Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 27, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Entity Registrant Name | ACORDA THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001008848 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2023 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Public Float | $ 16,055,406 | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Common Stock, Shares Outstanding | 1,242,098 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
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, 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 | ||
Auditor Firm ID | 42 | ||
Auditor Name | Ernst & Young, LLP | ||
Auditor Location | Stamford, Connecticut | ||
Title of each class | Common Stock $0.001 par value per share | ||
Trading Symbol | ACOR | ||
Name of each exchange on which registered | NASDAQ | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE The information required by Part III of Form 10-K is incorporated herein by reference to the definitive proxy statement for the registrant’s 2024 annual meeting of stockholders, or alternatively included in an amendment to this Form 10-K, which the registrant expects to file within 120 days of the registrant’s fiscal year ended December 31, 2023. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 29,979 | $ 37,536 |
Restricted cash | 381 | 6,884 |
Trade accounts receivable, net of allowances of $962 and $842, as of December 31, 2023 and 2022, respectively | 17,298 | 13,866 |
Prepaid expenses | 5,211 | 4,312 |
Inventory, net | 16,155 | 12,752 |
Other current assets | 5,770 | 6,765 |
Total current assets | 74,794 | 82,115 |
Property and equipment, net of accumulated depreciation | 2,079 | 2,603 |
Intangible assets, net of accumulated amortization and impairment | 22,987 | 305,087 |
Right of use asset, net of accumulated amortization | 4,221 | 5,287 |
Restricted cash | 255 | 255 |
Other assets | 4,189 | 248 |
Total assets | 108,525 | 395,595 |
Current liabilities: | ||
Accounts payable | 13,373 | 9,809 |
Accrued expenses and other current liabilities | 24,310 | 23,680 |
Convertible senior notes | 186,143 | 0 |
Current portion of lease liability | 1,588 | 1,545 |
Current portion of acquired contingent consideration | 2,132 | 2,532 |
Deferred revenue | 227 | 384 |
Total current liabilities | 227,773 | 37,950 |
Convertible senior notes | 0 | 167,031 |
Non-current portion of acquired contingent consideration | 27,368 | 38,668 |
Deferred tax liability | 0 | 44,202 |
Non-current portion of lease liability | 3,166 | 4,341 |
Other non-current liabilities | 8,174 | 9,781 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share. Authorized 1,000,000 shares at December 31, 2023 and 2022; no shares issued as of December 31, 2023 and 2022 | ||
Common stock, $0.001 par value per share. Authorized 3,083,333 shares at December 31, 2023 and 2022; issued 1,242,376 and 1,242,376 shares, including those held in treasury, as of December 31, 2023 and 2022, respectively | 1 | 24 |
Treasury stock at cost (278 shares at December 31, 2023 and December 31, 2022) | (638) | (638) |
Additional paid-in capital | 1,030,383 | 1,029,881 |
Accumulated deficit | (1,189,127) | (936,273) |
Accumulated other comprehensive loss | 1,425 | 628 |
Total stockholders' equity (deficit) | (157,956) | 93,622 |
Total liabilities and stockholders’ equity | $ 108,525 | $ 395,595 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | |||
Trade accounts receivable, allowances (in dollars) | $ 962 | $ 842 | |
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 | 3,083,333 | 3,083,333 | |
Common stock, issued shares | 1,242,376 | 1,242,376 | |
Treasury stock, shares | 278 | 278 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues: | ||
Total net revenues | $ 117,633 | $ 118,566 |
Costs and expenses: | ||
Cost of sales | 15,283 | 30,332 |
Research and development | 5,152 | 5,804 |
Selling, general and administrative | 89,698 | 106,256 |
Intangible asset impairment | 251,322 | |
Amortization of intangible assets | 30,764 | 30,764 |
Changes in fair value of derivative liability | (37) | |
Changes in fair value of acquired contingent consideration | (9,634) | (6,659) |
Other operating income | (12,554) | |
Total operating expenses | 382,585 | 153,906 |
Operating loss | (264,952) | (35,340) |
Other income (expense), net: | ||
Interest and amortization of debt discount expense | (31,533) | (30,200) |
Interest income | 530 | 1,909 |
Realized Gain (Loss) on FX Currency | (288) | (8) |
Gain on extinguishment of debt | 27,142 | |
Gain on disposal of property and equipment | 171 | |
Other income (expense) | 51 | 1,250 |
Total other income (expense), net | (31,069) | 93 |
Loss before taxes | (296,021) | (35,247) |
Benefit from (Provision for) income taxes | 43,167 | (30,669) |
Net loss | $ (252,854) | $ (65,916) |
Net loss per share—basic | $ (203.57) | $ (65.23) |
Net loss per share—diluted | $ (203.57) | $ (65.23) |
Weighted average common shares outstanding used in computing net loss per share—basic | 1,242 | 1,011 |
Weighted average common shares outstanding used in computing net loss per share—diluted | 1,242 | 1,011 |
Net Product Revenues | ||
Revenues: | ||
Total net revenues | $ 102,421 | $ 103,845 |
Royalty Revenues | ||
Revenues: | ||
Total net revenues | 15,113 | 14,221 |
License Revenue | ||
Revenues: | ||
Total net revenues | $ 99 | $ 500 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net Income (Loss) | $ (252,854) | $ (65,916) |
Other comprehensive income: | ||
Foreign currency translation adjustment | 797 | 1,645 |
Other comprehensive income, net of tax | 797 | 1,645 |
Comprehensive loss | $ (252,057) | $ (64,271) |
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 income (loss) |
Balance at Dec. 31, 2021 | $ 151,137 | $ 13 | $ (638) | $ 1,023,136 | $ (870,357) | $ (1,017) |
Balance (in shares) at Dec. 31, 2021 | 687 | |||||
Compensation expense for issuance of stock options to employees | 1,496 | 1,496 | ||||
Compensation expense and issuance of restricted stock to employees | (3) | (3) | ||||
Compensation expense and issuance of restricted stock to employees (in shares) | 5 | |||||
Interest payment for convertible notes | 5,263 | $ 11 | 5,252 | |||
Interest payment for convertible notes (in shares) | 550 | |||||
Other comprehensive income, net of tax | 1,645 | 1,645 | ||||
Net Income (Loss) | (65,916) | (65,916) | ||||
Balance at Dec. 31, 2022 | 93,622 | $ 24 | (638) | 1,029,881 | (936,273) | 628 |
Balance (in shares) at Dec. 31, 2022 | 1,242 | |||||
Compensation expense for issuance of stock options to employees | 479 | 479 | ||||
Reverse stock split adjustment | $ (23) | 23 | ||||
Other comprehensive income, net of tax | 797 | 797 | ||||
Net Income (Loss) | (252,854) | (252,854) | ||||
Balance at Dec. 31, 2023 | $ 157,956 | $ 1 | $ (638) | $ 1,030,383 | $ (1,189,127) | $ 1,425 |
Balance (in shares) at Dec. 31, 2023 | 1,242 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (252,854) | $ (65,916) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 478 | 1,493 |
Amortization of debt discount and debt issuance costs | 19,112 | 16,923 |
Depreciation and amortization expense | 31,666 | 32,809 |
Intangible asset impairment | 251,322 | |
Change in contingent consideration obligation | (9,634) | (6,659) |
Change in derivative liability | (37) | |
Non-cash lease expense | (66) | |
Gain on debt extinguishment | (27,142) | |
Non-cash royalty revenue | (4,762) | |
Deferred tax provision (benefit) | (43,177) | 30,669 |
Changes in assets and liabilities: | ||
Decrease (increase) in accounts receivable | (3,432) | 2,585 |
Increase in prepaid expenses and other current assets | (4) | (2,959) |
Decrease (increase) in inventory | (3,403) | 5,796 |
Increase in other assets | (3,965) | (237) |
Increase (decrease) in accounts payable, accrued expenses and other current liabilities | 884 | (7,359) |
Increase (decrease) in other non-current liabilities | (911) | 3,872 |
Net cash (used) in operating activities | (13,984) | (20,924) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (264) | (136) |
Net cash provided by investing activities | (264) | (136) |
Cash flows from financing activities: | ||
Net cash (used) in financing activities | 0 | 0 |
Effect of exchange rate changes on cash and cash equivalents and restricted cash | 188 | 512 |
Net (decrease) in cash and cash equivalents and restricted cash | (14,060) | (20,548) |
Cash, cash equivalents and restricted cash at beginning of period | 44,675 | 65,223 |
Cash, cash equivalents and restricted cash at end of period | 30,615 | 44,675 |
Supplemental disclosure: | ||
Cash paid for interest | 12,420 | 7,157 |
Cash paid for taxes | $ 804 | $ 199 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (252,854) | $ (65,916) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2023 | |
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. Voluntary Filing Under Chapter 11 Over the past several months, the Company, with the assistance of outside legal and financial advisors, have been engaged in a robust process to explore strategic alternatives and maximize value for the Company’s stakeholders in light of the upcoming maturity of its 6.00 % convertible senior secured notes that mature on December 1, 2024 (“2024 Notes”). During this process, the Company was, and continues to be, in regular communication with the holders of its 2024 Notes and their advisors. The Company evaluated every aspect of its business and has taken proactive steps to respond to the challenges the Company continues to face. Notwithstanding these measures, the Company engaged in an exhaustive process to find an appropriate strategic solution. The Company’s Board of Directors, after reviewing a number of alternatives, has determined that it is in the best interests of the Company and its stakeholders to pursue a sale of assets under Chapter 11 of the United States Bankruptcy Code (the “Code”), which the Company believes will ensure the Company obtains the maximum value for the Company and most importantly, that the Company’s products will be provided on an uninterrupted basis to patients who will continue to benefit from these much needed medications. The Company intends to commence voluntary proceedings under Chapter 11 in the United States Bankruptcy Court for the Southern District of New York (the “Court”) shortly after filing this Annual Report (the “Intended Chapter 11 Proceedings”). The Company expects to continue to operate its business as a “debtor in possession” in accordance with the applicable provisions of the Code and orders of the Court. The Company expects to request approval from the Court for certain customary “first day” motions to continue its ordinary course operations after the filing date of the Intended Chapter 11 Proceedings. Shortly following the commencement of the Intended Chapter 11 Proceedings, the Company expects to receive written notice from the staff of the Nasdaq Global Select Market (“Nasdaq”) notifying it that, as a result of the Chapter 11 filing, and in accordance with Nasdaq Listing Rules, the Company’s common stock will be delisted from the Nasdaq. In such event, the Company expects that its common stock would commence trading on the Pink Open Market (commonly referred to as the “pink sheets”). Asset Purchase Agreement Prior to the commencement of the Intended Chapter 11 Proceedings, on March 31, 2024 the Company entered into a “stalking horse” Asset Purchase Agreement (the “Asset Purchase Agreement”) with Merz Pharmaceuticals, LLC, a North Carolina limited liability company (the “Purchaser”), and, solely with respect to the guarantee of purchaser’s obligations thereunder, Merz Pharma GmbH & Co. KGaA, a German partnership (the “Purchaser Parent”). The Asset Purchase Agreement provides for the sale of substantially all of the Company’s assets (the “Purchased Assets”) to the Purchaser for $ 185.0 million, subject to certain adjustments as specified in the Asset Purchase Agreement. The Asset Purchase Agreement is subject to Court approval and compliance with agreed-upon bidding procedures under Section 363 of the Code (“Section 363”) allowing for the submission of higher or otherwise better offers and satisfaction of other agreed-upon conditions. In accordance with the sale process under Section 363, notice of the proposed sale to the Purchaser will be given to third parties and competing bids will be solicited over a specified period of time. The Company will manage the bidding process and evaluate the bids, in consultation with the Company’s advisors and as overseen by the Court. The Company cannot provide any assurance that the Company will be able to successfully complete a sale of the Purchased Assets or that it will be able to continue to fund the Company’s operations throughout the Intended Chapter 11 Proceedings. Restructuring Support Agreement Prior to the commencement of the Intended Chapter 11 Proceedings, on April 1, 2024 the Company entered into a Restructuring Support Agreement with the holders of a majority of its 2024 Notes (the “RSA Noteholders” and such agreement, the “Restructuring Support Agreement”). As contemplated in the Restructuring Support Agreement, the Company will seek to sell substantially all of its assets in a sale pursuant to Section 363. The Restructuring Support Agreement sets out certain milestones and conditions relating to the Section 363 sale process, subject to the terms and conditions contained therein. DIP Credit Agreement In order to fund the continued operations of the Company during the pendency of the Intended Chapter 11 Proceedings, the Company and certain of the RSA Noteholders agreed to the terms of a form of Debtor-in-Possession Credit Agreement (the “DIP Credit Agreement”) to be entered into by and among the Company, as borrower, and the lenders from time to time party thereto (collectively, the “DIP Lenders”, GLAS USA LLC, as administrative agent (the “DIP Administrative Agent”), and GLAS Americas, LLC, collateral agent (collectively, with the DIP Administrative Agent, the “DIP Agent”), pursuant to which the DIP Lenders would provide the Company with a senior secured, superpriority debtor-in-possession term loan facility in the maximum aggregate amount of $ 60.0 million (the “DIP Credit Facility,” and the commitments of the DIP Lenders thereunder, the “DIP Commitments” and, the loans thereunder, the “DIP Loans”), which, subject to the satisfaction of certain conditions precedent to drawing as set forth in the DIP Credit Agreement, including the approval of the Court, will be made available to the Company in multiple drawings as follows: (i) up to $ 10.0 million (“Interim DIP Loan Commitment”) will be made available for drawing upon entry by the Court of an interim order authorizing and approving the DIP Credit Facility on an interim basis (the “Interim DIP Order”), 00 (ii) up to $ 10.0 million (“Final DIP Loan Commitments”) will be made available for drawing upon entry of the Court of a final order authorizing and approving the DIP Credit Facility on a final basis (the “Final DIP Order” and together with the Interim DIP Order, the “DIP Orders”), and (iii) upon subject to entry of the Final Order, a roll-up facility in the aggregate maximum principal amount of $ 40.0 million, representing a roll-up of obligations under the 2024 Notes on a two dollars to one dollar basis of the DIP Commitments under the DIP Facility made by the RSA Noteholders. See Financing Arrangements in Part II, Item 7 of this Annual Report for more information. The management of the Company is responsible for the accompanying audited consolidated financial statements and the related information included in the notes to the consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (U.S.) and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Basis of Presentation On June 2, 2023, the Company filed an Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-20 reverse stock split and a proportionate reduction in the number of authorized shares from 61,666,666 to 3,083,333 . The Company’s common stock began trading on a split-adjusted basis on the Nasdaq Global Select Market on June 5, 2023. The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. All figures in this report relating to shares of the Company’s common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the reverse stock split. Use of Estimates The preparation of the consolidated financial statements requires management to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share‑based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities, measurement of changes in the fair value of acquired contingent consideration which is based on a probability weighted discounted cash flow valuation methodology, estimated deductions to determine net revenue such as allowances for customer credits, including estimated discounts, rebates, and chargebacks, which are estimated based on available information that will be adjusted to reflect known changes in the factors that impact such allowances, estimates of derivative liability associated with the exchange of the convertible senior secured notes due 2024, which is marked to market each quarter based on a binomial model, estimates of reserves for obsolete and excess inventory, and estimates of unrecognized tax benefits and valuation allowances on deferred tax assets w hich are based on an assessment of recoverability of the deferred tax assets against future taxable income. Actual results could differ from those estimates. Risks and Uncertainties The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, and protection of intellectual property rights. Cash and Cash Equivalents The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund which is unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. The Company maintains cash balances in excess of insured limits. Restricted Cash At December 31, 2023, the Company had $ 0.7 million of restricted cash, of which $ 0.3 consisted of collateralized standby letters of credit in connection with obligations under facility leases and $ 0.4 m illion held in a bank account with funds to cover the Company's self-funded employee health insurance.l See Note 7 to the Company’s Consolidated Financial Statements included in this report for a discussion of interest payments on the outstanding convertible senior secured notes due 2024. 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: December 31, 2023 December 31, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 29,979 $ 45,634 $ 37,536 Restricted cash 6,884 381 13,400 6,884 Restricted cash-non current 255 255 6,189 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 44,675 $ 30,615 $ 65,223 $ 44,675 Other Comprehensive Income (Loss) The Company’s other comprehensive income (loss) consisted of adjustments for foreign currency translation and is recorded and presented net of income tax. There was no income tax allocated to the foreign currency translation adjustment in Other Comprehensive Income (Loss) for the period ended December 31, 2023 and 2022. The cumulative foreign currency translation adjustment reported in Other Comprehensive Income (Loss) was $ 0.8 million and $ 1.6 million for the period ended December 31, 2023 and 2022, respectively. Inventory Inventory is stated at the lower of cost or net realizable value. The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company establishes reserves as necessary for obsolescence and excess inventory. The Company records a reserve for excess and obsolete inventory based on the expected future product sales volumes and the projected expiration of inventory and specifically identified obsolete inventory. Production costs related to idle capacity are not included in the cost of inventory but are charged directly to cost of sales in the period incurred. The following table provides the major classes of inventory: (In thousands) December 31, 2023 December 31, 2022 Raw materials $ 4,178 $ 6,212 Work-in-progress $ 2,491 $ — Finished goods 9,486 6,540 Total $ 16,155 $ 12,752 Ampyra Prior to October 2022, the cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) was based on agreed upon pricing with Alkermes. In the event Alkermes did not manufacture the products, Alkermes was entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances. No payments were made for the years ended December 31, 2023 and 2022. In October 2022, an arbitration panel issued a decision in our dispute with Alkermes and ruled that the existing license and supply agreements with Alkermes are unenforceable. As a result of the panel’s ruling, the Company no longer pays Alkermes any royalties on net sales for license and supply of Ampyra, and the Company is using an alternative source for supply of Ampyra. On September 30, 2010, the Company entered into a world-wide manufacturing services agreement with Patheon, Inc. as a second manufacturer for Ampyra (Dalfampridine-ER tablets, 10mg). Under the manufacturing services agreement, the Company agreed to purchase from Patheon, on a non-exclusive basis, a portion of our requirements for Ampyra in the United States. The Company pays Patheon a fixed per bottle fee (60 tablets per bottle) based on the annual quantity of Ampyra bottles that are delivered for sale. Patheon is currently the Company's sole manufacturer and packager of Ampyra for sales in the United States. The manufacturing services agreement is automatically renewed for successive one-year periods on December 31 of each year, unless either the Company or Patheon provide the other party with at least 12-months’ prior written notice of non-renewal. Either party may terminate manufacturing services agreement by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. The Company may also terminate the manufacturing services agreement upon certain regulatory actions or objections. Patheon may terminate the manufacturing services agreement if the Company assigns the agreement to a third party under certain circumstances. The manufacturing services agreement contains customary representations, warranties and covenants, including with respect to the ownership of any intellectual property created pursuant to the manufacturing services agreement, as well as provisions relating to ordering, payment and shipping terms, regulatory matters, reporting obligations, indemnity, confidentiality and other matters. The Company relies on a single third-party manufacturer to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra, and also on a single supplier for a critical excipient used in the manufacture of Ampyra. If these companies experience any disruption in their operations, the Company's supply of Ampyra could be delayed or interrupted until the problem is solved or the Company locates another source of supply or another packager, which may not be available. The Company may not be able to enter into alternative supply or packaging arrangements on terms that are commercially reasonable, if at all. Any new supplier or packager would also be required to qualify under applicable regulatory requirements. Because of these and other factors, the Company could experience substantial delays before they are able to obtain qualified replacement products or services from any new supplier or packager. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation, except for assets acquired in a business combination, which are recorded at fair value as of the acquisition date. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which ranges from one to seven years . Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on a straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred. Finite-Lived Intangible Assets The Company has finite lived intangible assets that are amortized on a straight-line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss in the statement of operations if the carrying value of the intangible asset exceeds its fair value. Fair value is generally estimated based on either appraised value or other valuation techniques. Events that could result in an impairment, or trigger an interim impairment assessment, may include actions by regulatory authorities with respect to the Company or its competitors, new or better products entering the market, changes in market share or market pricing, changes in the economic lives of the assets, changes in the legal framework covering patents, rights or licenses, and other market changes which could have a negative effect on cash flows and which could result in an impairment. Contingent Consideration The Company may record contingent consideration as part of the cost of business acquisitions. Contingent consideration is recognized at fair value as of the date of acquisition and recorded as a liability on the consolidated balance sheet. The contingent consideration is re-valued on a quarterly basis using a probability weighted discounted cash-flow approach until fulfillment or expiration of the contingency. Changes in the fair value of the contingent consideration are recognized in the statement of operations. Due to the Company's Asset Purchase and License agreement between Civitas, the Company's wholly owned subsidiary, and Alkermes in December 2010, the Company has recognized contingent consideration. See Note 13 to the Company’s Consolidated Financial Statements included in this report for a discussion on the Alkermes ARCUS agreement. Refer to Note 12 – Fair Value Measurements for more information about the contingent consideration liability. 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 commencement of the Intended Chapter 11 Proceedings was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the year ended December 31, 2023. The Company performed a recoverability test as of December 31, 2023 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 were less than the carrying value and the long-lived assets were impaired. The Company recognized an impairment charge of $ 251.3 million for the year ended December 31, 2023 in the Statement of Operations. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent red uctions in the carrying amount of the assets. Non-Cash Interest Expense on Liability Related to Sale of Future Royalties As of October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners, or HCRP (“Royalty Agreement”). In exchange for the payment of $ 40 million to the Company, HCRP obtained the right to receive Fampyra royalties payable by Biogen under the Collaboration and Licensing Agreement between the Company and Biogen (the “Biogen Collaboration Agreement”), up to an agreed upon threshold of royalties. This threshold was met during the second quarter of 2022 and its obligations to HCRP expired upon Biogen's payment of royalties for that quarter. As a result, the full benefit of the Fampyra royalty revenue reverted back to the Company and the Company will continue to receive the Fampyra royalty revenue from Biogen until the revenue stream ends. As of December 31, 2023 the liability related to the sale of future royalties is zero . Prior to satisfying its obligation to HCRP, since the Company maintained rights under the Biogen Collaboration Agreement, the Royalty Agreement has been accounted for as a liability that was amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. In order to determine the amortization of the liability, the Company estimated the total amount of future net royalty payments made to HCRP over the term of the agreement up to the agreed upon threshold of royalties. The total threshold of net royalties to be paid, less the net proceeds received was recorded as interest expense over the life of the liability. The Company imputes interest on the unamortized portion of the liability using the effective interest method and records interest expense based on the timing of the payments received over the term of the Royalty Agreement. The Company’s estimate of the interest rate under the arrangement is based on forecasted net royalty payments expected to be made to HCRP over the life of the Royalty Agreement. The Company estimated an effective annual interest rate of approximately 15 %. Over the course of the Royalty Agreement, the actual interest rate was affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company reassessed the effective interest rate and adjusted the rate prospectively as required. Non-cash royalty revenue is reflected as royalty revenue and non-cash interest expense is reflected as interest and amortization of debt discount expense in the Statement of Operations. Patent Costs Patent application and maintenance costs are expensed as incurred. Research and Development Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses. In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. Because of its limited financial resources, the Company previously suspended work on proprietary research and development programs, and has performed feasibility studies for potential collaborations with other companies that express interest in formulating their novel molecules for pulmonary delivery using the Company’s proprietary ARCUS technology. Accounting for Income Taxes The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized. In determining whether a tax position is recognized for financial statement purposes, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. Revenue Recognition ASC 606 outlines a five-step process for recognizing revenue from contracts with customers: i) identify the contract with the customer, ii) identify the performance obligations in the contract, (iii) determine the transaction price, iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon receipt of the product by the customer. 