Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 10, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | ACORDA THERAPEUTICS, INC. | |
Entity Central Index Key | 0001008848 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2022 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ACOR | |
Title of each class | Common Stock $0.001 par value per share | |
Name of each exchange on which registered | NASDAQ | |
Entity Common Stock, Shares Outstanding | 24,337,814 | |
Entity File Number | 001-31938 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 13-3831168 | |
Entity Address, Address Line One | 2 Blue Hill Plaza | |
Entity Address, Address Line Two | 3rd Floor | |
Entity Address, City or Town | Pearl River | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10965 | |
City Area Code | 914 | |
Local Phone Number | 347-4300 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 20,696 | $ 45,634 |
Restricted cash | 13,232 | 13,400 |
Trade accounts receivable, net of allowances of $888 and $1,012, as of September 30, 2022 and December 31, 2021, respectively | 14,690 | 17,002 |
Prepaid expenses | 5,111 | 6,574 |
Inventory, net | 15,252 | 18,548 |
Other current assets | 2,711 | 999 |
Total current assets | 71,692 | 102,157 |
Property and equipment, net of accumulated depreciation | 2,825 | 4,382 |
Intangible assets, net of accumulated amortization | 312,779 | 335,980 |
Right of use asset, net of accumulated amortization | 5,541 | 6,751 |
Restricted cash | 255 | 6,189 |
Other assets | 247 | 11 |
Total assets | 393,339 | 455,470 |
Current liabilities: | ||
Accounts payable | 11,505 | 10,845 |
Accrued expenses and other current liabilities | 26,705 | 28,605 |
Current portion of liability related to sale of future royalties | 4,460 | |
Current portion of lease liabilities | 1,454 | 8,186 |
Current portion of acquired contingent consideration | 2,359 | 1,929 |
Total current liabilities | 42,023 | 54,025 |
Convertible senior notes | 162,760 | 151,025 |
Derivative liability | 37 | |
Non-current portion of acquired contingent consideration | 35,241 | 47,671 |
Non-current portion of lease liabilities | 4,612 | 4,086 |
Non-current portion of loans payable | 24,929 | 27,645 |
Deferred tax liability | 42,228 | 13,930 |
Other non-current liabilities | 5,780 | 5,914 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share. Authorized 1,000,000 shares at September 30, 2022 and December 31, 2021; no shares issued as of September 30, 2022 and December 31, 2021, respectively | ||
Common stock, $0.001 par value per share. Authorized 61,666,666 shares at September 30, 2022 and December 31, 2021; issued 24,338,195 and 13,249,802 shares, including those held in treasury, as of September 30, 2022 and December 31, 2021, respectively | 24 | 13 |
Treasury stock at cost (5,543 shares at September 30, 2022 and December 31, 2021) | (638) | (638) |
Additional paid-in capital | 1,029,705 | 1,023,136 |
Accumulated deficit | (955,415) | (870,357) |
Accumulated other comprehensive loss | 2,090 | (1,017) |
Total stockholders’ equity | 75,766 | 151,137 |
Total liabilities and stockholders’ equity | $ 393,339 | $ 455,470 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Statement Of Financial Position [Abstract] | ||
Trade accounts receivable, allowances (in dollars) | $ 888 | $ 1,012 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, Authorized shares | 1,000,000 | 1,000,000 |
Preferred stock, issued shares | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, Authorized shares | 61,666,666 | 61,666,666 |
Common stock, issued shares | 24,338,195 | 13,249,802 |
Treasury stock, shares | 5,543 | 5,543 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Total net revenues | $ 33,511 | $ 31,456 | $ 87,096 | $ 92,104 |
Costs and expenses: | ||||
Cost of sales | 11,005 | 13,303 | 25,772 | 36,589 |
Research and development | 1,383 | 1,931 | 4,602 | 9,054 |
Selling, general and administrative | 22,997 | 29,623 | 80,002 | 95,959 |
Amortization of intangible assets | 7,691 | 7,691 | 23,073 | 23,073 |
Change in fair value of derivative liability | (288) | (37) | (868) | |
Changes in fair value of acquired contingent consideration | (4,576) | 2,205 | (10,709) | (4,224) |
Total operating expenses | 38,500 | 54,465 | 122,703 | 159,583 |
Operating loss | (4,989) | (23,009) | (35,607) | (67,479) |
Other income (expense), net: | ||||
Interest and amortization of debt discount expense | (7,465) | (7,167) | (22,501) | (22,697) |
Interest income | 17 | 1 | 38 | 4 |
Other income (expense) | 1,250 | 1 | ||
Realized loss on foreign currency transactions | (1) | (1) | (1) | (4) |
Total other expense, net | (7,449) | (7,167) | (21,214) | (22,696) |
Loss before taxes | (12,438) | (30,176) | (56,821) | (90,175) |
(Provision for) benefit from income taxes | (1,416) | 3,105 | (28,237) | 6,788 |
Net loss | $ (13,854) | $ (27,071) | $ (85,058) | $ (83,387) |
Net loss per share—basic | $ (0.57) | $ (2.43) | $ (4.69) | $ (8.17) |
Net loss per share—diluted | $ (0.57) | $ (2.43) | $ (4.69) | $ (8.17) |
Weighted average common shares outstanding used in computing net loss per share—basic | 24,290 | 11,131 | 18,148 | 10,204 |
Weighted average common shares outstanding used in computing net loss per share—diluted | 24,290 | 11,131 | 18,148 | 10,204 |
Net Product Revenues | ||||
Revenues: | ||||
Total net revenues | $ 29,964 | $ 27,851 | $ 76,023 | $ 81,297 |
Royalty Revenues | ||||
Revenues: | ||||
Total net revenues | 3,047 | $ 3,605 | 10,573 | $ 10,807 |
License Revenue | ||||
Revenues: | ||||
Total net revenues | $ 500 | $ 500 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (13,854) | $ (27,071) | $ (85,058) | $ (83,387) |
Other comprehensive income (loss), net of tax: | ||||
Foreign currency translation adjustment | 1,352 | 276 | 3,107 | 1,246 |
Other comprehensive income (loss), net of tax | 1,352 | 276 | 3,107 | 1,246 |
Comprehensive income (loss) | $ (12,502) | $ (26,795) | $ (81,951) | $ (82,141) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common stock | Treasury stock | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive (loss) income |
Balance at Dec. 31, 2020 | $ 237,955 | $ 9 | $ (638) | $ 1,007,790 | $ (766,403) | $ (2,803) |
Balance (in shares) at Dec. 31, 2020 | 9,476 | |||||
Compensation expense for issuance of stock options to employees | 483 | 483 | ||||
Compensation expense for issuance of restricted stock to employees | 224 | 224 | ||||
Other comprehensive income (loss), net of tax | 1,069 | 1,069 | ||||
Net income (loss) | (33,451) | (33,451) | ||||
Balance at Mar. 31, 2021 | 206,279 | $ 9 | (638) | 1,008,497 | (799,854) | (1,734) |
Balance (in shares) at Mar. 31, 2021 | 9,476 | |||||
Balance at Dec. 31, 2020 | 237,955 | $ 9 | (638) | 1,007,790 | (766,403) | (2,803) |
Balance (in shares) at Dec. 31, 2020 | 9,476 | |||||
Net income (loss) | (83,387) | |||||
Balance at Sep. 30, 2021 | 164,475 | $ 11 | (638) | 1,016,448 | (849,789) | (1,557) |
Balance (in shares) at Sep. 30, 2021 | 11,194 | |||||
Balance at Mar. 31, 2021 | 206,279 | $ 9 | (638) | 1,008,497 | (799,854) | (1,734) |
Balance (in shares) at Mar. 31, 2021 | 9,476 | |||||
Compensation expense for issuance of stock options to employees | 498 | 498 | ||||
Compensation expense for issuance of restricted stock to employees | 456 | 456 | ||||
Interest payment for convertible notes | 6,210 | $ 2 | 6,208 | |||
Interest payment for convertible notes (in shares) | 1,636 | |||||
Other comprehensive income (loss), net of tax | (99) | (99) | ||||
Net income (loss) | (22,864) | (22,864) | ||||
Balance at Jun. 30, 2021 | 190,481 | $ 11 | (638) | 1,015,659 | (822,718) | (1,833) |
Balance (in shares) at Jun. 30, 2021 | 11,112 | |||||
Compensation expense for issuance of stock options to employees | 455 | 455 | ||||
Compensation expense for issuance of restricted stock to employees | 334 | 334 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 82 | |||||
Other comprehensive income (loss), net of tax | 276 | 276 | ||||
Net income (loss) | (27,071) | (27,071) | ||||
Balance at Sep. 30, 2021 | 164,475 | $ 11 | (638) | 1,016,448 | (849,789) | (1,557) |
Balance (in shares) at Sep. 30, 2021 | 11,194 | |||||
Balance at Dec. 31, 2021 | 151,137 | $ 13 | (638) | 1,023,136 | (870,357) | (1,017) |
Balance (in shares) at Dec. 31, 2021 | 13,250 | |||||
Compensation expense for issuance of stock options to employees | 181 | 181 | ||||
Compensation expense for issuance of restricted stock to employees | 304 | 304 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 35 | |||||
Other comprehensive income (loss), net of tax | 449 | 449 | ||||
Net income (loss) | (24,522) | (24,522) | ||||
Balance at Mar. 31, 2022 | 127,549 | $ 13 | (638) | 1,023,621 | (894,879) | (568) |
Balance (in shares) at Mar. 31, 2022 | 13,285 | |||||
Balance at Dec. 31, 2021 | 151,137 | $ 13 | (638) | 1,023,136 | (870,357) | (1,017) |
Balance (in shares) at Dec. 31, 2021 | 13,250 | |||||
Net income (loss) | (85,058) | |||||
Balance at Sep. 30, 2022 | 75,766 | $ 24 | (638) | 1,029,705 | (955,415) | 2,090 |
Balance (in shares) at Sep. 30, 2022 | 24,338 | |||||
Balance at Mar. 31, 2022 | 127,549 | $ 13 | (638) | 1,023,621 | (894,879) | (568) |
Balance (in shares) at Mar. 31, 2022 | 13,285 | |||||
Compensation expense for issuance of stock options to employees | 471 | 471 | ||||
Interest payment for convertible notes | 5,263 | $ 11 | 5,252 | |||
Interest payment for convertible notes (in shares) | 10,992 | |||||
Other comprehensive income (loss), net of tax | 1,306 | 1,306 | ||||
Net income (loss) | (46,682) | (46,682) | ||||
Balance at Jun. 30, 2022 | 87,907 | $ 24 | (638) | 1,029,344 | (941,561) | 738 |
Balance (in shares) at Jun. 30, 2022 | 24,277 | |||||
Compensation expense for issuance of stock options to employees | 364 | 364 | ||||
Compensation expense for issuance of restricted stock to employees | (3) | (3) | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 61 | |||||
Other comprehensive income (loss), net of tax | 1,352 | 1,352 | ||||
Net income (loss) | (13,854) | (13,854) | ||||
Balance at Sep. 30, 2022 | $ 75,766 | $ 24 | $ (638) | $ 1,029,705 | $ (955,415) | $ 2,090 |
Balance (in shares) at Sep. 30, 2022 | 24,338 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (85,058) | $ (83,387) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Share-based compensation expense | 1,320 | 2,515 |
Amortization of debt discount and debt issuance costs | 12,356 | 12,672 |
Depreciation and amortization expense | 24,770 | 25,482 |
Change in acquired contingent consideration obligation | (10,709) | (4,224) |
Non-cash royalty revenue | (4,762) | (8,889) |
Deferred tax provision (benefit) | 28,300 | (6,788) |
Change in derivative liability | (37) | (868) |
Changes in assets and liabilities: | ||
Decrease in accounts receivable | 2,312 | 6,606 |
(Increase) decrease in prepaid expenses and other current assets | (258) | 2,629 |
Decrease in inventory | 3,297 | 5,813 |
Increase in other assets | (237) | |
(Decrease) increase in accounts payable, accrued expenses and other current liabilities | (844) | 4,875 |
Decrease in other non-current liabilities | (439) | (1,024) |
Net cash used in operating activities | (29,990) | (44,588) |
Cash flows from investing activities: | ||
Proceeds from sale of Chelsea facility, net | 73,969 | |
Purchases of property and equipment | (136) | (164) |
Purchases of intangible assets | (123) | (26) |
Net cash (used in) provided by investing activities | (259) | 73,779 |
Cash flows from financing activities: | ||
Repayment of Convertible Senior Notes Due 2021 | (69,000) | |
Repayment of loans payable | (655) | |
Net cash used in financing activities | (69,655) | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (790) | (511) |
Net decrease in cash, cash equivalents and restricted cash | (31,040) | (40,975) |
Cash, cash equivalents and restricted cash at beginning of period | 65,223 | 102,895 |
Cash, cash equivalents and restricted cash at end of period | 34,183 | 61,920 |
Supplemental disclosure: | ||
Cash paid for interest | 947 | 6 |
Cash paid for taxes | $ 133 | $ 46 |
Organization and Business Activ
Organization and Business Activities | 9 Months Ended |
