirement of treasury shares (in shares) | (5,407) | (5,407) | ||||||||
Retirement of treasury shares | 0 | $ (54) | (49,944) | $ (49,998) | ||||||
Ending balance (in shares) at Dec. 31, 2020 | 58,396 | 488 | 0 | |||||||
Ending balance at Dec. 31, 2020 | 162,266 | $ (12,939) | $ 583 | $ 5 | 566,916 | $ (26,699) | (384,187) | $ 13,760 | (21,051) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||
Net (loss) income | (77,329) | (77,329) | ||||||||
Other comprehensive income (loss) | $ (2,889) | (2,889) | ||||||||
Exercise of stock options (in shares) | 48 | 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 | 0 | |||||||
Ending balance at Dec. 31, 2021 | $ 78,244 | $ 586 | $ 5 | $ 549,349 | $ (447,756) | $ (23,940) | $ 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net (loss) income | $ (77,329) | $ 7,028 | $ (33,226) |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | |||
Depreciation and amortization | 815 | 1,690 | 2,486 |
Remeasurement of acquisition-related contingent consideration | 0 | 3,327 | 845 |
Remeasurement of financing-related contingent consideration | 0 | 435 | 378 |
Amortization of debt discount and debt issuance costs | 1,248 | 6,524 | 5,995 |
Changes in deferred tax | (15,666) | (7,431) | (6,334) |
Share-based compensation expense | 8,872 | 2,999 | 519 |
Gain on sale of Hospital Products | 0 | (45,760) | 0 |
Loss on deconsolidation of subsidiary | 0 | 0 | 1,750 |
Gain from release of certain liabilities | (217) | (3,364) | 0 |
Other adjustments | 1,272 | 142 | (254) |
Net changes in assets and liabilities | |||
Accounts receivable | 0 | 8,281 | 2,471 |
Inventories, net | 0 | (1,352) | 1,155 |
Prepaid expenses and other current assets | (439) | 1,863 | (1,187) |
Research and development tax credit receivable | 2,796 | 2,213 | (1,014) |
Accounts payable & other current liabilities | 4,232 | (2,788) | 4,641 |
Deferred revenue | 0 | 0 | (114) |
Accrued expenses | 895 | (13,226) | 357 |
Earn-out payments for contingent consideration in excess of acquisition-date fair value | 0 | (5,323) | (10,988) |
Royalty payments for contingent consideration payable in excess of original fair value | 0 | (866) | (1,748) |
Other assets and liabilities | (3,789) | (3,126) | (4,057) |
Net cash used in operating activities | (77,310) | (48,734) | (38,325) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (26) | (98) | (29) |
Proceeds from disposal of property and equipment | 0 | 0 | 154 |
Proceeds from the disposition of the Hospital Products | 16,500 | 25,500 | 0 |
Proceeds from sales of marketable securities | 102,224 | 36,284 | 63,246 |
Purchases of marketable securities | (61,769) | (131,407) | (24,648) |
Net cash provided by (used in) investing activities | 56,929 | (69,721) | 38,723 |
Cash flows from financing activities: | |||
Proceeds from the February 2020 private placement | 0 | 60,570 | 0 |
Proceeds from the May 2020 public offering | 0 | 116,924 | 0 |
Proceeds from issuance of ordinary shares | 263 | 2,189 | 118 |
Other financing activities, net | 0 | 0 | (145) |
Net cash provided by (used in) financing activities | 263 | 179,683 | (27) |
Effect of foreign currency exchange rate changes on cash and cash equivalents | (896) | 720 | 78 |
Net change in cash and cash equivalents | (21,014) | 61,948 | 449 |
Cash and cash equivalents at January 1 | 71,722 | 9,774 | 9,325 |
Cash and cash equivalents at December 31 | 50,708 | 71,722 | 9,774 |
Supplemental disclosures of cash flow information: | |||
Income taxes paid (refund), net | 76 | (1,701) | 140 |
Interest paid | $ 6,469 | $ 6,469 | $ 6,469 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
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 St. Louis, Missouri, United States (“U.S”). The Company’s lead product candidate, FT218, is an investigational once-nightly, extended-release formulation of sodium oxybate for the treatment of excessive daytime sleepiness (“EDS”) or cataplexy in adults with narcolepsy. The Company is primarily focused on the development and potential United States (“U.S.”) Food and Drug Administration (“FDA”) approval of FT218. In December 2020, the Company submitted a New Drug Application (“NDA”) to the FDA for FT218 to treat excessive daytime sleepiness or cataplexy in adults with narcolepsy. In February 2021, the NDA for FT218 was accepted by the FDA and was assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of October 15, 2021. On October 15, 2021, the Company announced that the FDA informed us that the review of the Company’s NDA for FT218 was ongoing beyond its previously assigned target action date. As of the date of this Annual Report, the FDA’s review of the Company’s NDA for FT218 remains ongoing. 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 approved or commercialized products in its portfolio. 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. The Company’s results of operations for the period January 1, 2019 through February 6, 2019 include the results of Avadel Specialty Pharmaceuticals, LLC (“Specialty Pharma”) prior to its February 6, 2019 voluntary petition for reorganization under Chapter 11 of the U.S. Bankruptcy Code. See Note 3: Subsidiary Bankruptcy and Deconsolidation. 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 Statements of Cash Flows for the fiscal year ended December 31, 2019 and balances within Note 14: Other Assets and Liabilities for the year ended December 31, 2020 to condense line items of the same nature into a single line. This change does not affect previously reported net cash flows used in operating activities in the Consolidated Statements of Cash Flows. Out of Period Adjustments In 2021, the Company determined that 0.50% of additional interest expense (the “Additional Interest”), as defined in the indenture dated as of February 16, 2018 among Avadel Finance Cayman Ltd, Avadel Pharmaceuticals PLC, and The Bank of New York Mellon as trustee (the “Indenture”), was owed on its long term 4.50% exchangeable unsecured senior notes due 2023 (the “2023 Notes”) from a period of February 17, 2019 through December 31, 2021, totaling $817, $773, and $635 for the years ended December 31, 2021, 2020 and 2019, respectively. At December 31, 2020, the Company’s accrued interest was understated by $1,408. The Additional Interest resulted from not removing a restrictive legend from the 2023 Notes 365 days following their original issuance on February 16, 2018. The restrictive legend was removed in March 2022 and the Additional Interest is no longer applicable following the date of removal of the restrictive legend. The Company identified and recorded an out of period adjustment for cumulative amount of the Additional Interest in 2021 of $1,408. Management assessed the materiality of the impact of the out of period adjustment on its financial statements, both quantitatively and qualitatively, and determined that it was not material for any quarterly or annual period. The 2023 Notes were issued on February 16, 2018 (the “Original Issuance”) with a restrictive legend which remained in place until March 14, 2022. Per the terms of the Indenture, if the restrictive legend on the 2023 Notes was not removed on the 365th day following the original issuance of the 2023 Notes, the Company owed Additional Interest, payable on each of the semi-annual interest payment dates of February 1 and August 1 beginning August 1, 2019 and each of the semi-annual payment dates thereafter until the restrictive legend was removed. The non-payment of the Additional Interest expense on the semi-annual payment dates, which was first due beginning August 1, 2019, is defined as an “Event of Default” in the Indenture, causing the Company to be in technical default of its 2023 Notes until the default was cured. The Additional Interest was paid to the trustee on March 10, 2022, which under the terms of the indenture, management believes cured the Event of Default for all periods. Additionally, on March 14, 2022, the restrictive legend on the 2023 Notes was removed and the Company is not subject to the Additional Interest after that date. Had the Company identified and been unable to cure the technical default prior to the issuance of its financial statements for fiscal years 2020 and 2019, it could have resulted in the reclassification of the long-term principal balance of 2023 Notes reported in those periods. As a result of curing the technical default, the Company classified the 2023 Notes as long-term at December 31, 2021 and 2020. The Indenture is included as Exhibit 4.2 to this Annual Report on Form 10-K. Revenue. Prior to June 30, 2020, revenue included sales of pharmaceutical products, licensing fees, and, if any, milestone payments for research and development (“R&D”) achievements. To determine the appropriate revenue recognition, the Company performs the following five steps: (i) Identify the contract(s) with a customer; (ii) Identify the performance obligations in the contract; (iii) Determine the transaction price; (iv) Allocate the transaction price to the performance obligations in the contract; and (v) Recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies the five-step model to contracts only when the Company and its customer’s rights and obligations under the contract can be determined, the contract has commercial substance, and it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. The Company identifies the promised goods or services in the contract to determine if they are separate performance obligations or if they should be bundled with other goods and services into a single performance obligation. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Sales Prior to June 30, 2020, the Company sold products primarily through wholesalers and considered these wholesalers to be the Company’s customers. Revenue from product sales is recognized when the customer obtains control of the Company’s product, which occurs typically upon receipt by the customer. The Company’s gross product sales were subject to a variety of price adjustments in arriving at reported net product sales. These adjustments included estimates of product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated based on analysis of historical data for the product or comparable products, future expectations for such products and other judgments and analysis. 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 $0, $312 and $372 for the years ended December 31, 2021, 2020 and 2019, 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. 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) income. 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) income (“AOCI”) in shareholders’ 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 5-10 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, 2021 and 2020. Long-Lived Assets. Long-lived assets include fixed assets and intangible assets. Prior to the sale of the Company’s portfolio of sterile injectable drugs used in the hospital setting (“Hospital Products”) on June 30, 2020, intangible assets consisted primarily of purchased licenses and intangible assets recognized as part of the Éclat Pharmaceuticals acquisition. Acquired in-process research and development (“IPR&D”) had an indefinite life and was not amortized until completion and development of the project, at which time the IPR&D became an amortizable asset, for which amortization of such intangible assets was computed using the straight-line method over the estimated useful life of the assets. 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. On June 30, 2020, the Company transferred its remaining intangible asset to Exela Sterile Medicines LLC (“Exela Buyer”) as part of the disposition of the Hospital Products. 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) income 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) income. |
Newly Issued Accounting Standar
Newly Issued Accounting Standards | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Changes and Error Corrections [Abstract] | |
Newly Issued Accounting Standards | Newly Issued Accounting Standards Recently 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. |
Subsidiary Bankruptcy and Decon
Subsidiary Bankruptcy and Deconsolidation | 12 Months Ended |
Dec. 31, 2021 | |
Reorganizations [Abstract] | |
Subsidiary Bankruptcy and Deconsolidation | Subsidiary Bankruptcy and Deconsolidation On February 6, 2019, the Company deconsolidated Specialty Pharma effective with the filing of the Chapter 11 bankruptcy and recorded a non-cash charge of approximately $2,678 for the year ended December 31, 2019. The Company recognized a non-cash gain of $217 and $3,364 from the release of certain liabilities that had been retained following the deconsolidation of Specialty Pharma. These gains are included in "Gain from release of certain liabilities" within non-operating (loss) income for the years ended December 31, 2021 and 2020. |
Disposition of the Hospital Pro