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 December 31, 2023, the Company had contract liabilities of $ 8.1 million, which are the upfront payments received as part of the Esteve Germany distribution agreement entered into in 2021 and the Chance China distribution agreement entered into in May 2023. The Company did no t have any contract assets as of December 31, 2023 or 2022. Product Revenues, Net Inbrija is distributed in the U.S. primarily through: a specialty pharmacy associated with the Company’s e-prescribing program, described below; AllianceRx Walgreens Prime, or Walgreens, a specialty pharmacy that delivers the medication to patients by mail; the cash pay program through Sterling and ASD Specialty Healthcare, Inc. (an Amerisource Bergen affiliate). Walgreens is the sole specialty pharmacy for U.S. sales of Inbrija. In 2022, the Company implemented an e-prescribing program for the distribution of Inbrija in the U.S. through a specialty pharmacy that supports electronic prescriptions. The Company believes the convenience of electronic prescribing may be preferred by some physicians and patients. Ampyra is distributed primarily through a network of specialty pharmacies, which deliver the medication to patients by mail. Net revenues from product sales is recognized at the transaction price when the customer obtains control of the Company’s products, which occurs at a point in time, typically upon receipt of the product by the customer, such as specialty pharmacy companies and distributors. The Company’s payment terms are between 30 to 60 days. The Company’s net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC 606 and are recorded for the Company’s estimate of cash consideration expected to be given by the Company to a customer that is presumed to be a reduction of the transaction price of the Company’s products and, therefore, are characterized as a reduction of revenue. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Discounts and Allowances Revenues from product sales are recorded at the transaction price, which includes estimates for discounts and allowances for which reserves are established and includes cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. Actual discounts and allowances are recorded following shipment of product and the appropriate reserves are credited. These reserves are classified as reductions of accounts receivable (if the amount is payable to the customer and right of offset exists) or a current liability (if the amount is payable to a party other than a customer). These allowances are established by management as its best estimate based on historical experience and data points available and are adjusted to reflect known changes in the factors that impact such reserves. Allowances for customer credits, chargebacks, rebates, data fees and wholesaler fees for services, returns, and discounts are established based on contractual terms with customers and analyses of historical usage of these items. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The nature of the Company’s allowances and accruals requiring critical estimates, and the specific considerations it uses in estimating their amounts are as follows: Government Chargebacks and Rebates: The Company contracts for Medicaid and other U.S. federal government programs to allow for its products to remain eligible for reimbursement under these programs. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. Based on the Company’s contracts and the most recent experience with respect to sales through each of these channels, the Company provides an allowance for chargebacks and rebates. The Company monitors the sales trends and adjust the chargeback and rebate percentages on a regular basis to reflect the most recent chargebacks and rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Managed Care Contract Rebates: The Company contracts with various managed care organizations including health insurance companies and pharmacy benefit managers. These contracts stipulate that rebates and, in some cases, administrative fees, are paid to these organizations provided the Company’s product is placed on a specific tier on the organization’s drug formulary. Based on the Company’s contracts and the most recent experience with respect to sales through managed care channels, the Company provides an allowance for managed care contract rebates. The Company monitors the sales trends and adjust the allowance on a regular basis to reflect the most recent rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Copay Mitigation Rebates: The Company offers copay mitigation to commercially insured patients who have coverage for their products (in accordance with applicable law) and are responsible for a cost share. Based on the Company’s contracts and the most recent experience with respect to actual copay assistance provided, the Company's provides an allowance for copay mitigation rebates. The Company monitors the sales trends and adjust the rebate percentages on a regular basis to reflect the most recent rebate experience. Cash Discounts: The Company sells directly to companies in their distribution network, which primarily includes specialty pharmacies, which deliver the medication to patients by mail, and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate). The Company generally provides invoice discounts for prompt payment for its products. The Company estimates its cash discounts based on the terms offered to its customers. Discounts are estimated based on rates that are explicitly stated in the Company’s contracts as it is expected they will take the discount and are recorded as a reduction of revenue at the time of product shipment when product revenue is recognized. The Company adjusts estimates based on actual activity as necessary. Product Returns: The Company offers no right of return except for products damaged upon receipt to Ampyra and Inbrija customers or a limited right of return based on the product’s expiration date to previous Zanaflex and Qutenza customers. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using historical sales information and inventory remaining in the distribution channel. Data Fees and Fees for Services Payable to Specialty Pharmacies: The Company has contracted with certain specialty pharmacies to obtain transactional data related to its products in order to develop a better understanding of its selling channel as well as patient activity and utilization by the Medicaid program and other government agencies and managed care organizations. The Company pays a variable fee to the specialty pharmacies to provide the Company the data. The Company also pays the specialty pharmacies a fee in exchange for providing distribution and inventory management services, including the provision of inventory management data to the Company. The Company estimates its fee for service accruals and allowances based on sales to each specialty pharmacy and the applicable contracted rate. Royalty Revenues The Company recognizes revenue for royalties under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: 1) sale or usage of the products or 2) satisfaction of the performance obligations. The Company has satisfied its performance obligations and therefore recognizes royalty revenue when the sales to which the royalties relate are completed. Royalty revenues recorded by the Company relate to the Company |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | (3) Leases The Company adopted the lease guidance under ASU 2016-02, "Leases" Topic 842 effective January 1, 2019. Under the guidance for lessees, leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. 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 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. In calculating the present value of the lease payments, the Company elected to utilize its incremental borrowing rate based on the remaining lease terms as of the January 1, 2019 adoption date. The Company has elected the practical expedient to combine lease and non-lease components as a single component. The lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the balance sheet as right-of-use assets, current operating lease liabilities and non-current operating lease liabilities. Additionally, the Company has elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases where the initial lease term is one year or less or for which the ROU asset at inception is deemed immaterial, the Company will not recognize ROU assets or lease liabilities. Those leases are expensed on a straight-line basis over the term of the lease. As of December 31, 2023, the Company serves as the lessee for two operating leases. The Company's leases have remaining lease terms of 3 years to 4.5 years. 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. Payments commenced 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. Waltham, Massachusetts 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 base rent under the lease is currently $ 1.3 million per year. In July 2023, the Company sublet to a third party approximately 13,000 square feet (approximately 49 %) of its lab space at the Waltham, Massachusetts location. The sublease commenced on August 1, 2023, and will last for the reminder of the Company’s lease agreement through 2026. Under the terms of the head lease the Company is not relieved of its obligation as lessee and will continue to make monthly rent payments. The Company performed a recoverability test of the sublease agreement upon inception by comparing the rental income under the sublease to the Company’s obligations under the head lease and noted no impairment existed on the head lease. The Company recognized sublease rental income of $ 0.3 million in 2023 and $ 0.7 mi llion per year beginning in 2024 until lease expiration in December 2026. The Company’s existing leases have remaining lease terms of 3 years to 4.5 years. The weighted-average remaining lease term for its operating leases was 3.4 years at December 31, 2023. The weighted-average discount rate was 7.97 % at December 31, 2023. ROU assets and lease liabilities related to the Company’s operating leases are as follows: (In thousands) Balance Sheet Classification December 31, 2023 December 31, 2022 Right-of-use assets Right of use assets $ 4,221 $ 5,287 Current lease liabilities Current portion of lease liabilities 1,588 1,545 Non-current lease liabilities Non-current portion of lease liabilities 3,166 4,341 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: Year ended December 31, Year ended December 31, (In thousands) 2023 2022 Operating lease cost $ 1,546 $ 3,843 Variable lease cost 426 2,005 Short-term lease cost 1 8 Total lease cost $ 1,973 $ 5,855 Future minimum commitments under all non-cancelable operating leases are as follows: (In thousands) 2024 1,588 2025 1,633 2026 1,678 2027 357 2028 182 Later years — Total lease payments 5,438 Less: Imputed interest ( 684 ) Present value of lease liabilities 4,754 Supplemental cash flow information activity related to the Company’s operating leases are as follows: (In thousands) December 31, 2023 December 31, 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 1,545 $ 8,191 |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | (4) Intangible Assets Intangible Assets Inbrija and ARCUS Technology In connection with the acquisition of Civitas in October 2014, the Company acquired global rights to Inbrija, a Phase 3 treatment candidate for Parkinson’s disease OFF periods, also known as OFF episodes. The acquisition of Civitas also included rights to Civitas’ proprietary ARCUS drug delivery technology, which the Company believes has potential to be used in the development of a variety of inhaled medicines. In December 2018, the FDA approved Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the transaction to the underlying assets acquired and liabilities assumed by the Company, based upon the estimated fair values of those assets and liabilities at the date of acquisition and classified the fair value of the acquired IPR&D as an indefinite-lived intangible asset until the successful completion of the associated research and development efforts. The value allocated to the indefinite lived intangible asset was $ 423 million. In December 2018, the Company received FDA approval for Inbrija and accordingly reclassified the indefinite lived intangible asset to a definite lived intangible asset with amortization commencing upon launch in February 2019. The commencement of the Intended Chapter 11 Proceedings was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the year ended December 31, 2023. The Company performed a recoverability test as of December 31, 2023 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 were less than the carrying value and the long-lived assets were impaired. The Company recognized an impairment charge of $ 251.3 million for the year ended December 31, 2023 in the Statement of Operations. The Company concluded there are no facts or circumstances that would indicate a need for changing the estimated remaining useful life of this asset. Websites Intangible assets also include certain website development costs which have been capitalized. The Company has developed several websites, each with its own purpose, including the general corporate website, product information websites and various other websites. The Company fully amortized website development costs as of December 31, 2023. The Company continually evaluates whether events or circumstances have occurred that indicate that the carrying value of the intangible assets may be impaired or that the estimated remaining useful lives of these assets may warrant revision. Other than the impairment identified above, as of December 31, 2023, the Company determined the remaining intangible assets were not impaired and that there are no facts or circumstances that would indicate a need for changing the estimated remaining useful lives of these assets. Intangible assets consisted of the following: December 31, 2023 December 31, 2022 (Dollars In thousands) Estimated Cost Additions Disposals Accumulated Impairment Net Cost Disposals Accumulated Net Inbrija (1) 11 423,000 — — ( 148,691 ) ( 251,322 ) 22,987 423,000 — ( 117,927 ) 305,073 Website 1 - 3 10,902 — ( 281 ) ( 10,621 ) — — 14,585 ( 3,683 ) ( 10,888 ) 14 $ 433,902 $ — $ ( 281 ) $ ( 159,312 ) $ ( 251,322 ) $ 22,987 $ 437,585 $ ( 3,683 ) $ ( 128,815 ) $ 305,087 (1) In December 2018, the Company received FDA approval for Inbrija and accordingly reclassified the indefinite lived intangible assets to definite lived intangible assets and began amortizing the assets upon launch in February 2019 . The Company recorded amortization expenses of $ 30.8 million pertaining to the intangible asset related to Inbrija for the year ended December 31, 2023. The Company recorded amortization expense of $ 30.8 million pertaining to the intangible asset related to Inbrija for the year ended December 31, 2022. Estimated future amortization expense for intangible assets subsequent to December 31, 2023 is as follows: (In thousands) 2024 $ 2,578 2025 $ 2,578 2026 $ 2,578 2027 $ 2,578 2028 $ 2,578 Thereafter $ 10,097 $ 22,987 The weighted-average remaining useful lives of all amortizable assets is approximately 11.0 years. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | (5) Property and Equipment Property and equipment consisted of the following: (In thousands) December 31, 2023 December 31, 2022 Estimated Machinery and equipment $ 2,316 $ 2,315 2 - 7 years Leasehold improvements 2,024 1,761 Lesser of useful life or remaining lease term Computer equipment 2,620 4,467 1 - 3 years Laboratory equipment 468 582 2 - 5 years Furniture and fixtures 233 233 4 - 7 years 7,661 9,358 Less accumulated depreciation ( 5,582 ) ( 6,755 ) $ 2,079 $ 2,603 Depreciation and amortization expense on property and equipment was $ 0.9 million and $ 1.9 million for the years ended December 31, 2023 and 2022, respectively. |
Common Stock Options and Restri
Common Stock Options and Restricted Stock | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Common Stock Options and Restricted Stock | (6) Common Stock Options and Restricted Stock On June 2, 2023, the Company filed an Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for- 20 reverse stock split and a proportionate reduction in the number of authorized shares from 61,666,666 to 3,083,333 . The Company’s common stock began trading on a split-adjusted basis on the Nasdaq Global Select Market on June 5, 2023. The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. All figures in this report relating to shares of the Company’s common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the reverse stock split. On January 12, 2006, the Company’s board of directors approved the adoption of the Acorda Therapeutics, Inc. 2006 Employee Incentive Plan (the 2006 Plan). The 2006 Plan served as the successor to the Company’s 1999 Plan, as amended, and no further option grants or stock issuances were to be made under the 1999 Plan after the effective date, as determined under Section 14 of the 2006 Plan. All employees of the Company were eligible to participate in the 2006 Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The 2006 Plan also covered the issuance of restricted stock. The 2006 Plan was administered by the Compensation Committee of the Board of Directors, which selected the individuals to be granted options and restricted stock, determined the time or times at which options and restricted stock were to be granted, determined the number of shares to be granted subject to any option or restricted stock and the duration of each option and restricted stock, and made any other determinations necessary, advisable, and/or appropriate to administer the 2006 Plan. Under the 2006 Plan, each option granted expires no later than the ten th anniversary of the date of its grant. The number of shares of common stock authorized for issuance under the 2006 Plan as of December 31, 2023 was 124,267 shares. As of December 31, 2023, the Company had granted an aggregate of 100,154 shares as restricted stock or subject to issuance upon exercise of stock options under the 2006 Plan, of which 5,945 shares remained subject to outstanding options. On June 9, 2015, the Company’s stockholders approved the adoption of the Acorda Therapeutics, Inc. 2015 Omnibus Incentive Compensation Plan (the 2015 Plan). The 2015 Plan serves as the successor to the Company’s 2006 Plan, as amended, and no further option or stock grants were made under the 2006 Plan after the effective date of the 2015 Plan. All employees of the Company are eligible to participate in the 2015 Plan, including executive officers, as well as directors, consultants, advisors and other service providers of the Company or any of its subsidiaries. The 2015 Plan also covers the issuance of restricted stock. The 2015 Plan is administered by the Compensation Committee of the Board of Directors, which selects the individuals to be granted options, restricted stock, and restricted stock units, determines the time or times at which options, restricted stock, and restricted stock units are to be granted, determines the number of shares to be granted subject to any option, restricted stock or restricted stock unit and the duration of each option, restricted stock, and restricted stock unit, and makes any other determinations necessary, advisable, and/or appropriate to administer the 2015 Plan. Under the 2015 Plan, each option granted expires no later than the ten th anniversary of the date of its grant. Since inception, the number of shares of common stock authorized for issuance under the 2015 Plan as of December 31, 2023 is 157,500 shares, plus shares underlying cancelled awards under the 2006 plan after the adoption of the 2015 plan. As of December 31, 2023, the Company had granted an aggregate of 124,796 shares either as restricted stock or shares subject to issuance upon the exercise of stock options under the 2015 Plan, of which 88,941 shares remained subject to outstanding options. On April 14, 2016, the Compensation Committee of the Company’s Board of Directors (the “Compensation Committee”) approved the Acorda Therapeutics, Inc. 2016 Inducement Plan (the “2016 Plan”) to provide equity compensation to certain individuals of the Company (or its subsidiaries) in order to induce such individuals to enter into employment with the Company or its subsidiaries. In 2023, no new stock option awards were issued under this plan to newly-hired executive officers as an inducement for them to become employed by the Company, and as of December 31, 2023, 8,500 shares remained outstanding and were the only awards that were outstanding under the 2016 Plan . On June 19, 2019, the Company’s stockholders approved the Company’s 2019 Employee Stock Purchase Plan (the “2019 ESPP”) at the annual meeting of stockholders pursuant to which up to 12,500 shares of the Company’s common stock, par value $ 0.001 per share may be issued thereunder (the “Plan Shares). As of December 31, 2023, there were 12,500 shares of common stock remaining authorized for issuance under the 2019 ESPP. The fair value of each option granted is estimated on the date of grant using the Black‑Scholes option‑pricing model with the following weighted average assumptions: Year ended December 31, 2023 2022 Employees and directors: Estimated volatility% 103.84 % 84.19 % Expected life in years 6.66 6.70 Risk free interest rate% 3.62 % 2.69 % Dividend yield — — The Company estimated volatility for purposes of computing compensation expense on its employee and director options using the historic volatility of the Company’s stock price. The expected life used to estimate the fair value of employee and director options is based on the historical life of the Company’s options based on exercise data. The weighted average fair value per share of options granted to employees and directors for the years ended December 31, 2023 and 2022 amounted to approximately $ 9.86 and $ 0.84 , respectively. No options were granted to non-employees for the years ended December 31, 2023 and 2022. During the year ended December 31, 2023, the Company granted 62,270 stock options to employees and directors under all plans. The stock options were issued with a weighted average exercise price of $ 12.31 per share. As a result of these grants, the total compensation charge to be recognized over the estimated service period is $ 0.6 million, of which $ 0.3 million was recognized during the year ended December 31, 2023. Compensation costs for options and restricted stock granted to employees and directors amounted to $ 0.5 million and $ 1.5 million, for the years ended December 31, 2023 and 2022, respectively. Compensation expense for options and restricted stock granted to employees and directors are classified in inventory, research and development, selling, general and administrative, and cost of sales expense based on employee job function. The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: Year ended December 31, (In thousands) 2023 2022 Research and development $ 11 $ 75 Selling, general and administrative 467 1,421 Total $ 478 $ 1,496 A summary of share‑based compensation activity for the year ended December 31, 2023 is presented below: Stock Option Activity Number thousands) Weighted-Average Weighted-Average Intrinsic Balance at December 31, 2022 52 $ 1,571.06 — — Granted 62 12.31 — — Forfeited and expired ( 11 ) 2,192.56 — — Exercised — — — — Balance at December 31, 2023 103 $ 568.85 7.5 $ 183,963 Vested and expected to vest at December 31, 2023 103 $ 572.25 7.5 $ 182,555 Vested and exercisable at December 31, 2023 59 $ 976.95 6.3 $ 79,123 Options Outstanding Options Exercisable Range of exercise price Outstanding as of Weighted-average Weighted- Exercisable as of Weighted- $ 6.19 - $ 11.29 4 7.6 $ 8.51 2 $ 7.39 $ 11.72 - $ 11.72 20 9.3 11.72 8 11.72 $ 12.25 - $ 12.50 30 9.0 12.50 11 12.50 $ 12.99 - $ 72.80 15 8.7 37.20 8 38.31 $ 74.80 - $ 75.00 11 7.4 74.84 6 74.86 $ 79.92 - $ 1,656.00 10 5.1 524.29 10 525.69 $ 1,794.00 - $ 4,288.80 10 2.1 3,634.83 10 3,634.83 $ 4,324.80 - $ 4,760.40 3 0.2 4,714.71 3 4,714.71 $ 4,797.60 - $ 4,797.60 0 0.1 4,797.60 0 4,797.60 $ 4,928.40 - $ 4,928.40 0 1.0 4,928.40 0 4,928.40 103 7.5 $ 568.85 59 $ 976.95 Restricted Stock Activity Restricted Stock Number of Shares Nonvested at December 31, 2022 $ — Granted — Vested — Forfeited — Nonvested at December 31, 2023 $ — Unrecognized compensation cost for unvested stock options and restricted stock awards as of December 31, 2023 totaled $ 0.5 million and is expected to be recognized over a weighted average period of approximately 1.2 years. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | (7) 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 are scheduled to mature on December 1, 2024 unless earlier converted in accordance with their terms prior to such date. However, the commencement of the Intended Chapter 11 Proceedings will constitute an event of default under the Indenture governing the 2024 Notes, which will in turn result in the 2024 Notes becoming immediately due and payable, along with accrued and unpaid interest. In addition, the Company’s common stock is likely to be delisted from Nasdaq following the consummation of the Intended Chapter 11 Proceedings, which would constitute a make-whole fundamental change that would provide holders of our 2024 Notes with the right to require the Company to repurchase their notes at a repurchase price equal to 100 % of the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any. The Company does not have the cash to make such a payment, which may complicate its ability to effectively complete the Intended Chapter 11 Proceedings and may result in its liquidation under Chapter 7. 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. Following the June 1, 2023 interest payment, the Company no longer has the option to pay interest on the 2024 Notes in its common stock and the Company has fully utilized the restricted cash that was set aside for the payment of interest on the 2024 Notes. 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 2.3810 shares of the Company’s common stock per $ 1,000 principal amount of 2024 Notes, representing an adjusted conversion price of approximately $ 420.00 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 adjusted again to reflect the 1-for-20 reverse split effected on June 2, 2023. As of December 31, 2023 the maximum number of shares that could be required to be issued would be 969,102 shares. 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. 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. 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, including the commencement of the Intended Chapter 11 Proceedings or a liquidation proceeding under Chapter 7, 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 the 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 million and recorded this amount as a derivative liability with an offsetting amount as a debt discount as a reduction to the carrying value of the 2024 Notes on the closing date, or December 24, 2019. 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 conversion feature is measured at fair value on a quarterly basis and the changes in the fair value of the conversion feature for the period will be recognized in the consolidated statements of operations. 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. The Company 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 December 31, 2023. The outstanding 2024 Note balances as of December 31, 2023 and December 31, 2022 consisted of the following: (In thousands) December 31, 2023 December 31, 2022 Liability component: Principal $ 207,000 $ 207,000 Less: debt discount and debt issuance costs, net ( 20,857 ) ( 39,969 ) Net carrying amount 186,143 167,031 Equity component 18,257 $ 18,257 Derivative liability-conversion Option $ — $ — 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. Accordingly, the total debt discount of $ 75.1 million, inclusive of the fair value of the embedded conversion feature derivative at issuance, is being amortized using the effective interest method through December 1, 2024. For the year ended December 31, 2023, the Company recognized $ 31.5 million of interest expense related to the 2024 Notes at the effective interest rate of 18.13 %. The fair value of the Company’s 2024 Notes was approximately $ 157.3 million as of December 31, 2023. 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 years ended December 31, 2023 and 2022: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Contractual interest expense $ 12,421 $ 12,420 Amortization of debt issuance costs 1,358 1,137 Amortization of debt discount 17,754 14,870 Total interest expense $ 31,533 $ 28,427 Non-Convertible Capital Loan The Company’s Biotie Therapies Ltd. 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). The loans were to be repaid only when consolidated retained earnings of Biotie Therapies Ltd. from the development of specific loan-funded product candidates is sufficient to fully repay the loans. In light of the decision to let lapse all patents having resulted from the funded projects, the Company filed an application with Business Finland for waiver of the loans and accrued interest. In July 2022, Business Finland granted these waivers, which became effective upon Biotie’s compliance with specified conditions to be completed, including a residual payment of approximately $ 0.1 million for one of the loans. As of December 31, 2022, Biotie Therapies Ltd. met the conditions for the waivers to be effective. The Company recorded a gain on extinguishment of debt of $ 27.1 million for the carrying amount including interest. Letters of Credit As of December 31, 2023, the Company has $ 0.3 million of cash collateralized standby letters of credit outstanding. See Note 2 to the Company’s Consolidated Financial Statements included in this report for a discussion of Restricted Cash. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Revenue Disclosure [Abstract] | |