Sep. 30, 2022 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Business Activities | (1) Organization and Business Activities Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information, Accounting Standards Codification (ASC) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated subsequent events through the date of this filing. Operating results for the three- and nine-month periods ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2021 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company's Annual Report on Form 10-K, for the year ended December 31, 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2021. Effective January 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes” (Topic 740). Effective January 1, 2022, the Company adopted ASU 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options”. The Company’s significant accounting policies have not changed materially from December 31, 2021. Basis of Presentation The Company reclassified the net proceeds from the sale of the Chelsea facility of $74.0 million for the nine-month period ended September 30, 2021 from financing activities to investing activities in the accompanying Consolidated Statement of Cash Flows. Restricted Cash The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 45,634 $ 20,696 $ 71,369 $ 36,168 Restricted cash 13,400 13,232 12,917 13,353 Restricted cash non-current 6,189 255 18,609 12,399 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 65,223 $ 34,183 $ 102,895 $ 61,920 Restricted cash represents an escrow account with funds to maintain the interest payments for an amount equal to all remaining scheduled interest payments on the outstanding convertible senior secured notes due 2024 through the interest payment date of June 1, 2023; and a Inventory The following table provides the major classes of inventory: (In thousands) September 30, 2022 December 31, 2021 Raw materials $ 3,333 $ 3,338 Finished goods 11,919 15,210 Total $ 15,252 $ 18,548 The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. On February 10, 2021, the Company completed the sale of its Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. In connection with the sale of the manufacturing operations, the Company transferred approximately $2.3 million of raw materials to Catalent. See Note 12 to the Company’s Consolidated Financial Statements included in this report for a discussion of assets transferred upon the sale. Additionally, in reviewing the inventory for slow moving or obsolete amounts the Company recorded a charge of $1.3 million for the remaining work-in-progress inventory that was scrapped or discarded during the nine-month period ended September 30, 2021. Foreign Currency Translation The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations. Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Ampyra and Inbrija in the U.S. for the three- and nine-month periods ended September 30, 2022 and 2021. Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer and significant negative economic trends. The decline in the trading price of the Company's common stock during the nine-month period ended September 30, 2022, and related decrease in the Company's market capitalization, was determined to be a triggering event in connection with the Company's review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2022. The Company performed a recoverability test as of September 30, 2022 using the undiscounted cash flows, which are the sum of the future undiscounted cash flows expected to be derived from the direct use of the long-lived assets to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s own assumptions about its own use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2022, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets. Liquidity The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, and obtain additional financing. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing its convertible senior secured notes due 2024, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether. At September 30, 2022, the Company had $20.7 million of cash and cash equivalents, compared to $45.6 million at December 31, 2021. The Company’s September 30, 2022 cash and cash equivalents balance does not include $12.4 million of restricted cash that is currently held in escrow under the terms of its convertible senior secured notes due 2024, which may potentially be released from escrow if the Company pays interest on those notes using shares of its common stock (the amount released would correspond to the amount of interest paid using shares). The Company incurred a net loss of $85.1 million for the nine-month period ended September 30, 2022. The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, “Presentation of Financials Statements—Going Concern” (“ASC Topic 205-40”), which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim consolidated financial statements are issued. Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgement by management. The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements contained in this report are issued. On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankrupt cy or liquidation. On November 11 , 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market , which forms the basis of the Company’s long-term strategic planning. The Company believes that its existing cash and cash equivalents will be sufficient to cover its cash flow requirements for at least the next twelve months from the issuance date of these financial statements. However, the Company’s future requirements may change and will depend on numerous factors, some of which may be beyond the Company’s control. Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were subsequent events that required disclosure or adjustment in these financial statements. See Note 15 to the Company’s Consolidated Financial Statements included in this report for a discussion of subsequent events. Accounting Pronouncements Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted. The Company adopted this guidance effective January 1, 2021. The adoption of this guidance did not have a significant impact on the consolidated financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The FASB is issuing this update to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this guidance effective January 1, 2022. The adoption of this guidance did not have a significant impact on the consolidated financial statements. Accounting Pronouncements Not Yet Adopted In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments”: The amendments in this update are to clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2020-03 are not expected to have a significant effect on current accounting practices. The ASU improves various financial instrument topics in the Codification to increase stakeholder awareness of the amendments and to expedite the improvement process by making the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. The ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022 with early application permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This update simplifies the accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature models which require separate accounting for embedded conversion features. This update also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions and requires the application of the if-converted method for calculating diluted earnings per share. ASU 2020-06 is effective for smaller reporting companies for fiscal periods beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In March, 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses: Troubled Debt Restructurings and Vintage Disclosures. The amendments in this Update eliminate the accounting guidance for Troubled Debt Restructurings by creditors in Subtopic 310-40, Receivables—Troubled Debt Restructurings by Creditors, while enhancing disclosure requirements for certain loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty. This update also includes amendments which require that an entity disclose current-period gross writeoffs by year of origination for financing receivables and net investments in leases within the scope of Subtopic 326-20, Financial Instruments—Credit Losses—Measured at Amortized Cost. The ASU is effective for entities that have adopted the amendments in Update 2016-13 for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In September, 2022, the FASB issued ASU 2022-04, Liabilities – Supplier Finance Programs: Disclosure of Supplier Finance Program Obligations. The amendments in this update address investor and other financial statement user requests for additional information about the use of supplier finance programs (the programs) by the buyer party to understand the effect of those programs on an entity’s working capital, liquidity, and cash flows. The ASU requires that a buyer in a supplier finance program disclose sufficient information about the program to allow a user of financial statements to understand the program’s nature, activity during the period, changes from period to period, and potential magnitude. The ASU is effective for entities that have fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue From Contract With Customer [Abstract] | |
Revenue | (3) Revenue In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has not yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g., receivable), before the entity transfers a good or service to the customer. As of September 30, 2022, the Company had contract liabilities of $6.1 million, as compared to $5.9 million as of December 31, 2021, which is the upfront payment received as part of the Esteve Germany distribution agreement entered into in 2021, and pre-payment of product ordered as part of the Esteve Spain supply agreement entered into in 2021. The Company did not have any contract liabilities as of September 30, 2021. The Company did not have any contract assets as of September 30, 2022 or 2021. The Company entered into distribution and supply agreements with Esteve Pharmaceuticals, which launched Inbrija in Germany in June 2022. The Company The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen. See Note 9 for additional information on the Company’s related payment obligation to HealthCare Royalty Partners, or HCRP, in connection with a 2017 royalty purchase agreement with HCRP. (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Revenues: Net product revenues: Ampyra $ 21,110 $ 20,026 $ 54,192 $ 62,035 Inbrija U.S. 7,848 7,804 18,957 19,240 Inbrija ex-U.S. 1,006 — 2,874 — Other — 21 — 22 Total net product revenues 29,964 27,851 76,023 81,297 Royalty Revenue 3,047 3,605 10,573 10,807 License Revenue 500 — 500 — Total net revenues $ 33,511 $ 31,456 $ 87,096 $ 92,104 |
Share-based Compensation
Share-based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-based Compensation | (4) Share-based Compensation During the three‑month periods ended September 30, 2022 and 2021, the Company recognized share-based compensation expense of $0.4 million and $0.9 million, respectively. During the nine-month periods ended September 30, 2022 and 2021, the Company recognized share-based compensation expense of $1.3 and $2.5 million, respectively. Activity in options and restricted stock during the nine-month period ended September 30, 2022 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended September 30, 2022 and 2021 were approximately $0.31 and $2.56, respectively. The weighted average fair value per share of options granted to employees for the nine-month periods ended September 30, 2022 and 2021 were approximately $0.84 and $2.58, respectively. The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: For the three-month period ended September 30, For the nine-month period ended September 30, (In thousands) 2022 2021 2022 2021 Research and development expense $ 14 $ 225 $ 66 $ 599 Selling, general and administrative expense 351 627 1,254 1,898 Cost of Sales (1 ) 2 0 18 Total $ 364 $ 854 $ 1,320 $ 2,515 A summary of share-based compensation activity for the nine-month period ended September 30, 2022 is presented below: Stock Option Activity Number of Shares (In Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In Balance at January 1, 2022 1,186 $ 94.38 Granted 97 1.19 Cancelled (230 ) 128.93 Exercised — — Balance at September 30, 2022 1,053 $ 78.24 6.0 $ — Vested and expected to vest at September 30, 2022 1,053 $ 78.24 6.0 $ — Vested and exercisable at September 30, 2022 713 $ 113.62 4.5 $ — Restricted Stock and Performance Stock Unit Activity (In thousands) Restricted Stock and Performance Stock Units Number of Shares Nonvested at January 1, 2022 116 Granted — Vested (103 ) Forfeited (7 ) Nonvested at September 30, 2022 6 Unrecognized compensation cost for unvested stock options, restricted stock awards, and restricted stock units as of September 30, 2022 totaled $0.8 million and is expected to be recognized over a weighted average period of approximately 2.7 years. During the nine‑month periods ended September 30, 2022, the Company did not make any repurchases of shares. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Loss Per Share | (5) Loss Per Share The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2022 and 2021: (In thousands, except per share data) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Basic and diluted Net loss—basic $ (13,854 ) $ (27,071 ) $ (85,058 ) $ (83,387 ) Net income (loss)—diluted $ (13,854 ) $ (27,071 ) $ (85,058 ) $ (83,387 ) Weighted average common shares outstanding used in computing net loss per share—basic 24,290 11,131 18,148 10,204 Plus: net effect of dilutive stock options and restricted common shares — — — — Weighted average common shares outstanding used in computing net loss per share—diluted 24,290 11,131 18,148 10,204 Net loss per share—basic $ (0.57 ) $ (2.43 ) $ (4.69 ) $ (8.17 ) Net loss per share—diluted $ (0.57 ) $ (2.43 ) $ (4.69 ) $ (8.17 ) Securities that could potentially be dilutive are excluded from the computation of diluted loss per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts. The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Denominator Stock options and restricted common shares 1,134 1,370 1,089 1,368 Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the three- and nine-month periods ended September 30, 2022 and 2021. Additionally, the impact of the convertible senior notes was determined to be anti-dilutive and excluded from the calculation of net loss per diluted share for the three- and nine-month periods ended September 30, 2022 and 2021. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (6) Income Taxes The Company’s effective income tax rate differs from the U.S. statutory rate primarily due to an increase in the valuation allowance and expense recorded on the equity forfeiture. For the three-month periods ended September 30, 2022 and 2021, the Company recorded a provision of $1.4 million and a benefit of $3.1 million for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended September 30, 2022 and 2021 were (11.3)% and 10.2%, respectively. The variances in the effective tax rates for the three-month period ended September 30, 2022, as compared to the three-month period ended September 30, 2021, was primarily due to an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, which increase includes the valuation allowance due to a deemed ownership change described below. For the nine-month periods ended September 30, 2022 and 2021, the Company recorded a provision from income taxes of $28.2 million and a benefit of $6.8 million, respectively. The effective income tax rates for the nine-month periods ended September 30, 2022 and 2021 were (49.69)% and 7.53%, respectively. The variance in the effective tax rates for the nine-month period ended September 30, 2022 as compared to the nine-month period ended September 30, 2021 was due primarily to forfeitures of equity of which no tax deduction is recorded and an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, which increase includes the valuation allowance due to a deemed ownership change described below. The Internal Revenue Code of 1986 contains certain provisions that can limit a taxpayer's ability to utilize net operating loss and tax credit carryforwards in any given year resulting from cumulative changes in ownership interests in excess of 50 percent over a three-year The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes. The Company has ongoing state examinations in Massachusetts and New Jersey which cover multiple years. There have been no proposed adjustments at this stage of the examination. The Minnesota examination was finalized during the second quarter of 2022 for years 2018 and 2019 with no adjustments. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (7) Fair Value Measurements The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30 , 2022 2024 which are valued using a binomial model. For assets and liabilities not accounted for at fair value, the carrying values of these accounts approximates their fair values at September 30 , 2022, except for the fair value of the Company’s convertible senior notes due December 2024 , which was approximately $ 157.3 million as of September 30 , 2022. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2). (In thousands) Level 1 Level 2 Level 3 September 30, 2022 Assets Carried at Fair Value: Money market funds $ 2,216 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 37,600 Derivative liability - conversion option — — — December 31, 2021 Assets Carried at Fair Value: Money market funds $ 12,192 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 49,600 Derivative liability - conversion option — — 37 The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value. Acquired contingent consideration (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Acquired contingent consideration: Balance, beginning of period $ 42,900 $ 41,200 $ 49,600 $ 48,200 Fair value change to contingent consideration included in the statement of operations (4,576 ) 2,205 (10,709 ) (4,224 ) Royalty payments (724 ) (405 ) (1,291 ) (976 ) Balance, end of period $ 37,600 $ 43,000 $ 37,600 $ 43,000 The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from Inbrija (levodopa inhalation powder) an FDA approved drug OFF periods in Parkinson’s disease. the estimated revenue forecast for Inbrija Inbrija. changes in the fair value of the contingent consideration primarily due to The acquired contingent consideration is classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach, including but not limited to, assumptions involving sales estimates for Inbrija Derivative Liability-Conversion Option The following table represents a reconciliation of the derivative liability recorded in connection with the issuance of the convertible senior secured notes due 2024: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Derivative Liability-Conversion Option Balance, beginning of period $ — $ 613 $ 37 $ 1,193 Fair value adjustment — (288 ) (37 ) (868 ) Balance, end of period $ — $ 325 $ — $ 325 During 2019, a derivative liability was initially recorded as a result of the issuance of the 6.00% Convertible Senior Secured Notes due 2024 (See Note 10 to the Consolidated Financial Statements included in this report for more information on the Convertible Senior Notes due 2024). The fair value measurement of the derivative liability is classified as Level 3 under the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include: (1) share price as of the valuation date, (2) assumed timing of conversion of the Notes, (3) historical volatility of the share price, and (4) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the derivative liability was determined using a binomial model that calculates the fair value of the Notes with the conversion feature as compared to the fair value of the Notes without the conversion feature, with the difference representing the value of the conversion feature, or the derivative liability. There are several embedded features within the Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as a derivative liability conversion option. |
Investments
Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments Debt And Equity Securities [Abstract] | |
Investments | (8) Investments There were no available-for-sale investments at September 30, 2022 and December 31, 2021, respectively. Short-term investments with maturities of three months or less from date of purchase have been classified as cash equivalents, and amounted to approximately $2.2 million and $12.2 million as of September 30, 2022 and December 31, 2021, respectively. There were no short-term investments with original maturities of greater than 3 months but less than 1 year as of September 30, 2022 and December 31, 2021, respectively. Additionally, there were no short-term investments in an unrealized loss position as of September 30, 2022 and December 31, 2021, respectively. Long-term investments have original maturities of greater than 1 year. There were no investments classified as long-term at September 30, 2022 or December 31, 2021. The Company has determined that there were no other-than-temporary declines in the fair values of its investments as of September 30, 2022 as the Company does not have any short or long-term investments as of September 30, 2022. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 9 Months Ended |
Sep. 30, 2022 | |
Deferred Revenue Disclosure [Abstract] | |
Liability Related to Sale of Future Royalties | (9) Liability Related to Sale of Future Royalties On October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners Since the Company maintained rights under the Biogen Collaboration Agreement, therefore, the Royalty Agreement has been accounted for as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. The Company recorded the receipt of the $40 million payment from HCRP and established a corresponding liability in the amount of $40 million, net of transaction costs of approximately $2.2 million. The net liability is classified between the current and non-current portion of liability related to the sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments to be received by HCRP in the 12 months following the financial statement reporting date. The total net royalties to be paid, less the net proceeds received, is recorded to interest expense using the effective interest method over the life of the Royalty Agreement. The Company estimates the payments to be made to HCRP over the term of the Royalty Agreement based on forecasted royalties and calculates the interest rate required to discount such payments back to the liability balance. Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company reassess the effective interest rate and adjust the rate prospectively as necessary. The Company has a liability related to the sale of future royalties of $0 and $7.5 million for the periods ending September 30, 2022 and 2021, respectively. The following table shows the activity within the liability account for the nine-month period ended September 30 (In thousands) September 30, 2022 September 30, 2021 Liability related to sale of future royalties - beginning balance $ 4,460 $ 15,257 Deferred transaction costs amortized 33 193 Non-cash royalty revenue payable to HCRP (4,739 ) (8,889 ) Non-cash interest expense recognized 246 891 Liability related to sale of future royalties - ending balance $ — $ 7,452 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | (10) Debt Convertible Senior Secured Notes Due 2024 On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of its outstanding 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”) for a combination of newly issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. For each $1,000 principal amount of exchanged 2021 Notes, the Company issued $750 principal amount of the 2024 Notes and made a cash payment of $200 (the “Exchange”). In the aggregate, the Company issued approximately $207.0 million aggregate principal amount of the 2024 Notes and paid approximate $55.2 million in cash to participating holders. The Exchange was conducted with a limited number of institutional holders of the 2021 Notes pursuant to Exchange Agreements dated as of December 20, 2019. The 2021 Notes received by the Company in the Exchange were cancelled in accordance with their terms. Accordingly, upon completion of the Exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand. The 2024 Notes were issued pursuant to an Indenture, dated as of December 23, 2019, among the Company, its wholly owned subsidiary, Civitas Therapeutics, Inc. (along with any domestic subsidiaries acquired or formed after the date of issuance, the “Guarantors”), and Wilmington Trust, National Association, as trustee and collateral agent (the “2024 Indenture”). The 2024 Notes are senior obligations of the Company and the Guarantors, secured by a first priority security interest in substantially all of the assets of the Company and the Guarantors, subject to certain exceptions described in the Security Agreement, dated as of December 23, 2019, between the grantors party thereto and Wilmington Trust, National Association, as collateral agent. The 2024 Notes will mature on December 1, 2024 unless earlier converted in accordance with their terms prior to such date. Interest on the 2024 Notes is payable semi-annually in arrears at a rate of 6.00% per annum on each June 1 and December 1, beginning on June 1, 2020. Under the 2024 Indenture, the Company may elect to pay interest in cash or shares of the Company’s common stock, subject to the satisfaction of certain conditions. If the Company elects to pay interest in shares of common stock, such common stock will have a per share value equal to 95% of the daily volume-weighted average price for the 10 trading days ending on and including the trading day immediately preceding the relevant interest payment date. Based on the current market price of the Company’s common stock and the Company’s remaining authorized shares of common stock that are not reserved for other purposes, the Company believes that for the foreseeable future interest payments on the 2024 notes will have to be made in cash. The 2024 Notes are convertible at the option of the holder into shares of common stock of the Company at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. The adjusted conversion rate for the 2024 Notes is 47.6190 shares of the Company’s common stock per $1,000 principal amount of 2024 Notes, representing an adjusted conversion price of approximately $21.00 per share of common stock. The conversion rate was adjusted to reflect the 1-for-6 reverse stock split effected on December 31, 2020 and is subject to additional adjustments in certain circumstances as described in the 2024 Indenture. The Company may elect to settle conversions of the 2024 Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Holders who convert their 2024 Notes prior to June 1, 2023 (other than in connection with a make-whole fundamental change) will also be entitled to an interest make-whole payment equal to the sum of all regularly scheduled stated interest payments, if any, due on such 2024 Notes on each interest payment date occurring after the conversion date for such conversion and on or before June 1, 2023. In addition, the Company will have the right to cause all 2024 Notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 130% of the adjusted