Disposition of the Hospital Products | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Disposition of the Hospital Products | Disposition of the Hospital Products On June 30, 2020 (the “Closing Date”), the Company announced the sale of its Hospital Products, which included its three FDA-approved commercial products, Akovaz, Bloxiverz and Vazculep, as well as Nouress, to the Exela Buyer pursuant to an Asset Purchase Agreement (the “Transaction”). Pursuant to the Transaction, the Exela Buyer agreed to pay a total aggregate consideration amount of $42,000, of which $14,500 was paid on the Closing Date and an additional $27,500 was paid in ten The Company was party to a Membership Interest Purchase Agreement, dated March 13, 2012, by and among the Company, Avadel Legacy, Breaking Stick Holdings, LLC, Deerfield Private Design International II, L.P. (“Deerfield International”), Deerfield Private Design Fund II, L.P. (“Deerfield Fund”) and Horizon Santé FLML, Sarl (“Horizon”) (the “Deerfield MIPA”) and a Royalty Agreement, dated February 4, 2013, by and among the Company, Avadel Legacy, the Deerfield Fund and Horizon (the “Deerfield Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Deerfield Royalty Agreement for obligations that arise after the Closing Date. The Company was also party to a Royalty Agreement, dated December 3, 2013, by and between the Company, Avadel Legacy and Broadfin Healthcare Master Fund, Ltd. (the “Broadfin Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Broadfin Royalty Agreement for obligations that arise after the Closing Date. The Company recorded a net gain on the sale of the Hospital Products of $45,760 during the year ended December 31, 2020 which has been recorded on the consolidated statements of (loss) income. The $45,760 gain represents the aggregate consideration of $42,000, less transaction fees of $2,928, plus the assets and liabilities either transferred to the Exela Buyer or eliminated by the Company due to the sale of the Hospital Products, which are listed below. June 30, 2020 Prepaid expenses and other current assets $ (134) Inventories (4,922) Goodwill (1,654) Intangible assets, net (407) Other non-current assets (1,095) Total long-term contingent consideration payable 14,900 Net liabilities disposed of 6,688 Aggregate consideration 42,000 Less transaction fees (2,928) Net gain on the sale of the Hospital Products $ 45,760 Subsequent to the disposition of the Hospital Products, the Company entered into a separate and distinct agreement with the Exela Buyer, whereby the Exela Buyer assumed all future returns of the Hospital Products in exchange for cash consideration paid by the Company. The Company recorded a $518 gain from this transaction, which is recorded in “Selling, general and administrative expenses” for the year ended December 31, 2020. The Company evaluated various qualitative and quantitative factors related to the disposition of the Hospital Products and determined that it did not meet the criteria for presentation as a discontinued operation. The unaudited pro forma condensed combined statements of (loss) income for the years ended December 31, 2020 and 2019 included below is being provided for information purposes only and are not necessarily indicative of the results of operations that would have resulted if the Transaction had actually occurred on the date indicated. The pro forma adjustments are based on available information and assumptions that the Company believes are attributable to the sale. Unaudited Pro Forma Condensed Combined Statement of (Loss) Income Year Ended December 31, 2020 As Reported Pro Forma Adjustments Notes Pro Forma Product sales $ 22,334 $ (22,175) (a) $ 159 Total operating expense 16,519 (8,392) (b) 8,127 Operating income (loss) 5,815 (13,783) (7,968) Loss before income taxes $ (5,082) $ (13,348) (c) $ (18,430) Unaudited Pro Forma Condensed Combined Statement of (Loss) Income Year Ended December 31, 2019 As Reported Pro Forma Adjustments Notes Pro Forma Product sales $ 59,215 $ (59,273) (a) $ (58) Total operating expense 83,327 (16,092) (d) 67,235 Operating loss (24,112) (43,181) (67,293) Loss before income taxes $ (38,582) $ (42,803) (e) $ (81,385) Adjustments to the pro forma unaudited condensed combined statements of (loss) income (a) This adjustment reflects Product sales attributable to the Hospital Products. (b) This adjustment reflects the following estimated expenses attributable to the Hospital Products: • Cost of products of $3,540. • R&D expenses of $322. • Selling, general and administrative expenses of $797. • Intangible asset amortization on acquired development technology for Vazculep of $406. • Changes in fair value of related party contingent consideration of $3,327. The Company will no longer be responsible for these payments. (c) This amount reflects the adjustments noted in (a) and (b) above, as well as estimated Changes in fair value of related party payable of $435 attributable to the Hospital Products. The Company will no longer be responsible for these payments. (d) This adjustment reflects the following estimated expenses attributable to the Hospital Products: • Cost of products of $11,368. • R&D expenses of $1,960. • Selling, general and administrative expenses of $1,102. • Intangible asset amortization on acquired development technology for Vazculep of $816. • Changes in fair value of related party contingent consideration of $845. The Company will no longer be responsible for these payments. (e) This amount reflects the adjustments noted in (a) and (d) above, as well as the reversal of estimated Changes in fair value of related party payable of $378 attributable to the Hospital Products. The Company will no longer be responsible for these payments. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition Prior to June 30, 2020, the Company generated revenue primarily from the sale of pharmaceutical products to customers. On June 30, 2020, the Company sold the Hospital Products. See Note 4: Disposition of the Hospital Products . Product Sales and Services Prior to June 30, 2020, the Company sold products primarily through wholesalers and considered these wholesalers to be its customers. Revenue from product sales was recognized when the customer obtained control of the Company’s product and its performance obligations were met, which occurred typically upon receipt of delivery to the customer. As is customary in the pharmaceutical industry, the Company’s gross product sales were subject to a variety of price adjustments in arriving at reported net product sales. These adjustments included estimates for product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated when the product is delivered based on analysis of historical data for the product or comparable products, as well as future expectations for such products. Reserves to reduce Gross Revenues to Net Revenues Revenues from product sales were recorded at the net selling price, which included estimated reserves to reduce gross product sales to net product sales resulting from product returns, chargebacks, payment discounts, rebates, and other sales allowances that are offered within contracts between the Company and its customers and end users. These reserves were based on the amounts earned or to be claimed on the related sales and were classified as reductions of accounts receivable if the amount was payable to the customer, except in the case of the estimated reserve for future expired product returns, which were classified as a liability. The reserves were classified as a liability if the amount is payable to a party other than a customer. Where appropriate, these estimated reserves took into consideration relevant factors such as the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflected the Company’s best estimates to reduce gross selling price to net selling price to which it expected to be entitled based on the terms of its contracts. The actual selling price ultimately received may differ from the Company’s estimates. Product Returns Consistent with industry practice, the Company maintained a returns policy that generally offered customers a right of return for product that has been purchased from the Company. The Company estimated the amount of product returns and records this estimate as a reduction of revenue in the period the related product revenue was recognized. The Company estimated product return liabilities based on analysis of historical data for the product or comparable products, as well as future expectations for such products and other judgments and analysis. Chargebacks, Discounts and Rebates Chargebacks, discounts and rebates represent the estimated obligations resulting from contractual commitments to sell products to its customers or end users at prices lower than the list prices charged to the Company’s wholesale customers. Customers charged the Company for the difference between the gross selling price they pay for the product and the ultimate contractual price agreed to between the Company and these end users. These reserves were established in the same period that the related revenue was recognized, resulting in a reduction of product revenue and accounts receivable. Chargebacks, discounts and rebates were estimated at the time of sale to the customer. Disaggregation of revenue The Company’s primary source of revenue was from the sale of pharmaceutical products, which are equally affected by the same economic factors as it relates to the nature, amount, timing, and uncertainty of revenue and cash flows. For further detail about the Company’s revenues by product, see Note 21: Company Operations by Product, Customer and Geography. Contract Balances The Company does not recognize revenue in advance of invoicing its customers and therefore has no related contract assets. A receivable is recognized in the period the Company sells its products and when the Company’s right to consideration is unconditional. There were no material deferred contract costs at December 31, 2021 and 2020. Transaction Price Allocated to the Remaining Performance Obligation For product sales, the Company generally satisfies its performance obligations within the same period the product is delivered. Product sales recognized in 2020 and 2019 from performance obligations satisfied (or partially satisfied) in previous periods were immaterial. No product sales were recognized in 2021. The Company has elected certain of the practical expedients from the disclosure requirement for remaining performance obligations for specific situations in which an entity need not estimate variable consideration to recognize revenue. Accordingly, the Company applies the practical expedient in ASC 606 to its stand-alone contracts and does not disclose information about variable consideration from remaining performance obligations for which it recognizes revenue. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 As of December 31, 2020 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 7 ) Mutual and money market funds $ 78,098 $ — $ — $ 104,672 $ — $ — Corporate bonds — 16,479 — — 22,155 — Government securities - U.S. — 9,471 — — 18,999 — Other fixed-income securities — 2,465 — — 3,854 — Total assets $ 78,098 $ 28,415 $ — $ 104,672 $ 45,008 $ — 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, 2021, there were no transfers in and out of Level 1, 2, or 3. During the twelve months ended December 31, 2021, 2020 and 2019, 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 $143,750 aggregate principal amount of the 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 value of the 2023 Notes at December 31, 2021 is $153,273. See Note 11: Long-Term Debt for additional information regarding the Company’s debt obligations. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The Company has 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’ equity, net of income tax effects. As of December 31, 2021, 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, 2021 and 2020, respectively: 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 2020 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 103,404 $ 1,288 $ (20) $ 104,672 Corporate bonds 21,811 350 (6) 22,155 Government securities - U.S. 18,849 155 (5) 18,999 Other fixed-income securities 3,839 22 (7) 3,854 Total $ 147,903 $ 1,815 $ (38) $ 149,680 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) income. The Company recognized gross realized gains of $174, $474 and $483 for the twelve months ended December 31, 2021, 2020 and 2019, respectively. These realized gains were offset by realized losses of $275, $912 and $151 for the twelve-months ended December 31, 2021, 2020 and 2019, respectively. The following table summarizes the estimated fair value of the Company’s investments in marketable debt securities, accounted for as available-for-sale securities and classified by the contractual maturity date of the securities as of December 31, 2021: Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Corporate bonds $ 5,288 $ 10,873 $ 318 $ — $ 16,479 Government securities - U.S. 1,531 5,938 807 1,195 9,471 Other fixed-income securities — 1,860 605 — 2,465 Total $ 6,819 $ 18,671 $ 1,730 $ 1,195 $ 28,415 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, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net The principal categories of property and equipment, net at December 31, 2021 and 2020, respectively, are as follows: Property and Equipment, net: 2021 2020 Software, office and computer equipment $ 448 $ 1,443 Furniture, fixtures and fittings 302 300 Less - accumulated depreciation (465) (1,384) Total $ 285 $ 359 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company’s goodwill is $16,836 at December 31, 2021 and 2020. The Company recorded amortization expense related to an amortizable intangible asset that was assumed by the Exela Buyer as part of the disposition of the Hospital Products on June 30, 2020 of $406 and $816 for the years ended December 31, 2020 and 2019, respectively. Refer to Note 4: Disposition of the Hospital Products . There was no amortization expense recorded during the year ended December 31, 2021. No impairment loss related to goodwill or intangible assets was recognized during the years ended December 31, 2021 or 2020. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
