Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 13, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Avadel Pharmaceuticals PLC | ||
Entity Central Index Key | 0001012477 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Trading Symbol | AVDL | ||
Entity Common Stock, Shares Outstanding | 37,355,511 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2018 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Emerging Growth Company | false | ||
Entity Smaller Reporting Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 221,263,931 |
Consolidated Statements of (Los
Consolidated Statements of (Loss) Income - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | |||
Total revenues | $ 103,269 | $ 173,245 | $ 150,246 |
Operating expenses: | |||
Cost of products | 17,516 | 16,301 | 13,248 |
Research and development expenses | 39,329 | 33,418 | 34,611 |
Selling, general and administrative expenses | 100,359 | 58,860 | 44,179 |
Intangible asset amortization | 6,619 | 3,659 | 13,888 |
(Gain) loss - changes in fair value of related party contingent consideration | (22,731) | (31,040) | 49,285 |
Impairment of intangible asset | 66,087 | 0 | 0 |
Restructuring costs | 1,016 | 2,542 | 0 |
Total operating expenses | 208,195 | 83,740 | 155,211 |
Operating (loss) income | (104,926) | 89,505 | (4,965) |
Investment and other income, net | 452 | 2,136 | 2,758 |
Interest expense | (10,622) | (1,052) | (963) |
Other income (expense) - changes in fair value of related party payable | 1,899 | 2,071 | (6,548) |
(Loss) income before income taxes | (113,197) | 92,660 | (9,718) |
Income tax (benefit) provision | (17,893) | 24,389 | 31,558 |
Net (loss) income | $ (95,304) | $ 68,271 | $ (41,276) |
Earnings (loss) per share | |||
Net income (loss) per share - basic (in usd per share) | $ (2.55) | $ 1.69 | $ (1) |
Net income (loss) per share - diluted (in usd per share) | $ (2.55) | $ 1.63 | $ (1) |
Weighted average number of shares outstanding | |||
Weighted average number of shares outstanding - basic (in shares) | 37,325 | 40,465 | 41,248 |
Weighted average number of shares outstanding - diluted (in shares) | 37,325 | 41,765 | 41,248 |
Product sales | |||
Revenues: | |||
Total revenues | $ 101,423 | $ 172,841 | $ 147,222 |
License revenue | |||
Revenues: | |||
Total revenues | $ 1,846 | $ 404 | $ 3,024 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net (loss) income | $ (95,304) | $ 68,271 | $ (41,276) |
Other comprehensive income (loss), net of tax: | |||
Foreign currency translation (loss) gain | (419) | 134 | (1,024) |
Net other comprehensive income, net of ($18), $28, $16 tax, respectively | 269 | 165 | 116 |
Total other comprehensive (loss) income, net of tax | (150) | 299 | (908) |
Total comprehensive (loss) income | $ (95,454) | $ 68,570 | $ (42,184) |
Consolidated Statements of Co_2
Consolidated Statements of Comprehensive (Loss) Income (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Unrealized gain (loss) on marketable securities, tax | $ (18) | $ 28 | $ 16 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 9,325 | $ 16,564 |
Marketable securities | 90,590 | 77,511 |
Accounts receivable | 11,330 | 14,785 |
Inventories, net | 4,770 | 6,157 |
Prepaid expenses and other current assets | 8,836 | 8,958 |
Total current assets | 124,851 | 123,975 |
Property and equipment, net | 1,911 | 3,001 |
Goodwill | 18,491 | 18,491 |
Intangible assets, net | 1,629 | 92,289 |
Research and development tax credit receivable | 7,272 | 5,272 |
Other non-current assets | 36,146 | 10,249 |
Total assets | 190,300 | 253,277 |
Current liabilities: | ||
Current portion of long-term debt | 106 | 111 |
Current portion of long-term related party payable | 9,439 | 25,007 |
Accounts payable | 3,503 | 7,477 |
Deferred revenue | 114 | 2,007 |
Accrued expenses | 21,695 | 50,926 |
Income taxes | 73 | 414 |
Other current liabilities | 3,453 | 597 |
Total current liabilities | 38,383 | 86,539 |
Long-term debt, less current portion | 115,734 | 156 |
Long-term related party payable, less current portion | 19,401 | 73,918 |
Other non-current liabilities | 14,002 | 7,084 |
Total liabilities | 187,520 | 167,697 |
Shareholders’ equity: | ||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; none issued or outstanding at December 31, 2018 and December 31, 2017, respectively | 0 | 0 |
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 42,720 issued and 37,313 outstanding at December 31, 2018, and 41,463 issued and 39,346 outstanding at December 31, 2017 | 427 | 414 |
Treasury shares, at cost, 5,407 and 2,117 shares held at December 31, 2018 and December 31, 2017, respectively | (49,998) | (22,361) |
Additional paid-in capital | 433,756 | 393,478 |
Accumulated deficit | (357,989) | (262,685) |
Accumulated other comprehensive loss | (23,416) | (23,266) |
Total shareholders’ equity | 2,780 | 85,580 |
Total liabilities and shareholders’ equity | $ 190,300 | $ 253,277 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) | Dec. 31, 2018$ / sharesshares | Dec. 31, 2017$ / sharesshares |
Statement of Financial Position [Abstract] | ||
Preferred shares, nominal value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 |
Preferred shares, shares authorized (in shares) | 50,000,000 | 50,000,000 |
Preferred shares, shares issued (in shares) | 0 | 0 |
Preferred shares, shares outstanding (in shares) | 0 | 0 |
Ordinary shares, nominal value (in usd or euro per share) | (per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 |
Ordinary shares, shares issued (in shares) | 42,720,000 | 41,463,000 |
Ordinary shares, shares outstanding (in shares) | 37,313,000 | 39,346,000 |
Treasury shares, held (in shares) | 5,407,000 | 2,117,000 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Ordinary shares | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Treasury Shares |
Beginning balance (in shares) at Dec. 31, 2015 | 41,241 | 0 | ||||
Beginning balance at Dec. 31, 2015 | $ 69,134 | $ 6,331 | $ 363,984 | $ (278,524) | $ (22,657) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net (loss) income | (41,276) | (41,276) | ||||
Other comprehensive loss | (908) | (908) | ||||
Subscription of warrants | 326 | 326 | ||||
Exercise of stock options or warrants (in shares) | 15 | |||||
Exercise of stock options or warrants | 114 | $ 2 | 112 | |||
Vesting of restricted shares (in shares) | 115 | |||||
Vesting of restricted shares | 0 | $ 18 | (18) | |||
Stock-based compensation expense | 14,679 | 14,679 | ||||
Cross-border merger nominal value adjustment | 0 | $ (5,937) | 5,937 | |||
Ending balance (in shares) at Dec. 31, 2016 | 41,371 | 0 | ||||
Ending balance at Dec. 31, 2016 | 42,069 | $ 414 | 385,020 | (319,800) | (23,565) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net (loss) income | 68,271 | 68,271 | ||||
Other comprehensive loss | 299 | 299 | ||||
Exercise of stock options or warrants (in shares) | 69 | |||||
Vesting of restricted shares (in shares) | 23 | |||||
Vesting of restricted shares | 0 | |||||
Stock-based compensation expense | 8,062 | 8,062 | ||||
Exercise of stock options | 396 | 396 | ||||
Share repurchases (in shares) | 2,117 | |||||
Share repurchases | (22,361) | $ (22,361) | ||||
Ending balance (in shares) at Dec. 31, 2017 | 41,463 | 2,117 | ||||
Ending balance at Dec. 31, 2017 | 85,580 | $ 414 | 393,478 | (262,685) | (23,266) | $ (22,361) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Adjustment to accumulated deficit (see Note 12: Income Taxes) | (11,156) | (11,156) | ||||
Net (loss) income | (95,304) | (95,304) | ||||
Other comprehensive loss | (150) | (150) | ||||
Exercise of stock options or warrants (in shares) | 82 | |||||
Vesting of restricted shares (in shares) | 547 | |||||
Vesting of restricted shares | 0 | $ 6 | (6) | |||
Stock-based compensation expense | 7,852 | 7,852 | ||||
Exercise of stock options | $ 535 | $ 1 | 534 | |||
Share repurchases (in shares) | 5,407 | 3,290 | ||||
Share repurchases | $ (27,637) | $ (27,637) | ||||
Exercise of warrants (in shares) | 603 | |||||
Exercise of warrants | 2,911 | $ 6 | 2,905 | |||
Expiration of warrants | 2,167 | 2,167 | ||||
Employee share purchase plan share issuance (in shares) | 25 | |||||
Employee share purchase plan share issuance | 127 | 127 | ||||
Equity component of 2023 Notes | 26,699 | 26,699 | ||||
Ending balance (in shares) at Dec. 31, 2018 | 42,720 | 5,407 | ||||
Ending balance at Dec. 31, 2018 | $ 2,780 | $ 427 | $ 433,756 | $ (357,989) | $ (23,416) | $ (49,998) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net (loss) income | $ (95,304) | $ 68,271 | $ (41,276) |
Adjustments to reconcile net (loss) income to net cash provided by operating activities: | |||
Depreciation and amortization | 7,430 | 4,883 | 14,489 |
Impairment of intangible asset | 66,087 | 0 | 0 |
Amortization of premiums on marketable securities | 2,823 | 732 | 918 |
Remeasurement of related party acquisition-related contingent consideration | (22,731) | (31,040) | 49,285 |
Remeasurement of related party financing-related contingent consideration | (1,899) | (2,071) | 6,548 |
Amortization of debt discount and debt issuance costs | 4,830 | 0 | 0 |
Change in deferred tax and income tax deferred charge | (19,152) | 3,556 | (4,000) |
Stock-based compensation expense | 7,852 | 8,072 | 14,679 |
Other adjustments | 1,365 | (968) | (331) |
Net changes in assets and liabilities | |||
Accounts receivable | 3,452 | 3,054 | (10,050) |
Inventories | 711 | (2,899) | 1,831 |
Prepaid expenses and other current assets | 3,577 | (3,741) | 3,412 |
Research and development tax credit receivable | (2,545) | (3,141) | 397 |
Accounts payable & other current liabilities | (2,032) | 595 | (434) |
Deferred revenue | (1,892) | (216) | (2,923) |
Accrued expenses | (10,640) | 13,187 | 6,764 |
Accrued income taxes | (341) | (786) | 1,778 |
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value | (19,468) | (31,636) | (20,252) |
Royalty payments for related party payable in excess of original fair value | (2,838) | (4,429) | (2,469) |
Other assets and liabilities | (2,001) | (4,761) | 535 |
Net cash (used in) provided by operating activities | (82,716) | 16,662 | 18,901 |
Cash flows from investing activities: | |||
Purchases of property and equipment | (178) | (591) | (1,201) |
Acquisitions of businesses, including cash acquired and other adjustments | 0 | 0 | 628 |
Purchase of intangible assets | (20,000) | (53,111) | 0 |
Proceeds from sales of marketable securities | 359,507 | 189,009 | 71,546 |
Purchases of marketable securities | (376,310) | (151,005) | (107,603) |
Net cash used in investing activities | (36,981) | (15,698) | (36,630) |
Cash flows from financing activities: | |||
Proceeds from debt issuance | 143,750 | 0 | 0 |
Payments for debt issuance costs | (6,190) | 0 | 0 |
Earn-out payments for related party contingent consideration | (645) | (1,246) | (6,892) |
Royalty payments for related party payable | 0 | 0 | (1,225) |
Exercise of warrants | 2,911 | 0 | 0 |
Proceeds from issuance of ordinary shares and warrants | 577 | 404 | 440 |
Share repurchases | (27,637) | (22,361) | 0 |
Other financing activities, net | (107) | (115) | (277) |
Net cash provided by (used in) financing activities | 112,659 | (23,318) | (7,954) |
Effect of foreign currency exchange rate changes on cash and cash equivalents | (201) | (297) | (166) |
Net change in cash and cash equivalents | (7,239) | (22,651) | (25,849) |
Cash and cash equivalents at January 1 | 16,564 | 39,215 | 65,064 |
Cash and cash equivalents at December 31 | 9,325 | 16,564 | 39,215 |
Supplemental disclosures of cash flow information: | |||
Income tax paid | 776 | 19,143 | 27,180 |
Interest paid | $ 3,359 | $ 1,050 | $ 788 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 branded specialty pharmaceutical company. Our primarily focus is on the development and potential FDA approval for FT218 which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, we market three sterile injectable drugs used in the hospital setting which were developed under our “unapproved marketed drug” (UMD) program. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.. Our current marketed products include: • Akovaz® (ephedrine sulfate injection, USP), an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia • Bloxiverz® (neostigmine methylsulfate injection), a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. • Vazculep® (phenylephrine hydrochloride injection), an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Each of our Akovaz , Bloxiverz and Vazculep products is used primarily in the hospital setting and was developed under our UMD program . • Noctiva™ , a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Due to disappointing results after a substantial investment of resources after Noctiva’s commercial launch in March 2018 , Avadel Specialty Pharmaceuticals LLC, (“Specialty Pharma”), the Avadel subsidiary responsible for the marketing and sale of Noctiva, made a voluntary filing for Chapter 11 bankruptcy protection on February 6, 2019. Although Specialty Pharma currently continues its marketing and sales efforts for this product, Avadel anticipates that Specialty Pharma will discontinue all activities with respect to Noctiva during 2019 as a result of the bankruptcy. The Company was incorporated in Ireland on December 1, 2015 as a private limited company, and re-registered as an Irish public limited company on November 21, 2016. Our headquarters are in Dublin, Ireland and we have operations in St. Louis, Missouri, United States, and Lyon, France. The Company is the successor to Flamel Technologies S.A., a French société anonyme (“Flamel”), as the result of the Merger described above, in which Flamel merged with and into the Company at 11:59:59 p.m., Central Europe Time, on December 31, 2016 (the “Merger”) pursuant to the agreement between Flamel and Avadel entitled Common Draft Terms of Cross-Border Merger dated as of June 29, 2016 (the “Merger Agreement”). Immediately prior to the Merger, the Company was a wholly owned subsidiary of Flamel. In accordance with the Merger Agreement, as a result of the Merger: • Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel. • our authorized share capital is $5,500 divided into 500,000 ordinary shares with a nominal value of $0.01 each and 50,000 preferred shares with a nominal value of $0.01 each ◦ all outstanding ordinary shares of Flamel, €0.122 nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company, $0.01 nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying $5,937 on our balance sheet from ordinary shares to additional paid-in capital ◦ our Board of Directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point such an authorization may be renewed by shareholders. The Board of Directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation. • all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company. Thus, the Merger changed the jurisdiction of our incorporation from France to Ireland, and an ordinary share of the Company held (either directly or represented by an ADS) immediately after the Merger continued to represent the same proportional interest in our equity owned by the holder of a share of Flamel immediately prior to the Merger. Prior to completion of the Merger, the Flamel ADSs were listed on the Nasdaq Global Market (“Nasdaq”) under the trading symbol “FLML”; and immediately after the Merger the Company’s ADSs were listed for and began trading on Nasdaq on January 3, 2017 under the trading symbol “AVDL.” Further details about the reincorporation, the Merger and the Merger Agreement are contained in our definitive proxy statement filed with the SEC on July 5, 2016. Under Irish law, the Company can only pay dividends and repurchase shares out of distributable reserves, as discussed further in the Company’s proxy statement filed with the SEC as of July 5, 2016. Upon completion of the Merger, the Company did not have any distributable reserves. On February 15, 2017, the Company filed a petition with the High Court of Ireland seeking the court’s confirmation of a reduction of the Company’s share premium so that it can be treated as distributable reserves for the purposes of Irish law. On March 6, 2017, the High Court issued its order approving the reduction of the Company’s share premium by $317,254 which can be treated as distributable reserves. Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. Our results of operations for the period January 1, 2018 through February 16, 2018 and for the years ended December 31, 2017 and 2016 include the results of FSC Therapeutics and FSC Laboratories, Inc., (collectively “FSC”), prior to its February 16, 2018 disposition date. See Note 16 : Divestiture of the Pediatric Assets , for additional information. All intercompany accounts and transactions have been eliminated. Revenue. Revenue includes sales of pharmaceutical products, licensing fees, and, if any, milestone payments for research and development (“R&D”) achievements. Effective January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modified retrospective transition method applied to all open contracts as at December 31, 2017. The adoption of the new standard did not have a material effect on the overall timing or amount of revenue recognized when compared to prior accounting standards. See Note 3 : Revenue Recognition for expanded disclosures related to this new pronouncement. 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 products primarily through wholesalers and considers these wholesalers to be its customers. Revenue from product sales is recognized when the customer obtains control of the Company’s product, which occurs typically upon receipt by the customer. As is customary in the pharmaceutical industry, the Company’s gross product sales are subject to a variety of price adjustments in arriving at reported net product sales. These adjustments include estimates of product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated based on analysis of historical data for the product or comparable products, future expectations for such products and other judgments and analysis. For generic products and branded products where the ultimate net selling price to customer is estimable, the Company recognizes revenues upon delivery to the wholesaler. For new product launches the Company recognizes revenue if sufficient data is available to determine product acceptance in the marketplace such that product returns may be estimated based on historical or analog product data and there is probable evidence of reorders and consideration is made of wholesaler inventory levels. As part of the third quarter 2016 launch of Akovaz, the Company determined that sufficient data was available to determine the ultimate net selling price to the customer and therefore recognized revenue upon delivery to our wholesaler customers. Prior to the second quarter 2016, the Company did not have sufficient historical or analog product data to estimate certain revenue deductions. As such, we could not accurately estimate the ultimate net selling price of our hospital portfolio of products and as a result delayed revenue recognition until the wholesaler sold the product through to end customers. During the second quarter of 2016, it was determined that we now had sufficient evidence, history, data and internal controls to estimate the ultimate selling price of our products upon shipment from our warehouse to our customers, the wholesalers. Accordingly, we discontinued the sell-through revenue approach and now recognize revenue once the product is delivered to the wholesaler. As a result of this change in accounting estimate, we recognized $5,981 in additional revenue, or $0.05 per diluted share, for the twelve months ended December 31, 2016 that previously would have been deferred until sold by the wholesalers to the hospitals. License Revenue The Company from time to time may enter into out-licensing agreements under which it licenses to third parties certain rights to its products or intellectual property. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; development, regulatory, and commercial milestone payments; and sales-based royalty payments. Each of these payments results in license revenue. For a complete discussion of the accounting for net product revenue and license revenues, see Note 3 : Revenue Recognition . Government Grants. The Company receives financial support for various research or investment projects from governmental agencies. From time to time we receive funds, primarily from the French government, to finance certain R&D projects. These funds are repayable on commercial success of the project. In the absence of commercial success, the Company is released of our obligation to repay the funds and as such the funds are recognized in the consolidated statements of (loss) income as an offset to R&D expense. The absence of commercial success must be formally confirmed by the granting authority. Should the Company wish to discontinue the R&D to which the funding is associated, the granting authority must be informed and a determination made as to how much, if any, of the grant must be repaid. Research and Development (“R&D”). R&D expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, and other R&D expenses. Clinical studies and outside services 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 stock-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. The Company recognizes R&D tax credits received from the French government for spending on innovative R&D as an offset of R&D expenses. Advertising Expenses. We expense the costs of advertising as incurred. Advertising expenses were $17,562 , $2,214 and $1,294 for the years ended December 31, 2018, 2017 and 2016, respectively. Stock-based Compensation. The Company accounts for stock-based compensation based on the estimated grant-date fair value. The fair value of stock options and warrants is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Sholes model, estimates are made of the underlying volatility of AVDL stock, a risk-free rate and an expected term of the option or warrant. We estimated the expected term using a simplified method, as we do not have enough historical exercise data for a majority of such options and warrants 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. We account 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, we determine 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. We recognize deferred tax assets to the extent that we believe that these assets are more likely than not to be realized. In making such a determination, we consider 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 we determine that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) we determine 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, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits in the income tax expense line in the accompanying consolidated statements of (loss) income. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months. Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive income (“AOCI”) in shareholders’ equity, with the exception of unrealized losses believed to be other-than-temporary, if any, which are reported in earnings in the current period. The cost of securities sold is based upon the specific identification method. Accounts Receivable. Accounts receivable are stated at amounts invoiced net of allowances for doubtful accounts and certain other gross to net variable consideration deductions. The Company makes judgments as to our ability to collect outstanding receivables and provides allowances for the portion of receivables deemed uncollectible. Provision is made based upon a specific review of all significant outstanding invoices. A majority of accounts receivable is due from four significant customers. Inventories. Inventories consist of raw materials and finished products, which are stated at lower of cost or net realizable value, using the first-in, first-out (“FIFO”) method. Raw materials used in the production of pre-clinical and clinical products are expensed as R&D costs when consumed. The Company establishes reserves for inventory estimated to be obsolete, unmarketable or slow-moving on a case by case 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: Laboratory equipment 4-8 years Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 5-10 years Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. The Company has determined that we operate in a single segment and has a single reporting unit associated with the development and commercialization of pharmaceutical products. The annual test for goodwill impairment is a two-step process. The first step is a comparison of the fair value of the reporting unit with its carrying amount, including goodwill. If this step indicates impairment, then, in the second step, the loss is measured as the excess of recorded goodwill over the implied fair value of the goodwill. Implied fair value of goodwill is the excess of the fair value of the reporting unit as a whole over the fair value of all separately identified assets and liabilities within the reporting unit. The Company tests goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. During the fourth quarter of 2018, we performed our required annual impairment test of goodwill and have determined that no impairment of goodwill existed at December 31, 2018 or 2017. Long-Lived Assets. Long-lived assets include fixed assets and intangible assets. Intangible assets consist primarily of purchased licenses and intangible assets recognized as part of the Éclat acquisition. Acquired IPR&D has an indefinite life and is not amortized until completion and development of the project, at which time the IPR&D becomes an amortizable asset, for which amortization of such intangible assets is computed using the straight-line method over the estimated useful life of the assets. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. During the fourth quarter of 2018, we recorded a $66,087 impairment charge to the entire acquired developed technology related to Noctiva (see Note 9: Goodwill and Intangible Assets ). The Company had determined that no impairment existed at December 31, 2017. Acquisition-related Contingent Consideration. The acquisition-related contingent consideration payables arising from the acquisition of Éclat Pharmaceuticals (i.e., our hospital products) and FSC (our pediatrics products), which was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018, are accounted for at fair-value (see Note 11: Long-Term Related Party Payable and Note 16: Divestiture of the Pediatric Assets ). The fair value of the warrants issued in connection with the Éclat acquisition were estimated using a Black-Scholes model. A portion of these warrants were exercised on February 23, 2018 and the remaining warrants expired on March 12, 2018. See Note 11: Long-Term Related Party Payable . The fair value of acquisition-related contingent consideration payable is estimated using a discounted cash flow model based on the long-term sales or gross profit forecasts of the specified hospital or pediatric products using an appropriate discount rate. There are a number of estimates used when determining the fair value of these earn-out payments. These estimates include, but are not limited to, the long-term pricing environment, market size, market share the related products are forecast to achieve, the cost of goods related to such products and an appropriate discount rate to use when present valuing the related cash flows. These estimates can and often do change based on changes in current market conditions, competition, management judgment and other factors. Changes to these estimates can have and have had a material impact on our consolidated statements of (loss) income and balance sheets. Changes in fair value of these liabilities are recorded in the consolidated statements of (loss) income within operating expenses as changes in fair value of related party contingent consideration. Financing-related Royalty Agreements. We also entered into two royalty agreements with related parties in connection with certain financing arrangements. We elected the fair value option for the measurement of the financing-related contingent consideration payable associated with the royalty agreements with certain Deerfield and Broadfin entities, both of whom are related parties (see Note 11: Long-Term Related Party Payable ). The fair value of financing-related royalty agreements is estimated using the same components used to determine the fair value of the acquisition-related contingent consideration noted above, with the exception of cost of products sold. Changes to these components can also have a material impact on our consolidated statements of (loss) income and balance sheets. Changes in the fair value of this liability are recorded in the consolidated statements of (loss) income as other income (expense) - changes in fair value of related party payable. Foreign Currency Translation. At December 31, 2018, the reporting currency of the Company and our wholly-owned subsidiaries is the U.S. dollar. Prior to December 31, 2016, each of the Company’s non-U.S. subsidiaries and the parent entity, Flamel, used the Euro as their functional currency. At December 31, 2016, in conjunction with the Merger described above, Avadel determined the U.S. dollar is our functional currency. Subsidiaries and entities that do not use the U.S. dollar as their functional currency translate 1) profit and loss accounts at the average exchange rates during the reporting period, 2) assets and liabilities at period end exchange rates and 3) shareholders’ equity accounts at historical rates. Resulting translation gains and losses are included as a separate component of shareholders’ equity in accumulated other comprehensive loss. Assets and liabilities, excluding available-for-sale marketable securities, denominated in a currency other than the subsidiary’s functional currency are translated to the subsidiary’s functional currency at period end exchange rates with resulting gains and losses recognized in the consolidated statements of (loss) income. Use of Estimates. The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including marketable securities and contingent liabilities at the date of the consolidated financial statements and the reported amounts of sales and expenses during the periods presented. These estimates and assumptions are based on the best information available to management at the balance sheet dates and depending on the nature of the estimate can require significant judgments. Changes to these estimates and judgments can have and have had a material impact on our consolidated statements of (loss) income and balance sheets. Actual results could differ from those estimates under different assumptions or conditions. |
