Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 26, 2024 | Jun. 30, 2023 | |
Entity Information [Line Items] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-37977 | ||
Entity Registrant Name | AVADEL PHARMACEUTICALS PLC | ||
Entity Incorporation, State or Country Code | L2 | ||
Entity Tax Identification Number | 98-1341933 | ||
Entity Address, Address Line One | 10 Earlsfort Terrace | ||
Entity Address, City or Town | Dublin 2 | ||
Entity Address, Country | IE | ||
Entity Address, Postal Zip Code | D02 T380 | ||
Country Region | 353 | ||
City Area Code | 1 | ||
Local Phone Number | 901-5201 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Document Financial Statement Error Correction | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 1,459,121,731 | ||
Entity Common Stock, Shares Outstanding | 90,576,998 | ||
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, 2023, 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 | 2023 | ||
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 $0.01 per share** | ||
Trading Symbol | AVDL | ||
Security Exchange Name | NASDAQ |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Name | Deloitte and Touche LLP |
Auditor Location | St. Louis, Missouri |
Auditor Firm ID | 34 |
Consolidated Statements of Loss
Consolidated Statements of Loss - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | |||
Net product revenue | $ 27,963,000 | $ 0 | $ 0 |
Cost of products sold | 846,000 | 0 | 0 |
Gross profit | 27,117,000 | 0 | 0 |
Operating expenses: | |||
Research and development expenses | 13,261,000 | 20,700,000 | 17,104,000 |
Selling, general and administrative expenses | 151,705,000 | 74,516,000 | 68,495,000 |
Restructuring expense (income) | 0 | 3,345,000 | (53,000) |
Total operating expenses | 164,966,000 | 98,561,000 | 85,546,000 |
Operating loss | (137,849,000) | (98,561,000) | (85,546,000) |
Investment and other income (expense), net | 87,000 | (536,000) | 2,343,000 |
Interest expense | (9,886,000) | (12,342,000) | (9,942,000) |
Loss on extinguishment of debt | (13,129,000) | 0 | 0 |
Loss before income taxes | (160,777,000) | (111,439,000) | (93,145,000) |
Income tax (benefit) provision | (501,000) | 26,025,000 | (15,816,000) |
Net loss | $ (160,276,000) | $ (137,464,000) | $ (77,329,000) |
Net loss per share - basic (in usd per share) | $ (2) | $ (2.29) | $ (1.32) |
Net loss per share - diluted (in usd per share) | $ (2) | $ (2.29) | $ (1.32) |
Weighted average number of shares outstanding - basic (in shares) | 80,174 | 60,094 | 58,535 |
Weighted average number of shares outstanding - diluted (in shares) | 80,174 | 60,094 | 58,535 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (160,276) | $ (137,464) | $ (77,329) |
Other comprehensive income (loss), net of tax: | |||
Foreign currency translation gain (loss) | 331 | (597) | (1,228) |
Net other comprehensive income (loss), net of income tax benefit of $0, $0, and $214, respectively | 2,843 | (1,804) | (1,661) |
Total other comprehensive income (loss), net of tax | 3,174 | (2,401) | (2,889) |
Total comprehensive loss | $ (157,102) | $ (139,865) | $ (80,218) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net other comprehensive income (loss), tax benefit | $ 0 | $ 0 | $ 214 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 31,167 | $ 73,981 |
Marketable securities | 73,944 | 22,518 |
Accounts receivable, net | 12,103 | 0 |
Inventories | 10,380 | 0 |
Research and development tax credit receivable | 1,322 | 2,248 |
Prepaid expenses and other current assets | 5,286 | 2,096 |
Total current assets | 134,202 | 100,843 |
Property and equipment, net | 585 | 839 |
Operating lease right-of-use assets | 2,591 | 1,713 |
Goodwill | 16,836 | 16,836 |
Research and development tax credit receivable | 332 | 1,232 |
Other non-current assets | 10,152 | 11,322 |
Total assets | 164,698 | 132,785 |
Current liabilities: | ||
Current portion of long-term debt | 0 | 37,668 |
Current portion of operating lease liability | 934 | 960 |
Accounts payable | 11,433 | 7,890 |
Accrued expenses | 24,227 | 7,334 |
Other current liabilities | 261 | 1,941 |
Total current liabilities | 36,855 | 55,793 |
Long-term debt | 0 | 91,614 |
Long-term operating lease liability | 1,690 | 780 |
Royalty financing obligation | 32,760 | 0 |
Other non-current liabilities | 5,654 | 5,743 |
Total liabilities | 76,959 | 153,930 |
Shareholders’ equity (deficit): | ||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; 5,194 issued and outstanding at December 31, 2023 and 488 issued and outstanding at December 31, 2022 | 52 | 5 |
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 89,825 issued and outstanding at December 31, 2023 and 62,878 issued and outstanding at December 31, 2022 | 898 | 628 |
Additional paid-in capital | 855,452 | 589,783 |
Accumulated deficit | (745,496) | (585,220) |
Accumulated other comprehensive loss | (23,167) | (26,341) |
Total shareholders’ equity (deficit) | 87,739 | (21,145) |
Total liabilities and shareholders’ equity (deficit) | $ 164,698 | $ 132,785 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Jun. 26, 2023 | Apr. 03, 2023 | Dec. 31, 2022 | 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) | 5,194,000 | 488,000 | |||
Preferred shares, shares outstanding (in shares) | 5,194,000 | 488,000 | |||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 | |||
Ordinary shares, shares issued (in shares) | 89,825,000 | 62,878,000 | |||
Ordinary shares, shares outstanding (in shares) | 89,825,000 | 62,878,000 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands | Total | April 2027 Notes | October 2023 Notes | At-the-market offering program | Public offering | Cumulative Effect, Period of Adoption, Adjustment | Ordinary shares | Ordinary shares April 2027 Notes | Ordinary shares October 2023 Notes | Ordinary shares At-the-market offering program | Ordinary shares Public offering | Preferred shares | Preferred shares Public offering | Additional paid-in capital | Additional paid-in capital April 2027 Notes | Additional paid-in capital October 2023 Notes | Additional paid-in capital At-the-market offering program | Additional paid-in capital Public offering | Additional paid-in capital Cumulative Effect, Period of Adoption, Adjustment | Accumulated deficit | Accumulated deficit Cumulative Effect, Period of Adoption, Adjustment | Accumulated other comprehensive loss |
Beginning balance (in shares) at Dec. 31, 2020 | 58,396 | 488 | ||||||||||||||||||||
Beginning balance at Dec. 31, 2020 | $ 162,266 | $ (12,939) | $ 583 | $ 5 | $ 566,916 | $ (26,699) | $ (384,187) | $ 13,760 | $ (21,051) | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||
Net loss | (77,329) | (77,329) | ||||||||||||||||||||
Other comprehensive income (loss) | (2,889) | (2,889) | ||||||||||||||||||||
Exercise of stock options (in shares) | 48 | |||||||||||||||||||||
Exercise of stock options | 169 | $ 1 | 168 | |||||||||||||||||||
Vesting of restricted shares (in shares) | 159 | |||||||||||||||||||||
Vesting of restricted shares | 0 | $ 2 | (2) | |||||||||||||||||||
Employee share purchase plan share issuance (in shares) | 17 | |||||||||||||||||||||
Employee share purchase plan share issuance | 94 | 94 | ||||||||||||||||||||
Share-based compensation expense | 8,872 | 8,872 | ||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2021 | 58,620 | 488 | ||||||||||||||||||||
Ending balance at Dec. 31, 2021 | 78,244 | $ 586 | $ 5 | 549,349 | $ (26,699) | (447,756) | $ 13,760 | (23,940) | ||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||
Net loss | (137,464) | (137,464) | ||||||||||||||||||||
Other comprehensive income (loss) | (2,401) | (2,401) | ||||||||||||||||||||
Change in fair value of October 2023 Notes conversion feature | 5,508 | 5,508 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 3,588 | |||||||||||||||||||||
Issuance of common stock, net of issuance costs | $ 25,318 | $ 36 | $ 25,282 | |||||||||||||||||||
Amortization of deferred issuance costs | (45) | (45) | ||||||||||||||||||||
Exercise of stock options (in shares) | 451 | |||||||||||||||||||||
Exercise of stock options | 2,460 | $ 4 | 2,456 | |||||||||||||||||||
Vesting of restricted shares (in shares) | 144 | |||||||||||||||||||||
Vesting of restricted shares | 0 | $ 1 | (1) | |||||||||||||||||||
Employee share purchase plan share issuance (in shares) | 75 | |||||||||||||||||||||
Employee share purchase plan share issuance | 222 | $ 1 | 221 | |||||||||||||||||||
Share-based compensation expense | 7,013 | 7,013 | ||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2022 | 62,878 | 488 | ||||||||||||||||||||
Ending balance at Dec. 31, 2022 | (21,145) | $ 628 | $ 5 | 589,783 | (585,220) | (26,341) | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||||||
Net loss | (160,276) | (160,276) | ||||||||||||||||||||
Other comprehensive income (loss) | 3,174 | 3,174 | ||||||||||||||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,564 | 12,205 | 4,706 | |||||||||||||||||||
Issuance of common stock, net of issuance costs | $ 11,913 | $ 134,151 | $ 16 | $ 122 | $ 47 | $ 11,897 | $ 133,982 | |||||||||||||||
Amortization of deferred issuance costs | $ (16) | (16) | ||||||||||||||||||||
Exchange/Settlement of Notes (in shares) | 12,347 | 408 | ||||||||||||||||||||
Exchange/Settlement of Notes | $ 101,812 | $ 22 | $ 123 | $ 4 | $ 101,689 | $ 18 | ||||||||||||||||
Exercise of stock options (in shares) | 342 | 343 | ||||||||||||||||||||
Exercise of stock options | $ 2,062 | $ 4 | 2,058 | |||||||||||||||||||
Vesting of restricted shares (in shares) | 33 | |||||||||||||||||||||
Employee share purchase plan share issuance (in shares) | 47 | |||||||||||||||||||||
Employee share purchase plan share issuance | 231 | $ 1 | 230 | |||||||||||||||||||
Share-based compensation expense | 15,811 | 15,811 | ||||||||||||||||||||
Ending balance (in shares) at Dec. 31, 2023 | 89,825 | 5,194 | ||||||||||||||||||||
Ending balance at Dec. 31, 2023 | $ 87,739 | $ 898 | $ 52 | $ 855,452 | $ (745,496) | $ (23,167) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (160,276) | $ (137,464) | $ (77,329) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,766 | 1,493 | 815 |
Amortization of debt discount and debt issuance costs | 2,796 | 6,052 | 1,248 |
Changes in deferred taxes | 0 | 26,025 | (15,666) |
Share-based compensation expense | 15,811 | 7,013 | 8,872 |
Loss on extinguishment of debt | 13,129 | 0 | 0 |
Other adjustments | 1,262 | 2,042 | 1,055 |
Net changes in assets and liabilities | |||
Accounts receivable | (12,103) | 0 | 0 |
Inventories | (9,532) | 0 | 0 |
Prepaid expenses and other current assets | (3,127) | 30,815 | (439) |
Research and development tax credit receivable | 1,884 | 30 | 2,796 |
Accounts payable & other current liabilities | 1,545 | (3,108) | 4,232 |
Accrued expenses | 16,892 | 227 | 895 |
Other assets and liabilities | 1,442 | (3,429) | (3,789) |
Net cash used in operating activities | (128,511) | (70,304) | (77,310) |
Cash flows from investing activities: | |||
Purchases of property and equipment | 0 | (716) | (26) |
Proceeds from the disposition of the Hospital Products | 0 | 0 | 16,500 |
Proceeds from sales of marketable securities | 187,136 | 83,828 | 102,224 |
Purchases of marketable securities | (237,229) | (3,414) | (61,769) |
Net cash (used in) provided by investing activities | (50,093) | 79,698 | 56,929 |
Cash flows from financing activities: | |||
Payments for debt issuance costs | (4,357) | (4,804) | 0 |
Proceeds from royalty purchase agreement | 30,000 | 0 | 0 |
Proceeds from stock option exercises and employee share purchase plan | 2,293 | 2,682 | 263 |
Net cash provided by financing activities | 135,335 | 14,543 | 263 |
Effect of foreign currency exchange rate changes on cash and cash equivalents | 455 | (664) | (896) |
Net change in cash and cash equivalents | (42,814) | 23,273 | (21,014) |
Cash and cash equivalents at January 1 | 73,981 | 50,708 | 71,722 |
Cash and cash equivalents at December 31 | 31,167 | 73,981 | 50,708 |
Supplemental disclosures of cash flow information: | |||
Interest paid | 5,250 | 9,660 | 6,469 |
Income taxes (refunded) paid, net | 0 | (29,058) | 76 |
February 2023 Notes | |||
Cash flows from financing activities: | |||
Payments for Notes | (17,500) | (8,653) | 0 |
October 2023 Notes | |||
Cash flows from financing activities: | |||
Payments for Notes | (21,165) | 0 | 0 |
Public offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of shares, net of issue costs | 134,151 | 0 | 0 |
At-the-market offering program | |||
Cash flows from financing activities: | |||
Proceeds from issuance of shares, net of issue costs | $ 11,913 | $ 25,318 | $ 0 |
Consolidated Statements of Sh_2
Consolidated Statements of Shareholders' Equity (Deficit) (Parenthetical) | 12 Months Ended |
Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | |
Accounting Standards Update [Extensible Enumeration] | Accounting Standards Update 2020-06 [Member] |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a biopharmaceutical company. The Company is registered as an Irish public limited company. The Company’s headquarters are in Dublin, Ireland with operations in Dublin, Ireland and St. Louis, Missouri, United States (“U.S.”). LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy. LUMRYZ was approved by the U.S. Food and Drug Administration (“FDA”) on May 1, 2023. The FDA also granted Orphan Drug Exclusivity to LUMRYZ for a period of seven years until May 1, 2030. In June 2023, the Company commercially launched LUMRYZ in the U.S. In approving LUMRYZ, the FDA required a risk evaluation and mitigation strategy (“REMS”) for LUMRYZ to help ensure that the benefits of the drug in the treatment of cataplexy and EDS in adults with narcolepsy outweigh the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of the drug. Under this REMS, healthcare providers who prescribe the drug must be specially certified; pharmacies, that dispense the drug must be specially certified; and the drug must be dispensed only to patients who have enrolled in the LUMRYZ REMS and completed all REMS requirements including documentation of safe use conditions, among other requirements. As of the date of this Annual Report, the Company’s only commercialized product is LUMRYZ. The Company continues to evaluate opportunities to expand its product portfolio. Liquidity. The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. On March 29, 2023, the Company and Avadel CNS Pharmaceuticals, LLC, an indirect wholly-owned subsidiary of the Company (“Avadel CNS”), entered into a royalty purchase agreement (“RPA”) with RTW Investments, L.P. (“RTW”) that could provide the Company up to $75,000 of royalty financing in two tranches. The first tranche of $30,000 became available upon satisfaction of certain conditions which included the Company’s first shipment of LUMRYZ. The second tranche is available to use, at the Company’s election, if it achieves quarterly net revenue of $25,000 by the quarter ending June 30, 2024. The second tranche expires if the Company does not elect to use it by August 31, 2024. On August 1, 2023, the Company received the first tranche of $30,000. At March 31, 2023, the Company had outstanding $117,375 aggregate principal amount of its 4.50% exchangeable senior notes due October 2023 (the “October 2023 Notes”). Over the course of April 3 and April 4, 2023, Avadel Finance Cayman Limited, a Cayman Islands exempted company and an indirect wholly-owned subsidiary of the Company (the “Issuer”), completed an exchange of $96,188 of its $117,375 October 2023 Notes for $106,268 of a new series of 6.0% exchangeable notes due April 2027 (the “April 2027 Notes”). The Issuer settled, with a combination of cash and American Depositary Shares (“ADSs”), the remaining $21,187 aggregate principal amount of the October 2023 Notes in October 2023. The aggregate amount of cash and ADSs delivered to holders for the October 2023 Notes, including accrued interest was $21,641 and 408 ADSs, respectively. On April 3, 2023, the Company completed the sale of 12,205 ordinary shares, nominal value $0.01 per share (“Ordinary Shares”) in the form of ADSs and 4,706 Series B Non-Voting Convertible Preferred Shares (“Series B Preferred Shares”) in an underwritten public offering. The Company received proceeds, net of underwriter fees and issuance costs of $134,151. On May 31, 2023 and in accordance with the terms of the Indenture of the April 2027 Notes (the “Indenture”), dated as of April 3, 2023, the Issuer exercised its option to exchange (the “Mandatory Exchange”) $106,268 of aggregate principal amount of the April 2027 Notes, which represents all of the April 2027 Notes outstanding under the Indenture. The Mandatory Exchange consideration per one thousand dollars of principal April 2027 Notes exchanged consisted of 116.1846 of the Company’s ADSs, representing a corresponding number of the Company’s ordinary shares, nominal value $0.01 per share, plus accrued and unpaid interest thereon. The aggregate amount of ADSs and cash in respect of accrued and unpaid interest delivered to holders of Notes in the Mandatory Exchange was 12,347 ADSs and $1,470, respectively. The Mandatory Exchange closed on June 26, 2023. Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S., the requirements of Form 10-K and Article 10 of Regulation S-X. The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. Reclassifications Certain reclassifications are made to prior year amounts whenever necessary to conform with the current year presentation. Certain reclassifications have been made within Note 13: Other Assets and Liabilities for the year ended December 31, 2022 to condense line items of the same nature into a single line. Concentrations of Risk. A significant portion of the Company’s cash, cash equivalents and marketable securities are held at two financial institutions. Due to their size, the Company believes these financial institutions represent minimal credit risk. The Company has not experienced any losses on its cash, cash equivalents, or marketable securities. The Company is subject to credit risk from its accounts receivable related to the sale of LUMRYZ. The Company extends credit to its customers, specialty pharmacies. Customer creditworthiness is monitored, and collateral is not required. Amounts owed to the Company are presented net of an allowance that includes an 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. As of December 31, 2023, the Company did not recognize any allowances for credit losses. As of December 31, 2023, three customers accounted for 100% of gross accounts receivable, Caremark LLC (“Caremark”), which accounted for 52% of gross accounts receivable; Accredo Health Group, Inc. (“Accredo”), which accounted for 28% of gross accounts receivable; and Optum Frontier Therapies LLC (“Optum”), which accounted for 20% of gross accounts receivable. As of December 31, 2022, the Company did not have accounts receivable. The Company attempts to maintain multiple suppliers for its active pharmaceutical ingredient (“API”) and manufacturing in order to mitigate the risk of shortfall and inability to supply market demand, but is subject to risk due to a limited number of providers. The API is currently manufactured by two source contract development and manufacturing organizations (“CDMOs”) in the U.S. The drug product for commercial lots is manufactured by one source CDMO in the U.S. and one source CDMO outside of the U.S. Revenue. Revenue includes sales of LUMRYZ. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when the performance obligations to the customer have been satisfied through the transfer of control of the goods or services. To determine the appropriate revenue recognition for arrangements that the Company believes are within the scope of ASC 606, we perform 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. For contracts that are determined to be within the scope of ASC 606, 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 The Company sells LUMRYZ to specialty pharmacies and considers those specialty pharmacies to be its customers. Under ASC 606, revenue from product sales is recognized when the customer obtains control of the product, which occurs typically upon receipt by the customer. The Company’s gross product sales are subject to a variety of price adjustments to arrive at reported net product revenue. These adjustments include estimates of payment discounts, specialty pharmacy fees, patient financial assistance programs, rebates and product returns and are estimated based on contractual arrangements, historical trends, expected utilization of such products and other judgments and analysis. Reserves for Variable Consideration Revenues from product sales are recorded at the estimated net selling price, which includes reserves for estimated variable consideration to reduce gross product sales to net product revenue resulting from payment discounts, specialty pharmacy fees, patient financial assistance programs, rebates and product returns. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable if the amount is payable to the customer. The reserves are classified as a liability if the amount is payable to a party other than a customer. Where appropriate, these estimated reserves take into consideration relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, historical trends, current and expected patient demand and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates to reduce gross selling price to net selling price. The actual net selling price ultimately may differ from our estimates. Cost of Products Sold. Cost of products sold includes the cost of the API, manufacturing and distribution costs, packaging costs and freight. LUMRYZ was approved by the FDA on May 1, 2023 and the Company began shipping product to its customers in June 2023. Products sold includes inventory purchased or produced that was expensed as research and development costs prior to FDA approval. Inventories. Inventories consist of raw materials, work in process and finished products, which are stated at lower of cost or net realizable value, using the first-in, first- out method. Raw materials used in the production of pre-clinical and clinical products are expensed as research and development costs. The Company establishes reserves for inventory estimated to be obsolete, unmarketable or slow-moving on a case by case basis. The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained for a drug candidate. As such, the Company began capitalizing costs related to inventory in May 2023 upon FDA approval of LUMRYZ. Manufacturing costs associated with inventory purchased or produced prior to FDA approval were recorded as research and development expense in prior periods. Accordingly, cost of products sold in the near term will likely be lower than in later periods given the sales of pre-approval inventory will carry little to no manufacturing costs as such costs were previously expensed to research and development. 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 $6,452 for the year ended December 31, 2023. Branded advertising expenses were immaterial for the years ended December 31, 2022 and 2021, respectively. Share-based Compensation. The Company accounts for share-based compensation based on the estimated grant-date fair value. The fair value of stock options is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Scholes model, estimates are made of the underlying volatility of Avadel stock, a risk-free rate and an expected term of the option or warrant. The Company estimates the expected term using a simplified method, as the Company does not have enough historical exercise data for a majority of such options upon which to estimate an expected term. The Company recognizes compensation cost, net of an estimated forfeiture rate, using the accelerated method over the requisite service period of the award. Income Taxes. The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2023, the Company's cumulative loss position was significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets. Given the weight of objectively verifiable historical losses from operations, the Company continues to record a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company records uncertain tax positions on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits in the income tax expense line in the consolidated statements of loss. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months. Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in shareholders’ equity (deficit) , 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. Property and Equipment. Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. The Company has determined that it operates in a single segment and have a single reporting unit associated with the development and commercialization of pharmaceutical products. The Company tests goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. The Company determined that no impairment of goodwill existed at December 31, 2023 and 2022. Long-Lived Assets. Long-lived assets include fixed assets and right of use assets at contract manufacturing organizations. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market-based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. Certain long-lived assets are amortized using the straight-line method over a five year useful life. Total amortization expense of long-lived assets for the year ended December 31, 2023, 2022 and 2021 was $588, $391 and $0, respectively. Lease Obligations. The Company determines if a contract is a lease at the inception of the arrangement. Right-of-use assets and operating lease liabilities are recognized at commencement date based on the present value of remaining lease payments over the lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. Short term leases with an initial term of 12 months or less are not recorded on the balance sheet and the associated lease payments are recognized in the consolidated statements of loss on a straight-line basis over the lease term. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. The Company’s lease agreements may contain variable costs such as common area maintenance, insurance, real estate taxes or other costs. Variable lease costs are expensed as incurred on the consolidated statements of loss. Use of Estimates. |
Newly Issued Accounting Standar
Newly Issued Accounting Standards | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Changes and Error Corrections [Abstract] | |
Newly Issued Accounting Standards | Newly Issued Accounting Standards Previously Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. The FASB’s amendments primarily impacted ASC 740, Income Taxes , and may impact both interim and annual reporting periods. ASU 2019-12 was effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years and early adoption was 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 reduced 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 required 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 i nstrument may be settled in cash or shares. This ASU was effective for fiscal years beginning January 1, 2022 and interim periods therein. Early adoption was permitted, but no earlier than fiscal years beginning after December 15, 2020. The amendments may be adopted through either a modified retrospective method, or a fully retrospective method. The Company elected to early adopt ASU 2020-06 as of January 1, 2021 using a modified retrospective method. The Company’s 4.50% exchangeable senior notes due 2023 were a convertible instrument with a cash-conversion feature that was accounted for within the scope of Subtopic 470-20. The Company calculated the cumulative-effect adjustment as of January 1, 2021 by comparing (i) the historical amortization schedule for the 2023 Notes through December 31, 2020 and (ii) an updated amortization schedule wherein the conversion feature within the 2023 Notes would not be separated as an equity component and subsequently recognized as non-cash interest expense under ASC 835-30. The adoption resulted in a $26,699 decrease in additional paid-in capital, a $12,939 increase in long-term debt, and a $13,760 increase to the opening balance of retained earnings. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures. The ASU is effective for annual periods beginning |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company’s source of net product revenue during the year ended December 31, 2023 consists solely of sales of LUMRYZ in the U.S. For the year ended December 31, 2023, three customers accounted for 100% of sales. The following table presents a summary of the percentage of total gross sales to customers : Twelve Months Ended December 31, Sales by Customer: 2023 Accredo 41 % Caremark 39 % Optum 20 % |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 As of December 31, 2022 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 5) Mutual and money market funds $ — $ — $ — $ 22,518 $ — $ — Government securities - U.S. 73,944 — — — — — Total assets $ 73,944 $ — $ — $ 22,518 $ — $ — 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 twelve months ended December 31, 2023, there were no transfers in and out of Level 1, 2, or 3. During the twelve months ended December 31, 2023, 2022, and 2021, the Company did not recognize any allowances for credit losses. Some of the Company’s financial instruments, such as cash and cash equivalents, accounts receivable and accounts payable, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature. Royalty Financing Obligation As of December 31, 2023, the carrying value of the royalty financing obligation under the RPA approximated its fair value and was measured using the estimates of forecasted net product revenue based on current contractual and statutory requirements, specific known market events and trends, industry data, historical trends, current and expected patient demand and forecasted customer buying and payment patterns (Level 3 inputs). See Note 11: Royalty Financing Obligation for additional information regarding the Company’s royalty financing obligation. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2023 | |
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 (deficit), net of income tax effects. As of December 31, 2023, 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, 2023 and 2022, respectively: 2023 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Government securities - U.S. $ 72,990 $ 954 $ — $ 73,944 Total $ 72,990 $ 954 $ — $ 73,944 2022 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 24,407 $ — $ (1,889) $ 22,518 Total $ 24,407 $ — $ (1,889) $ 22,518 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 (expense), net in the accompanying consolidated statements of loss. The Company recognized gross realized gains of $988, $584 and $174 for the twelve months ended December 31, 2023, 2022 and 2021, respectively. These realized gains were offset by realized losses of $2,791, $2,338 and $275 for the twelve-months ended December 31, 2023, 2022 and 2021, respectively. The following table summarizes the estimated fair value of the Company’s investments in marketable debt securities, accounted for as available-for-sale debt securities and classified by the contractual maturity date of the securities as of December 31, 2023 : Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Government securities - U.S. $ 73,944 $ — $ — $ — $ 73,944 Total $ 73,944 $ — $ — $ — $ 73,944 The Company has classified its investment in available-for-sale marketable debt 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. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The principal categories of inventories at December 31, 2023 were comprised of the following: Inventory: 2023 Raw materials and supplies $ 5,291 Work in process 2,037 Finished goods 3,052 Total $ 10,380 The Company had no capitalized inventories at December 31, 2022. The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained for a drug candidate. As such, the Company began capitalizing costs related to inventory in May 2023 upon FDA approval of LUMRYZ. Manufacturing costs associated with inventory purchased or produced prior to FDA approval were recorded as research and development expense in prior periods. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net The principal categories of property and equipment, net at December 31, 2023 and 2022, respectively, are as follows: Property and Equipment, net: 2023 2022 Software, office and computer equipment $ 832 $ 832 Furniture, fixtures and fittings 634 634 Less - accumulated depreciation (881) (627) Total $ 585 $ 839 |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill | Goodwill The Company’s goodwill is $16,836 at December 31, 2023 and 2022. No impairment loss related to goodwill was recognized during the years ended December 31, 2023 or 2022. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company leases office space and a production suite. All leased facilities are classified as operating leases with remaining lease terms between one The components of lease costs, which are included in selling, general and administrative expenses in the consolidated statements of loss for the years ended December 31, 2023, 2022 and 2021 were as follows: Lease cost: 2023 2022 2021 Operating lease costs $ 1,039 $ 1,028 $ 821 Sublease income (123) (116) (110) Total lease cost $ 916 $ 912 $ 711 During the year ended December 31, 2023, the Company increased its operating lease liabilities by $1,803 due to an increase in the lease term for the production suite, offset by $1,036 for cash paid. During the year ended December 31, 2022, the Company reduced its operating lease liabilities by $963 for cash paid. As of December 31, 2023, the Company’s operating leases have a weighted-average remaining lease term of 3.7 years and a weighted-average discount rate of 7.8%. 