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 two The components of lease costs, which are included in selling, general and administrative expenses in the consolidated statements of (loss) income of years ended December 31, 2021, 2020 and 2019 were as follows: Lease cost: 2021 2020 2019 Operating lease costs (1) $ 821 $ 1,133 $ 1,515 Sublease income (2) (110) (336) (276) Total lease cost $ 711 $ 797 $ 1,239 (1) Variable lease costs were immaterial for the years ended December 31, 2021, 2020 and 2019. (2) Represents sublease income received for office subleases. During the years ended December 31, 2021 and 2020, the Company reduced its operating lease liabilities by $578 and $769 for cash paid. During the year ended December 31, 2021, the Company remeasured its production suite lease liability. During the year ended December 31, 2021, the Company did not enter into any new operating or finance leases. As of December 31, 2021, the Company’s operating leases have a weighted-average remaining lease term of 2.9 years and a weighted-average discount rate of 4.9%. 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 2022 $ 974 2023 1,013 2024 614 2025 206 2026 — Thereafter — Total lease payments 2,807 Less: interest 200 Present value of lease liabilities $ 2,607 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt Long-term debt is summarized as follows: December 31, 2021 December 31, 2020 Principal amount of 4.50% exchangeable senior notes due 2023 $ 143,750 $ 143,750 Less: unamortized debt discount and issuance costs, net (1,353) (15,540) Net carrying amount of liability component 142,397 128,210 Less: current maturities — — Long-term debt $ 142,397 $ 128,210 Equity component: Equity component of exchangeable notes, net of issuance costs $ — $ (26,699) For the years ended December 31, 2021, 2020 and 2019, the total interest expense was $9,942, $12,994 and $12,464, respectively, with coupon interest expense of $6,469 for each period and the amortization of debt issuance costs and debt discount of $1,248, $6,525 and $5,995, respectively. Current period interest expense also included $2,225 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. See Note 1: Background and Basis of Presentation for further details. As described in Note 2: Newly Issued Accounting Standards , the Company elected to early adopt ASU 2020-06 as of January 1, 2021 using a modified retrospective method. The adoption resulted in a $12,939 increase in long-term debt and a $26,699 decrease in the equity component of the 2023 Notes. 2023 Notes 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 4.50% exchangeable senior notes due 2023 (the “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 2023 Notes a 30-day option to purchase up to an additional $18,750 aggregate principal amount of the 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 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. The 2023 Notes will be 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. Holders of the 2023 Notes may convert their 2023 Notes, at their option, only under the following circumstances prior to the close of business on the business day immediately preceding August 1, 2022, under the circumstances and during the periods set forth below and regardless of the conditions described below, on or after August 1, 2022 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 August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 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 August 1, 2022, regardless of whether a holder of the 2023 Notes has the right to require the Company to repurchase the 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 August 1, 2022, all or any portion of a the holder’s 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 August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time during any calendar quarter commencing after the calendar quarter ending on June 30, 2018 (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 2023 Notes for redemption pursuant to Article 16 to the Indenture prior to the close of business on the business day immediately preceding August 1, 2022, then a holder of the 2023 Notes may surrender all or any portion of its 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 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 2023 Notes may exchange its 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, |
Contingent Consideration Payabl
Contingent Consideration Payable | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Contingent Consideration Payable | Contingent Consideration Payable Prior to the sale of the Hospital Products on June 30, 2020, the Company computed the fair value of the contingent consideration using several significant assumptions and when those assumptions changed, due to underlying market conditions, the fair value of these liabilities changed as well. Prior to the sale of the Hospital Products, these changes had a material impact on the Company’s consolidated statements of (loss) income and balance sheets. As part of the sale of the Hospital Products on June 30, 2020, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy and the Company under the Deerfield Royalty Agreement and the Broadfin Royalty Agreement. As of December 31, 2021 and 2020, the balance of the contingent consideration payable is $0. The following table summarizes changes to the contingent consideration payables, a recurring Level 3 measurement, for the twelve-month periods ended December 31, 2020 and 2019: Contingent Consideration Payable: Balance Balance at December 31, 2018 $ 28,840 Payments of related party payable (12,736) Fair value adjustments (1) 1,223 Balance at December 31, 2019 17,327 Payments of contingent consideration payable (6,189) Fair value adjustments (1) 3,762 Disposition of the Hospital Products (14,900) Balance at December 31, 2020 $ — |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of loss before income taxes for the years ended twelve months ended December 31, are as follows: Loss Before Income Taxes: 2021 2020 2019 Ireland $ (36,631) $ (27,205) $ (50,134) U.S. (56,687) 22,335 10,401 France 173 (212) 1,151 Total loss before income taxes $ (93,145) $ (5,082) $ (38,582) The income tax benefit consists of the following for the years ended December 31: Income Tax Benefit: 2021 2020 2019 Current: U.S. - Federal $ — $ (12,810) $ — U.S. - State 60 20 97 Total current 60 (12,790) 97 Deferred: Ireland — — (1,256) U.S. - Federal (15,876) 680 (4,093) U.S. - State — — (104) Total deferred (15,876) 680 (5,453) Income tax benefit $ (15,816) $ (12,110) $ (5,356) The reconciliation between income taxes at the statutory rate and the Company’s benefit for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2021 2020 2019 Income tax benefit - at statutory tax rate $ (11,642) $ (636) $ (4,823) Differences in international tax rates (8,950) 1,755 (1,218) Nondeductible changes in fair value of contingent consideration — 988 121 Intercompany asset transfer — — (8,190) Change in valuation allowances 4,296 4,231 7,379 Nondeductible share-based compensation 645 1,060 1,039 Hospital Products sale — (9,328) — Unrealized tax benefits 239 (274) (261) State and local taxes (net of federal) 60 20 (7) Change in U.S. tax law — (9,124) — Nondeductible interest expense 2,173 1,728 982 Orphan drug and R&D tax credit (1,524) (2,793) — Other (1,113) 263 (378) Income tax benefit - at effective income tax rate $ (15,816) $ (12,110) $ (5,356) In 2021, the income tax benefit increased by $3,706 when compared to the same period in 2020. The increase in the income tax benefit in 2021 was primarily driven by the additional tax benefit from an increase in the net operating losses in the U.S. in 2021, when compared to the same period in 2020. This was partially offset by the nonrecurring nature of tax benefits recognized in 2020 from the sale of the Company’s Hospital Products and passage of the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) in the U.S. In 2020, the income tax benefit increased by $6,754 when compared to the same period in 2019. The increase in the income tax benefit in 2020 was primarily driven by the tax benefits from the sale of the Company’s Hospital Products and passage of the CARES Act in the U.S. The Company recorded additional tax benefit in 2020 from the Orphan Drug and R&D tax credit in the U.S. Tax benefit from the intercompany asset transfer recorded in 2019 did not recur, resulting in a partial offset of tax benefits described above. 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 2017. During 2020, the Company completed the 2015 through 2017 U.S. Federal Tax Audit. Completion of the audit resulted in an assessment of $1,937 for the 2015 through 2017 U.S. Federal Tax Returns compared to the IRS Claims of $50,695 made on July 2, 2019 and the updated IRS Claims of $9,302 on October 2, 2019 made as part of the Specialty Pharma bankruptcy proceedings, which at this time does not include interest and penalties. 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 2021 2020 2019 Balance at January 1: $ 3,143 $ 6,465 $ 5,315 Increases for tax positions of prior years — — 2,416 Statute of limitations expiration — — (1,266) Settlements — (3,322) — Balance at December 31: $ 3,143 $ 3,143 $ 6,465 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, 2021, 2020 and 2019, there are $2,483, $2,483 and $3,806 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 expense. During the years ended December 31, 2021, 2020 and 2019, the Company recognized approximately $239, $203 and $555 in interest and penalties. The Company had approximately $1,777 and $1,475 for the payment of interest and penalties accrued at December 31, 2021 and 2020, 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, 2021 and 2020 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 35,990 $ 31,302 Orphan drug and R&D tax credit 4,964 2,793 Share-based compensation 4,108 2,626 Amortization 3,429 3,701 Other 662 423 Gross deferred tax assets 49,153 40,845 Deferred tax liabilities: Other (925) (890) Prepaid expenses (75) (75) Gross deferred tax liabilities (1,000) (965) Less: valuation allowances (24,025) (21,624) Net deferred tax assets $ 24,128 $ 18,256 At December 31, 2021, the Company had $124,720 of net operating losses in Ireland that do not have an expiration date and $74,406 of net operating losses in the U.S. Of the $74,406 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 $64,041 are due to the losses at US Holdings. 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, 2021, the Company recorded $4,045 of valuation allowances related to Irish net operating losses. 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 recorded a valuation allowance against all of its net operating losses in Ireland and France as of December 31, 2021 and 2020. The Company intends to continue maintaining a full valuation allowance on the Irish net operating losses until there is sufficient evidence to support the reversal of all or some portion of these allowances. While the Company believes it is more likely than not that it will be able to realize the deferred tax assets in the U.S., the Company continues to monitor any unfavorable changes that could ultimately impact its assessment of the realizability of the Company’s U.S. deferred tax assets. If the Company experiences an ownership change under Internal Revenue Code Section 382, the U.S. net operating losses could also be limited in their utilization. At December 31, 2021, the Company has unremitted earnings of $3,916 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, 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. As of December 31, 2020, the Company’s net research tax credit receivable amounts to $6,771 and represents a French gross research tax credit of $6,396 and an Irish gross research tax credit of $375. 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. During the twelve months ended December 31, 2020, the income tax benefit includes a discrete tax benefit of $9,124 as a result of the Company’s ability under the CARES Act to carry back net operating losses incurred to periods when the statutory U.S. Federal tax rate was 35% versus the Company’s current U.S. Federal tax rate of 21%. During the twelve months ended December 31, 2020, the Company received $3,351 in cash tax refunds from carryback claims related to the CARES Act from the carryback of 2018 tax losses. 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. |
Other Assets and Liabilities
Other Assets and Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
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: 2021 2020 Income tax receivable (see Note 13 ) $ 29,097 $ 18,615 Prepaid and other expenses 3,179 1,018 Guarantee from Armistice 279 318 Other 271 798 Receivable from Exela (see Note 4 ) — 16,500 Short-term deposit — 1,477 Total $ 32,826 $ 38,726 Other Non-Current Assets: 2021 2020 Deferred tax assets (see Note 13 ) $ 24,128 $ 18,256 Right of use assets at contract manufacturing organizations 8,549 5,201 Guarantee from Armistice 771 1,050 Other 329 432 Total $ 33,777 $ 24,939 Accrued Expenses: 2021 2020 Accrued compensation $ 3,167 $ 1,697 Accrued professional fees 2,678 2,781 Accrued outsourced contract costs 1,048 473 Customer allowances 217 1,030 Accrued restructuring (see Note 16 ) 41 520 Total $ 7,151 $ 6,501 Other Current Liabilities: 2021 2020 Accrued interest $ 4,920 $ 2,695 Guarantee to Deerfield 280 319 Other 70 160 Due to Exela — 2,026 Total $ 5,270 $ 5,200 Other Non-Current Liabilities: 2021 2020 Tax liabilities and other $ 3,143 $ 3,159 Guarantee to Deerfield 774 1,053 Total $ 3,917 $ 4,212 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2021 | |
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, 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 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 will infringe at least one claim of US 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’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. Second 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 Pharmaceuticals, LLC will infringe at least one claim of US 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. Third 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 Pharmaceuticals, LLC will infringe at least one claim of US 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 January 7, 2022, Avadel CNS Pharmaceuticals LLC 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 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. Material Commitments At December 31, 2021, the Company has one commitment with its primary contract manufacturer related to facility upgrades and the purchase and validation of equipment to be used in the manufacture of FT218. The total cost of this commitment is estimated to be approximately $5,500 and is expected to be completed during the year ending December 31, 2022. The Company has incurred approximately $3,348 of this commitment during the year ended December 31, 2021. The Company also has a commitment with another contract manufacturer that commences in the first quarter of 2022 and will continue until FDA approval of the contract manufacturer. The commitment will be approximately $3,000 per year. Guarantees 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 $1,054 at December 31, 2021. 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 $1,050 at December 31, 2021. This asset is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield. The fair values of the Company’s guarantee to Deerfield and the guarantee received by the Company from Armistice largely offset and when combined are not material. |
Restructuring Costs