Liability Related to Sale of Future Royalties | (8) Liability Related to Sale of Future Royalties As of October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners, or HCRP (the “Royalty Agreement”). In exchange for the payment of $ 40 million to the Company, HCRP obtained the right to receive Fampyra royalties payable by Biogen under the Biogen Collaboration Agreement up to an agreed upon threshold of royalties. This threshold was met during the second quarter of 2022 and its obligations to HCRP expired upon Biogen’s payment of royalties for that quarter. 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 was classified between the current and non-current portion of liability related to sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments received by HCRP. The total net royalties 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 estimated the payments made to HCRP over the term of the Royalty Agreement based on forecasted royalties and calculated the interest rate required to discount such payments back to the liability balance. Over the course of the Royalty Agreement, the actual interest rate was affected by the amount and timing of net royalty revenue recognized and changes in the forecasted revenue. On a quarterly basis, the Company reassessed the effective interest rate and adjusted the rate prospectively as necessary. The following table shows the activity within the liability account for the years ended December 31, 2023 and December 2022. (In thousands) December 31, 2023 December 31, 2022 Liability related to sale of future royalties - beginning balance $ — $ 4,460 Deferred transaction costs amortized — 33 Non-cash royalty revenue payable to HCRP — ( 4,739 ) Non-cash interest expense recognized — 246 Liability related to sale of future royalties - ending balance $ — $ — The interest and debt discount amortization expense is reflected as interest and amortization of debt discount expense in the Statement of Operations. |
Corporate Restructuring
Corporate Restructuring | 12 Months Ended |
Dec. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Corporate Restructuring | (9 ) Corporate Restructuring For the years ended December 31, 2023 and 2022, the Company incurred pre-tax severance and employee separation related expenses of approximately $ 0.0 and $ 0.3 million, respectively, associated with the restructuring. Of the pre-tax severance and employee separation related expenses incurred, $ 0.0 and $ 0.3 million were recorded in selling, general and administrative expenses for the years ended December 31, 2023 and 2022, respectively. A summary of the restructuring costs for the years ended December 31, 2023 and 2022 is as follows: (In thousands) Restructuring Costs Restructuring Liability as of December 31, 2021 $ 1,851 2022 Restructuring costs 251 2022 Payments ( 2,102 ) Restructuring Liability as of December 31, 2022 $ — 2023 Restructuring costs — 2023 Payments — Restructuring Liability as of December 31, 2023 $ — |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | (10) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: (In thousands) December 31, 2023 December 31, 2022 Product allowances accruals $ 9,750 $ 8,899 Bonus payable 3,719 4,329 Accrued interest 1,035 1,035 Sales force commissions and incentive payments payable 989 667 Administrative expenses — 366 Vacation accrual 1,494 1,477 Research and development expense accruals — 895 Commercial and marketing expense accruals — 2,892 Royalties payable 1,167 — Legal, accounting, and other professional services 1,521 50 Trade relations — 278 Other accrued expenses 4,635 2,792 Total $ 24,310 $ 23,680 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (11) Commitments and Contingencies The Company’s long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. Under certain supply agreements and other agreements with manufacturers and suppliers, the Company is required to make payments for the manufacture and supply of its clinical and approved products. The Company’s major outstanding contractual obligations are for payments related to its convertible notes, operating leases and commitments to purchase inventory. The following table summarizes the contractual obligations at December 31, 2023 and the effect such obligations are expected to have on the Company’s liquidity and cash flow in future periods: Payments due by period (1) (In thousands) Total Less than 1-3 years 4-5 years Convertible Senior Notes (2) $ 218,420 $ 218,420 $ — $ — Operating leases (3) 5,438 1,588 3,311 539 Inventory purchase commitments (4) 38,346 17,546 10,400 10,400 Catalent Termination (5) 4,000 4,000 — — Total 266,204 241,554 13,711 10,939 (1) Excludes a liability for uncertain tax positions totaling $ 6.0 million. This liability has been excluded because the Company cannot currently make a reliable estimate of the period in which the liability will be payable, if ever. (2) Represents the future payments of principal and interest to be made on the convertible senior secured notes due 2024 issued in December 2019. The notes are scheduled to mature on December 1, 2024 . However, the commencement of the Intended Chapter 11 Proceedings will constitute an event of default under the Indenture governing the 2024 Notes, which will in turn result in the 2024 Notes becoming immediately due and payable, along with accrued and unpaid interest. Refer to Note 7. (3) Represents payments for the operating leases of the Company’s Pearl River NY headquarters, the Company’s lab and office space in Waltham, MA. (4) Includes minimum purchase commitment from Catalent for Inbrija under the manufacturing services (supply) agreement. The Company terminated its existing supply agreement with Catalent on December 31, 2022 and renegotiated a new supply agreement effective January 1, 2023. Under the terms of the new supply agreement with Catalent, the Company is required to make minimum purchase obligations through 2024. Furthermore, the Company agreed that it would reimburse a portion of Catalent’s costs in completing the installation and qualification of the PSD-7, which the Company believes will be beneficial to its future production needs, in the amount of up to $ 2 million. The Company paid $ 0.5 million in 2023 and will provide up to $ 1.5 million in 2024 in two quarterly installments. (5) Represents the termination fee payable to Catalent that discontinued the Company's obligations under the 2021 MSA. The termination fee is payable in April 2024. License Agreements Under the Company’s various other research, license and collaboration agreements with other parties, it is obligated to make milestone payments of up to an aggregate of approximately $ 18.7 million over the life of the contracts. Under certain agreements, the Company is required to pay royalties for the use of technologies and products in its R&D activities and in the commercialization of products. The amount and timing of any of the foregoing payments are not known due to the uncertainty surrounding the successful research, development and commercialization of the products. See Note 13 to the Company’s Consolidated Financial Statements included in this report for a discussion on license, research, and collaboration agreements. Employment Agreements The Company has, or has agreed to enter into, employment agreements with all of its executive officers which provide for, among other benefits, certain severance, bonus and other payments and COBRA premium coverage, as well as certain rights relating to their equity compensation awards, if their employment is terminated for reasons other than cause or if they terminate their employment for good reason (as those terms are defined in the agreements). The agreements also provide for certain increased rights if their employment terminates following a change in control (as defined in the agreements). The Company’s contractual commitments table does not include these severance payment obligations. Other From time to time, the Company may be involved in litigation or other legal proceedings relating to claims arising out of operations in the normal course of its business, including the matters described below. The outcome of litigation and other legal proceedings is unpredictable, and regardless of outcome, they can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. In July 2020, the Company filed an arbitration demand with the American Arbitration Association against Alkermes plc (“Alkermes") after the parties were unable to resolve a dispute over license and supply royalties following the 2018 expiration of an Alkermes patent relating to Ampyra . In October 2022, an arbitration panel issued a final decision in this dispute and awarded to the Company $ 15 million plus prejudgment interest of $ 1.5 million. In addition, as a result of the panel’s ruling, the Company no longer has to pay Alkermes any royalties on net sales for license and supply of Ampyra, and is free to use alternative sources for supply of Ampyra , which the Company has already secured. On October 21, 2022, the Company 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. In November 2022, the arbitration tribunal corrected the award amount and granted the Company another $ 1.6 million plus pre-judgment interest of $ 0.2 million. On November 9, 2020, Drug Royalty III, L.P., and LSRC III S.ar.l. (collectively, “DRI”) filed an arbitration claim against us with the American Arbitration Association under a September 26, 2003 License Agreement that the Company 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 us to DRI of $ 750,000 expressly without any admission of wrongdoing. Although the Company believed they had valid defenses to this claim, the Company also believed that the settlement was in the best interests of the Company and our stockholders to avoid the future expense and distraction associated with continuing the arbitration. The Company recorded a liability of $ 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 and a corresponding gain of $ 1.3 million was recorded in the consolidated statement of operations as other income. On August 20, 2020, ratiopharm Gmbh (“ratiopharm”) filed nullity actions against us in the German Federal Patent Court seeking to invalidate both of the Company’s German patents that derived from its European patents, EP 1732548 (the ‘548 patent) and EP 2377536 (the ‘536 patent), with claims directed to the use of a sustained dalfampridine composition to increase walking speed in a patient with multiple sclerosis. In November 2021, the German Federal Patent Court issued preliminary opinions indicating that the claimed subject matter of the ‘548 patent lacked inventive step and the claimed subject matter of the ‘536 patent lacked novelty and inventive step. At oral hearings in February 2022 and April 2022, the German Federal Patent Court dismissed ratiopharm’s action against the ‘536 patent and the ‘548 patent, respectively, as inadmissible because of ongoing formality proceedings relating to these patents in the European Patent Office. Ratiopharm appealed the decision on the ‘536 patent but not the decision on the ‘548 patent. On December 6, 2022, the German Federal Court of Justice held that ratiopharm’s ‘536 nullity action was admissible and remanded the case back to the German Federal Patent Court. On January 11, 2022, Stada Arzneimittel (“Arzneimittel”) also filed a nullity action against the ‘536 patent. The ratiopharm and Arzneimittel ‘536 nullity actions have been consolidated. In November 2023, the German Federal Patent Court issued a preliminary opinion indicating that the claimed subject matter of the ‘536 patent lacked novelty and inventive step. At an oral hearing on March 4, 2024, the German Federal Patent Court held that the ‘536 patent was invalid. The Company is considering an appeal of this decision and will make a determination following receipt of the formal written decision. On July 27, 2022, Teva GmbH (“Teva”) also filed a nullity action against the ‘548 patent, in the same court as the ratiopharm nullity actions. On January 27, 2023, the German Federal Patent Court issued a preliminary opinion in the ‘548 Teva nullity action that the claimed subject matter of the ‘548 patent lacked inventive step. At an oral hearing on July 11, 2023, the German Federal Patent Court held that the ‘548 patent was invalid. The German Federal Patent Court issued its formal written decision on the ‘548 patent on November 10, 2023. The Company appealed the decision on December 11, 2023 and the appeal is now pending before the Federal Court of Justice The Company is working with Biogen to vigorously defend these actions and enforce its patent rights. 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 (the “ 2021 MSA") with a Catalent affiliate pursuant to which they agreed to manufacture Inbrija for the Company at the Chelsea facility. The manufacturing services agreement provided that Catalent would manufacture Inbrija, to the Company’s specifications, and the Company would purchase Inbrija exclusively from Catalent during the term of the manufacturing services agreement. Under the Company’s agreement with Catalent, it was obligated to make minimum purchase commitments for Inbrija of $ 18 million annually through the expiration of the agreement on December 31, 2030. In December 2021, the Company and Catalent amended the manufacturing services agreement to adjust the structure of the minimum payment terms for the period from July 1, 2021 through June 30, 2022 (the “Adjustment Period”). Under the amendment, the minimum payment obligation for the Adjustment Period was replaced with payments to Catalent for actual product delivered during the Adjustment Period subject to a cap for the Adjustment Period that corresponds to its original minimum purchase obligation for that period (i.e., $ 17 million), and with certain payments being made in the first half of 2022 instead of during the second half of 2021. As a result of the amendment, payments to Catalent for product delivered during the Adjustment Period were approximately $ 8.4 million less than the $ 17 million minimum inventory purchase obligation for that period. On December 31, 2022, the Company and Catalent entered into a termination letter, which was subsequently amended and restated in March 2023 (the “Termination Letter”), to terminate the 2021 MSA. In connection with the termination of the 2021 MSA, the Company will pay a $ 4 million termination fee to Catalent, payable in April 2024. The parties also entered into a Settlement and Release Agreement with respect to certain batches of Inbrija that were not delivered in 2022 as scheduled, and that are now expected in the first quarter of 2023, and to resolve all other outstanding manufacturing issues. Effective January 1, 2023, the Company entered into a new manufacturing services agreement, which was subsequently amended in March 2023 (as amended in March 2023, the “New MSA”) with Catalent. Under the New MSA, Catalent will continue to manufacture Inbrija (levodopa inhalation powder) through 2030, with reduced minimum annual commitments through 2024 and significantly lower pricing thereafter. The New MSA provides for the scale-up of new spray drying equipment (“PSD-7”), which will provide expanded capacity for the long-term world-wide manufacturing requirements of Inbrija. The Company is subject to a purchase commitment in 2024 of at least 24 batches of Inbrija, at a total cost of $ 15.5 million. Thereafter, in 2025, the Company will pay Catalent a fixed per capsule fee based on the amount of Inbrija that is delivered for sale in the United States and other markets. It is anticipated that by 2026, the PSD-7 equipment will be fully operational, which will significantly reduce the per capsule fees for all markets. The Company agreed to a minimum purchase requirement of at least three batches per year on the PSD-7 equipment. In addition, the Company paid Catalent $ 2.0 million in 2023 in connection with certain activities relating to the operational readiness of the PSD-7, and the Company paid $ 0.5 million in 2023 and will provide up to $ 1.5 million in 2024 for capital expenditures to assist in the capacity expansion efforts. The New MSA, unless earlier terminated, will continue until December 31, 2030, and will be automatically extended for successive two-year periods unless either the Company or Catalent provides the other with at least 18-months’ prior written notice of non-renewal. Either party may terminate the New MSA by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. The Company may also terminate the New MSA upon certain specified regulatory events and for convenience upon 180 days’ prior written notice. The Company agreed to purchase from Catalent all of our requirements for Inbrija for the United States, Germany, Spain and Latin America except in the case of termination or certain supply disruptions. For China, the Company is not required to purchase their supply from Catalent and may arrange for an alternate supplier. For other countries, the Company may be released from exclusivity as long as the Company purchases at least two batches from Catalent in the applicable year, subject to certain rights of first refusal on alternative source of supply arrangements. During the year ended December 31, 2023, the Company incurred approximately $ 10.5 million of purchase commitments with Catalent, of which $ 10.5 million are recognized as inventory within our balance sheet for the period. Under the New MSA with Catalent, the Company has a minimum remaining purchase of $ 15.5 million through December 31, 2024, and $ 5.2 million annually from January 1, 2026 through December 31, 2030. In January 2023, the Company filed a petition in the District Court for the Southern District of New York to confirm and modify the arbitral award. In that arbitration, the arbitration panel found in the Company’s favor that Alkermes leveraged its patent to illegally obtain royalties beyond the life of the patent in which was a violation of federal law. The panel held that Alkermes’ conduct in continuing to charge royalties after the patent expired was unlawful per se and that the underlying agreements were unenforceable. The panel awarded the Company approximately $ 18.3 million, including interest, representing license royalties overpaid since July 2020. The Company is asking the District Court to confirm the Award, with modifications to the extent the panel disregarded federal law by declining to award royalties the Company paid prior to July 2020 and after July 2018, the date on which the panel found that the parties’ agreements were unenforceable as a matter of law. The Company is seeking restitution of the remaining illegal royalties that the panel found were demanded and collected by Alkermes in violation of the law in the amount of approximately $ 65 million together with pre- and post-award interest and costs. On February 8, 2023, Alkermes filed a brief opposing the relief requested in the Company’s petition and requesting that the award be confirmed without modification. The Company filed a brief in response on February 22, 2023. The District Court will likely schedule oral argument on the petition and render its decision sometime thereafter. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (12) Fair Value Measurements The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the market in which the reporting entity transacts. The Company bases fair value on the assumptions market participants would use when pricing the asset or liability. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices, interest rates, exchange rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability. The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring and non-recurring basis as of December 31, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. (In thousands) Level 1 Level 2 Level 3 2023 Recurring: Assets Carried at Fair Value: Money market funds $ — $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 29,500 Non-Recurring: Assets Carried at Fair Value: Impaired finite-lived intangible — — 22,987 2022 Recurring: Assets Carried at Fair Value: Money market funds $ 15,322 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 41,200 Items Measured at Fair Value on a Recurring Basis The Company’s Level 1 assets consist of investments in a Treasury money market fund and U.S. government securities. The Company’s Level 3 liabilities represent acquired contingent consideration related to the acquisition of Civitas which are valued using a probability weighted discounted cash flow valuation approach and derivative liabilities related to conversion options for the convertible senior notes due December 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 December 31, 2023, except for the fair value of the Company’s convertible senior notes due December 2024 , which was approximately $ 157.3 million as of December 31, 2023. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2). 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) Year ended December 31, 2023 Year ended December 31, 2022 Acquired contingent consideration: Balance, beginning of period $ 41,200 $ 49,600 Fair value change to contingent consideration (unrealized) statement of operations ( 9,634 ) ( 6,659 ) Royalty payments ( 2,066 ) ( 1,741 ) Balance, end of period $ 29,500 $ 41,200 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 for the treatment of OFF periods of Parkinson’s disease. Using this approach, expected future cash flows are calculated over the expected life of the agreement and discounted to estimate the current value of the liability at the period end date. Some of the more significant assumptions made in the valuation include (i) the estimated revenue forecast for Inbrija, and (ii) discount period and rate. The milestone payment outcomes ranged from $ 0 to $ 18.7 million for Inbrija. The valuation is performed quarterly and changes to the fair value of the contingent consideration are included in the statement of operations. For the year ended December 31, 2023, changes in the fair value of the acquired contingent consideration were primarily due to the change in projected revenue and the recalculation of cash flows for the passage of time, as well as a decrease in the discount rate. See Note 13 to the Company’s Consolidated Financial Statements included in this report for a discussion about the Alkermes ARCUS agreement. 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 and estimated discount rates, the estimated fair value could be significantly higher or lower than the fair value determined. Derivative Liability 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) Year ended December 31, 2023 Year ended December 31, 2022 Derivative Liability-Conversion Option Balance, beginning of period $ — $ 37 Fair value adjustment — ( 37 ) Balance, end of period $ — $ — 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 7 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 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. The derivative liability conversion feature is measured at fair value on a quarterly basis and changes in the fair value will be recorded in the consolidated statement of operations. 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. The Company performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations. The resulting fair value of these conversion options was calculated to be $ 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 December 31, 2023. Key inputs used in the calculation of the fair value include stock price, volatility, risky (bond) rate, and the last observed bond price during the year ended December 31, 2023. Items Measured at Fair Value on a Non-Recurring Basis During the year ended December 31, 2023, the Company performed a recoverability test on its long-lived assets, and determined carrying amount of the finite-lived Inbrija intangible asset exceeded its fair value. The Company recorded a $ 251.3 million impairment charge for the year ended December 31, 2023. The recoverable portion of the finite-lived Inbrija intangible asset was adjusted to fair value using an income approach. The fair value measurement was categorized as a Level 3 based on inputs in the valuation technique used. The key assumptions used in the calculation of fair value include management’s projections of future cash flows. Other key assumptions include a growth rate, discount rate, and earnings before interest depreciation and amortization (“EBITDA”) margins based on the estimated weighted average cost of capital that incorporates risks specific to the Company. The Company used an average growth rate of 8.2 %. The Company used a discount rate of 27.0 %. |