conversion price for a specified period of time and certain other conditions are satisfied. Holders of the 2024 Notes will have the right, at their option, to require the Company to purchase their 2024 Notes if a fundamental change (as defined in the 2024 Indenture) occurs, such as a delisting of the Company’s common stock from the Nasdaq Global Select Market, in each case, at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. If a make-whole fundamental change occurs, as described in the 2024 Indenture, and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the adjusted conversion rate as described in the 2024 Indenture. Subject to a number of exceptions and qualifications, the 2024 Indenture restricts the ability of the Company and certain of its subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, which includes, among other items, indebtedness incurred to refinance the 2021 Notes, (iv) create liens on their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or (vii) merge, consolidate or sell of all or substantially all of their assets. The 2024 Indenture also requires the Company to make an offer to repurchase the 2024 Notes upon the occurrence of certain asset sales. The 2024 Indenture provides that a number of events will constitute an event of default, including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by the Company to make required payments under other indebtedness of the Company or certain subsidiaries having an outstanding principal amount of $30.0 million or more, (vii) failure by the Company or certain subsidiaries to pay final judgments aggregating in excess of $30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the United States of a product determined by the U.S. FDA to be bioequivalent to Inbrija. In the case of an event of default arising from certain events of bankruptcy or insolvency with respect to the Company, all outstanding 2024 Notes will become due and payable immediately without further action or notice. If any other event of default occurs and is continuing, the trustee or the holders of at least 25% in aggregate principal amount of the then outstanding 2024 Notes may declare all the notes to be due and payable immediately. The Company determined that the exchange of the 2021 Notes for 2024 Notes qualified for a debt extinguishment and recognized a gain on extinguishment of $55.1 million for the year ended December 31, 2019, representing the difference between the fair value of the liability component immediately before the exchange and the carrying value of the debt. The Company recorded an adjustment of $38.4 million to additional paid-in capital to adjust the equity component of 2021 Notes in connection with the extinguishment. The Company assessed all terms and features of the 2024 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2024 Notes, including the conversion, put and call features. The Company concluded the conversion features required bifurcation as a derivative. The fair value of the conversion features derivative was determined based on the difference between the fair value of the 2024 Notes with the conversion options and the fair value of the 2024 Notes without the conversion options using a binomial model. The Company determined that the fair value of the derivative upon issuance of the 2024 Notes was $59.4 There are several embedded features within the 2024 Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as the derivative liability conversion option. The Company received stockholder approval on August 28, 2020 to increase the number of authorized shares of the Company’s common stock from 13,333,333 shares to 61,666,666 shares. As a result of the share approval, the Company determined that multiple embedded conversion options met the conditions for equity classification. performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations for the shares underlying the 2024 Notes. The resulting fair value of these conversion options was $18.3 million, which was reclassified to equity and presented in the statement of stockholder’s equity as of September 30, 2020, net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of these conversion features was calculated to be negligible as of September 30, 2022. The outstanding 2024 Note balances as of September 30 (In thousands) September 30, 2022 December 31, 2021 Liability component: Principal 207,000 $ 207,000 Less: debt discount and debt issuance costs, net (44,240 ) (55,975 ) Net carrying amount $ 162,760 $ 151,025 Equity component $ 18,257 $ 18,257 Derivative liability-conversion option $ — $ 37 The Company determined that the expected life of the 2024 Notes was equal to the period through December 1, 2024 as this represents the point at which the 2024 Notes will mature unless earlier converted in accordance with their terms prior to such date. September 30, 2022 September 30 In connection with the issuance of the 2024 Notes, the Company incurred approximately $5.7 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance sheet. The portion allocated to the 2024 Notes is amortized to interest expense over the expected life of the 2024 Notes using the effective interest method. The following table sets forth total interest expense recognized related to the 2024 Notes for the three- and nine-month periods ended September 30 (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Contractual interest expense $ 3,105 $ 3,105 $ 9,315 $ 9,315 Amortization of debt issuance costs 291 243 834 698 Amortization of debt discount 3,797 3,179 10,902 9,130 Total interest expense $ 7,193 $ 6,527 $ 21,051 $ 19,143 Convertible Senior Notes Due 2021 On June 17, 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”). On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of its then-outstanding 2021 Notes for a combination of newly issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. The 2021 Notes received by the Company in the exchange were cancelled in accordance with their terms. Accordingly, upon completion of the exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand. In accounting for the issuance of the 2021 Notes, the Company separated the 2021 Notes into liability and equity components. 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 carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the 2021 Notes as a whole. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. In connection with the issuance of the 2021 Notes, the Company incurred approximately $7.5 million 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 $7.5 million of debt issuance costs, $1.3 million were allocated to the equity component and recorded as a reduction to additional paid-in capital and $6.2 million were allocated to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance sheet. The portion allocated to the liability component is amortized to interest expense over the expected life of the 2021 Notes using the effective interest method. The Company wrote off $ 1.2 million of issuance cost associated with the exchange of the 2021 Notes. The following table sets forth total interest expense recognized related to the 2021 Notes for the three- and nine-month periods ended September 30 (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Contractual interest expense $ — $ — $ — $ 428 Amortization of debt issuance costs — — — 95 Amortization of debt discount — — — 934 Total interest expense $ — $ — $ — $ 1,457 Non-Convertible Capital Loans Our Biotie subsidiary received fourteen non-convertible capital loans granted by Business Finland (formerly Tekes) for research and development of specific drug candidates, with an aggregate adjusted acquisition-date fair value of $20.5 million (€18.2 million) and an aggregate carrying value of $24.9 $14.5 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | (11) Leases In February 2016, the FASB issued ASU 2016-02, “Leases” Topic 842, which amends the guidance in former ASC Topic 840, Leases The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 4.25 years to 5.75 years. The Company has exercised the option to terminate the Ardsley lease with a termination date of June 22, 2022. Operating Leases The Company leases certain office space, manufacturing and warehouse space under arrangements classified as leases under ASC 842. Leases with an initial term of 12 months or less are not recorded on the balance sheet; the Company recognizes lease expense for these leases on a straight-line basis over the lease term. Ardsley, New York The Company was previously headquartered at a leased facility in Ardsley, New York with approximately 160,000 square feet of space. In September 2021, the Company sent the landlord notice of exercise of its early termination option under the lease, which was effective on June 22, 2022. In connection with the lease termination, the Company paid an early termination fee of approximately $4.7 million. Concurrent with the Ardsley lease termination, in June 2022, the Company relocated its corporate headquarters to a substantially smaller subleased office in Pearl River, New York, described below. Pearl River, New York In June 2022, the Company entered into a 6-year sublease for an aggregate of approximately 21,000 square feet of space in Pearl River, New York. The Company has no options to extend the term of the sublease. The Pearl River sublease provides for monthly payments of rent during the lease term. The base rent is currently $0 through December 31, 2022, with payments commencing on January 1, 2023 with a base rent of $0.3 million per year, subject to an annual 2.0% escalation factor in each subsequent year thereafter. Chelsea, Massachusetts The Company’s Civitas subsidiary leased a manufacturing facility in Chelsea, Massachusetts which it used to manufacture On February 10, 2021, the Company completed the sale of its Chelsea manufacturing operations to Catalent Pharma Solutions and assigned the lease of the Chelsea facility to a Catalent affiliate. In 2018, the Company initiated a renovation and expansion of a building within the Chelsea manufacturing facility that increased the size of the facility to approximately 95,000 square feet. The project added a new size 7 spray dryer manufacturing production line for Inbrija and other ARCUS products that has greater capacity than the existing size 4 spray dryer manufacturing production line, and created additional warehousing space for manufactured product. All costs to renovate and expand the facility through the date of assignment to Catalent were borne by the Company. Since the February 10, 2021 sale of the manufacturing operations, Catalent has been responsible for finalizing the expansion, including obtaining needed regulatory approvals. However, given the potential importance of the expansion to the Company’s business, in December 2021 the Company agreed to fund $1.5 million of Catalent’s costs to complete the size 7 spray dryer expansion, which will be payable by the Company in four quarterly installments after the later of January 1, 2024 or FDA qualification and approval for use of the size 7 spray dryer. Additional Facilities In October 2016, the Company entered into a 10-year lease agreement with a term commencing January 1, 2017, for approximately 26,000 square feet of lab and office space in Waltham, MA. The lease provides for monthly rental payments over the lease term. The Company’s leases have remaining lease terms of 4.25 years to 5.75 years, which reflects the exercise of the early termination of the Company’s Ardsley, NY lease as described above. The weighted-average remaining lease term for the Company’s operating leases was 4.6 years at September 30, 2022. The weighted-average discount rate was 7.89% at September 30, 2022. ROU assets and lease liabilities related to the Company’s operating leases are as follows: (In thousands) Balance Sheet Classification September 30, 2022 December 31, 2021 Right-of-use assets Right of use assets $ 5,541 $ 6,751 Current lease liabilities Current portion of lease liabilities 1,454 8,186 Non-current lease liabilities Non-current portion of lease liabilities 4,612 4,086 The Company has lease agreements that contain both lease and non-lease components. The Company accounts for lease components together with non-lease components (e.g., common-area maintenance). The components of lease costs were as follows: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Operating lease cost $ 431 $ 1,600 $ 3,390 $ 4,593 Variable lease cost 132 948 1,960 3,283 Short-term lease cost 1 339 7 829 Total lease cost $ 564 $ 2,887 $ 5,357 $ 8,705 Future minimum commitments under all non-cancelable operating leases are as follows: (In thousands) 2022 (excluding the three months ended September 30, 2022) $ 295 2023 1,546 2024 1,588 2025 1,633 2026 1,678 Later years 539 Total lease payments 7,279 Less: Imputed interest (1,213 ) Present value of lease liabilities $ 6,066 Supplemental cash flow information related to the Company’s operating leases are as follows: (In thousands) Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 295 $ 4,605 |
Disposal of Assets
Disposal of Assets | 9 Months Ended |
Sep. 30, 2022 | |
Property Plant And Equipment [Abstract] | |