Restructuring Costs | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring Costs 2019 French Restructuring During the second quarter of 2019, the Company initiated a plan to discontinue all French R&D activities, which resulted in the redundancy and reduction of its entire workforce at its Vénissieux, France site (“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 R&D 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, 2021 and 2020 were immaterial. Restructuring charges associated with this plan of $4,855 of were recognized during the year ended December 31, 2019. Included in the 2019 French Restructuring charges of $4,855 were charges for employee severance, benefits and other costs of $4,339, charges related to fixed asset impairment of $629, charges related to the early termination penalty related to the office and copier lease terminations of $887, partially offset by a benefit of $1,000 related to the reversal of the French retirement indemnity obligation. At December 31, 2021, there are no future expected retirement indemnity benefits to be paid. 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, 2021 and 2020: 2019 French Restructuring Obligation: 2021 2020 Balance of restructuring accrual at January 1, $ 248 $ 1,922 (Benefit) charges for employee severance, benefits and other costs (122) 172 Payments (77) (1,813) Foreign currency impact (8) (33) Balance of restructuring accrual at December 31, $ 41 $ 248 The 2019 French Restructuring liability of $41 is included in the consolidated balance sheet in accrued expenses at December 31, 2021. 2019 Corporate Restructuring During the first quarter of 2019, the Company announced a plan to reduce its corporate workforce by more than 50% (the “2019 Corporate Restructuring”). The reduction in workforce is primarily a result of the exit of Noctiva during the first quarter of 2019 (see Note 3: Subsidiary Bankruptcy and Deconsolidation ), as well as an effort to better align the Company’s remaining cost structure at its U.S. and Ireland locations with its ongoing and future planned projects. The reduction in workforce was completed during the year ended December 31, 2020. Restructuring income associated with this plan for the years ended December 31, 2021 and 2020 were immaterial. Restructuring charges associated with this plan of $1,755 were recognized during the year ended December 31, 2019. Included in the 2019 Corporate Restructuring charges of $1,755 for the year ended December 31, 2019 were charges for employee severance, benefit and other costs of $3,406, charges related to the early termination penalty related to the office lease termination of $288, the write-off of $125 of property, plant and equipment, net, partially offset by a benefit of $2,064 related to share based compensation forfeitures related to the employees affected by the global reduction in workforce. The Company does not expect to incur any additional expenses related to the 2019 Corporate Restructuring. |
Equity Instruments and Transact
Equity Instruments and Transactions | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021, the Company had 58,620 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, 2021. 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 “Base Prospectus”), and any amendments or supplements thereto (together, the “Securities”); 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 on February 4, 2020 (the “Sales Agreement”), the 2020 Shelf Registration Statement, the Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement. The transactions costs associated with the 2020 Shelf Registration Statement totaled $428 of which $214 was charged against additional paid-in capital during the twelve months ended December 31, 2020 as a result of the May 2020 Public Offering, discussed below. The remaining costs of $214 are recorded as a prepaid asset at December 31, 2021. 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. Retirement of Treasury Shares In August 2020, the Company retired all of its 5,407 treasury shares, or $49,998 previously repurchased ordinary shares. As a result, the Company reduced additional paid-in capital by $49,944 and ordinary shares by $54 during the twelve months ended December 31, 2020. The portion allocated to additional paid-in capital is determined pro rata by applying a percentage, determined by dividing the number of shares to be retired by the number of shares issued and outstanding as of the retirement date, to the balance of additional paid-in capital as of the retirement date. Based on this calculation, the entirety of the excess of repurchase price over par of $49,944 was allocated to additional paid-in capital. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation Compensation expense included in the Company’s consolidated statements of (loss) income for all share-based compensation arrangements was as follows for the periods ended December 31, 2021, 2020 and 2019, respectively: Share-based Compensation Expense: 2021 2020 2019 Research and development $ 758 $ 139 $ 429 Selling, general and administrative 8,114 3,281 2,154 Restructuring costs — (421) (2,064) Total share-based compensation expense $ 8,872 $ 2,999 $ 519 As of December 31, 2021, the Company expects $18,429 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 3.2 years. The excess tax benefit related to share-based compensation recorded by the Company was not material for the years ended December 31, 2021, 2020 and 2019. 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, 2021, there were 1,336 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, 2021, the Company had not issued any shares under this Inducement Plan. 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. 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. 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, 2021, 2020 and 2019, are as follows: Stock Option Assumptions: 2021 2020 2019 Stock option grants: Expected term (years) 6.20 6.08 6.25 Expected volatility 73.91 % 75.76 % 56.48 % Risk-free interest rate 1.10 % 0.72 % 2.52 % 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, 2021 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2021 5,898 $ 7.02 Granted 2,857 8.20 Exercised (48) 3.54 Forfeited (234) 7.13 Expired (70) 12.62 Stock options outstanding, December 31, 2021 8,403 $ 7.39 7.83 years $ 12,204 Stock options exercisable, December 31, 2021 3,256 $ 7.88 5.88 years $ 6,291 The aggregate intrinsic value of options exercisable at December 31, 2021, 2020 and 2019 was $6,291, $1,841, and $572, respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2021, 2020 and 2019 was $5.36, $4.63 and $1.24 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, 2021, 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, 2021 347 $ 5.87 Granted 99 8.22 Vested (160) 5.05 Forfeited (12) 7.08 Non-vested restricted share awards outstanding, December 31, 2021 274 $ 7.14 The weighted average grant date fair value of restricted share awards granted during the years ended December 31, 2021, 2020 and 2019 was $8.22, $7.69 and $2.47, respectively. 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 FT218 and the other 50% vest one year following achievement of those milestones (“2020 PSU awards”). The Company has not yet recognized any share-based compensation expense related to the 2020 PSU awards as the regulatory milestones have not yet been met; however, in the event the performance conditions are met before a certain date, approximately 100% of the outstanding shares, or $1,786 of compensation expense will be recognized by the Company for the 2020 PSU awards outstanding as of December 31, 2021. 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 Company has not yet recognized any share-based compensation expense related to the 2021 PSU awards as the objectives have not yet been met; however, in the event the performance conditions are met and exceeded, approximately 150% of the outstanding shares, or $3,509 of compensation expense will be recognized by the Company for the 2021 PSU awards outstanding as of December 31, 2021. A summary of the Company’s performance share units awards as of December 31, 2021, 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, 2021 257 $ 7.09 Granted 285 8.20 Vested — — Forfeited (7) 5.36 Non-vested performance share awards outstanding, December 31, 2021 535 $ 7.71 The weighted average grant date fair value of performance share awards granted during the years ended December 31, 2021 and 2020 was $8.20 and $7.09 per share, respectively. There were no performance share awards granted during the year ended December 31, 2019. 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, 2021 and 2020, the Company issued 17 and 49 ordinary shares to employees, respectively. Expense related to the ESPP for the years ended December 31, 2021, 2020 and 2019 was immaterial. |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share | Net (Loss) Income Per Share Basic net (loss) income per share is calculated by dividing net (loss) income by the weighted average number of shares outstanding during each period. Diluted net (loss) income per share is calculated by dividing net (loss) income - diluted by the diluted number of shares outstanding during each period. Except where the result would be anti-dilutive to net (loss) income, diluted net (loss) income 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. The dilutive effect of the PSUs will be calculated using the treasury stock method, if and when the contingent vesting condition is achieved. A reconciliation of basic and diluted net (loss) income per share, together with the related shares outstanding in thousands for the years ended December 31, 2021, 2020 and 2019, is as follows: Net (Loss) Income Per Share: 2021 2020 2019 Net (loss) income $ (77,329) $ 7,028 $ (33,226) Weighted average shares: Basic shares 58,535 52,996 37,403 Effect of dilutive securities—employee and director equity awards outstanding — 1,945 — Diluted shares 58,535 54,941 37,403 Net (loss) income per share - basic $ (1.32) $ 0.13 $ (0.89) Net (loss) income per share - diluted $ (1.32) $ 0.13 $ (0.89) |
Comprehensive Loss
Comprehensive Loss | 12 Months Ended |
Dec. 31, 2021 | |
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: 2021 2020 2019 Foreign currency translation adjustment: Beginning balance $ (22,627) $ (23,738) $ (23,621) Net other comprehensive (loss) income (1,228) 1,111 (117) Balance at December 31, $ (23,855) $ (22,627) $ (23,738) Unrealized (loss) gain on marketable securities, net Beginning balance $ 1,576 $ 932 $ 205 Net other comprehensive (loss) income, net of income tax benefit (expense) of $214, $(202), $(43), respectively (1,661) 644 727 Balance at December 31, $ (85) $ 1,576 $ 932 Accumulated other comprehensive loss at December 31, $ (23,940) $ (21,051) $ (22,806) |
Company Operations by Product,
Company Operations by Product, Customer and Geographic Area | 12 Months Ended |
Dec. 31, 2021 | |
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 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. On June 30, 2020, the Company sold the Hospital Products. See Note 4: Disposition of the Hospital Products . The Company had no revenue during the twelve months ended December 31, 2021. The following table presents a summary of total revenues by product for the twelve months ended December 31, 2020 and 2019: Revenue by Product: 2020 2019 Bloxiverz $ 2,201 $ 7,479 Vazculep 10,429 33,152 Akovaz 9,545 18,642 Other 159 (58) Product sales $ 22,334 $ 59,215 The following table presents a summary of total revenues by significant customer for the twelve months ended December 31, 2020 and 2019: Revenue by Significant Customer: 2020 2019 McKesson Corporation $ 5,758 $ 14,900 Cardinal Health 5,155 15,088 AmerisourceBergen 3,155 12,059 QuVa Pharma 3,117 3,252 Others 5,149 13,916 Product sales $ 22,334 $ 59,215 All revenue earned during the years ended December 31, 2020 and 2019 was generated in the U.S. Concentration of credit risk with respect to accounts receivable was limited due to the high credit quality comprising a significant portion of the Company’s customers. Management periodically monitors the creditworthiness of the Company’s customers and believes that it has adequately provided for any exposure to potential credit loss. Currently, the Company is working with contract manufacturing organizations for the manufacture of FT218. Additionally, the Company purchases raw materials used in FT218 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, 2021, 2020, and 2019: Long-lived Assets by Geographic Region: 2021 2020 2019 U.S. $ 19,605 $ 20,424 $ 22,254 France — 11 196 Ireland 9,817 6,047 7,244 Total $ 29,422 $ 26,482 $ 29,694 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions As noted in Note 4: Disposition of the Hospital Products, prior to June 30, 2020, the Company was party to a Membership Interest Purchase Agreement by and among the Company, Avadel Legacy, Breaking Stick Holdings, LLC, Deerfield Private Design International II, L.P. (“Deerfield International”), Deerfield Private Design Fund II, L.P. (“Deerfield Fund”) and Horizon Santé FLML, Sarl (“Horizon”) (the “Deerfield MIPA”) and a Royalty Agreement by and among the Company, Avadel Legacy, the Deerfield Fund and Horizon (the “Deerfield Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Deerfield MIPA (with respect to certain sections thereof) and the Royalty Agreement were assigned to the Exela Buyer. Pursuant to the Purchase Agreement, the Exela Buyer assumed and will pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Deerfield Royalty Agreement for obligations that arise after the Closing Date. Prior to June 30, 2020, the Company was also party to a Royalty Agreement by and between itself, Avadel Legacy and Broadfin Healthcare Master Fund, Ltd. (the “Broadfin Royalty Agreement”). In connection with the closing of the sale of the Hospital Products, the Broadfin Royalty Agreement was assigned to the Exela Buyer and the Exela Buyer assumed and shall pay, perform, satisfy and discharge the liabilities and obligations of Avadel Legacy under the Broadfin Royalty Agreement for obligations that arise after the Closing Date. Refer to Note 12: Contingent Consideration Payable |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
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 St. Louis, Missouri, United States (“U.S”). The Company’s lead product candidate, FT218, is an investigational once-nightly, extended-release formulation of sodium oxybate for the treatment of excessive daytime sleepiness (“EDS”) or cataplexy in adults with narcolepsy. The Company is primarily focused on the development and potential United States (“U.S.”) Food and Drug Administration (“FDA”) approval of FT218. In December 2020, the Company submitted a New Drug Application (“NDA”) to the FDA for FT218 to treat excessive daytime sleepiness or cataplexy in adults with narcolepsy. In February 2021, the NDA for FT218 was accepted by the FDA and was assigned a Prescription Drug User Fee Act (“PDUFA”) target action date of October 15, 2021. On October 15, 2021, the Company announced that the FDA informed us that the review of the Company’s NDA for FT218 was ongoing beyond its previously assigned target action date. As of the date of this Annual Report, the FDA’s review of the Company’s NDA for FT218 remains ongoing. |