Effect of New Accounting Standa
Effect of New Accounting Standards | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Effect of New Accounting Standards | Effect of New Accounting Standards Recently Adopted Accounting Guidance In March 2017, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) No. 2017-07, “Improving the Presentation of Net Periodic Pension Cost and Net Periodic Postretirement Benefit Costs.” The standard requires the service component of pension and other postretirement benefit expense to be presented in the same statement of income lines as other employee compensation costs, however, the other components will be presented outside of operating income. In addition, only the service cost component will be eligible for capitalization in assets. The Company adopted this standard in the first quarter of 2018 and it had an immaterial impact on our consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments .” ASU 2016-15 identifies how certain cash receipts and cash payments are presented and classified in the Statement of Cash Flows under Topic 230. ASU 2016-15 is effective for the Company for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. ASU 2016-15 should be applied retrospectively and early adoption is permitted, including adoption in an interim period. The Company adopted this standard in the first quarter of 2018 and it had an immaterial impact on our consolidated financial statements. In May 2014, the FASB issued ASU 2014-09 “ Revenue from Contracts with Customers ” which supersedes the most current revenue recognition requirements. This ASU requires entities to recognize revenue in a way that depicts the transfer of goods or services to customers in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services. Through May 2016, the FASB issued ASU 2016-08 “Principal versus Agent Considerations (Reporting Revenue Gross versus Net),” ASU 2016-10 “Identifying Performance Obligations and Licensing,” and ASU 2016-12, “Narrow-Scope Improvements and Practical Expedients,” which provide supplemental adoption guidance and clarification to ASU 2014-09, respectively. The Company adopted this pronouncement under the modified retrospective method of transition in the first quarter of 2018. The adoption of the new standard did not have a material effect on the overall timing or amount of revenue recognized when compared to current accounting standards. The impact to the Company of adopting the new revenue standard primarily relates to additional and expanded disclosures. See Note 3 : Revenue Recognition . In January 2016, the FASB issued ASU 2016-01, “Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities .” The amendments in this update address certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. The new guidance required the change in fair value of equity investments with readily determinable fair values to be recognized through the statement of income. Upon adoption, the change in the fair value of our available-for-sale equity investments is recognized in our consolidated statement of income (loss) rather than as a component of our consolidated statement of comprehensive income (loss). The Company adopted this standard in the first quarter of 2018 and it had an immaterial impact on our consolidated financial statements. Recent Accounting Guidance Not Yet Adopted In August 2018, the FASB issued ASU 2018-13, “ Fair Value Measurement (Topic 820): Disclosure Framework— Changes to the Disclosure Requirement for Fair Value Measurement ” which amends certain disclosure requirements over Level 1, Level 2 and Level 3 fair value measurements. The amendments in ASU 2018-13 are effective for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2018-13. In January 2017, the FASB issued ASU 2017-04, “ Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment.” This update eliminates step 2 from the goodwill impairment test, and requires the goodwill impairment test to be performed by comparing the fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This guidance is effective for the Company in the first quarter of 2020. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company will assess the timing of adoption and impact of this guidance to future impairment considerations. In February 2016, the FASB issued ASU 2016-02, “Leases” which supersedes ASC 840 “Leases” and creates a new topic, ASC 842 “Leases.” This update requires lessees to recognize on their balance sheet a lease liability and a lease asset for all leases, including operating leases, with a term greater than 12 months. The update also expands the required quantitative and qualitative disclosures surrounding leases. This update is effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years, with earlier application permitted. In July 2018, the FASB issued ASU 2018-11 “Targeted Improvements”, amending certain aspects of the new leasing standard. The amendment allows an additional optional transition method whereby an entity records a cumulative effect adjustment to opening retained earnings in the year of adoption without restating prior periods, which the Company has elected. On adoption, the Company currently expects to recognize additional operating liabilities of approximately $5,100 , with corresponding Right of Use (ROU) assets of approximately the same amount based on the present value of the remaining minimum rental payments. The new standard also provides practical expedients for a company’s ongoing accounting. We currently expect to elect the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, we will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. We also currently expect to elect the practical expedient to not separate lease and non-lease components for all of our leases. |
Revenue Recognition (Notes)
Revenue Recognition (Notes) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company generates revenue primarily from the sale of pharmaceutical products to customers. From time to time the Company also generates revenue from licensing arrangements whereby the Company provides access to certain of its intellectual property. Periods prior to January 1, 2018 Product Sales and Services Revenue is generally realized or realizable and earned when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the seller’s price to the buyer is fixed or determinable, and collectability is reasonably assured. The Company recorded revenue from product sales when title and risk of ownership transferred to the customer, which was typically upon delivery to the customer and when the selling price was determinable. Licensing Revenues From time to time, the Company enters into licensing agreements for the license of technology used for developing modified controlled release of oral pharmaceutical products. Non-refundable fees where the Company had continuing performance obligations were deferred and recognized ratably over the projected performance period. Milestone payments, which were typically related to regulatory, commercial or other achievements by the Company or their licensees and distributors, were recognized as revenues when the milestone was accomplished and collection was reasonably assured. Periods commencing January 1, 2018 Product Sales and Services Effective January 1, 2018, the Company implemented ASC 606, Revenue From Contracts With Customers. The Company sells products primarily through wholesalers and considers these wholesalers to be its customers. Under ASC 606, revenue from product sales is recognized when the customer obtains control of the Company’s product and the Company’s performance obligations are met, which occurs typically upon receipt of delivery to the customer. As is customary in the pharmaceutical industry, the Company’s gross product sales are subject to a variety of price deductions in arriving at reported net product sales. These adjustments include estimates for product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated when the product is delivered based on analysis of historical data for the product or comparable products, as well as future expectations for such products. Reserves to reduce Gross Revenues to Net Revenues Revenues from product sales are recorded at the net selling price, which includes estimated reserves to reduce gross product sales to net product sales resulting from product returns, chargebacks, payment discounts, rebates, and other sales allowances that are offered within contracts between the Company and its customers and end users. These reserves 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, except in the case of the estimated reserve for future expired product returns, which are classified as a liability. 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 the Company’s historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates to reduce gross selling price to net selling price to which it expects to be entitled based on the terms of its contracts. The actual selling price ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Product Returns Consistent with industry practice, the Company maintains a returns policy, that generally offers customers a right of return for product that has been purchased from the Company. The Company estimates the amount of product returns and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities based on analysis of historical data for the product or comparable products, as well as future expectations for such products. Chargebacks, Discounts and Rebates Chargebacks, discounts and rebates represent the estimated obligations resulting from contractual commitments to sell products to its customers or end users at prices lower than the list prices charged to our wholesale customers. Customers charge the Company for the difference between the gross selling price they pay for the product and the ultimate contractual price agreed to between the Company and these end users. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable. Chargebacks, discounts and rebates are estimated at the time of sale to the customer. Revenue from licensing arrangements The terms of the Company’s licensing agreements may contain multiple performance obligations, including certain R&D activities. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments. Each of these payments results in license revenues. License of Intellectual Property If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Disaggregation of revenue The Company’s primary source of revenue is from the sale of pharmaceutical products, which are equally affected by the same economic factors as it relates to the nature, amount, timing, and uncertainty of revenue and cash flows. For further detail about the Company’s revenues by product, see Note 21 : Company Operations by Product, Customer and Geography. Contract Balances The Company does not recognize revenue in advance of invoicing its customers and therefore has no related contract assets. A receivable is recognized in the period the Company sells its products and when the Company’s right to consideration is unconditional. See the consolidated balance sheets for the balance of accounts receivable at December 31, 2018 . See below for contract liability discussion and balance related to a license agreement. There were no material deferred contract costs at December 31, 2018 . Transaction Price Allocated to the Remaining Performance Obligation For product sales, the Company generally satisfies its performance obligations within the same period the product is delivered. Product sales recognized in 2018 from performance obligations satisfied (or partially satisfied) in previous periods were immaterial. For certain licenses of intellectual property, specifically those with performance obligations satisfied over time, the Company allocates a portion of the transaction price to that performance obligation and recognizes revenue using an appropriate measure of progress towards development of the product. In December 2018, the Company reached an agreement to exit a contract and our remaining performance obligations and recognized the remaining $1,600 of deferred revenue, which represented the unsatisfied performance obligations associated with a license agreement. At December 31, 2018, the deferred revenue balance related to this obligation is $0 . The Company has elected certain of the practical expedients from the disclosure requirement for remaining performance obligations for specific situations in which an entity need not estimate variable consideration to recognize revenue. Accordingly, the Company applies the practical expedient in ASC 606 to its stand-alone contracts and does not disclose information about variable consideration from remaining performance obligations for which the Company recognizes revenue. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
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, we use 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, we 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, 2018 As of December 31, 2017 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 5) Equity securities $ 9,145 $ — $ — $ 468 $ — $ — Money market funds 52,996 — — 44,481 — — Corporate bonds — 6,339 — — 9,262 — Government securities - U.S. — 12,701 — — 19,050 — Other fixed-income securities — 9,409 — — 4,250 — Total assets $ 62,141 $ 28,449 $ — $ 44,949 $ 32,562 $ — Related party payable (see Note 11) — — 28,840 — — 98,925 Total liabilities $ — $ — $ 28,840 $ — $ — $ 98,925 A review of fair value hierarchy classifications is conducted on a quarterly basis. Changes in the observability of valuation inputs may result in a reclassification for certain financial assets or liabilities. During the fiscal year ended December 31, 2018 , there were no transfers in and out of Level 1, 2, or 3. During the twelve months ended December 31, 2018 , 2017 and 2016 , we did not recognize any other-than-temporary impairment loss. 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. Debt We estimate the fair value of our $143,750 aggregate principal amount of 4.50% exchangeable senior notes due 2023 (the “2023 Notes”), a Level 2 input, based on interest rates that would be currently available to the Company for issuance of similar types of debt instruments with similar terms and remaining maturities or recent trading prices obtained from brokers. The estimated fair value of the 2023 Notes at December 31, 2018 based on recent trading activity was $81,490 compared to a book value of $115,691 . Additionally, the Company’s other debt is reflected in the balance sheet at carrying value, which approximates fair value, as these represent non-interest bearing grants from the French government and are repayable only if the research project is technically or commercially successful. See Note 10 : Long-Term Debt for additional information regarding our debt obligations. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The Company has investments in available-for-sale marketable securities which are recorded at fair market value. Prior to January 1, 2018, unrealized gains and losses on all securities are recorded as other comprehensive income (loss) in shareholders’ equity, net of income tax effects. On January 1, 2018, the Company adopted ASU 2016-01, which requires the change in the fair value of available-for-sale equity investments to be recognized in our consolidated statements of (loss) income rather than as a component of our consolidated statement of comprehensive income (loss). For the year ended December 31, 2018 , the net unrealized loss on our available-for-sale equity investments, recorded as a component of investment income in the accompanying consolidated statements of (loss) income, was $956 . The net unrealized gain on our available-for-sale equity investments was immaterial for the year ended December 31, 2017 and $344 for the year ended December 31, 2016 . These amounts were recorded as other comprehensive income in shareholders’ equity, net of income tax effects for the year ended December 31, 2017 . 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, 2018 and 2017 , respectively: 2018 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Equity securities $ 10,101 $ — $ (956 ) $ 9,145 Money market funds 52,733 316 (53 ) 52,996 Corporate bonds 6,411 7 (79 ) 6,339 Government securities - U.S. 12,714 66 (79 ) 12,701 Other fixed-income securities 9,400 22 (13 ) 9,409 Total $ 91,359 $ 411 $ (1,180 ) $ 90,590 2017 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Equity securities $ 443 $ 31 $ (6 ) $ 468 Money market funds 44,525 — (44 ) 44,481 Corporate bonds 9,285 1 (24 ) 9,262 Government securities - U.S. 19,080 — (30 ) 19,050 Other fixed-income securities 4,259 — (9 ) 4,250 Total $ 77,592 $ 32 $ (113 ) $ 77,511 We determine realized gains or losses on the sale of marketable securities on a specific identification method. We recognized gross realized gains of $317 , $1,677 , and $1,265 for the twelve months ended December 31, 2018 , 2017 , and 2016 , respectively. These realized gains were offset by realized losses of $565 , $1,390 , and $586 for the twelve-months ended December 31, 2018 , 2017 , and 2016 , respectively. We reflect these gains and losses as a component of investment income in the accompanying consolidated statements of (loss) income. The following table summarizes the estimated fair value of our investments in marketable debt securities, accounted for as available-for-sale securities and classified by the contractual maturity date of the securities as of December 31, 2018 : Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Corporate bonds $ 1,511 $ 4,828 $ — $ — $ 6,339 Government securities - U.S. 771 11,145 281 504 12,701 Other fixed-income securities — 9,409 — — 9,409 Total $ 2,282 $ 25,382 $ 281 $ 504 $ 28,449 The Company has classified our investment in available-for-sale marketable securities as current assets in the consolidated balance sheets as the securities need to be available for use, if required, to fund current operations. There are no restrictions on the sale of any securities in our investment portfolio. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The principal categories of inventories, net reserves of $4,757 and $1,039 at December 31, 2018 and 2017 , respectively, are comprised of the following: Inventory: 2018 2017 Finished goods $ 4,270 $ 4,774 Raw materials 500 1,383 Total $ 4,770 $ 6,157 Total net reserves increased by $3,718 during the year ended December 31, 2018 driven largely by approximately $2,583 of reserves related to Noctiva inventory. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net The principal categories of property and equipment, net at December 31, 2018 and 2017 , respectively, are as follows: Property and Equipment, net: 2018 2017 Laboratory equipment $ 8,864 $ 10,135 Software, office and computer equipment 2,487 3,115 Furniture, fixtures and fittings 3,715 4,779 Less - accumulated depreciation (13,155 ) (15,028 ) Total $ 1,911 $ 3,001 Depreciation expense for the years ended December 31, 2018 , 2017 and 2016 was $811 , $1,224 and $601 , respectively. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Acquisitions | Acquisitions On February 5, 2016, the Company acquired FSC, a specialty pharmaceutical company dedicated to providing innovative solutions to unmet medical needs for pediatric patients, from Deerfield CSF, LLC, a Deerfield Management company (“Deerfield CSF”), a related party. The Company disposed of these pediatric assets on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets . This acquisition was accounted for using the acquisition method of accounting and, accordingly, its results were included in the Company’s consolidated financial statements from the date of acquisition until the date of divestiture. Total consideration to acquire FSC was $21,659 , and was funded with a combination of the following, partially offset by $ 467 as a result of a net working capital settlement from the seller: • $15,000 long-term liability to Deerfield CSF. Under the terms of the acquisition agreement, the Company will pay $1,050 annually for five years with a final payment in January 2021 of $15,000 . • an estimate of $ 6,659 in contingent consideration to Deerfield CSF. Under the terms of the acquisition agreement, the Company shall pay quarterly a 15% royalty on the net sales of certain FSC products, up to $12,500 for a period not exceeding ten years. These items were reported in related party payable within the Company’s consolidated balance sheet at December 31, 2017, and is further disclosed in Note 11 : Long-Term Related Party Payable . These related party payables were disposed of as a part of the February 2018 sale. See Note 16 : Divestiture of the Pediatric Assets . The fair values assigned to the acquired assets and liabilities were recognized as follows: Assigned Fair Value: Amount Accounts receivable $ 142 Inventories 1,135 Prepaid expenses and other current assets 1,712 Intangible assets: Acquired product marketing rights 16,600 Acquired developed technology 4,300 Deferred tax assets 853 Other assets 277 Accounts payable and other liabilities (3,827 ) Total $ 21,192 A portion of the transaction attributable to certain intangible assets was taxable for income tax purposes which resulted in recording some of the assets at fair value for both book and tax purposes. Transaction expenses were not material. The useful lives on FSC acquired intangible assets ranged from nine to fifteen years. After its acquisition on February 5, 2016, FSC contributed $5,985 to the Company’s net sales for the twelve-month period ended December 31, 2016. FSC incurred a loss of $5,839 for the twelve-month period ended December 31, 2016. Had the FSC acquisition been completed as of the beginning of 2016, the Company’s unaudited pro forma net revenue and net loss for the twelve months ended December 31, 2016 would have been as follows: Pro Forma Net Revenue and Income (Loss): 2016 Net revenue $ 150,721 Net loss (42,290 ) On February 12, 2018, the Company, together with its subsidiaries Avadel Pharmaceuticals (USA), Inc., Avadel Pediatrics, Inc., FSC Therapeutics, LLC (“FSC Therapeutics”), and Avadel US Holdings, Inc. (“Holdings”), as the “Sellers,” entered into an asset purchase agreement (the “Purchase Agreement”) with Cerecor, Inc. (“Cerecor”). The transaction closed on February 16, 2018 wherein Cerecor purchased from the Sellers four pediatric commercial stage assets – Karbinal™ ER, Cefaclor, Flexichamber™ and AcipHex® Sprinkle™, together with certain associated business assets – which were held by FSC. See Note 16: Divestiture of the Pediatric Assets . |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company’s amortizable and unamortizable intangible assets at December 31, 2018 and 2017 , respectively, are as follows: 2018 2017 Goodwill and Intangible Assets: Gross Value Accumulated Amortization Impairment Net Carrying Amount Gross Value Accumulated Amortization Net Carrying Amount Amortizable intangible assets: Acquired developed technology - Noctiva $ 73,111 $ (7,024 ) $ (66,087 ) $ — $ 73,111 $ (1,401 ) $ 71,710 Acquired developed technology - Vazculep 12,061 (10,432 ) — 1,629 12,061 (9,616 ) 2,445 Acquired product marketing rights (1) — — — — 16,600 (2,132 ) 14,468 Acquired developed technology (1) — — — — 4,300 (634 ) 3,666 Total amortizable intangible assets $ 85,172 $ (17,456 ) $ (66,087 ) $ 1,629 $ 106,072 $ (13,783 ) $ 92,289 Unamortizable intangible assets: Goodwill $ 18,491 $ — $ — $ 18,491 $ 18,491 $ — $ 18,491 Total unamortizable intangible assets $ 18,491 $ — $ — $ 18,491 $ 18,491 $ — $ 18,491 (1) These intangible assets were purchased by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets . The Company recorded amortization expense related to amortizable intangible assets of $6,619 , $3,659 and $13,888 for the years ended December 31, 2018 , 2017 and 2016 , respectively. During the year ended December 31, 2017 , the Company acquired $73,111 in developed technology as part of the Exclusive License and Assignment Agreement (ELAA) with Serenity Pharmaceuticals, LLC. The aggregate cost was composed of an upfront payment of $50,000 , an accrued payment of $20,000 which was paid for Noctiva during the year ended December 31, 2018 , and $3,111 of transaction costs. The Company amortizes the developed technology over a 13 year period, which began October 1, 2017. During the fourth quarter 2018, certain conditions came to light, largely the lack of a meaningful increase in Noctiva prescriptions despite the substantial investment of resources, which indicated that the carrying value of the asset, may not be fully recoverable. As such, the Company performed an impairment test based on a comparison of the pretax discounted cash flows expected to be generated by the asset, which is a Level 3 fair value estimate, to the recorded value of the asset and concluded that the associated cash flows did not support any of the carrying value of the intangible asset and the Company recorded a full impairment charge of $66,087 at December 31, 2018 related to the acquired developed technology associated with Noctiva. The February 6, 2019 Chapter 11 bankruptcy filing of Specialty Pharma, the subsidiary which markets, sells and distributes Noctiva, confirmed management’s conclusion on the impairment. This impairment charge is included in the line “Impairment of intangible asset” in the consolidated statements of (loss) income. Amortizable intangible assets are amortized over their estimated useful lives, which range from three to fifteen years, using the straight-line method. At December 31, 2018 , total future amortization of intangible assets for the next five years is as follows: Estimated Amortization Expense: Amount 2019 $ 815 2020 814 2021 — 2022 — 2023 — |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Long-Term Debt Long-Term debt is summarized as follows: December 31, 2018 December 31, 2017 Principal amount of 4.50% exchangeable senior notes due 2023 $ 143,750 $ — Less: unamortized debt discount and issuance costs, net (28,059 ) — Net carrying amount of liability component 115,691 — Other debt 149 267 Subtotal 115,840 267 Less: current maturities (106 ) (111 ) Long-term debt $ 115,734 $ 156 Equity component: Equity component of exchangeable notes, net of issuance costs $ (26,699 ) $ — Issuance of Debt Securities On February 16, 2018, Avadel Finance Cayman Limited, a Cayman Islands exempted company (the “Issuer”) and an indirect wholly-owned subsidiary of the Company, issued $125,000 aggregate principal amount of 4.50% exchangeable senior notes due 2023 (the “2023 Notes”) in a private placement (the “Offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act. In connection with the Offering, the Issuer granted the initial purchasers of the 2023 Notes a 30-day option to purchase up to an additional $18,750 aggregate principal amount of the 2023 Notes, which was fully exercised on February 16, 2018. Net proceeds received by the Company, after issuance costs and discounts, were approximately $137,560 . The Company pays 4.50% cash interest per year on the principal amount of the 2023 Notes, payable semi-annually in arrears on February 1 and August 1 of each year, beginning on August 1, 2018, to holders of record at the close of business on the preceding January 15 or July 15, respectively. Interest accrues on the principal amount of the 2023 Notes from