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 2024 $ 1,091 2025 683 2026 477 2027 477 2028 316 Thereafter — Total lease payments 3,044 Less: interest (420) Present value of lease liabilities $ 2,624 |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt The Company had no exchangeable senior notes as of December 31, 2023. Long-term debt as of December 31, 2022 is summarized as follows: Exchangeable Senior Notes: 2022 Principal amount of 4.50% exchangeable senior notes due October 2023 $ 117,375 Principal amount of 4.50% exchangeable senior notes due February 2023 17,500 Less: unamortized debt discount and issuance costs, net (5,593) Net carrying amount of liability component 129,282 Less: current maturities, net of $1,019 unamortized debt discount and issuance costs (37,668) Long-term debt $ 91,614 For the years ended December 31, 2023, 2022 and 2021, the total interest expense for exchangeable senior notes was $6,143, $12,342 and $9,942, respectively, with coupon interest expense of $3,347, $6,405 and $6,469 for each period, respectively, and the amortization of debt issuance costs and debt discount of $2,796, $6,052 and $1,248 for each period, respectively. February 2023 Notes On February 16, 2018, the Issuer issued $125,000 aggregate principal amount of its 4.50% exchangeable senior notes due February 2023 (the “February 2023 Notes”) in a private placement (the “Offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act. In connection with the Offering, the Issuer granted the initial purchasers of the February 2023 Notes a 30-day option to purchase up to an additional $18,750 aggregate principal amount of the February 2023 Notes, which was fully exercised on February 16, 2018. Net proceeds received by the Company, after issuance costs and discounts, were approximately $137,560. The February 2023 Notes were the Company’s senior unsecured obligations and ranked 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. October 2023 Notes On April 5, 2022, the Issuer completed the exchange of $117,375 of its February 2023 Notes for a new series of its October 2023 Notes (the “2022 Exchange Transaction”). The remaining $26,375 aggregate principal amount of the February 2023 Notes were not exchanged and maintained a maturity date of February 1, 2023. On November 4, 2022, the Company repurchased $8,875 of its February 2023 Notes and on the maturity date of February 1, 2023, the Company repaid, with cash on hand, the remaining $17,500 aggregate principal amount of its February 2023 Notes. The Company accounted for the October 2023 Notes as a modification to the February 2023 Notes. The Company paid $4,804 in fees to note holders of the October 2023 Notes that are amortized over the remaining term of the October 2023 Notes. The Company paid approximately $5,450 in fees to third parties that were expensed as part of the completed 2022 Exchange Transaction. Additionally, the fair value of the unseparated, embedded conversion feature increased by $5,508, which reduced the carrying amount of the convertible debt instrument as an unamortized debt discount, with a corresponding increase in additional paid-in capital. The $5,508 was amortized over the remaining term of the October 2023 Notes as a component of interest expense. Over the course of April 3 and April 4, 2023, the Issuer completed an exchange of $96,188 of its $117,375 October 2023 Notes for $106,268 of the April 2027 Notes. The remaining $21,187 aggregate principal amount of the October 2023 Notes matured on October 2, 2023. The Issuer settled, with a combination of cash and ADSs, the remaining $21,187 aggregate principal amount of the October 2023 Notes in October 2023. The aggregate amount of cash and ADSs delivered to holders for the October 2023 Notes and accrued and unpaid interest was $21,641 and 408 ADSs, respectively. April 2027 Notes The Company accounted for the exchange of the October 2023 Notes for the April 2027 Notes as an extinguishment of $96,188 of its October 2023 Notes. The Company recorded a loss on the extinguishment of $13,129 as a result of the exchange. On June 26, 2023, and in accordance with the terms of the Indenture, the Company completed the Mandatory Exchange of $106,268 of aggregate principal amount of the April 2027 Notes, which represents all of the April 2027 Notes outstanding under the Indenture. The Mandatory Exchange consideration per one thousand dollars of principal Notes exchanged consisted of 116.1846 of ADSs representing a corresponding number of the Company’s ordinary shares, nominal value $0.01 per share, plus accrued and unpaid interest thereon. The aggregate amount of ADSs and cash in respect of accrued and unpaid interest delivered to holders of Notes in the Mandatory Exchange was 12,347 ADSs and $1,470, respectively. |
Royalty Financing Obligation
Royalty Financing Obligation | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Royalty Financing Obligation | Royalty Financing Obligation On March 29, 2023, the Company and Avadel CNS entered into the RPA with RTW that could provide the Company up to $75,000 of royalty financing in two tranches. The first tranche of $30,000 became available upon satisfaction of certain conditions which included the Company’s first shipment of LUMRYZ. The second tranche is available to use, at the Company’s election, if it achieves quarterly net revenue of $25,000 by the quarter ending June 30, 2024. The second tranche expires if the Company does not elect to use it by August 31, 2024. On August 1, 2023, the Company received the first tranche of $30,000. As a result of receiving the first tranche, the Company is required to make quarterly royalty payments calculated as 3.75% of worldwide net product revenue of LUMRYZ, up to a total payback of $75,000. The RPA is recorded as a royalty financing obligation on the consolidated balance sheet based on the Company’s evaluation of the terms of the RPA. The accounts receivable and inventory balances of LUMRYZ are pledged as collateral for the RPA. There are no subjective acceleration clauses or provisions, and there are no covenants in violation or other clauses that would cause the full amount of the royalty financing obligation to be callable. As such, the RPA is recorded as a long-term obligation on the consolidated balance sheet. The Company imputes interest using the effective interest method and records interest expense based on the unamortized royalty financing obligation. The Company’s estimate of the interest rate under the RPA is based primarily on forecasted net revenue and the calculated amounts and timing of net royalty payments to reach the total payback of $75,000. As of December 31, 2023 the effective interest rate is estimated as 30.4%. The Company will account for changes in the imputed interest rate resulting from changes in forecasted net product revenue using the prospective method. The following table shows the activity within the royalty financing obligation account for the period ended December 31, 2023. Royalty Financing Obligation: 2023 Royalty financing obligation – beginning balance $ — Receipt of the first tranche of the royalty financing obligation 30,000 Accretion of imputed interest expense on royalty financing obligation 3,743 Less: royalty payments made to RTW (253) Royalty financing obligation – ending balance 33,490 Less: royalty payable to RTW classified within accrued expenses (730) Royalty financing obligation, non-current $ 32,760 The accretion of imputed interest expense is reflected as interest expense in the consolidated statements of loss. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of (loss) income before income taxes for the following years ended December 31, are as follows: (Loss) Income Before Income Taxes: 2023 2022 2021 Ireland $ (45,689) $ (53,717) $ (36,631) U.S. (114,942) (57,755) (56,687) France (146) 33 173 Total loss before income taxes $ (160,777) $ (111,439) $ (93,145) The income tax (benefit) provision consists of the following for the years ended December 31: Income Tax (Benefit) Provision: 2023 2022 2021 Current: U.S. - State $ (661) $ — $ 60 Total current (661) — 60 Deferred: U.S. - Federal — 25,896 (15,876) U.S. - State 160 129 — Total deferred 160 26,025 (15,876) Income tax (benefit) provision $ (501) $ 26,025 $ (15,816) The reconciliation between income taxes at the statutory rate and the Company’s (benefit) provision for income taxes is as follows for the following years ended December 31: Reconciliation to Effective Income Tax Rate: 2023 2022 2021 Income tax (benefit) provision - at statutory tax rate $ (20,097) $ (13,916) $ (11,642) Differences in international tax rates (6,341) (9,921) (8,950) Change in valuation allowances 24,332 48,734 4,296 Nondeductible share-based compensation 798 1,424 645 Unrealized tax benefits 160 258 239 State and local taxes (net of federal) (5,614) (4,467) 60 Nondeductible interest expense 4,362 4,239 2,173 Orphan drug and R&D tax credit 899 — (1,524) Other 1,000 (326) (1,113) Income tax (benefit) provision - at effective income tax rate $ (501) $ 26,025 $ (15,816) In 2023, the income tax benefit was $501, a change of $26,526 from income tax provision of $26,025. The change in the effective tax rate for the year ended December 31, 2023 is primarily driven by the valuation allowances recorded against our deferred tax assets during the prior period. The effective tax rate for 2021 was impacted by the geographic mix of earnings. Unrecognized Tax Benefits The Company or one of its subsidiaries files income tax returns in Ireland, France, U.S. and various states. The Company is no longer subject to Irish, French, U.S. Federal, and state and local examinations for years before 2019. 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 2023 2022 2021 Balance at January 1: $ 3,143 $ 3,143 $ 3,143 Increases for tax positions of prior years — — — Statute of limitations expiration (108) — — Settlements — — — Balance at December 31: $ 3,035 $ 3,143 $ 3,143 The Company expects that within the next twelve months the unrecognized tax benefits could decrease by an immaterial amount and the interest could increase by an immaterial amount. At December 31, 2023, 2022 and 2021, there are $3,035, $3,143,and $2,483 of unrecognized tax benefits that if recognized would affect the annual effective tax rate. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax provision. During the years ended December 31, 2023, 2022 and 2021, the Company recognized approximately $268, $258 and $239 in interest and penalties. The Company had approximately $2,372, $2,103, and $1,777 for the payment of interest and penalties accrued at December 31, 2023, 2022, and 2021, respectively. Deferred Tax Assets (Liabilities) Deferred income tax provisions reflect the effect of temporary differences between consolidated financial statement and tax reporting of income and expense items. The net deferred tax assets (liabilities) at December 31, 2023 and 2022 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 71,051 $ 53,393 Royalty income 8,378 — Share-based compensation 7,347 4,684 Orphan drug and R&D tax credit 4,065 4,964 Capitalized research costs 1,738 2,108 Interest expense carryforward 1,368 1,216 Other 1,322 1,521 Amortization 1,159 3,541 Gross deferred tax assets 96,428 71,427 Deferred tax liabilities: Prepaid expenses — (86) Gross deferred tax liabilities — (86) Less: valuation allowances (96,428) (71,341) Net deferred tax assets $ — $ — At December 31, 2023, the Company had $111,647 of net operating losses in Ireland that do not have an expiration date and $212,426 of net operating losses and $5,469 163(j) carryforwards in the U.S. Of the $212,426 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 $195,595 are due to the losses at US Holdings, of which $6,466 are state net operating losses. The portion due to the acquisition of FSC will expire in 2034 through 2035. The remaining U.S. net operating loss and 163(j) carryforwards do not have an expiration date. 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, 2023, the Company recorded a net increase to the valuation allowance related primarily to current year net operating losses of $25,087. 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. In addition to net operating losses and 163(j) carryforwards, the Company has U.S. Orphan Drug tax credit carryforwards of $3,059 as well as U.S. Research and Development credits of $1,005. The Orphan Drug Credit and Research and Development credits will expire in 2040 through 2043. The Company's cumulative loss position is significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets. Given the weight of objectively verifiable historical losses from operations, the Company has recorded a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company recorded a valuation allowance against all of its net operating losses in Ireland, France and the U.S. as of December 31, 2023 and 2022. The Company intends to continue maintaining a full valuation allowance on the Irish, French and U.S. net operating losses until there is sufficient evidence to support the reversal of all or some portion of these allowances. At December 31, 2023, the Company has unremitted earnings of $3,854 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 |
Other Assets and Liabilities
Other Assets and Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
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: 2023 2022 Prepaid and other expenses $ 4,373 $ 1,523 Other 913 573 Total $ 5,286 $ 2,096 Other Non-Current Assets: 2023 2022 Right of use assets at contract manufacturing organizations $ 9,905 $ 10,686 Other 247 636 Total $ 10,152 $ 11,322 Accrued Expenses: 2023 2022 Accrued professional fees $ 11,767 $ 4,040 Accrued compensation 7,492 1,613 Reserve for variable consideration 4,044 — Royalty payable to RTW 730 — Accrued outsourced contract costs 194 1,208 Accrued restructuring — 473 Total $ 24,227 $ 7,334 Other Current Liabilities: 2023 2022 Other $ 261 $ 292 Accrued interest — 1,649 Total $ 261 $ 1,941 Other Non-Current Liabilities: 2023 2022 Tax liabilities $ 5,407 $ 5,246 Other 247 497 Total $ 5,654 $ 5,743 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 and December 31, 2022, there were no contingent liabilities with respect to any litigation, arbitration or administrative or other proceeding that are reasonably likely to have a material adverse effect on the Company’s consolidated financial position, results of operations, cash flows or liquidity. First Jazz Complaint On May 12, 2021, Jazz Pharmaceuticals, Inc. (“Jazz”) filed a formal complaint (the “First Complaint”) initiating a lawsuit in the United States District Court for the District of Delaware (the “Court”) against Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Management Corporation, Avadel Legacy Pharmaceuticals, LLC, Avadel Specialty Pharmaceuticals, LLC, and Avadel CNS Pharmaceuticals, LLC (collectively, the “Avadel Parties”). In the First Complaint, Jazz alleges the sodium oxybate product (“Proposed Product”) described in the NDA owned by Avadel CNS Pharmaceuticals, LLC (“Avadel CNS”) will infringe at least one claim of U.S. Patent No. 8731963, 10758488, 10813885, 10959956 and/or 10966931 (collectively, the “patents-in-suit”). The First Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On June 3, 2021, the Avadel Parties timely filed their Answer and Counterclaims (the “Avadel Answer”) with the Court in response to the First Complaint. The Avadel Answer generally denies the allegations set forth in the First Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patents-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of each patent-in-suit, and ii) a declaratory judgment of invalidity of each patent-in-suit. On June 18, 2021, Jazz filed its Answer (“Jazz Answer”) with the Court in response to the Avadel Answer. The Jazz Answer generally denies the allegations set forth in the Avadel Answer and sets forth a single affirmative defense asserting that Avadel has failed to state a claim for which relief can be granted. On June 21, 2021, the Court issued an oral order requiring the parties to i) confer regarding proposed dates to be included in the Court’s scheduling order for the case, and ii) submit a proposed order, including a proposal for the length and timing of trial, to the Court by no later than July 21, 2021. On July 30, 2021, the Court issued a scheduling order establishing timing for litigation events including i) a claim construction hearing date of August 2, 2022, and ii) a trial date of October 30, 2023. On October 18, 2021, consistent with the scheduling order, Jazz filed a status update with the Court indicating that Jazz did not intend to file a preliminary injunction with the Court at this time. Jazz further indicated that it would provide the Court with an update regarding whether preliminary injunction proceedings may be necessary after receiving further information regarding the FDA’s action on Avadel CNS’s NDA. On January 4, 2022, the Court entered an agreed order dismissing this case with respect to Avadel Pharmaceuticals plc, Avadel US Holdings, Inc., Avadel Specialty Pharmaceuticals, LLC, Avadel Legacy Pharmaceuticals, LLC, and Avadel Management Corporation. A corresponding order was entered in the two below cases on the same day. On February 25, 2022, Jazz filed an amended Answer to the Avadel Parties’ Counterclaims (“the Jazz First Amended Answer”). The Jazz First Amended Answer is substantially similar to the Jazz Answer except insofar as it adds an affirmative defense for judicial estoppel and unclean hands. Corresponding amended answers were filed in the two below cases on the same day. On June 23, 2022, Avadel CNS filed a Renewed