Disposal of Assets | (12) Disposal of Assets On January 12, 2021 the Company and Catalent entered into an asset purchase agreement, pursuant to which the Company agreed to sell to Catalent certain assets related to the Company’s manufacturing activities located at the facilities situated in Chelsea, Massachusetts (the “Chelsea Facility”) and Waltham, Massachusetts (the “Waltham Facility”), for a purchase price of $80 million, plus an additional $2.3 million for raw materials transferred, and the assumption by Catalent of certain liabilities relating to such manufacturing activities. The Company closed the transaction on February 10, 2021. The Company determined that the criterion to classify the Chelsea manufacturing operations as assets held for sale within the Company’s consolidated balance sheet effective December 31, 2020 were met. Accordingly, the assets were classified as current assets held for sale at December 31, 2020 as the Company, at that time, expected to divest the Chelsea manufacturing operations within the next twelve months. The classification to assets held for sale impacted the net book value of the assets expected to be transferred upon sale. The estimated fair value of the Chelsea manufacturing operations was determined using the purchase price in the purchase agreement along with estimated broker, accounting, legal, and other selling expenses, which resulted in a fair value less costs to sell of approximately $71.8 million. The carrying value of the assets classified as held for sale was approximately $129.7 million, which included property and equipment of $129.6 million and prepaid expenses of $0.1 million. As a result, the Company recorded a loss on assets held for sale of $57.9 million against the Chelsea manufacturing operations. Upon completion of the divestiture, final net proceeds were $74.0 million. Additionally, the expected divestiture of the Chelsea manufacturing operations was not deemed to represent a fundamental strategic shift that would have a major effect on the Company’s operations, and accordingly, the operating results of the Chelsea manufacturing operations were not reported as discontinued operations in the Company’s consolidated statement of income as of December 31, 2020. The Company closed the transaction on February 10, 2021. In addition to the property and equipment, prepaid expenses, and raw materials, the Company also assigned the lease of the Chelsea Facility to a Catalent affiliate, which had a net carrying value of $(0.5) million as of the close date. During the three-month period ended March 31, 2021, the Company recorded a gain on disposal of approximately $0.5 million based on the net assets transferred and final net proceeds received at the close. |
Corporate Restructuring
Corporate Restructuring | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring And Related Activities [Abstract] | |
Corporate Restructuring | (13) Corporate Restructuring In January 2021 and September 2021, the Company announced corporate restructurings to reduce costs, more closely align operating expenses with expected revenue, and focus its resources on Inbrija. As part of the January 2021 restructuring, the Company reduced headcount by approximately 16% through a reduction in force (excluding the employees that transferred to Catalent at the closing of the sale of the Company’s Chelsea manufacturing operations). All of the reduction in personnel in connection with the January 2021 restructuring took place during the three-month period ended March 31, 2021. As part of the September 2021 restructuring, the Company reduced headcount by approximately 15 % through a reduction in force. Most of this reduction in force took place in September 2021, and was materially completed as of March 31, 2022, with negligible expenses incurred in the second quarter of 2022. During the nine-month period ended September 30, 2022, the Company incurred $0.3 million of restructuring charges, substantially all of which were cash expenditures for severance and other employee separation-related costs. All of the restructuring charges were recorded in selling, general and administrative expenses for the nine-month period ended September 30, 2022. A summary of the restructuring charges for the nine-month period ended September 30, 2022 is as follows: (In thousands) Restructuring Costs Restructuring Liability as of December 31, 2021 $ 1,851 Q1 Restructuring Costs 226 Q1 Restructuring Payments (1,700 ) Restructuring Liability as of March 31, 2022 $ 377 Q2 Restructuring Costs 25 Q2 Restructuring Payments (145 ) Restructuring Liability as of June 30, 2022 $ 257 Q3 Restructuring Costs — Q3 Restructuring Payments (257 ) Restructuring Liability as of September 30, 2022 $ (0 ) |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (14) Commitments and Contingencies On November 9, 2020, Drug Royalty III, L.P., and LSRC III S.ar.l. (collectively, “DRI”) filed an arbitration claim against the Company with the American Arbitration Association under a September 26, 2003 License Agreement that it originally entered into with Rush-Presbyterian St. Luke’s Medical Center (“Rush”). DRI previously purchased license royalty rights under the license agreement from Rush. DRI alleged a dispute over the last-to-expire patent covering sales of the drug Ampyra under the license agreement, and claimed damages based on unpaid license royalties of $6 million plus interest. On June 28, 2022, the Company settled DRI’s claim in exchange for a payment by the Company to DRI of $750,000 expressly without any admission of wrongdoing. Although the Company believed it had valid defenses to this claim, it also believed that the settlement was in the best interests of the Company and its stockholders to avoid the future expense and distraction associated with continuing the arbitration $2 million for the year ended December 31, 2020 in accrued expense and other current liabilities related to the dispute. As a result of the settlement, during the quarter ended September 30, 2022, this accrual was reduced to the $750,000 settlement amount and a corresponding gain of $1.3 million was recorded in the consolidated statement of operations as other income From time to time the Company is involved in litigation or other legal proceedings relating to claims arising out of operations in the normal course of business. The Company has assessed all litigation and legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for these other matters. Litigation expenses are expensed as incurred. On February 10, 2021, the Company sold its Chelsea manufacturing operations to Catalent Pharma Solutions. In connection with the sale, the Company entered into a long-term, global manufacturing services (supply) agreement with a Catalent affiliate pursuant to which they have agreed to manufacture Inbrija for the Company at the Chelsea facility. The manufacturing services agreement provides that Catalent will manufacture Inbrija, to the Company’s specifications, and the Company will purchase Inbrija exclusively from Catalent during the term of the manufacturing services agreement; provided that such exclusivity requirement will not apply to Inbrija intended for sale in China. Under the Company’s agreement with Catalent, it is obligated to make minimum inventory purchase commitments for Inbrija through the expiration of the agreement on December 31, 2030. During the quarter ended September 30, 2022, the Company incurred approximately $7.7 million of purchase commitments with Catalent, of which $3.9 million are recognized as inventory within the Company’s balance sheet and $3.8 million are recognized as cost of sales within the Company’s consolidated statement of operations for the period. As of September 30, 2022, the minimum remaining purchase commitment to Catalent was $4.5 million through December 31, 2022, and $18.0 million annually each year thereafter. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | (15) Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events that required disclosure or adjustment in these financial statements except for the following disclosure: Alkermes Arbitration On October 16, 2022, the Company issued a press release announcing that a three-judge arbitration panel has issued a final decision in a dispute regarding licensing royalties relating to AMPYRA. The Company was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, the Company will be permitted to cease paying Alkermes a double-digit percentage of net sales for the license and supply of AMPYRA, and the Company is now free to use alternative sources for supply of AMPYRA, which the Company has already secured. On October 21, 2022, we made a submission to the arbitration panel to correct the award to include an additional $1.6 million that was inadvertently omitted from the initial award calculation, which amount Alkermes does not dispute. We are awaiting the arbitration tribunal’s decision on this corrected award amount and the amount of pre-judgment interest to be applied to this corrected award amount. Shareholder Vote On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankruptcy or liquidation. On November 11, 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market, which forms the basis of the Company’s long-term strategic planning. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company reclassified the net proceeds from the sale of the Chelsea facility of $74.0 million for the nine-month period ended September 30, 2021 from financing activities to investing activities in the accompanying Consolidated Statement of Cash Flows. |
Restricted Cash | Restricted Cash The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 45,634 $ 20,696 $ 71,369 $ 36,168 Restricted cash 13,400 13,232 12,917 13,353 Restricted cash non-current 6,189 255 18,609 12,399 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 65,223 $ 34,183 $ 102,895 $ 61,920 Restricted cash represents an escrow account with funds to maintain the interest payments for an amount equal to all remaining scheduled interest payments on the outstanding convertible senior secured notes due 2024 through the interest payment date of June 1, 2023; and a |
Inventory | Inventory The following table provides the major classes of inventory: (In thousands) September 30, 2022 December 31, 2021 Raw materials $ 3,333 $ 3,338 Finished goods 11,919 15,210 Total $ 15,252 $ 18,548 The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. On February 10, 2021, the Company completed the sale of its Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. In connection with the sale of the manufacturing operations, the Company transferred approximately $2.3 million of raw materials to Catalent. See Note 12 to the Company’s Consolidated Financial Statements included in this report for a discussion of assets transferred upon the sale. Additionally, in reviewing the inventory for slow moving or obsolete amounts the Company recorded a charge of $1.3 million for the remaining work-in-progress inventory that was scrapped or discarded during the nine-month period ended September 30, 2021. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations. |
Segment and Geographic Information | Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Ampyra and Inbrija in the U.S. for the three- and nine-month periods ended September 30, 2022 and 2021. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer and significant negative economic trends. The decline in the trading price of the Company's common stock during the nine-month period ended September 30, 2022, and related decrease in the Company's market capitalization, was determined to be a triggering event in connection with the Company's review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2022. The Company performed a recoverability test as of September 30, 2022 using the undiscounted cash flows, which are the sum of the future undiscounted cash flows expected to be derived from the direct use of the long-lived assets to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s own assumptions about its own use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2022, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets. |
Liquidity | Liquidity The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, and obtain additional financing. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing its convertible senior secured notes due 2024, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether. At September 30, 2022, the Company had $20.7 million of cash and cash equivalents, compared to $45.6 million at December 31, 2021. The Company’s September 30, 2022 cash and cash equivalents balance does not include $12.4 million of restricted cash that is currently held in escrow under the terms of its convertible senior secured notes due 2024, which may potentially be released from escrow if the Company pays interest on those notes using shares of its common stock (the amount released would correspond to the amount of interest paid using shares). The Company incurred a net loss of $85.1 million for the nine-month period ended September 30, 2022. The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, “Presentation of Financials Statements—Going Concern” (“ASC Topic 205-40”), which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim consolidated financial statements are issued. Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgement by management. The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements contained in this report are issued. On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankrupt cy or liquidation. On November 11 , 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market , which forms the basis of the Company’s long-term strategic planning. The Company believes that its existing cash and cash equivalents will be sufficient to cover its cash flow requirements for at least the next twelve months from the issuance date of these financial statements. However, the Company’s future requirements may change and will depend on numerous factors, some of which may be beyond the Company’s control. |