and including the date the 2023 Notes were issued or from, and including, the last date in respect of which interest has been paid or provided for, as the case may be, to, but excluding, the next interest payment date. The 2023 Notes are general, unsecured obligations of the Issuer, and are fully and unconditionally guaranteed by the Company on a senior unsecured basis. There are no financial debt covenants associated with the 2023 Notes. The 2023 Notes are the Company’s senior unsecured obligations and rank equally in right of payment with all of the Company’s existing and future senior unsecured indebtedness and effectively junior to any of the Company’s existing and future secured indebtedness, to the extent of the value of the assets securing such indebtedness. The 2023 Notes will be exchangeable at the option of the holders at an initial exchange rate of 92.6956 ADSs per $1 principal amount of 2023 Notes, which is equivalent to an initial exchange price of approximately $10.79 per ADS. Such initial exchange price represents a premium of approximately 20% to the $8.99 per ADS closing price on The Nasdaq Global Market on February 13, 2018. Upon the exchange of any 2023 Notes, the Issuer will pay or cause to be delivered, as the case may be, cash, ADSs or a combination of cash and ADSs, at the Issuer’s election. Holders of the 2023 Notes may convert their 2023 Notes, at their option, only under the following circumstances prior to the close of business on the business day immediately preceding August 1, 2022, under the circumstances and during the periods set forth below and regardless of the conditions described below, on or after August 1, 2022 and prior to the close of business on the business day immediately preceding the maturity date: • Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time during the five business day period immediately after any five consecutive trading day period (the “Measurement Period”) in which the trading price per $1 principal amount of 2023 Notes, as determined following a request by a holder of the 2023 Notes, for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the ADSs and the exchange rate on each such trading day. • If a transaction or event that constitutes a fundamental change or a make-whole fundamental change occurs prior to the close of business on the business day immediately preceding August 1, 2022, regardless of whether a holder of the 2023 Notes has the right to require the Company to repurchase the 2023 Notes, or if Avadel is a party to a merger event that occurs prior to the close of business on the business day immediately preceding August 1, 2022, all or any portion of a the holder’s 2023 Notes may be surrendered for exchange at any time from or after the date that is 95 scheduled trading days prior to the anticipated effective date of the transaction (or, if later, the earlier of (x) the business day after the Company gives notice of such transaction and (y) the actual effective date of such transaction) until 35 trading days after the actual effective date of such transaction or, if such transaction also constitutes a fundamental change, until the related fundamental change repurchase date. • Prior to the close of business on the business day immediately preceding August 1, 2022, a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time during any calendar quarter commencing after the calendar quarter ending on June 30, 2018 (and only during such calendar quarter), if the last reported sale price of the ADSs for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the exchange price on each applicable trading day. • If the Company calls the 2023 Notes for redemption pursuant to Article 16 to the Indenture prior to the close of business on the business day immediately preceding August 1, 2022, then a holder of the 2023 Notes may surrender all or any portion of its 2023 Notes for exchange at any time prior to the close of business on the second business day prior to the redemption date, even if the 2023 Notes are not otherwise exchangeable at such time. After that time, the right to exchange shall expire, unless the Company defaults in the payment of the redemption price, in which case a holder of the 2023 Notes may exchange its 2023 Notes until the redemption price has been paid or duly provided for. The Company considered the guidance in ASC 815-15, Embedded Derivatives , to determine if this instrument contains an embedded feature that should be separately accounted for as a derivative. ASC 815 provides for an exception to this rule when convertible notes, as host instruments, are deemed to be conventional, as defined by ASC 815-40. The Company determined that this exception applies due, in part, to our ability to settle the 2023 Notes in cash, ADSs or a combination of cash and ADSs, at our option. The Company has therefore applied the guidance provided by ASC 470-20, Debt with Conversion and Other Options which requires that the 2023 Notes be separated into debt and equity components at issuance and a value be assigned to each. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The equity component of the 2023 Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2023 Notes and the fair value of the liability of the 2023 Notes on its issuance date. The excess of the principal amount of the liability component over its carrying amount (the “Debt Discount”) is amortized to interest expense using the effective interest method over the term of the 2023 Notes. The equity component is not remeasured as long as it continues to meet the conditions for equity classification. In connection with the issuance of the 2023 Notes, we incurred approximately $6,190 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $6,190 of debt issuance costs, $1,201 were allocated to the equity component and recorded as a reduction to additional paid-in capital and $4,989 were allocated to the liability component and recorded as a reduction to debt on our consolidated balance sheets. The portion allocated to the liability component is amortized to interest expense using the effective interest method over the same five -year term as the related 2023 Notes. Other Debt French government agencies provide financing to French companies for R&D. At December 31, 2018 and 2017 , the Company had outstanding loans of $149 and $267 , respectively for various programs. These loans do not bear interest and are repayable only in the event the research project is technically or commercially successful. Potential repayment is scheduled to occur through 2019. During the years ended December 31, 2018 , 2017 and 2016 , the Company repaid $193 , $115 and $277 , of loans associated with specific research projects, respectively. In addition, during 2017, the Company received a waiver of repayment for the remaining portion of certain loans of $539 , on the basis of limited commercial and technical success. Amounts waived are reported as reductions to R&D expenses in the Company’s consolidated statements of (loss) income. No such waivers were received during 2018 or 2016. |
Long-Term Related Party Payable
Long-Term Related Party Payable | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-Term Related Party Payable | Long-Term Related Party Payable Long-term related party payable and related activity are reported at fair value and consist of the following at December 31, 2018 and 2017 , respectively: Activity during the Twelve Months Ended December 31, 2018 Changes in Fair Value of Related Party Payable Balance, December 31, 2017 Payments to Related Parties Operating (Gain) Expense Other Income Expiration of Warrants Disposal Balance, Acquisition-related contingent consideration: Warrants - Éclat Pharmaceuticals (a) $ 2,479 $ — $ (312 ) $ — $ (2,167 ) $ — $ — Earn-out payments - Éclat Pharmaceuticals (b) 67,744 (19,468 ) (22,661 ) — — — 25,615 Royalty agreement - FSC (c) 5,740 (645 ) 242 — — (5,337 ) — Financing-related: Royalty agreement - Deerfield (d) 5,392 (1,922 ) — (1,286 ) — — 2,184 Royalty agreement - Broadfin (e) 2,570 (916 ) — (613 ) — — 1,041 Long-term liability - FSC (f) 15,000 — — — — (15,000 ) — Total related party payable 98,925 $ (22,951 ) $ (22,731 ) $ (1,899 ) $ (2,167 ) $ (20,337 ) 28,840 Less: Current portion (25,007 ) (9,439 ) Total long-term related party payable $ 73,918 $ 19,401 Each of the above items is associated with related parties as further described in Note 22 : Related Party Transactions. (a) As part of the consideration for the Company’s acquisition of Éclat Pharmaceuticals, LLC on March 13, 2012, the Company issued two warrants to a related party with a six -year term which allow for the purchase of a combined total of 3,300 ordinary shares of Avadel. One warrant was exercisable for 2,200 ordinary shares at an exercise price of $7.44 per share, and the other warrant was exercisable for 1,100 ordinary shares at an exercise price of $11.00 per share. On February 23, 2018, the related party exercised in full the warrant for 2,200 ordinary shares. On March 12, 2018, the remaining warrant for 1,100 ordinary shares expired worthless. The fair value of the warrants was estimated on a quarterly basis using a Black-Scholes option pricing model with the following assumptions as of December 31: Assumptions for the Warrant Valuation: 2017 Stock price $ 8.20 Weighted average exercise price per share 8.63 Expected term (years) 0.25 Expected volatility 37.90 % Risk-free interest rate 1.39 % Expected dividend yield — These Black-Scholes fair value measurements are based on significant inputs not observable in the market and thus represent a level 3 measurement as defined in ASC 820. The fair value of the warrant consideration is most sensitive to movement in the Company’s share price and expected volatility at the balance sheet date. Expected term : The expected term of the options or warrants represents the period of time between the grant date and the time the options or warrants are either exercised or forfeited, including an estimate of future forfeitures for outstanding options or warrants. Given the limited historical data and the grant of stock options and warrants to a limited population, 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. 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 our inception and has no plan to distribute dividends in the foreseeable future. At the closing date of the 2012 Éclat acquisition and at December 31, 2017, it was uncertain whether the Company would ultimately fulfill its obligation under these warrants using ordinary shares or cash. Accordingly, pursuant to the guidance of ASC 480, the Company determined that these warrants should be classified as a liability. This classification as a liability was further supported by the Company’s determination, pursuant to the guidance of ASC 815-40-15-7(i), that these warrants could also not be considered as being indexed to the Company’s own ordinary shares, on the basis that the exercise price for the warrants is determined in U.S. dollars, although the functional currency of the Company at the closing date of the Éclat acquisition was the Euro. (b) In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield. Breaking Stick is majority owned by Deerfield, with a minority interest owned by certain current and former employees. As part of the consideration, the Company committed to provide quarterly earn-out payments equal to 20% of any gross profit generated by certain Éclat products. These payments will continue in perpetuity, to the extent gross profit of the related products also continue in perpetuity. (c) In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part included a commitment to pay quarterly a 15% royalty on the net sales of certain FSC products, up to $12,500 for a period not exceeding ten years. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets. (d) As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of $2,600 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 1.75% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with such debt financing transaction, the Company granted Deerfield a security interest in the product registration rights of the Eclat products. (e) As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a related party and current shareholder, the Company received cash of $2,200 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 0.834% royalty on the net sales of certain Éclat products until December 31, 2024. (f) In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part consisted of payments totaling $1,050 annually for five years with a final payment in January 2021 of $15,000 . Substantially all of FSC’s, and its subsidiaries, assets were pledged as collateral under this agreement. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets. At December 31, 2018 , the fair value of each related party payable listed in (b), (d) and (e) above was estimated using a discounted cash flow model based on estimated and projected annual net revenues or gross profit, as appropriate, of each of the specified Éclat products using an appropriate risk-adjusted discount rate of 15% . These fair value measurements are based on significant inputs not observable in the market and thus represent a level 3 measurement as defined in ASC 820. Subsequent changes in the fair value of the acquisition-related related party payables, resulting primarily from management’s revision of key assumptions, will be recorded in the consolidated statements of (loss) income in the line items entitled “Changes in fair value of related party contingent consideration” for items noted in (b) above and in “Other expense - changes in fair value of related party payable” for items (d) and (e) above. See Note 1 : Summary of Significant Accounting Policies under the caption Acquisition-related Contingent Consideration and Financing-related Royalty Agreements for more information on key assumptions used to determine the fair value of these liabilities. The Company has chosen to make a fair value election pursuant to ASC 825, “Financial Instruments” for its royalty agreements detailed in items (d) and (e) above. These financing-related liabilities are recorded at fair market value on the consolidated balance sheets and the periodic change in fair market value is recorded as a component of “Other expense – changes in fair value of related party payable” on the consolidated statements of (loss) income. The following table summarizes changes to the related party payables, a recurring Level 3 measurement, for the twelve-month periods ended December 31, 2018 , 2017 and 2016 : Related Party Payable: Balance Balance at December 31, 2015 $ 122,693 Additions (2) 21,659 Payments of related party payable (30,838 ) Fair value adjustments (1) 55,833 Balance at December 31, 2016 169,347 Payments of related party payable (37,311 ) Fair value adjustments (1) (33,111 ) Balance at December 31, 2017 98,925 Payments of related party payable (22,951 ) Fair value adjustments (1) (24,630 ) Expiration of warrants (2,167 ) Disposition of the pediatrics assets (20,337 ) Balance at December 31, 2018 $ 28,840 (1) Fair value adjustments are reported as “(Gain) loss - changes in fair value of related party contingent consideration” and “Other income (expense) - changes in fair value of related party payable” in the consolidated statements of (loss) income. (2) Relates to the acquisition of FSC. See items (c) and (f) above. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of (loss) income before income taxes for the years ended twelve months ended December 31, are as follows: (Loss) Income Before Income Taxes: 2018 2017 2016 Ireland $ (42,604 ) $ (3,123 ) $ (22,866 ) United States (70,340 ) 92,754 32,786 France (253 ) 3,029 (19,638 ) Total (loss) income before income taxes $ (113,197 ) $ 92,660 $ (9,718 ) The income tax provision consists of the following for the years ended December 31: Income Tax (Benefit) Provision: 2018 2017 2016 Current: United States - Federal $ — $ 18,064 $ 30,738 United States - State 330 331 1,081 France — 265 5,267 Total current 330 18,660 37,086 Deferred: United States - Federal (19,503 ) 4,686 (6,443 ) United States - State 1,280 1,043 (23 ) France — — 938 Total deferred (18,223 ) 5,729 (5,528 ) Income tax (benefit) provision $ (17,893 ) $ 24,389 $ 31,558 The reconciliation between Domestic income taxes at the statutory rate and the Company’s (benefit) provision for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2018 2017 2016 Statutory tax rate 12.5 % 12.5 % 12.5 % Differences in international tax rates 8.0 % 22.2 % (31.9 )% Nondeductible changes in fair value of contingent consideration 4.0 % (11.6 )% (165.0 )% Income tax deferred charge — % — % (9.7 )% Change in valuation allowances (5.3 )% (0.7 )% 11.8 % Nondeductible stock-based compensation (1.3 )% (0.4 )% (14.8 )% Cross border merger — % 0.3 % (100.6 )% Unrealized tax benefits (1.3 )% 1.4 % (15.2 )% State and local taxes (net of federal) (0.3 )% 0.3 % (9.6 )% Change in U.S. tax law (0.2 )% 3.8 % — % Nondeductible interest expense (1.1 )% — % — % Other 0.7 % (1.5 )% (2.3 )% Effective income tax rate 15.7 % 26.3 % (324.8 )% Income tax (benefit) provision - at statutory tax rate $ (14,149 ) $ 11,582 $ (1,215 ) Differences in international tax rates (9,039 ) 20,557 3,097 Nondeductible changes in fair value of contingent consideration (4,559 ) (10,779 ) 16,036 Income tax deferred charge — — 938 Change in valuation allowances 5,998 (610 ) (1,143 ) Nondeductible stock-based compensation 1,499 (375 ) 1,436 Cross-border merger — 265 9,773 Unrecognized tax benefits 1,440 1,296 1,475 State and local taxes (net of federal) 299 252 934 Change in U.S. tax law 274 3,513 — Nondeductible interest expense 1,269 — — Other (925 ) (1,312 ) 227 Income tax (benefit) provision - at effective income tax rate $ (17,893 ) $ 24,389 $ 31,558 In 2018, the income tax provision decreased by $42,282 when compared to the same period in 2017. The decrease in the income tax provision was primarily driven by a significant reduction in the amount of taxable income recorded in the U.S. and Ireland in 2018, when compared to 2017. There was also a significant increase in valuation allowance in 2018, when compared to the same period in 2017 as a result of the decrease in taxable income in Ireland. In 2018, there was a significant decrease in amounts related to change in U.S. tax law due to the 2017 U.S. Tax Cuts and Jobs Act. In 2017, the income tax provision decreased by $7,169 when compared to the same period in 2016. The decrease in the income tax provision was primarily driven by a significant reduction in the amount of taxable income recorded in the U.S. in 2017, when compared to 2016. In 2017, the Company did not incur any significant additional income tax provision associated with the Cross-Border Merger as a majority of the transaction was completed in 2016. In 2017, the Company recorded $3,513 of tax provision associated with the U.S. Tax Cuts and Jobs Act signed into law in the U.S. in December of 2017. Unrecognized Tax Benefits The Company or one of its subsidiaries files income tax returns in Ireland, France, U.S. and various states. With few exceptions, the Company is no longer subject to Irish, French, U.S. Federal, and state and local examinations for years before 2014. The Internal Revenue Service (IRS) commenced an examination of the Company's U.S. income tax return for 2015 in the 4th quarter of 2016. The French tax authority commenced an examination of the Company's French tax return for 2017 in the first quarter of 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 2018 2017 2016 Balance at January 1: $ 3,954 $ 1,686 $ 448 Additions based on tax positions related to the current year 1,087 2,268 1,578 Increases (decreases) for tax positions of prior years 274 — (340 ) Balance at December 31: $ 5,315 $ 3,954 $ 1,686 The Company does not expect within the next twelve months, as a result of activities performed in various jurisdictions, that the unrecognized tax benefits will change. However, interest and penalties could change by up to $500 . At December 31, 2018 , 2017, and 2016, there are $4,597 , $3,349 , and $1,565 of unrecognized tax benefits that if recognized would affect the annual effective tax rate. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the years ended December 31, 2018 , 2017, and 2016, the Company recognized approximately $725 , $304 , and $26 in interest and penalties. The Company had approximately $1,057 , and $331 for the payment of interest and penalties accrued at December 31, 2018 , and 2017, 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, 2018 and 2017 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 19,510 $ 9,831 Amortization 20,642 7,563 Stock based compensation 4,587 4,375 Fair value royalty agreements — 635 Fair value contingent consideration 384 870 Other 479 406 Gross deferred tax assets 45,602 23,680 Deferred tax liabilities: Amortization (308 ) (2,419 ) Accounts receivable (661 ) (936 ) Prepaid expenses (405 ) (1,094 ) Gross deferred tax liabilities (1,374 ) (4,449 ) Less: valuation allowances (21,199 ) (15,354 ) Net deferred tax assets $ 23,029 $ 3,877 At December 31, 2018, the Company had $72,453 of net operating losses in Ireland and $3,259 of net operating losses in France that do not have an expiration date and $25,840 of net operating losses and carryforwards in the U.S. Of the $25,840 of net operating losses and carryforwards in the U.S., $10,365 were acquired due to the acquisition of FSC in 2016 and $15,475 is due to the losses and carryforwards generated at U.S. Holdings in 2018. The portion due to the acquisition of FSC will expire in 2034 through 2035. A valuation allowance is recorded if, based on the weight of available evidence, it is more likely than not that a deferred tax asset will not be realized. This assessment is based on an evaluation of the level of historical taxable income and projections for future taxable income. While the Company believes it is more likely than not that it will be able to realize the deferred tax assets in the U.S., the Company continues to monitor changes in the U.S. hospital products market as unfavorable changes could ultimately impact our assessment of the realizability of our U.S. deferred tax assets. 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 may not be fully utilized before they expire. We recorded a valuation allowance against all of our net operating losses in Ireland and France as of both December 31, 2018, and December 31, 2017. We intend to continue maintaining a full valuation allowance on the Irish and French net operating losses until there is sufficient evidence to support the reversal of all or some portion of these allowances. At December 31, 2018, the Company has unremitted earnings of $2,798 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 our 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. Research and Development Tax Credits Receivable The French and Irish governments provide tax credits to companies for spending on innovative R&D. These credits are recorded as an offset of R&D expenses and are credited against income taxes payable in years after being incurred or, if not so utilized, are recoverable in cash after a specified period of time, which may differ depending on the tax credit regime. As of December 31, 2018, the Company’s research tax credit receivable, net amounts to $7,555 and represents a French gross research tax credit of $6,922 and an Irish gross research tax credit of $633 . As of December 31, 2017, the Company’s net research tax credit receivable amounted to $5,272 and represented a French gross research tax credit of $4,754 and an Irish gross research tax credit of $518 . Income Tax Deferred Charge On December 16, 2014, we transferred all of our intangible intellectual property from our French entity to our Irish entity as part of a global reorganization. The intellectual property includes patents on drug delivery platforms, clinical data sets and other intangible assets related to the pipeline of proprietary products in development. This intra-entity transaction resulted in a charge of $14,088 of related taxes to the French government in December 2014. As this represents an intra-entity transaction, no deferred tax asset was originally recognized, but rather was recorded as $986 of prepaid expenses and $13,102 of a long-term income tax deferred charge asset in accordance with ASC 740-10-25-3 (e). This income tax deferred charge asset is amortized over the tax life of the asset at a rate of 7% per year and will result in tax relief in Ireland of $8,500 from 2016 to 2029, subject to the ability to realize tax benefits for additional deductions. At December 31, 2016, the balance of these respective accounts was classified as prepaid expenses of $814 and income tax deferred charge asset of $10,342 . In 2017, the Company adopted the provisions of ASU 2016-16, related to Intra-Entity Transfers of Assets Other Than Inventory. Adoption of ASU 2016-16 eliminated the $11,156 income tax deferred charge recorded within the consolidated balance sheet as of December 31, 2016. In addition to the elimination of the income tax deferred charge, the Company recorded a deferred tax asset of $7,954 related to the remaining unamortized tax basis of the intangible intellectual property. A full valuation allowance was recorded against the deferred tax asset as sufficient evidence does not exist at this time that the Company will be able to utilize these benefits. Cross-Border Merger In 2016, we changed our jurisdiction of incorporation from France to Ireland by merging with and into our wholly owned Irish subsidiary. Information about the reincorporation was included in the definitive proxy statement filed with the Securities and Exchange Commission on July 5, 2016. Prior to the merger, the Company submitted a request to the French tax authorities seeking to benefit from a special regime for mergers and demergers, conditional upon a formal consent of the French tax authority, which would allow for the deferral of a portion of the tax cost of the cross-border merger. In 2017, the Company received a letter from the French tax authorities indicating that our request to benefit from the special regime had been declined. Completion of the cross-border merger resulted in the recognition of a net income tax provision of $4,266 , after considering tax benefits from the utilization of current and prior year French net operating losses. The Company was able to utilize $4,266 of French research and development tax credits to offset the remaining cost of the transaction. The Company also removed $111,495 of French net operating losses as the carryforward of these losses was contingent on receiving favorable consent from the French tax authority. The French net operating losses had a full valuation allowance, resulting in no impact to the income tax provision from their removal. 2017 Tax Cuts and Jobs Act On December 22, 2017, the U.S. government enacted the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act includes significant changes to the U.S. corporate income tax system including: a federal corporate rate reduction from 35% to 21%; limitations on the deductibility of interest expense and executive compensation; creation of the base erosion anti-abuse tax (“BEAT”) and a new minimum tax. As a result of the Act being signed into law, the Company recognized a charge of $274 and $3,513 in 2018 and 2017, respectively, related to the re-measurement of its U.S. net deferred tax assets and certain unrecognized tax benefits at the lower enacted corporate tax rates. A majority of the provisions in the Tax Act are effective January 1, 2018. |
Post-Retirement Benefit Plans