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. The Company’s results of operations for the period January 1, 2019 through February 6, 2019 include the results of Avadel Specialty Pharmaceuticals, LLC (“Specialty Pharma”) prior to its February 6, 2019 voluntary petition for reorganization under Chapter 11 of the U.S. Bankruptcy Code. See Note 3: Subsidiary Bankruptcy and Deconsolidation. |
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 Statements of Cash Flows for the fiscal year ended December 31, 2019 and balances within Note 14: Other Assets and Liabilities |
Revenue | Revenue. Prior to June 30, 2020, revenue included sales of pharmaceutical products, licensing fees, and, if any, milestone payments for research and development (“R&D”) achievements. To determine the appropriate revenue recognition, the Company performs the following five steps: (i) Identify the contract(s) with a customer; (ii) Identify the performance obligations in the contract; (iii) Determine the transaction price; (iv) Allocate the transaction price to the performance obligations in the contract; and (v) Recognize revenue when (or as) the entity satisfies a performance obligation. The Company applies the five-step model to contracts only when the Company and its customer’s rights and obligations under the contract can be determined, the contract has commercial substance, and it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. The Company identifies the promised goods or services in the contract to determine if they are separate performance obligations or if they should be bundled with other goods and services into a single performance obligation. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product Sales |
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 $0, $312 and $372 for the years ended December 31, 2021, 2020 and 2019, 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. 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) income. 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) income (“AOCI”) in shareholders’ 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 5-10 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, 2021 and 2020. |
Long-Lived Assets | Long-Lived Assets. Long-lived assets include fixed assets and intangible assets. Prior to the sale of the Company’s portfolio of sterile injectable drugs used in the hospital setting (“Hospital Products”) on June 30, 2020, intangible assets consisted primarily of purchased licenses and intangible assets recognized as part of the Éclat Pharmaceuticals acquisition. Acquired in-process research and development (“IPR&D”) had an indefinite life and was not amortized until completion and development of the project, at which time the IPR&D became an amortizable asset, for which amortization of such intangible assets was computed using the straight-line method over the estimated useful life of the assets. 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. On June 30, 2020, the Company transferred its remaining intangible asset to Exela Sterile Medicines LLC (“Exela Buyer”) as part of the disposition of the Hospital Products. |
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) income 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) income. |
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) income and balance sheets. Actual results could differ from those estimates under different assumptions or conditions. |
Recently Adopted Accounting Guidance | Recently 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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 5-10 years The principal categories of property and equipment, net at December 31, 2021 and 2020, respectively, are as follows: Property and Equipment, net: 2021 2020 Software, office and computer equipment $ 448 $ 1,443 Furniture, fixtures and fittings 302 300 Less - accumulated depreciation (465) (1,384) Total $ 285 $ 359 |
Disposition of the Hospital Bus
Disposition of the Hospital Business - (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Assets and Liabilities either Transferred Or Eliminated Representing the Aggregate Consideration of Disposal Group | The $45,760 gain represents the aggregate consideration of $42,000, less transaction fees of $2,928, plus the assets and liabilities either transferred to the Exela Buyer or eliminated by the Company due to the sale of the Hospital Products, which are listed below. June 30, 2020 Prepaid expenses and other current assets $ (134) Inventories (4,922) Goodwill (1,654) Intangible assets, net (407) Other non-current assets (1,095) Total long-term contingent consideration payable 14,900 Net liabilities disposed of 6,688 Aggregate consideration 42,000 Less transaction fees (2,928) Net gain on the sale of the Hospital Products $ 45,760 |
Schedule of Error Corrections and Prior Period Adjustments | The unaudited pro forma condensed combined statements of (loss) income for the years ended December 31, 2020 and 2019 included below is being provided for information purposes only and are not necessarily indicative of the results of operations that would have resulted if the Transaction had actually occurred on the date indicated. The pro forma adjustments are based on available information and assumptions that the Company believes are attributable to the sale. Unaudited Pro Forma Condensed Combined Statement of (Loss) Income Year Ended December 31, 2020 As Reported Pro Forma Adjustments Notes Pro Forma Product sales $ 22,334 $ (22,175) (a) $ 159 Total operating expense 16,519 (8,392) (b) 8,127 Operating income (loss) 5,815 (13,783) (7,968) Loss before income taxes $ (5,082) $ (13,348) (c) $ (18,430) Unaudited Pro Forma Condensed Combined Statement of (Loss) Income Year Ended December 31, 2019 As Reported Pro Forma Adjustments Notes Pro Forma Product sales $ 59,215 $ (59,273) (a) $ (58) Total operating expense 83,327 (16,092) (d) 67,235 Operating loss (24,112) (43,181) (67,293) Loss before income taxes $ (38,582) $ (42,803) (e) $ (81,385) Adjustments to the pro forma unaudited condensed combined statements of (loss) income (a) This adjustment reflects Product sales attributable to the Hospital Products. (b) This adjustment reflects the following estimated expenses attributable to the Hospital Products: • Cost of products of $3,540. • R&D expenses of $322. • Selling, general and administrative expenses of $797. • Intangible asset amortization on acquired development technology for Vazculep of $406. • Changes in fair value of related party contingent consideration of $3,327. The Company will no longer be responsible for these payments. (c) This amount reflects the adjustments noted in (a) and (b) above, as well as estimated Changes in fair value of related party payable of $435 attributable to the Hospital Products. The Company will no longer be responsible for these payments. (d) This adjustment reflects the following estimated expenses attributable to the Hospital Products: • Cost of products of $11,368. • R&D expenses of $1,960. • Selling, general and administrative expenses of $1,102. • Intangible asset amortization on acquired development technology for Vazculep of $816. • Changes in fair value of related party contingent consideration of $845. The Company will no longer be responsible for these payments. (e) This amount reflects the adjustments noted in (a) and (d) above, as well as the reversal of estimated Changes in fair value of related party payable of $378 attributable to the Hospital Products. The Company will no longer be responsible for these payments. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on 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, 2021 As of December 31, 2020 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 7 ) Mutual and money market funds $ 78,098 $ — $ — $ 104,672 $ — $ — Corporate bonds — 16,479 — — 22,155 — Government securities - U.S. — 9,471 — — 18,999 — Other fixed-income securities — 2,465 — — 3,854 — Total assets $ 78,098 $ 28,415 $ — $ 104,672 $ 45,008 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 and 2020, respectively: 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 2020 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 103,404 $ 1,288 $ (20) $ 104,672 Corporate bonds 21,811 350 (6) 22,155 Government securities - U.S. 18,849 155 (5) 18,999 Other fixed-income securities 3,839 22 (7) 3,854 Total $ 147,903 $ 1,815 $ (38) $ 149,680 |
Investments Classified by Contractual Maturity Date | The following table summarizes the estimated fair value of the Company’s investments in marketable debt securities, accounted for as available-for-sale securities and classified by the contractual maturity date of the securities as of December 31, 2021: Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Corporate bonds $ 5,288 $ 10,873 $ 318 $ — $ 16,479 Government securities - U.S. 1,531 5,938 807 1,195 9,471 Other fixed-income securities — 1,860 605 — 2,465 Total $ 6,819 $ 18,671 $ 1,730 $ 1,195 $ 28,415 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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 5-10 years The principal categories of property and equipment, net at December 31, 2021 and 2020, respectively, are as follows: Property and Equipment, net: 2021 2020 Software, office and computer equipment $ 448 $ 1,443 Furniture, fixtures and fittings 302 300 Less - accumulated depreciation (465) (1,384) Total $ 285 $ 359 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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) income of years ended December 31, 2021, 2020 and 2019 were as follows: Lease cost: 2021 2020 2019 Operating lease costs (1) $ 821 $ 1,133 $ 1,515 Sublease income (2) (110) (336) (276) Total lease cost $ 711 $ 797 $ 1,239 (1) Variable lease costs were immaterial for the years ended December 31, 2021, 2020 and 2019. (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 2022 $ 974 2023 1,013 2024 614 2025 206 2026 — Thereafter — Total lease payments 2,807 Less: interest 200 Present value of lease liabilities $ 2,607 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-term debt is summarized as follows: December 31, 2021 December 31, 2020 Principal amount of 4.50% exchangeable senior notes due 2023 $ 143,750 $ 143,750 Less: unamortized debt discount and issuance costs, net (1,353) (15,540) Net carrying amount of liability component 142,397 128,210 Less: current maturities — — Long-term debt $ 142,397 $ 128,210 Equity component: Equity component of exchangeable notes, net of issuance costs $ — $ (26,699) |
Contingent Consideration Paya_2
Contingent Consideration Payable (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Related Party Transactions | The following table summarizes changes to the contingent consideration payables, a recurring Level 3 measurement, for the twelve-month periods ended December 31, 2020 and 2019: Contingent Consideration Payable: Balance Balance at December 31, 2018 $ 28,840 Payments of related party payable (12,736) Fair value adjustments (1) 1,223 Balance at December 31, 2019 17,327 Payments of contingent consideration payable (6,189) Fair value adjustments (1) 3,762 Disposition of the Hospital Products (14,900) Balance at December 31, 2020 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule Of Components Of Loss Before Income Tax | The components of loss before income taxes for the years ended twelve months ended December 31, are as follows: Loss Before Income Taxes: 2021 2020 2019 Ireland $ (36,631) $ (27,205) $ (50,134) U.S. (56,687) 22,335 10,401 France 173 (212) 1,151 Total loss before income taxes $ (93,145) $ (5,082) $ (38,582) |
Schedule Of Income Tax (Benefit) Provision | The income tax benefit consists of the following for the years ended December 31: Income Tax Benefit: 2021 2020 2019 Current: U.S. - Federal $ — $ (12,810) $ — U.S. - State 60 20 97 Total current 60 (12,790) 97 Deferred: Ireland — — (1,256) U.S. - Federal (15,876) 680 (4,093) U.S. - State — — (104) Total deferred (15,876) 680 (5,453) Income tax benefit $ (15,816) $ (12,110) $ (5,356) |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between income taxes at the statutory rate and the Company’s benefit for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2021 2020 2019 Income tax benefit - at statutory tax rate $ (11,642) $ (636) $ (4,823) Differences in international tax rates (8,950) 1,755 (1,218) Nondeductible changes in fair value of contingent consideration — 988 121 Intercompany asset transfer — — (8,190) Change in valuation allowances 4,296 4,231 7,379 Nondeductible share-based compensation 645 1,060 1,039 Hospital Products sale — (9,328) — Unrealized tax benefits 239 (274) (261) State and local taxes (net of federal) 60 20 (7) Change in U.S. tax law — (9,124) — Nondeductible interest expense 2,173 1,728 982 Orphan drug and R&D tax credit (1,524) (2,793) — Other (1,113) 263 (378) Income tax benefit - at effective income tax rate $ (15,816) $ (12,110) $ (5,356) |
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 2021 2020 2019 Balance at January 1: $ 3,143 $ 6,465 $ 5,315 Increases for tax positions of prior years — — 2,416 Statute of limitations expiration — — (1,266) Settlements — (3,322) — Balance at December 31: $ 3,143 $ 3,143 $ 6,465 |
Schedule of Deferred Tax Assets and Liabilities | The net deferred tax assets (liabilities) at December 31, 2021 and 2020 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 35,990 $ 31,302 Orphan drug and R&D tax credit 4,964 2,793 Share-based compensation 4,108 2,626 Amortization 3,429 3,701 Other 662 423 Gross deferred tax assets 49,153 40,845 Deferred tax liabilities: Other (925) (890) Prepaid expenses (75) (75) Gross deferred tax liabilities (1,000) (965) Less: valuation allowances (24,025) (21,624) Net deferred tax assets $ 24,128 $ 18,256 |
Other Assets and Liabilities (T
Other Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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: 2021 2020 Income tax receivable (see Note 13 ) $ 29,097 $ 18,615 Prepaid and other expenses 3,179 1,018 Guarantee from Armistice 279 318 Other 271 798 Receivable from Exela (see Note 4 ) — 16,500 Short-term deposit — 1,477 Total $ 32,826 $ 38,726 |