Subsequent Events | Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were subsequent events that required disclosure or adjustment in these financial statements. See Note 15 to the Company’s Consolidated Financial Statements included in this report for a discussion of subsequent events. |
Accounting Pronouncements Adopted | Accounting Pronouncements Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted. The Company adopted this guidance effective January 1, 2021. The adoption of this guidance did not have a significant impact on the consolidated financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The FASB is issuing this update to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this guidance effective January 1, 2022. The adoption of this guidance did not have a significant impact on the consolidated financial statements. |
Accounting Pronouncements Not Yet Adopted | Accounting Pronouncements Not Yet Adopted In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments”: The amendments in this update are to clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2020-03 are not expected to have a significant effect on current accounting practices. The ASU improves various financial instrument topics in the Codification to increase stakeholder awareness of the amendments and to expedite the improvement process by making the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. The ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022 with early application permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This update simplifies the accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature models which require separate accounting for embedded conversion features. This update also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions and requires the application of the if-converted method for calculating diluted earnings per share. ASU 2020-06 is effective for smaller reporting companies for fiscal periods beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In March, 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses: Troubled Debt Restructurings and Vintage Disclosures. The amendments in this Update eliminate the accounting guidance for Troubled Debt Restructurings by creditors in Subtopic 310-40, Receivables—Troubled Debt Restructurings by Creditors, while enhancing disclosure requirements for certain loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty. This update also includes amendments which require that an entity disclose current-period gross writeoffs by year of origination for financing receivables and net investments in leases within the scope of Subtopic 326-20, Financial Instruments—Credit Losses—Measured at Amortized Cost. The ASU is effective for entities that have adopted the amendments in Update 2016-13 for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In September, 2022, the FASB issued ASU 2022-04, Liabilities – Supplier Finance Programs: Disclosure of Supplier Finance Program Obligations. The amendments in this update address investor and other financial statement user requests for additional information about the use of supplier finance programs (the programs) by the buyer party to understand the effect of those programs on an entity’s working capital, liquidity, and cash flows. The ASU requires that a buyer in a supplier finance program disclose sufficient information about the program to allow a user of financial statements to understand the program’s nature, activity during the period, changes from period to period, and potential magnitude. The ASU is effective for entities that have fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 45,634 $ 20,696 $ 71,369 $ 36,168 Restricted cash 13,400 13,232 12,917 13,353 Restricted cash non-current 6,189 255 18,609 12,399 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 65,223 $ 34,183 $ 102,895 $ 61,920 |
Schedule of Major Classes of Inventory | The following table provides the major classes of inventory: (In thousands) September 30, 2022 December 31, 2021 Raw materials $ 3,333 $ 3,338 Finished goods 11,919 15,210 Total $ 15,252 $ 18,548 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue From Contract With Customer [Abstract] | |
Disaggregation of Revenue | The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen. See Note 9 for additional information on the Company’s related payment obligation to HealthCare Royalty Partners, or HCRP, in connection with a 2017 royalty purchase agreement with HCRP. (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Revenues: Net product revenues: Ampyra $ 21,110 $ 20,026 $ 54,192 $ 62,035 Inbrija U.S. 7,848 7,804 18,957 19,240 Inbrija ex-U.S. 1,006 — 2,874 — Other — 21 — 22 Total net product revenues 29,964 27,851 76,023 81,297 Royalty Revenue 3,047 3,605 10,573 10,807 License Revenue 500 — 500 — Total net revenues $ 33,511 $ 31,456 $ 87,096 $ 92,104 |
Share-based Compensation (Table
Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Share-based Compensation Expense | The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: For the three-month period ended September 30, For the nine-month period ended September 30, (In thousands) 2022 2021 2022 2021 Research and development expense $ 14 $ 225 $ 66 $ 599 Selling, general and administrative expense 351 627 1,254 1,898 Cost of Sales (1 ) 2 0 18 Total $ 364 $ 854 $ 1,320 $ 2,515 |
Schedule of Stock Option Activity | A summary of share-based compensation activity for the nine-month period ended September 30, 2022 is presented below: Number of Shares (In Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In Balance at January 1, 2022 1,186 $ 94.38 Granted 97 1.19 Cancelled (230 ) 128.93 Exercised — — Balance at September 30, 2022 1,053 $ 78.24 6.0 $ — Vested and expected to vest at September 30, 2022 1,053 $ 78.24 6.0 $ — Vested and exercisable at September 30, 2022 713 $ 113.62 4.5 $ — |
Restricted Stock and Performance Stock Unit | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Restricted Stock and Performance Stock Unit Activity | (In thousands) Restricted Stock and Performance Stock Units Number of Shares Nonvested at January 1, 2022 116 Granted — Vested (103 ) Forfeited (7 ) Nonvested at September 30, 2022 6 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Loss per Share | The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2022 and 2021: (In thousands, except per share data) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Basic and diluted Net loss—basic $ (13,854 ) $ (27,071 ) $ (85,058 ) $ (83,387 ) Net income (loss)—diluted $ (13,854 ) $ (27,071 ) $ (85,058 ) $ (83,387 ) Weighted average common shares outstanding used in computing net loss per share—basic 24,290 11,131 18,148 10,204 Plus: net effect of dilutive stock options and restricted common shares — — — — Weighted average common shares outstanding used in computing net loss per share—diluted 24,290 11,131 18,148 10,204 Net loss per share—basic $ (0.57 ) $ (2.43 ) $ (4.69 ) $ (8.17 ) Net loss per share—diluted $ (0.57 ) $ (2.43 ) $ (4.69 ) $ (8.17 ) |
Schedule of Anti-dilutive Securities Excluded from Calculation of Net Loss per Diluted Share | The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Denominator Stock options and restricted common shares 1,134 1,370 1,089 1,368 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | (In thousands) Level 1 Level 2 Level 3 September 30, 2022 Assets Carried at Fair Value: Money market funds $ 2,216 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 37,600 Derivative liability - conversion option — — — December 31, 2021 Assets Carried at Fair Value: Money market funds $ 12,192 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 49,600 Derivative liability - conversion option — — 37 |
Contingent Consideration Liability | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Schedule of Contingent Liabilities | The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value. (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Acquired contingent consideration: Balance, beginning of period $ 42,900 $ 41,200 $ 49,600 $ 48,200 Fair value change to contingent consideration included in the statement of operations (4,576 ) 2,205 (10,709 ) (4,224 ) Royalty payments (724 ) (405 ) (1,291 ) (976 ) Balance, end of period $ 37,600 $ 43,000 $ 37,600 $ 43,000 |
Derivative Liability-Conversion Option | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Schedule of Fair Value Reconciliation of Derivative Liabilities | The following table represents a reconciliation of the derivative liability recorded in connection with the issuance of the convertible senior secured notes due 2024: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Derivative Liability-Conversion Option Balance, beginning of period $ — $ 613 $ 37 $ 1,193 Fair value adjustment — (288 ) (37 ) (868 ) Balance, end of period $ — $ 325 $ — $ 325 |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Deferred Revenue Disclosure [Abstract] | |
Schedule of Activity Within Liability Related to Sale of Future Royalties | The following table shows the activity within the liability account for the nine-month period ended September 30 (In thousands) September 30, 2022 September 30, 2021 Liability related to sale of future royalties - beginning balance $ 4,460 $ 15,257 Deferred transaction costs amortized 33 193 Non-cash royalty revenue payable to HCRP (4,739 ) (8,889 ) Non-cash interest expense recognized 246 891 Liability related to sale of future royalties - ending balance $ — $ 7,452 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Convertible Senior Secured Notes due 2024 | |
Summary of Outstanding Note Balances | The outstanding 2024 Note balances as of September 30 (In thousands) September 30, 2022 December 31, 2021 Liability component: Principal 207,000 $ 207,000 Less: debt discount and debt issuance costs, net (44,240 ) (55,975 ) Net carrying amount $ 162,760 $ 151,025 Equity component $ 18,257 $ 18,257 Derivative liability-conversion option $ — $ 37 |
Schedule of Interest Expense Recognized Related to the Notes | The following table sets forth total interest expense recognized related to the 2024 Notes for the three- and nine-month periods ended September 30 (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Contractual interest expense $ 3,105 $ 3,105 $ 9,315 $ 9,315 Amortization of debt issuance costs 291 243 834 698 Amortization of debt discount 3,797 3,179 10,902 9,130 Total interest expense $ 7,193 $ 6,527 $ 21,051 $ 19,143 |
Convertible Senior Notes due 2021 | |
Schedule of Interest Expense Recognized Related to the Notes | The following table sets forth total interest expense recognized related to the 2021 Notes for the three- and nine-month periods ended September 30 (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Contractual interest expense $ — $ — $ — $ 428 Amortization of debt issuance costs — — — 95 Amortization of debt discount — — — 934 Total interest expense $ — $ — $ — $ 1,457 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Schedule of ROU Assets and Lease Liabilities Related to Operating Leases | ROU assets and lease liabilities related to the Company’s operating leases are as follows: (In thousands) Balance Sheet Classification September 30, 2022 December 31, 2021 Right-of-use assets Right of use assets $ 5,541 $ 6,751 Current lease liabilities Current portion of lease liabilities 1,454 8,186 Non-current lease liabilities Non-current portion of lease liabilities 4,612 4,086 |
Components of Lease Costs | The components of lease costs were as follows: (In thousands) Three-month period ended September 30, 2022 Three-month period ended September 30, 2021 Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Operating lease cost $ 431 $ 1,600 $ 3,390 $ 4,593 Variable lease cost 132 948 1,960 3,283 Short-term lease cost 1 339 7 829 Total lease cost $ 564 $ 2,887 $ 5,357 $ 8,705 |
Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases | Future minimum commitments under all non-cancelable operating leases are as follows: (In thousands) 2022 (excluding the three months ended September 30, 2022) $ 295 2023 1,546 2024 1,588 2025 1,633 2026 1,678 Later years 539 Total lease payments 7,279 Less: Imputed interest (1,213 ) Present value of lease liabilities $ 6,066 |