License, Research and Collabora
License, Research and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Collaborative Arrangement Disclosure [Abstract] | |
License, Research and Collaboration Agreements | (13) License, Research and Collaboration Agreements Alkermes plc The Company is a party to a 2003 amended and restated license agreement and a 2003 supply agreement with Alkermes for Ampyra. Under the license agreement, the Company has exclusive worldwide rights to Ampyra, as well as Alkermes’ formulation for any other mono or di-aminopyridines, for all indications, including multiple sclerosis and spinal cord injury. The Company is obligated to pay Alkermes milestone payments and royalties based on a percentage of net product sales and the quantity of product shipped by Alkermes to the Company. Subject to early termination provisions, the Alkermes license terminates on a country by country basis on the latter to occur of fifteen years from the date of the agreement, the expiration of the last Alkermes patent to expire or the existence of competition in that country. Under the supply agreement, Alkermes has the right to manufacture for the Company, subject to certain exceptions, Ampyra and other products covered by these agreements at specified prices calculated as a percentage of net product sales of the product shipped by Alkermes to the Company. In the event Alkermes does not manufacture 100 % of the products, it is entitled to a compensating payment for the quantities of product provided by the alternative manufacturer. Supply Agreements Alkermes Prior to October 2022, the Company was a party to a 2003 supply agreement with Alkermes relating to the manufacture and supply of Ampyra by Alkermes. The Company was obligated to purchase at least 75 % of its annual requirements of Ampyra from Alkermes, unless Alkermes was unable or unwilling to meet its requirements, for a percentage of net product sales and the quantity of product shipped by Alkermes to the Company. In those circumstances, where the Company elected to purchase less than 100 % of its requirements from Alkermes, the Company was obligated to make certain compensatory payments to Alkermes. Alkermes was required to assist the Company in qualifying a second manufacturer to manufacture and supply the Company with Ampyra subject to its obligations to Alkermes. In July 2020, the Company filed an arbitration demand with the American Arbitration Association against Alkermes after the parties were unable to resolve a dispute over license and supply royalties following the 2018 expiration of an Alkermes patent relating to Ampyra. In October 2022, a three-judge arbitration panel issued a final decision in this dispute and awarded to the Company an aggregate of $ 18.3 million including prejudgment interest and subsequent correction of a calculation error in the initial award. In addition, the arbitration panel ruled the agreements with Alkermes as unenforceable, and as a result the Company no longer pays Alkermes any royalties on net sales for license and supply of Ampyra, and the Company is using an alternative source for supply of Ampyra. The cost savings associated with this decision have greatly benefited Ampyra's value to the Company. In 2020 Biogen paid the Company $ 15 million based on achievement of a specified sales milestone (all subject to the Company’s payment obligations to Alkermes under the Company’s license agreement with them). The Company is entitled to receive additional payments from Biogen that exceed $ 300 million in the aggregate based on achievement of future regulatory and sales milestones, although the Company does not anticipate achievement of any of those milestones in the foreseeable future. Biogen is also required to make double-digit tiered royalty payments to the Company on sales of Fampyra. In January 2024, the Company received notice of termination from Biogen of the Collaboration Agreement. Accordingly, the Company will regain global commercialization rights to Fampyra. Biogen exercised its right to terminate the Collaboration Agreement in order to shift resources towards upcoming launches and programs that align with its priorities. The termination will be effective as of January 1, 2025. Refer to Note 17 for more information. Patheon As a result of the arbitration ruling in October 2022, the Company was free to obtain supply of Ampyra from alternative sources and Patheon became the Company's sole manufacturer and packager of Ampyra for sales in the United States. The manufacturing services agreement with Patheon is automatically renewed for successive one-year periods on December 31 of each year, unless either the Company or Patheon provide the other party with at least 12-months’ prior written notice of non-renewal. Either party may terminate manufacturing services agreement by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. The Company may also terminate the manufacturing services agreement upon certain regulatory actions or objections. Patheon may terminate the manufacturing services agreement if the Company assigns the agreement to a third party under certain circumstances. The Company relies on a single third-party manufacturer to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra, and also on a single supplier for a critical excipient used in the manufacture of Ampyra. If these companies experience any disruption in their operations, the Company's supply of Ampyra could be delayed or interrupted until the problem is solved or the Company locates another source of supply or another packager, which may not be available. The Company may not be able to enter into alternative supply or packaging arrangements on terms that are commercially reasonable, if at all. Any new supplier or packager would also be required to qualify under applicable regulatory requirements. Because of these and other factors, the Company could experience substantial delays before they are able to obtain qualified replacement products or services from any new supplier or packager. Biogen Inc. The Company has an exclusive collaboration and license agreement with Biogen Inc., (Biogen) to develop and commercialize Ampyra (known as Fampyra outside the U.S.) in markets outside the United States (the Collaboration Agreement). Under the Collaboration Agreement, Biogen was granted the exclusive right to commercialize Ampyra and other products containing aminopyridines developed under that agreement in all countries outside of the U.S., which grant includes a sublicense of the Company’s rights under an existing license agreement between the Company and Alkermes. Biogen has responsibility for regulatory activities and future clinical development of Fampyra in ex-U.S. markets worldwide. The Company also entered into a related supply agreement with Biogen (the Supply Agreement), pursuant to which the Company will supply Biogen with its requirements for the licensed products through the Company’s existing supply agreement with Alkermes. In October 2022, an arbitration panel issued a decision in our dispute with Alkermes and awarded to the Company approximately $ 18.3 million including prejudgment interest and subsequent correction of an error in calculating the initial award. In addition, as a result of the panel’s ruling, the Company no longer has to pay Alkermes any royalties on net sales for license and supply of Ampyra, and the Company is free to use alternative sources for supply of Ampyra, which the Company has already secured for U.S. supply. However, the arbitration panel also ruled that the existing license and supply agreements with Alkermes are unenforceable. Accordingly, absent a new supply agreement with Alkermes or another supplier, the Company will not be able to exclusively supply Fampyra to Biogen under the terms of our supply arrangement with them. While the Company has engaged in discussions with Biogen relating to the supply of Fampyra, there can be no assurance that such discussions will result in a continuation of supply by the Company, Alkermes or a third party manufacturer. If Biogen is unable to obtain supply of the licensed product could constitute a breach under the existing supply agreement with Biogen resulting in termination of the license and supply agreements with Biogen or otherwise result in the cessation of sales of Fampyra and loss of royalty revenue in the future. In January 2024, the Company received notice of termination from Biogen of the Collaboration Agreement. Accordingly, the Company will regain global commercialization rights to Fampyra. Biogen exercised its right to terminate the Collaboration Agreement in order to shift resources towards upcoming launches and programs that align with its priorities. The termination will be effective as of January 1, 2025. The Company plans to assume commercialization responsibilities during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory and the Company expects to enter into additional collaborations and distribution arrangements with third parties to transition commercialization of Fampyra. Alkermes (ARCUS products) In December 2010, Civitas, the Company’s wholly owned subsidiary, entered into the Asset Purchase and License Agreement (“Alkermes Agreement”), in which Civitas licensed or acquired from Alkermes certain pulmonary development programs and INDs, underlying intellectual property and laboratory equipment associated with the pulmonary business of Alkermes. The assets acquired includes (i) patents, patent applications and related know-how and documentation; (ii) a formulation of inhaled L-dopa; (iii) several other pulmonary development programs and INDs, which are part of the platform device and formulation IP; (iv) instruments, laboratory equipment and apparatus; and (v) inhalers, inhaler molds, tools, and the associated assembled equipment. In addition, Civitas leased the facility where the Alkermes operations were previously housed in Chelsea, Massachusetts. Under the terms of the Alkermes Agreement, Civitas will also pay to Alkermes royalties for each licensed product as follows: (i) for all licensed products sold by Civitas, Civitas will pay Alkermes a mid-single digit percentage of net sales of such licensed products and (ii) for all licensed products sold by a collaboration partner, Civitas will pay Alkermes the lower of a mid-single digit percentage of net sales of such licensed products in a given calendar year or a percentage in the low-to-mid-double digits of all collaboration partner revenue received in such calendar year. Notwithstanding the foregoing, in no event shall the royalty paid be less than a low-single digit percentage of net sales of a licensed product in any calendar year. As consideration for the agreement with Alkermes, Civitas issued stock and also agreed to pay Alkermes royalties on future net product sales from products developed from licensed technology under the Alkermes Agreement. The fair value of the future royalties is classified as contingent consideration. The Company estimates the fair value of this contingent consideration based on future revenue projections and estimated probabilities of receiving regulatory approval and commercializing such products. Refer to Note 12 – Fair Value Measurements for more information about the contingent consideration liability. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (14) Income Taxes The domestic and foreign components of (loss) income before income taxes were as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Domestic $ ( 295,429 ) $ ( 60,179 ) Foreign ( 592 ) 24,932 Total $ ( 296,021 ) $ ( 35,247 ) The benefit (expense) from income taxes in 2023 and 2022 consists of current and deferred federal, state and foreign taxes as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Current: Federal $ ( 118 ) $ ( 243 ) State ( 850 ) ( 115 ) Foreign ( 71 ) ( 37 ) ( 1,039 ) ( 395 ) Deferred: Federal 25,909 ( 30,234 ) State 18,297 ( 40 ) Foreign — — 44,206 ( 30,274 ) Total benefit from income taxes $ 43,167 $ ( 30,669 ) As of December 31, 2023, the Company’s U.S. consolidated federal NOL carryforwards on a tax return basis are approximately $ 114.7 million which can be carried forward indefinitely and, under the Act, limited to 80 % of taxable income in any year in which it will be utilized. Biotie Therapies, Inc. (“Biotie US”), which was converted to an LLC during 2023 and now a wholly owned subsidiary of Acorda, filed a separate company federal income tax return and has a net operating loss carryforward of approximately $ 120.8 million as of December 31, 2023. These losses, which begin to expire in 2026 , were historically not more likely than not to be realized and had been fully offset with a full valuation allowance. The Company’s capital loss carryforward of approximately $ 42.3 million is fully offset with a valuation allowance. The capital loss carryforward will expire in 2026. The Company had available state NOL carryforwards of approximately $ 312.9 million as of December 31, 2023 and 2022. The state losses are expected to begin to expire in 2027 , although not all states conform to the federal carryforward period and occasionally limit the use of net operating losses for a period of time. The Company has $ 7.3 million of net operating loss carryforwards outside of the U.S. as of December 31, 2023, that expired in 2024 , all of which are fully reserved with a valuation allowance. The Company’s U.S. federal research and development and orphan drug credit carryforwards of $ 35.0 million and $ 35.1 million as of December 31, 2023 and 2022, respectively, begin to expire in 2024 . The timing differences between the financial reporting and tax treatment of income and expenses results in deferred tax assets and liabilities, which are included within the consolidated balance sheet. The Company must assess the likelihood that any recorded deferred tax assets will be recovered against future taxable income. To the extent the Company believes it is more likely than not that any portion of the deferred tax asset will not be recoverable, a valuation allowance must be established. To the extent the Company establishes a valuation allowance or changes the allowance in a future period, income tax expense will be impacted. The Company continued to maintain a full valuation allowance against its net U.S. and net foreign deferred tax assets of Biotie at December 31, 2023. During 2023, the Company recorded a full valuation allowance on the Acorda filling group's deferred balances. The Company had a net increase of $ 23.9 million of valuation allowance. The increase was primarily due to the impairment of the Civitas IPR&D intangible asset which resulted in an overall net deferred tax asset position as of December 31, 2023. Due to the weight of the negative evidence, a full valuation allowance was recorded against the Company's net deferred tax assets. The reconciliation of the statutory U.S. federal income tax rate to the Company’s effective income tax rate is as follows: Year ended December 31, 2023 Year ended December 31, 2022 U.S. federal statutory tax rate 21.0 % 21.0 % State and local income taxes 4.6 % ( 0.3 )% Stock option compensation — ( 0.2 )% Stock option shortfall ( 0.7 )% ( 8.8 )% GILTI Inclusion — ( 8.3 )% Uncertain tax positions 0.1 % 0.4 % Other nondeductible and permanent differences ( 0.9 )% ( 7.7 )% U.S. write-off/expiration — ( 255.8 )% Valuation allowance, net of foreign tax rate ( 9.4 )% 151.6 % Biotie Finland cancellation of debt exclusion — 21.7 % Federal return to provision differences ( 0.1 )% ( 0.6 )% Effective income tax rate 14.6 % ( 87.0 )% The Company’s overall effective tax rate is affected by the increase in the valuation allowance state income taxes and, the forfeitures of equity based compensation for which no tax deduction is recorded. Provisions have been made for deferred taxes based on the differences between the basis of the assets and liabilities for financial statement purposes and the basis of the assets and liabilities for tax purposes using currently enacted tax rates and regulations that will be in effect when the differences are expected to be recovered or settled. The components of the deferred tax assets and liabilities are as follows: (In thousands) December 31, 2023 December 31, 2022 Deferred tax assets: Net operating loss carryforward $ 70,007 $ 74,576 Capital loss carryforward 11,227 11,100 Tax credits 34,292 34,301 Stock based compensation 6,475 8,896 Contingent consideration 7,827 10,807 Employee compensation 1,296 1,438 Rebate and returns reserve 2,419 2,003 Capitalized R&D 895 1,191 Other 5,424 5,421 Total deferred tax assets $ 139,862 $ 149,733 Valuation allowance ( 130,642 ) ( 106,702 ) Total deferred tax assets net of valuation allowance $ 9,220 $ 43,031 Deferred tax liabilities: Intangible assets ( 4,327 ) ( 77,876 ) Convertible debt ( 4,812 ) ( 9,190 ) Depreciation ( 81 ) ( 167 ) Total deferred tax liabilities $ ( 9,220 ) $ ( 87,233 ) Net deferred tax liability $ — $ ( 44,202 ) The Company follows authoritative guidance regarding accounting for uncertainty in income taxes, which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The beginning and ending amounts of unrecognized tax benefits reconciles as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Beginning of period balance $ 6,237 $ 6,370 Decreases for tax positions taken during a ( 212 ) ( 133 ) End of period balance $ 6,025 $ 6,237 Accrued interest and penalties would be disclosed within the related liabilities lines in the consolidated balance sheet and recorded as a component of income tax expense. All of its unrecognized tax benefits, if recognized, would impact the effective tax rate. The Company is subject to taxation in the United States and various state and foreign jurisdictions. The Company has operations in the United States and Puerto Rico, as well as filing obligations in Finland, Switzerland and Germany. Typically, the period for the statute of limitations ranges from 3 to 5 years, however, this could be extended due to the Company’s NOL carryforward position in a number of its jurisdictions. The tax authorities generally have the ability to review income tax returns for periods where the statute of limitations has previously expired and can subsequently adjust the NOL carryforward or tax credit amounts. Accordingly, the Company does not expect to reverse any portion of the unrecognized tax benefits within the next year. The beginning and ending amounts of valuation allowances reconcile as follows: Balance at Balance at (In thousands) Beginning of Period Additions Deductions End of Period Valuation allowance for deferred tax assets: Year ended December 31, 2022 $ 193,253 233 ( 86,784 ) $ 106,702 Year ended December 31, 2023 $ 106,702 27,866 ( 3,926 ) $ 130,642 |
Loss Per Share
Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Loss Per Share | (15) Loss Per Share The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2023 and 2022: (In thousands, except per share data) Year ended December 31, 2023 Year ended December 31, 2022 Basic and diluted Net loss $ ( 252,854 ) $ ( 65,916 ) Weighted average common shares outstanding used in 1,242 1,011 Plus: net effect of dilutive stock options and unvested — — Weighted average common shares outstanding used in 1,242 1,011 Net loss per share—basic $ ( 203.57 ) $ ( 65.23 ) Net loss per share—diluted $ ( 203.57 ) $ ( 65.23 ) The difference between basic and diluted shares is that diluted shares include the dilutive effect of the assumed exercise of outstanding securities. The Company’s stock options and unvested shares of restricted common stock could have the most significant impact on diluted shares. 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 income per diluted share because their effects were anti-dilutive: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Denominator Stock options and restricted common shares 103 50 Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the years ended December 31, 2023 and 2022. Additionally, the impact of the convertible debt was determined to be anti-dilutive an d excluded from the calculation of net income per diluted share for the years ended December 31, 2023 and 2022. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | (16) Employee Benefit Plan Effective September 1, 1999, the Company adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all employees of the Company. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) plan, subject to defined limitations. The plan includes an employer match contribution to employee deferrals. For each dollar an employee invests up to 6 % of his or her earnings, the Company will contribute an additional 50 cents into the funds. The Company’s expense related to the plan was $ 0.7 million and $ 0.8 million for the years ended December 31, 2023 and 2022, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | (17) Subsequent Events Global Commercialization Rights to Fampyra On January 8, 2024, the Company received notice of termination from Biogen of the Collaboration Agreement. Accordingly, the Company will regain global commercialization rights to Fampyra. Biogen exercised its right to terminate the Collaboration Agreement in order to shift resources towards upcoming launches and programs that align with its priorities. The termination will be effective as of January 1, 2025. The Company will continue to receive double-digit tiered royalties on net sales of Fampyra until the transfer of regulatory authorizations have been completed on a country-by-country basis. Thereafter, the Company will receive revenues directly in markets serviced by the Company or through distributors or partners Effective as of January 1, 2025, the Collaboration Agreement will be terminated in its entirety and the license rights granted by the Company to Biogen will terminate. Following January 1, 2025, the Company will not be entitled to receive any further royalty or milestone payments from Biogen. The Company and Biogen are working together toward a transition for the Company to commercialize and supply Fampyra for the great majority of people with multiple sclerosis outside the U.S. currently being served. The Company plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory. Asset Purchase Agreement Prior to the commencement of the Intended Chapter 11 Proceedings, on March 31, 2024 the Company entered into a “stalking horse” Asset Purchase Agreement (the “Asset Purchase Agreement”) Merz Pharmaceuticals, LLC a North Carolina limited liability company (the “Purchaser”), and, solely with respect to the guarantee of purchaser’s obligations thereunder, Merz Pharma GmbH & Co. KGaA, a German partnership (the “Purchaser Parent”). The Asset Purchase Agreement provides for the sale of substantially all of the Company’s assets (the “Purchased Assets”) to the Purchaser for $ 185.0 , subject to certain adjustments as specified in the Asset Purchase Agreement. The Purchase Agreement is subject to Court approval and compliance with agreed-upon bidding procedures under Section 363 of the Code (“Section 363”) allowing for the submission of higher or otherwise better offers and satisfaction of other agreed-upon conditions. In accordance with the sale process under Section 363, notice of the proposed sale to the Purchaser will be given to third parties and competing bids will be being solicited over a specified period of time. The Company will manage the bidding process and evaluate the bids, in consultation with its advisors and as overseen by the Court. The Company cannot provide any assurance that it will be able to successfully complete a sale of the Purchased Assets or that it will be able to continue to fund its operations throughout the Intended Chapter 11 Proceedings. Restructuring Support Agreement Prior to the commencement of the Intended Chapter 11 Proceedings, on April 1, 2024 the Company entered into a Restructuring Support Agreement with the holders of a majority of its 2024 Notes (the “RSA Noteholders” and such agreement, the “Restructuring Support Agreement”). As contemplated in the Restructuring Support Agreement, the Company will seek to sell substantially all of its assets in a sale pursuant to Section 363. The Restructuring Support Agreement sets out certain milestones and conditions of the Company relating to the Section 363 sale process, subject to the terms and conditions contained therein. DIP Credit Agreement In order to fund the continued operations of the Company during the pendency of the Intended Chapter 11 Proceedings, the Company and certain of the RSA Noteholders agreed to the terms of a form of Debtor-in-Possession Credit Agreement (the “DIP Credit Agreement”) to be entered into by and among the Company, as borrower, and the lenders from time to time party thereto (collectively, the “DIP Lenders”, GLAS USA LLC, as administrative agent (the “DIP Administrative Agent”), and GLAS Americas, LLC, collateral agent (collectively, with the DIP Administrative Agent, the “DIP Agent”), pursuant to which the DIP Lenders would provide the Company with a senior secured, superpriority debtor-in-possession term loan facility in the maximum aggregate amount of $ 60.0 million (the “DIP Credit Facility,” and the commitments of the DIP Lenders thereunder, the “DIP Commitments” and, the loans thereunder, the “DIP Loans”), which, subject to the satisfaction of certain conditions precedent to drawing as set forth in the DIP Credit Agreement, including the approval of the Court, will be made available to the Company in multiple drawings as follows: (i) up to $ 10.0 million (“Interim DIP Loan Commitment”) will be made available for drawing upon entry by the Court of an interim order authorizing and approving the DIP Credit Facility on an interim basis (the “Interim DIP Order”), 00 (ii) up to $ 10.0 million (“Final DIP Loan Commitments”) will be made available for drawing upon entry of the Court of a final order authorizing and approving the DIP Credit Facility on a final basis (the “Final DIP Order” and together with the Interim DIP Order, the “DIP Orders”), and (iii) upon subject to entry of the Final Order, a roll-up facility in the aggregate maximum principal amount of $ 40.0 million, representing a roll-up of obligations under the 2024 Notes on a two dollars to one dollar basis of the DIP Commitments under the DIP Facility made by the RSA Noteholders. See Financing Arrangements in Part II, Item 7 of this Annual Report for more information. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (U.S.) and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Basis of Presentation | Basis of Presentation On June 2, 2023, the Company filed an Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware to effect a 1-for-20 reverse stock split and a proportionate reduction in the number of authorized shares from 61,666,666 to 3,083,333 . The Company’s common stock began trading on a split-adjusted basis on the Nasdaq Global Select Market on June 5, 2023. The reverse stock split applied equally to all outstanding shares of the common stock and did not modify the rights or preferences of the common stock. All figures in this report relating to shares of the Company’s common stock (such as share amounts, per share amounts, and conversion rates and prices), including in the financial statements and accompanying notes to the financial statements, have been retroactively restated to reflect the reverse stock split. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements requires management to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share‑based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities, measurement of changes in the fair value of acquired contingent consideration which is based on a probability weighted discounted cash flow valuation methodology, estimated deductions to determine net revenue such as allowances for customer credits, including estimated discounts, rebates, and chargebacks, which are estimated based on available information that will be adjusted to reflect known changes in the factors that impact such allowances, estimates of derivative liability associated with the exchange of the convertible senior secured notes due 2024, which is marked to market each quarter based on a binomial model, estimates of reserves for obsolete and excess inventory, and estimates of unrecognized tax benefits and valuation allowances on deferred tax assets w hich are based on an assessment of recoverability of the deferred tax assets against future taxable income. Actual results could differ from those estimates. |