Schedule of Other Non-Current Assets | Other Non-Current Assets: 2021 2020 Deferred tax assets (see Note 13 ) $ 24,128 $ 18,256 Right of use assets at contract manufacturing organizations 8,549 5,201 Guarantee from Armistice 771 1,050 Other 329 432 Total $ 33,777 $ 24,939 |
Schedule of Accrued Expenses | Accrued Expenses: 2021 2020 Accrued compensation $ 3,167 $ 1,697 Accrued professional fees 2,678 2,781 Accrued outsourced contract costs 1,048 473 Customer allowances 217 1,030 Accrued restructuring (see Note 16 ) 41 520 Total $ 7,151 $ 6,501 |
Schedule of Other Current Liabilities | Other Current Liabilities: 2021 2020 Accrued interest $ 4,920 $ 2,695 Guarantee to Deerfield 280 319 Other 70 160 Due to Exela — 2,026 Total $ 5,270 $ 5,200 |
Schedule of Other Non-Current Liabilities | Other Non-Current Liabilities: 2021 2020 Tax liabilities and other $ 3,143 $ 3,159 Guarantee to Deerfield 774 1,053 Total $ 3,917 $ 4,212 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table sets forth activities for the Company’s cost reduction plan obligations for the years ended December 31, 2021 and 2020: 2019 French Restructuring Obligation: 2021 2020 Balance of restructuring accrual at January 1, $ 248 $ 1,922 (Benefit) charges for employee severance, benefits and other costs (122) 172 Payments (77) (1,813) Foreign currency impact (8) (33) Balance of restructuring accrual at December 31, $ 41 $ 248 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Compensation expense included in the Company’s consolidated statements of (loss) income for all share-based compensation arrangements was as follows for the periods ended December 31, 2021, 2020 and 2019, respectively: Share-based Compensation Expense: 2021 2020 2019 Research and development $ 758 $ 139 $ 429 Selling, general and administrative 8,114 3,281 2,154 Restructuring costs — (421) (2,064) Total share-based compensation expense $ 8,872 $ 2,999 $ 519 |
Schedule of Share Based Payment Award Stock Options and Warrant Grants Valuation Assumptions | The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2021, 2020 and 2019, are as follows: Stock Option Assumptions: 2021 2020 2019 Stock option grants: Expected term (years) 6.20 6.08 6.25 Expected volatility 73.91 % 75.76 % 56.48 % Risk-free interest rate 1.10 % 0.72 % 2.52 % Expected dividend yield — — — |
Schedule of Share-based Compensation, Stock Options, 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, 2021 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2021 5,898 $ 7.02 Granted 2,857 8.20 Exercised (48) 3.54 Forfeited (234) 7.13 Expired (70) 12.62 Stock options outstanding, December 31, 2021 8,403 $ 7.39 7.83 years $ 12,204 Stock options exercisable, December 31, 2021 3,256 $ 7.88 5.88 years $ 6,291 |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | A summary of the Company’s restricted share awards as of December 31, 2021, 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, 2021 347 $ 5.87 Granted 99 8.22 Vested (160) 5.05 Forfeited (12) 7.08 Non-vested restricted share awards outstanding, December 31, 2021 274 $ 7.14 A summary of the Company’s performance share units awards as of December 31, 2021, 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, 2021 257 $ 7.09 Granted 285 8.20 Vested — — Forfeited (7) 5.36 Non-vested performance share awards outstanding, December 31, 2021 535 $ 7.71 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share Reconciliation | A reconciliation of basic and diluted net (loss) income per share, together with the related shares outstanding in thousands for the years ended December 31, 2021, 2020 and 2019, is as follows: Net (Loss) Income Per Share: 2021 2020 2019 Net (loss) income $ (77,329) $ 7,028 $ (33,226) Weighted average shares: Basic shares 58,535 52,996 37,403 Effect of dilutive securities—employee and director equity awards outstanding — 1,945 — Diluted shares 58,535 54,941 37,403 Net (loss) income per share - basic $ (1.32) $ 0.13 $ (0.89) Net (loss) income per share - diluted $ (1.32) $ 0.13 $ (0.89) |
Comprehensive Loss (Tables)
Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Accumulated Other Comprehensive Income (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: 2021 2020 2019 Foreign currency translation adjustment: Beginning balance $ (22,627) $ (23,738) $ (23,621) Net other comprehensive (loss) income (1,228) 1,111 (117) Balance at December 31, $ (23,855) $ (22,627) $ (23,738) Unrealized (loss) gain on marketable securities, net Beginning balance $ 1,576 $ 932 $ 205 Net other comprehensive (loss) income, net of income tax benefit (expense) of $214, $(202), $(43), respectively (1,661) 644 727 Balance at December 31, $ (85) $ 1,576 $ 932 Accumulated other comprehensive loss at December 31, $ (23,940) $ (21,051) $ (22,806) |
Company Operations by Product_2
Company Operations by Product, Customer and Geographic Area (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Revenue from External Customers by Product and Services | The following table presents a summary of total revenues by product for the twelve months ended December 31, 2020 and 2019: Revenue by Product: 2020 2019 Bloxiverz $ 2,201 $ 7,479 Vazculep 10,429 33,152 Akovaz 9,545 18,642 Other 159 (58) Product sales $ 22,334 $ 59,215 |
Schedule of Revenue by Major Customers by Reporting Segments | The following table presents a summary of total revenues by significant customer for the twelve months ended December 31, 2020 and 2019: Revenue by Significant Customer: 2020 2019 McKesson Corporation $ 5,758 $ 14,900 Cardinal Health 5,155 15,088 AmerisourceBergen 3,155 12,059 QuVa Pharma 3,117 3,252 Others 5,149 13,916 Product sales $ 22,334 $ 59,215 |
Revenue from External Customers by Geographic Areas | All revenue earned during the years ended December 31, 2020 and 2019 was generated in the U.S.Concentration of credit risk with respect to accounts receivable was limited due to the high credit quality comprising a significant portion of the Company’s customers. Management periodically monitors the creditworthiness of the Company’s customers and believes that it has adequately provided for any exposure to potential credit loss. |
Long-lived Assets by Geographic Areas | The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2021, 2020, and 2019: Long-lived Assets by Geographic Region: 2021 2020 2019 U.S. $ 19,605 $ 20,424 $ 22,254 France — 11 196 Ireland 9,817 6,047 7,244 Total $ 29,422 $ 26,482 $ 29,694 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Stock [Line Items] | |||
Interest expense, debt | $ 9,942,000 | $ 12,994,000 | $ 12,464,000 |
Operating expenses | 85,546,000 | 16,519,000 | 83,327,000 |
Goodwill impairment loss | 0 | 0 | |
Advertising | |||
Class of Stock [Line Items] | |||
Operating expenses | $ 0 | 312,000 | 372,000 |
4.50% Exchangeable Senior Notes Due 2023 | |||
Class of Stock [Line Items] | |||
Debt instrument, additional interest expense, percentage | 0.50% | ||
Interest rate | 4.50% | ||
Additional interest expense | $ 817,000 | $ 773,000 | $ 635,000 |
4.50% Exchangeable Senior Notes Due 2023 | Pro Forma Adjustments | |||
Class of Stock [Line Items] | |||
Interest expense, debt | $ 1,408,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 12 Months Ended |
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) | 5 years |
Leasehold improvements, furniture, fixtures and fittings | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, useful life (in years) | 10 years |
Newly Issued Accounting Stand_2
Newly Issued Accounting Standards (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | $ 78,244 | $ 162,266 | $ (29,199) | $ 2,780 |
Additional paid-in capital | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | 549,349 | 566,916 | 434,391 | 433,756 |
Accumulated deficit | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | (447,756) | (384,187) | $ (391,215) | $ (357,989) |
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 | $ 142,397 | $ 128,210 | ||
4.50 Percent Exchangeable Senior Notes Due 2023 | Senior Notes | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Interest rate | 4.50% |
Subsidiary Bankruptcy and Dec_2
Subsidiary Bankruptcy and Deconsolidation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Business Acquisition, Contingent Consideration [Line Items] | |||
Charge for deconsolidation of subsidiary | $ 0 | $ 0 | $ 2,678 |
Gain from release of certain liabilities | $ 217 | $ 3,364 | 0 |
Specialty Pharma | |||
Business Acquisition, Contingent Consideration [Line Items] | |||
Charge for deconsolidation of subsidiary | $ 2,678 |
Disposition of the Hospital B_2
Disposition of the Hospital Business Narrative (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Proceeds from the disposition of the Hospital Products | $ 16,500 | $ 25,500 | $ 0 | |
Selling, general and administrative | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Gain (loss) on disposition of assets | 518 | |||
The Business | Disposal Group, Disposed of by Sale, Not Discontinued Operations | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Aggregate consideration | $ 42,000 | 42,000 | ||
Initial cash consideration | 14,500 | |||
Additional consideration paid in monthly installments | $ 27,500 | |||
Payment installment term (in months) | 10 months | |||
Proceeds from the disposition of the Hospital Products | $ 16,500 | 11,000 | ||
Net gain on the sale of the Hospital Products | $ 45,760 | 45,760 | ||
Transaction fees | $ 2,928 | $ 2,928 |
Disposition of the Hospital B_3
Disposition of the Hospital Business Components of Consideration and Assets and Liabilities Either Transferred or Eliminated (Details) - The Business - Disposal Group, Disposed of by Sale, Not Discontinued Operations - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2020 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Prepaid expenses and other current assets | $ (134) | |
Inventories | (4,922) | |
Goodwill | (1,654) | |
Intangible assets, net | (407) | |
Other non-current assets | (1,095) | |
Total long-term contingent consideration payable | 14,900 | |
Net liabilities disposed of | 6,688 | |
Aggregate consideration | 42,000 | $ 42,000 |
Less transaction fees | (2,928) | (2,928) |
Net gain on the sale of the Hospital Products | $ 45,760 | $ 45,760 |
Disposition of the Hospital B_4
Disposition of the Hospital Business - Unaudited Pro Forma Condensed Combined Statement of Income (Loss) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Product sales | $ 0 | $ 22,334,000 | $ 59,215,000 |
Total operating expense | 85,546,000 | 16,519,000 | 83,327,000 |
Operating income (loss) | (85,546,000) | 5,815,000 | (24,112,000) |
Cost of products | 0 | 5,742,000 | 12,125,000 |
Research and development expenses | 17,104,000 | 20,442,000 | 32,917,000 |
Selling, general and administrative expenses | 68,495,000 | 32,405,000 | 30,183,000 |
Intangible asset amortization | 0 | 406,000 | 816,000 |
Changes in fair value of contingent consideration | 0 | 3,327,000 | 845,000 |
Other expense - changes in fair value of contingent consideration payable | $ 0 | 435,000 | 378,000 |
Pro Forma | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Product sales | 159,000 | (58,000) | |
Total operating expense | 8,127,000 | 67,235,000 | |
Operating income (loss) | (7,968,000) | (67,293,000) | |
Loss before income taxes | (18,430,000) | (81,385,000) | |
As Reported | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Product sales | 22,334,000 | 59,215,000 | |
Total operating expense | 16,519,000 | 83,327,000 | |
Operating income (loss) | 5,815,000 | (24,112,000) | |
Loss before income taxes | (5,082,000) | (38,582,000) | |
Pro Forma Adjustments | Pro Forma | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Product sales | (22,175,000) | (59,273,000) | |
Total operating expense | (8,392,000) | (16,092,000) | |
Operating income (loss) | (13,783,000) | (43,181,000) | |
Loss before income taxes | (13,348,000) | (42,803,000) | |
Pro Forma Adjustments | Pro Forma | Disposal Group, Disposed of by Sale, Not Discontinued Operations | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Cost of products | 3,540,000 | 11,368,000 | |
Research and development expenses | 322,000 | 1,960,000 | |
Selling, general and administrative expenses | 797,000 | 1,102,000 | |
Intangible asset amortization | 406,000 | 816,000 | |
Changes in fair value of contingent consideration | 3,327,000 | 845,000 | |
Other expense - changes in fair value of contingent consideration payable | $ 435,000 | $ 378,000 |
Fair Value Measurements - Measu
Fair Value Measurements - Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 106,513 | $ 149,680 |
Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 78,098 | 104,672 |
Corporate bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 16,479 | 22,155 |
Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 9,471 | 18,999 |
Other fixed-income securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 2,465 | 3,854 |
Fair Value Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 78,098 | 104,672 |
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 | 78,098 | 104,672 |
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 | 28,415 | 45,008 |
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 | 16,479 | 22,155 |
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 | 9,471 | 18,999 |
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 | 2,465 | 3,854 |
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, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | $ 142,397 | $ 128,210 |
Estimate of Fair Value Measurement | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt | 153,273 | |
4.50% Exchangeable Senior Notes Due 2023 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Long-term debt, gross | $ 143,750 | $ 143,750 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Investments, Debt and Equity Securities [Abstract] | |||
Marketable securities, realized gains | $ 174 | $ 474 | $ 483 |
Marketable securities, realized loss | $ 275 | $ 912 | $ 151 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | $ 106,812 | $ 147,903 |
Unrealized Gains | 948 | 1,815 |
Unrealized Losses | (1,247) | (38) |
Fair Value | 106,513 | 149,680 |
Mutual and money market funds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 78,331 | 103,404 |
Unrealized Gains | 813 | 1,288 |
Unrealized Losses | (1,046) | (20) |
Fair Value | 78,098 | 104,672 |
Corporate bonds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 16,478 | 21,811 |
Unrealized Gains | 94 | 350 |
Unrealized Losses | (93) | (6) |
Fair Value | 16,479 | 22,155 |
Government securities - U.S. | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 9,530 | 18,849 |