Motion for Judgment on the Pleadings, with respect to its counterclaim against Jazz seeking to have U.S. Patent No. 8731963 (the “REMS Patent”) delisted from the Orange Book and seeking to have the motion resolved concurrent with the parties’ Markman hearing on August 31, 2022. On July 7, 2022, Jazz filed a response styled as Objections to Avadel CNS’ Motion for Judgment on the Pleadings. On July 14, 2022, Avadel CNS replied to Jazz’s response, and on July 21, 2022, Avadel CNS requested oral argument on its delisting motion simultaneous with the Markman hearing. On August 24, 2022, the Court ordered Jazz to respond substantively to Avadel CNS’ motion, which Jazz did on August 26, 2022. Avadel CNS filed its reply on August 28, 2022. On August 23, 2022, the Markman hearing was postponed. On September 7, 2022, the case was reassigned to a new judge, and the Markman hearing was held on October 25, 2022. At the Markman hearing, Avadel CNS reiterated its request for an expedited hearing on the Renewed Motion for Judgment on the Pleadings for the delisting of the REMS Patent. On October 28, 2022, the Court granted Avadel CNS’ request and scheduled the hearing for November 15, 2022. The Court held the Markman hearing on November 15, 2022 and issued a claim construction ruling on November 18, 2022. Also on November 18, 2022 the Court granted Avadel’s Renewed Motion for Judgment on the Pleadings and ordered Jazz to request delisting of the REMS Patent from the Orange Book. On November 22, 2022, Jazz appealed that decision and on December 14, 2022, the Federal Circuit issued a stay of the delisting order until further notice. Oral argument was held February 14, 2023. On February 24, 2023, the United States Court of Appeals for the Federal Court affirmed the previous ruling from the Court, ordering the delisting of the REMS Patent from the Orange Book, which has since occurred. On March 7, 2023, in response to a joint stipulation filed by the parties, the Court issued an order dismissing Jazz’s infringement claims against the Avadel Parties relating to the REMS Patent as well as Avadel Parties’ noninfringement and invalidity counterclaims relating to the REMS Patent. On March 15, 2023, the parties submitted a Stipulation and Proposed Order Modifying the Case Schedule to accommodate additional claim construction proceedings. That stipulation remains pending before the Court. On April 26, 2023, the parties filed their Supplemental Joint Claim Construction Brief. On July 3, 2023, the Court issued a modified scheduling order establishing a new trial date of February 26, 2024. On July 21, 2023, in response to a Court order, the parties submitted a Stipulation and Proposed Order Modifying the Case Schedule with an updated proposed schedule to accommodate additional claim construction proceedings. On August 4, 2023, the Court entered a modified version of the parties’ proposed schedule, which was revised on August 28, 2023. The parties’ Second Supplemental Joint Claim Construction Brief was filed on October 10, 2023, and a Markman hearing regarding the disputed terms occurred on November 1, 2023. The Court issued its claim construction order on December 15, 2023. On August 15, 2023, Avadel renewed its request to consolidate this litigation with the litigation described in the Avadel Complaint below. On November 3, 2023, the Court denied that request. On November 30, 2023, the parties filed cross motions for summary judgment. The parties filed opposition briefs on December 15, 2023. The parties filed reply briefs on December 22, 2024. On February 14, 2024, the Court denied the parties’ summary judgment motions. On February 15, 2024, the Court held its Pretrial Conference, in advance of the ongoing February 26, 2024 trial. Second Jazz Complaint On August 4, 2021, Jazz filed another formal complaint (the “Second Complaint”) initiating a lawsuit in the Court against the Avadel Parties. In the Second Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of U.S. Patent No. 11077079. The Second Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On September 9, 2021, the Avadel Parties timely filed their Answer and Counterclaims (the “Second Avadel Answer”) with the Court in response to the Second Complaint. The Second Avadel Answer generally denies the allegations set forth in the Second Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of the patent-in-suit, and ii) a declaratory judgment of invalidity of the patent-in-suit. On October 22, 2021, the Court issued an oral order stating that this case should proceed on the same schedule as the case filed on May 12, 2021. On September 7, 2022, the case was reassigned to a new judge. Third Jazz Complaint On November 10, 2021, Jazz filed another formal complaint (the “Third Complaint”) initiating a lawsuit in the Court against the Avadel Parties. In the Third Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of U.S. Patent No. 11147782. The Third Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. This case will proceed on the same schedule as the cases associated with the First and Second Complaints above. On December 21, 2021, the Court entered a revised schedule for the First, Second and Third Complaints, setting a new claim construction date of August 31, 2022. On January 7, 2022, Avadel CNS timely filed its Answer and Counterclaims (the “Third Avadel Answer”) with the Court in response to the Third Complaint. The Third Avadel Answer generally denies the allegations set forth in the Third Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims seeking i) a declaratory judgment of non-infringement of the patent-in-suit, and ii) a declaratory judgment of invalidity/unenforceability of the patent-in-suit. On September 7, 2022, the case was reassigned to a new judge. Fourth Jazz Complaint On July 15, 2022, Jazz filed another formal complaint (the “Fourth Complaint”) initiating a lawsuit in the Court against Avadel CNS. In the Fourth Complaint, Jazz alleges the Proposed Product described in the NDA owned by Avadel CNS will infringe at least one claim of the REMS Patent, which was asserted in the First Complaint. The FDA required Avadel CNS to file a Paragraph IV certification against the REMS Patent, which Avadel CNS did under protest, consistent with its Renewed Motion for Judgment on the Pleadings for the delisting of the REMS Patent from the Orange Book, which was later ordered to be delisted in the above First Jazz Complaint action. Avadel CNS provided the required notice of its Paragraph IV certification to Jazz, and Jazz reasserted the REMS Patent in a separate action following receipt of that notice. The Fourth Complaint further includes typical relief requests such as preliminary and permanent injunctive relief, monetary damages and attorneys’ fees, costs and expenses. On September 7, 2022, the case was reassigned to a new judge. On September 21, 2022, Jazz served the Fourth Complaint. On October 21, 2022, Avadel CNS timely filed its Answer and Counterclaims (the “Fourth Avadel Answer”) with the Court in response to the Fourth Complaint. The Fourth Avadel Answer generally denies the allegations set forth in the Fourth Complaint, includes numerous affirmative defenses (including, but not limited to, non-infringement and invalidity of the patent-in-suit), and asserts a number of counterclaims for i) a declaratory judgment of non-infringement of the patent-in-suit, ii) a declaratory judgment of invalidity/unenforceability of the patent-in-suit, iii) delisting of the patent-in-suit from the Orange Book; iv) monopolization under the Sherman Antitrust Act of 1890 (the “Sherman Act”); and v) attempted monopolization under the Sherman Act. On December 9, 2022, Jazz filed a Motion to Dismiss Avadel’s Antitrust Counterclaims. Avadel filed its opposition brief on December 27, 2022, and Jazz filed its reply brief on January 6, 2022. On January 11, 2023, Avadel filed a request for oral argument on the motion, which is still pending. On March 6, 2023, the parties filed a stipulation of dismissal, dismissing Jazz’s claims with respect to the REMS Patent and Avadel CNS’s related non-infringement and invalidity counterclaims. The Court entered that stipulation on March 7, 2023. On May 19, 2023, the Court issued a scheduling order establishing timing for litigation events including i) completion of fact discovery by March 14, 2024, and ii) a deadline for case dispositive motions of September 20, 2024. On January 23, 2024, the parties submitted a stipulation to extend the case schedule. On January 24, 2024, the Court ordered an extension of the case schedule, including i) completion of fact discovery by June 20, 2024 and ii) a deadline for case dispositive motions by January 31, 2025. On January 24, 2024, the Court issued an order setting a pretrial conference for October 30, 2025 and a 5-day trial to begin on November 3, 2025. On June 29, 2023, Jazz filed a Motion to Stay the case, pending resolution of its Motion to Dismiss. Briefing on that Motion to Stay closed on August 10, 2023. Avadel Complaint On April 14, 2022, Avadel CNS and Avadel Pharmaceuticals plc (collectively the “Avadel Plaintiffs”) filed a formal complaint (the “Avadel Complaint”) initiating a lawsuit in the Court against Jazz and Jazz Pharmaceuticals Ireland Ltd. (collectively, the “Jazz Parties”). In the Avadel Complaint, the Avadel Plaintiffs allege that the Jazz Parties breached certain confidential disclosure agreements and misappropriated certain of the Avadel Plaintiffs’ trade secrets. The Avadel Complaint further includes typical relief requests such as injunctive relief, monetary damages and attorneys’ fees, costs and expenses, as well as seeking correction of inventorship of certain Jazz patents, for which the Jazz Parties claim ownership, to include former Avadel Plaintiffs’ scientists. On June 2, 2022, Jazz answered the Avadel Complaint. The Answer generally denies the allegations set forth in the Avadel Complaint and includes various affirmative defenses. On July 8, 2022, Jazz filed a Motion for Judgment on the Pleadings seeking to have all Counts dismissed for failure to state a claim upon which relief can be granted. The Avadel Plaintiffs’ response to that Motion was filed with the Court on July 29, 2022. Jazz’s reply was filed with the Court on August 5, 2022. On February 2, 2023, the Court held a hearing on Jazz’s Motion for Judgment on the Pleadings. On September 7, 2022, the case was reassigned to a new judge. On February 2, 2023, the Court held a hearing on Jazz’s Motion for Judgment on the Pleadings. On July 18, 2023, the Court denied Jazz’s Motion for Judgment on the Pleadings. On August 15, 2023, the parties submitted competing proposed scheduling orders, and Avadel requested consolidation with the above First Jazz Complaint litigation. That request for consolidation was denied on November 3, 2023. On November 17, 2023, the parties submitted an updated joint proposed scheduling order. On January 30, 2024, the parties agreed to a 6-week stay of discovery and submitted a proposed stipulation extending certain case deadlines to accommodate the same. On February 9, 2024, the parties submitted an updated proposed scheduling order consistent with that stipulation, setting the close of fact discovery for August 9, 2024 and a trial date of December 15, 2025. That proposed scheduling order remains pending before the Court as of the date of this Annual Report on Form 10-K. Jazz’s Administrative Procedure Act Complaint On June 22, 2023, Jazz filed an Administrative Procedure Act suit against the FDA, the U.S. Department of Health and Human Services, the Secretary of Health and Human Services and the Commissioner of Food and Drugs (the “Federal Defendants”) in the United States District Court for the District of Columbia (the “DC Court”) related to the NDA for LUMRYZ. This suit alleges that the FDA’s approval of LUMRYZ was an unlawful agency action and asks the DC Court to set aside FDA’s approval of LUMRYZ. On June 28, 2023, the DC Court granted Avadel CNS’s unopposed motion to intervene in the case to defend the FDA’s decision. On August 14, 2023, the Court entered a scheduling order establishing timing for litigation events including early summary judgment briefing closing December 22, 2023. On September 22, 2023, Jazz filed its Motion for Summary Judgment. On October 20, 2023, the FDA and Avadel filed their Cross Motions for Summary Judgment. Briefing on the parties’ motions closed January 4, 2024. On February 14, 2024, the Court set hearing for oral argument on the parties’ motions for February 27, 2024. On February 21, 2024, the Court rescheduled the oral argument to April 9, 2024. Material Commitments The Company has a five year commitment with a contract manufacturer of approximately $2,700 to $4,200 per year as determined by the terms of the agreement with the contract manufacturer. Guarantees The fair values of the Company’s guarantee to Deerfield Capital L.P. (“Deerfield”) and the guarantee received by the Company from Armistice Capital Master Fund, Ltd. largely offset and when combined are not material. Deerfield Guarantee In connection with the Company’s February 2018 divestiture of its pediatric assets, including four pediatric commercial stage assets – Karbinal™ ER, Cefaclor, Flexichamber™ and AcipHex® Sprinkle™ (“FSC products”), to Cerecor, Inc. (“Cerecor”), the Company guaranteed to Deerfield a quarterly royalty payment of 15% on net sales of the FSC products through February 6, 2026 (“FSC Product Royalties”), in an aggregate amount of up to approximately $10,300. Given the Company’s explicit guarantee to Deerfield, the Company recorded the guarantee in accordance with ASC 460. The balance of this guarantee liability was $501 at December 31, 2023. 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 $495 at December 31, 2023. This asset is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield noted above. |
Equity Instruments and Transact
Equity Instruments and Transactions | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023, the Company had 89,825 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 5,194 are currently issued and outstanding as of December 31, 2023. 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, each of which may be represented by ADSs, preferred shares, nominal value US$0.01 per share (the “Preferred Shares”), debt securities (the “Debt Securities”), warrants to purchase Ordinary Shares, ADSs, Preferred Shares and/or Debt Securities (the “Warrants”), and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2020 Shelf Registration Statement, the base prospectus contained in the 2020 Shelf Registration Statement (the “2020 Base Prospectus”), and any amendments or supplements thereto; including b. up to $50,000 of ADSs that may be issued and sold from time to time pursuant to the terms of an Open Market Sale Agreement SM , entered into with Jefferies LLC (“Jefferies”) in February 2020 (the “Sales Agreement”), the 2020 Shelf Registration Statement, the 2020 Base Prospectus and the terms of the sales agreement prospectus contained in the 2020 Shelf Registration Statement. The Company agreed to pay Jefferies a commission up to 3.0% of the aggregate gross sales proceeds of such ADSs. During the year ended December 31, 2022, the Company issued and sold 3,588 ADSs, resulting in net proceeds to the Company of approximately $25,318, pursuant to the Sales Agreement. No ADSs were issued and sold from the 2020 Base Prospectus during the year ended December 31, 2023. The 2020 Shelf Registration Statement expired on February 14, 2023. In August 2022, the Company filed with the SEC a new shelf registration statement on Form S-3 (the “2022 Shelf Registration Statement”) (File No. 333-267198) that allows issuance and sale by the Company, from time to time, of: a. up to $500,000 in aggregate of Ordinary Shares, each of which may be represented by ADSs, Preferred Shares, Debt Securities, Warrants, and/or units consisting of Ordinary Shares, ADSs, Preferred Shares, one or more Debt Securities or Warrants in one or more series, in any combination, pursuant to the terms of the 2022 Shelf Registration Statement, the base prospectus contained in the 2022 Shelf Registration Statement (the “2022 Base Prospectus”), and any amendments or supplements thereto; including b. up to $100,000 of ADSs that may be issued and sold from time to time pursuant to the Sales Agreement, the 2022 Shelf Registration Statement, the 2022 Base Prospectus and the terms of the sales agreement prospectus contained in the 2022 Shelf Registration Statement. As of December 31, 2023, the Company issued and sold 1,564 ADSs, resulting in net proceeds to the Company of approximately $11,913 , pursuant to the Sales Agreement. The Company may offer and sell up to an additional $96,064 of ADSs under the ATM Program that remains available for sale pursuant to the 2022 Base Prospectus. The transactions costs associated with the 2022 Shelf Registration Statement totaled $192, of which $135 remain recorded within prepaid expenses and other current assets at December 31, 2023. April 2023 Public Offering On April 3, 2023, the Company completed the sale of 12,205 Ordinary Shares in the form of ADSs and 4,706 Series B Preferred Shares in an underwritten public offering. The Company received proceeds, net of underwriter fees and issuance costs of $134,151. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation Compensation expense included in the Company’s consolidated statements of loss for all share-based compensation arrangements was as follows for the periods ended December 31, 2023, 2022, and 2021, respectively: Share-based Compensation Expense: 2023 2022 2021 Selling, general and administrative $ 15,248 $ 6,844 $ 8,114 Research and development 563 169 758 Total share-based compensation expense $ 15,811 $ 7,013 $ 8,872 As of December 31, 2023, the Company expects $13,962 of unrecognized expense related to granted, but non-vested share-based compensation arrangements to be incurred in future periods. This expense is expected to be recognized over a weighted average period of 2.5 years. In 2022, the Company granted options with performance conditions to employees of which 50% vest upon the achievement of certain commercial milestones related to LUMRYZ and the other 50% vest one year following achievement of those milestones (“2022 Performance Options”). In May 2023, the achievement of the milestones related to the 2022 Performance Options became probable, and the Company recognized the compensation costs that would have been recognized had the performance factor been considered probable since the inception of the award. In June 2023, achievement of these milestones was met and 50% of the 2022 Performance Options vested. As of December 31, 2023, the Company has recognized $6,996 in share-based compensation for the 2022 Performance Options. The excess tax benefit related to share-based compensation recorded by the Company was not material for the years ended December 31, 2023, 2022, and 2021. Upon exercise of stock options, or upon the issuance of restricted share awards or performance share unit awards, the Company issues new shares. At December 31, 2023, there were 6,883 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, 2023, the Company had 348 shares available for issuance under this Inducement Plan in subsequent periods. Determining the Fair Value of Stock Options The Company measures the total fair value of stock options on the grant date using the Black-Scholes option-pricing model and recognizes each grant’s fair value as compensation expense over the period that the option vests. Other than the 2022 Performance Options described above, options are granted to employees of the Company and become exercisable ratably over four years following the grant date and expire ten years after the grant date. Prior to 2021, the Company issued stock options to its Board of Directors as compensation for services rendered that are exercisable ratably over three years following the grant date, and expire ten years after the grant date. Beginning in 2021, the Company issued stock options to its Board of Directors as compensation for services rendered and are exercisable one year following the grant date and expire ten years after the grant date. The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2023, 2022 and 2021 are as follows: Stock Option Assumptions: 2023 2022 2021 Stock option grants: Expected term (years) 6.2 6.1 6.2 Expected volatility 100.1 % 93.4 % 73.9 % Risk-free interest rate 3.9 % 2.7 % 1.1 % 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, 2023 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2023 9,304 $ 6.67 Granted 1,437 11.34 Exercised (342) 6.02 Forfeited (96) 12.58 Expired (4) 7.36 Stock options outstanding, December 31, 2023 10,299 $ 7.29 7.2 $ 811 Stock options exercisable, December 31, 2023 6,337 $ 6.82 6.3 $ 627 The aggregate intrinsic value of options exercised during the year ended December 31, 2023, 2022, and 2021 was $2,612, $877, and $249, respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2023, 2022, and 2021 was $9.14, $4.02, and $5.36 per share, respectively. Restricted Share Awards Restricted share awards represent Company shares issued free of charge to employees of the Company as compensation for services rendered. The Company measures the total fair value of restricted share awards on the grant date using the Company’s stock price at the time of the grant. Restricted share awards granted to employees vest over a four-year period; one-fourth (1/4) on each anniversary of the grant date. Compensation expense for such awards granted is recognized over the applicable vesting period. A summary of the Company’s restricted share awards as of December 31, 2023, 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, 2023 56 $ 7.95 Granted — — Vested (33) 7.77 Forfeited — — Non-vested restricted share awards outstanding, December 31, 2023 23 $ 8.20 No restricted share awards were granted during the years ended December 31, 2023 and 2022. The weighted average grant date fair value of restricted share awards granted during the year ended December 31, 2021 was $8.22 per share. Performance Share Units Awards Performance share units awards (“PSUs”) represent Company shares issued free of charge to employees of the Company as compensation for achieving specified 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 2021, the Company granted performance share awards of which 50% vest upon achievement of certain corporate objectives and the second 50% vests one year following achievement of those objectives (“2021 PSU awards”). The objectives of the 2021 PSU awards were not met and the 2021 PSU awards were forfeited in 2022. The Company did not recognize any share-based compensation expense related to the 2021 PSU awards. The weighted average grant date fair value of performance share awards granted during the years ended December 31, 2021 was $8.20 per share. No performance share awards were granted during the year ended December 31, 2022. As of December 31, 2023, there were 555 performance share awards that did not have an accounting grant date due to the discretionary nature of the performance criteria. Accordingly, no grant date fair value was established and there were no performance share awards considered granted during the year ended December 31, 2023. 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, 2023, 2022 and 2021 the Company issued 47, 75, and 17 ordinary shares to employees, respectively. Expense related to the ESPP for the years ended December 31, 2023, 2022 and 2021 was immaterial. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of shares outstanding during each period. Diluted net loss per share is calculated by dividing net loss - diluted by the diluted number of shares outstanding during each period. Except where the result would be anti-dilutive to net loss, diluted net loss per share would be calculated assuming the impact of the conversion of the February 2023 Notes and the October 2023 Notes (together, 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 had a choice to settle the conversion obligations under the 2023 Notes in cash, shares or any combination of the two. The Company utilized the if-converted method to reflect the impact of the conversion of the 2023 Notes, unless the result was anti-dilutive. This method assumed the conversion of the 2023 Notes into shares of the Company’s ordinary shares and reflected the elimination of the interest expense related to the 2023 Notes. The dilutive effect of the stock options, restricted stock units, preferred shares and ordinary shares expected to be issued under the Company’s ESPP has been calculated using the treasury stock method. A reconciliation of basic and diluted net loss per share, together with the related shares outstanding in thousands for the years ended December 31, 2023, 2022 and 2021, is as follows: Net Loss Per Share: 2023 2022 2021 Net loss $ (160,276) $ (137,464) $ (77,329) Weighted average shares: Basic shares 80,174 60,094 58,535 Effect of dilutive securities—employee and director equity awards outstanding — — — Diluted shares 80,174 60,094 58,535 Net loss per share - basic $ (2.00) $ (2.29) $ (1.32) Net loss per share - diluted $ (2.00) $ (2.29) $ (1.32) Potential ordinary shares of 513, 17,941, 15,327 and were excluded from the calculation of weighted average shares for the years ended December 31, 2023, 2022 and 2021 respectively, because either their effect was considered to be anti-dilutive or they were related to shares from PSUs for which the contingent vesting condition had not been achieved. For the years ended December 31, 2023, 2022 and 2021, the effects of dilutive securities were entirely excluded from the calculation of net loss per share as a net loss was reported in these periods. |
Comprehensive Loss
Comprehensive Loss | 12 Months Ended |
Dec. 31, 2023 | |
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: 2023 2022 2021 Foreign currency translation adjustment: Beginning balance $ (24,452) $ (23,855) $ (22,627) Net other comprehensive income (loss) 331 (597) (1,228) Balance at December 31, $ (24,121) $ (24,452) $ (23,855) Unrealized gain (loss) on marketable securities, net Beginning balance $ (1,889) $ (85) $ 1,576 Net other comprehensive income (loss), net of income tax benefit of $0, $0, and $214, respectively 2,843 (1,804) (1,661) Balance at December 31, $ 954 $ (1,889) $ (85) Accumulated other comprehensive loss at December 31, $ (23,167) $ (26,341) $ (23,940) The effect on the Company’s consolidated financial statements of amounts reclassified out of accumulated other comprehensive loss was immaterial for all periods presented. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information The Company has determined that it operates in one segment, the development and commercialization of pharmaceutical products, including controlled-release therapeutic products based on its proprietary polymer based technology. The Company’s Chief Operating Decision Maker is the Chief Executive Officer (“CEO”). The CEO reviews profit and loss information on a consolidated basis to assess performance and make overall operating decisions as well as resource allocations. All products are included in one segment because the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. 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, 2023 and 2022: Long-lived Assets by Geographic Region: 2023 2022 U.S. $ 18,413 $ 19,414 Ireland 11,751 11,296 Total $ 30,164 $ 30,710 |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2023 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II Valuation and Qualifying Accounts | Schedule II Valuation and Qualifying Accounts (In thousands) Deferred Tax Asset Valuation Allowance: Balance, Additions Deductions Other Changes Balance, 2023 $ 71,341 $ 30,918 $ (6,586) $ 755 $ 96,428 2022 $ 24,025 $ 48,734 $ — $ (1,418) $ 71,341 2021 $ 21,624 $ 4,235 $ (51) $ (1,783) $ 24,025 a. Additions to the deferred tax asset valuation allowance relate to movements on certain French, Irish and U.S. deferred tax assets where we continue to maintain a valuation allowance until sufficient positive evidence exists to support reversal. b. Deductions to the deferred tax asset valuation allowance include movements relating to utilization of net operating losses and tax credit carryforwards, release in valuation allowance and other movements including adjustments following finalization of tax returns. c. Other changes to the deferred tax asset valuation allowance including currency translation adjustments recorded directly in equity, account method changes and the impact of corporate restructuring. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) Attributable to Parent | $ (160,276) | $ (137,464) | $ (77,329) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Nature of Operations | Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a biopharmaceutical company. The Company is registered as an Irish public limited company. The Company’s headquarters are in Dublin, Ireland with operations in Dublin, Ireland and St. Louis, Missouri, United States (“U.S.”). LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (“EDS”) in adults with narcolepsy. LUMRYZ was approved by the U.S. Food and Drug Administration (“FDA”) on May 1, 2023. The FDA also granted Orphan Drug Exclusivity to LUMRYZ for a period of seven years until May 1, 2030. In June 2023, the Company commercially launched LUMRYZ in the U.S. In approving LUMRYZ, the FDA required a risk evaluation and mitigation strategy (“REMS”) for LUMRYZ to help ensure that the benefits of the drug in the treatment of cataplexy and EDS in adults with narcolepsy outweigh the risks of serious adverse outcomes resulting from inappropriate prescribing, misuse, abuse, and diversion of the drug. Under this REMS, healthcare providers who prescribe the drug must be specially certified; pharmacies, that dispense the drug must be specially certified; and the drug must be dispensed only to patients who have enrolled in the LUMRYZ REMS and completed all REMS requirements including documentation of safe use conditions, among other requirements. As of the date of this Annual Report, the Company’s only commercialized product is LUMRYZ. The Company continues to evaluate opportunities to expand its product portfolio. |
Liquidity | Liquidity. The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. |
Basis of Presentation | Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S., the requirements of Form 10-K and Article 10 of Regulation S-X. The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. |
Reclassifications | Reclassifications Certain reclassifications are made to prior year amounts whenever necessary to conform with the current year presentation. Certain reclassifications have been made within Note 13: Other Assets and Liabilities |
Concentrations of Risk | Concentrations of Risk. A significant portion of the Company’s cash, cash equivalents and marketable securities are held at two financial institutions. Due to their size, the Company believes these financial institutions represent minimal credit risk. The Company has not experienced any losses on its cash, cash equivalents, or marketable securities. The Company is subject to credit risk from its accounts receivable related to the sale of LUMRYZ. The Company extends credit to its customers, specialty pharmacies. Customer creditworthiness is monitored, and collateral is not required. Amounts owed to the Company are presented net of an allowance that includes an 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. As of December 31, 2023, the Company did not recognize any allowances for credit losses. As of December 31, 2023, three customers accounted for 100% of gross accounts receivable, Caremark LLC (“Caremark”), which accounted for 52% of gross accounts receivable; Accredo Health Group, Inc. (“Accredo”), which accounted for 28% of gross accounts receivable; and Optum Frontier Therapies LLC (“Optum”), which accounted for 20% of gross accounts receivable. As of December 31, 2022, the Company did not have accounts receivable. The Company attempts to maintain multiple suppliers for its active pharmaceutical ingredient (“API”) and manufacturing in order to mitigate the risk of shortfall and inability to supply market demand, but is subject to risk due to a limited number of providers. The API is currently manufactured by two source contract development and manufacturing organizations |
Revenue and Cost of Products Sold | Revenue. Revenue includes sales of LUMRYZ. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, an entity recognizes revenue when the performance obligations to the customer have been satisfied through the transfer of control of the goods or services. To determine the appropriate revenue recognition for arrangements that the Company believes are within the scope of ASC 606, we perform 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. For contracts that are determined to be within the scope of ASC 606, 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 The Company sells LUMRYZ to specialty pharmacies and considers those specialty pharmacies to be its customers. Under ASC 606, revenue from product sales is recognized when the customer obtains control of the product, which occurs typically upon receipt by the customer. The Company’s gross product sales are subject to a variety of price adjustments to arrive at reported net product revenue. These adjustments include estimates of payment discounts, specialty pharmacy fees, patient financial assistance programs, rebates and product returns and are estimated based on contractual arrangements, historical trends, expected utilization of such products and other judgments and analysis. Reserves for Variable Consideration Revenues from product sales are recorded at the estimated net selling price, which includes reserves for estimated variable consideration to reduce gross product sales to net product revenue resulting from payment discounts, specialty pharmacy fees, patient financial assistance programs, rebates and product returns. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable if the amount is payable to the customer. The reserves are classified as a liability if the amount is payable to a party other than a customer. Where appropriate, these estimated reserves take into consideration relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, historical trends, current and expected patient demand and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates to reduce gross selling price to net selling price. The actual net selling price ultimately may differ from our estimates. Cost of Products Sold. Cost of products sold includes the cost of the API, manufacturing and distribution costs, packaging costs and freight. LUMRYZ was approved by the FDA on May 1, 2023 and the Company began shipping product to its customers in June 2023. Products sold includes inventory purchased or produced that was expensed as research and development costs prior to FDA approval. |