Risks and Uncertainties | Risks and Uncertainties The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to commercialization of products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, and protection of intellectual property rights. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund which is unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. The Company maintains cash balances in excess of insured limits. |
Restricted Cash | Restricted Cash At December 31, 2023, the Company had $ 0.7 million of restricted cash, of which $ 0.3 consisted of collateralized standby letters of credit in connection with obligations under facility leases and $ 0.4 m illion held in a bank account with funds to cover the Company's self-funded employee health insurance.l See Note 7 to the Company’s Consolidated Financial Statements included in this report for a discussion of interest payments on the outstanding convertible senior secured notes due 2024. 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: December 31, 2023 December 31, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 29,979 $ 45,634 $ 37,536 Restricted cash 6,884 381 13,400 6,884 Restricted cash-non current 255 255 6,189 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 44,675 $ 30,615 $ 65,223 $ 44,675 |
Other Comprehensive Loss | Other Comprehensive Income (Loss) The Company’s other comprehensive income (loss) consisted of adjustments for foreign currency translation and is recorded and presented net of income tax. There was no income tax allocated to the foreign currency translation adjustment in Other Comprehensive Income (Loss) for the period ended December 31, 2023 and 2022. The cumulative foreign currency translation adjustment reported in Other Comprehensive Income (Loss) was $ 0.8 million and $ 1.6 million for the period ended December 31, 2023 and 2022, respectively. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. The Company capitalizes inventory costs associated with the Company's products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company establishes reserves as necessary for obsolescence and excess inventory. The Company records a reserve for excess and obsolete inventory based on the expected future product sales volumes and the projected expiration of inventory and specifically identified obsolete inventory. Production costs related to idle capacity are not included in the cost of inventory but are charged directly to cost of sales in the period incurred. The following table provides the major classes of inventory: (In thousands) December 31, 2023 December 31, 2022 Raw materials $ 4,178 $ 6,212 Work-in-progress $ 2,491 $ — Finished goods 9,486 6,540 Total $ 16,155 $ 12,752 Ampyra Prior to October 2022, the cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) was based on agreed upon pricing with Alkermes. In the event Alkermes did not manufacture the products, Alkermes was entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances. No payments were made for the years ended December 31, 2023 and 2022. In October 2022, an arbitration panel issued a decision in our dispute with Alkermes and ruled that the existing license and supply agreements with Alkermes are unenforceable. As a result of the panel’s ruling, the Company no longer pays Alkermes any royalties on net sales for license and supply of Ampyra, and the Company is using an alternative source for supply of Ampyra. On September 30, 2010, the Company entered into a world-wide manufacturing services agreement with Patheon, Inc. as a second manufacturer for Ampyra (Dalfampridine-ER tablets, 10mg). Under the manufacturing services agreement, the Company agreed to purchase from Patheon, on a non-exclusive basis, a portion of our requirements for Ampyra in the United States. The Company pays Patheon a fixed per bottle fee (60 tablets per bottle) based on the annual quantity of Ampyra bottles that are delivered for sale. Patheon is currently the Company's sole manufacturer and packager of Ampyra for sales in the United States. The manufacturing services agreement is automatically renewed for successive one-year periods on December 31 of each year, unless either the Company or Patheon provide the other party with at least 12-months’ prior written notice of non-renewal. Either party may terminate manufacturing services agreement by written notice under certain circumstances, including material breach (subject to specified cure periods) or insolvency. The Company may also terminate the manufacturing services agreement upon certain regulatory actions or objections. Patheon may terminate the manufacturing services agreement if the Company assigns the agreement to a third party under certain circumstances. The manufacturing services agreement contains customary representations, warranties and covenants, including with respect to the ownership of any intellectual property created pursuant to the manufacturing services agreement, as well as provisions relating to ordering, payment and shipping terms, regulatory matters, reporting obligations, indemnity, confidentiality and other matters. The Company relies on a single third-party manufacturer to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra, and also on a single supplier for a critical excipient used in the manufacture of Ampyra. If these companies experience any disruption in their operations, the Company's supply of Ampyra could be delayed or interrupted until the problem is solved or the Company locates another source of supply or another packager, which may not be available. The Company may not be able to enter into alternative supply or packaging arrangements on terms that are commercially reasonable, if at all. Any new supplier or packager would also be required to qualify under applicable regulatory requirements. Because of these and other factors, the Company could experience substantial delays before they are able to obtain qualified replacement products or services from any new supplier or packager. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation, except for assets acquired in a business combination, which are recorded at fair value as of the acquisition date. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which ranges from one to seven years . Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on a straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred. |
Intangible Assets | Finite-Lived Intangible Assets The Company has finite lived intangible assets that are amortized on a straight-line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If impairment indicators are present or changes in circumstance suggest that impairment may exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each intangible asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss in the statement of operations if the carrying value of the intangible asset exceeds its fair value. Fair value is generally estimated based on either appraised value or other valuation techniques. Events that could result in an impairment, or trigger an interim impairment assessment, may include actions by regulatory authorities with respect to the Company or its competitors, new or better products entering the market, changes in market share or market pricing, changes in the economic lives of the assets, changes in the legal framework covering patents, rights or licenses, and other market changes which could have a negative effect on cash flows and which could result in an impairment. |
Contingent Consideration | Contingent Consideration The Company may record contingent consideration as part of the cost of business acquisitions. Contingent consideration is recognized at fair value as of the date of acquisition and recorded as a liability on the consolidated balance sheet. The contingent consideration is re-valued on a quarterly basis using a probability weighted discounted cash-flow approach until fulfillment or expiration of the contingency. Changes in the fair value of the contingent consideration are recognized in the statement of operations. Due to the Company's Asset Purchase and License agreement between Civitas, the Company's wholly owned subsidiary, and Alkermes in December 2010, the Company has recognized contingent consideration. See Note 13 to the Company’s Consolidated Financial Statements included in this report for a discussion on the Alkermes ARCUS agreement. Refer to Note 12 – Fair Value Measurements for more information about the contingent consideration liability. |
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 commencement of the Intended Chapter 11 Proceedings was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the year ended December 31, 2023. The Company performed a recoverability test as of December 31, 2023 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 were less than the carrying value and the long-lived assets were impaired. The Company recognized an impairment charge of $ 251.3 million for the year ended December 31, 2023 in the Statement of Operations. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent red uctions in the carrying amount of the assets. |
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | Non-Cash Interest Expense on Liability Related to Sale of Future Royalties As of October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners, or HCRP (“Royalty Agreement”). In exchange for the payment of $ 40 million to the Company, HCRP obtained the right to receive Fampyra royalties payable by Biogen under the Collaboration and Licensing Agreement between the Company and Biogen (the “Biogen Collaboration Agreement”), up to an agreed upon threshold of royalties. This threshold was met during the second quarter of 2022 and its obligations to HCRP expired upon Biogen's payment of royalties for that quarter. As a result, the full benefit of the Fampyra royalty revenue reverted back to the Company and the Company will continue to receive the Fampyra royalty revenue from Biogen until the revenue stream ends. As of December 31, 2023 the liability related to the sale of future royalties is zero . Prior to satisfying its obligation to HCRP, since the Company maintained rights under the Biogen Collaboration Agreement, the Royalty Agreement has been accounted for as a liability that was amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. In order to determine the amortization of the liability, the Company estimated the total amount of future net royalty payments made to HCRP over the term of the agreement up to the agreed upon threshold of royalties. The total threshold of net royalties to be paid, less the net proceeds received was recorded as interest expense over the life of the liability. The Company imputes interest on the unamortized portion of the liability using the effective interest method and records interest expense based on the timing of the payments received over the term of the Royalty Agreement. The Company’s estimate of the interest rate under the arrangement is based on forecasted net royalty payments expected to be made to HCRP over the life of the Royalty Agreement. The Company estimated an effective annual interest rate of approximately 15 %. Over the course of the Royalty Agreement, the actual interest rate was affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company reassessed the effective interest rate and adjusted the rate prospectively as required. Non-cash royalty revenue is reflected as royalty revenue and non-cash interest expense is reflected as interest and amortization of debt discount expense in the Statement of Operations. |
Patent Costs | Patent Costs Patent application and maintenance costs are expensed as incurred. |
Research and Development | Research and Development Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses. In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. Because of its limited financial resources, the Company previously suspended work on proprietary research and development programs, and has performed feasibility studies for potential collaborations with other companies that express interest in formulating their novel molecules for pulmonary delivery using the Company’s proprietary ARCUS technology. |
Accounting for Income Taxes | Accounting for Income Taxes The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized. In determining whether a tax position is recognized for financial statement purposes, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. |
Revenue Recognition | Revenue Recognition ASC 606 outlines a five-step process for recognizing revenue from contracts with customers: i) identify the contract with the customer, ii) identify the performance obligations in the contract, (iii) determine the transaction price, iv) allocate the transaction price to the separate performance obligations in the contract, and (v) recognize revenue associated with the performance obligations as they are satisfied. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Once a contract is determined to be within the scope of ASC 606, the Company determines the performance obligations that are distinct. The Company recognizes as revenues the amount of the transaction price that is allocated to each respective performance obligation when the performance obligation is satisfied or as it is satisfied. Generally, the Company's performance obligations are transferred to customers at a point in time, typically upon receipt of the product by the customer. 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 December 31, 2023, the Company had contract liabilities of $ 8.1 million, which are the upfront payments received as part of the Esteve Germany distribution agreement entered into in 2021 and the Chance China distribution agreement entered into in May 2023. The Company did no t have any contract assets as of December 31, 2023 or 2022. Product Revenues, Net Inbrija is distributed in the U.S. primarily through: a specialty pharmacy associated with the Company’s e-prescribing program, described below; AllianceRx Walgreens Prime, or Walgreens, a specialty pharmacy that delivers the medication to patients by mail; the cash pay program through Sterling and ASD Specialty Healthcare, Inc. (an Amerisource Bergen affiliate). Walgreens is the sole specialty pharmacy for U.S. sales of Inbrija. In 2022, the Company implemented an e-prescribing program for the distribution of Inbrija in the U.S. through a specialty pharmacy that supports electronic prescriptions. The Company believes the convenience of electronic prescribing may be preferred by some physicians and patients. Ampyra is distributed primarily through a network of specialty pharmacies, which deliver the medication to patients by mail. Net revenues from product sales is recognized at the transaction price when the customer obtains control of the Company’s products, which occurs at a point in time, typically upon receipt of the product by the customer, such as specialty pharmacy companies and distributors. The Company’s payment terms are between 30 to 60 days. The Company’s net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC 606 and are recorded for the Company’s estimate of cash consideration expected to be given by the Company to a customer that is presumed to be a reduction of the transaction price of the Company’s products and, therefore, are characterized as a reduction of revenue. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Discounts and Allowances Revenues from product sales are recorded at the transaction price, which includes estimates for discounts and allowances for which reserves are established and includes cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. Actual discounts and allowances are recorded following shipment of product and the appropriate reserves are credited. These reserves are classified as reductions of accounts receivable (if the amount is payable to the customer and right of offset exists) or a current liability (if the amount is payable to a party other than a customer). These allowances are established by management as its best estimate based on historical experience and data points available and are adjusted to reflect known changes in the factors that impact such reserves. Allowances for customer credits, chargebacks, rebates, data fees and wholesaler fees for services, returns, and discounts are established based on contractual terms with customers and analyses of historical usage of these items. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The nature of the Company’s allowances and accruals requiring critical estimates, and the specific considerations it uses in estimating their amounts are as follows: Government Chargebacks and Rebates: The Company contracts for Medicaid and other U.S. federal government programs to allow for its products to remain eligible for reimbursement under these programs. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. Based on the Company’s contracts and the most recent experience with respect to sales through each of these channels, the Company provides an allowance for chargebacks and rebates. The Company monitors the sales trends and adjust the chargeback and rebate percentages on a regular basis to reflect the most recent chargebacks and rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Managed Care Contract Rebates: The Company contracts with various managed care organizations including health insurance companies and pharmacy benefit managers. These contracts stipulate that rebates and, in some cases, administrative fees, are paid to these organizations provided the Company’s product is placed on a specific tier on the organization’s drug formulary. Based on the Company’s contracts and the most recent experience with respect to sales through managed care channels, the Company provides an allowance for managed care contract rebates. The Company monitors the sales trends and adjust the allowance on a regular basis to reflect the most recent rebate experience. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. Copay Mitigation Rebates: The Company offers copay mitigation to commercially insured patients who have coverage for their products (in accordance with applicable law) and are responsible for a cost share. Based on the Company’s contracts and the most recent experience with respect to actual copay assistance provided, the Company's provides an allowance for copay mitigation rebates. The Company monitors the sales trends and adjust the rebate percentages on a regular basis to reflect the most recent rebate experience. Cash Discounts: The Company sells directly to companies in their distribution network, which primarily includes specialty pharmacies, which deliver the medication to patients by mail, and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate). The Company generally provides invoice discounts for prompt payment for its products. The Company estimates its cash discounts based on the terms offered to its customers. Discounts are estimated based on rates that are explicitly stated in the Company’s contracts as it is expected they will take the discount and are recorded as a reduction of revenue at the time of product shipment when product revenue is recognized. The Company adjusts estimates based on actual activity as necessary. Product Returns: The Company offers no right of return except for products damaged upon receipt to Ampyra and Inbrija customers or a limited right of return based on the product’s expiration date to previous Zanaflex and Qutenza customers. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized. The Company currently estimates product return liabilities using historical sales information and inventory remaining in the distribution channel. Data Fees and Fees for Services Payable to Specialty Pharmacies: The Company has contracted with certain specialty pharmacies to obtain transactional data related to its products in order to develop a better understanding of its selling channel as well as patient activity and utilization by the Medicaid program and other government agencies and managed care organizations. The Company pays a variable fee to the specialty pharmacies to provide the Company the data. The Company also pays the specialty pharmacies a fee in exchange for providing distribution and inventory management services, including the provision of inventory management data to the Company. The Company estimates its fee for service accruals and allowances based on sales to each specialty pharmacy and the applicable contracted rate. Royalty Revenues The Company recognizes revenue for royalties under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following: 1) sale or usage of the products or 2) satisfaction of the performance obligations. The Company has satisfied its performance obligations and therefore recognizes royalty revenue when the sales to which the royalties relate are completed. Royalty revenues recorded by the Company relate to the Company’s License and Collaboration agreement with Biogen for sales of Fampyra, and an agreement with Neurelis Inc. for sales of Valtoco. Royalty revenues from Neurelis was capped at $ 5.1 million. No further royalties from sales of Valtoco are expected. License Revenues License revenues relates to the Collaboration Agreement with Biogen which provides for milestone payments for the achievement of certain regulatory and sales milestones during the term of the agreement. Regulatory milestones are contingent upon the approval of Fampyra for new indications outside of the U.S. Sales milestones are contingent upon the achievement of certain net sales targets for Fampyra sales outside of the U.S. The Company recognizes license revenues under ASC 606, which provides constraints for entities to recognize license revenues which is deemed to be variable by requiring the Company to estimate the amount of consideration to which it is entitled in exchange for transferring the promised goods or services to a customer. The Company recognizes an estimate of revenues to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the milestone is achieved. For regulatory milestones, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s control or the licensee’s control, such as regulatory approvals, are generally not considered probable of being achieved until those approvals are received. For sales-based milestones, the Company recognizes revenues upon the achievement of the specific sale milestones. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from upfront license fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other rights and obligations, the Company determines whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, the Company uses its judgment in determining the appropriate method of measuring progress for purposes of recognizing revenue from the up-front license fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Esteve and Chance Distribution and Supply Agreements In November 2021, the Company entered into distribution and supply agreements with Esteve Pharmaceuticals to commercialize Inbrija in Germany. Under the terms of the distribution agreement, the Company received a $ 5.9 million upfront payment, and is entitled to receive additional sales-based milestones. Similarly, in July 2021, the Company entered into a distribution and supply agreement with Esteve to commercialize Inbrija in Spain. Under the terms of the supply agreements, the Company is entitled to receive a significant double-digit percent of the selling price of Inbrija in exchange for supply of the product. Esteve launched in Germany in June 2022, and Spain in February 2023. In May 2023, the Company entered into a distribution agreement and a commercial supply agreement with Hangzhou Chance Pharmaceuticals Co., Ltd (“Chance”), for the exclusive distribution of Inbrija in China. Chance is obligated to use commercially reasonable efforts to market Inbrija in China. The agreements remain in effect until the earlier of (a) the last commercial sale of Inbrija on a jurisdiction- by- jurisdiction basis, and (b) 12 years from the effective date of the agreements, subject to customary termination for insolvency and certain other termination rights. The Company received a non-refundable upfront payment of $ 2.5 million, and a near term milestone payment of up to $ 6 million, depending on the clinical study requirements to be determined by the Chinese National Medical Products Administration (NMPA). The Company will also receive $ 3 million upon regulatory approval of Inbrija in China, up to $ 132.5 million in sales milestones based on specified sales volumes, and a fixed fee for each carton of Inbrija supplied to Chance. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Esteve, is a customer. The Company identified the following promises in the arrangement: the trademark license and marketing and distribution rights and the supply of minimum purchase commitments. The Company further determined that the promise for additional supply exceeding minimum purchase commitments represented a customer option, which would create an obligation for the Company if exercised by Esteve. No additional or material upfront consideration is owed to the Company by Esteve upon exercise of the customer option for the right to additional supply and it is offered at the same percent of selling price as the supply of minimum purchase commitments. Accordingly, it was assessed as a material right and, therefore, a separate performance obligation in the arrangement. The Company then determined that the trademark license and marketing and distribution rights and the supply of minimum purchase commitments were not distinct from one another and must be combined as a performance obligation. Based on this determination, as well as the considerations noted above with respect to the material right for additional supply, the Company identified two distinct performance obligations at the inception of the contract: (i) the combined performance obligation, (ii) the material right for additional supply. As of December 31, 2023, the Company had contract liabilities of $ 8.1 million, as compared to $ 6.1 million as of December 31, 2022, which are the upfront payments received under the terms of the Company’s supply and distribution agreements with Hangzhou Chance Pharmaceuticals Co., Ltd. (“Chance”) and Esteve Pharmaceuticals GmbH (“Esteve Germany”) related to the commercialization of Inbrija in China and Germany, respectively. The Company did no t have any contract assets as of December 31, 2023 or 2022. The Company launched Inbrija in Germany in June 2022 and Spain in February 2023, and expects to launch in China in 2025 . The Company recognized $ 4.8 million of revenues during the period ended December 31, 2023 from the supply agreement with Esteve Pharmaceuticals. As of December 31, 2023, approximately $ 0.2 million of revenue is expected to be recognized from remaining performance obligations for the Esteve agreement over the next 12 months as goods are shipped. The Company expects to recognize revenue of these remaining performance obligations over the n ext 8 years in Germany and 11 years in China, with the balance recognized thereafter . The Company will re-evaluate the transaction price in each reporting period and as certain events are resolved or other changes in circumstances occur. Additionally, the Company is eligible to receive additional payments based on the achievements by Esteve and Chance of sales-based milestones. Variable consideration related these sales-based milestones was fully constrained due to the fact that it was probable that a significant reversal of cumulative revenue would occur, given the inherent uncertainty of success with these future milestones. The following table disaggregates the Company’s revenues by major source (in thousands): (In thousands) Fiscal Year Ended December 31, 2023 Fiscal Year Ended December 31, 2022 Revenues: Net product revenues: Ampyra $ 63,940 $ 72,945 Inbrija U.S. 33,644 27,989 Inbrija ex-U.S. 4,837 2,911 Total net product revenues 102,421 103,845 Royalty Revenues 15,113 14,221 License Revenue 99 500 Total net revenues $ 117,633 $ 118,566 |