Post-Retirement Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Post-Retirement Benefits Plans | Post-Retirement Benefit Plans Post-Retirement Benefit Contributions to French Government Agencies The Company is required by French law for our French employees to deduct specific monthly payroll amounts to support post-retirement benefit programs sponsored by the relevant government agencies in France. As the ultimate obligation is maintained by the French government agencies, there is no additional liability recorded by the Company in connection with these plans. (Income) expenses recognized for these plans were $(69) in 2018 , $123 in 2017 , and $348 in 2016 . The 2018 and 2017 pension expense does not include the retirement indemnity curtailment gains of $148 and $717 , respectively, which was associated with the reduction of certain defined benefit retirement plan liabilities due to the reduction in force. See Note 17 : Restructuring Costs - France for more discussion. Retirement Indemnity Obligation – France French law requires the Company to provide for the payment of a lump sum retirement indemnity to French employees based upon years of service and compensation at retirement. The retirement indemnity has been actuarially calculated on the assumption of voluntary retirement at a government-defined retirement age. Benefits do not vest prior to retirement. Any actuarial gains or losses are recognized in the Company’s consolidated statements of (loss) income in the periods in which they occur. The benefit obligation is calculated as the present value of estimated future benefits to be paid, using the following assumptions for the years ended December 31: Retirement Benefit Obligation Assumptions: 2018 2017 2016 Compensation rate increase 2.75 % 3.00 % 3.00 % Discount rate 1.50 % 1.25 % 1.31 % Employee turn-over Actuarial standard and average of the last 5 years Average age of retirement 60 to 65 years actuarial standard based on age and professional status Certain actuarial assumptions, such as discount rate, have a significant effect on the amounts reported for net periodic benefit cost and accrued retirement indemnity benefit obligation amounts. The discount rate is determined annually by benchmarking a published long-term bond index using the iBoxx € Corporates AA 10+ index. Changes in the funded status of the retirement indemnity benefit plans were as follows for the years ended December 31: Retirement Benefit Obligation Activity: 2018 2017 Retirement indemnity benefit obligation, beginning of year $ 1,303 $ 2,431 Service cost 93 132 Interest cost 17 21 Plan amendment — (829 ) Benefits paid (12 ) — Curtailment gain (148 ) (717 ) Actuarial loss (178 ) (25 ) Exchange rate changes (51 ) 290 Retirement indemnity benefit obligation, end of year $ 1,024 $ 1,303 The lump sum retirement indemnity is accrued on the Company’s consolidated balance sheets within non-current other liabilities, excluding the current portion. As these are not funded benefit plans, there are no respective assets recorded. The future expected benefits to be paid over the next five years and for the five years thereafter is as follows for the years ended December 31: Future Retirement Indemnity Benefit Obligation: Balance 2019 $ — 2020 — 2021 — 2022 17 2023 — Next five years 158 Total $ 175 |
Other Assets and Liabilities
Other Assets and Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
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: 2018 2017 Valued-added tax recoverable $ 1,378 $ 1,206 Prepaid and other expenses 2,145 7,106 Guarantee from Armistice (see Note 16 ) 534 — Income tax receivable 921 518 Research and development tax credit receivable 283 — Short-term deposit 3,350 — Other 225 128 Total $ 8,836 $ 8,958 Other Non-Current Assets: 2018 2017 Deferred tax assets $ 23,029 $ 3,877 Long-term deposits 1,477 3,350 Guarantee from Armistice (see Note 16 ) 5,697 — Right of use assets at contract manufacturing organizations 5,894 2,909 Other 49 113 Total $ 36,146 $ 10,249 Accrued Expenses: 2018 2017 Accrued compensation $ 3,971 $ 3,157 Accrued social charges 1,009 1,204 Accrued restructuring (see Note 17 ) 879 1,000 Customer allowances 6,541 10,613 Accrued ELAA payment — 20,000 Accrued contract research organization charges 1,000 156 Accrued contract manufacturing organization costs 2,028 2,327 Accrued contract sales organization and marketing costs 3,469 7,641 Other 2,798 4,828 Total $ 21,695 $ 50,926 Other Non-Current Liabilities: 2018 2017 Provision for retirement indemnity $ 1,024 $ 1,303 Customer allowances 1,352 1,636 Unrecognized tax benefits 5,315 3,954 Guarantee to Deerfield (see Note 16 ) 5,717 — Other 594 191 Total $ 14,002 $ 7,084 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contingent Liabilities and Commitments | Contingent Liabilities and Commitments Litigation The Company is subject to potential liabilities generally incidental to our 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, 2018 and December 31, 2017, 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. Some of the patents covering our Noctiva TM product (the “Noctiva Patents”) are the subject of litigation initiated by Ferring Pharmaceuticals Inc. and two of its foreign affiliates, who manufacture a competing product known as Nocdurna. Nocdurna was approved by the FDA in June 2018 and commercially launched in the U.S. in November 2018. In this litigation (the “Ferring Litigation”), Ferring seeks to invalidate and disputes the inventorship of the Noctiva Patents, seeks damages for various alleged breaches of contractual and common law duties, and seeks damages for alleged infringement by Noctiva TM of Ferring’s “Nocdurna” trademark. Avadel’s indirectly wholly owned subsidiary, Specialty Pharma and certain other parties including Serenity Pharmaceuticals, LLC (“Serentiy”) (the licensor of the Noctiva Patents) have been actively defending this litigation, and have made certain counterclaims against Ferring, including for infringement of the Noctiva Patents and a declaratory judgment of noninfringement with respect to Ferring’s “Nocdurna” trademark. The court has dismissed Ferring’s inventorship claim and its claims for alleged breaches of contractual and common law duties, although these dismissals may be appealed by Ferring. On February 15, 2019, Specialty Pharma and its co-defendants moved to stay the litigation pending completion of the bankruptcy proceeding of Specialty Pharma. Adverse outcomes from this litigation could have material adverse effects on the value of the Specialty Pharma’s license to Noctiva TM . On January 21, 2019, Serenity provided notice to Specialty Pharma of an alleged breach of the parties’ Noctiva license agreement. Serenity alleges principally that Specialty Pharma breached its contractual obligation to devote commercially reasonable efforts to the commercialization of Noctiva and seeks unspecified damages. On January 27, 2019, Specialty Pharma notified Serenity of a claim for $1.7 million in damages as a result of Serenity’s breach of its contractual obligation to pay the costs of the Ferring Litigation. Serenity’s notice to Specialty Pharma invoked the dispute resolution provisions of the Noctiva license agreement, which culminate in arbitration, but neither party has yet initiated an arbitration proceeding or filed suit. Adverse outcomes from this potential litigation could have material adverse effects on the financial position of Specialty Pharma. On February 6, 2019, Specialty Pharma commenced a Chapter 11 bankruptcy case under the U.S. Bankruptcy Code to fulfill its strategic objective of divesting from the business of marketing and distributing Noctiva™. As a result of the commencement of the bankruptcy case, all pending litigation against Specialty Pharma is automatically stayed and will remain stayed during the pendency of the Chapter 11 case unless and until the bankruptcy court enters an order modifying or lifting the stay. The automatic stay of the bankruptcy code also precludes the commencement of any new litigation against Specialty Pharma unless the bankruptcy court orders otherwise. See Part I, Item 3 of this Annual Report on Form 10-K for more discussion. Material Commitments At December 31, 2018, the Company has various commitments to purchase finished product from customers . Commitments for these arrangements, at maximum quantities and at contractual prices over the remaining life of the contract, and excluding any waived commitments, are as follows for the years ended December 31: Purchase Commitments: Balance 2019 $ 10,754 2020 5,948 2021 4,880 2022 4,880 2023 220 Thereafter — Total $ 26,682 The Company also has a commitment with a contract manufacturer related to the construction and preparation of a production suite at the contract manufacturer’s facility, which is substantially complete at December 31, 2018. Subsequent to the initial build and preparation of the production suite, this commitment also includes annual production suite fees of approximately $3,000 to $4,000 which would commence at the time of FDA approval of the product and continue thereafter for five years. These amounts are not included in the table above, as the start date has not been determined. Included in the purchase commitments above, is approximately $15,308 of an obligation of Specialty Pharma, which on February 6, 2019, filed for Chapter 11 bankruptcy protection. For the year ended December 31, 2018 , the Company paid $9,965 related to the above purchase commitments. The Company and our subsidiaries lease office facilities under noncancelable operating leases expiring at various dates. Rent expense, net of rental income, was $1,213 , $1,146 and $970 in 2018, 2017, and 2016, respectively. Minimum rental commitments for non-cancelable leases in effect at December 31, 2018 are as follows: Lease Commitment: Balance 2019 $ 1,191 2020 1,208 2021 1,008 2022 767 2023 695 Thereafter 967 Total $ 5,836 Other than the above commitments, there were no other material commitments outside of the normal course of business. Material commitments in the normal course of business include long-term debt, long-term related party payable, and post-retirement benefit plan obligations which are disclosed in Note 10 : Long-Term Debt, Note 11 : Long-Term Related Party Payable, and Note 13 : Post-Retirement Benefit Plans , respectively. Contractual Obligations The following table presents contractual obligations of the Company at December 31, 2018 : Payments Due by Period Contractual Obligations: Total Less than 1 to 3 3 to 5 More than Long-term debt and interest $ 173,009 $ 6,575 $ 12,981 $ 153,453 $ — Long-term related party payable 51,284 9,439 8,713 7,250 25,882 Purchase commitments 26,682 10,754 10,828 5,100 — Operating leases 5,836 1,191 2,217 1,461 967 Total contractual cash obligations $ 256,811 $ 27,959 $ 34,739 $ 167,264 $ 26,849 Included in the purchase commitments total above, is approximately $15,308 of an obligation of Specialty Pharma, which on February 6, 2019, filed for Chapter 11 bankruptcy protection. |
Divestiture of the Pediatric As
Divestiture of the Pediatric Assets (Notes) | 12 Months Ended |
Dec. 31, 2018 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Divestiture of the Pediatric Assets | Divestiture of the Pediatric Assets On February 12, 2018, the Company, together with its subsidiaries Avadel Pharmaceuticals (USA), Inc., Avadel Pediatrics, Inc., FSC Therapeutics, LLC (“FSC Therapeutics”), and Avadel US Holdings, Inc. (“Holdings”), as the “Sellers,” entered into an asset purchase agreement (the “Purchase Agreement”) with Cerecor, Inc. (“Cerecor”). The transaction closed on February 16, 2018 wherein Cerecor purchased from the Sellers four pediatric commercial stage assets – Karbinal™ ER, Cefaclor, Flexichamber™ and AcipHex® Sprinkle™, together with certain associated business assets – which were held by FSC. The Company acquired FSC in February 2016 from Deerfield and certain of its affiliates. Pursuant to the Purchase Agreement, Cerecor assumed the Company’s remaining payment obligations to Deerfield under the Membership Interest Purchase Agreement, dated as of February 5, 2016, between Holdings, Flamel Technologies SA (the predecessor of the Company) and Deerfield and certain of its affiliates, which payment obligations consisted of the following (collectively, the “Assumed Obligations”): (i) a quarterly payment of $263 beginning in July 2018 and ending in October 2020, amounting to an aggregate payment obligation of $2,625 ; (ii) a payment in January 2021 of $15,263 ; and (iii) a quarterly royalty payment of 15% on net sales of the FSC products through February 5, 2026 (“FSC Product Royalties”), in an aggregate amount of up to approximately $10,300 . Cerecor also assumed certain contracts and other obligations related to the acquired assets, and in that connection Holdings agreed to pay Cerecor certain make-whole payments associated with obligations Cerecor is assuming related to a certain supply contract related to Karbinal™ ER. In conjunction with the divestiture, the Company also entered into the following arrangements: License and Development Agreement Also, in connection with the closing under the Purchase Agreement, Flamel Ireland Limited, an Irish limited company operating under the trade name of Avadel Ireland (“Avadel Ireland”) and a wholly-owned subsidiary of the Company, and Cerecor entered into a license and development agreement (the “License and Development Agreement”) pursuant to which, among other things: • Avadel Ireland will provide Cerecor with four product formulations utilizing Avadel Ireland’s LiquiTime™ technology, and will complete pilot bioequivalence studies for such product formulations within 18 months; • Cerecor will reimburse Avadel Ireland for development costs of the four LiquiTime™ products in excess of $1,000 in the aggregate; • Upon transfer of the four product formulations, Cerecor will assume all remaining development costs and responsibilities for the product development, clinical studies, NDA applications and associated filing fees; and • Upon regulatory approval and commercial launch of any LiquiTime™ products, Cerecor will pay Avadel Ireland quarterly royalties based on a percentage of net sales of any such products in the mid-single digit range. Deerfield Guarantee In connection with the closing under the Purchase Agreement, the Company and Holdings provided their guarantee (the “Deerfield Guarantee”) in favor of Deerfield. Under the Deerfield Guarantee, the Company and Holdings guaranteed to Deerfield the payment by Cerecor of the Assumed Obligations under the Membership Interest Purchase Agreement between the Company and Deerfield dated February 5, 2016. The Assumed Obligations include (i) a quarterly payment of $263 beginning in July 2018 and ending in October 2020, amounting to an aggregate payment obligation of $2,625 ; (ii) a payment in January 2021 of $15,263 ; and (iii) 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 . In addition, under the Deerfield Guarantee, the Company and Holdings guaranteed that Deerfield would receive certain minimum annual FSC Product Royalties through February 6, 2026 (the “Minimum Royalties”). Given the Company’s explicit guarantee to Deerfield, the Company recorded the guarantee in accordance with ASC 460. A valuation was performed, which was based largely on an analysis of the potential timing of each possible cash outflow described above and the likelihood of Cerecor’s default on such payments assuming an S&P credit rating of CCC+. The result of this valuation identified a guarantee liability of $6,643 . This liability is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield. At December 31, 2018 , the carrying value of this liability was $6,253 . Armistice Guarantee In connection with the closing under the Purchase Agreement, Armistice Capital Master Fund, Ltd., the majority shareholder of Cerecor, guaranteed to Holdings the payment by Cerecor of the Assumed Obligations, including the Minimum Royalties. A valuation of the guarantee asset was performed in accordance with ASC 460 “ Guarantees ” and a guarantee asset of $6,620 was recorded. This asset is being amortized proportionately based on undiscounted cash outflows through the remainder of the contract with Deerfield noted above. At December 31, 2018 , the carrying value of this asset was $6,231 . The fair values of the Avadel guarantee to Deerfield and the guarantee received by Avadel from Armistice largely offset and when combined are not material. Based on management’s review of ASU 2014-08, “ Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity” , the disposition of our pediatric assets and related liabilities did not qualify for discontinued operations reporting. Our results of operations for the period January 1, 2018 through February 16, 2018 and for the years ended December 31, 2017 and 2016 include the results of FSC, prior to its February 16, 2018 disposition date. The net impact of this transaction was not material to the consolidated statements of (loss) income. |
Restructuring Costs - France
Restructuring Costs - France | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs - France | Restructuring Costs - France During the first quarter of 2017, the Company announced a plan to reduce our workforce at our Venniseux, France site by approximately 50% . This reduction is an effort to align the Company’s cost structure with our ongoing and future planned projects. In July 2017, the Company completed negotiations with the works council for our French operations and received approval from the French Labor Commission (DIRECCTE) to implement the plan. The reduction is substantially complete at December 31, 2018. Restructuring charges for the year ended December 31, 2018 of $1,016 , include a provision related to a dispute with severed employees of $776 related to severance benefits and is also net of the curtailment gain of $148 . Restructuring charges of $2,542 for the year ended December 31, 2017, are net of the curtailment gain of $717 . The following table sets forth activities for the Company’s cost reduction plan obligations for the year ended December 31, 2018 : Restructuring Obligation: 2018 2017 Balance of restructuring accrual at January 1, $ 1,000 $ — Charges for employee severance, benefits and other 1,164 3,259 Payments (1,261 ) (2,600 ) Foreign currency impact (24 ) 341 Balance of restructuring accrual at December 31, $ 879 $ 1,000 The restructuring accrual at December 31, 2018 is included the consolidated balance sheet in accrued expenses. |
Equity Instruments and Stock Ba
Equity Instruments and Stock Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Equity Instruments and Stock Based Compensation | Equity Instruments and Stock-Based Compensation Capital Stock We have 500,000 shares of authorized ordinary shares with a nominal value of $0.01 per common share. As of December 31, 2018 , we had 42,720 and 37,313 shares of 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. We have 50,000 shares of authorized preferred shares, $0.01 nominal value, no ne of which is currently outstanding. Share Repurchases In March 2017, the Board of Directors approved an authorization to repurchase up to $25,000 of Avadel ordinary shares represented by ADSs. Under this authorization, which has an indefinite duration, share repurchases may be made in the open market, in block transactions on or off the exchange, in privately negotiated transactions, or through other means as determined by the Board of Directors and in accordance with the regulations of the Securities and Exchange Commission. The timing and amount of repurchases, if any, will depend on a variety of factors, including the price of our shares, cash resources, alternative investment opportunities, corporate and regulatory requirements and market conditions. This share repurchase program may be modified, suspended or discontinued at any time without prior notice. We may also from time to time establish a trading plan under Rule 10b5-1 of the Securities and Exchange Act of 1934 to facilitate purchases of our shares under this program. Additionally, on February 12, 2018, the Board of Directors approved an authorization to repurchase up to $18,000 of Avadel ordinary shares represented by American Depository Shares in connection with our Convertible Notes Offering completed on February 16, 2018. See Note 10: Long-Term Debt . In March 2018, the Board of Directors approved an authorization to repurchase up to $7,000 of Avadel ordinary shares represented by American Depository Shares, bring the total authorization to $50,000. As of December 31, 2018 , the Company had repurchased 5,407 ordinary shares for $49,998 . Stock-Based Compensation Compensation expense included in the Company’s consolidated statements of (loss) income for all stock-based compensation arrangements was as follows for the periods ended December 31: Stock-based Compensation Expense: 2018 2017 2016 Research and development $ 880 $ 672 $ 3,523 Selling, general and administrative 6,972 7,400 11,156 Total stock-based compensation expense $ 7,852 $ 8,072 $ 14,679 As of December 31, 2018 , the Company expects $6,726 of unrecognized expense related to granted, but non-vested stock-based compensation arrangements to be incurred in future periods. This expense is expected to be recognized over a weighted average period of 2.3 years. The excess tax benefit related to stock-based compensation recorded by the Company was $0 for the year ended December 31, 2018 and not material for the years ended December 31, 2017 and 2016. Upon exercise of stock options or warrants, or upon the issuance of restricted share awards, the Company issues new shares. At December 31, 2018 , there were 1,873,147 shares authorized for stock option grants, warrant grants and restricted share award grants in subsequent periods. Determining the Fair Value of Stock Options and Warrants The Company measures the total fair value of stock options and warrants 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 or warrant vests. Options are granted to employees of the Company and become exercisable ratably over four years following the grant date and expire ten years after the grant date. Prior to 2017, warrants were typically issued to the Company’s Board of Directors as compensation for services rendered and generally become exercisable within one year following the grant date, and expire four years after the grant date. Beginning in 2017, the Company issues stock options to our Board of Directors as compensation for services rendered and generally become exercisable within one year following the grant date, and expire four years after the grant date. The weighted-average assumptions under the Black-Scholes option-pricing model for stock option and warrant grants as of December 31, 2018 , 2017 and 2016 , are as follows: Stock Option and Warrant Assumptions: 2018 2017 2016 Stock option grants: Expected term (years) 6.25 6.25 6.25 Expected volatility 56.59 % 58.82 % 58.39 % Risk-free interest rate 2.68 % 2.20 % 2.04 % Expected dividend yield — — — Warrant grants: Expected term (years) — 0 2.50 Expected volatility — % — % 60.57 % Risk-free interest rate — % — % 0.82 % Expected dividend yield — — — Expected term : The expected term of the options or warrants represents the period of time between the grant date and the time the options or warrants are either exercised or forfeited, including an estimate of future forfeitures for outstanding options or warrants. Given the limited historical data and the grant of stock options and warrants to a limited population, 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 our inception, and has 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, 2018 is as follows: Stock Option Activity and Other Data: Number of Stock Options Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Stock options outstanding, January 1, 2018 5,041 $ 11.34 Granted 138 6.67 Exercised (82 ) 6.52 Forfeited (428 ) 10.04 Expired (68 ) 12.41 Stock options outstanding, December 31, 2018 4,601 $ 11.39 7.25 years $ — Stock options exercisable, December 31, 2018 3,005 $ 11.99 6.66 years $ — The aggregate intrinsic value of options exercisable at December 31, 2018 , 2017 and 2016 was $0 , $1,161 , and $58 , respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2018 , 2017 and 2016 was $3.60 , $5.20 and $6.14 per share, respectively. Warrants A summary of the combined warrant activity and other data for the year ended December 31, 2018 is as follows: Warrant Activity and Other Data: Number of Warrants Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Warrants outstanding, January 1, 2018 894 $ 16.77 Granted — — Exercised — — Forfeited — — Expired (298 ) 14.87 Warrants outstanding, December 31, 2018 596 $ 17.72 1.03 years $ — Warrants exercisable, December 31, 2018 596 $ 17.72 1.03 years $ — Each of the above warrants is convertible into one ordinary share. There was no aggregate intrinsic value of warrants exercised during the years ended December 31, 2018 , 2017 and 2016 . The weighted average grant date fair value of warrants granted during the year ended December 31, 2016 was $2.99 per share. There were no warrants granted during the years ended December 31, 2018 and 2017. At January 1, 2018, an additional 3,300 warrants were outstanding and exercisable relative to consideration paid for the Company’s acquisition of Éclat Pharmaceuticals, LLC on March 13, 2012. These warrants are not considered stock-based compensation and are therefore excluded from the above tables, and instead are addressed within Note 11 : Long-Term Related Party Payable . On February 23, 2018, the related party exercised in full the warrant to purchase 2,200 ordinary shares. On March 12, 2018 the remaining warrants to purchase 1,100 ordinary shares expired. 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 prior to 2016 generally cliff vest at the end of a four -year vesting period, and are expensed over a two or four -year service period. Restricted share awards granted during 2016 are fully expensed at the date of grant as they contain no service requirement. Employees, however, have a two -year acquisition period from grant date and are then free to trade these awards. Restricted share awards granted during and after 2017 vest over a three -year period; two-thirds (2/3) vesting on the second anniversary of the grant date and the remaining one-third (1/3) vesting on the third anniversary of the grant date. Beginning in 2018, the Company issues restricted share awards to our Board of Directors vesting over a three-year period; one-third (1/3) vesting on each of the three anniversaries of the grant date. Compensation expense for such awards granted during and after 2017 is recognized over the applicable vesting period. A summary of the Company’s restricted share awards as of December 31, 2018 , 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 Fair Value Non-vested restricted share awards outstanding, January 1, 2018 819 $ 11.51 Granted 279 5.87 Vested (548 ) 12.78 Forfeited (59 ) 8.95 Non-vested restricted share awards outstanding, December 31, 2018 491 $ 7.20 The weighted average grant date fair value of restricted share awards granted during the years ended December 31, 2018 , 2017 and 2016 was $5.87 , $8.95 and $12.11 , respectively. Employee Share Purchase Plan In 2017, the Board of Directors approved of 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. As of December 31, 2018, the Company has issued 25 ordinary shares to employees. |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share | Net (Loss) Income Per Share Basic net (loss) income per share is calculated by dividing net (loss) income by the weighted average number of shares outstanding during each period. Diluted net (loss) income per share is calculated by dividing net (loss) income by the diluted number of shares outstanding during each period. Except where the result would be anti-dilutive to net (loss) income, diluted net (loss) income per share would be calculated assuming the impact of the conversion of the 2023 Notes, the exercise of outstanding equity compensation awards, ordinary shares expected to be issued under our employee stock purchase plan (“ESPP”) and the exercise of contingent consideration warrants, all which have been exercised or have expired during the first quarter of 2018. We have a choice to settle the conversion obligation under the 2023 Notes in cash, shares or any combination of the two. We utilize the if-converted method to reflect the impact of the conversion of the 2023 Notes, unless the result is anti-dilutive. This method assumes the conversion of the 2023 Notes into shares of our ordinary shares and reflects the elimination of the interest expense related to the 2023 Notes. The dilutive effect of the warrants, stock options, RSU’s and ordinary shares expected to be issued under or ESPP has been calculated using the treasury stock method. A reconciliation of basic and diluted net (loss) income per share, together with the related shares outstanding in thousands for the years ended December 31, is as follows: Net (Loss) Income Per Share: 2018 2017 2016 Net (loss) income $ (95,304 ) $ 68,271 $ (41,276 ) Weighted average shares: Basic shares 37,325 40,465 41,248 Effect of dilutive securities—employee and director equity awards outstanding and 2023 Notes — 1,300 — Diluted shares 37,325 41,765 41,248 Net (loss) income per share - basic $ (2.55 ) $ 1.69 $ (1.00 ) Net (loss) income per share - diluted $ (2.55 ) $ 1.63 $ (1.00 ) Potential common shares of 17,529 , 6,368 , and 8,564 were excluded from the calculation of weighted average shares for the years ended December 31, 2018 , 2017 and 2016 , respectively, because their effect was considered to be anti-dilutive. For the years ended December 31, 2018 and 2016, the effects of dilutive securities were entirely excluded from the calculation of net (loss) income per share as a net loss was reported in these periods. |
Comprehensive (Loss) Income
Comprehensive (Loss) Income | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Comprehensive Income (Loss) | Comprehensive (Loss) Income The following table shows the components of accumulated other comprehensive (loss) income for the twelve months ended December 31, net of immaterial tax effects: Accumulated Other Comprehensive (Loss) Income: 2018 2017 2016 Foreign currency translation adjustment: Beginning balance $ (23,202 ) $ (23,336 ) $ (22,312 ) Net other comprehensive (loss) income (419 ) 134 (1,024 ) Balance at December 31, (23,621 ) (23,202 ) (23,336 ) Unrealized gain (loss) on marketable securities, net Beginning balance (64 ) (229 ) (345 ) Net other comprehensive income, net of ($18), $28, $16, tax, respectively 269 165 116 Balance at December 31, 205 (64 ) (229 ) Accumulated other comprehensive loss at December 31, $ (23,416 ) $ (23,266 ) $ (23,565 ) |