Inventories | Inventories. Inventories consist of raw materials, work in process and finished products, which are stated at lower of cost or net realizable value, using the first-in, first- out method. Raw materials used in the production of pre-clinical and clinical products are expensed as research and development costs. The Company establishes reserves for inventory estimated to be obsolete, unmarketable or slow-moving on a case by case basis. The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained for a drug candidate. As such, the Company began capitalizing costs related to inventory in May 2023 upon FDA approval of LUMRYZ. Manufacturing costs associated with inventory purchased or produced prior to FDA approval were recorded as research and development expense in prior periods. Accordingly, cost of products sold in the near term will likely be lower than in later periods given the sales of pre-approval inventory will carry little to no manufacturing costs as such costs were previously expensed to research and development. |
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. |
Share-based Compensation | Share-based Compensation. |
Income Taxes | Income Taxes. The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes deferred tax assets to the extent that the Company believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of December 31, 2023, the Company's cumulative loss position was significant negative evidence in assessing the need for a valuation allowance on its deferred tax assets. Given the weight of objectively verifiable historical losses from operations, the Company continues to record a full valuation allowance on its deferred tax assets. The Company will be able to reverse the valuation allowance when it has shown its ability to generate taxable income on a consistent basis in future periods. The valuation allowance does not have an impact on the Company's ability to utilize any net operating losses or other tax attributes to offset cash taxes payable as these items are still eligible to be used. The Company records uncertain tax positions on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits in the income tax expense line in the consolidated statements of loss. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents. |
Marketable Securities | Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in shareholders’ equity (deficit) , 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. |
Property and Equipment | Property and Equipment. Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years |
Goodwill | Goodwill. |
Long-Lived Assets | Long-Lived Assets. Long-lived assets include fixed assets and right of use assets at contract manufacturing organizations. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market-based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on |
Lease Obligations | Lease Obligations. The Company determines if a contract is a lease at the inception of the arrangement. Right-of-use assets and operating lease liabilities are recognized at commencement date based on the present value of remaining lease payments over the lease term. For this purpose, the Company considers only payments that are fixed and determinable at the time of commencement. The Company reviews all options to extend, terminate, or purchase its right-of-use assets at the inception of the lease and will include these options in the lease term when they are reasonably certain of being exercised. Short term leases with an initial term of 12 months or less are not recorded on the balance sheet and the associated lease payments are recognized in the consolidated statements of loss on a straight-line basis over the lease term. The Company’s lease contracts do not provide a readily determinable implicit rate. The Company’s estimated incremental borrowing rate is based on information available at the inception of the lease. The Company’s lease agreements may contain variable costs such as common area maintenance, insurance, real estate taxes or other costs. Variable lease costs are expensed as incurred on the consolidated statements of loss. |
Use of Estimates | Use of Estimates. |
Previously Adopted Accounting Guidance | Previously Adopted Accounting Guidance In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. The FASB’s amendments primarily impacted ASC 740, Income Taxes , and may impact both interim and annual reporting periods. ASU 2019-12 was effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years and early adoption was 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 reduced 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 required 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 i nstrument may be settled in cash or shares. This ASU was effective for fiscal years beginning January 1, 2022 and interim periods therein. Early adoption was permitted, but no earlier than fiscal years beginning after December 15, 2020. The amendments may be adopted through either a modified retrospective method, or a fully retrospective method. The Company elected to early adopt ASU 2020-06 as of January 1, 2021 using a modified retrospective method. The Company’s 4.50% exchangeable senior notes due 2023 were a convertible instrument with a cash-conversion feature that was accounted for within the scope of Subtopic 470-20. The Company calculated the cumulative-effect adjustment as of January 1, 2021 by comparing (i) the historical amortization schedule for the 2023 Notes through December 31, 2020 and (ii) an updated amortization schedule wherein the conversion feature within the 2023 Notes would not be separated as an equity component and subsequently recognized as non-cash interest expense under ASC 835-30. The adoption resulted in a $26,699 decrease in additional paid-in capital, a $12,939 increase in long-term debt, and a $13,760 increase to the opening balance of retained earnings. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures. The ASU is effective for annual periods beginning |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Useful Life | Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years The principal categories of property and equipment, net at December 31, 2023 and 2022, respectively, are as follows: Property and Equipment, net: 2023 2022 Software, office and computer equipment $ 832 $ 832 Furniture, fixtures and fittings 634 634 Less - accumulated depreciation (881) (627) Total $ 585 $ 839 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Percentage of Total Sales to Customers | The following table presents a summary of the percentage of total gross sales to customers : Twelve Months Ended December 31, Sales by Customer: 2023 Accredo 41 % Caremark 39 % Optum 20 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Instruments Measured at Fair Value on a Recurring Basis | The following table summarizes the financial instruments measured at fair value on a recurring basis classified in the fair value hierarchy (Level 1, 2 or 3) based on the inputs used for valuation in the accompanying consolidated balance sheets: As of December 31, 2023 As of December 31, 2022 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 5) Mutual and money market funds $ — $ — $ — $ 22,518 $ — $ — Government securities - U.S. 73,944 — — — — — Total assets $ 73,944 $ — $ — $ 22,518 $ — $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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, 2023 and 2022, respectively: 2023 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Government securities - U.S. $ 72,990 $ 954 $ — $ 73,944 Total $ 72,990 $ 954 $ — $ 73,944 2022 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Mutual and money market funds $ 24,407 $ — $ (1,889) $ 22,518 Total $ 24,407 $ — $ (1,889) $ 22,518 |
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 debt securities and classified by the contractual maturity date of the securities as of December 31, 2023 : Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Government securities - U.S. $ 73,944 $ — $ — $ — $ 73,944 Total $ 73,944 $ — $ — $ — $ 73,944 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Principal Categories of Inventories | The principal categories of inventories at December 31, 2023 were comprised of the following: Inventory: 2023 Raw materials and supplies $ 5,291 Work in process 2,037 Finished goods 3,052 Total $ 10,380 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 2-10 years The principal categories of property and equipment, net at December 31, 2023 and 2022, respectively, are as follows: Property and Equipment, net: 2023 2022 Software, office and computer equipment $ 832 $ 832 Furniture, fixtures and fittings 634 634 Less - accumulated depreciation (881) (627) Total $ 585 $ 839 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 for the years ended December 31, 2023, 2022 and 2021 were as follows: Lease cost: 2023 2022 2021 Operating lease costs $ 1,039 $ 1,028 $ 821 Sublease income (123) (116) (110) Total lease cost $ 916 $ 912 $ 711 |
Maturities of Operating Lease Liabilities | Maturities of the Company’s operating lease liabilities were as follows: Maturities: Operating Leases 2024 $ 1,091 2025 683 2026 477 2027 477 2028 316 Thereafter — Total lease payments 3,044 Less: interest (420) Present value of lease liabilities $ 2,624 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-term debt as of December 31, 2022 is summarized as follows: Exchangeable Senior Notes: 2022 Principal amount of 4.50% exchangeable senior notes due October 2023 $ 117,375 Principal amount of 4.50% exchangeable senior notes due February 2023 17,500 Less: unamortized debt discount and issuance costs, net (5,593) Net carrying amount of liability component 129,282 Less: current maturities, net of $1,019 unamortized debt discount and issuance costs (37,668) Long-term debt $ 91,614 The following table shows the activity within the royalty financing obligation account for the period ended December 31, 2023. Royalty Financing Obligation: 2023 Royalty financing obligation – beginning balance $ — Receipt of the first tranche of the royalty financing obligation 30,000 Accretion of imputed interest expense on royalty financing obligation 3,743 Less: royalty payments made to RTW (253) Royalty financing obligation – ending balance 33,490 Less: royalty payable to RTW classified within accrued expenses (730) Royalty financing obligation, non-current $ 32,760 |
Royalty Financing Obligation (T
Royalty Financing Obligation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Royalty Financing Obligation | Long-term debt as of December 31, 2022 is summarized as follows: Exchangeable Senior Notes: 2022 Principal amount of 4.50% exchangeable senior notes due October 2023 $ 117,375 Principal amount of 4.50% exchangeable senior notes due February 2023 17,500 Less: unamortized debt discount and issuance costs, net (5,593) Net carrying amount of liability component 129,282 Less: current maturities, net of $1,019 unamortized debt discount and issuance costs (37,668) Long-term debt $ 91,614 The following table shows the activity within the royalty financing obligation account for the period ended December 31, 2023. Royalty Financing Obligation: 2023 Royalty financing obligation – beginning balance $ — Receipt of the first tranche of the royalty financing obligation 30,000 Accretion of imputed interest expense on royalty financing obligation 3,743 Less: royalty payments made to RTW (253) Royalty financing obligation – ending balance 33,490 Less: royalty payable to RTW classified within accrued expenses (730) Royalty financing obligation, non-current $ 32,760 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule Of Components Of (Loss) Income Before Income Tax | The components of (loss) income before income taxes for the following years ended December 31, are as follows: (Loss) Income Before Income Taxes: 2023 2022 2021 Ireland $ (45,689) $ (53,717) $ (36,631) U.S. (114,942) (57,755) (56,687) France (146) 33 173 Total loss before income taxes $ (160,777) $ (111,439) $ (93,145) |
Schedule Of Income Tax Provision (Benefit) | The income tax (benefit) provision consists of the following for the years ended December 31: Income Tax (Benefit) Provision: 2023 2022 2021 Current: U.S. - State $ (661) $ — $ 60 Total current (661) — 60 Deferred: U.S. - Federal — 25,896 (15,876) U.S. - State 160 129 — Total deferred 160 26,025 (15,876) Income tax (benefit) provision $ (501) $ 26,025 $ (15,816) |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between income taxes at the statutory rate and the Company’s (benefit) provision for income taxes is as follows for the following years ended December 31: Reconciliation to Effective Income Tax Rate: 2023 2022 2021 Income tax (benefit) provision - at statutory tax rate $ (20,097) $ (13,916) $ (11,642) Differences in international tax rates (6,341) (9,921) (8,950) Change in valuation allowances 24,332 48,734 4,296 Nondeductible share-based compensation 798 1,424 645 Unrealized tax benefits 160 258 239 State and local taxes (net of federal) (5,614) (4,467) 60 Nondeductible interest expense 4,362 4,239 2,173 Orphan drug and R&D tax credit 899 — (1,524) Other 1,000 (326) (1,113) Income tax (benefit) provision - at effective income tax rate $ (501) $ 26,025 $ (15,816) |
Summary of Unrecognized Tax Benefits | The following table summarizes the activity related to the Company’s unrecognized tax benefits for the twelve months ended December 31: Unrecognized Tax Benefit Activity 2023 2022 2021 Balance at January 1: $ 3,143 $ 3,143 $ 3,143 Increases for tax positions of prior years — — — Statute of limitations expiration (108) — — Settlements — — — Balance at December 31: $ 3,035 $ 3,143 $ 3,143 |
Schedule of Deferred Tax Assets and Liabilities | The net deferred tax assets (liabilities) at December 31, 2023 and 2022 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 71,051 $ 53,393 Royalty income 8,378 — Share-based compensation 7,347 4,684 Orphan drug and R&D tax credit 4,065 4,964 Capitalized research costs 1,738 2,108 Interest expense carryforward 1,368 1,216 Other 1,322 1,521 Amortization 1,159 3,541 Gross deferred tax assets 96,428 71,427 Deferred tax liabilities: Prepaid expenses — (86) Gross deferred tax liabilities — (86) Less: valuation allowances (96,428) (71,341) Net deferred tax assets $ — $ — |
Other Assets and Liabilities (T
Other Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets: 2023 2022 Prepaid and other expenses $ 4,373 $ 1,523 Other 913 573 Total $ 5,286 $ 2,096 |
Schedule of Other Non-Current Assets | Other Non-Current Assets: 2023 2022 Right of use assets at contract manufacturing organizations $ 9,905 $ 10,686 Other 247 636 Total $ 10,152 $ 11,322 |
Schedule of Accrued Expenses | Accrued Expenses: 2023 2022 Accrued professional fees $ 11,767 $ 4,040 Accrued compensation 7,492 1,613 Reserve for variable consideration 4,044 — Royalty payable to RTW 730 — Accrued outsourced contract costs 194 1,208 Accrued restructuring — 473 Total $ 24,227 $ 7,334 |
Schedule of Other Current Liabilities | Other Current Liabilities: 2023 2022 Other $ 261 $ 292 Accrued interest — 1,649 Total $ 261 $ 1,941 |
Schedule of Other Non-Current Liabilities | Other Non-Current Liabilities: 2023 2022 Tax liabilities $ 5,407 $ 5,246 Other 247 497 Total $ 5,654 $ 5,743 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Compensation Expense for Share-Based Compensation Arrangements | Compensation expense included in the Company’s consolidated statements of loss for all share-based compensation arrangements was as follows for the periods ended December 31, 2023, 2022, and 2021, respectively: Share-based Compensation Expense: 2023 2022 2021 Selling, general and administrative $ 15,248 $ 6,844 $ 8,114 Research and development 563 169 758 Total share-based compensation expense $ 15,811 $ 7,013 $ 8,872 |
Schedule of Weighted-Average Assumptions | The weighted-average assumptions under the Black-Scholes option-pricing model for stock option grants as of December 31, 2023, 2022 and 2021 are as follows: Stock Option Assumptions: 2023 2022 2021 Stock option grants: Expected term (years) 6.2 6.1 6.2 Expected volatility 100.1 % 93.4 % 73.9 % Risk-free interest rate 3.9 % 2.7 % 1.1 % Expected dividend yield — — — |