Summary of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to the Company’s operating leases are as follows: (In thousands) Nine-month period ended September 30, 2022 Nine-month period ended September 30, 2021 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 295 $ 4,605 |
Corporate Restructuring (Tables
Corporate Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring And Related Activities [Abstract] | |
Summary of Restructuring Charges | A summary of the restructuring charges for the nine-month period ended September 30, 2022 is as follows: (In thousands) Restructuring Costs Restructuring Liability as of December 31, 2021 $ 1,851 Q1 Restructuring Costs 226 Q1 Restructuring Payments (1,700 ) Restructuring Liability as of March 31, 2022 $ 377 Q2 Restructuring Costs 25 Q2 Restructuring Payments (145 ) Restructuring Liability as of June 30, 2022 $ 257 Q3 Restructuring Costs — Q3 Restructuring Payments (257 ) Restructuring Liability as of September 30, 2022 $ (0 ) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Nov. 11, 2022 | Oct. 18, 2022 USD ($) | Jun. 22, 2022 $ / shares | Oct. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Segment | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||||||
Proceeds from sale of facility | $ 74,000 | ||||||||
Transfer of raw material | $ 2,300 | $ 2,300 | |||||||
Charge for excess and obsolete inventory | $ 1,300 | ||||||||
Segment and Geographic Information | |||||||||
Number of operating segments | Segment | 1 | ||||||||
Number of reportable operating segments | Segment | 1 | ||||||||
Net loss | (13,854) | $ (27,071) | $ (85,058) | (83,387) | |||||
VERSION A | |||||||||
Segment and Geographic Information | |||||||||
Cash and cash equivalents | 20,700 | 20,700 | $ 45,600 | ||||||
Restricted cash | 12,400 | 12,400 | |||||||
Net loss | (85,100) | ||||||||
Trading price of common stock | $ / shares | $ 1 | ||||||||
Consecutive days for complying with trading price of listed securities | 30 days | ||||||||
Number of additional days for complying with requirement of trading price of listed securities | 180 days | ||||||||
Cut off date on or before compliance with requirement of trading price of listed securities | Dec. 19, 2022 | ||||||||
Closing bid price of common stock | $ / shares | $ 1 | ||||||||
Consecutive days for complying with Minimum bid requirement | 10 days | ||||||||
Number of additional days for complying with minimum bid requirement | 180 days | ||||||||
VERSION A | 2024 Notes | |||||||||
Segment and Geographic Information | |||||||||
Repurchase principal amount, Percentage | 100% | ||||||||
Subsequent Event | VERSION A | |||||||||
Segment and Geographic Information | |||||||||
Common stock, interest payment | $ 6,200 | ||||||||
Licensing royalties received | $ 16,500 | ||||||||
Common stock, interest payment due date | December 1, 2022 | ||||||||
Stockholders' equity, reverse stock split | 1-for-2 to 1-for-20 | ||||||||
Letters of Credit | |||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||||||
Restricted Cash and Cash Equivalents | $ 300 | $ 300 | |||||||
Chelsea Facility | |||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||||||
Proceeds from sale of facility | $ 74,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 20,696 | $ 45,634 | $ 36,168 | $ 71,369 |
Restricted cash | 13,232 | 13,400 | 13,353 | 12,917 |
Restricted cash non-current | 255 | 6,189 | 12,399 | 18,609 |
Total Cash, cash equivalents and restricted cash per statement of cash flows | $ 34,183 | $ 65,223 | $ 61,920 | $ 102,895 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Major Classes of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,333 | $ 3,338 |
Finished goods | 11,919 | 15,210 |
Total | $ 15,252 | $ 18,548 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||||
Contract Liabilities | $ 6,100,000 | $ 0 | $ 6,100,000 | $ 0 | $ 5,900,000 |
Contract assets | 0 | 0 | 0 | 0 | |
Revenues | $ 33,511,000 | $ 31,456,000 | 87,096,000 | $ 92,104,000 | |
Esteve Pharmaceuticals [Member] | |||||
Disaggregation Of Revenue [Line Items] | |||||
Revenues | $ 2,900,000 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 33,511 | $ 31,456 | $ 87,096 | $ 92,104 |
Ampyra | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 21,110 | 20,026 | 54,192 | 62,035 |
Inbrija U.S. | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 7,848 | 7,804 | 18,957 | 19,240 |
Inbrija ex-U.S. | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 1,006 | 2,874 | ||
Other | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 21 | 22 | ||
Net Product Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 29,964 | 27,851 | 76,023 | 81,297 |
Royalty Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 3,047 | $ 3,605 | 10,573 | $ 10,807 |
License Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 500 | $ 500 |
Share-based Compensation - Addi
Share-based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Share-based compensation expense recognized | $ 364 | $ 854 | $ 1,320 | $ 2,515 |
Weighted average fair value of options granted (in dollars per share) | $ 0.31 | $ 2.56 | $ 0.84 | $ 2.58 |
Unrecognized compensation costs for unvested stock options, restricted stock awards and restricted stock units | $ 800 | $ 800 | ||
Weighted average period | 2 years 8 months 12 days | |||
Purchase of Treasury Stock ,Shares | 0 |
Share-based Compensation - Sche
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 364 | $ 854 | $ 1,320 | $ 2,515 |
Research and development expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | 14 | 225 | 66 | 599 |
Selling, general, and administrative expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | 351 | 627 | 1,254 | 1,898 |
Cost of sales | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ (1) | $ 2 | $ 0 | $ 18 |
Share-based Compensation - Sc_2
Share-based Compensation - Schedule of Stock Options Activity (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Stock Option Activity | |
Beginning balance (in shares) | shares | 1,186 |
Granted (in shares) | shares | 97 |
Cancelled (in shares) | shares | (230) |
Ending balance (in shares) | shares | 1,053 |
Vested and expected to vest at the end of the period | shares | 1,053 |
Vested and exercisable at the end of the period | shares | 713 |
Weighted Average Exercise Price | |
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 94.38 |
Granted (in dollars per share) | $ / shares | 1.19 |
Cancelled (in dollars per share) | $ / shares | 128.93 |
Balance at the end of the period (in dollars per share) | $ / shares | 78.24 |
Vested and expected to vest at the end of the period (in dollars per share) | $ / shares | 78.24 |
Vested and exercisable at the end of the period (in dollars per share) | $ / shares | $ 113.62 |
Weighted Average Remaining Contractual Term | |
Balance at the end of the period | 6 years |
Vested and expected to vest at the end of the period | 6 years |
Vested and exercisable at the end of the period | 4 years 6 months |
Share-based Compensation - Sc_3
Share-based Compensation - Schedule of Restricted Stock and Performance Stock Unit Activity (Details) - Restricted Stock and Performance Stock Unit shares in Thousands | 9 Months Ended |
Sep. 30, 2022 shares | |
Restricted Stock and Performance Stock Units | |
Nonvested at the beginning of the period (in shares) | 116 |
Granted (in shares) | 0 |
Vested (in shares) | (103) |
Forfeited (in shares) | (7) |
Nonvested at the end of the period (in shares) | 6 |
Loss Per Share - Schedule of Co
Loss Per Share - Schedule of Computation of Basic and Diluted Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Basic and diluted | ||||
Net loss—basic | $ (13,854) | $ (27,071) | $ (85,058) | $ (83,387) |
Net income (loss)—diluted | $ (13,854) | $ (27,071) | $ (85,058) | $ (83,387) |
Weighted average common shares outstanding used in computing net loss per share—basic | 24,290 | 11,131 | 18,148 | 10,204 |
Weighted average common shares outstanding used in computing net loss per share—diluted | 24,290 | 11,131 | 18,148 | 10,204 |
Net loss per share—basic | $ (0.57) | $ (2.43) | $ (4.69) | $ (8.17) |
Net loss per share—diluted | $ (0.57) | $ (2.43) | $ (4.69) | $ (8.17) |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Antidilutive Securities Excluded from Calculation of Net Loss Per Diluted Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock options and restricted common shares | ||||
Antidilutive Securities | ||||
Anti-dilutive securities excluded from computation of loss per share (in shares) | 1,134 | 1,370 | 1,089 | 1,368 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | ||||
(Provision for) benefit from income taxes | $ 1,416 | $ (3,105) | $ 28,237 | $ (6,788) |
Effective income tax rate (as a percent) | (11.30%) | 10.20% | (49.69%) | 7.53% |
Change Of Control Ownership Percentage Threshold | 50% | |||
Change Of Control Ownership Measurement Period | 3 years | |||
Valuation allowance on deferred tax assets | $ 25,000 | $ 25,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | 9 Months Ended | |||||||
Sep. 17, 2020 USD ($) shares | Dec. 24, 2019 | Sep. 30, 2022 USD ($) shares | Sep. 30, 2020 USD ($) | Dec. 31, 2021 shares | Sep. 30, 2021 | Aug. 28, 2020 shares | Dec. 31, 2019 shares | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Notes, interest rate | 6% | |||||||
Common stock, Authorized shares | shares | 61,666,666 | 61,666,666 | 61,666,666 | 13,333,333 | 13,333,333 | |||
Derivative liability reclassified to equity | $ 18,300,000 | |||||||
Income tax effects on equity transactions | $ 4,400,000 | |||||||
Inbrija | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Milestone payment, minimum | $ 0 | |||||||
Milestone payment, maximum | $ 18,100,000 | |||||||
Convertible Senior Secured Notes due 2024 | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Debt instrument maturity date | 2024-12 | |||||||
Notes, interest rate | 6% | 6% | ||||||
Notes, maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||||
Fair Value, Inputs, Level 2 | Convertible Senior Secured Notes due 2024 | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Convertible senior notes | $ 157,300,000 | |||||||
Level 3 | Weighted Discounted Cash Flow Valuation Approach | Discount Rate | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Acquired contingent consideration, measurement input | 23 | 20.5 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Liabilities Carried at Fair Value: | ||
Derivative liability | $ 37 | |
Level 1 | Recurring basis | Money Market Funds | ||
Assets Carried at Fair Value: | ||
Assets, Fair Value | $ 2,216 | 12,192 |
Level 3 | Recurring basis | ||
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | $ 37,600 | 49,600 |
Derivative liability | $ 37 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Contingent Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||||
Balance, beginning of period | $ 42,900 | $ 41,200 | $ 49,600 | $ 48,200 |
Fair value change to contingent consideration included in the statement of operations | (4,576) | 2,205 | (10,709) | (4,224) |
Royalty payments | (724) | (405) | (1,291) | (976) |
Balance, end of period | $ 37,600 | $ 43,000 | $ 37,600 | $ 43,000 |
Fair Value Measurements - Sch_3
Fair Value Measurements - Schedule of Fair Value Reconciliation of Derivative Liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value Reconciliation Of Derivative Liability [Line Items] | |||
Balance, beginning of period | $ 37 | ||
Convertible Senior Secured Notes due 2024 | |||
Fair Value Reconciliation Of Derivative Liability [Line Items] | |||
Balance, beginning of period | $ 613 | 37 | $ 1,193 |
Fair value adjustment | (288) | $ (37) | (868) |
Balance, end of period | $ 325 | $ 325 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investments | $ 0 | $ 0 |
Long-term investments | 0 | 0 |
Short-term investments | 0 | 0 |
Short Term Investments | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Cash and cash equivalents | $ 2,200,000 | $ 12,200,000 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties - Additional Information (Details) - Royalty Purchase Agreement - USD ($) $ in Thousands | 9 Months Ended | ||||
Oct. 01, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Liability Related To Sale Of Future Royalties [Line Items] | |||||
Payment from royalties | $ 40,000 | ||||
Royalty liability | 40,000 | ||||
Net of transaction costs | $ 2,200 | $ 33 | $ 193 | ||
Liability related to sale of future royalties - ending balance | $ 0 | $ 7,452 | $ 4,460 | $ 15,257 |
Liability Related to Sale of _4
Liability Related to Sale of Future Royalties - Schedule of Activity Within Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Oct. 01, 2017 | Sep. 30, 2022 | Sep. 30, 2021 | |
Liability Related To Sale Of Future Royalties [Line Items] | |||
Non-cash royalty revenue payable to HCRP | $ (4,762) | $ (8,889) | |
Royalty Purchase Agreement | |||
Liability Related To Sale Of Future Royalties [Line Items] | |||
Liability related to sale of future royalties - beginning balance | 4,460 | 15,257 | |
Deferred transaction costs amortized | $ 2,200 | 33 | 193 |
Non-cash royalty revenue payable to HCRP | (4,739) | (8,889) | |
Non-cash interest expense recognized | 246 | 891 | |
Liability related to sale of future royalties - ending balance | $ 0 | $ 7,452 |
Debt - Additional Information (