Company Operations by Product,
Company Operations by Product, Customer and Geographic Area | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Company Operations by Product, Customer and Geographic Area | Company Operations by Product, Customer and Geographic Area The Company has determined that we operate in one segment, the development and commercialization of pharmaceutical products, including controlled-release therapeutic products based on our proprietary polymer based technology. The Company’s Chief Operating Decision Maker is the interim CEO. The interim CEO reviews profit and loss information on a consolidated basis to assess performance and make overall operating decisions as well as resource allocations. All products are included in one segment because the Company’s products have similar economic and other characteristics, including the nature of the products and production processes, type of customers, distribution methods and regulatory environment. The following table presents a summary of total revenues by these products for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Product: 2018 2017 2016 Bloxiverz $ 20,850 $ 45,596 $ 82,896 Vazculep 42,916 38,187 39,796 Akovaz 33,759 80,617 16,831 Noctiva 1,204 — — Other 2,694 8,441 7,699 Total product sales 101,423 172,841 147,222 License revenue 1,846 404 3,024 Total revenues $ 103,269 $ 173,245 $ 150,246 Concentration of credit risk with respect to accounts receivable is limited due to the high credit quality comprising a significant portion of the Company’s customers. Management periodically monitors the creditworthiness of our customers and believes that we have adequately provided for any exposure to potential credit loss. The following table presents a summary of total revenues by significant customer for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Significant Customer: 2018 2017 2016 Customer A $ 26,794 $ 44,762 $ 51,648 Customer B 25,413 37,965 39,359 Customer C 18,620 25,691 30,916 Customer D 9,653 53,342 17,728 Others 20,943 11,081 7,571 Total product sales 101,423 172,841 147,222 License revenue 1,846 404 3,024 Total revenues $ 103,269 $ 173,245 $ 150,246 As of December 31, 2018 , the Company had four customers, each of which are substantial wholesale distributors, and accounted for 10% or more of the accounts receivable balance. One customer accounted for 32% , or $3,571 , a second customer accounted for 24% or $2,755 , a third customer accounted for 24% or $2,789 , and a fourth customer accounted for 10% or $1,174 . As of December 31, 2018 , the Company had no significant past due account receivable balances. The following table summarizes revenues by geographic region for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Geographic Region: 2018 2017 2016 United States $ 101,423 $ 172,841 $ 147,283 Ireland 1,846 404 2,963 Total revenues $ 103,269 $ 173,245 $ 150,246 Currently we depend on a single contract manufacturing organization for the manufacture of Bloxiverz, Vazculep and Noctiva and two contract manufacturing organizations for the manufacture of Akovaz, from which we derive a majority of our revenues. Additionally, we purchase certain raw materials used in our products from a limited number of suppliers, including a single supplier for certain key ingredients. Non-monetary long-lived assets primarily consist of property and equipment, goodwill and intangible assets. The following table summarizes non-monetary long-lived assets by geographic region as of December 31, 2018 , 2017 , and 2016 : Long-lived Assets by Geographic Region: 2018 2017 2016 United States $ 27,761 $ 116,536 $ 42,021 France 1,365 2,257 2,524 Ireland 6,028 1,360 202 Total $ 35,154 $ 120,153 $ 44,747 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield Capital L.P (“Deerfield”), a significant shareholder of the Company. At December 31, 2018, the remaining consideration obligation for this transaction consisted of commitments to make earnout payments to Breaking Stick of 20% of any gross profit generated by certain Éclat products (the “Products”). Breaking Stick is majority owned by Deerfield, with a minority interest owned by certain current and former employees. The Company entered into a Security Agreement dated March 13, 2012 with Breaking Stick, whereby Breaking Stick was granted a security interest in various tangible and intangible assets related to the Products to secure the obligations of Éclat and Avadel US Holdings, Inc., including the full and prompt payment of royalties to Breaking Stick under the Royalty Agreement. As part of a February 2013 debt financing transaction conducted with Deerfield Management, Éclat entered into a Royalty Agreement with Horizon Santé FLML, Sarl and Deerfield Private Design Fund II, L.P., both affiliates of the Deerfield Entities (together, “Deerfield PDF/Horizon”). The Royalty Agreement provides for the Company to pay Deerfield PDF/Horizon 1.75% of the net sales of the Products sold by the Company and any of our affiliates until December 31, 2024 , with royalty payments paid in arrears for each calendar quarter during the term of the Royalty Agreement. The Company has also entered into a Security Agreement dated February 4, 2013 with Deerfield PDF/Horizon, whereby Deerfield PDF/Horizon was granted a security interest in the various tangible and intangible assets related to the Products to secure the obligations of Éclat and Avadel US Holdings, Inc., including the full and prompt payment of royalties to Deerfield PDF/Horizon under the Royalty Agreement. As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund (“Broadfin”), the Company also entered into a Royalty Agreement with Broadfin, a significant shareholder of the Company, dated as of December 3, 2013 (the “Broadfin Royalty Agreement”). Pursuant to the Broadfin Royalty Agreement, the Company is required to pay a royalty of 0.834% on the net sales of certain products sold by the Company and any of our affiliates until December 31, 2024 with royalty payments paid in arrears for each calendar quarter during the term of the Royalty Agreement. The Company has also entered into a Security Agreement dated December 3, 2013 with Broadfin, whereby Broadfin was granted a security interest in the various tangible and intangible assets related to the Products to secure the obligations of Éclat and Avadel US Holdings, Inc., including the full and prompt payment of royalties to Broadfin under the Royalty Agreement. The Company entered into an agreement dated February 5, 2016 to acquire FSC Holdings, LLC (“FSC”), a specialty pharmaceutical company dedicated to providing innovative solutions to unmet medical needs for pediatric patients, from Deerfield CSF, LLC, a Deerfield Management company (“Deerfield”), a related party. Under the terms of the acquisition, which was completed on February 8, 2016, the Company was to pay $1,050 annually for five years with a final payment in January 2021 of $15,000 for a total of $20,250 to Deerfield for all of the equity interests in FSC. The Company will also pay Deerfield a 15% royalty per annum on net sales of the current FSC products, up to $12,500 for a period not exceeding ten years. These obligations were assumed by Cerecor in connection with the divestiture of the Company’s pediatric products on February 16, 2018. In connection with the divestiture, the Company provided their guarantee in favor of Deerfield and in return, Armistice Capital Master Fund, Inc., the majority shareholder of Cerecor, guaranteed to the Company the payment by Cerecor of the Assumed Obligations mentioned in Note 16 : Divestiture of the Pediatric Assets. See Note 16 for further discussion around the divestiture. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Events Corporate Restructuring . In February 2019, Avadel announced a corporate restructuring in order to focus efforts and resources on the clinical development of FT218. In conjunction with the restructuring, Avadel will reduce its workforce by more than 50%, and Specialty Pharma made a voluntary filing for bankruptcy protection under Chapter 11 of the U.S. Bankruptcy Code on February 6, 2019. As noted above, Specialty Pharma is a special-purpose entity and wholly-owned subsidiary responsible solely for the sales, marketing and distribution of Noctiva . These restructuring actions were taken to exit Noctiva ™ quickly and efficiently, and are not expected to materially impact any other aspect of the Company’s business, including the ability to operate its sterile injectables hospital business, complete the FT218 Phase 3 clinical trial, and complete development of the Company’s fourth UMD product. The Company estimates that it will incur approximately $10 to $15 million of one-time pre-tax charges for severance and other costs related to the restructuring. For the years ended December 31, 2018 and 2017, the Company generated sales of $1,204 and $0 , respectively, and incurred selling, general and administrative expenses of $62,268 and $13,536 , respectively and research and development expenses of $2,782 and $1,688 , respectively, related to the Noctiva product. |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule of Valuation and Qualifying Accounts Disclosure | Schedule II Valuation and Qualifying Accounts (In thousands) Deferred Tax Asset Valuation Allowance: Balance, Beginning of Period Additions (a) Deductions (b) Other Changes (c) Balance, End of Period 2018 $ 15,354 $ 6,089 $ (75 ) $ (169 ) $ 21,199 2017 $ 7,599 $ 391 $ (664 ) $ 8,028 $ 15,354 2016 $ 45,516 $ 6,873 $ (42,417 ) $ (2,373 ) $ 7,599 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 and removal 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 and account method changes. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Nature of Operations | Nature of Operations. Avadel Pharmaceuticals plc (Nasdaq: AVDL) (“Avadel,” the “Company,” “we,” “our,” or “us”) is a branded specialty pharmaceutical company. Our primarily focus is on the development and potential FDA approval for FT218 which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy. In addition, we market three sterile injectable drugs used in the hospital setting which were developed under our “unapproved marketed drug” (UMD) program. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.. Our current marketed products include: • Akovaz® (ephedrine sulfate injection, USP), an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia • Bloxiverz® (neostigmine methylsulfate injection), a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. • Vazculep® (phenylephrine hydrochloride injection), an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Each of our Akovaz , Bloxiverz and Vazculep products is used primarily in the hospital setting and was developed under our UMD program . • Noctiva™ , a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Due to disappointing results after a substantial investment of resources after Noctiva’s commercial launch in March 2018 , Avadel Specialty Pharmaceuticals LLC, (“Specialty Pharma”), the Avadel subsidiary responsible for the marketing and sale of Noctiva, made a voluntary filing for Chapter 11 bankruptcy protection on February 6, 2019. Although Specialty Pharma currently continues its marketing and sales efforts for this product, Avadel anticipates that Specialty Pharma will discontinue all activities with respect to Noctiva during 2019 as a result of the bankruptcy. The Company was incorporated in Ireland on December 1, 2015 as a private limited company, and re-registered as an Irish public limited company on November 21, 2016. Our headquarters are in Dublin, Ireland and we have operations in St. Louis, Missouri, United States, and Lyon, France. The Company is the successor to Flamel Technologies S.A., a French société anonyme (“Flamel”), as the result of the Merger described above, in which Flamel merged with and into the Company at 11:59:59 p.m., Central Europe Time, on December 31, 2016 (the “Merger”) pursuant to the agreement between Flamel and Avadel entitled Common Draft Terms of Cross-Border Merger dated as of June 29, 2016 (the “Merger Agreement”). Immediately prior to the Merger, the Company was a wholly owned subsidiary of Flamel. In accordance with the Merger Agreement, as a result of the Merger: • Flamel ceased to exist as a separate entity and the Company continued as the surviving entity and assumed all of the assets and liabilities of Flamel. • our authorized share capital is $5,500 divided into 500,000 ordinary shares with a nominal value of $0.01 each and 50,000 preferred shares with a nominal value of $0.01 each ◦ all outstanding ordinary shares of Flamel, €0.122 nominal value per share, were canceled and exchanged on a one-for-one basis for newly issued ordinary shares of the Company, $0.01 nominal value per share. This change in nominal value of our outstanding shares resulted in our reclassifying $5,937 on our balance sheet from ordinary shares to additional paid-in capital ◦ our Board of Directors is authorized to issue preferred shares on a non-pre-emptive basis, for a maximum period of five years, at which point such an authorization may be renewed by shareholders. The Board of Directors has discretion to dictate terms attached to the preferred shares, including voting, dividend, conversion rights, and priority relative to other classes of shares with respect to dividends and upon a liquidation. • all outstanding American Depositary Shares (ADSs) representing ordinary shares of Flamel were canceled and exchanged on a one-for-one basis for ADSs representing ordinary shares of the Company. Thus, the Merger changed the jurisdiction of our incorporation from France to Ireland, and an ordinary share of the Company held (either directly or represented by an ADS) immediately after the Merger continued to represent the same proportional interest in our equity owned by the holder of a share of Flamel immediately prior to the Merger. Prior to completion of the Merger, the Flamel ADSs were listed on the Nasdaq Global Market (“Nasdaq”) under the trading symbol “FLML”; and immediately after the Merger the Company’s ADSs were listed for and began trading on Nasdaq on January 3, 2017 under the trading symbol “AVDL.” Further details about the reincorporation, the Merger and the Merger Agreement are contained in our definitive proxy statement filed with the SEC on July 5, 2016. |
Basis of Presentation | Basis of Presentation. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The consolidated financial statements include the accounts of the Company and all subsidiaries. All intercompany accounts and transactions have been eliminated. |
Revenue | Revenue. Revenue includes sales of pharmaceutical products, licensing fees, and, if any, milestone payments for research and development (“R&D”) achievements. Effective January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modified retrospective transition method applied to all open contracts as at December 31, 2017. The adoption of the new standard did not have a material effect on the overall timing or amount of revenue recognized when compared to prior accounting standards. See Note 3 : Revenue Recognition for expanded disclosures related to this new pronouncement. 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 products primarily through wholesalers and considers these wholesalers to be its customers. Revenue from product sales is recognized when the customer obtains control of the Company’s product, which occurs typically upon receipt by the customer. As is customary in the pharmaceutical industry, the Company’s gross product sales are subject to a variety of price adjustments in arriving at reported net product sales. These adjustments include estimates of product returns, chargebacks, payment discounts, rebates, and other sales allowances and are estimated based on analysis of historical data for the product or comparable products, future expectations for such products and other judgments and analysis. For generic products and branded products where the ultimate net selling price to customer is estimable, the Company recognizes revenues upon delivery to the wholesaler. For new product launches the Company recognizes revenue if sufficient data is available to determine product acceptance in the marketplace such that product returns may be estimated based on historical or analog product data and there is probable evidence of reorders and consideration is made of wholesaler inventory levels. As part of the third quarter 2016 launch of Akovaz, the Company determined that sufficient data was available to determine the ultimate net selling price to the customer and therefore recognized revenue upon delivery to our wholesaler customers. Prior to the second quarter 2016, the Company did not have sufficient historical or analog product data to estimate certain revenue deductions. As such, we could not accurately estimate the ultimate net selling price of our hospital portfolio of products and as a result delayed revenue recognition until the wholesaler sold the product through to end customers. During the second quarter of 2016, it was determined that we now had sufficient evidence, history, data and internal controls to estimate the ultimate selling price of our products upon shipment from our warehouse to our customers, the wholesalers. Accordingly, we discontinued the sell-through revenue approach and now recognize revenue once the product is delivered to the wholesaler. As a result of this change in accounting estimate, we recognized $5,981 in additional revenue, or $0.05 per diluted share, for the twelve months ended December 31, 2016 that previously would have been deferred until sold by the wholesalers to the hospitals. License Revenue The Company from time to time may enter into out-licensing agreements under which it licenses to third parties certain rights to its products or intellectual property. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, upfront license fees; development, regulatory, and commercial milestone payments; and sales-based royalty payments. Each of these payments results in license revenue. |
Governmental Grants | Government Grants. The Company receives financial support for various research or investment projects from governmental agencies. From time to time we receive funds, primarily from the French government, to finance certain R&D projects. These funds are repayable on commercial success of the project. In the absence of commercial success, the Company is released of our obligation to repay the funds and as such the funds are recognized in the consolidated statements of (loss) income as an offset to R&D expense. The absence of commercial success must be formally confirmed by the granting authority. Should the Company wish to discontinue the R&D to which the funding is associated, the granting authority must be informed and a determination made as to how much, if any, of the grant must be repaid. |
Research and Development | Research and Development (“R&D”). R&D expenses consist primarily of costs related to clinical studies and outside services, personnel expenses, and other R&D expenses. Clinical studies and outside services 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 stock-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. The Company recognizes R&D tax credits received from the French government for spending on innovative R&D as an offset of R&D expenses. |
Stock-based Compensation | Stock-based Compensation. The Company accounts for stock-based compensation based on the estimated grant-date fair value. The fair value of stock options and warrants is estimated using Black-Scholes option-pricing valuation models (“Black-Scholes model”). As required by the Black-Sholes model, estimates are made of the underlying volatility of AVDL stock, a risk-free rate and an expected term of the option or warrant. We estimated the expected term using a simplified method, as we do not have enough historical exercise data for a majority of such options and warrants upon which to estimate an expected term. The Company recognizes compensation cost, net of an estimated forfeiture rate, using the accelerated method over the requisite service period of the award. |
Income Taxes | Income Taxes. We account 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, we determine 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. We recognize deferred tax assets to the extent that we believe that these assets are more likely than not to be realized. In making such a determination, we consider 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 we determine that we would be able to realize our deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. We record uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) we determine 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, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. We recognize interest and penalties related to unrecognized tax benefits in the income tax expense line in the accompanying consolidated statements of (loss) income. Accrued interest and penalties are included on the related tax liability line in the consolidated balance sheets. |
Cash and Cash Equivalents | Cash and Cash Equivalents. Cash and cash equivalents consist of cash on hand, cash on deposit and fixed term deposits which are highly liquid investments with original maturities of less than three months. |
Marketable Securities | Marketable Securities. The Company’s marketable securities are considered to be available for sale and are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive income (“AOCI”) in shareholders’ equity, with the exception of unrealized losses believed to be other-than-temporary, if any, which are reported in earnings in the current period. The cost of securities sold is based upon the specific identification method. |
Accounts Receivables | Accounts Receivable. Accounts receivable are stated at amounts invoiced net of allowances for doubtful accounts and certain other gross to net variable consideration deductions. The Company makes judgments as to our ability to collect outstanding receivables and provides allowances for the portion of receivables deemed uncollectible. Provision is made based upon a specific review of all significant outstanding invoices. A majority of accounts receivable is due from four significant customers. |
Inventories | Inventories. Inventories consist of raw materials and finished products, which are stated at lower of cost or net realizable value, using the first-in, first-out (“FIFO”) method. Raw materials used in the production of pre-clinical and clinical products are expensed as R&D costs when consumed. The Company establishes reserves for inventory estimated to be obsolete, unmarketable or slow-moving on a case by case basis. |
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: Laboratory equipment 4-8 years Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 5-10 years |
Goodwill | Goodwill. Goodwill represents the excess of the acquisition consideration over the fair value of assets acquired and liabilities assumed. The Company has determined that we operate in a single segment and has a single reporting unit associated with the development and commercialization of pharmaceutical products. The annual test for goodwill impairment is a two-step process. The first step is a comparison of the fair value of the reporting unit with its carrying amount, including goodwill. If this step indicates impairment, then, in the second step, the loss is measured as the excess of recorded goodwill over the implied fair value of the goodwill. Implied fair value of goodwill is the excess of the fair value of the reporting unit as a whole over the fair value of all separately identified assets and liabilities within the reporting unit. The Company tests goodwill for impairment annually and when events or changes in circumstances indicate that the carrying value may not be recoverable. During the fourth quarter of 2018, we performed our required annual impairment test of goodwill and have determined that no impairment of goodwill existed at December 31, 2018 or 2017. |
Long-Lived Assets | Long-Lived Assets. Long-lived assets include fixed assets and intangible assets. Intangible assets consist primarily of purchased licenses and intangible assets recognized as part of the Éclat acquisition. Acquired IPR&D has an indefinite life and is not amortized until completion and development of the project, at which time the IPR&D becomes an amortizable asset, for which amortization of such intangible assets is computed using the straight-line method over the estimated useful life of the assets. Long-lived assets are reviewed for impairment whenever conditions indicate that the carrying value of the assets may not be fully recoverable. Such impairment tests are based on a comparison of the pretax undiscounted cash flows expected to be generated by the asset to the recorded value of the asset or other market based value approaches. If impairment is indicated, the asset value is written down to its market value if readily determinable or its estimated fair value based on discounted cash flows. Any significant changes in business or market conditions that vary from current expectations could have an impact on the fair value of these assets and any potential associated impairment. During the fourth quarter of 2018, we recorded a $66,087 impairment charge to the entire acquired developed technology related to Noctiva (see Note 9: Goodwill and Intangible Assets ). The Company had determined that no impairment existed at December 31, 2017. |
Acquisition-related Contingent Consideration | Acquisition-related Contingent Consideration. The acquisition-related contingent consideration payables arising from the acquisition of Éclat Pharmaceuticals (i.e., our hospital products) and FSC (our pediatrics products), which was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018, are accounted for at fair-value (see Note 11: Long-Term Related Party Payable and Note 16: Divestiture of the Pediatric Assets ). The fair value of the warrants issued in connection with the Éclat acquisition were estimated using a Black-Scholes model. A portion of these warrants were exercised on February 23, 2018 and the remaining warrants expired on March 12, 2018. See Note 11: Long-Term Related Party Payable . The fair value of acquisition-related contingent consideration payable is estimated using a discounted cash flow model based on the long-term sales or gross profit forecasts of the specified hospital or pediatric products using an appropriate discount rate. There are a number of estimates used when determining the fair value of these earn-out payments. These estimates include, but are not limited to, the long-term pricing environment, market size, market share the related products are forecast to achieve, the cost of goods related to such products and an appropriate discount rate to use when present valuing the related cash flows. These estimates can and often do change based on changes in current market conditions, competition, management judgment and other factors. Changes to these estimates can have and have had a material impact on our consolidated statements of (loss) income and balance sheets. Changes in fair value of these liabilities are recorded in the consolidated statements of (loss) income within operating expenses as changes in fair value of related party contingent consideration. |
Financing-related Royalty Agreements | Financing-related Royalty Agreements. We also entered into two royalty agreements with related parties in connection with certain financing arrangements. We elected the fair value option for the measurement of the financing-related contingent consideration payable associated with the royalty agreements with certain Deerfield and Broadfin entities, both of whom are related parties (see Note 11: Long-Term Related Party Payable ). The fair value of financing-related royalty agreements is estimated using the same components used to determine the fair value of the acquisition-related contingent consideration noted above, with the exception of cost of products sold. Changes to these components can also have a material impact on our consolidated statements of (loss) income and balance sheets. Changes in the fair value of this liability are recorded in the consolidated statements of (loss) income as other income (expense) - changes in fair value of related party payable. |