Unrealized Gains | 39 | 155 |
Unrealized Losses | (98) | (5) |
Fair Value | 9,471 | 18,999 |
Other fixed-income securities | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 2,473 | 3,839 |
Unrealized Gains | 2 | 22 |
Unrealized Losses | (10) | (7) |
Fair Value | $ 2,465 | $ 3,854 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Maturities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Securities, Available-for-sale [Line Items] | ||
Fair Value | $ 106,513 | $ 149,680 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 5,288 | |
1-5 Years | 10,873 | |
5-10 Years | 318 | |
Greater than 10 Years | 0 | |
Fair Value | 16,479 | 22,155 |
Government securities - U.S. | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 1,531 | |
1-5 Years | 5,938 | |
5-10 Years | 807 | |
Greater than 10 Years | 1,195 | |
Fair Value | 9,471 | 18,999 |
Other fixed-income securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 0 | |
1-5 Years | 1,860 | |
5-10 Years | 605 | |
Greater than 10 Years | 0 | |
Fair Value | 2,465 | $ 3,854 |
Debt Securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 6,819 | |
1-5 Years | 18,671 | |
5-10 Years | 1,730 | |
Greater than 10 Years | 1,195 | |
Fair Value | $ 28,415 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Less - accumulated depreciation | $ (465) | $ (1,384) | |
Property and equipment, net | 285 | 359 | |
Depreciation | 97 | 287 | $ 459 |
Software, office and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 448 | 1,443 | |
Furniture, fixtures and fittings | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 302 | $ 300 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Goodwill | $ 16,836,000 | $ 16,836,000 | |
Intangible asset amortization | 0 | 406,000 | $ 816,000 |
Impairment loss related to goodwill or intangible assets | $ 0 | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease, payments | $ 578 | $ 769 |
Operating lease, weighted average remaining lease term (in years) | 2 years 10 months 24 days | |
Operating lease, weighted average discount rate, percent | 4.90% | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 2 years | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 4 years |
Leases - Components of lease co
Leases - Components of lease costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease costs | $ 821 | $ 1,133 | $ 1,515 |
Sublease income | (110) | (336) | (276) |
Total lease cost | $ 711 | $ 797 | $ 1,239 |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 974 |
2023 | 1,013 |
2024 | 614 |
2025 | 206 |
2026 | 0 |
Thereafter | 0 |
Total lease payments | 2,807 |
Less: interest | 200 |
Present value of lease liabilities | $ 2,607 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Less: current maturities | $ 0 | $ 0 |
Long-term debt | $ 142,397 | 128,210 |
4.50% Exchangeable Senior Notes Due 2023 | ||
Debt Instrument [Line Items] | ||
Interest rate | 4.50% | |
Senior Notes | ||
Debt Instrument [Line Items] | ||
Less: unamortized debt discount and issuance costs, net | $ (1,353) | (15,540) |
Total | 142,397 | 128,210 |
Equity component of exchangeable notes, net of issuance costs | 0 | (26,699) |
Senior Notes | 4.50% Exchangeable Senior Notes Due 2023 | ||
Debt Instrument [Line Items] | ||
Principal amount of 4.50% exchangeable senior notes due 2023 | $ 143,750 | $ 143,750 |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) $ / shares in Units, $ in Thousands | Feb. 16, 2018USD ($)day$ / sharesRate | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Interest expense, debt | $ 9,942 | $ 12,994 | $ 12,464 | ||
Coupon interest expense | 6,469 | 6,469 | 6,469 | ||
Amortization of debt discount and debt issuance costs | 1,248 | 6,524 | 5,995 | ||
Total shareholders’ (deficit) equity | 78,244 | 162,266 | (29,199) | $ 2,780 | |
ADSs, conversion ratio | Rate | 9269.56% | ||||
Additional paid-in capital | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Total shareholders’ (deficit) equity | 549,349 | 566,916 | 434,391 | $ 433,756 | |
Cumulative Effect, Period of Adoption, Adjustment | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Long-term debt | 12,939 | ||||
Total shareholders’ (deficit) equity | (12,939) | ||||
Cumulative Effect, Period of Adoption, Adjustment | Additional paid-in capital | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Total shareholders’ (deficit) equity | (26,699) | ||||
Senior Notes | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Amortization of debt discount and debt issuance costs | 1,248 | 6,525 | 5,995 | ||
Long-term debt | 142,397 | 128,210 | |||
4.50% Exchangeable Senior Notes Due 2023 | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Additional interest expense | $ 817 | $ 773 | $ 635 | ||
Interest rate | 4.50% | ||||
4.50% Exchangeable Senior Notes Due 2023 | Convertible Debt | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Debt instrument, face amount | $ 125,000 | ||||
Interest rate | 4.50% | ||||
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 | 20.00% | ||||
ADS purchased, price per share (in dollars per share) | $ / shares | $ 8.99 | ||||
4.50% Exchangeable Senior Notes Due 2023 | Convertible Debt | Debt Instrument, Redemption, 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 | 98.00% | ||||
4.50% Exchangeable Senior Notes Due 2023 | Convertible Debt | Debt Instrument, Redemption, 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 2023 | Convertible Debt | Debt Instrument, Redemption, 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 | 130.00% | ||||
4.50% Exchangeable Senior Notes Due 2023 | Senior Notes | |||||
Schedule of Capitalization, Long-term Debt [Line Items] | |||||
Additional interest expense | $ 2,225 |
Contingent Consideration Paya_3
Contingent Consideration Payable - Narrative (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Contingent consideration payable | $ 0 | $ 0 |
Contingent Consideration Paya_4
Contingent Consideration Payable - Payable Balance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Business Combination, Changes in Related Party Payable [Roll Forward] | ||
Related party payable, beginning balance | $ 17,327 | $ 28,840 |
Payments of related party payable | (6,189) | (12,736) |
Fair value adjustments | 3,762 | 1,223 |
Disposition of the Hospital Products | (14,900) | |
Related party payable, ending balance | $ 0 | $ 17,327 |
Income Taxes - Income (Loss) Be
Income Taxes - Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes [Line Items] | |||
Total loss before income taxes | $ (93,145) | $ (5,082) | $ (38,582) |
Ireland | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | (36,631) | (27,205) | (50,134) |
U.S. | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | (56,687) | 22,335 | 10,401 |
France | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | $ 173 | $ (212) | $ 1,151 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
U.S. - Federal | $ 0 | $ (12,810) | $ 0 |
U.S. - State | 60 | 20 | 97 |
Total current | 60 | (12,790) | 97 |
Deferred: | |||
Ireland | 0 | 0 | (1,256) |
U.S. - Federal | (15,876) | 680 | (4,093) |
U.S. - State | 0 | 0 | (104) |
Total deferred | (15,876) | 680 | (5,453) |
Income tax benefit | $ (15,816) | $ (12,110) | $ (5,356) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Income tax benefit - at statutory tax rate | $ (11,642) | $ (636) | $ (4,823) |
Differences in international tax rates | (8,950) | 1,755 | (1,218) |
Nondeductible changes in fair value of contingent consideration | 0 | 988 | 121 |
Intercompany asset transfer | 0 | 0 | (8,190) |
Change in valuation allowances | 4,296 | 4,231 | 7,379 |
Nondeductible share-based compensation | 645 | 1,060 | 1,039 |
Hospital Products sale | 0 | (9,328) | 0 |
Unrealized tax benefits | 239 | (274) | (261) |
State and local taxes (net of federal) | 60 | 20 | (7) |
Change in U.S. tax law | 0 | (9,124) | 0 |
Nondeductible interest expense | 2,173 | 1,728 | 982 |
Orphan drug and R&D tax credit | (1,524) | (2,793) | 0 |
Other | (1,113) | 263 | (378) |
Income tax benefit | $ (15,816) | $ (12,110) | $ (5,356) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 02, 2019 | Jul. 02, 2019 | |
Income Taxes [Line Items] | |||||
Increase (decrease) in income tax benefit | $ 3,706 | $ 6,754 | |||
Amortization | 3,429 | 3,701 | |||
Deferred income tax expense (benefit) | (15,876) | 680 | $ (5,453) | ||
Unrecognized tax benefits | 2,483 | 2,483 | 3,806 | ||
Income tax penalties and interest expense | 239 | 203 | $ 555 | ||
Income tax penalties and interest accrued | 1,777 | 1,475 | |||
Unremitted earnings | 3,916 | ||||
Deferred tax assets, tax credit carryforwards, research | 3,668 | 6,771 | |||
CARES Act, change in tax rate, deferred tax liability, income tax benefit | 9,124 | ||||
CARES Act, cash tax refunds | 3,351 | ||||
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 | 124,720 | ||||
Operating loss carryforwards, valuation allowance (decrease) | 4,045 | ||||
Gross research tax credit | 529 | 375 | |||
U.S. | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | 74,406 | ||||
France | |||||
Income Taxes [Line Items] | |||||
Gross research tax credit | 3,139 | 6,396 | |||
Internal Revenue Service (IRS) | Speciality Pharama | |||||
Income Taxes [Line Items] | |||||
Bankruptcy claims, amount of filed claims likely to be denied | $ 1,937 | $ 9,302 | $ 50,695 | ||
FSC | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | 10,365 | ||||
U.S. Holdings | |||||
Income Taxes [Line Items] | |||||
Net operating loss carryforwards | $ 64,041 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Unrecognized Tax Benefit Activity [Roll Forward] | |||
Beginning balance | $ 3,143 | $ 6,465 | $ 5,315 |
Increases for tax positions of prior years | 0 | 0 | 2,416 |
Statute of limitations expiration | 0 | 0 | (1,266) |
Settlements | 0 | (3,322) | 0 |
Ending balance | $ 3,143 | $ 3,143 | $ 6,465 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 35,990 | $ 31,302 |
Orphan drug and R&D tax credit | 4,964 | 2,793 |
Share-based compensation | 4,108 | 2,626 |
Amortization | 3,429 | 3,701 |
Other | 662 | 423 |
Gross deferred tax assets | 49,153 | 40,845 |
Deferred tax liabilities: | ||
Other | (925) | (890) |
Prepaid expenses | (75) | (75) |
Gross deferred tax liabilities | (1,000) | (965) |
Less: valuation allowances | (24,025) | (21,624) |
Net deferred tax assets | $ 24,128 | $ 18,256 |
Other Assets and Liabilities -
Other Assets and Liabilities - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Income tax receivable (see Note 13) | $ 29,097 | $ 18,615 |
Prepaid and other expenses | 3,179 | 1,018 |
Guarantee from Armistice | 279 | 318 |
Other | 271 | 798 |
Receivable from Exela (see Note 4) | 0 | 16,500 |
Short-term deposit | 0 | 1,477 |
Total | $ 32,826 | $ 38,726 |
Other Assets and Liabilities _2
Other Assets and Liabilities - Other Non-Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Deferred tax assets (see Note 13) | $ 24,128 | $ 18,256 |
Right of use assets at contract manufacturing organizations | 8,549 | 5,201 |
Guarantee from Armistice | 771 | 1,050 |
Other | 329 | 432 |
Total | $ 33,777 | $ 24,939 |
Other Assets and Liabilities _3
Other Assets and Liabilities - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Accrued compensation | $ 3,167 | $ 1,697 |
Accrued professional fees | 2,678 | 2,781 |
Accrued outsourced contract costs | 1,048 | 473 |
Customer allowances | 217 | 1,030 |
Accrued restructuring (see Note 16) | 41 | 520 |
Total | $ 7,151 | $ 6,501 |
Other Assets and Liabilities _4
Other Assets and Liabilities - Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Accrued interest | $ 4,920 | $ 2,695 |
Guarantee to Deerfield | 280 | 319 |
Other | 70 | 160 |
Due to Exela | 0 | 2,026 |
Other current liabilities | $ 5,270 | $ 5,200 |
Other Assets and Liabilities _5
Other Assets and Liabilities - Other Non-Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other Liabilities Disclosure [Abstract] | ||
Tax liabilities and other | $ 3,143 | $ 3,159 |
Guarantee to Deerfield | 774 | 1,053 |
Total | $ 3,917 | $ 4,212 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Feb. 28, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Purchase obligation | $ 5,500 | ||
Costs incurred, purchase obligation | 3,348 | ||
Contractual obligation, annual amount | 3,000 | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guarantee to Deerfield | 774 | $ 1,053 | |
Costs incurred, purchase obligation | 3,348 | ||
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 | 1,054 | ||
Discontinued Operations, Disposed of by Sale | Cerecor | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guaranty assets | $ 1,050 | ||
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 | 15.00% | ||
Royalty payable on net sales, maximum | $ 10,300 |
Restructuring Costs - Narrative
Restructuring Costs - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 | |
2019 French Restructuring Obligation | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | $ 4,855 | |||
Operating lease, impairment loss | 629 | |||
Fixed asset impairment | 887 | |||
Restructuring reserve | $ 41 | $ 248 | 1,922 | |
Payments for restructuring | 77 | 1,813 | ||
2019 French Restructuring Obligation | Accrued Liabilities | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring reserve | 41 | |||
2019 French Restructuring Obligation | Employee Severance | ||||
Restructuring Cost and Reserve [Line Items] | ||||
(Benefit) charges for employee severance, benefits and other costs | (122) | 172 | 4,339 | |
2019 French Restructuring Obligation | Retirement Indemnity Obligation | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | 0 | 1,000 | ||
2019 Corporate Restructuring Obligations | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | 1,755 | |||
Fixed asset impairment | 288 | |||
Write-off of property, plant and equipment | 125 | |||
Share-based compensation forfeitures related to the employees affected by the global reduction in workforce | 2,064 | |||
2019 Corporate Restructuring Obligations | Employee Severance | ||||
Restructuring Cost and Reserve [Line Items] | ||||
(Benefit) charges for employee severance, benefits and other costs | 3,406 | |||
Percent reduction in workforce | 50.00% | |||
Payments for restructuring | $ 272 | $ 1,014 | $ 2,326 |
Restructuring Costs - Severance
Restructuring Costs - Severance Obligation (Details) - 2019 French Restructuring Obligation - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Restructuring Reserve [Roll Forward] | |||
Beginning balance of accrued costs | $ 248 | $ 1,922 | |
Payments | (77) | (1,813) | |