Summary of Stock Option Activity | A summary of the combined stock option activity and other data for the Company’s stock option plans for the year ended December 31, 2023 is as follows: Stock Option Activity and Other Data: Number of Stock Weighted Average Weighted Average Aggregate Stock options outstanding, January 1, 2023 9,304 $ 6.67 Granted 1,437 11.34 Exercised (342) 6.02 Forfeited (96) 12.58 Expired (4) 7.36 Stock options outstanding, December 31, 2023 10,299 $ 7.29 7.2 $ 811 Stock options exercisable, December 31, 2023 6,337 $ 6.82 6.3 $ 627 |
Summary of Restricted Share Awards | A summary of the Company’s restricted share awards as of December 31, 2023, 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, 2023 56 $ 7.95 Granted — — Vested (33) 7.77 Forfeited — — Non-vested restricted share awards outstanding, December 31, 2023 23 $ 8.20 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Reconciliation of Basic and Diluted Net Loss Per Share | A reconciliation of basic and diluted net loss per share, together with the related shares outstanding in thousands for the years ended December 31, 2023, 2022 and 2021, is as follows: Net Loss Per Share: 2023 2022 2021 Net loss $ (160,276) $ (137,464) $ (77,329) Weighted average shares: Basic shares 80,174 60,094 58,535 Effect of dilutive securities—employee and director equity awards outstanding — — — Diluted shares 80,174 60,094 58,535 Net loss per share - basic $ (2.00) $ (2.29) $ (1.32) Net loss per share - diluted $ (2.00) $ (2.29) $ (1.32) |
Comprehensive Loss (Tables)
Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Accumulated Other Comprehensive Loss | The following table shows the components of accumulated other comprehensive loss for the year ended December 31, net of immaterial tax effects: Accumulated Other Comprehensive Loss: 2023 2022 2021 Foreign currency translation adjustment: Beginning balance $ (24,452) $ (23,855) $ (22,627) Net other comprehensive income (loss) 331 (597) (1,228) Balance at December 31, $ (24,121) $ (24,452) $ (23,855) Unrealized gain (loss) on marketable securities, net Beginning balance $ (1,889) $ (85) $ 1,576 Net other comprehensive income (loss), net of income tax benefit of $0, $0, and $214, respectively 2,843 (1,804) (1,661) Balance at December 31, $ 954 $ (1,889) $ (85) Accumulated other comprehensive loss at December 31, $ (23,167) $ (26,341) $ (23,940) |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Segment Reporting [Abstract] | |
Long-lived Assets by Geographic Areas | The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2023 and 2022: Long-lived Assets by Geographic Region: 2023 2022 U.S. $ 18,413 $ 19,414 Ireland 11,751 11,296 Total $ 30,164 $ 30,710 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) $ / shares in Units, shares in Thousands | 1 Months Ended | 12 Months Ended | |||||||||
Aug. 01, 2023 USD ($) | Jun. 26, 2023 USD ($) $ / shares shares | Apr. 04, 2023 USD ($) | Apr. 03, 2023 USD ($) $ / shares shares | Mar. 29, 2023 USD ($) | Oct. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Mar. 31, 2023 USD ($) | Feb. 01, 2023 USD ($) | |
Class of Stock [Line Items] | |||||||||||
Royalty financing, proceeds, maximum | $ 75,000,000 | ||||||||||
Proceeds from royalty purchase agreement | $ 30,000,000 | $ 0 | $ 0 | ||||||||
Royalty financing, quarterly net revenue target | $ 25,000,000 | ||||||||||
Debt converted, shares issued (in shares) | shares | 12,347 | ||||||||||
Ordinary shares, nominal value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | |||||||
Net proceeds from shares issued | $ 134,151,000 | ||||||||||
ADSs, conversion ratio | 0.1161846 | ||||||||||
Debt converted | $ 1,470,000 | ||||||||||
Advertising expenses | $ 6,452,000 | $ 0 | 0 | ||||||||
Goodwill impairment loss | $ 0 | 0 | |||||||||
Customer Concentration Risk | Accounts receivable | Three customers | |||||||||||
Class of Stock [Line Items] | |||||||||||
Concentration risk, percentage | 100% | ||||||||||
Customer Concentration Risk | Accounts receivable | Caremark | |||||||||||
Class of Stock [Line Items] | |||||||||||
Concentration risk, percentage | 52% | ||||||||||
Customer Concentration Risk | Accounts receivable | Accredo | |||||||||||
Class of Stock [Line Items] | |||||||||||
Concentration risk, percentage | 28% | ||||||||||
Customer Concentration Risk | Accounts receivable | Optum | |||||||||||
Class of Stock [Line Items] | |||||||||||
Concentration risk, percentage | 20% | ||||||||||
American Depositary Shares | |||||||||||
Class of Stock [Line Items] | |||||||||||
Debt converted, shares issued (in shares) | shares | 408 | ||||||||||
Ordinary shares | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued (in shares) | shares | 12,205 | ||||||||||
Series B Non-Voting Convertible Preferred Shares | |||||||||||
Class of Stock [Line Items] | |||||||||||
Shares issued (in shares) | shares | 4,706 | ||||||||||
Royalty Financing | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from royalty purchase agreement | $ 30,000,000 | $ 30,000,000 | |||||||||
October 2023 Notes | |||||||||||
Class of Stock [Line Items] | |||||||||||
Debt repaid | $ 21,165,000 | 0 | $ 0 | ||||||||
October 2023 Notes | Senior Notes | |||||||||||
Class of Stock [Line Items] | |||||||||||
Principal amount | $ 21,187,000 | $ 117,375,000 | $ 117,375,000 | $ 17,500,000 | |||||||
Interest rate | 4.50% | 4.50% | |||||||||
Debt exchanged | $ 96,188,000 | ||||||||||
Debt repaid | $ 21,641,000 | ||||||||||
April 2027 Notes | Senior Notes | |||||||||||
Class of Stock [Line Items] | |||||||||||
Principal amount | $ 106,268,000 | ||||||||||
Interest rate | 6% | ||||||||||
Debt converted | $ 106,268,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment Useful Lives (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Software, office and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life (in years) | 3 years | ||
Leasehold improvements, furniture, fixtures and fittings | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life (in years) | 2 years | ||
Leasehold improvements, furniture, fixtures and fittings | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life (in years) | 10 years | ||
Fixed Assets and Right Of Use Assets, Contract Manufacturing Organizations | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, useful life (in years) | 5 years | ||
Amortization | $ 588 | $ 391 | $ 0 |
Newly Issued Accounting Stand_2
Newly Issued Accounting Standards (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | $ 87,739 | $ (21,145) | $ 78,244 | $ 162,266 |
Additional paid-in capital | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | 855,452 | 589,783 | 549,349 | 566,916 |
Accumulated deficit | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Total shareholders’ (deficit) equity | $ (745,496) | (585,220) | (447,756) | (384,187) |
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) | (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 | $ 13,760 | ||
Senior Notes | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Long-term debt | $ 129,282 | |||
4.50 Percent Exchangeable Senior Notes Due 2023 | Senior Notes | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Interest rate | 4.50% |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Concentration Risk [Line Items] | |||
Net product revenue | $ 27,963,000 | $ 0 | $ 0 |
Three customers | Revenue from Contract with Customer Benchmark | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 100% | ||
Accredo | Revenue from Contract with Customer Benchmark | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 41% | ||
Caremark | Revenue from Contract with Customer Benchmark | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 39% | ||
Optum | Revenue from Contract with Customer Benchmark | Customer Concentration Risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, percentage | 20% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 73,944 | $ 22,518 |
Mutual and money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 22,518 | |
Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 73,944 | |
Fair Value Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 73,944 | 22,518 |
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 | 0 | 22,518 |
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 | 73,944 | 0 |
Fair Value Measurements, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
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 | 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 | ||
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 | Government securities - U.S. | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 0 | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | $ 72,990 | $ 24,407 |
Unrealized Gains | 954 | 0 |
Unrealized Losses | 0 | (1,889) |
Fair Value | 73,944 | 22,518 |
Government securities - U.S. | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 72,990 | |
Unrealized Gains | 954 | |
Unrealized Losses | 0 | |
Fair Value | $ 73,944 | |
Mutual and money market funds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 24,407 | |
Unrealized Gains | 0 | |
Unrealized Losses | (1,889) | |
Fair Value | $ 22,518 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |||
Marketable securities, realized gains | $ 988 | $ 584 | $ 174 |
Marketable securities, realized loss | $ 2,791 | $ 2,338 | $ 275 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Contractual Maturity Dates (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Total | $ 73,944 | $ 22,518 |
Total | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 73,944 | |
1-5 Years | 0 | |
5-10 Years | 0 | |
Greater than 10 Years | 0 | |
Total | 73,944 | |
Government securities - U.S. | ||
Debt Securities, Available-for-sale [Line Items] | ||
Less than 1 Year | 73,944 | |
1-5 Years | 0 | |
5-10 Years | 0 | |
Greater than 10 Years | 0 | |
Total | $ 73,944 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials and supplies | $ 5,291 | |
Work in process | 2,037 | |
Finished goods | 3,052 | |
Total | $ 10,380 | $ 0 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | |||
Less - accumulated depreciation | $ (881) | $ (627) | |
Property and equipment, net | 585 | 839 | |
Depreciation | 254 | 162 | $ 97 |
Software, office and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 832 | 832 | |
Furniture, fixtures and fittings | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 634 | $ 634 |
Goodwill (Details)
Goodwill (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Goodwill | $ 16,836,000 | $ 16,836,000 |
Impairment loss related to goodwill | $ 0 | $ 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Lessee, Lease, Description [Line Items] | ||
Increase in operating lease liabilities | $ 1,803 | |
Operating lease, payments | $ 1,036 | $ 963 |
Operating lease, weighted average remaining lease term (in years) | 3 years 8 months 12 days | |
Operating lease, weighted average discount rate, percent | 7.80% | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 1 year | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Operating lease, term of contract | 5 years |
Leases - Components of lease co
Leases - Components of lease costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | |||
Operating lease costs | $ 1,039 | $ 1,028 | $ 821 |
Sublease income | (123) | (116) | (110) |
Total lease cost | $ 916 | $ 912 | $ 711 |
Leases - Maturities of operatin
Leases - Maturities of operating lease liabilities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Leases [Abstract] | |
2024 | $ 1,091 |
2025 | 683 |
2026 | 477 |
2027 | 477 |
2028 | 316 |
Thereafter | 0 |
Total lease payments | 3,044 |
Less: interest | (420) |
Present value of lease liabilities | $ 2,624 |
Long-Term Debt - Schedule of Lo
Long-Term Debt - Schedule of Long-Term Debt (Details) - Senior Notes - USD ($) $ in Thousands | Oct. 31, 2023 | Mar. 31, 2023 | Feb. 01, 2023 | Dec. 31, 2022 | Feb. 16, 2018 |
Debt Instrument [Line Items] | |||||
Less: unamortized debt discount and issuance costs, net | $ (5,593) | ||||
Net carrying amount of liability component | 129,282 | ||||
Less: current maturities, net of $1,019 unamortized debt discount and issuance costs | (37,668) | ||||
Long-term debt | 91,614 | ||||
Unamortized debt discount and issuance costs | 1,019 | ||||
October 2023 Notes | |||||
Debt Instrument [Line Items] | |||||
Principal amount | $ 21,187 | $ 117,375 | $ 17,500 | $ 117,375 | |
Interest rate | 4.50% | 4.50% | |||
February 2023 Notes | |||||
Debt Instrument [Line Items] | |||||
Principal amount | $ 17,500 | ||||
Interest rate | 4.50% | 4.50% |
Long-Term Debt - Narrative (Det
Long-Term Debt - Narrative (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Jun. 26, 2023 USD ($) $ / shares shares | Apr. 04, 2023 USD ($) | Apr. 05, 2022 USD ($) | Feb. 16, 2018 USD ($) | Oct. 31, 2023 USD ($) shares | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Apr. 03, 2023 $ / shares | Mar. 31, 2023 USD ($) | Feb. 01, 2023 USD ($) | Nov. 04, 2022 USD ($) | |
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Interest expense | $ 9,886 | $ 12,342 | $ 9,942 | |||||||||
Amortization of debt issuance costs and debt discount | 2,796 | 6,052 | 1,248 | |||||||||
Proceeds from issuance of long-term debt | 30,000 | 0 | 0 | |||||||||
Payments of debt issuance costs | 4,357 | 4,804 | 0 | |||||||||
Change in fair value of October 2023 Notes conversion feature | $ 5,508 | 5,508 | ||||||||||
Increase in fair value of unseparated embedded conversion feature | 5,508 | |||||||||||
ADSs, conversion ratio | 0.1161846 | |||||||||||
Debt converted | $ 1,470 | |||||||||||
Debt converted, shares issued (in shares) | shares | 12,347 | |||||||||||
Loss on extinguishment of debt | $ 13,129 | $ 13,129 | $ 0 | 0 | ||||||||
Ordinary shares, nominal value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||||||||
American Depositary Shares | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Debt converted, shares issued (in shares) | shares | 408 | |||||||||||
Senior Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Interest expense | $ 6,143 | $ 12,342 | 9,942 | |||||||||
Coupon interest expense | 3,347 | 6,405 | 6,469 | |||||||||
Amortization of debt issuance costs and debt discount | 2,796 | 6,052 | 1,248 | |||||||||
February 2023 Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Debt repaid | 17,500 | $ 8,653 | 0 | |||||||||
February 2023 Notes | Senior Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Interest rate | 4.50% | 4.50% | ||||||||||
Long-term debt, gross | $ 17,500 | |||||||||||
February 2023 Notes | Convertible Debt | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Debt instrument, face amount | $ 125 | |||||||||||
Option to purchase aggregate principal amount, term | 30 days | |||||||||||
Option to increase aggregate principal amount | $ 18,750 | |||||||||||
Proceeds from issuance of long-term debt | $ 137,560 | |||||||||||
October 2023 Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Debt repaid | $ 21,165 | $ 0 | $ 0 | |||||||||
October 2023 Notes | Senior Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Interest rate | 4.50% | 4.50% | ||||||||||
Long-term debt, gross | $ 21,187 | $ 117,375 | $ 117,375 | $ 17,500 | ||||||||
Payments of debt issuance costs | 4,804 | |||||||||||
Debt exchanged | $ 96,188 | |||||||||||
Debt repaid | $ 21,641 | |||||||||||
October 2023 Notes | Senior Notes | Third Party | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Payments of debt issuance costs | 5,450 | |||||||||||
October 2023 Notes | Convertible Debt | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Debt instrument, face amount | 26,375 | |||||||||||
Debt instrument, exchange amount | $ 117,375 | |||||||||||
Debt instrument, repurchased face amount | $ 8,875 | |||||||||||
April 2027 Notes | Senior Notes | ||||||||||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||||||||||
Interest rate | 6% | |||||||||||
Long-term debt, gross | $ 106,268 | |||||||||||
Debt converted | $ 106,268 |
Royalty Financing Obligation -
Royalty Financing Obligation - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Aug. 01, 2023 | Mar. 29, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | |||||
Royalty financing, proceeds, maximum | $ 75,000 | ||||
Proceeds from royalty purchase agreement | $ 30,000 | $ 0 | $ 0 | ||
Royalty financing, quarterly net revenue target | $ 25,000 | ||||
Quarterly royalty payments for royalty financing, percentage | 3.75% | ||||
Royalty Financing | |||||
Debt Instrument [Line Items] | |||||
Proceeds from royalty purchase agreement | $ 30,000 | $ 30,000 | |||
Effective interest rate | 30.40% |
Royalty Financing Obligation _2
Royalty Financing Obligation - Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Aug. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Instrument, Increase (Decrease), Net [Roll Forward] | ||||
Receipt of the first tranche of the royalty financing obligation | $ 30,000 | $ 0 | $ 0 | |
Accretion of imputed interest expense on royalty financing obligation | 9,886 | 12,342 | $ 9,942 | |
Less: royalty payments made to RTW | (253) | |||
Royalty Financing | ||||
Debt Instrument, Increase (Decrease), Net [Roll Forward] | ||||
Royalty financing obligation – beginning balance | 0 | |||
Receipt of the first tranche of the royalty financing obligation | $ 30,000 | 30,000 | ||
Accretion of imputed interest expense on royalty financing obligation | 3,743 | |||