Foreign Currency Translation | Foreign Currency Translation. At December 31, 2018, the reporting currency of the Company and our wholly-owned subsidiaries is the U.S. dollar. Prior to December 31, 2016, each of the Company’s non-U.S. subsidiaries and the parent entity, Flamel, used the Euro as their functional currency. At December 31, 2016, in conjunction with the Merger described above, Avadel determined the U.S. dollar is our functional currency. Subsidiaries and entities that do not use the U.S. dollar as their functional currency translate 1) profit and loss accounts at the average exchange rates during the reporting period, 2) assets and liabilities at period end exchange rates and 3) shareholders’ equity accounts at historical rates. Resulting translation gains and losses are included as a separate component of shareholders’ equity in accumulated other comprehensive loss. Assets and liabilities, excluding available-for-sale marketable securities, denominated in a currency other than the subsidiary’s functional currency are translated to the subsidiary’s functional currency at period end exchange rates with resulting gains and losses recognized in the consolidated statements of (loss) income. |
Use of Estimates | Use of Estimates. The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including marketable securities and contingent liabilities at the date of the consolidated financial statements and the reported amounts of sales and expenses during the periods presented. These estimates and assumptions are based on the best information available to management at the balance sheet dates and depending on the nature of the estimate can require significant judgments. Changes to these estimates and judgments can have and have had a material impact on our consolidated statements of (loss) income and balance sheets. Actual results could differ from those estimates under different assumptions or conditions. |
Effect of New Accounting Standards | In January 2017, the FASB issued ASU 2017-04, “ Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment.” This update eliminates step 2 from the goodwill impairment test, and requires the goodwill impairment test to be performed by comparing the fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This guidance is effective for the Company in the first quarter of 2020. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company will assess the timing of adoption and impact of this guidance to future impairment considerations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Schedule of Property and Equipment Useful Life | Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Laboratory equipment 4-8 years Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 5-10 years The principal categories of property and equipment, net at December 31, 2018 and 2017 , respectively, are as follows: Property and Equipment, net: 2018 2017 Laboratory equipment $ 8,864 $ 10,135 Software, office and computer equipment 2,487 3,115 Furniture, fixtures and fittings 3,715 4,779 Less - accumulated depreciation (13,155 ) (15,028 ) Total $ 1,911 $ 3,001 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis | The following table summarizes the financial instruments measured at fair value on a recurring basis classified in the fair value hierarchy (Level 1, 2 or 3) based on the inputs used for valuation in the accompanying consolidated balance sheets: As of December 31, 2018 As of December 31, 2017 Fair Value Measurements: Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Marketable securities (see Note 5) Equity securities $ 9,145 $ — $ — $ 468 $ — $ — Money market funds 52,996 — — 44,481 — — Corporate bonds — 6,339 — — 9,262 — Government securities - U.S. — 12,701 — — 19,050 — Other fixed-income securities — 9,409 — — 4,250 — Total assets $ 62,141 $ 28,449 $ — $ 44,949 $ 32,562 $ — Related party payable (see Note 11) — — 28,840 — — 98,925 Total liabilities $ — $ — $ 28,840 $ — $ — $ 98,925 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 and 2017 , respectively: 2018 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Equity securities $ 10,101 $ — $ (956 ) $ 9,145 Money market funds 52,733 316 (53 ) 52,996 Corporate bonds 6,411 7 (79 ) 6,339 Government securities - U.S. 12,714 66 (79 ) 12,701 Other fixed-income securities 9,400 22 (13 ) 9,409 Total $ 91,359 $ 411 $ (1,180 ) $ 90,590 2017 Marketable Securities: Adjusted Cost Unrealized Gains Unrealized Losses Fair Value Equity securities $ 443 $ 31 $ (6 ) $ 468 Money market funds 44,525 — (44 ) 44,481 Corporate bonds 9,285 1 (24 ) 9,262 Government securities - U.S. 19,080 — (30 ) 19,050 Other fixed-income securities 4,259 — (9 ) 4,250 Total $ 77,592 $ 32 $ (113 ) $ 77,511 |
Investments Classified by Contractual Maturity Date | The following table summarizes the estimated fair value of our investments in marketable debt securities, accounted for as available-for-sale securities and classified by the contractual maturity date of the securities as of December 31, 2018 : Maturities Marketable Debt Securities: Less than 1 Year 1-5 Years 5-10 Years Greater than 10 Years Total Corporate bonds $ 1,511 $ 4,828 $ — $ — $ 6,339 Government securities - U.S. 771 11,145 281 504 12,701 Other fixed-income securities — 9,409 — — 9,409 Total $ 2,282 $ 25,382 $ 281 $ 504 $ 28,449 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | The principal categories of inventories, net reserves of $4,757 and $1,039 at December 31, 2018 and 2017 , respectively, are comprised of the following: Inventory: 2018 2017 Finished goods $ 4,270 $ 4,774 Raw materials 500 1,383 Total $ 4,770 $ 6,157 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment is stated at historical cost less accumulated depreciation. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives: Laboratory equipment 4-8 years Software, office and computer equipment 3 years Leasehold improvements, furniture, fixtures and fittings 5-10 years The principal categories of property and equipment, net at December 31, 2018 and 2017 , respectively, are as follows: Property and Equipment, net: 2018 2017 Laboratory equipment $ 8,864 $ 10,135 Software, office and computer equipment 2,487 3,115 Furniture, fixtures and fittings 3,715 4,779 Less - accumulated depreciation (13,155 ) (15,028 ) Total $ 1,911 $ 3,001 |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Schedule of Recognized Identified Assets Acquired and Liabilities Assumed | The fair values assigned to the acquired assets and liabilities were recognized as follows: Assigned Fair Value: Amount Accounts receivable $ 142 Inventories 1,135 Prepaid expenses and other current assets 1,712 Intangible assets: Acquired product marketing rights 16,600 Acquired developed technology 4,300 Deferred tax assets 853 Other assets 277 Accounts payable and other liabilities (3,827 ) Total $ 21,192 |
Business Acquisition, Pro Forma Information | Had the FSC acquisition been completed as of the beginning of 2016, the Company’s unaudited pro forma net revenue and net loss for the twelve months ended December 31, 2016 would have been as follows: Pro Forma Net Revenue and Income (Loss): 2016 Net revenue $ 150,721 Net loss (42,290 ) |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets and Goodwill | The Company’s amortizable and unamortizable intangible assets at December 31, 2018 and 2017 , respectively, are as follows: 2018 2017 Goodwill and Intangible Assets: Gross Value Accumulated Amortization Impairment Net Carrying Amount Gross Value Accumulated Amortization Net Carrying Amount Amortizable intangible assets: Acquired developed technology - Noctiva $ 73,111 $ (7,024 ) $ (66,087 ) $ — $ 73,111 $ (1,401 ) $ 71,710 Acquired developed technology - Vazculep 12,061 (10,432 ) — 1,629 12,061 (9,616 ) 2,445 Acquired product marketing rights (1) — — — — 16,600 (2,132 ) 14,468 Acquired developed technology (1) — — — — 4,300 (634 ) 3,666 Total amortizable intangible assets $ 85,172 $ (17,456 ) $ (66,087 ) $ 1,629 $ 106,072 $ (13,783 ) $ 92,289 Unamortizable intangible assets: Goodwill $ 18,491 $ — $ — $ 18,491 $ 18,491 $ — $ 18,491 Total unamortizable intangible assets $ 18,491 $ — $ — $ 18,491 $ 18,491 $ — $ 18,491 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | At December 31, 2018 , total future amortization of intangible assets for the next five years is as follows: Estimated Amortization Expense: Amount 2019 $ 815 2020 814 2021 — 2022 — 2023 — |
Long-Term Debt - (Tables)
Long-Term Debt - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | Long-Term debt is summarized as follows: December 31, 2018 December 31, 2017 Principal amount of 4.50% exchangeable senior notes due 2023 $ 143,750 $ — Less: unamortized debt discount and issuance costs, net (28,059 ) — Net carrying amount of liability component 115,691 — Other debt 149 267 Subtotal 115,840 267 Less: current maturities (106 ) (111 ) Long-term debt $ 115,734 $ 156 Equity component: Equity component of exchangeable notes, net of issuance costs $ (26,699 ) $ — |
Long-Term Related Party Payab_2
Long-Term Related Party Payable (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Related Party Transactions | Long-term related party payable and related activity are reported at fair value and consist of the following at December 31, 2018 and 2017 , respectively: Activity during the Twelve Months Ended December 31, 2018 Changes in Fair Value of Related Party Payable Balance, December 31, 2017 Payments to Related Parties Operating (Gain) Expense Other Income Expiration of Warrants Disposal Balance, Acquisition-related contingent consideration: Warrants - Éclat Pharmaceuticals (a) $ 2,479 $ — $ (312 ) $ — $ (2,167 ) $ — $ — Earn-out payments - Éclat Pharmaceuticals (b) 67,744 (19,468 ) (22,661 ) — — — 25,615 Royalty agreement - FSC (c) 5,740 (645 ) 242 — — (5,337 ) — Financing-related: Royalty agreement - Deerfield (d) 5,392 (1,922 ) — (1,286 ) — — 2,184 Royalty agreement - Broadfin (e) 2,570 (916 ) — (613 ) — — 1,041 Long-term liability - FSC (f) 15,000 — — — — (15,000 ) — Total related party payable 98,925 $ (22,951 ) $ (22,731 ) $ (1,899 ) $ (2,167 ) $ (20,337 ) 28,840 Less: Current portion (25,007 ) (9,439 ) Total long-term related party payable $ 73,918 $ 19,401 Each of the above items is associated with related parties as further described in Note 22 : Related Party Transactions. (a) As part of the consideration for the Company’s acquisition of Éclat Pharmaceuticals, LLC on March 13, 2012, the Company issued two warrants to a related party with a six -year term which allow for the purchase of a combined total of 3,300 ordinary shares of Avadel. One warrant was exercisable for 2,200 ordinary shares at an exercise price of $7.44 per share, and the other warrant was exercisable for 1,100 ordinary shares at an exercise price of $11.00 per share. On February 23, 2018, the related party exercised in full the warrant for 2,200 ordinary shares. On March 12, 2018, the remaining warrant for 1,100 ordinary shares expired worthless. The following table summarizes changes to the related party payables, a recurring Level 3 measurement, for the twelve-month periods ended December 31, 2018 , 2017 and 2016 : Related Party Payable: Balance Balance at December 31, 2015 $ 122,693 Additions (2) 21,659 Payments of related party payable (30,838 ) Fair value adjustments (1) 55,833 Balance at December 31, 2016 169,347 Payments of related party payable (37,311 ) Fair value adjustments (1) (33,111 ) Balance at December 31, 2017 98,925 Payments of related party payable (22,951 ) Fair value adjustments (1) (24,630 ) Expiration of warrants (2,167 ) Disposition of the pediatrics assets (20,337 ) Balance at December 31, 2018 $ 28,840 (1) Fair value adjustments are reported as “(Gain) loss - changes in fair value of related party contingent consideration” and “Other income (expense) - changes in fair value of related party payable” in the consolidated statements of (loss) income. (2) Relates to the acquisition of FSC. See items (c) and (f) above. (b) In March 2012, the Company acquired all of the membership interests of Éclat from Breaking Stick Holdings, L.L.C. (“Breaking Stick”, formerly Éclat Holdings), an affiliate of Deerfield. Breaking Stick is majority owned by Deerfield, with a minority interest owned by certain current and former employees. As part of the consideration, the Company committed to provide quarterly earn-out payments equal to 20% of any gross profit generated by certain Éclat products. These payments will continue in perpetuity, to the extent gross profit of the related products also continue in perpetuity. (c) In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part included a commitment to pay quarterly a 15% royalty on the net sales of certain FSC products, up to $12,500 for a period not exceeding ten years. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets. (d) As part of a February 2013 debt financing transaction conducted with Deerfield, the Company received cash of $2,600 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 1.75% royalty on the net sales of certain Éclat products until December 31, 2024. In connection with such debt financing transaction, the Company granted Deerfield a security interest in the product registration rights of the Eclat products. (e) As part of a December 2013 debt financing transaction conducted with Broadfin Healthcare Master Fund, a related party and current shareholder, the Company received cash of $2,200 in exchange for entering into a royalty agreement whereby the Company shall pay quarterly a 0.834% royalty on the net sales of certain Éclat products until December 31, 2024. (f) In February 2016, the Company acquired all of the membership interests of FSC from Deerfield. The consideration for this transaction in part consisted of payments totaling $1,050 annually for five years with a final payment in January 2021 of $15,000 . Substantially all of FSC’s, and its subsidiaries, assets were pledged as collateral under this agreement. This obligation was assumed by the buyer as part of the disposition of the pediatrics products on February 16, 2018. See Note 16 : Divestiture of the Pediatric Assets. |
Schedule Of Fair Value Assumptions Of Warrant | The fair value of the warrants was estimated on a quarterly basis using a Black-Scholes option pricing model with the following assumptions as of December 31: Assumptions for the Warrant Valuation: 2017 Stock price $ 8.20 Weighted average exercise price per share 8.63 Expected term (years) 0.25 Expected volatility 37.90 % Risk-free interest rate 1.39 % Expected dividend yield — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule Of Components Of Income Before Income Tax | The components of (loss) income before income taxes for the years ended twelve months ended December 31, are as follows: (Loss) Income Before Income Taxes: 2018 2017 2016 Ireland $ (42,604 ) $ (3,123 ) $ (22,866 ) United States (70,340 ) 92,754 32,786 France (253 ) 3,029 (19,638 ) Total (loss) income before income taxes $ (113,197 ) $ 92,660 $ (9,718 ) |
Schedule Of Income Tax Payments | The income tax provision consists of the following for the years ended December 31: Income Tax (Benefit) Provision: 2018 2017 2016 Current: United States - Federal $ — $ 18,064 $ 30,738 United States - State 330 331 1,081 France — 265 5,267 Total current 330 18,660 37,086 Deferred: United States - Federal (19,503 ) 4,686 (6,443 ) United States - State 1,280 1,043 (23 ) France — — 938 Total deferred (18,223 ) 5,729 (5,528 ) Income tax (benefit) provision $ (17,893 ) $ 24,389 $ 31,558 |
Schedule of Effective Income Tax Rate Reconciliation | The reconciliation between Domestic income taxes at the statutory rate and the Company’s (benefit) provision for income taxes is as follows for the years ended December 31: Reconciliation to Effective Income Tax Rate: 2018 2017 2016 Statutory tax rate 12.5 % 12.5 % 12.5 % Differences in international tax rates 8.0 % 22.2 % (31.9 )% Nondeductible changes in fair value of contingent consideration 4.0 % (11.6 )% (165.0 )% Income tax deferred charge — % — % (9.7 )% Change in valuation allowances (5.3 )% (0.7 )% 11.8 % Nondeductible stock-based compensation (1.3 )% (0.4 )% (14.8 )% Cross border merger — % 0.3 % (100.6 )% Unrealized tax benefits (1.3 )% 1.4 % (15.2 )% State and local taxes (net of federal) (0.3 )% 0.3 % (9.6 )% Change in U.S. tax law (0.2 )% 3.8 % — % Nondeductible interest expense (1.1 )% — % — % Other 0.7 % (1.5 )% (2.3 )% Effective income tax rate 15.7 % 26.3 % (324.8 )% Income tax (benefit) provision - at statutory tax rate $ (14,149 ) $ 11,582 $ (1,215 ) Differences in international tax rates (9,039 ) 20,557 3,097 Nondeductible changes in fair value of contingent consideration (4,559 ) (10,779 ) 16,036 Income tax deferred charge — — 938 Change in valuation allowances 5,998 (610 ) (1,143 ) Nondeductible stock-based compensation 1,499 (375 ) 1,436 Cross-border merger — 265 9,773 Unrecognized tax benefits 1,440 1,296 1,475 State and local taxes (net of federal) 299 252 934 Change in U.S. tax law 274 3,513 — Nondeductible interest expense 1,269 — — Other (925 ) (1,312 ) 227 Income tax (benefit) provision - at effective income tax rate $ (17,893 ) $ 24,389 $ 31,558 |
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 2018 2017 2016 Balance at January 1: $ 3,954 $ 1,686 $ 448 Additions based on tax positions related to the current year 1,087 2,268 1,578 Increases (decreases) for tax positions of prior years 274 — (340 ) Balance at December 31: $ 5,315 $ 3,954 $ 1,686 |
Schedule of Deferred Tax Assets and Liabilities | The net deferred tax assets/liabilities at December 31, 2018 and 2017 resulted from the following temporary differences: Net Deferred Tax Assets and Liabilities: 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 19,510 $ 9,831 Amortization 20,642 7,563 Stock based compensation 4,587 4,375 Fair value royalty agreements — 635 Fair value contingent consideration 384 870 Other 479 406 Gross deferred tax assets 45,602 23,680 Deferred tax liabilities: Amortization (308 ) (2,419 ) Accounts receivable (661 ) (936 ) Prepaid expenses (405 ) (1,094 ) Gross deferred tax liabilities (1,374 ) (4,449 ) Less: valuation allowances (21,199 ) (15,354 ) Net deferred tax assets $ 23,029 $ 3,877 |
Post-Retirement Benefit Plans (
Post-Retirement Benefit Plans (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Schedule Of Defined Benefit Plan Assumptions | The benefit obligation is calculated as the present value of estimated future benefits to be paid, using the following assumptions for the years ended December 31: Retirement Benefit Obligation Assumptions: 2018 2017 2016 Compensation rate increase 2.75 % 3.00 % 3.00 % Discount rate 1.50 % 1.25 % 1.31 % Employee turn-over Actuarial standard and average of the last 5 years Average age of retirement 60 to 65 years actuarial standard based on age and professional status |
Schedule of Changes in Accumulated Postemployment Benefit Obligations | Changes in the funded status of the retirement indemnity benefit plans were as follows for the years ended December 31: Retirement Benefit Obligation Activity: 2018 2017 Retirement indemnity benefit obligation, beginning of year $ 1,303 $ 2,431 Service cost 93 132 Interest cost 17 21 Plan amendment — (829 ) Benefits paid (12 ) — Curtailment gain (148 ) (717 ) Actuarial loss (178 ) (25 ) Exchange rate changes (51 ) 290 Retirement indemnity benefit obligation, end of year $ 1,024 $ 1,303 |
Schedule Of Defined Benefit Plan Expected Future Benefit | The future expected benefits to be paid over the next five years and for the five years thereafter is as follows for the years ended December 31: Future Retirement Indemnity Benefit Obligation: Balance 2019 $ — 2020 — 2021 — 2022 17 2023 — Next five years 158 Total $ 175 |
Other Assets and Liabilities (T
Other Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Various other assets and liabilities are summarized for the years ended December 31, as follows: Prepaid Expenses and Other Current Assets: 2018 2017 Valued-added tax recoverable $ 1,378 $ 1,206 Prepaid and other expenses 2,145 7,106 Guarantee from Armistice (see Note 16 ) 534 — Income tax receivable 921 518 Research and development tax credit receivable 283 — Short-term deposit 3,350 — Other 225 128 Total $ 8,836 $ 8,958 |
Schedule of Other Non-Current Assets | Other Non-Current Assets: 2018 2017 Deferred tax assets $ 23,029 $ 3,877 Long-term deposits 1,477 3,350 Guarantee from Armistice (see Note 16 ) 5,697 — Right of use assets at contract manufacturing organizations 5,894 2,909 Other 49 113 Total $ 36,146 $ 10,249 |
Schedule of Accrued Expenses | Accrued Expenses: 2018 2017 Accrued compensation $ 3,971 $ 3,157 Accrued social charges 1,009 1,204 Accrued restructuring (see Note 17 ) 879 1,000 Customer allowances 6,541 10,613 Accrued ELAA payment — 20,000 Accrued contract research organization charges 1,000 156 Accrued contract manufacturing organization costs 2,028 2,327 Accrued contract sales organization and marketing costs 3,469 7,641 Other 2,798 4,828 Total $ 21,695 $ 50,926 |
Schedule of Other Non-Current Liabilities | Other Non-Current Liabilities: 2018 2017 Provision for retirement indemnity $ 1,024 $ 1,303 Customer allowances 1,352 1,636 Unrecognized tax benefits 5,315 3,954 Guarantee to Deerfield (see Note 16 ) 5,717 — Other 594 191 Total $ 14,002 $ 7,084 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Contractual Obligation, Fiscal Year Maturity Schedule | The following table presents contractual obligations of the Company at December 31, 2018 : Payments Due by Period Contractual Obligations: Total Less than 1 to 3 3 to 5 More than Long-term debt and interest $ 173,009 $ 6,575 $ 12,981 $ 153,453 $ — Long-term related party payable 51,284 9,439 8,713 7,250 25,882 Purchase commitments 26,682 10,754 10,828 5,100 — Operating leases 5,836 1,191 2,217 1,461 967 Total contractual cash obligations $ 256,811 $ 27,959 $ 34,739 $ 167,264 $ 26,849 Included in the purchase commitments total above, is approximately $15,308 of an obligation of Specialty Pharma, which on February 6, 2019, filed for Chapter 11 bankruptcy protection. Commitments for these arrangements, at maximum quantities and at contractual prices over the remaining life of the contract, and excluding any waived commitments, are as follows for the years ended December 31: Purchase Commitments: Balance 2019 $ 10,754 2020 5,948 2021 4,880 2022 4,880 2023 220 Thereafter — Total $ 26,682 |
Schedule of Future Minimum Rental Payments for Operating Leases | The Company and our subsidiaries lease office facilities under noncancelable operating leases expiring at various dates. Rent expense, net of rental income, was $1,213 , $1,146 and $970 in 2018, 2017, and 2016, respectively. Minimum rental commitments for non-cancelable leases in effect at December 31, 2018 are as follows: Lease Commitment: Balance 2019 $ 1,191 2020 1,208 2021 1,008 2022 767 2023 695 Thereafter 967 Total $ 5,836 |
Restructuring Costs - France (T
Restructuring Costs - France (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table sets forth activities for the Company’s cost reduction plan obligations for the year ended December 31, 2018 : Restructuring Obligation: 2018 2017 Balance of restructuring accrual at January 1, $ 1,000 $ — Charges for employee severance, benefits and other 1,164 3,259 Payments (1,261 ) (2,600 ) Foreign currency impact (24 ) 341 Balance of restructuring accrual at December 31, $ 879 $ 1,000 |
Equity Instruments and Stock _2
Equity Instruments and Stock Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Compensation expense included in the Company’s consolidated statements of (loss) income for all stock-based compensation arrangements was as follows for the periods ended December 31: Stock-based Compensation Expense: 2018 2017 2016 Research and development $ 880 $ 672 $ 3,523 Selling, general and administrative 6,972 7,400 11,156 Total stock-based compensation expense $ 7,852 $ 8,072 $ 14,679 |
Schedule of Share Based Payment Award Stock Options and Warrant Grants Valuation Assumptions | The weighted-average assumptions under the Black-Scholes option-pricing model for stock option and warrant grants as of December 31, 2018 , 2017 and 2016 , are as follows: Stock Option and Warrant Assumptions: 2018 2017 2016 Stock option grants: Expected term (years) 6.25 6.25 6.25 Expected volatility 56.59 % 58.82 % 58.39 % Risk-free interest rate 2.68 % 2.20 % 2.04 % Expected dividend yield — — — Warrant grants: Expected term (years) — 0 2.50 Expected volatility — % — % 60.57 % Risk-free interest rate — % — % 0.82 % Expected dividend yield — — — |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of the combined stock option activity and other data for the Company’s stock option plans for the year ended December 31, 2018 is as follows: Stock Option Activity and Other Data: Number of Stock Options Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Stock options outstanding, January 1, 2018 5,041 $ 11.34 Granted 138 6.67 Exercised (82 ) 6.52 Forfeited (428 ) 10.04 Expired (68 ) 12.41 Stock options outstanding, December 31, 2018 4,601 $ 11.39 7.25 years $ — Stock options exercisable, December 31, 2018 3,005 $ 11.99 6.66 years $ — |
Schedule of Stockholders' Equity Note, Warrants or Rights | A summary of the combined warrant activity and other data for the year ended December 31, 2018 is as follows: Warrant Activity and Other Data: Number of Warrants Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Warrants outstanding, January 1, 2018 894 $ 16.77 Granted — — Exercised — — Forfeited — — Expired (298 ) 14.87 Warrants outstanding, December 31, 2018 596 $ 17.72 1.03 years $ — Warrants exercisable, December 31, 2018 596 $ 17.72 1.03 years $ — |
Disclosure of Share-based Compensation Arrangements by Share-based Payment Award | A summary of the Company’s restricted share awards as of December 31, 2018 , 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 Fair Value Non-vested restricted share awards outstanding, January 1, 2018 819 $ 11.51 Granted 279 5.87 Vested (548 ) 12.78 Forfeited (59 ) 8.95 Non-vested restricted share awards outstanding, December 31, 2018 491 $ 7.20 |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share Reconciliation | A reconciliation of basic and diluted net (loss) income per share, together with the related shares outstanding in thousands for the years ended December 31, is as follows: Net (Loss) Income Per Share: 2018 2017 2016 Net (loss) income $ (95,304 ) $ 68,271 $ (41,276 ) Weighted average shares: Basic shares 37,325 40,465 41,248 Effect of dilutive securities—employee and director equity awards outstanding and 2023 Notes — 1,300 — Diluted shares 37,325 41,765 41,248 Net (loss) income per share - basic $ (2.55 ) $ 1.69 $ (1.00 ) Net (loss) income per share - diluted $ (2.55 ) $ 1.63 $ (1.00 ) |
Comprehensive Income (Loss) (Ta
Comprehensive Income (Loss) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Accumulated Other Comprehensive Income (Loss) | The following table shows the components of accumulated other comprehensive (loss) income for the twelve months ended December 31, net of immaterial tax effects: Accumulated Other Comprehensive (Loss) Income: 2018 2017 2016 Foreign currency translation adjustment: Beginning balance $ (23,202 ) $ (23,336 ) $ (22,312 ) Net other comprehensive (loss) income (419 ) 134 (1,024 ) Balance at December 31, (23,621 ) (23,202 ) (23,336 ) Unrealized gain (loss) on marketable securities, net Beginning balance (64 ) (229 ) (345 ) Net other comprehensive income, net of ($18), $28, $16, tax, respectively 269 165 116 Balance at December 31, 205 (64 ) (229 ) Accumulated other comprehensive loss at December 31, $ (23,416 ) $ (23,266 ) $ (23,565 ) |
Company Operations by Product_2
Company Operations by Product, Customer and Geographic Area (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Revenue from External Customers by Product and Services | The following table presents a summary of total revenues by these products for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Product: 2018 2017 2016 Bloxiverz $ 20,850 $ 45,596 $ 82,896 Vazculep 42,916 38,187 39,796 Akovaz 33,759 80,617 16,831 Noctiva 1,204 — — Other 2,694 8,441 7,699 Total product sales 101,423 172,841 147,222 License revenue 1,846 404 3,024 Total revenues $ 103,269 $ 173,245 $ 150,246 |
Schedule of Revenue by Major Customers by Reporting Segments | The following table presents a summary of total revenues by significant customer for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Significant Customer: 2018 2017 2016 Customer A $ 26,794 $ 44,762 $ 51,648 Customer B 25,413 37,965 39,359 Customer C 18,620 25,691 30,916 Customer D 9,653 53,342 17,728 Others 20,943 11,081 7,571 Total product sales 101,423 172,841 147,222 License revenue 1,846 404 3,024 Total revenues $ 103,269 $ 173,245 $ 150,246 |
Revenue from External Customers by Geographic Areas | The following table summarizes revenues by geographic region for the twelve months ended December 31, 2018 , 2017 , and 2016 : Revenue by Geographic Region: 2018 2017 2016 United States $ 101,423 $ 172,841 $ 147,283 Ireland 1,846 404 2,963 Total revenues $ 103,269 $ 173,245 $ 150,246 |
Long-lived Assets by Geographic Areas | ep and Noctiva and two contract manufacturing organizations for the manufacture of Akovaz, from which we derive a ma |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 12 Months Ended | ||||
Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Mar. 06, 2017USD ($) | Dec. 30, 2016€ / shares | |
Class of Stock [Line Items] | |||||
Authorized share capital | $ 5,500,000 | ||||
Ordinary shares, shares authorized (in shares) | shares | 500,000,000 | 500,000,000 | 500,000,000 | ||
Ordinary shares, nominal value (in usd or euro per share) | (per share) | $ 0.01 | $ 0.01 | $ 0.01 | € 0.122 | |
Preferred shares, shares authorized (in shares) | shares | 50,000,000 | 50,000,000 | 50,000,000 | ||
Preferred shares, nominal value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||
Adjustment to reduce share premium | $ 317,254,000 | ||||
Operating expenses | $ 208,195,000 | $ 83,740,000 | $ 155,211,000 | ||
Ordinary shares | |||||
Class of Stock [Line Items] | |||||
Cross-border merger nominal value adjustment | (5,937,000) | ||||
Advertising | |||||
Class of Stock [Line Items] | |||||
Operating expenses | $ 17,562,000 | $ 2,214,000 | $ 1,294,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Revenue (Details) - Change in Accounting Method Accounted for as Change in Estimate $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / shares | |
Change in Accounting Estimate [Line Items] | |
Product sales and services | $ | $ 5,981 |
Effect on earnings per diluted share (in usd per share) | $ / shares | $ 0.05 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Laboratory equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives (in years) | 8 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives (in years) | 4 years |
Software, office and computer equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives (in years) | 3 years |
Furniture, fixtures and fittings | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives (in years) | 10 years |
Furniture, fixtures and fittings | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, estimated useful lives (in years) | 5 years |
Effect of New Accounting Stan_2
Effect of New Accounting Standards (Details Textual) - USD ($) $ in Thousands | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Right of use assets at contract manufacturing organizations | $ 5,894 | $ 2,909 | |
Scenario, Forecast | Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Operating Lease, liability | $ 5,100 | ||
Right of use assets at contract manufacturing organizations | $ 5,100 |
Revenue Recognition (Details)
Revenue Recognition (Details) | Dec. 31, 2018USD ($) |
Revenue from Contract with Customer [Abstract] | |
Revenue, remaining performance obligation, amount | $ 1,600,000 |
Contract with customer, liability | $ 0 |
Fair Value Measurements - Measu
Fair Value Measurements - Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Feb. 16, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | $ 90,590 | |||
Fair Value | $ 77,511 | |||
Long-term related party payable, less current portion | 19,401 | 73,918 | ||
Long-term debt | 115,840 | 267 | ||
Equity securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Equity securities | 9,145 | |||
Fair Value | 468 | |||
Money market funds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 52,996 | |||
Fair Value | 44,481 | |||
Corporate bonds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 6,339 | |||
Fair Value | 9,262 | |||
Government securities - U.S. | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 12,701 | |||
Fair Value | 19,050 | |||
Other fixed-income securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 9,409 | |||
Fair Value | 4,250 | |||
Level 1 | Money market funds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 52,996 | |||
Fair Value Measurements, Recurring | Level 1 | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Total assets | 62,141 | $ 44,949 | ||
Fair Value Measurements, Recurring | Level 1 | Equity securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Equity securities | 9,145 | |||
Fair Value | 468 | |||
Fair Value Measurements, Recurring | Level 1 | Money market funds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair Value | 44,481 | |||
Fair Value Measurements, Recurring | Level 2 | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Total assets | 28,449 | 32,562 | ||
Fair Value Measurements, Recurring | Level 2 | Corporate bonds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | 6,339 | |||
Fair Value | 9,262 | |||
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 | 12,701 | |||
Fair Value | 19,050 | |||
Fair Value Measurements, Recurring | Level 2 | Other fixed-income securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Marketable securities | $ 9,409 | |||
Fair Value | 4,250 | |||
Fair Value Measurements, Recurring | Level 3 | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Long-term related party payable, less current portion | 28,840 | 98,925 | ||
Total liabilities | $ 28,840 | $ 98,925 | ||
4.50% Exchangeable Senior Notes Due 2023 | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Interest rate | 4.50% | 4.50% | 4.50% | |
Senior Notes | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Long-term debt | $ 115,691 | $ 0 | ||
Senior Notes | 4.50% Exchangeable Senior Notes Due 2023 | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Long-term debt | 143,750 | $ 0 | ||
Long-term debt, fair value | $ 81,490 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |||
Equity securities, gross unrealized loss | $ 956 | ||
Equity securities, gross unrealized gain | $ 344 | ||
Marketable securities, realized gains | 317 | $ 1,677 | 1,265 |
Marketable securities, realized loss | $ 565 | $ 1,390 | $ 586 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | $ 91,359 | |
Unrealized Gains | 411 | |
Unrealized Losses | (1,180) | |
Fair Value | 90,590 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | $ 77,592 | |
Unrealized Gains | 32 | |
Unrealized Losses | (113) | |
Fair Value | 77,511 | |
Equity securities | ||
Debt Securities, Trading, and Equity Securities, FV-NI [Abstract] | ||
Adjusted Cost | 10,101 | |
Unrealized Gains | 0 | |
Unrealized Losses | (956) | |
Fair Value | 9,145 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | 443 | |
Unrealized Gains | 31 | |
Unrealized Losses | (6) | |
Fair Value | 468 | |
Money market funds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 52,733 | |
Unrealized Gains | 316 | |
Unrealized Losses | (53) | |
Fair Value | 52,996 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | 44,525 | |
Unrealized Gains | 0 | |
Unrealized Losses | (44) | |
Fair Value | 44,481 | |
Corporate bonds | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 6,411 | |
Unrealized Gains | 7 | |
Unrealized Losses | (79) | |
Fair Value | 6,339 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | 9,285 | |
Unrealized Gains | 1 | |
Unrealized Losses | (24) | |
Fair Value | 9,262 | |
Government securities - U.S. | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 12,714 | |
Unrealized Gains | 66 | |
Unrealized Losses | (79) | |
Fair Value | 12,701 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | 19,080 | |
Unrealized Gains | 0 | |
Unrealized Losses | (30) | |
Fair Value | 19,050 | |
Other fixed-income securities | ||
Debt Securities, Available-for-sale, Fair Value to Amortized Cost [Abstract] | ||
Adjusted Cost | 9,400 | |
Unrealized Gains | 22 | |
Unrealized Losses | (13) | |
Fair Value | $ 9,409 | |
ASU 2016-01 Transition [Abstract] | ||
Adjusted Cost | 4,259 | |
Unrealized Gains | 0 | |
Unrealized Losses | (9) | |
Fair Value | $ 4,250 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Maturities (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Fair Value | $ 90,590 |
Corporate bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Less than 1 Year | 1,511 |
1-5 Years | 4,828 |
5-10 Years | 0 |
Greater than 10 Years | 0 |
Fair Value | 6,339 |
Government securities - U.S. | |
Debt Securities, Available-for-sale [Line Items] | |
Less than 1 Year | 771 |
1-5 Years | 11,145 |
5-10 Years | 281 |
Greater than 10 Years | 504 |
Fair Value | 12,701 |
Other fixed-income securities | |
Debt Securities, Available-for-sale [Line Items] | |
Less than 1 Year | 0 |
1-5 Years | 9,409 |
5-10 Years | 0 |
Greater than 10 Years | 0 |
Fair Value | 9,409 |
Debt Securities | |
Debt Securities, Available-for-sale [Line Items] | |
Less than 1 Year | 2,282 |
1-5 Years | 25,382 |
5-10 Years | 281 |
Greater than 10 Years | 504 |
Fair Value | $ 28,449 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 4,270 | $ 4,774 |
Raw materials | 500 | 1,383 |
Total | 4,770 | 6,157 |
Inventory [Line Items] | ||
Inventory reserves | 4,757 | $ 1,039 |
Inventory adjustments | 3,718 | |
Noctiva | ||
Inventory [Line Items] | ||
Inventory adjustments | $ 2,583 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | |||
Less - accumulated depreciation | $ (13,155) | $ (15,028) | |
Property and equipment, net | 1,911 | 3,001 | |
Depreciation | 811 | 1,224 | $ 601 |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 8,864 | 10,135 | |
Software, office and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 2,487 | 3,115 | |
Furniture, fixtures and fittings | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 3,715 | $ 4,779 |
Acquisitions (Details Textual)
Acquisitions (Details Textual) - USD ($) | Feb. 05, 2016 | Feb. 29, 2016 | Dec. 31, 2013 | Feb. 28, 2013 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Payments to acquire businesses, gross | $ 22,951,000 | $ 37,311,000 | $ 30,838,000 | ||||
Percentage of royalty payable on net sales | 0.834% | ||||||
Deerfield CSF LLC | Affiliated Entity | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Percentage of royalty payable on net sales | 1.75% | ||||||
FSC | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Business combination, consideration transferred | $ 21,659,000 | ||||||
Payment for settlement of net working capital | $ 467,000 | ||||||
Business combination, pro forma information, revenue of acquiree since acquisition date, actual | 5,985,000 | ||||||
Business combination, pro forma information, loss of acquiree since acquisition date, actual | $ 5,839,000 | ||||||
FSC | Maximum | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Acquired intangible assets useful life (in years) | 15 years | ||||||
FSC | Minimum | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Acquired intangible assets useful life (in years) | 9 years | ||||||
FSC | Deerfield CSF LLC | Affiliated Entity | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Business combination, recognized identifiable assets acquired and liabilities assumed, noncurrent liabilities, long-term debt | $ 15,000,000 | ||||||
Payments to acquire businesses, gross | $ 1,050,000 | $ 1,050,000 | |||||
Debt instrument, term (in years) | 5 years | 5 years | |||||
Business combination, contingent consideration, liability | $ 6,659,000 | ||||||
Percentage of royalty payable on net sales | 15.00% | 15.00% | |||||
FSC | Deerfield CSF LLC | Affiliated Entity | Maximum | |||||||
Business Combination, Separately Recognized Transactions [Line Items] | |||||||
Royalty guarantees, commitments, amount | $ 12,500,000 | ||||||
Royalty guarantees, commitments, term (in years) | 10 years | 10 years |
Acquisitions - Purchase Price A
Acquisitions - Purchase Price Allocation (Details) - FSC $ in Thousands | Feb. 05, 2016USD ($) |
Business Acquisition [Line Items] | |
Accounts receivable | $ 142 |
Inventories | 1,135 |
Prepaid expenses and other current assets | 1,712 |
Deferred tax assets | 853 |
Other assets | 277 |
Accounts payable and other liabilities | (3,827) |
Total | 21,192 |
Marketing Rights | |
Business Acquisition [Line Items] | |
Intangible assets | 16,600 |
Developed Technology | |
Business Acquisition [Line Items] | |
Intangible assets | $ 4,300 |
Acquisitions - Pro Forma Inform
Acquisitions - Pro Forma Information (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Business Combinations [Abstract] | |
Net revenue | $ 150,721 |
Net loss | $ (42,290) |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Net Book Value (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Amortizable intangible assets: | ||
Amortizable intangible assets: Gross Value | $ 85,172,000 | $ 106,072,000 |
Amortizable intangible assets: Accumulated Amortization | (17,456,000) | (13,783,000) |
Amortizable intangible assets, Impairment | (66,087,000) | |
Amortizable intangible assets: Net Book Value | 1,629,000 | 92,289,000 |
Unamortizable intangible assets: | ||
Unamortizable intangible assets: Goodwill, Gross Value | 18,491,000 | 18,491,000 |
Unamortizable intangible assets: Accumulated Amortization | 0 | 0 |
Unamortizable intangible assets: Net Book Value | 18,491,000 | 18,491,000 |
In Process Research and Development | Noctiva | ||
Amortizable intangible assets: | ||
Amortizable intangible assets: Gross Value | 73,111,000 | 73,111,000 |
Amortizable intangible assets: Accumulated Amortization | (7,024,000) | (1,401,000) |
Amortizable intangible assets, Impairment | (66,087,000) | |
Amortizable intangible assets: Net Book Value | 0 | 71,710,000 |
In Process Research and Development | Vazculep | ||
Amortizable intangible assets: | ||
Amortizable intangible assets: Gross Value | 12,061,000 | 12,061,000 |
Amortizable intangible assets: Accumulated Amortization | (10,432,000) | (9,616,000) |
Amortizable intangible assets, Impairment | 0 | |
Amortizable intangible assets: Net Book Value | 1,629,000 | 2,445,000 |
Marketing Rights | ||
Amortizable intangible assets: | ||
Amortizable intangible assets: Gross Value | 0 | 16,600,000 |
Amortizable intangible assets: Accumulated Amortization | 0 | (2,132,000) |
Amortizable intangible assets, Impairment | 0 | |
Amortizable intangible assets: Net Book Value | 0 | 14,468,000 |
Developed Technology | ||
Amortizable intangible assets: | ||
Amortizable intangible assets: Gross Value | 0 | 4,300,000 |
Amortizable intangible assets: Accumulated Amortization | 0 | (634,000) |
Amortizable intangible assets, Impairment | 0 | |
Amortizable intangible assets: Net Book Value | $ 0 | $ 3,666,000 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets (Details Textual) - USD ($) $ in Thousands | Oct. 01, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Finite-Lived Intangible Assets [Line Items] | ||||
Intangible asset amortization | $ 6,619 | $ 3,659 | $ 13,888 | |
Upfront payment for developed technology | 20,000 | 53,111 | 0 | |
Accrued contract research organization charges | 1,000 | 156 | ||
Transaction costs | 3,111 | |||
Impairment of intangible asset | $ 66,087 | 0 | $ 0 | |
Maximum | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Estimated useful life (in years) | 15 years | |||
Minimum | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Estimated useful life (in years) | 3 years | |||
Developed Technology | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Developed technology acquired | $ 73,111 | |||
Upfront payment for developed technology | $ 50,000 | |||
Accrued contract research organization charges | $ 20,000 | |||
Amortization period (in years) | 13 years |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Estimate Future Amortization (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2019 | $ 815 |
2020 | 814 |
2021 | 0 |
2022 | 0 |
2023 | $ 0 |
Long-Term Debt Schedule of Long
Long-Term Debt Schedule of Long-Term Debt Instruments (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Feb. 16, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | |||
Total | $ 115,840 | $ 267 | |
Other debt | 594 | 191 | |
Less: current maturities | (106) | (111) | |
Long-term debt, less current portion | $ 115,734 | $ 156 | |
4.50% Exchangeable Senior Notes Due 2023 | |||
Debt Instrument [Line Items] | |||
Interest rate | 4.50% | 4.50% | 4.50% |
Senior Notes | |||
Debt Instrument [Line Items] | |||
Less: unamortized debt discount and issuance costs, net | $ (28,059) | $ 0 | |
Total | 115,691 | 0 | |
Equity component of exchangeable notes, net of issuance costs | (26,699) | 0 | |
Senior Notes | 4.50% Exchangeable Senior Notes Due 2023 | |||
Debt Instrument [Line Items] | |||
Long-term debt | 143,750 | 0 | |
Loans Payable | |||
Debt Instrument [Line Items] | |||
Other debt | $ 149 | $ 267 |
Long-Term Debt (Details Textual
Long-Term Debt (Details Textual) | Feb. 16, 2018USD ($) | Dec. 31, 2018USD ($)day$ / shares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Proceeds from loans or conditional grants | $ 143,750,000 | $ 0 | $ 0 | |
ADS, option price per share (in dollars per share) | $ / shares | $ 10.79 | |||
ADS premium percentage | 20.00% | |||
ADS purchased, price per share (in dollars per share) | $ / shares | $ 8.99 | |||
Other debt | $ 594,000 | 191,000 | ||
Repayments of loans | 6,190,000 | 0 | 0 | |
Research and development arrangement, waiver of loan repayment | $ 0 | 539,000 | 0 | |
Convertible Debt | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Remaining discount amortization period | 5 years | |||
Loans Payable | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Other debt | $ 149,000 | 267,000 | ||
Research Projects Loan | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Repayments of loans | $ 193,000 | $ 115,000 | $ 277,000 | |
4.50% Exchangeable Senior Notes Due 2023 | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Debt instrument, face amount | $ 125,000,000 | |||
Interest rate | 4.50% | 4.50% | 4.50% | |
Option to increase aggregate principal amount | $ 18,750,000 | |||
Proceeds from loans or conditional grants | $ 137,560,000 | |||
ADSs, conversion ratio | 92.6956 | |||
4.50% Exchangeable Senior Notes Due 2023 | Convertible Debt | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Debt discount and issuance costs, net | $ 6,190,000 | |||
Debt issuance cost allocated to equity component | 1,201,000 | |||
Debt issuance cost allocated to liability component | $ 4,989,000 | |||
Debt Instrument, Redemption, Period One [Member] | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Consecutive business days | 5 days | |||
Consecutive trading days | day | 5 | |||
Debt Instrument, Redemption, Period Two [Member] | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Scheduled threshold trading days | 95 days | |||
Threshold trading days | day | 35 | |||
Debt Instrument, Redemption, Period Three [Member] | ||||
Schedule of Capitalization, Long-term Debt [Line Items] | ||||
Consecutive trading days | day | 30 | |||
Threshold trading days | day | 20 | |||
Threshold percentage of stock price trigger | 130.00% |
Long-Term Related Party Payab_3
Long-Term Related Party Payable - Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Long-Term Related Party Payable | |||
Related party payable, beginning balance | $ 98,925 | $ 169,347 | $ 122,693 |
Payments to Related Parties | (22,951) | (37,311) | (30,838) |
Operating (Gain) Expense | (22,731) | (31,040) | 49,285 |
Other Income | (1,899) | ||
Expiration of Warrants | (2,167) | ||
Disposal | (20,337) | ||
Related party payable, ending balance | 28,840 | 98,925 | $ 169,347 |
Less: Current portion | (9,439) | (25,007) | |
Total long-term related party payable | 19,401 | 73,918 | |
Financing-related: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 15,000 | ||
Payments to Related Parties | 0 | ||
Operating (Gain) Expense | 0 | ||
Other Income | 0 | ||
Expiration of Warrants | 0 | ||
Disposal | (15,000) | ||
Related party payable, ending balance | 0 | 15,000 | |
Warrant | Acquisition-related contingent consideration: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 2,479 | ||
Payments to Related Parties | 0 | ||
Operating (Gain) Expense | (312) | ||
Other Income | 0 | ||
Expiration of Warrants | (2,167) | ||
Disposal | 0 | ||
Related party payable, ending balance | 0 | 2,479 | |
Earn-out payments | Acquisition-related contingent consideration: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 67,744 | ||
Payments to Related Parties | (19,468) | ||
Operating (Gain) Expense | (22,661) | ||
Other Income | 0 | ||
Expiration of Warrants | 0 | ||
Disposal | 0 | ||
Related party payable, ending balance | 25,615 | 67,744 | |
Royalty agreement - FSC | Acquisition-related contingent consideration: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 5,740 | ||
Payments to Related Parties | (645) | ||
Operating (Gain) Expense | 242 | ||
Other Income | 0 | ||
Expiration of Warrants | 0 | ||
Disposal | (5,337) | ||
Related party payable, ending balance | 0 | 5,740 | |
Royalty agreement - Deerfield | Financing-related: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 5,392 | ||
Payments to Related Parties | (1,922) | ||
Operating (Gain) Expense | 0 | ||
Other Income | (1,286) | ||
Expiration of Warrants | 0 | ||
Disposal | 0 | ||
Related party payable, ending balance | 2,184 | 5,392 | |
Royalty agreement - Broadfin | Financing-related: | |||
Long-Term Related Party Payable | |||
Related party payable, beginning balance | 2,570 | ||
Payments to Related Parties | (916) | ||
Operating (Gain) Expense | 0 | ||
Other Income | (613) | ||
Expiration of Warrants | 0 | ||
Disposal | 0 | ||
Related party payable, ending balance | $ 1,041 | $ 2,570 |
Long-Term Related Party Payab_4
Long-Term Related Party Payable - Warrant Fair Value Assumptions (Details) - Warrant | Dec. 31, 2017$ / shares |
Stock price | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Stock price (in dollars per share) | $ 8.20 |
Weighted average exercise price per share | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Exercise price of warrants (in usd per share) | $ 8.63 |
Expected term (years) | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Warrants and rights outstanding, expected term (years) | 3 months |
Expected volatility | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Warrants and rights outstanding, measurement input | 0.3790 |
Risk-free interest rate | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Warrants and rights outstanding, measurement input | 0.0139 |
Expected dividend yield | |
Schedule of Capitalization, Long-term Debt [Line Items] | |
Warrants and rights outstanding, measurement input | 0 |
Long-Term Related Party Payab_5
Long-Term Related Party Payable - Payable Balance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Business Combination, Changes in Related Party Payable [Roll Forward] | |||
Related party payable, beginning balance | $ 98,925 | $ 169,347 | $ 122,693 |
Additions | 21,659 | ||
Payments of related party payable | (22,951) | (37,311) | (30,838) |
Fair value adjustments | (24,630) | (33,111) | 55,833 |
Expiration of Warrants | (2,167) | ||
Disposal | (20,337) | ||
Related party payable, ending balance | $ 28,840 | $ 98,925 | $ 169,347 |
Long-Term Related Party Payab_6
Long-Term Related Party Payable (Details Textual) - USD ($) | Feb. 05, 2016 | Mar. 13, 2012 | Jan. 31, 2021 | Feb. 29, 2016 | Dec. 31, 2013 | Feb. 28, 2013 | Mar. 31, 2012 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 12, 2018 | Feb. 23, 2018 | Mar. 12, 2012 |
Line of Credit Facility [Line Items] | |||||||||||||
Number of securities called by each warrant (in shares) | 1 | ||||||||||||
Percentage of royalty payable on net sales | 0.834% | ||||||||||||
Cash consideration received on royalty agreement | $ 2,200,000 | ||||||||||||
Payments to acquire businesses, gross | $ 22,951,000 | $ 37,311,000 | $ 30,838,000 | ||||||||||
Minimum | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Discounted cash flow risk adjusted discount rate | 15.00% | ||||||||||||
Affiliated Entity | Deerfield CSF LLC | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Percentage of royalty payable on net sales | 1.75% | ||||||||||||
Cash consideration received on royalty agreement | $ 2,600,000 | ||||||||||||
Eclat Pharmaceuticals | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Warrants issued | 2 | ||||||||||||
Warrant term (in years) | 6 years | ||||||||||||
Number of securities called by warrants (in shares) | 3,300 | ||||||||||||
Exercise price of warrants (in usd per share) | $ 11 | ||||||||||||
Number of securities called by each warrant (in shares) | 2,200,000 | 1,100 | |||||||||||
Percentage of earn-out payments | 20.00% | ||||||||||||
Remaining warrants outstanding expired | 1,100,000 | ||||||||||||
Eclat Pharmaceuticals | Exercise Price 1 | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Exercise price of warrants (in usd per share) | $ 7.44 | ||||||||||||
Number of securities called by each warrant (in shares) | 2,200 | 2,200 | |||||||||||
FSC | Affiliated Entity | Deerfield CSF LLC | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Percentage of royalty payable on net sales | 15.00% | 15.00% | |||||||||||
Royalty amount | $ 12,500,000 | ||||||||||||
Payments to acquire businesses, gross | $ 1,050,000 | $ 1,050,000 | |||||||||||
Debt instrument, term (in years) | 5 years | 5 years | |||||||||||
FSC | Affiliated Entity | Deerfield CSF LLC | Scenario, Forecast | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Final payment to acquire business gross | $ 15,000,000 | ||||||||||||
FSC | Affiliated Entity | Deerfield CSF LLC | Maximum | |||||||||||||
Line of Credit Facility [Line Items] | |||||||||||||
Royalty guarantees, commitments, term (in years) | 10 years | 10 years |
Income Taxes - Income (Loss) Be
Income Taxes - Income (Loss) Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | |||
Income (loss) before income taxes | $ (113,197) | $ 92,660 | $ (9,718) |
Ireland | |||
Income Taxes [Line Items] | |||
Income (loss) before income taxes | (42,604) | (3,123) | (22,866) |
United States | |||
Income Taxes [Line Items] | |||
Income (loss) before income taxes | (70,340) | 92,754 | 32,786 |
France | |||
Income Taxes [Line Items] | |||
Income (loss) before income taxes | $ (253) | $ 3,029 | $ (19,638) |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current: | |||
United States - Federal | $ 0 | $ 18,064 | $ 30,738 |
United States - State | 330 | 331 | 1,081 |
France | 0 | 265 | 5,267 |
Total current | 330 | 18,660 | 37,086 |
Deferred: | |||
United States - Federal | (19,503) | 4,686 | (6,443) |
United States - State | 1,280 | 1,043 | (23) |
France | 0 | 0 | 938 |
Total deferred | (18,223) | 5,729 | (5,528) |
Income tax (benefit) provision | $ (17,893) | $ 24,389 | $ 31,558 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Tax Rate (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Statutory tax rate | 12.49945% | 12.50% | 12.50% |
Differences in international tax rates | 8.00% | 22.20% | (31.90%) |
Nondeductible changes in fair value of contingent consideration | 4.00% | (11.60%) | (165.00%) |
Income tax deferred charge | 0.00% | 0.00% | (9.70%) |
Change in valuation allowances | (5.30%) | (0.70%) | 11.80% |
Nondeductible stock-based compensation | (1.30%) | (0.40%) | (14.80%) |
Cross border merger | 0.00% | 0.30% | (100.60%) |
Unrealized tax benefits | (1.30%) | 1.40% | (15.20%) |
State and local taxes (net of federal) | (0.30%) | 0.30% | (9.60%) |
Change in U.S. tax law | (0.20%) | 3.80% | 0.00% |
Nondeductible interest expense | (1.10%) | 0.00% | 0.00% |
Other | 0.70% | (1.50%) | (2.30%) |
Effective income tax rate | 15.70% | 26.30% | (324.80%) |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Income tax provision (benefit) - at statutory tax rate | $ (14,149) | $ 11,582 | $ (1,215) |
International tax rates differential | (9,039) | 20,557 | 3,097 |
Nondeductible changes in fair value of contingent consideration | (4,559) | (10,779) | 16,036 |
Income tax deferred charge | 0 | 0 | 938 |
Change in valuation allowances | 5,998 | (610) | (1,143) |
Nondeductible stock-based compensation | 1,499 | (375) | 1,436 |
Cross-border merger | 0 | 265 | 9,773 |
Unrecognized tax benefits | 1,440 | 1,296 | 1,475 |
State and local taxes (net of federal) | 299 | 252 | 934 |
Change in U.S. tax law | 274 | 3,513 | 0 |
Nondeductible interest expense | 1,269 | 0 | 0 |
Other | (925) | (1,312) | 227 |
Income tax (benefit) provision | $ (17,893) | $ 24,389 | $ 31,558 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefit (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Unrecognized Tax Benefit Activity [Roll Forward] | |||
Beginning balance | $ 3,954 | $ 1,686 | $ 448 |
Additions based on tax positions related to the current year | 1,087 | 2,268 | 1,578 |
Increases (decreases) for tax positions of prior years | 274 | 0 | (340) |
Ending balance | $ 5,315 | $ 3,954 | $ 1,686 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 |
Deferred tax assets: | ||||
Net operating loss carryforwards | $ 19,510 | $ 9,831 | ||
Amortization | 20,642 | 7,563 | ||
Stock based compensation | 4,587 | 4,375 | ||
Fair value royalty agreements | 0 | 635 | ||
Fair value contingent consideration | 384 | 870 | ||
Other | 479 | 406 | ||
Gross deferred tax assets | 45,602 | 23,680 | ||
Deferred tax liabilities: | ||||
Amortization | (308) | (2,419) | ||
Accounts receivable | (661) | (936) | ||
Prepaid expenses | (405) | (1,094) | ||
Gross deferred tax liabilities | (1,374) | (4,449) | ||
Less: valuation allowances | (21,199) | (15,354) | ||
Net deferred tax assets | $ 23,029 | $ 3,877 | $ 10,342 | $ 13,102 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | ||||
Statutory tax rate | 12.49945% | 12.50% | 12.50% | |