Concentration of Risk | Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash, cash equivalents, restricted cash, short-term investments and accounts receivable. The Company does not require any collateral for its accounts receivable. The Company maintains cash, cash equivalents and restricted cash with approved financial institutions. The Company is exposed to credit risks and liquidity in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution. The Company does not own or operate, and currently does not plan to own or operate, facilities for production and packaging of its product Ampyra and Inbrija. It relies and expects to continue to rely on third parties for the production and packaging of its commercial products and clinical trial materials for all of its products except Inbrija. Prior to the sale of the facility in February 2021, the Company leased a manufacturing facility in Chelsea, Massachusetts which produced Inbrija for clinical trials and commercial supply. Prior to October 2022, the Company relied primarily on Alkermes for its supply of Ampyra. Under its supply agreement with Alkermes, the Company was obligated to purchase at least 75 % of its yearly supply of Ampyra from Alkermes, and was also required to make compensatory payments if it did not purchase 100 % of its requirements from Alkermes, subject to certain specified exceptions. The Company and Alkermes agreed that the Company may purchase up to 25 % of its annual requirements from Patheon, a mutually agreed-upon second manufacturing source, with compensatory payments. The Company and Alkermes also relied on a single third-party manufacturer, Regis, to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra. In October 2022, an arbitration panel issued a decision in the Company's dispute with Alkermes and awarded to the Company approximately $ 18.3 million including prejudgment interest and declared the Company's agreements with Alkermes unenforceable. Of the total award amount of $ 18.3 million, the Company recorded $ 16.6 million as a reduction to operating expenses and $ 1.7 million as interest income. As a result of the panel’s ruling, the Company no longer pays Alkermes any royalties on net sales for license and supply of Ampyra. The Company had previously designated Patheon, Inc. as a second manufacturing source of Ampyra. In connection with that designation, the Company entered into a manufacturing agreement with Patheon, and Alkermes assisted the Company in transferring manufacturing technology to Patheon. Patheon now supplies the Company with its Ampyra needs. The Company relies on a single third-party manufacturer to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra, and also on a single supplier for a critical excipient used in the manufacture of Ampyra. If these companies experience any disruption in their operations, the Company's supply of Ampyra could be delayed or interrupted until the problem is solved or the Company locates another source of supply or another packager, which may not be available. The Company may not be able to enter into alternative supply or packaging arrangements on terms that are commercially reasonable, if at all. Any new supplier or packager would also be required to qualify under applicable regulatory requirements. Because of these and other factors, the Company could experience substantial delays before they are able to obtain qualified replacement products or services from any new supplier or packager. The Company’s principal direct customers for the year ended December 31, 2023 were a network of specialty pharmacies and ASD Specialty Healthcare, Inc. (an Amerisource Bergen affiliate) for Inbrija and a network of specialty pharmacies for Ampyra. The Company periodically assesses the financial strength of these customers and establishes allowances for anticipated losses, if necessary. Five customers individually accounted for more than 10% of the Company’s revenues related to specialty pharmacies and approximately 90 % of total revenues in 2023, and approximately 91 % of total revenues in 2022. Four customers individually accounted for more than 10% of the Company’s accounts receivable related to specialty pharmacies and approximately 87 % of total accounts receivable as of December 31, 2023, and approximately 85 % of total accounts receivable as of December 31, 2022. |
Allowance for Cash Discounts | Allowance for Cash Discounts An allowance for cash discounts is accrued based on historical usage rates at the time of product shipment. The Company adjusts accruals based on actual activity as necessary. Cash discounts are typically settled with customers within 34 days after the end of each calendar month. The Company provided cash discount allowances of $ 2.0 million and $ 1.8 million for the years ended December 31, 2023 and 2022, respectively. The Company’s reserve for cash discount allowances was $ 0.3 million and $ 0.4 million as of December 31, 2023 and 2022, respectively. (in thousands) Cash Balance at December 31, 2021 $ 780 Allowances for sales 1,830 Actual credits ( 2,203 ) Balance at December 31, 2022 $ 407 Allowances for sales 1,978 Actual credits ( 2,058 ) Balance at December 31, 2023 $ 327 |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts A portion of the Company’s accounts receivable may not be collected. The Company provides reserves based on an evaluation of the aging of its trade receivable portfolio and an analysis of high-risk customers. The Company has not historically experienced material losses related to credit risk. The allowance for doubtful accounts is $ 0.2 million and $ 0.1 million as of December 31, 2023 and December 31, 2022, respectively. The Company recorded write-offs of $ 0.1 million and $ 0.2 million for the years ended December 31, 2023 and December 31, 2022, respectively. |
Allowance for Chargebacks | Allowance for Chargebacks Based upon the Company’s contracts and the most recent experience with respect to sales with the U.S. government, the Company provides an allowance for chargebacks. The Company monitors the sales trends and adjusts the chargebacks on a regular basis to reflect the most recent chargebacks experience. The Company recorded a charge of $ 3.0 million and $ 3.4 million for the years ended December 31, 2023 and December 31, 2022, respectively. The Company made a payment of $ 2.9 million and $ 3.2 million related to the chargebacks allowances for the years ended December 31, 2023 and December 31, 2022, respectively. The Company’s reserve for chargebacks allowance were $ 0.4 million as of December 31, 2023 and $ 0.3 million as of December 31, 2022. |
Contingencies | Contingencies The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. Litigation expenses are expensed as incurred. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts. The Company considers that fair value should be based on the assumptions market participants would use when pricing the asset or liability. The following methods are used to estimate the fair value of the Company’s financial instruments: (a) Cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these instruments; (b) Short-term investments are recorded based primarily on quoted market prices; (c) Finite-lived Inbrija intangible asset is measured at fair value using a discounted cash flow approach; (d) Acquired contingent consideration related to the Civitas acquisition is measured at fair value using a probability weighted, discounted cash flow approach; (e) Convertible senior secured notes due 2024 were measured at fair value based on market quoted prices of the debt securities; and (f) Derivative liability related to conversion options of the convertible senior secured notes due 2024 is measured at fair value using a binomial model. |
Earnings per Share | Earnings per Share Basic net income (loss) per share and diluted net income per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method), the vesting of restricted stock and the potential dilutive effects of the conversion options on the Company’s convertible debt. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. The dilutive effect of outstanding shares is reflected in diluted earnings per share by application of the treasury stock method or if-converted method, as applicable, at each reporting period. See Note 15 to the Company’s Consolidated Financial Statements included in this report for a discussion on earnings (loss) per share. |
Share-based Compensation | Share‑based Compensation The Company has various share‑based employee and non-employee compensation plans. See Note 6 to the Company’s Consolidated Financial Statements included in this report for a discussion of share-based compensation. The Company accounts for stock options and restricted stock granted to employees and non-employees by recognizing the costs resulting from all share-based payment transactions in the consolidated financial statements at their fair values. The Company estimates the fair value of each option on the date of grant using the Black‑Scholes closed-form option‑pricing model based on assumptions of expected volatility of its common stock, prevailing interest rates, an estimated forfeiture rate, and the expected term of the stock options, and the Company recognizes that cost as an expense ratably over the associated service period. |
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 to date are derived from the sales of Ampyra and Inbrija for the years ended December 31, 2023 and December 31, 2022, respectively. |
Accumulated Other Comprehensive Income | Accumulated Other Comprehensive Income Unrealized gains (losses) from the Company’s investment securities and adjustments for foreign currency translation are included in accumulated other comprehensive income within the consolidated balance sheet. |
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. As of December 31, 2023, the Company had cash, cash equivalents, and restricted cash of approximately $ 30.6 million. Restricted cash includes $ 0.4 million related to self-funded employee health insurance and $ 0.3 million is related to collateralized standby letters of credit. The Company incurred net losses of $ 252.9 million and $ 65.9 million for the years ended December 31, 2023 and 2022, respectively. 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 Financial 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 judgment 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. The Company believes that its existing cash and cash equivalents will not be sufficient to cover its cash flow requirements. The 2024 Notes mature on December 1, 2024 , unless earlier converted in accordance with their terms. However, the commencement of the Intended Chapter 11 Proceedings will constitute an event of default under the Indenture governing the 2024 Notes, which will in turn result in the 2024 Notes becoming immediately due and payable, along with accrued and unpaid interest. At December 31, 2023, the principal balance outstanding under the 2024 Notes was $ 207.0 million. Additionally, for the duration of the Intended Chapter 11 Proceedings, the Company’s operations and its ability to develop and execute its business plan, its financial condition, its liquidity and its continuation as a going concern will be subject to a high degree of risk and uncertainty associated with the Intended Chapter 11 Proceedings. The amount of the 2024 Notes significantly exceeds the price the Purchaser has agreed to pay for the Purchased Assets and the noteholders’ security interest in substantially all of the Company’s remaining assets (including any recovery the Company receives from its ongoing litigation with Alkermes as described in this Annual Report) will continue following the consummation of the Section 363 sale and Intended Chapter 11 Proceedings. |
Recent Accounting Pronouncements - Adopted | Recent 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 intra-period 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 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 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. |
Recent Accounting Pronouncements - Not Yet Adopted | Recent Accounting Pronouncements - Not Yet Adopted 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 November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures. This update requires a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and provide in interim periods all disclosures about a reportable segment's profit or loss and assets that are currently required annually. Additionally, it requires a public entity to disclose the title and position of the Chief Operating Decision Maker (CODM). The ASU does not change how a public entity identifies its operating segments, aggregates them, or applies the quantitative thresholds to determine its reportable segments. The new standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. This update enhances the transparency and decision usefulness of income tax disclosures. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. For entities other than public business entities, the amendments are effective for annual periods beginning after December 15, 2025. The Company is currently assessing the impact that this guidance may have on its consolidated financial statements. |
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 17 to the Company's Consolidated Financial Statements included in this report for a discussion of subsequent events. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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: December 31, 2023 December 31, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 29,979 $ 45,634 $ 37,536 Restricted cash 6,884 381 13,400 6,884 Restricted cash-non current 255 255 6,189 255 Total Cash, cash equivalents and restricted cash per statement of cash flows $ 44,675 $ 30,615 $ 65,223 $ 44,675 |
Schedule of Major Classes of Inventory | The following table provides the major classes of inventory: (In thousands) December 31, 2023 December 31, 2022 Raw materials $ 4,178 $ 6,212 Work-in-progress $ 2,491 $ — Finished goods 9,486 6,540 Total $ 16,155 $ 12,752 |
Disaggregation of Revenue | The following table disaggregates the Company’s revenues by major source (in thousands): (In thousands) Fiscal Year Ended December 31, 2023 Fiscal Year Ended December 31, 2022 Revenues: Net product revenues: Ampyra $ 63,940 $ 72,945 Inbrija U.S. 33,644 27,989 Inbrija ex-U.S. 4,837 2,911 Total net product revenues 102,421 103,845 Royalty Revenues 15,113 14,221 License Revenue 99 500 Total net revenues $ 117,633 $ 118,566 |
Summary of Allowance for Cash Discounts | (in thousands) Cash Balance at December 31, 2021 $ 780 Allowances for sales 1,830 Actual credits ( 2,203 ) Balance at December 31, 2022 $ 407 Allowances for sales 1,978 Actual credits ( 2,058 ) Balance at December 31, 2023 $ 327 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 December 31, 2023 December 31, 2022 Right-of-use assets Right of use assets $ 4,221 $ 5,287 Current lease liabilities Current portion of lease liabilities 1,588 1,545 Non-current lease liabilities Non-current portion of lease liabilities 3,166 4,341 |
Components of Lease Costs | The components of lease costs were as follows: Year ended December 31, Year ended December 31, (In thousands) 2023 2022 Operating lease cost $ 1,546 $ 3,843 Variable lease cost 426 2,005 Short-term lease cost 1 8 Total lease cost $ 1,973 $ 5,855 |
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) 2024 1,588 2025 1,633 2026 1,678 2027 357 2028 182 Later years — Total lease payments 5,438 Less: Imputed interest ( 684 ) Present value of lease liabilities 4,754 |
Summary of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information activity related to the Company’s operating leases are as follows: (In thousands) December 31, 2023 December 31, 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 1,545 $ 8,191 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets | Intangible assets consisted of the following: December 31, 2023 December 31, 2022 (Dollars In thousands) Estimated Cost Additions Disposals Accumulated Impairment Net Cost Disposals Accumulated Net Inbrija (1) 11 423,000 — — ( 148,691 ) ( 251,322 ) 22,987 423,000 — ( 117,927 ) 305,073 Website 1 - 3 10,902 — ( 281 ) ( 10,621 ) — — 14,585 ( 3,683 ) ( 10,888 ) 14 $ 433,902 $ — $ ( 281 ) $ ( 159,312 ) $ ( 251,322 ) $ 22,987 $ 437,585 $ ( 3,683 ) $ ( 128,815 ) $ 305,087 (1) In December 2018, the Company received FDA approval for Inbrija and accordingly reclassified the indefinite lived intangible assets to definite lived intangible assets and began amortizing the assets upon launch in February 2019 . |
Schedule of Estimated Future Amortization Expense for Intangible Assets | Estimated future amortization expense for intangible assets subsequent to December 31, 2023 is as follows: (In thousands) 2024 $ 2,578 2025 $ 2,578 2026 $ 2,578 2027 $ 2,578 2028 $ 2,578 Thereafter $ 10,097 $ 22,987 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property and equipment | Property and equipment consisted of the following: (In thousands) December 31, 2023 December 31, 2022 Estimated Machinery and equipment $ 2,316 $ 2,315 2 - 7 years Leasehold improvements 2,024 1,761 Lesser of useful life or remaining lease term Computer equipment 2,620 4,467 1 - 3 years Laboratory equipment 468 582 2 - 5 years Furniture and fixtures 233 233 4 - 7 years 7,661 9,358 Less accumulated depreciation ( 5,582 ) ( 6,755 ) $ 2,079 $ 2,603 |
Common Stock Options and Rest_2
Common Stock Options and Restricted Stock (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Weighted Average Assumptions Using the Black-Scholes Option Pricing Model | The fair value of each option granted is estimated on the date of grant using the Black‑Scholes option‑pricing model with the following weighted average assumptions: Year ended December 31, 2023 2022 Employees and directors: Estimated volatility% 103.84 % 84.19 % Expected life in years 6.66 6.70 Risk free interest rate% 3.62 % 2.69 % Dividend yield — — |
Schedule of Share-based Compensation Expense | The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: Year ended December 31, (In thousands) 2023 2022 Research and development $ 11 $ 75 Selling, general and administrative 467 1,421 Total $ 478 $ 1,496 |
Schedule of Stock Option Activity | A summary of share‑based compensation activity for the year ended December 31, 2023 is presented below: Stock Option Activity Number thousands) Weighted-Average Weighted-Average Intrinsic Balance at December 31, 2022 52 $ 1,571.06 — — Granted 62 12.31 — — Forfeited and expired ( 11 ) 2,192.56 — — Exercised — — — — Balance at December 31, 2023 103 $ 568.85 7.5 $ 183,963 Vested and expected to vest at December 31, 2023 103 $ 572.25 7.5 $ 182,555 Vested and exercisable at December 31, 2023 59 $ 976.95 6.3 $ 79,123 |
Schedule of Stock Options Activity, By Exercise Price Range | Options Outstanding Options Exercisable Range of exercise price Outstanding as of Weighted-average Weighted- Exercisable as of Weighted- $ 6.19 - $ 11.29 4 7.6 $ 8.51 2 $ 7.39 $ 11.72 - $ 11.72 20 9.3 11.72 8 11.72 $ 12.25 - $ 12.50 30 9.0 12.50 11 12.50 $ 12.99 - $ 72.80 15 8.7 37.20 8 38.31 $ 74.80 - $ 75.00 11 7.4 74.84 6 74.86 $ 79.92 - $ 1,656.00 10 5.1 524.29 10 525.69 $ 1,794.00 - $ 4,288.80 10 2.1 3,634.83 10 3,634.83 $ 4,324.80 - $ 4,760.40 3 0.2 4,714.71 3 4,714.71 $ 4,797.60 - $ 4,797.60 0 0.1 4,797.60 0 4,797.60 $ 4,928.40 - $ 4,928.40 0 1.0 4,928.40 0 4,928.40 103 7.5 $ 568.85 59 $ 976.95 |
Schedule of Restricted Stock Activity | Restricted Stock Number of Shares Nonvested at December 31, 2022 $ — Granted — Vested — Forfeited — Nonvested at December 31, 2023 $ — |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 years ended December 31, 2023 and 2022: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Contractual interest expense $ 12,421 $ 12,420 Amortization of debt issuance costs 1,358 1,137 Amortization of debt discount 17,754 14,870 Total interest expense $ 31,533 $ 28,427 |
Convertible Senior Secured Notes due 2024 | |
Summary of Outstanding Note Balances | The outstanding 2024 Note balances as of December 31, 2023 and December 31, 2022 consisted of the following: (In thousands) December 31, 2023 December 31, 2022 Liability component: Principal $ 207,000 $ 207,000 Less: debt discount and debt issuance costs, net ( 20,857 ) ( 39,969 ) Net carrying amount 186,143 167,031 Equity component 18,257 $ 18,257 Derivative liability-conversion Option $ — $ — |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 years ended December 31, 2023 and December 2022. (In thousands) December 31, 2023 December 31, 2022 Liability related to sale of future royalties - beginning balance $ — $ 4,460 Deferred transaction costs amortized — 33 Non-cash royalty revenue payable to HCRP — ( 4,739 ) Non-cash interest expense recognized — 246 Liability related to sale of future royalties - ending balance $ — $ — |
Corporate Restructuring (Tables
Corporate Restructuring (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Summary of Restructuring Costs | A summary of the restructuring costs for the years ended December 31, 2023 and 2022 is as follows: (In thousands) Restructuring Costs Restructuring Liability as of December 31, 2021 $ 1,851 2022 Restructuring costs 251 2022 Payments ( 2,102 ) Restructuring Liability as of December 31, 2022 $ — 2023 Restructuring costs — 2023 Payments — Restructuring Liability as of December 31, 2023 $ — |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Expenses And Other Current Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Current liabilities | (In thousands) December 31, 2023 December 31, 2022 Product allowances accruals $ 9,750 $ 8,899 Bonus payable 3,719 4,329 Accrued interest 1,035 1,035 Sales force commissions and incentive payments payable 989 667 Administrative expenses — 366 Vacation accrual 1,494 1,477 Research and development expense accruals — 895 Commercial and marketing expense accruals — 2,892 Royalties payable 1,167 — Legal, accounting, and other professional services 1,521 50 Trade relations — 278 Other accrued expenses 4,635 2,792 Total $ 24,310 $ 23,680 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Minimum Significant Contractual Obligations | Payments due by period (1) (In thousands) Total Less than 1-3 years 4-5 years Convertible Senior Notes (2) $ 218,420 $ 218,420 $ — $ — Operating leases (3) 5,438 1,588 3,311 539 Inventory purchase commitments (4) 38,346 17,546 10,400 10,400 Catalent Termination (5) 4,000 4,000 — — Total 266,204 241,554 13,711 10,939 (1) Excludes a liability for uncertain tax positions totaling $ 6.0 million. This liability has been excluded because the Company cannot currently make a reliable estimate of the period in which the liability will be payable, if ever. (2) Represents the future payments of principal and interest to be made on the convertible senior secured notes due 2024 issued in December 2019. The notes are scheduled to mature on December 1, 2024 . However, the commencement of the Intended Chapter 11 Proceedings will constitute an event of default under the Indenture governing the 2024 Notes, which will in turn result in the 2024 Notes becoming immediately due and payable, along with accrued and unpaid interest. Refer to Note 7. (3) Represents payments for the operating leases of the Company’s Pearl River NY headquarters, the Company’s lab and office space in Waltham, MA. (4) Includes minimum purchase commitment from Catalent for Inbrija under the manufacturing services (supply) agreement. The Company terminated its existing supply agreement with Catalent on December 31, 2022 and renegotiated a new supply agreement effective January 1, 2023. Under the terms of the new supply agreement with Catalent, the Company is required to make minimum purchase obligations through 2024. Furthermore, the Company agreed that it would reimburse a portion of Catalent’s costs in completing the installation and qualification of the PSD-7, which the Company believes will be beneficial to its future production needs, in the amount of up to $ 2 million. The Company paid $ 0.5 million in 2023 and will provide up to $ 1.5 million in 2024 in two quarterly installments. (5) Represents the termination fee payable to Catalent that discontinued the Company's obligations under the 2021 MSA. The termination fee is payable in April 2024. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
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 and Non-recurring Basis | The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring and non-recurring basis as of December 31, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. (In thousands) Level 1 Level 2 Level 3 2023 Recurring: Assets Carried at Fair Value: Money market funds $ — $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 29,500 Non-Recurring: Assets Carried at Fair Value: Impaired finite-lived intangible — — 22,987 2022 Recurring: Assets Carried at Fair Value: Money market funds $ 15,322 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 41,200 |
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) Year ended December 31, 2023 Year ended December 31, 2022 Acquired contingent consideration: Balance, beginning of period $ 41,200 $ 49,600 Fair value change to contingent consideration (unrealized) statement of operations ( 9,634 ) ( 6,659 ) Royalty payments ( 2,066 ) ( 1,741 ) Balance, end of period $ 29,500 $ 41,200 |
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) Year ended December 31, 2023 Year ended December 31, 2022 Derivative Liability-Conversion Option Balance, beginning of period $ — $ 37 Fair value adjustment — ( 37 ) Balance, end of period $ — $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Domestic and Foreign Components of (Loss) Income Before Income Taxes | The domestic and foreign components of (loss) income before income taxes were as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Domestic $ ( 295,429 ) $ ( 60,179 ) Foreign ( 592 ) 24,932 Total $ ( 296,021 ) $ ( 35,247 ) |