Royalty financing obligation – ending balance | 33,490 | $ 0 | ||
Less: royalty payable to RTW classified within accrued expenses | (730) | |||
Long-term Debt, Excluding Current Maturities | $ 32,760 |
Income Taxes - Income (Loss) Be
Income Taxes - Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | |||
Total loss before income taxes | $ (160,777) | $ (111,439) | $ (93,145) |
Ireland | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | (45,689) | (53,717) | (36,631) |
U.S. | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | (114,942) | (57,755) | (56,687) |
France | |||
Income Taxes [Line Items] | |||
Total loss before income taxes | $ (146) | $ 33 | $ 173 |
Income Taxes - Income Tax Benef
Income Taxes - Income Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | |||
U.S. - State | $ (661) | $ 0 | $ 60 |
Total current | (661) | 0 | 60 |
Deferred: | |||
U.S. - Federal | 0 | 25,896 | (15,876) |
U.S. - State | 160 | 129 | 0 |
Total deferred | 160 | 26,025 | (15,876) |
Income tax (benefit) provision | $ (501) | $ 26,025 | $ (15,816) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Income tax (benefit) provision - at statutory tax rate | $ (20,097) | $ (13,916) | $ (11,642) |
Differences in international tax rates | (6,341) | (9,921) | (8,950) |
Change in valuation allowances | 24,332 | 48,734 | 4,296 |
Nondeductible share-based compensation | 798 | 1,424 | 645 |
Unrealized tax benefits | 160 | 258 | 239 |
State and local taxes (net of federal) | (5,614) | (4,467) | 60 |
Nondeductible interest expense | 4,362 | 4,239 | 2,173 |
Orphan drug and R&D tax credit | 899 | 0 | (1,524) |
Other | 1,000 | (326) | (1,113) |
Income tax (benefit) provision | $ (501) | $ 26,025 | $ (15,816) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | |||
Income tax (benefit) provision | $ (501) | $ 26,025 | $ (15,816) |
Decrease in income tax provision | 26,526 | ||
Unrecognized tax benefits | 3,035 | 3,143 | 2,483 |
Income tax penalties and interest expense | 268 | 258 | 239 |
Income tax penalties and interest accrued | 2,372 | 2,103 | $ 1,777 |
Unremitted earnings | 3,854 | ||
Research tax credit receivable | 1,654 | 3,480 | |
Orphan Drug tax credit | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | 3,059 | ||
Research and Development tax credits | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | 1,005 | ||
Ireland | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 111,647 | ||
Operating loss carryforwards, valuation allowance (decrease) | 25,087 | ||
Gross research tax credit | 817 | 568 | |
U.S. | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 212,426 | ||
U.S. | 163(j) Credits | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | 5,469 | ||
France | |||
Income Taxes [Line Items] | |||
Gross research tax credit | 837 | $ 2,912 | |
FSC | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 10,365 | ||
U.S. Holdings | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 195,595 | ||
U.S. Holdings | State | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 6,466 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Unrecognized Tax Benefit Activity [Roll Forward] | |||
Beginning balance | $ 3,143 | $ 3,143 | $ 3,143 |
Increases for tax positions of prior years | 0 | 0 | 0 |
Statute of limitations expiration | (108) | 0 | 0 |
Settlements | 0 | 0 | 0 |
Ending balance | $ 3,035 | $ 3,143 | $ 3,143 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 71,051 | $ 53,393 |
Royalty income | 8,378 | 0 |
Share-based compensation | 7,347 | 4,684 |
Amortization | 1,159 | 3,541 |
Orphan drug and R&D tax credit | 4,065 | 4,964 |
Capitalized research costs | 1,738 | 2,108 |
Other | 1,322 | 1,521 |
Interest expense carryforward | 1,368 | 1,216 |
Gross deferred tax assets | 96,428 | 71,427 |
Deferred tax liabilities: | ||
Prepaid expenses | 0 | (86) |
Gross deferred tax liabilities | 0 | (86) |
Less: valuation allowances | (96,428) | (71,341) |
Net deferred tax assets | $ 0 | $ 0 |
Other Assets and Liabilities -
Other Assets and Liabilities - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Prepaid and other expenses | $ 4,373 | $ 1,523 |
Other | 913 | 573 |
Total | $ 5,286 | $ 2,096 |
Other Assets and Liabilities _2
Other Assets and Liabilities - Other Non-Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Right of use assets at contract manufacturing organizations | $ 9,905 | $ 10,686 |
Other | 247 | 636 |
Total | $ 10,152 | $ 11,322 |
Other Assets and Liabilities _3
Other Assets and Liabilities - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Accrued professional fees | $ 11,767 | $ 4,040 |
Accrued compensation | 7,492 | 1,613 |
Reserve for variable consideration | 4,044 | 0 |
Royalty payable to RTW | 730 | 0 |
Accrued outsourced contract costs | 194 | 1,208 |
Accrued restructuring | 0 | 473 |
Total | $ 24,227 | $ 7,334 |
Other Assets and Liabilities _4
Other Assets and Liabilities - Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Other | $ 261 | $ 292 |
Accrued interest | 0 | 1,649 |
Other current liabilities | $ 261 | $ 1,941 |
Other Assets and Liabilities _5
Other Assets and Liabilities - Other Non-Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Tax liabilities | $ 5,407 | $ 5,246 |
Other | 247 | 497 |
Total | $ 5,654 | $ 5,743 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Feb. 28, 2018 | Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Purchase commitment, period (in years) | 5 years | ||
Other | $ 247 | $ 497 | |
Minimum | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Contractual obligation, annual amount | 2,700 | ||
Maximum | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Contractual obligation, annual amount | 4,200 | ||
Discontinued Operations, Disposed of by Sale | 2016 MIPA | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Other | 501 | ||
Discontinued Operations, Disposed of by Sale | Cerecor | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Guaranty assets | $ 495 | ||
FSC | Discontinued Operations, Disposed of by Sale | 2016 MIPA | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||
Percentage of royalty payable on net sales | 15% | ||
Royalty payable on net sales, maximum | $ 10,300 |
Equity Instruments and Transa_2
Equity Instruments and Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Apr. 03, 2023 | Feb. 29, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 26, 2023 | Aug. 31, 2022 | |
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 | $ 0.01 | ||
Ordinary shares, shares issued (in shares) | 89,825,000 | 62,878,000 | ||||
Ordinary shares, shares outstanding (in shares) | 89,825,000 | 62,878,000 | ||||
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) | 5,194,000 | 488,000 | ||||
Preferred shares, shares outstanding (in shares) | 5,194,000 | 488,000 | ||||
Net proceeds from shares issued | $ 134,151 | |||||
Prepaid expenses and other current assets | $ 5,286 | $ 2,096 | ||||
Restricted Shares | ||||||
Class of Stock [Line Items] | ||||||
Granted (in shares) | 0 | 0 | ||||
Ordinary shares | ||||||
Class of Stock [Line Items] | ||||||
Shares issued (in shares) | 12,205,000 | |||||
Series B Non-Voting Convertible Preferred Shares | ||||||
Class of Stock [Line Items] | ||||||
Shares issued (in shares) | 4,706,000 | |||||
2020 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Maximum aggregate offering price of securities under shelf registration | $ 250 | |||||
Maximum aggregate offering price of ADSs under shelf registration | $ 50 | |||||
Sales agent commission, as a percent of aggregate gross sales proceeds | 3% | |||||
At-the-market offering program | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock, net of issuance costs | $ 11,913 | $ 25,318 | ||||
Net proceeds from shares issued | 11,913 | |||||
Remaining authorized aggregate offering price under registration | 96,064 | |||||
At-the-market offering program | Ordinary shares | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock, net of issuance costs | $ 16 | $ 36 | ||||
At-the-market offering program | American Depositary Shares | ||||||
Class of Stock [Line Items] | ||||||
Shares issued (in shares) | 1,564,000 | 3,588,000 | ||||
2022 Shelf Registration Statement | ||||||
Class of Stock [Line Items] | ||||||
Maximum aggregate offering price of securities under shelf registration | $ 500 | |||||
Maximum aggregate offering price of ADSs under shelf registration | $ 100 | |||||
Transaction costs | $ 192 | |||||
Prepaid expenses and other current assets | $ 135 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 15,811 | $ 7,013 | $ 8,872 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 15,248 | 6,844 | 8,114 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 563 | $ 169 | $ 758 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 26, 2023 | Apr. 03, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized compensation expense | $ 13,962 | |||||
Weighted average period for unrecognized expense (in years) | 2 years 6 months | |||||
Stock-based compensation expense | $ 15,811 | $ 7,013 | $ 8,872 | |||
Aggregate intrinsic value of options exercised | $ 2,612 | $ 877 | $ 249 | |||
Grant date fair value of options granted (in usd per share) | $ 9.14 | $ 4.02 | $ 5.36 | |||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | $ 0.01 | $ 0.01 | $ 0.01 | ||
Inducement Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Maximum number of shares reserved and available for issuance (in shares) | 1,500,000 | |||||
Shares available for issuance (in shares) | 348,000 | |||||
2017 Avadel Employee Share Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for issuance (in shares) | 1,000,000 | |||||
Ordinary shares, nominal value (in usd per share) | $ 0.01 | |||||
Purchase price of common stock, percentage | 85% | |||||
Performance Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 6,996 | |||||
Weighted average grant fair value of free share awards (in usd per share) | $ 8.20 | |||||
Awards that did not have an accounting grant date (in shares) | 555,000 | |||||
Granted (in shares) | 0 | 0 | ||||
Performance Shares | Share-based Payment Arrangement, Employee | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 47,000 | 75,000 | 17,000 | |||
Performance Shares | Vest Upon the Achievement of Certain Regulatory Milestones | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50% | |||||
Performance Shares | Vest One Year Following Achievement of Milestones | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50% | |||||
Vesting period (in years) | 1 year | |||||
Performance Shares | Vest Upon Achievement of Certain Corporate Objectives | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50% | |||||
Performance Shares | Vest One Year Following Achievement of Certain Corporate Objectives | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 50% | |||||
Vesting period (in years) | 1 year | |||||
Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 4 years | |||||
Number of shares authorized (in shares) | 6,883,000 | |||||
Expiration period (in years) | 10 years | |||||
Stock Option | Board of Directors | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 1 year | 3 years | ||||
Expiration period (in years) | 10 years | 10 years | ||||
Restricted Shares | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average grant fair value of free share awards (in usd per share) | $ 0 | $ 8.22 | ||||
Granted (in shares) | 0 | 0 | ||||
Restricted Share Awards Granted to Employees | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period (in years) | 4 years | |||||
Restricted Share Awards Granted to Employees | Tranche One | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 25% | |||||
Restricted Share Awards Granted to Employees | Tranche Two | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 25% | |||||
Restricted Share Awards Granted to Employees | Tranche Three | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 25% | |||||
Restricted Share Awards Granted to Employees | Tranche Four | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting percentage | 25% |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 2 years 6 months | ||
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 1 month 6 days | 6 years 2 months 12 days |
Expected volatility | 100.10% | 93.40% | 73.90% |
Risk-free interest rate | 3.90% | 2.70% | 1.10% |
Expected dividend yield | 0% | 0% | 0% |
Share-Based Compensation - St_2
Share-Based Compensation - Stock Options (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Stock Options, Outstanding [Roll Forward] | |
Stock options outstanding, beginning balance (in shares) | shares | 9,304 |
Granted (in shares) | shares | 1,437 |
Exercised (in shares) | shares | (342) |
Forfeited (in shares) | shares | (96) |
Expired (in shares) | shares | (4) |
Stock options outstanding, ending balance (in shares) | shares | 10,299 |
Stock options exercisable (in shares) | shares | 6,337 |
Stock Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Stock options outstanding, beginning balance (in usd per share) | $ / shares | $ 6.67 |
Granted (in usd per share) | $ / shares | 11.34 |
Exercised (in usd per share) | $ / shares | 6.02 |
Forfeited (in usd per share) | $ / shares | 12.58 |
Expired (in usd per share) | $ / shares | 7.36 |
Stock options outstanding, ending balance (in usd per share) | $ / shares | 7.29 |
Stock options exercisable (in usd per share) | $ / shares | $ 6.82 |
Stock options outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 2 months 12 days |
Stock options exercisable, Weighted Average Remaining Contractual Life (in years) | 6 years 3 months 18 days |
Stock options outstanding, Aggregate Intrinsic Value | $ | $ 811 |
Stock options exercisable, Aggregate Intrinsic Value | $ | $ 627 |
Share-Based Compensation - Rest
Share-Based Compensation - Restricted Share Activity (Details) - Restricted Shares - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Free Share Activity and Other Data, Nonvested [Roll Forward] | |||
Outstanding, beginning balance (in shares) | 56,000 | ||
Granted (in shares) | 0 | 0 | |
Vested (in shares) | (33,000) | ||
Forfeited (in shares) | 0 | ||
Outstanding, ending balance (in shares) | 23,000 | 56,000 | |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | |||
Nonvested free share award, beginning balance (in usd per share) | $ 7.95 | ||
Granted (in usd per share) | 0 | $ 8.22 | |
Vested (in usd per share) | 7.77 | ||
Forfeited (in usd per share) | 0 | ||
Nonvested free share award, ending balance (in usd per share) | $ 8.20 | $ 7.95 |
Net Loss Per Share - Reconcilia
Net Loss Per Share - Reconciliation of basic and diluted EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (160,276) | $ (137,464) | $ (77,329) |
Weighted average shares: | |||
Basic shares (in shares) | 80,174 | 60,094 | 58,535 |
Effect of dilutive securities—employee and director equity awards outstanding (in shares) | 0 | 0 | 0 |
Diluted shares (in shares) | 80,174 | 60,094 | 58,535 |
Net loss per share - basic (in usd per share) | $ (2) | $ (2.29) | $ (1.32) |
Net loss per share - diluted (in usd per share) | $ (2) | $ (2.29) | $ (1.32) |
Net Loss Per Share - Narrative
Net Loss Per Share - Narrative (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |||
Antidilutive securities excluded from computation of earnings per share (in shares) | 513 | 17,941 | 15,327 |
Comprehensive Loss (Details)
Comprehensive Loss (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
Beginning balance | $ (21,145) | $ 78,244 | $ 162,266 |
Net other comprehensive income (loss) | (157,102) | (139,865) | (80,218) |
Ending balance | 87,739 | (21,145) | 78,244 |
Net other comprehensive income (loss), tax benefit | 0 | 0 | 214 |
Foreign currency translation adjustment | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
Beginning balance | (24,452) | (23,855) | (22,627) |
Net other comprehensive income (loss) | 331 | (597) | (1,228) |
Ending balance | (24,121) | (24,452) | (23,855) |
Unrealized gain (loss) on marketable securities, net | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
Beginning balance | (1,889) | (85) | 1,576 |
Net other comprehensive income (loss) | 2,843 | (1,804) | (1,661) |
Ending balance | 954 | (1,889) | (85) |
Accumulated other comprehensive loss | |||
AOCI Attributable to Parent, Net of Tax [Roll Forward] | |||
Beginning balance | (26,341) | (23,940) | (21,051) |
Ending balance | $ (23,167) | $ (26,341) | $ (23,940) |
Segment Information - Narrative
Segment Information - Narrative (Details) | 12 Months Ended |
Dec. 31, 2023 segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Number of reportable segments | 1 |
Segment Information - Long-Live
Segment Information - Long-Lived Assets by Geographic Region (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Long-lived Assets by Geographic Region: | ||
Long-lived assets | $ 30,164 | $ 30,710 |
U.S. | ||
Long-lived Assets by Geographic Region: | ||
Long-lived assets | 18,413 | 19,414 |
Ireland | ||
Long-lived Assets by Geographic Region: | ||
Long-lived assets | $ 11,751 | $ 11,296 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | $ 71,341 | $ 24,025 | $ 21,624 |
Additions | 30,918 | 48,734 | 4,235 |
Deductions | (6,586) | 0 | (51) |
Other Changes | 755 | (1,418) | (1,783) |
Balance at end of period | $ 96,428 | $ 71,341 | $ 24,025 |