Increase (decrease) in income tax provision | $ (42,282,000) | $ (7,169,000) | ||
Interest and penalties could change by up to | 500,000 | |||
Tax cost associated with Tax Cuts and Jobs Act | 3,513,000 | |||
Income tax provision effect of cross-border merger | 0 | 265,000 | $ 9,773,000 | |
Income tax provision effect of transfer of intellectual property | 0 | 0 | 938,000 | |
Unrecognized tax benefits | 4,597,000 | 3,349,000 | 1,565,000 | |
Income tax penalties and interest expense | 725,000 | 304,000 | 26,000 | |
Income tax penalties and interest accrued | 1,057,000 | 331,000 | ||
Unremitted earnings | 2,798,000 | |||
Deferred tax assets, tax credit carryforwards, research | 7,555,000 | 5,272,000 | ||
Current deferred tax liabilities | 518,000 | |||
Research tax credit utilized | 4,266,000 | |||
Income tax charge | (17,893,000) | 24,389,000 | 31,558,000 | |
Tax-related prepaid expenses | $ 986,000 | 814,000 | ||
Deferred tax assets | $ 13,102,000 | 23,029,000 | 3,877,000 | 10,342,000 |
Deferred tax amortized rate | 7.00% | |||
Income tax deferred charge | 11,156,000 | |||
Income tax provision related to cross-border merger | 4,266,000 | |||
Tax charge due to remeasurement | 274,000 | $ 3,513,000 | 0 | |
FSC | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 10,365,000 | |||
U.S. Holdings | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | 15,475,000 | |||
Ireland | ||||
Income Taxes [Line Items] | ||||
Statutory tax rate | 12.50% | 12.50% | ||
Net operating loss carryforwards | 72,453,000 | |||
Gross research tax credit | 633,000 | |||
Tax relief amount | 8,500,000 | |||
France | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | 3,259,000 | |||
Gross research tax credit | 6,922,000 | $ 4,754,000 | ||
Income tax charge | $ 14,088,000 | |||
Removal of operating loss carryforwards | 111,495,000 | |||
United States | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 25,840,000 | |||
Intellectual Property | ||||
Income Taxes [Line Items] | ||||
Deferred tax assets, intangible asset | $ 7,954,000 |
Post-Retirement Benefit Plans -
Post-Retirement Benefit Plans - Benefit Obligation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Compensation rate increase | 2.75% | 3.00% | 3.00% |
Discount rate | 1.50% | 1.25% | 1.31% |
Employee turn-over description | Actuarial standard and average of the last 5 years | Actuarial standard and average of the last 5 years | Actuarial standard and average of the last 5 years |
Employee turn-over, average years | 5 years | 5 years | 5 years |
Average age of retirement description | 60 to 65 years actuarial standard based on age and professional status | 60 to 65 years actuarial standard based on age and professional status | 60 to 65 years actuarial standard based on age and professional status |
Minimum | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Average age of retirement (in years) | 60 years | 60 years | 60 years |
Maximum | |||
Defined Benefit Plan Disclosure [Line Items] | |||
Average age of retirement (in years) | 65 years | 65 years | 65 years |
Post-Retirement Benefit Plans_2
Post-Retirement Benefit Plans - Benefit Obligation Activity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Benefits [Abstract] | ||
Retirement indemnity benefit obligation, beginning of year | $ 1,303 | $ 2,431 |
Service cost | 93 | 132 |
Interest cost | 17 | 21 |
Plan amendment | 0 | (829) |
Benefits paid | (12) | 0 |
Curtailment gain | (148) | (717) |
Actuarial loss | (178) | (25) |
Exchange rate changes | (51) | 290 |
Retirement indemnity benefit obligation, end of year | $ 1,024 | $ 1,303 |
Post-Retirement Benefit Plans_3
Post-Retirement Benefit Plans - Future Obligation (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Retirement Benefits [Abstract] | |
2019 | $ 0 |
2020 | 0 |
2021 | 0 |
2022 | 17 |
2023 | 0 |
Next five years | 158 |
Total | $ 175 |
Post-Retirement Benefit Plans_4
Post-Retirement Benefit Plans (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | |||
Defined contribution plan, increase (decrease) in cost recognized | $ (69) | $ 123 | $ 348 |
Curtailment gain | $ 148 | $ 717 |
Other Assets and Liabilities -
Other Assets and Liabilities - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Liabilities Disclosure [Abstract] | ||
Valued-added tax recoverable | $ 1,378 | $ 1,206 |
Prepaid and other expenses | 2,145 | 7,106 |
Guarantee from Armistice (see Note 16) | 534 | 0 |
Income tax receivable | 921 | 518 |
Research and development tax credit receivable | 283 | 0 |
Short-term deposit | 3,350 | 0 |
Other | 225 | 128 |
Total | $ 8,836 | $ 8,958 |
Other Assets and Liabilities _2
Other Assets and Liabilities - Other Non-Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 |
Other Liabilities Disclosure [Abstract] | ||||
Deferred tax assets | $ 23,029 | $ 3,877 | $ 10,342 | $ 13,102 |
Long-term deposits | 1,477 | 3,350 | ||
Guarantee from Armistice (see Note 16) | 5,697 | 0 | ||
Right of use assets at contract manufacturing organizations | 5,894 | 2,909 | ||
Other | 49 | 113 | ||
Total | $ 36,146 | $ 10,249 |
Other Assets and Liabilities _3
Other Assets and Liabilities - Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Liabilities Disclosure [Abstract] | ||
Accrued compensation | $ 3,971 | $ 3,157 |
Accrued social charges | 1,009 | 1,204 |
Accrued restructuring (see Note 17) | 879 | 1,000 |
Customer allowances | 6,541 | 10,613 |
Accrued ELAA payment | 0 | 20,000 |
Accrued contract research organization charges | 1,000 | 156 |
Accrued contract manufacturing organization costs | 2,028 | 2,327 |
Accrued contract sales organization and marketing costs | 3,469 | 7,641 |
Other | 2,798 | 4,828 |
Total | $ 21,695 | $ 50,926 |
Other Assets and Liabilities _4
Other Assets and Liabilities - Other Non-Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Other Liabilities Disclosure [Abstract] | ||||
Provision for retirement indemnity | $ 1,024 | $ 1,303 | $ 2,431 | |
Customer allowances | 1,352 | 1,636 | ||
Unrecognized tax benefits | 5,315 | 3,954 | $ 1,686 | $ 448 |
Guarantee to Deerfield | 5,717 | 0 | ||
Other | 594 | 191 | ||
Total | $ 14,002 | $ 7,084 |
Contingent Liabilities and Co_3
Contingent Liabilities and Commitments (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 21, 2019 | |
Commitments And Contingencies [Line Items] | ||||
Other commitment | $ 51,284 | |||
Purchase commitment, period (in years) | 5 years | |||
Purchase obligation | $ 26,682 | |||
Operating leases, rent expense, net | 1,213 | $ 1,146 | $ 970 | |
Inventories | ||||
Commitments And Contingencies [Line Items] | ||||
Payment of purchase commitment | 9,965 | |||
Initial Build Of Production Suite | Minimum | ||||
Commitments And Contingencies [Line Items] | ||||
Other commitment | 300 | |||
Annual Production Suite Fees | Minimum | ||||
Commitments And Contingencies [Line Items] | ||||
Other commitment | 3,000 | |||
Annual Production Suite Fees | Maximum | ||||
Commitments And Contingencies [Line Items] | ||||
Other commitment | 4,000 | |||
Specialty Pharma Obligation | ||||
Commitments And Contingencies [Line Items] | ||||
Purchase obligation | $ 15,308 | |||
Threatened Litigation | Subsequent event | ||||
Commitments And Contingencies [Line Items] | ||||
Loss contingency, estimate of possible loss | $ 1,700 |
Contingent Liabilities and Co_4
Contingent Liabilities and Commitments - Purchase Commitments (Details) - Inventories $ in Thousands | Dec. 31, 2018USD ($) |
Purchase Commitments: | |
2019 | $ 10,754 |
2020 | 5,948 |
2021 | 4,880 |
2022 | 4,880 |
2023 | 220 |
Thereafter | 0 |
Total | $ 26,682 |
Contingent Liabilities and Co_5
Contingent Liabilities and Commitments - Lease Commitments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Lease Commitment: | |
2019 | $ 1,191 |
2020 | 1,208 |
2021 | 1,008 |
2022 | 767 |
2023 | 695 |
Thereafter | 967 |
Total | $ 5,836 |
Contingent Liabilities and Co_6
Contingent Liabilities and Commitments - Contractual Obligations (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Long-term debt and interest | |
Total | $ 173,009 |
Less than 1 Year | 6,575 |
1 to 3 Years | 12,981 |
3 to 5 Years | 153,453 |
More than 5 Years | 0 |
Long-term related party payable (undiscounted) | |
Total | 51,284 |
Less than 1 Year | 9,439 |
1 to 3 Years | 8,713 |
3 to 5 Years | 7,250 |
More than 5 Years | 25,882 |
Purchase commitments | |
Total | 26,682 |
Less than 1 Year | 10,754 |
1 to 3 Years | 10,828 |
3 to 5 Years | 5,100 |
More than 5 Years | 0 |
Operating leases | |
Total | 5,836 |
Less than 1 Year | 1,191 |
1 to 3 Years | 2,217 |
3 to 5 Years | 1,461 |
More than 5 Years | 967 |
Total contractual cash obligations | |
Total | 256,811 |
Less than 1 Year | 27,959 |
1 to 3 Years | 34,739 |
3 to 5 Years | 167,264 |
More than 5 Years | 26,849 |
Specialty Pharma Obligation | |
Purchase commitments | |
Total | $ 15,308 |
Divestiture of the Pediatric _2
Divestiture of the Pediatric Assets - Narrative (Details) - USD ($) $ in Thousands | Feb. 12, 2018 | Jan. 31, 2021 | Dec. 31, 2013 | Dec. 31, 2018 | Dec. 31, 2017 |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Percentage of royalty payable on net sales | 0.834% | ||||
Guarantee to Deerfield | $ 5,717 | $ 0 | |||
2016 MIPA | Discontinued Operations, Disposed of by Sale | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Noncash or part noncash acquisition, debt assumed | $ 2,625 | ||||
Debt instrument, periodic payment, interest | 263 | ||||
Research and development reimbursement, in excess of | 1,000 | ||||
Guarantee to Deerfield | 6,643 | 6,253 | |||
Guaranty assets | $ 6,620 | $ 6,231 | |||
2016 MIPA | Discontinued Operations, Disposed of by Sale | FSC | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Percentage of royalty payable on net sales | 15.00% | ||||
Royalty payable on net sales, maximum | $ 10,300 | ||||
2016 MIPA | Discontinued Operations, Disposed of by Sale | Scenario, Forecast | |||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |||||
Repayments of assumed debt | $ 15,263 |
Restructuring Costs - France -
Restructuring Costs - France - (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Mar. 31, 2017 | |
Restructuring Cost and Reserve [Line Items] | |||
Restructuring costs | $ 1,164 | $ 3,259 | |
Severance costs | 776 | ||
Curtailment gain | 148 | 717 | |
Lyon France Workforce Reduction | Employee Severance | |||
Restructuring Cost and Reserve [Line Items] | |||
Percent reduction in workforce | 50.00% | ||
Restructuring costs | $ 1,016 | $ 2,542 |
Restructuring Costs - France _2
Restructuring Costs - France - Severance Obligation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Restructuring Reserve [Roll Forward] | ||
Beginning balance of accrued costs | $ 1,000 | $ 0 |
Charges for employee severance, benefits and other | 1,164 | 3,259 |
Payments | (1,261) | (2,600) |
Foreign currency impact | (24) | 341 |
Ending balance of accrued costs | $ 879 | $ 1,000 |
Equity Instruments and Stock _3
Equity Instruments and Stock Based Compensation (Details Textual) | 12 Months Ended | |||||||||||
Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015 | Mar. 31, 2018USD ($) | Mar. 12, 2018shares | Feb. 23, 2018shares | Feb. 12, 2018USD ($) | Jan. 01, 2018shares | Mar. 31, 2017USD ($) | Dec. 30, 2016€ / shares | Mar. 12, 2012shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Ordinary shares, shares authorized (in shares) | 500,000,000 | 500,000,000 | 500,000,000 | |||||||||
Ordinary shares, nominal value (in usd or euro per share) | (per share) | $ 0.01 | $ 0.01 | $ 0.01 | € 0.122 | ||||||||
Ordinary shares, shares issued (in shares) | 42,720,000 | 41,463,000 | ||||||||||
Ordinary shares, shares outstanding (in shares) | 37,313,000 | 39,346,000 | ||||||||||
Preferred shares, shares authorized (in shares) | 50,000,000 | 50,000,000 | 50,000,000 | |||||||||
Preferred shares, nominal value (in usd per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | |||||||||
Preferred shares, shares outstanding (in shares) | 0 | 0 | ||||||||||
Authorized repurchase amount | $ | $ 7,000,000 | $ 18,000,000 | $ 25,000,000 | |||||||||
Stock repurchase program, remaining authorized repurchase amount | $ | $ 50,000,000 | |||||||||||
Share repurchases (in shares) | 5,407,000 | |||||||||||
Share repurchases | $ | $ (49,998,000) | $ (22,361,000) | ||||||||||
Unrecognized compensation expense | $ | $ 6,726,000 | |||||||||||
Weighted average period for unrecognized expense (in years) | 2 years 4 months 6 days | |||||||||||
Excess tax benefit related to stock-based compensation | $ | $ 0 | |||||||||||
Aggregate intrinsic value of options exercised | $ | $ 0 | $ 1,161,000 | $ 58,000 | |||||||||
Grant date fair value of options granted (in usd per share) | $ / shares | $ 3.60 | $ 5.20 | $ 6.14 | |||||||||
Number of securities called by each warrant (in shares) | 1 | |||||||||||
Grant date fair value of warrants granted (in usd per share) | $ / shares | $ 2.99 | |||||||||||
Additional warrants outstanding | 3,300,000 | |||||||||||
Warrant | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Weighted average period for unrecognized expense (in years) | 0 years | 0 years | 2 years 6 months | |||||||||
Vesting period (in years) | 1 year | |||||||||||
Expiration period (in years) | 4 years | |||||||||||
Aggregate intrinsic value of warrants exercised | $ | $ 0 | $ 0 | $ 0 | |||||||||
Granted (in shares) | 0 | 0 | ||||||||||
Free Share Award | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting period (in years) | 2 years | 3 years | 4 years | |||||||||
Granted (in shares) | 279,000 | 12.11 | ||||||||||
Weighted average grant fair value of free share awards | $ / shares | $ 5.87 | $ 8.95 | ||||||||||
Free Share Award | Minimum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Service period (in years) | 2 years | |||||||||||
Free Share Award | Maximum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Service period (in years) | 4 years | |||||||||||
Stock Option | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting period (in years) | 4 years | |||||||||||
Expiration period (in years) | 10 years | |||||||||||
Number of shares authorized (in shares) | 1,873,147,000 | |||||||||||
2017 Avadel Employee Share Purchase Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Ordinary shares, nominal value (in usd or euro per share) | $ / shares | $ 0.01 | |||||||||||
Shares available for issuance under ESPP | 1,000,000 | |||||||||||
Purchase price of common stock, percentage | 85.00% | |||||||||||
Stock issued during period, employee share purchase plans (in shares) | 25,000 | |||||||||||
Eclat Pharmaceuticals | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of securities called by each warrant (in shares) | 2,200,000 | 1,100 | ||||||||||
Remaining warrants outstanding expired | 1,100,000 | |||||||||||
2/3 vesting at second anniversary of grant date | Free Share Award, Grants during 2017 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 67.00% | |||||||||||
1/3 vesting at third anniversary of grant date | Free Share Award, Grants during 2017 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | |||||||||||
1/3 vesting at third anniversary of grant date | Free Share Award, Grants beginning 2018 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | |||||||||||
1/3 vesting at first anniversary of grant date | Free Share Award, Grants beginning 2018 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% | |||||||||||
1/3 vesting at second anniversary of grant date | Free Share Award, Grants beginning 2018 | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 33.00% |
Equity Instruments and Stock _4
Equity Instruments and Stock Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 7,852 | $ 8,072 | $ 14,679 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 880 | 672 | 3,523 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 6,972 | $ 7,400 | $ 11,156 |
Equity Instruments and Stock _5
Equity Instruments and Stock Based Compensation - Fair Value Assumptions (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 2 years 4 months 6 days | ||
Excess tax benefit related to stock-based compensation | $ 0 | ||
Warrant | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 0 years | 0 years | 2 years 6 months |
Expected volatility | 0.00% | 0.00% | 60.57% |
Risk-free interest rate | 0.00% | 0.00% | 0.82% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Aggregate intrinsic value of warrants exercised | $ 0 | $ 0 | $ 0 |
Granted (in shares) | 0 | 0 | |
Stock Option | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Expected volatility | 56.59% | 58.82% | 58.39% |
Risk-free interest rate | 2.68% | 2.20% | 2.04% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Equity Instruments and Stock _6
Equity Instruments and Stock Based Compensation - Stock Options (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($)$ / sharesshares | |
Stock Options, Outstanding [Roll Forward] | |
Stock options outstanding, beginning balance (in shares) | shares | 5,041 |
Granted (in shares) | shares | 138 |
Exercised (in shares) | shares | (82) |
Forfeited (in shares) | shares | (428) |
Expired (in shares) | shares | (68) |
Stock options outstanding, ending balance (in shares) | shares | 4,601 |
Stock options exercisable (in shares) | shares | 3,005 |
Stock Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Stock options outstanding, beginning balance (in usd per share) | $ / shares | $ 11.34 |
Granted (in usd per share) | $ / shares | 6.67 |
Exercised (in usd per share) | $ / shares | 6.52 |
Forfeited (in usd per share) | $ / shares | 10.04 |
Expired (in usd per share) | $ / shares | 12.41 |
Stock options outstanding, ending balance (in usd per share) | $ / shares | 11.39 |
Stock options exercisable (in usd per share) | $ / shares | $ 11.99 |
Stock options outstanding, Weighted Average Remaining Contractual Life (in years) | 7 years 3 months |
Stock options exercisable, Weighted Average Remaining Contractual Life (in years) | 6 years 7 months 28 days |
Stock options outstanding, Aggregate Intrinsic Value | $ | $ 0 |
Stock options exercisable, Aggregate Intrinsic Value | $ | $ 0 |
Equity Instruments and Stock _7
Equity Instruments and Stock Based Compensation - Warrants (Details) - Warrant - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Warrant Activity and Other Data, Outstanding [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 894,000 | |
Granted (in shares) | 0 | 0 |
Exercised (in shares) | 0 | |
Forfeited (in shares) | 0 | |
Expired (in shares) | (298,000) | |
Outstanding, ending balance (in shares) | 596,000 | 894,000 |
Warrants exercisable (in shares) | 596,000 | |
Warrant Activity and Other Data, Weighted Average Exercise Price [Abstract] | ||
Warrants outstanding, beginning balance (in usd per share) | $ 16.77 | |
Granted (in usd per share) | 0 | |
Exercised (in usd per share) | 0 | |
Forfeited (in usd per share) | 0 | |
Expired (in usd per share) | 14.87 | |
Warrants outstanding, ending balance (in usd per share) | 17.72 | $ 16.77 |
Warrants exercisable (in usd per share) | $ 17.72 | |
Warrants outstanding, Weighted Average Remaining Contractual Life (in years) | 1 year 11 days | |
Warrants exercisable, Weighted Average Remaining Contractual Life (in years) | 1 year 11 days | |
Warrants outstanding, Aggregate Intrinsic Value | $ 0 | |
Warrants exercisable, Aggregate Intrinsic Value | $ 0 |
Equity Instruments and Stock _8
Equity Instruments and Stock Based Compensation - Free Share Awards (Details) - Free Share Award - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Free Share Activity and Other Data, Nonvested [Roll Forward] | |||
Outstanding, beginning balance (in shares) | 819,000 | ||
Granted (in shares) | 279,000 | 12.11 | |
Vested (in shares) | (548,000) | ||
Forfeited (in shares) | (59,000) | ||
Outstanding, ending balance (in shares) | 491,000 | 819,000 | |
Free Share Activity and Other Data, Weighted Average Grant Date Fair Value [Abstract] | |||
Nonvested free share award, beginning balance (in usd per share) | $ 11.51 | ||
Granted (in usd per share) | 5.87 | $ 8.95 | |
Vested (in usd per share) | 12.78 | ||
Forfeited (in usd per share) | 8.95 | ||
Nonvested free share award, ending balance (in usd per share) | $ 7.20 | $ 11.51 |
Earnings (Loss) Per Share - Rec
Earnings (Loss) Per Share - Reconciliation of basic and diluted EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |||
Net (loss) income | $ (95,304) | $ 68,271 | $ (41,276) |
Weighted average shares: | |||
Basic shares (in shares) | 37,325 | 40,465 | 41,248 |
Effect of dilutive securities - options and warrants outstanding (in shares) | 0 | 1,300 | 0 |
Diluted shares (in shares) | 37,325 | 41,765 | 41,248 |
Net income (loss) per share - basic (in usd per share) | $ (2.55) | $ 1.69 | $ (1) |
Net income (loss) per share - diluted (in usd per share) | $ (2.55) | $ 1.63 | $ (1) |
Earnings (Loss) Per Share (Deta
Earnings (Loss) Per Share (Details Textual) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |||
Antidilutive securities excluded from computation of earnings per share | 17,529 | 6,368 | 8,564 |
Comprehensive Income (Loss) (De
Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | $ 85,580 | $ 42,069 | $ 69,134 |
Net other comprehensive (loss) income | (95,454) | 68,570 | (42,184) |
Ending balance | 2,780 | 85,580 | 42,069 |
Foreign currency translation adjustment | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | (23,202) | (23,336) | (22,312) |
Net other comprehensive (loss) income | (419) | 134 | (1,024) |
Ending balance | (23,621) | (23,202) | (23,336) |
Unrealized gain (loss) on marketable securities, net | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | (64) | (229) | (345) |
Net other comprehensive (loss) income | 269 | 165 | 116 |
Ending balance | 205 | (64) | (229) |
Accumulated other comprehensive loss | |||
Accumulated Other Comprehensive Income (Loss) | |||
Beginning balance | (23,266) | (23,565) | (22,657) |
Ending balance | $ (23,416) | $ (23,266) | $ (23,565) |
Comprehensive Income (Loss) (_2
Comprehensive Income (Loss) (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stockholders' Equity Note [Abstract] | |||
Unrealized gain (loss) on marketable securities, tax | $ (18) | $ 28 | $ 16 |
Company Operations by Product_3
Company Operations by Product, Customer and Geographic Area - Revenue by Product (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | |||
Total revenues | $ 103,269 | $ 173,245 | $ 150,246 |
Bloxiverz | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 20,850 | 45,596 | 82,896 |
Vazculep | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 42,916 | 38,187 | 39,796 |
Akovaz | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 33,759 | 80,617 | 16,831 |
Noctiva | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 1,204 | 0 | 0 |
Other | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 2,694 | 8,441 | 7,699 |
Product sales | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 101,423 | 172,841 | 147,222 |
License revenue | |||
Segment Reporting Information [Line Items] | |||
Total revenues | $ 1,846 | $ 404 | $ 3,024 |
Company Operations by Product_4
Company Operations by Product, Customer and Geographic Area - Revenue by Significant Customer (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | |||
Total revenues | $ 103,269 | $ 173,245 | $ 150,246 |
Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 101,423 | 172,841 | 147,222 |
Customer A | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 26,794 | 44,762 | 51,648 |
Customer B | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 25,413 | 37,965 | 39,359 |
Customer C | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 18,620 | 25,691 | 30,916 |
Customer D | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 9,653 | 53,342 | 17,728 |
Others | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 20,943 | 11,081 | 7,571 |
License revenue | |||
Segment Reporting Information [Line Items] | |||
Total revenues | 1,846 | 404 | 3,024 |
License revenue | Wholesaler Customer | |||
Segment Reporting Information [Line Items] | |||
Total revenues | $ 1,846 | $ 404 | $ 3,024 |
Company Operations by Product_5
Company Operations by Product, Customer and Geographic Area - Data by Geographic Region (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue by Geographic Region: | |||
Total revenues | $ 103,269 | $ 173,245 | $ 150,246 |
Long-lived Assets by Geographic Region: | |||
Long-lived assets | 35,154 | 120,153 | 44,747 |
United States | |||
Revenue by Geographic Region: | |||
Total revenues | 172,841 | 147,283 | |
Long-lived Assets by Geographic Region: | |||
Long-lived assets | 27,761 | 116,536 | 42,021 |
France | |||
Long-lived Assets by Geographic Region: | |||
Long-lived assets | 1,365 | 2,257 | 2,524 |
Ireland | |||
Revenue by Geographic Region: | |||
Total revenues | 1,846 | 404 | 2,963 |
Long-lived Assets by Geographic Region: | |||
Long-lived assets | $ 6,028 | $ 1,360 | $ 202 |
Company Operations by Product_6
Company Operations by Product, Customer and Geographic Area (Details Textual) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | |
Segment Reporting [Abstract] | ||
Number of segments | segment | 1 | |
Concentration Risk [Line Items] | ||
Accounts receivable | $ 11,330 | $ 14,785 |
Accounts Receivable | Customer Concentration Risk | Customer One | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 32.00% | |
Accounts receivable | $ 3,571 | |
Accounts Receivable | Customer Concentration Risk | Customer Two | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 24.00% | |
Accounts receivable | $ 2,755 | |
Accounts Receivable | Customer Concentration Risk | Customer Three | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 24.00% | |
Accounts receivable | $ 2,789 | |
Accounts Receivable | Customer Concentration Risk | Customer Four | ||
Concentration Risk [Line Items] | ||
Concentration risk, percentage | 10.00% | |
Accounts receivable | $ 1,174 |
Related Party Transactions (Det
Related Party Transactions (Details Textual) - USD ($) | Feb. 05, 2016 | Dec. 03, 2013 | Jan. 31, 2021 | Feb. 29, 2016 | Dec. 31, 2013 | Feb. 28, 2013 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Related Party Transaction [Line Items] | |||||||||
Payments to acquire businesses, gross | $ 22,951,000 | $ 37,311,000 | $ 30,838,000 | ||||||
Percentage of royalty payable on net sales | 0.834% | ||||||||
Royalty Agreement Terms | |||||||||
Related Party Transaction [Line Items] | |||||||||
Debt repayment term date | Dec. 31, 2024 | Dec. 31, 2024 | |||||||
Long-term debt repayment percentage | 0.834% | 1.75% | |||||||
Eclat Pharmaceuticals | |||||||||
Related Party Transaction [Line Items] | |||||||||
Percentage of earn out payment | 20.00% | ||||||||
Affiliated Entity | Deerfield CSF LLC | |||||||||
Related Party Transaction [Line Items] | |||||||||
Percentage of royalty payable on net sales | 1.75% | ||||||||
Affiliated Entity | Deerfield CSF LLC | FSC | |||||||||
Related Party Transaction [Line Items] | |||||||||
Payments to acquire businesses, gross | $ 1,050,000 | $ 1,050,000 | |||||||
Debt instrument, term (in years) | 5 years | 5 years | |||||||
Percentage of royalty payable on net sales | 15.00% | 15.00% | |||||||
Scenario, Forecast | Affiliated Entity | Deerfield CSF LLC | FSC | |||||||||
Related Party Transaction [Line Items] | |||||||||
Final payment to acquire business gross | $ 15,000,000 | ||||||||
Total payments to acquire business gross | $ 20,250,000 | ||||||||
Maximum | Affiliated Entity | Deerfield CSF LLC | FSC | |||||||||
Related Party Transaction [Line Items] | |||||||||
Royalty guarantees, commitments, amount | $ 12,500,000 | ||||||||
Royalty guarantees, commitments, term (in years) | 10 years | 10 years |
Subsequent Event (Details Textu
Subsequent Event (Details Textual) - USD ($) $ in Thousands | Feb. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Subsequent Event [Line Items] | ||||
Severance costs | $ 776 | |||
Revenue | 103,269 | $ 173,245 | $ 150,246 | |
Selling, general and administrative expenses | 100,359 | 58,860 | 44,179 | |
Research and development expenses | 39,329 | 33,418 | 34,611 | |
Noctiva | ||||
Subsequent Event [Line Items] | ||||
Revenue | 1,204 | 0 | $ 0 | |
Noctiva | Specialty Pharma | Discontinued Operations, Disposed of by Means Other than Sale | ||||
Subsequent Event [Line Items] | ||||
Revenue | 1,204 | 0 | ||
Selling, general and administrative expenses | 62,268 | 13,536 | ||
Research and development expenses | $ 2,782 | $ 1,688 | ||
Subsequent event | Scenario, Forecast | Noctiva | Specialty Pharma | ||||
Subsequent Event [Line Items] | ||||
Workforce reduction, percentage | 50.00% | |||
Subsequent event | Minimum | Scenario, Forecast | Noctiva | Specialty Pharma | ||||
Subsequent Event [Line Items] | ||||
Severance costs | $ 10,000 | |||
Subsequent event | Maximum | Scenario, Forecast | Noctiva | Specialty Pharma | ||||
Subsequent Event [Line Items] | ||||
Severance costs | $ 15,000 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of period | $ 15,354 | $ 7,599 | $ 45,516 |
Additions: Charges to expense | 6,089 | 391 | 6,873 |
Deductions | (75) | (664) | (42,417) |
Other changes | (169) | 8,028 | (2,373) |
Balance at end of period | $ 21,199 | $ 15,354 | $ 7,599 |