Foreign currency impact | (8) | (33) | |
Ending balance of accrued costs | 41 | 248 | $ 1,922 |
Employee Severance | |||
Restructuring Reserve [Roll Forward] | |||
(Benefit) charges for employee severance, benefits and other costs | $ (122) | $ 172 | $ 4,339 |
Equity Instruments and Transa_2
Equity Instruments and Transactions (Details) - USD ($) | Apr. 28, 2020 | Feb. 21, 2020 | Aug. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
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 | $ 0.01 | ||||
Ordinary shares, shares issued (in shares) | 58,620,000 | 58,396,000 | |||||
Ordinary shares, shares outstanding (in shares) | 58,620,000 | 58,396,000 | |||||
Preferred shares, shares authorized (in shares) | 50,000,000 | 50,000,000 | |||||
Preferred shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Preferred shares, shares issued (in shares) | 488,000 | 488,000 | |||||
Preferred shares, shares outstanding (in shares) | 488,000 | 488,000 | |||||
Maximum aggregate offering price of securities under shelf registration | $ 250,000 | ||||||
Maximum aggregate offering price of ADSs under shelf registration | 50,000 | ||||||
Transaction costs | $ 428,000 | ||||||
Prepaid expenses and other current assets | $ 32,826,000 | $ 38,726,000 | |||||
February 2020 private placement | 60,570,000 | ||||||
Proceeds from the February 2020 private placement | 0 | 60,570,000 | $ 0 | ||||
Maximum threshold percentage for trigger of convertible preferred stock | 9.99% | ||||||
Retirement of treasury shares (in shares) | 5,407,000 | ||||||
Retirement of treasury shares | 0 | ||||||
Securities Purchase Agreement | |||||||
Class of Stock [Line Items] | |||||||
February 2020 private placement | $ 65,000,000 | ||||||
Proceeds from the February 2020 private placement | $ 60,570,000 | ||||||
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 | 11,630,000 | ||||||
Public offering, price per share (in dollars per share) | $ 10.75 | ||||||
Public offering, proceeds | $ 125,000,000 | ||||||
Net proceeds from public offering | $ 116,924,000 | ||||||
Additional paid-in capital | |||||||
Class of Stock [Line Items] | |||||||
Charges against additional paid-in capital | 214,000 | ||||||
Prepaid expenses and other current assets | $ 214,000 | ||||||
February 2020 private placement | 60,478,000 | ||||||
Issuance costs recorded as a reduction to additional paid-in capital | $ 4,430,000 | ||||||
Retirement of treasury shares | $ 49,944,000 | $ 49,944,000 | |||||
Treasury Shares | |||||||
Class of Stock [Line Items] | |||||||
Retirement of treasury shares (in shares) | 5,407,000 | ||||||
Retirement of treasury shares | 49,998,000 | $ 49,998,000 | |||||
Ordinary shares | |||||||
Class of Stock [Line Items] | |||||||
February 2020 private placement | $ 87,000 | ||||||
Stock issued during period, new issues (in shares) | 8,680,000 | ||||||
Retirement of treasury shares (in shares) | 5,407,000 | ||||||
Retirement of treasury shares | $ 54,000 | $ 54,000 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 8,872 | $ 2,999 | $ 519 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 758 | 139 | 429 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 8,114 | 3,281 | 2,154 |
Restructuring costs | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 0 | $ (421) | $ (2,064) |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | 48 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | Feb. 29, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Ordinary shares, nominal value (in usd or euro per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||
Unrecognized compensation expense | $ 18,429 | |||||
Weighted average period for unrecognized expense (in years) | 3 years 2 months 12 days | |||||
Aggregate intrinsic value of options exercised | $ 6,291 | $ 1,841 | $ 572 | |||
Grant date fair value of options granted (in usd per share) | $ 5.36 | $ 4.63 | $ 1.24 | |||
Stock-based compensation expense | $ 8,872 | $ 2,999 | $ 519 | |||
Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Employee share purchase plan share issuance (in shares) | 17,000 | 49,000 | 54,000 | |||
Restricted Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 3 years | |||||
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 | |||||
Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares authorized (in shares) | 1,336,000 | |||||
Vesting period (in years) | 4 years | |||||
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) | 3 years | |||||
Expiration period (in years) | 10 years | |||||
Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 285,000 | |||||
Weighted average grant fair value of free share awards | $ 8.20 | $ 7.09 | $ 0 | |||
Vesting percentage | 100.00% | |||||
Stock-based compensation expense | $ 1,786 | |||||
Performance Shares | Share-based Payment Arrangement, Employee | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 17,000 | 49,000 | ||||
2017 Avadel Employee Share Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Ordinary shares, nominal value (in usd or euro per share) | $ 0.01 | |||||
Shares available for issuance under ESPP | 1,000,000 | |||||
Purchase price of common stock, percentage | 85.00% | |||||
Inducement Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of shares reserved and available for issuance (in shares) | 1,500,000 | |||||
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 | 67.00% | |||||
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 | 33.00% | |||||
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 | 25.00% | |||||
1/3 vesting at third anniversary of grant date | Restricted Share Awards, Grants Beginning In 2018 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 33.00% | |||||
Vest One Year Following Achievement Of Milestones | Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 1 year | |||||
Vesting percentage | 50.00% | |||||
Vest Upon The Achievement Of Certain Regulatory Milestones | Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50.00% | |||||
Vest Upon Achievement Of Certain Corporate Objectives | Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50.00% | |||||
Stock-based compensation expense | $ 3,509 | |||||
Vest One Year Following Achievement Of Certain Corporate Objectives | Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 1 year | |||||
Vesting percentage | 50.00% | |||||
Vest Upon Achievement Of Certain Corporate Objectives Being Met And Exceeded | Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 150.00% |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 3 years 2 months 12 days | ||
Stock Option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 2 months 12 days | 6 years 29 days | 6 years 3 months |
Expected volatility | 73.91% | 75.76% | 56.48% |
Risk-free interest rate | 1.10% | 0.72% | 2.52% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Stock Options, Outstanding [Roll Forward] | |
Stock options outstanding, beginning balance (in shares) | shares | 5,898 |
Granted (in shares) | shares | 2,857 |
Exercised (in shares) | shares | (48) |
Forfeited (in shares) | shares | (234) |
Expired (in shares) | shares | (70) |
Stock options outstanding, ending balance (in shares) | shares | 8,403 |
Stock options exercisable (in shares) | shares | 3,256 |
Stock Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Stock options outstanding, beginning balance (in usd per share) | $ / shares | $ 7.02 |
Granted (in usd per share) | $ / shares | 8.20 |
Exercised (in usd per share) | $ / shares | 3.54 |
Forfeited (in usd per share) | $ / shares | 7.13 |
Expired (in usd per share) | $ / shares | 12.62 |
Stock options outstanding, ending balance (in usd per share) | $ / shares | 7.39 |
Stock options exercisable (in usd per share) | $ / shares | $ 7.88 |
Stock options outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 9 months 29 days |
Stock options exercisable, Weighted Average Remaining Contractual Life (in years) | 5 years 10 months 17 days |
Stock options outstanding, Aggregate Intrinsic Value | $ | $ 12,204 |
Stock options exercisable, Aggregate Intrinsic Value | $ | $ 6,291 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Stock and Performance Unit Share Activity (Details) - $ / shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Free Share Award | |||
Free Share Activity and Other Data, Nonvested [Roll Forward] | |||
Outstanding, beginning balance (in shares) | 347 | ||
Granted (in shares) | 99 | ||
Vested (in shares) | (160) | ||
Forfeited (in shares) | (12) | ||
Outstanding, ending balance (in shares) | 274 | 347 | |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | |||
Nonvested free share award, beginning balance (in usd per share) | $ 5.87 | ||
Granted (in usd per share) | 8.22 | $ 7.69 | $ 2.47 |
Vested (in usd per share) | 5.05 | ||
Forfeited (in usd per share) | 7.08 | ||
Nonvested free share award, ending balance (in usd per share) | $ 7.14 | $ 5.87 | |
Performance Shares | |||
Free Share Activity and Other Data, Nonvested [Roll Forward] | |||
Outstanding, beginning balance (in shares) | 257 | ||
Granted (in shares) | 285 | ||
Vested (in shares) | 0 | ||
Forfeited (in shares) | (7) | ||
Outstanding, ending balance (in shares) | 535 | 257 | |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | |||
Nonvested free share award, beginning balance (in usd per share) | $ 7.09 | ||
Granted (in usd per share) | 8.20 | $ 7.09 | $ 0 |
Vested (in usd per share) | 0 | ||
Forfeited (in usd per share) | 5.36 | ||
Nonvested free share award, ending balance (in usd per share) | $ 7.71 | $ 7.09 |
Net (Loss) Income Per Share - R
Net (Loss) Income Per Share - Reconciliation of basic and diluted EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||
Net (loss) income | $ (77,329) | $ 7,028 | $ (33,226) |
Weighted Average Number of Shares Outstanding, Diluted [Abstract] | |||
Basic shares (in shares) | 58,535 | 52,996 | 37,403 |
Effect of dilutive securities—employee and director equity awards outstanding (in shares) | 0 | 1,945 | 0 |
Diluted shares (in shares) | 58,535 | 54,941 | 37,403 |
Net income (loss) per share - basic (in usd per share) | $ (1.32) | $ 0.13 | $ (0.89) |
Net income (loss) per share - diluted (in usd per share) | $ (1.32) | $ 0.13 | $ (0.89) |
Net (Loss) Income Per Share - N
Net (Loss) Income Per Share - Narrative (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||
Antidilutive securities excluded from computation of earnings per share | 15,327 | 14,915 | 16,740 |
Comprehensive Loss (Details)
Comprehensive Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | $ 162,266 | $ (29,199) | $ 2,780 |
Net other comprehensive (loss) income | (80,218) | 8,783 | (32,616) |
Ending balance | 78,244 | 162,266 | (29,199) |
Unrealized gain (loss) on marketable securities, tax | 214 | (202) | (43) |
Foreign currency translation adjustment | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | (22,627) | (23,738) | (23,621) |
Net other comprehensive (loss) income | (1,228) | 1,111 | (117) |
Ending balance | (23,855) | (22,627) | (23,738) |
Unrealized gain (loss) on marketable securities, net | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | 1,576 | 932 | 205 |
Net other comprehensive (loss) income | (1,661) | 644 | 727 |
Ending balance | (85) | 1,576 | 932 |
Accumulated other comprehensive loss | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | (21,051) | (22,806) | (23,416) |
Ending balance | $ (23,940) | $ (21,051) | $ (22,806) |
Company Operations by Product_3
Company Operations by Product, Customer and Geographic Area - Revenue by Product (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Segment Reporting [Abstract] | |||
Number of reportable segments | segment | 1 | ||
Number of operating segments | segment | 1 | ||
Product sales | $ 0 | $ 22,334,000 | $ 59,215,000 |
Segment Reporting Information [Line Items] | |||
Product sales | $ 0 | 22,334,000 | 59,215,000 |
Bloxiverz | |||
Segment Reporting [Abstract] | |||
Product sales | 2,201,000 | 7,479,000 | |
Segment Reporting Information [Line Items] | |||
Product sales | 2,201,000 | 7,479,000 | |
Vazculep | |||
Segment Reporting [Abstract] | |||
Product sales | 10,429,000 | 33,152,000 | |
Segment Reporting Information [Line Items] | |||
Product sales | 10,429,000 | 33,152,000 | |
Akovaz | |||
Segment Reporting [Abstract] | |||
Product sales | 9,545,000 | 18,642,000 | |
Segment Reporting Information [Line Items] | |||
Product sales | 9,545,000 | 18,642,000 | |
Other | |||
Segment Reporting [Abstract] | |||
Product sales | 159,000 | (58,000) | |
Segment Reporting Information [Line Items] | |||
Product sales | $ 159,000 | $ (58,000) |
Company Operations by Product_4
Company Operations by Product, Customer and Geographic Area - Revenue by Significant Customer (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Segment Reporting Information [Line Items] | |||
Product sales | $ 0 | $ 22,334,000 | $ 59,215,000 |
McKesson Corporation | |||
Segment Reporting Information [Line Items] | |||
Product sales | 5,758,000 | 14,900,000 | |
Cardinal Health | |||
Segment Reporting Information [Line Items] | |||
Product sales | 5,155,000 | 15,088,000 | |
AmerisourceBergen | |||
Segment Reporting Information [Line Items] | |||
Product sales | 3,155,000 | 12,059,000 | |
QuVa Pharma | |||
Segment Reporting Information [Line Items] | |||
Product sales | 3,117,000 | 3,252,000 | |
Others | |||
Segment Reporting Information [Line Items] | |||
Product sales | $ 5,149,000 | $ 13,916,000 |
Company Operations by Product_5
Company Operations by Product, Customer and Geographic Area - Data by Geographic Region (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Long-lived Assets by Geographic Region: | |||
Long-lived assets | $ 29,422 | $ 26,482 | $ 29,694 |
U.S. | |||
Long-lived Assets by Geographic Region: | |||
Long-lived assets | 19,605 | 20,424 | 22,254 |
France | |||
Long-lived Assets by Geographic Region: | |||
Long-lived assets | 0 | 11 | 196 |
Ireland | |||
Long-lived Assets by Geographic Region: | |||
Long-lived assets | $ 9,817 | $ 6,047 | $ 7,244 |
Subsequent Events (Details)
Subsequent Events (Details) - Convertible Debt - USD ($) $ in Thousands | Mar. 16, 2022 | Feb. 16, 2018 |
4.50% Exchangeable Senior Notes Due 2023 | ||
Subsequent Event [Line Items] | ||
Debt instrument, face amount | $ 125,000 | |
Subsequent event | 4.50% Exchangeable Senior Notes Due October 2, 2023 | ||
Subsequent Event [Line Items] | ||
Debt instrument, face amount | $ 117,375 | |
Subsequent event | 4.50% Exchangeable Senior Notes Due 2023 | ||
Subsequent Event [Line Items] | ||
Debt instrument, face amount | $ 26,375 |