Schedule of Benefit from Income Taxes | The benefit (expense) from income taxes in 2023 and 2022 consists of current and deferred federal, state and foreign taxes as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Current: Federal $ ( 118 ) $ ( 243 ) State ( 850 ) ( 115 ) Foreign ( 71 ) ( 37 ) ( 1,039 ) ( 395 ) Deferred: Federal 25,909 ( 30,234 ) State 18,297 ( 40 ) Foreign — — 44,206 ( 30,274 ) Total benefit from income taxes $ 43,167 $ ( 30,669 ) |
Schedule of Reconciliation of the Statutory U.S. Federal Income Tax Rate to the Entity's Effective Income Tax Rate | The reconciliation of the statutory U.S. federal income tax rate to the Company’s effective income tax rate is as follows: Year ended December 31, 2023 Year ended December 31, 2022 U.S. federal statutory tax rate 21.0 % 21.0 % State and local income taxes 4.6 % ( 0.3 )% Stock option compensation — ( 0.2 )% Stock option shortfall ( 0.7 )% ( 8.8 )% GILTI Inclusion — ( 8.3 )% Uncertain tax positions 0.1 % 0.4 % Other nondeductible and permanent differences ( 0.9 )% ( 7.7 )% U.S. write-off/expiration — ( 255.8 )% Valuation allowance, net of foreign tax rate ( 9.4 )% 151.6 % Biotie Finland cancellation of debt exclusion — 21.7 % Federal return to provision differences ( 0.1 )% ( 0.6 )% Effective income tax rate 14.6 % ( 87.0 )% |
Schedule of Deferred Tax Assets and Liabilities | The components of the deferred tax assets and liabilities are as follows: (In thousands) December 31, 2023 December 31, 2022 Deferred tax assets: Net operating loss carryforward $ 70,007 $ 74,576 Capital loss carryforward 11,227 11,100 Tax credits 34,292 34,301 Stock based compensation 6,475 8,896 Contingent consideration 7,827 10,807 Employee compensation 1,296 1,438 Rebate and returns reserve 2,419 2,003 Capitalized R&D 895 1,191 Other 5,424 5,421 Total deferred tax assets $ 139,862 $ 149,733 Valuation allowance ( 130,642 ) ( 106,702 ) Total deferred tax assets net of valuation allowance $ 9,220 $ 43,031 Deferred tax liabilities: Intangible assets ( 4,327 ) ( 77,876 ) Convertible debt ( 4,812 ) ( 9,190 ) Depreciation ( 81 ) ( 167 ) Total deferred tax liabilities $ ( 9,220 ) $ ( 87,233 ) Net deferred tax liability $ — $ ( 44,202 ) |
Schedule of Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits | The beginning and ending amounts of unrecognized tax benefits reconciles as follows: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Beginning of period balance $ 6,237 $ 6,370 Decreases for tax positions taken during a ( 212 ) ( 133 ) End of period balance $ 6,025 $ 6,237 |
Reconciliation of Beginning and Ending Amounts of Valuation Allowances | The beginning and ending amounts of valuation allowances reconcile as follows: Balance at Balance at (In thousands) Beginning of Period Additions Deductions End of Period Valuation allowance for deferred tax assets: Year ended December 31, 2022 $ 193,253 233 ( 86,784 ) $ 106,702 Year ended December 31, 2023 $ 106,702 27,866 ( 3,926 ) $ 130,642 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Earnings per Share | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2023 and 2022: (In thousands, except per share data) Year ended December 31, 2023 Year ended December 31, 2022 Basic and diluted Net loss $ ( 252,854 ) $ ( 65,916 ) Weighted average common shares outstanding used in 1,242 1,011 Plus: net effect of dilutive stock options and unvested — — Weighted average common shares outstanding used in 1,242 1,011 Net loss per share—basic $ ( 203.57 ) $ ( 65.23 ) Net loss per share—diluted $ ( 203.57 ) $ ( 65.23 ) |
Schedule of Anti-dilutive Securities Excluded from Calculation of Net Income per Diluted Share | The following amounts were not included in the calculation of net income per diluted share because their effects were anti-dilutive: (In thousands) Year ended December 31, 2023 Year ended December 31, 2022 Denominator Stock options and restricted common shares 103 50 |
Organization and Business Act_2
Organization and Business Activities - Additional Information (Details) - USD ($) | 12 Months Ended | ||||
Mar. 31, 2024 | Dec. 24, 2019 | Dec. 31, 2023 | Jan. 08, 2024 | Dec. 31, 2019 | |
Subsequent event | |||||
Organization and Business Activities [Line Items] | |||||
Sale of purchased assets | $ 185,000,000 | ||||
DIP Credit Facility | Maximum | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-possession term loan facility, maximum aggregate amount | $ 60,000,000 | ||||
DIP Credit Facility | Maximum | Subsequent event | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-possession term loan facility, maximum aggregate amount | $ 60,000,000 | ||||
Interim DIP Order | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-Possession Financing, Borrowings Outstanding | 0 | ||||
Interim DIP Order | Subsequent event | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-Possession Financing, Borrowings Outstanding | 0 | ||||
Interim DIP Loan Commitment | Maximum | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-Possession Financing, Borrowings Outstanding | 10,000,000 | ||||
Interim DIP Loan Commitment | Maximum | Subsequent event | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-Possession Financing, Borrowings Outstanding | 10,000,000 | ||||
Final DIP Loan Commitment | Maximum | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-possession term loan facility, maximum aggregate amount | 40,000,000 | ||||
Debtor-in-Possession Financing, Borrowings Outstanding | $ 10,000,000 | ||||
Final DIP Loan Commitment | Maximum | Subsequent event | |||||
Organization and Business Activities [Line Items] | |||||
Debtor-in-possession term loan facility, maximum aggregate amount | 40,000,000 | ||||
Debtor-in-Possession Financing, Borrowings Outstanding | $ 10,000,000 | ||||
Convertible Senior Secured Notes due 2024 | |||||
Organization and Business Activities [Line Items] | |||||
Interest rate (as a percent) | 6% | 6% | 6% | ||
Notes maturity date | Dec. 01, 2024 | Dec. 01, 2024 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||||||||||
Jun. 02, 2023 shares | Sep. 30, 2022 | Dec. 24, 2019 USD ($) | Oct. 01, 2017 USD ($) | Oct. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) Customer Segment shares | Dec. 31, 2022 USD ($) Segment shares | Dec. 31, 2020 | Mar. 31, 2023 shares | Dec. 31, 2021 USD ($) | Sep. 17, 2020 shares | Dec. 31, 2019 shares | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Reverse stock split, description | 1-for-20 reverse stock split | 1-for-20 reverse stock split | ||||||||||
Stockholders' equity note, stock split, conversion ratio | 0.05 | |||||||||||
Common stock, Authorized shares | shares | 3,083,333 | 3,083,333 | 61,666,666 | 13,333,333 | ||||||||
Other Comprehensive Income (Loss) | ||||||||||||
Foreign currency translation adjustment, Tax | $ 0 | $ 0 | ||||||||||
Foreign currency translation adjustment | 797,000 | 1,645,000 | ||||||||||
Property and Equipment | ||||||||||||
Impairment Charges | 251,300,000 | |||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Liability related to sale of future royalties | 0 | |||||||||||
Operating expenses | 382,585,000 | 153,906,000 | ||||||||||
Interest income | $ 530,000 | 1,909,000 | ||||||||||
Allowance for Cash Discounts | ||||||||||||
Time period needed typically to settle cash discounts | 34 days | |||||||||||
Allowance for cash discounts | $ 2,000,000 | 1,800,000 | ||||||||||
Reserve for allowance for cash discounts | 300,000 | 400,000 | ||||||||||
Allowance for Doubtful Accounts | ||||||||||||
Allowance for doubtful accounts | 200,000 | 100,000 | ||||||||||
Allowance for doubtful accounts, write-offs | 100,000 | 200,000 | ||||||||||
Allowance related to chargebacks | 3,000,000 | 3,400,000 | ||||||||||
Payment related to chargebacks | 2,900,000 | 3,200,000 | ||||||||||
Reserve for chargebacks allowance | $ 400,000 | $ 300,000 | ||||||||||
Segment and Geographic Information | ||||||||||||
Number of operating segments | Segment | 1 | 1 | ||||||||||
Number of reportable operating segments | Segment | 1 | 1 | ||||||||||
Cash, cash equivalents, and restricted cash | $ 30,615,000 | $ 44,675,000 | $ 65,223,000 | |||||||||
Restricted cash | 700,000 | |||||||||||
Net Income (Loss) | $ (252,854,000) | (65,916,000) | ||||||||||
Product revenue | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Number of customers | Customer | 5 | |||||||||||
Accounts receivable | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Number of customers | Customer | 4 | |||||||||||
Convertible Senior Secured Notes due 2024 | ||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Reverse stock split, description | 1-for-6 | |||||||||||
Segment and Geographic Information | ||||||||||||
Notes, maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||||||||
Principal | $ 207,000,000 | $ 207,000,000 | ||||||||||
VERSION A | ||||||||||||
Segment and Geographic Information | ||||||||||||
Cash, cash equivalents, and restricted cash | 30,600,000 | |||||||||||
Net Income (Loss) | $ (252,900,000) | $ (65,900,000) | ||||||||||
Alkermes | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Litigation Settlement, Amount Awarded from Other Party | $ 18,300,000 | |||||||||||
Operating expenses | 16,600,000 | |||||||||||
Interest income | 1,700,000 | |||||||||||
Alkermes | Supply agreement | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Litigation Settlement, Amount Awarded from Other Party | $ 18,300,000 | |||||||||||
Royalty Agreement | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Non cash royalty payment received | $ 40,000,000 | |||||||||||
Estimated effective annual interest rate | 15% | |||||||||||
Minimum | ||||||||||||
Property and Equipment | ||||||||||||
Estimated useful lives | 1 year | |||||||||||
Minimum | Supply agreement | Alkermes License Agreement | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Purchase requirements threshold percentage | 75% | |||||||||||
Maximum | ||||||||||||
Property and Equipment | ||||||||||||
Estimated useful lives | 7 years | |||||||||||
Maximum | Supply agreement | Alkermes License Agreement | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Purchase requirements threshold percentage | 100% | |||||||||||
Maximum | Supply agreement | Patheon Inc Second Manufacturing agreement | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Purchase requirements threshold percentage | 25% | |||||||||||
UNITED STATES | Customers | Product revenue | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Concentration risk, percentage | 90% | 91% | ||||||||||
UNITED STATES | Customers | Accounts receivable | ||||||||||||
Non-Cash Interest Expense on Liability Related to Sale of Future Royalties | ||||||||||||
Concentration risk, percentage | 87% | 85% | ||||||||||
Self-Funded Employee Health Insurance | ||||||||||||
Segment and Geographic Information | ||||||||||||
Restricted cash | $ 400,000 | |||||||||||
Self-Funded Employee Health Insurance | VERSION A | ||||||||||||
Segment and Geographic Information | ||||||||||||
Restricted cash | 400,000 | |||||||||||
Letters of Credit | ||||||||||||
Restricted Cash | ||||||||||||
Restricted Cash and Cash Equivalents | 300,000 | |||||||||||
Segment and Geographic Information | ||||||||||||
Restricted cash | 300,000 | |||||||||||
Letters of Credit | VERSION A | ||||||||||||
Segment and Geographic Information | ||||||||||||
Restricted cash | $ 300,000 | |||||||||||
Previously Reported | ||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||
Common stock, Authorized shares | shares | 3,083,333 | 61,666,666 | 61,666,666 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Revenue Recognition - (Additional Information) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
May 31, 2023 | Nov. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Contract Liabilities | $ 8,100,000 | |||
Contract Assets | 0 | $ 0 | ||
Revenues | 117,633,000 | 118,566,000 | ||
Hangzhou Chance Pharmaceuticals Co., Ltd | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Termination period | 12 years | |||
Non-refundable upfront payment | $ 2,500,000 | |||
Amount receivable upon regulatory approval | 3,000,000 | |||
Esteve Germany [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Upfront Payment Received | $ 5,900,000 | |||
Esteve Pharmaceuticals and Hangzhou Chance Pharmaceuticals Co Ltd [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Contract Liabilities | 8,100,000 | 6,100,000 | ||
Revenue from remaining performance obligation | 200,000 | |||
Esteve Pharmaceuticals | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Revenues | 4,800,000 | |||
Royalty Revenues | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Revenues | 15,113,000 | $ 14,221,000 | ||
Royalty Revenues | Neurelis Collaboration Agreement | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Royalty revenue capped | $ 5,100,000 | |||
Minimum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Product revenue payment term | 30 days | |||
Maximum | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Product revenue payment term | 60 days | |||
Maximum | Hangzhou Chance Pharmaceuticals Co., Ltd | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Near term milestone payment | 6,000,000 | |||
Sales milestones | $ 132,500,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Additional Information (Details1) - Esteve Pharmaceuticals and Hangzhou Chance Pharmaceuticals Co., Ltd. $ in Millions | Dec. 31, 2023 USD ($) |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue from remaining performance obligation | $ 0.2 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2040-01-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | |
Germany | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 8 years |
China | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-01-01 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 11 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 29,979 | $ 37,536 | $ 45,634 |
Restricted cash | 381 | 6,884 | 13,400 |
Restricted cash-non current | 255 | 255 | 6,189 |
Total Cash, cash equivalents and restricted cash per statement of cash flows | $ 30,615 | $ 44,675 | $ 65,223 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Schedule of Major Classes of Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,178 | $ 6,212 |
Work-in-progress | 2,491 | |
Finished goods | 9,486 | 6,540 |
Total | $ 16,155 | $ 12,752 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | $ 117,633 | $ 118,566 |
Ampyra | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | 63,940 | 72,945 |
Inbrija U.S. | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | 33,644 | 27,989 |
Inbrija ex-U.S. | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | 4,837 | 2,911 |
Net Product Revenues | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | 102,421 | 103,845 |
Royalty Revenues | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | 15,113 | 14,221 |
License Revenue | ||
Disaggregation Of Revenue [Line Items] | ||
Total net revenues | $ 99 | $ 500 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Summary of Allowance for Cash Discounts (Details) - Cash discounts - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Valuation And Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ 407 | $ 780 |
Allowances for sales | 1,978 | 1,830 |
Actual credits | (2,058) | (2,203) |
Ending balance | $ 327 | $ 407 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 12 Months Ended | |||||
Dec. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) ft² OperatingLease | Dec. 31, 2022 USD ($) | Jul. 31, 2023 ft² | Jun. 30, 2022 ft² | Oct. 31, 2016 USD ($) ft² | |
Operating Lease Information | ||||||
Right-of-use assets | $ 4,221 | $ 5,287 | ||||
Operating lease description | As of December 31, 2023, the Company serves as the lessee for two operating leases. The Company's leases have remaining lease terms of 3 years to 4.5 years. | |||||
Operating lease renewal option | true | |||||
Operating lease weighted-average remaining lease term | 3 years 4 months 24 days | |||||
Operating lease weighted-average discount rate | 7.97% | |||||
Sublease rental income recognized | $ 300 | |||||
Number of operating leases | OperatingLease | 2 | |||||
Forecast [Member] | ||||||
Operating Lease Information | ||||||
Sublease rental income recognized | $ 700 | |||||
Ardsley, New York | ||||||
Operating Lease Information | ||||||
Area of leased property | ft² | 160,000 | |||||
Termination option effective date | Jun. 22, 2022 | |||||
Termination Fee | $ 4,700 | |||||
Pearl River, New York | ||||||
Operating Lease Information | ||||||
Lease term | 6 years | |||||
Area of leased property | ft² | 21,000 | |||||
Operating sublease, existence of option to extend | false | |||||
Base rent payment commencing on January 1, 2023 | $ 300 | |||||
Base rent subject to annual escalation percentage | 2% | |||||
Waltham, MA | ||||||
Operating Lease Information | ||||||
Area of space sublet to third party under operating lease | ft² | 13,000 | |||||
Percentage of area of space sublet to third party under operating lease | 49% | |||||
Waltham, MA | Office and Laboratory Space | ||||||
Operating Lease Information | ||||||
Lease term | 10 years | |||||
Area of leased property | ft² | 26,000 | |||||
Base Rent | $ 1,300 | |||||
Minimum | ||||||
Operating Lease Information | ||||||
Operating lease remaining lease term | 3 years | |||||
Maximum | ||||||
Operating Lease Information | ||||||
Operating lease remaining lease term | 4 years 6 months |
Leases - Schedule of ROU Assets
Leases - Schedule of ROU Assets and Lease Liabilities Related to Operating Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Right-of-use assets | $ 4,221 | $ 5,287 |
Current lease liabilities | 1,588 | 1,545 |
Non-current lease liabilities | $ 3,166 | $ 4,341 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Leases [Abstract] | ||
Operating lease cost | $ 1,546 | $ 3,843 |
Variable lease cost | 426 | 2,005 |
Short-term lease cost | 1 | 8 |
Total lease cost | $ 1,973 | $ 5,855 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Leases [Abstract] | |
2024 | $ 1,588 |
2025 | 1,633 |
2026 | 1,678 |
2027 | 357 |
2028 | 182 |
Total lease payments | 5,438 |
Less: Imputed interest | (684) |
Operating Lease, Liability | $ 4,754 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating cash flow information: | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 1,545 | $ 8,191 |
Intangible Assets - Additional
Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2018 | |
Intangible Assets | |||
Impairment Charges | $ 251,300 | ||
Amortization expenses of intangible assets including website development | 30,800 | $ 30,800 | |
Amortization expenses of intangible assets | $ 30,764 | $ 30,764 | |
Weighted-average remaining useful lives of all amortizable assets | 11 years | ||
Inbrija | IPR&D | |||
Intangible Assets | |||
Indefinite-lived intangible asset, Cost | $ 423,000 |
Intangible Assets - Schedule of
Intangible Assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Intangible Assets | ||
Finite-lived intangible asset, Accumulated Amortization | $ (159,312) | $ (128,815) |
Finite-lived intangible asset, Net Carrying Amount | 22,987 | 305,087 |
Finite-lived intangible asset, Impairment | (251,322) | |
Intangible asset, Cost | 433,902 | 437,585 |
Intangible asset, Disposals | (281) | (3,683) |
Intangible asset, Net Carrying Amount | 22,987 | 305,087 |
Inbrija | ||
Intangible Assets | ||
Finite-lived intangible asset, Accumulated Amortization | $ (148,691) | $ (117,927) |
Estimated Remaining Useful Lives (Years) | 11 years | 11 years |
Finite-lived intangible asset, Cost | $ 423,000 | $ 423,000 |
Finite-lived intangible asset, Net Carrying Amount | 22,987 | 305,073 |
Finite-lived intangible asset, Impairment | (251,322) | |
Website Development Costs | Minimum | ||
Intangible Assets | ||
Finite-lived intangible asset, Accumulated Amortization | $ (10,621) | $ (10,888) |
Estimated Remaining Useful Lives (Years) | 1 year | 1 year |
Finite-lived intangible asset, Cost | $ 10,902 | $ 14,585 |
Finite-lived intangible asset, Disposals | $ (281) | (3,683) |
Finite-lived intangible asset, Net Carrying Amount | $ 14 | |
Website Development Costs | Maximum | ||
Intangible Assets | ||
Estimated Remaining Useful Lives (Years) | 3 years | 3 years |
Intangible Assets - Schedule _2
Intangible Assets - Schedule of Estimated Future Amortization Expense for Intangible Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Estimated future amortization expense | ||
2024 | $ 2,578 | |
2025 | 2,578 | |
2026 | 2,578 | |
2027 | 2,578 | |
2028 | 2,578 | |
Thereafter | 10,097 | |
Finite-lived intangible asset, Net Carrying Amount | $ 22,987 | $ 305,087 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and Equipment | ||
Property and equipment | $ 7,661 | $ 9,358 |
Less accumulated depreciation | (5,582) | (6,755) |
Property and equipment, net | $ 2,079 | 2,603 |
Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 1 year | |
Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years | |
Machinery and equipment | ||
Property and Equipment | ||
Property and equipment | $ 2,316 | 2,315 |
Machinery and equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 2 years | |
Machinery and equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years | |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment | $ 2,024 | 1,761 |
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember | |
Computer equipment | ||
Property and Equipment | ||
Property and equipment | $ 2,620 | 4,467 |
Computer equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 1 year | |
Computer equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 3 years | |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment | $ 468 | 582 |
Laboratory equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 2 years | |
Laboratory equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 5 years | |
Furniture and fixtures | ||
Property and Equipment | ||
Property and equipment | $ 233 | $ 233 |
Furniture and fixtures | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 4 years | |
Furniture and fixtures | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 0.9 | $ 1.9 |
Common Stock Options and Rest_3
Common Stock Options and Restricted Stock - Additional Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||
Jun. 02, 2023 shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 | Mar. 31, 2023 shares | Sep. 17, 2020 shares | Dec. 31, 2019 shares | Jun. 19, 2019 $ / shares | |
Share-based compensation expense | ||||||||
Reverse stock split, description | 1-for-20 reverse stock split | 1-for-20 reverse stock split | ||||||
Stockholders' equity note, stock split, conversion ratio | 0.05 | |||||||
Common stock, Authorized shares | 3,083,333 | 3,083,333 | 61,666,666 | 13,333,333 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||
Options granted (in shares) | 62,000 | |||||||
Weighted average exercise price | $ / shares | $ 568.85 | $ 1,571.06 | ||||||
Share-based compensation expense recognized | $ | $ 478 | $ 1,496 | ||||||
Total unrecognized compensation costs related to unvested stock options and restricted stock awards that the company expects to recognize | $ | $ 500 | |||||||
Weighted average period | 1 year 2 months 12 days | |||||||
Stock Options | Employees and Directors | ||||||||
Share-based compensation expense | ||||||||
Weighted average fair value of options granted (in dollars per share) | $ / shares | $ 9.86 | $ 0.84 | ||||||
Options granted (in shares) | 62,270 | |||||||
Weighted average exercise price | $ / shares | $ 12.31 | |||||||
Total compensation charge to be recognized over service period | $ | $ 600 | |||||||
Share-based compensation expense recognized | $ | $ 300 | |||||||
Stock Options | Non Employee | ||||||||
Share-based compensation expense | ||||||||
Options granted (in shares) | 0 | 0 | ||||||
Stock Options and Restricted Stock Awards | Employees and Directors | ||||||||
Share-based compensation expense | ||||||||
Share-based compensation expense recognized | $ | $ 500 | $ 1,500 | ||||||
The 2006 Plan | ||||||||
Share-based compensation expense | ||||||||
Expiration period | 10 years | |||||||
Number of shares authorized for issuance | 124,267 | |||||||
Aggregate restricted stock granted (in shares) | 100,154 | |||||||
Remaining restricted stock subject to outstanding options (in shares) | 5,945 | |||||||
The 2015 Plan | ||||||||
Share-based compensation expense | ||||||||
Expiration period | 10 years | |||||||
Number of shares authorized for issuance | 157,500 | |||||||
Aggregate restricted stock granted (in shares) | 124,796 | |||||||
Remaining restricted stock subject to outstanding options (in shares) | 88,941 | |||||||
The 2016 Plan | ||||||||
Share-based compensation expense | ||||||||
Options Issued | 8,500 | |||||||
The 2019 ESPP Plan | ||||||||
Share-based compensation expense | ||||||||
Common stock, Authorized shares | 12,500 | |||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | |||||||
Previously Reported | ||||||||
Share-based compensation expense | ||||||||
Common stock, Authorized shares | 3,083,333 | 61,666,666 | 61,666,666 |
Common Stock Options and Rest_4
Common Stock Options and Restricted Stock - Schedule of Weighted Average Assumptions Using the Black-Scholes Option Pricing Model (Details) - Stock Options | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Estimated volatility (as a percent) | 103.84% | 84.19% |
Expected life | 6 years 7 months 28 days | 6 years 8 months 12 days |
Risk free interest rate (as a percent) | 3.62% | 2.69% |
Common Stock Options and Rest_5
Common Stock Options and Restricted Stock - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense recognized | $ 478 | $ 1,496 |
Research And Development [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense recognized | 11 | 75 |
Selling, general and administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense recognized | $ 467 | $ 1,421 |
Common Stock Options and Rest_6
Common Stock Options and Restricted Stock - Schedule of Stock Options Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Stock Option Activity | |
Beginning balance (in shares) | shares | 52 |
Granted (in shares) | shares | 62 |
Forfeited and expired (in shares) | shares | (11) |
Ending balance (in shares) | shares | 103 |
Vested and expected to vest at the end of the period | shares | 103 |
Vested and exercisable at the end of the period | shares | 59 |
Weighted Average Exercise Price | |
Balance at the beginning of the period (in dollars per share) | $ / shares | $ 1,571.06 |
Granted (in dollars per share) | $ / shares | 12.31 |
Forfeited and expired (in dollars per share) | $ / shares | 2,192.56 |
Balance at the end of the period (in dollars per share) | $ / shares | 568.85 |
Vested and expected to vest at the end of the period (in dollars per share) | $ / shares | 572.25 |
Vested and exercisable at the end of the period (in dollars per share) | $ / shares | $ 976.95 |
Weighted Average Remaining Contractual Term | |
Balance at the end of the period | 7 years 6 months |
Vested and expected to vest at the end of the period | 7 years 6 months |
Vested and exercisable at the end of the period | 6 years 3 months 18 days |
Intrinsic Value | |
Balance at the end of the period | $ | $ 183,963 |
Vested and expected to vest at the end of the period | $ | 182,555 |
Vested and exercisable at the end of the period | $ | $ 79,123 |
Common Stock Options and Rest_7
Common Stock Options and Restricted Stock - Schedule of Stock Options Activity, By Exercise Price Range (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 103 |
Weighted-average remaining contractual life | 7 years 6 months |
Weighted-average exercise price (in dollars per share) | $ 568.85 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 59 |
Weighted-average exercise price (In dollars per share) | $ 976.95 |
Range $6.19 - $11.29 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 6.19 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 11.29 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 4 |
Weighted-average remaining contractual life | 7 years 7 months 6 days |