Debt - Additional Information (Details) $ / shares in Units, € in Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
Sep. 17, 2020 USD ($) shares | Dec. 24, 2019 USD ($) TradingDay | Sep. 30, 2022 USD ($) $ / shares shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) Loan $ / shares shares | Sep. 30, 2021 USD ($) | Sep. 30, 2020 USD ($) | Dec. 31, 2019 USD ($) shares | Sep. 30, 2022 EUR (€) shares | Jul. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) shares | Aug. 28, 2020 shares | Jun. 17, 2014 USD ($) | |
Debt Instrument [Line Items] | |||||||||||||
Interest rate (as a percent) | 6% | ||||||||||||
Cash payment made for exchange of notes | $ 200 | ||||||||||||
Aggregate payment on debt exchange | 55,200,000 | $ 69,000,000 | |||||||||||
Gain on debt extinguishment | $ 55,100,000 | ||||||||||||
Adjusted equity component of convertible notes exchange | $ 38,400,000 | ||||||||||||
Common stock, Authorized shares | shares | 61,666,666 | 61,666,666 | 61,666,666 | 13,333,333 | 61,666,666 | 61,666,666 | 13,333,333 | ||||||
Derivative liability reclassified to equity | $ 18,300,000 | ||||||||||||
Income tax effects on equity transactions | $ 4,400,000 | ||||||||||||
Interest expense | $ 7,465,000 | $ 7,167,000 | $ 22,501,000 | $ 22,697,000 | |||||||||
Non Convertible Debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal | 24,900,000 | 24,900,000 | |||||||||||
Fair value of debt | 20,500,000 | $ 20,500,000 | € 18.2 | ||||||||||
Number Of Loans | Loan | 14 | ||||||||||||
Non Convertible Debt | Finland S Ministry Of Finance Rate | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Residual payment amount | $ 50,000,000 | ||||||||||||
Non Convertible Debt | Finland S Ministry Of Finance Rate | Biotie | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Cash | 14,500,000 | $ 14,500,000 | |||||||||||
Convertible Senior Notes due 2021 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Principal amount of debt exchanged | $ 276,000,000 | ||||||||||||
Interest rate (as a percent) | 1.75% | 1.75% | |||||||||||
Principal amount denomination for debt conversion | $ 1,000 | ||||||||||||
Principal | $ 345,000,000 | ||||||||||||
Debt instrument, principal amount outstanding | $ 69,000,000 | 69,000,000 | 69,000,000 | ||||||||||
Debt issuance costs | $ 7,500,000 | 7,500,000 | |||||||||||
Reclassification of derivative liability to equity, net of tax | 1,300,000 | ||||||||||||
Debt issuance costs allocated to liability component | 6,200,000 | ||||||||||||
Debt issuance cost associated with exchange, written off | $ 1,200,000 | ||||||||||||
Convertible Senior Secured Notes due 2024 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest rate (as a percent) | 6% | 6% | 6% | 6% | |||||||||
Principal amount of debt issued for exchange | $ 750 | ||||||||||||
Principal | $ 207,000,000 | ||||||||||||
Debt instrument, principal amount outstanding | $ 207,000,000 | $ 207,000,000 | $ 207,000,000 | ||||||||||
Notes maturity date | Dec. 01, 2024 | Dec. 01, 2024 | |||||||||||
Interest payment in shares, percentage of daily volume-weighted average price | 95% | ||||||||||||
Notes frequency of periodic payment | semi-annually in arrears | ||||||||||||
Interest in shares of common stock, threshold trading days | TradingDay | 10 | ||||||||||||
Initial conversion rate of common stock | 47.6190 | ||||||||||||
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares | $ 21 | $ 21 | |||||||||||
Principal amount of Notes or an integral multiple thereof in which holder may repurchase the Notes | $ 1,000 | $ 1,000 | |||||||||||
Stockholders' equity, reverse stock split | 1-for-6 | ||||||||||||
Debt instrument conversion threshold stock price percentage | 130% | ||||||||||||
Repurchase principal amount, Percentage | 100% | ||||||||||||
Debt default, non payment of interest, period | 30 days | ||||||||||||
Debt default, failure to convert notes, period | 5 days | ||||||||||||
Debt default, non-compliance with covenants, period | 60 days | ||||||||||||
Fair value of derivative liability | $ 59,400,000 | $ 37,000 | |||||||||||
Debt discount | $ 75,100,000 | ||||||||||||
Interest expense | 7,200,000 | $ 21,100,000 | |||||||||||
Effective interest rate on liability component (as a percent) | 18.13% | ||||||||||||
Debt fair value amount | 157,300,000 | 157,300,000 | |||||||||||
Debt issuance costs | $ 5,700,000 | $ 5,700,000 | |||||||||||
Convertible Senior Secured Notes due 2024 | Minimum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt default, non-payment of outstanding principal | $ 30,000,000 | ||||||||||||
Debt default, failure to pay final judgements | $ 30,000,000 | ||||||||||||
Debt default, percentage of principal outstanding required for immediate payment | 25% |
Debt - Summary of Outstanding N
Debt - Summary of Outstanding Note Balances (Details) - Convertible Senior Secured Notes due 2024 - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 24, 2019 |
Debt Instrument [Line Items] | |||
Principal | $ 207,000 | $ 207,000 | |
Less: debt discount and debt issuance costs, net | (44,240) | (55,975) | |
Net carrying amount | 162,760 | 151,025 | |
Equity component | $ 18,257 | 18,257 | |
Derivative liability-conversion option | $ 37 | $ 59,400 |
Debt - Schedule of Interest Exp
Debt - Schedule of Interest Expense Recognized Related to the Notes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Debt Instrument [Line Items] | ||||
Total interest expense | $ 7,465 | $ 7,167 | $ 22,501 | $ 22,697 |
Convertible Senior Secured Notes due December 2024 | ||||
Debt Instrument [Line Items] | ||||
Contractual interest expense | 3,105 | 3,105 | 9,315 | 9,315 |
Amortization of debt issuance costs | 291 | 243 | 834 | 698 |
Amortization of debt discount | 3,797 | 3,179 | 10,902 | 9,130 |
Total interest expense | $ 7,193 | $ 6,527 | $ 21,051 | 19,143 |
Convertible Senior Notes due September 2021 | ||||
Debt Instrument [Line Items] | ||||
Contractual interest expense | 428 | |||
Amortization of debt issuance costs | 95 | |||
Amortization of debt discount | 934 | |||
Total interest expense | $ 1,457 |
Leases - Additional Information
Leases - Additional Information (Details) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Jun. 30, 2022 ft² | Dec. 31, 2018 ft² | Oct. 31, 2016 USD ($) ft² | |
Operating Lease Information | |||||
Operating lease description | Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 4.25 years to 5.75 years. The Company has exercised the option to terminate the Ardsley lease with a termination date of June 22, 2022. | ||||
Operating lease renewal option | true | ||||
Operating lease termination option | true | ||||
Operating lease termination date | Jun. 22, 2022 | ||||
Operating lease weighted-average remaining lease term | 4 years 7 months 6 days | ||||
Operating lease weighted-average discount rate | 7.89% | ||||
Ardsley, New York | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 160,000 | ||||
Termination option effective date | Jun. 22, 2022 | ||||
Termination Fee | $ 4,700,000 | ||||
Pearl River, New York | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 21,000 | ||||
Lease term | 6 years | ||||
Operating sublease, existence of option to extend | false | ||||
Base rent | $ 0 | ||||
Base rent payment commencing on January 1, 2023 | $ 300,000 | ||||
Base rent subject to annual escalation percentage | 2% | ||||
Chelsea, Massachusetts | Manufacturing Facility | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 95,000 | ||||
Contribution Of Fund Agreed | $ 1,500,000 | ||||
Waltham, MA | Office and Laboratory Space | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 26,000 | ||||
Lease term | 10 years | ||||
Base rent | $ 1,200,000 | ||||
Minimum | |||||
Operating Lease Information | |||||
Operating lease remaining lease term | 4 years 3 months | ||||
Maximum [Member] | |||||
Operating Lease Information | |||||
Operating lease remaining lease term | 5 years 9 months |
Leases - Schedule of ROU Assets
Leases - Schedule of ROU Assets and Lease Liabilities Related to Operating Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Right-of-use assets | $ 5,541 | $ 6,751 |
Current lease liabilities | 1,454 | 8,186 |
Non-current lease liabilities | $ 4,612 | $ 4,086 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases [Abstract] | ||||
Operating lease cost | $ 431 | $ 1,600 | $ 3,390 | $ 4,593 |
Variable lease cost | 132 | 948 | 1,960 | 3,283 |
Short-term lease cost | 1 | 339 | 7 | 829 |
Total lease cost | $ 564 | $ 2,887 | $ 5,357 | $ 8,705 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Leases [Abstract] | |
2022 (excluding the three months ended September 30, 2022) | $ 295 |
2023 | 1,546 |
2024 | 1,588 |
2025 | 1,633 |
2026 | 1,678 |
Later years | 539 |
Total lease payments | 7,279 |
Less: Imputed interest | (1,213) |
Present value of lease liabilities | $ 6,066 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating cash flow information: | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 295 | $ 4,605 |
Disposal of Assets - Additional
Disposal of Assets - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Feb. 10, 2021 | Jan. 12, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | |
Long Lived Assets Held For Sale [Line Items] | ||||
Estimated fair value of assets held for sale | $ 71.8 | |||
Carrying value of the assets held for sale | 129.7 | |||
Proceeds from completion of divestiture | 74 | |||
Prepaid Expenses | ||||
Long Lived Assets Held For Sale [Line Items] | ||||
Carrying value of the assets held for sale | 0.1 | |||
Property and Equipment | ||||
Long Lived Assets Held For Sale [Line Items] | ||||
Carrying value of the assets held for sale | 129.6 | |||
Manufacturing Facility | ||||
Long Lived Assets Held For Sale [Line Items] | ||||
Loss on assets held for sale | $ 57.9 | |||
Catalent | Chelsea, Massachusetts | ||||
Long Lived Assets Held For Sale [Line Items] | ||||
Purchase price of assets related to manufacturing activities | $ 80 | |||
Additional raw materials purchase price | $ 2.3 | |||
Catalent | Leases | ||||
Long Lived Assets Held For Sale [Line Items] | ||||
Carrying value of the assets held for sale | $ (0.5) | |||
Loss on assets held for sale | $ 0.5 |
Corporate Restructuring - Addit
Corporate Restructuring - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Jan. 31, 2021 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | |
Restructuring And Related Activities [Abstract] | |||||
Approximate percentage of headcount reduction | 16% | 15% | |||
Restructuring Charges For Severance And Other Employee Separation Related Cost | $ 25 | $ 226 | $ 300 |
Corporate Restructuring - Summa
Corporate Restructuring - Summary of Restructuring Charges (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2022 | |
Restructuring And Related Activities [Abstract] | ||||
Restructuring Liability | $ 257 | $ 377 | $ 1,851 | $ 1,851 |
Restructuring Charges For Severance And Other Employee Separation Related Cost | 25 | 226 | 300 | |
Restructuring Payments | (257) | (145) | (1,700) | |
Restructuring Liability | $ 0 | $ 257 | $ 377 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Jun. 28, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Loss Contingencies [Line Items] | |||||||
Commitments and contingencies | |||||||
Cost of sales | 11,005,000 | $ 13,303,000 | 25,772,000 | $ 36,589,000 | |||
Inventory, net | 15,252,000 | 15,252,000 | $ 18,548,000 | ||||
Catalent | |||||||
Loss Contingencies [Line Items] | |||||||
Cost of sales | 3,800,000 | ||||||
Inventory, net | 3,900,000 | 3,900,000 | |||||
Minimum purchase commitment | 7,700,000 | ||||||
Purchase Commitment, Remaining Minimum Amount Committed | 4,500,000 | 4,500,000 | |||||
Purchase Commitment Remaining Minimum Amount Committed There After | 18,000,000 | 18,000,000 | |||||
Licensing Agreements | |||||||
Loss Contingencies [Line Items] | |||||||
Commitments and contingencies | $ 2,000,000 | ||||||
Unpaid license royalties | 6,000,000 | $ 6,000,000 | |||||
Payments for legal settlements | $ 750,000 | 750,000 | |||||
Gain related to litigation settlement | $ 1,300,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Nov. 11, 2022 | Oct. 21, 2022 | Oct. 16, 2022 | Jun. 22, 2022 |
VERSION A | ||||
Subsequent Event [Line Items] | ||||
Trading price of common stock | $ 1 | |||
Consecutive days for complying with trading price of listed securities | 30 days | |||
Number of additional days for complying with requirement of trading price of listed securities | 180 days | |||
Cut off date on or before compliance with requirement of trading price of listed securities | Dec. 19, 2022 | |||
Closing bid price of common stock | $ 1 | |||
Consecutive days for complying with Minimum bid requirement | 10 days | |||
Number of additional days for complying with minimum bid requirement | 180 days | |||
VERSION A | 2024 Notes | ||||
Subsequent Event [Line Items] | ||||
Repurchase principal amount, Percentage | 100% | |||
Subsequent Event | VERSION A | ||||
Subsequent Event [Line Items] | ||||
Stockholders' equity, reverse stock split | 1-for-2 to 1-for-20 | |||
Alkermes | ||||
Subsequent Event [Line Items] | ||||
Licensing royalties, Awarded amount | $ 15 | |||
Licensing royalties, prejudgment interest | $ 1.5 | |||
Licensing royalties, Additional awarded amount | $ 1.6 |