Weighted-average exercise price (in dollars per share) | $ 8.51 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 2 |
Weighted-average exercise price (In dollars per share) | $ 7.39 |
Range$11.72 - $11.72 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 11.72 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 11.72 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 20 |
Weighted-average remaining contractual life | 9 years 3 months 18 days |
Weighted-average exercise price (in dollars per share) | $ 11.72 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 8 |
Weighted-average exercise price (In dollars per share) | $ 11.72 |
Range $12.25 - $12.50 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 12.25 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 12.5 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 30 |
Weighted-average remaining contractual life | 9 years |
Weighted-average exercise price (in dollars per share) | $ 12.5 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 11 |
Weighted-average exercise price (In dollars per share) | $ 12.5 |
Range $12.99 - $72.80 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 12.99 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 72.8 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 15 |
Weighted-average remaining contractual life | 8 years 8 months 12 days |
Weighted-average exercise price (in dollars per share) | $ 37.2 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 8 |
Weighted-average exercise price (In dollars per share) | $ 38.31 |
Range $74.80 - $75.00 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 74.8 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 75 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 11 |
Weighted-average remaining contractual life | 7 years 4 months 24 days |
Weighted-average exercise price (in dollars per share) | $ 74.84 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 6 |
Weighted-average exercise price (In dollars per share) | $ 74.86 |
Range $79.92 - $1,656.00 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 79.92 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 1,656 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 10 |
Weighted-average remaining contractual life | 5 years 1 month 6 days |
Weighted-average exercise price (in dollars per share) | $ 524.29 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 10 |
Weighted-average exercise price (In dollars per share) | $ 525.69 |
Range $1,794.00 - $4,288.80 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 1,794 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 4,288.8 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 10 |
Weighted-average remaining contractual life | 2 years 1 month 6 days |
Weighted-average exercise price (in dollars per share) | $ 3,634.83 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 10 |
Weighted-average exercise price (In dollars per share) | $ 3,634.83 |
Range $4,324.80 - $4,760.40 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 4,324.8 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 4,760.4 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 3 |
Weighted-average remaining contractual life | 2 months 12 days |
Weighted-average exercise price (in dollars per share) | $ 4,714.71 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 3 |
Weighted-average exercise price (In dollars per share) | $ 4,714.71 |
Range $4,797.60 - $4,797.60 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 4,797.6 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 4,797.6 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 0 |
Weighted-average remaining contractual life | 1 month 6 days |
Weighted-average exercise price (in dollars per share) | $ 4,797.6 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 0 |
Weighted-average exercise price (In dollars per share) | $ 4,797.6 |
Range $4,928.40 - $4,928.40 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 4,928.4 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 4,928.4 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 0 |
Weighted-average remaining contractual life | 1 year |
Weighted-average exercise price (in dollars per share) | $ 4,928.4 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 0 |
Weighted-average exercise price (In dollars per share) | $ 4,928.4 |
Debt - Additional Information (
Debt - Additional Information (Details) $ / shares in Units, € in Millions | 9 Months Ended | 12 Months Ended | ||||||||
Jun. 02, 2023 | Sep. 17, 2020 USD ($) shares | Dec. 24, 2019 USD ($) | Sep. 30, 2020 USD ($) | Dec. 31, 2023 USD ($) Loan $ / shares shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2020 | Dec. 31, 2019 USD ($) shares | Dec. 31, 2023 EUR (€) shares | Jul. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | ||||||||||
Cash payment made for exchange of notes | $ 200 | |||||||||
Aggregate payment on debt exchange | 55,200,000 | |||||||||
Reverse stock split, description | 1-for-20 reverse stock split | 1-for-20 reverse stock split | ||||||||
Maximum number of shares issued | shares | 969,102 | 969,102 | ||||||||
Gain on extinguishment of debt | $ 27,142,000 | $ 55,100,000 | ||||||||
Adjusted equity component of convertible notes exchange | $ 38,400,000 | |||||||||
Common stock, Authorized shares | shares | 61,666,666 | 3,083,333 | 3,083,333 | 13,333,333 | 3,083,333 | |||||
Derivative liability reclassified to equity | $ 18,300,000 | |||||||||
Income tax effects on equity transactions | $ 4,400,000 | $ 4,400,000 | ||||||||
Interest expense | 31,533,000 | $ 30,200,000 | ||||||||
Letters of Credit | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Restricted Cash and Cash Equivalents | 300,000 | |||||||||
Non-Convertible Capital Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Fair value of debt | $ 20,500,000 | € 18.2 | ||||||||
Number of loans | Loan | 14 | |||||||||
Non-Convertible Capital Loan | Finland's Ministry of Finance | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Residual payment amount | $ 100,000 | |||||||||
Convertible Senior Notes due 2021 | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount of debt exchanged | $ 276,000,000 | |||||||||
Interest rate (as a percent) | 1.75% | |||||||||
Principal amount denomination for debt conversion | $ 1,000 | |||||||||
Debt instrument, principal amount outstanding | $ 69,000,000 | |||||||||
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 | $ 207,000,000 | ||||||||
Debt instrument, principal amount outstanding | $ 207,000,000 | 207,000,000 | ||||||||
Notes maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||||||
Notes frequency of periodic payment | semi-annually in arrears | |||||||||
Initial conversion rate of common stock | 0.0002381 | |||||||||
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares | $ 420 | |||||||||
Principal amount of Notes or an integral multiple thereof in which holder may repurchase the Notes | $ 1,000 | |||||||||
Reverse stock split, description | 1-for-6 | |||||||||
Debt instrument conversion threshold stock price percentage | 130% | |||||||||
Debt repurchase price percentage on principal amount | 100% | |||||||||
Debt default, nonpayment 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 | |||||||||
Debt discount | 75,100,000 | |||||||||
Interest expense | $ 31,533,000 | $ 28,427,000 | ||||||||
Effective interest rate on liability component (as a percent) | 18.13% | 18.13% | ||||||||
Debt fair value amount | $ 157,300,000 | |||||||||
Debt Issuance Costs, Gross | $ 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) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 24, 2019 |
Convertible Senior Notes due 2021 | |||
Debt Instrument [Line Items] | |||
Principal | $ 69,000 | ||
Convertible Senior Secured Notes due 2024 | |||
Debt Instrument [Line Items] | |||
Principal | 207,000 | $ 207,000 | |
Less: debt discount and debt issuance costs, net | (20,857) | (39,969) | |
Net carrying amount | 186,143 | 167,031 | |
Equity component | $ 18,257 | $ 18,257 | |
Derivative liability-conversion Option | $ 59,400 |
Debt - Schedule of Interest Exp
Debt - Schedule of Interest Expense Recognized Related to the Notes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||
Total interest expense | $ 31,533 | $ 30,200 |
Convertible Senior Secured Notes due 2024 | ||
Debt Instrument [Line Items] | ||
Contractual interest expense | 12,421 | 12,420 |
Amortization of debt issuance costs | 1,358 | 1,137 |
Amortization of debt discount | 17,754 | 14,870 |
Total interest expense | $ 31,533 | $ 28,427 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties - Additional Information (Details) - Royalty Purchase Agreement $ in Millions | Oct. 01, 2017 USD ($) |
Liability Related to Sale of Future Royalties [Line Items] | |
Payment from royalties | $ 40 |
Royalty liability | 40 |
Net of transaction costs | $ 2.2 |
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) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Liability Related to Sale of Future Royalties [Line Items] | |
Non-cash royalty revenue payable to HCRP | $ (4,762) |
Royalty Purchase Agreement | |
Liability Related to Sale of Future Royalties [Line Items] | |
Liability related to sale of future royalties - beginning balance | 4,460 |
Deferred transaction costs amortized | 33 |
Non-cash royalty revenue payable to HCRP | (4,739) |
Non-cash interest expense recognized | $ 246 |
Corporate Restructuring - Addit
Corporate Restructuring - Additional Information (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Restructuring Cost And Reserve [Line Items] | ||
Pre-tax charges for severance and employee separation related costs | $ 0 | $ 0.3 |
Selling, General and Administrative Expenses | ||
Restructuring Cost And Reserve [Line Items] | ||
Pre-tax charges for severance and employee separation related costs | $ 0 | $ 0.3 |
Corporate Restructuring - Summa
Corporate Restructuring - Summary of Restructuring Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | ||
Restructuring Liability | $ 1,851 | |
Restructuring costs | $ 251 | |
Payments | $ (2,102) |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Expenses And Other Current Liabilities [Abstract] | ||
Product allowances accruals | $ 9,750 | $ 8,899 |
Bonus payable | 3,719 | 4,329 |
Accrued interest | 1,035 | 1,035 |
Sales force commissions and incentive payments payable | 989 | 667 |
Administrative expenses | 366 | |
Vacation accrual | 1,494 | 1,477 |
Research and development expense accruals | 895 | |
Commercial and marketing expense accruals | 2,892 | |
Royalties payable | 1,167 | |
Legal, accounting, and other professional services | 1,521 | 50 |
Trade relations | 278 | |
Other accrued expenses | 4,635 | 2,792 |
Total | $ 24,310 | $ 23,680 |
Commitments and Contingencies -
Commitments and Contingencies - Summary of Minimum Significant Contractual Obligations (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Operating leases | |
Total lease payments | $ 5,438 |
Less than 1 year | 1,588 |
1-3 years | 539 |
4-5 years | 3,311 |
Total | |
Total | 266,204 |
Less than 1 year | 241,554 |
1-3 years | 10,939 |
4-5 years | 13,711 |
Catalent | |
Catalent Termination | |
Total | 4,000 |
Convertible Senior Notes | |
Long term debt | |
Net carrying amount | 218,420 |
Less than 1 year | 218,420 |
Inventory Purchase Commitments | |
Purchase commitments | |
Total | 38,346 |
Less than 1 year | 17,546 |
1-3 years | 10,400 |
4-5 years | $ 10,400 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Minimum Significant Contractual Obligations (Parenthetical) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Commitment And Contingencies [Line Items] | |||
Liability for uncertain tax position | $ 6,000 | ||
Purchase Commitment, Description | The Company terminated its existing supply agreement with Catalent on December 31, 2022 and renegotiated a new supply agreement effective January 1, 2023. Under the terms of the new supply agreement with Catalent, the Company is required to make minimum purchase obligations through 2024. | ||
Reimbursement amount | $ 2,000 | ||
Reimbursement amount paid | $ 500 | ||
Forecast [Member] | |||
Commitment And Contingencies [Line Items] | |||
Reimbursement amount to be paid | $ 1,500 | ||
Catalent Member | |||
Commitment And Contingencies [Line Items] | |||
Contribution of fund agreed | 2,000 | ||
Termination fee payment | 4,000 | ||
Termination fee payment | $ 4,000 | ||
Convertible Senior Notes | |||
Commitment And Contingencies [Line Items] | |||
Notes maturity date | Dec. 01, 2024 | ||
Long-term liability | $ 218,420 | ||
New Convertible Senior Notes | |||
Commitment And Contingencies [Line Items] | |||
Notes maturity date | Dec. 01, 2024 |
Commitments and Contingencies_3
Commitments and Contingencies - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||
Oct. 21, 2022 | Jun. 28, 2022 | Jan. 31, 2023 | Nov. 30, 2022 | Oct. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2020 | |
Commitment And Contingencies [Line Items] | ||||||||||
Commitments and contingencies | ||||||||||
Purchase Commitment, Description | The Company terminated its existing supply agreement with Catalent on December 31, 2022 and renegotiated a new supply agreement effective January 1, 2023. Under the terms of the new supply agreement with Catalent, the Company is required to make minimum purchase obligations through 2024. | |||||||||
Capital expenditure provision in 2023 | $ 500,000 | |||||||||
Inventory, net | 16,155,000 | 12,752,000 | ||||||||
Other Assets, Current | 5,770,000 | 6,765,000 | ||||||||
Cost of sales | 15,283,000 | $ 30,332,000 | ||||||||
Alkermes | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Licensing royalties, awarded amount | $ 18,300,000 | $ 15,000,000 | ||||||||
Licensing royalties, prejudgment interest | $ 1,500,000 | |||||||||
Litigation settlement additional amount submitted | $ 1,600,000 | |||||||||
Licensing royalties, Additional awarded amount | $ 1,600,000 | |||||||||
Licensing royalties, additional prejudgment interest | $ 200,000 | |||||||||
Remaining illegal royalties with pre- and post-award interest and costs | $ 65,000,000 | |||||||||
Catalent Member | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Purchase commitments in 2024 | 15,500,000 | |||||||||
Purchase commitments in January 1, 2026 through December 31, 2030 | 5,200,000 | |||||||||
Contribution of fund agreed | 2,000,000 | |||||||||
Minimum purchase commitment | 10,500,000 | |||||||||
Inventory, net | 10,500,000 | |||||||||
Catalent Member | Inbrija | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Purchase Obligation | 18,000,000 | |||||||||
Purchase commitments in 2024 | 15,500,000 | |||||||||
Cost of sales | $ 8,400,000 | |||||||||
Licensing Agreements | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Unpaid license royalties | 6,000,000 | |||||||||
Commitments and contingencies | $ 2,000,000 | |||||||||
Payments for legal settlements | $ 750,000 | $ 750,000 | ||||||||
Gain related to litigation settlement | $ 1,300,000 | |||||||||
Maximum | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Maximum milestone payments | 18,700,000 | |||||||||
Capital expenditure provision in 2024 | 1,500,000 | |||||||||
Minimum | Catalent Member | Inbrija | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Original Purchase Obligation | $ 17,000,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring and Non-recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets Carried at Fair Value: | ||
Impaired finite-lived intangible asset | $ 22,987 | $ 305,087 |
Level 1 | Recurring basis | ||
Assets Carried at Fair Value: | ||
Assets, Fair Value | $ 15,322 | |
Investment, Type [Extensible Enumeration] | Money Market Funds [Member] | |
Level 3 | Recurring basis | ||
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | 29,500 | $ 41,200 |
Level 3 | Non-Recurring Basis | ||
Assets Carried at Fair Value: | ||
Impaired finite-lived intangible asset | $ 22,987 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Contingent Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||
Balance, beginning of period | $ 41,200 | $ 49,600 |
Fair value change to contingent consideration (unrealized) included in the statement of operations | $ (9,634) | $ (6,659) |
Fair Value, Liability, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Business Combination, Contingent Consideration Arrangements, Change in Amount of Contingent Consideration, Liability | Business Combination, Contingent Consideration Arrangements, Change in Amount of Contingent Consideration, Liability |
Royalty payments | $ (2,066) | $ (1,741) |
Balance, end of period | $ 29,500 | $ 41,200 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Millions | 9 Months Ended | 12 Months Ended | ||||
Sep. 17, 2020 | Dec. 24, 2019 | Sep. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2019 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Common stock, Authorized shares | 61,666,666 | 3,083,333 | 3,083,333 | 13,333,333 | ||
Income tax effects on equity transactions | $ 4.4 | $ 4.4 | ||||
Derivative liability reclassified to equity | $ 18.3 | |||||
Impairment on long-lived assets | $ 251.3 | |||||
Level 3 | Non-Recurring Basis | Discount Rate | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Finite-lived intangible asset, measurement input | 0.27 | |||||
Level 3 | Non-Recurring Basis | Average Growth Rate | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Finite-lived intangible asset, measurement input | 0.082 | |||||
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% | 6% | |||
Notes, maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||
Convertible Senior Secured Notes due 2024 | Level 2 | Recurring basis | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Convertible senior notes | $ 157.3 | |||||
Inbrija | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Milestone payment, minimum | 0 | |||||
Milestone payment, maximum | 18.7 | |||||
Inbrija | Level 3 | Non-Recurring Basis | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Impairment on long-lived assets | $ 251.3 |
Fair Value Measurements - Sch_3
Fair Value Measurements - Schedule of Fair Value Reconciliation of Derivative Liability (Details) - Convertible Senior Secured Notes due 2024 $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Fair Value Reconciliation Of Derivative Liability [Line Items] | |
Balance, beginning of period | $ 37 |
Fair value adjustment | $ (37) |
License, Research and Collabo_2
License, Research and Collaboration Agreements - Alkermes License - Additional Information (Details) - Alkermes License Agreement | 12 Months Ended | |
Dec. 31, 2003 | Dec. 31, 2023 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
License termination period | 15 years | |
Percentage of products under supply agreement | 100% |
License, Research and Collabo_3
License, Research and Collaboration Agreements - Supply Agreement - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Oct. 31, 2022 | Dec. 31, 2023 | Dec. 31, 2020 | |
Alkermes | ||||
Supply Agreement | ||||
Licensing royalties, awarded amount | $ 18.3 | |||
Alkermes License Agreement | ||||
Supply Agreement | ||||
Cost Of License Payable | $ 15 | |||
Biogen | ||||
Supply Agreement | ||||
Additional payments based on the successful achievement of future regulatory or sales milestones | $ 300 | |||
Supply agreement | Alkermes | ||||
Supply Agreement | ||||
Licensing royalties, awarded amount | $ 18.3 | |||
Supply agreement | Maximum | Patheon Inc Second Manufacturing agreement | ||||
Supply Agreement | ||||
Purchase requirements threshold percentage | 25% | |||
Supply agreement | Alkermes License Agreement | Ampyra | Alkermes | ||||
Supply Agreement | ||||
Minimum agreed percentage of annual requirements for purchase | 75% | |||
Supply agreement | Alkermes License Agreement | Maximum | ||||
Supply Agreement | ||||
Purchase requirements threshold percentage | 100% |
License, Research and Collabo_4
License, Research and Collaboration Agreements - Biogen Agreement - Additional Information (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended |
Oct. 31, 2022 | Dec. 31, 2020 | |
Biogen | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Additional payments based on the successful achievement of future regulatory or sales milestones | $ 300 | |
Alkermes | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Licensing royalties, awarded amount | $ 18.3 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax [Line Items] | |||
Net increase in valuation allowance | $ 23,900 | ||
Deferred tax assets, valuation allowance | $ 130,642 | $ 106,702 | $ 193,253 |
US federal corporate tax rate | 21% | 21% | |
Minimum | |||
Recent Accounting Pronouncements | |||
Expiration term for statute of limitations | 3 years | ||
Maximum | |||
Recent Accounting Pronouncements | |||
Expiration term for statute of limitations | 5 years | ||
Federal | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 114,700 | ||
Percentage of taxable income will be utilized in any year | 80% | ||
Operating loss carryforwards additional | $ 42,300 | ||
Biotie U S | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 120,800 | ||
Operating loss, expected expiration beginning year | 2026 | ||
State | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 312,900 | ||
Operating loss, expected expiration beginning year | 2027 | ||
Outside U.S. | |||
Income Tax [Line Items] | |||
Operating loss carryforwards | $ 7,300 | ||
Operating loss, expected expiration beginning year | 2024 | ||
Research [Member] | |||
Income Tax [Line Items] | |||
Tax credit carry-forwards | $ 35,000 | $ 35,100 | |
Tax credit carry-forward, expiration beginning year | 2024 |
Income Taxes - Schedule of Dome
Income Taxes - Schedule of Domestic and Foreign Components of (Loss) Income Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax [Line Items] | ||
(Loss) income before taxes | $ (296,021) | $ (35,247) |
Domestic | ||
Income Tax [Line Items] | ||
(Loss) income before taxes | (295,429) | (60,179) |
Foreign | ||
Income Tax [Line Items] | ||
(Loss) income before taxes | $ (592) | $ 24,932 |
Income Taxes - Schedule of Bene
Income Taxes - Schedule of Benefit from Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current: | ||
Federal | $ (118) | $ (243) |
State | (850) | (115) |
Foreign | (71) | (37) |
Total | (1,039) | (395) |
Deferred: | ||
Federal | 25,909 | (30,234) |
State | 18,297 | (40) |
Total | 44,206 | (30,274) |
Total benefit from income taxes | $ 43,167 | $ (30,669) |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of the Statutory U.S. Federal Income Tax Rate to the Entity's Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of statutory federal income tax rate to effective income tax rate | ||
U.S. federal statutory tax rate | 21% | 21% |
State and local income taxes | 4.60% | (0.30%) |
Stock option compensation | 0% | (0.20%) |
Stock option shortfall | (0.70%) | (8.80%) |
GILTI Inclusion | 0% | (8.30%) |
Uncertain tax positions | 0.10% | 0.40% |
Other nondeductible and permanent differences | (0.90%) | (7.70%) |
U.S. write-off/expiration | 0% | (255.80%) |
Valuation allowance, net of foreign tax rate differential | (9.40%) | 151.60% |
Biotie Finland cancellation of debt exclusion | 0% | 21.70% |
Federal return to provision differences | (0.10%) | (0.60%) |
Effective income tax rate | 14.60% | (87.00%) |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | |||
Net operating loss carryforward | $ 70,007 | $ 74,576 | |
Capital loss carryforward | 11,227 | 11,100 | |
Tax credits | 34,292 | 34,301 | |
Stock based compensation | 6,475 | 8,896 | |
Contingent consideration | 7,827 | 10,807 | |
Employee compensation | 1,296 | 1,438 | |
Rebate and returns reserve | 2,419 | 2,003 | |
Capitalized R&D | 895 | 1,191 | |
Other | 5,424 | 5,421 | |
Total deferred tax assets | 139,862 | 149,733 | |
Valuation allowance | (130,642) | (106,702) | $ (193,253) |
Total deferred tax assets net of valuation allowance | 9,220 | 43,031 | |
Deferred tax liabilities: | |||
Intangible assets | (4,327) | (77,876) | |
Convertible debt | (4,812) | (9,190) | |
Depreciation | (81) | (167) | |
Total deferred tax liabilities | (9,220) | (87,233) | |
Net deferred tax liability | $ 0 | $ (44,202) |
Income Taxes - Schedule of Re_2
Income Taxes - Schedule of Reconciliation of Beginning and Ending Amounts of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of unrecognized tax benefits | ||
Beginning of period balance | $ 6,237 | $ 6,370 |
Decreases for tax positions taken during a prior period | (212) | (133) |
End of period balance | $ 6,025 | $ 6,237 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Beginning and Ending Amounts of Valuation Allowances (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Valuation allowance for deferred tax assets, Balance at Beginning of Period | $ 106,702 | $ 193,253 |
Valuation allowance for deferred tax assets, Additions | 27,866 | 233 |
Valuation allowance for deferred tax assets, Deductions | (3,926) | (86,784) |
Valuation allowance for deferred tax assets, Balance at End of Period | $ 130,642 | $ 106,702 |
Loss Per Share - Schedule of Co
Loss Per Share - Schedule of Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Basic and diluted | ||
Net Income (Loss) | $ (252,854) | $ (65,916) |
Weighted average common shares outstanding used in computing net loss per share—basic | 1,242 | 1,011 |
Weighted average common shares outstanding used in computing net loss per share—diluted | 1,242 | 1,011 |
Net loss per share—basic | $ (203.57) | $ (65.23) |
Net loss per share—diluted | $ (203.57) | $ (65.23) |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Antidilutive Securities Excluded from Calculation of Net Income Per Diluted Share (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2021 | |
Stock options and restricted common shares | ||
Antidilutive Securities | ||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | 103 | 50 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Details) - 401(k) plan - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Defined Contribution Plan Disclosure [Line Items] | ||
Percentage of employee earnings eligible for additional company contribution | 6% | |
Additional company contribution for each dollar of employee contribution (as a percent) | 50% | |
Company expense related to the defined contribution plan | $ 0.7 | $ 0.8 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | Mar. 31, 2024 | Jan. 08, 2024 | Dec. 31, 2023 |
DIP Credit Facility | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-possession term loan facility, maximum aggregate amount | $ 60,000,000 | ||
Interim DIP Order | |||
Subsequent Event [Line Items] | |||
Debtor-in-Possession Financing, Borrowings Outstanding | 0 | ||
Interim DIP Loan Commitment | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-Possession Financing, Borrowings Outstanding | 10,000,000 | ||
Final DIP Loan Commitment | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-possession term loan facility, maximum aggregate amount | 40,000,000 | ||
Debtor-in-Possession Financing, Borrowings Outstanding | $ 10,000,000 | ||
Subsequent event | |||
Subsequent Event [Line Items] | |||
Sale of purchased assets | $ 185,000,000 | ||
Subsequent event | DIP Credit Facility | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-possession term loan facility, maximum aggregate amount | $ 60,000,000 | ||
Subsequent event | Interim DIP Order | |||
Subsequent Event [Line Items] | |||
Debtor-in-Possession Financing, Borrowings Outstanding | 0 | ||
Subsequent event | Interim DIP Loan Commitment | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-Possession Financing, Borrowings Outstanding | 10,000,000 | ||
Subsequent event | Final DIP Loan Commitment | Maximum | |||
Subsequent Event [Line Items] | |||
Debtor-in-possession term loan facility, maximum aggregate amount | 40,000,000 | ||
Debtor-in-Possession Financing, Borrowings Outstanding | $ 10,000,000 |