Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 09, 2023 | |
Cover [Abstract] | ||
Entity Registrant Name | ACORDA THERAPEUTICS, INC. | |
Entity Central Index Key | 0001008848 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2023 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ACOR | |
Title of each class | Common Stock $0.001 par value per share | |
Name of each exchange on which registered | NASDAQ | |
Entity Common Stock, Shares Outstanding | 1,242,098 | |
Entity File Number | 001-31938 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 13-3831168 | |
Entity Address, Address Line One | 2 Blue Hill Plaza | |
Entity Address, Address Line Two | 3rd Floor | |
Entity Address, City or Town | Pearl River | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10965 | |
City Area Code | 914 | |
Local Phone Number | 347-4300 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 32,468 | $ 37,536 |
Restricted cash | 861 | 6,884 |
Trade accounts receivable, net of allowances of $791 and $842, as of September 30, 2023 and December 31, 2022, respectively | 11,977 | 13,866 |
Prepaid expenses | 5,042 | 4,312 |
Inventory, net | 17,942 | 12,752 |
Other current assets | 5,438 | 6,765 |
Total current assets | 73,728 | 82,115 |
Property and equipment, net of accumulated depreciation | 2,210 | 2,603 |
Intangible assets, net of accumulated amortization | 282,006 | 305,087 |
Right of use asset, net of accumulated amortization | 4,496 | 5,287 |
Restricted cash | 255 | 255 |
Other non-current assets | 3,649 | 248 |
Total assets | 366,344 | 395,595 |
Current liabilities: | ||
Accounts payable | 12,330 | 9,809 |
Accrued expenses and other current liabilities | 29,344 | 23,680 |
Current portion of lease liabilities | 1,578 | 1,545 |
Current portion of acquired contingent consideration | 2,577 | 2,532 |
Deferred revenue | 465 | 384 |
Total current liabilities | 46,294 | 37,950 |
Convertible senior notes | 181,043 | 167,031 |
Non-current portion of acquired contingent consideration | 30,223 | 38,668 |
Non-current portion of lease liabilities | 3,468 | 4,341 |
Deferred tax liability | 38,544 | 44,202 |
Other non-current liabilities | 7,815 | 9,781 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share. Authorized 1,000,000 shares at June 31, 2023 and December 31, 2022; no shares issued as of June 30, 2023 and December 31, 2022, respectively | ||
Common stock, $0.001 par value per share. Authorized 3,083,333 shares at June 30, 2023 and December 31, 2022; issued 1,242,376 shares,including those held in treasury, as of June 30, 2023 and December 31, 2022, respectively | 1 | 24 |
Treasury stock at cost (278 shares at June 30, 2023 and December 31, 2022) | (638) | (638) |
Additional paid-in capital | 1,030,243 | 1,029,881 |
Accumulated deficit | (971,366) | (936,273) |
Accumulated other comprehensive income | 717 | 628 |
Total stockholders’ equity | 58,957 | 93,622 |
Total liabilities and stockholders’ equity | $ 366,344 | $ 395,595 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Trade accounts receivable, allowances (in dollars) | $ 791 | $ 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Total net revenues | $ 27,715 | $ 33,511 | $ 79,648 | $ 87,096 |
Costs and expenses: | ||||
Cost of sales | 3,387 | 11,005 | 9,685 | 25,772 |
Research and development | 1,207 | 1,383 | 4,143 | 4,602 |
Selling, general and administrative | 23,152 | 22,997 | 67,492 | 80,002 |
Amortization of intangible assets | 7,691 | 7,691 | 23,073 | 23,073 |
Change in fair value of derivative liability | (37) | |||
Changes in fair value of acquired contingent consideration | (5,203) | (4,576) | (7,118) | (10,709) |
Total operating expenses | 30,234 | 38,500 | 97,275 | 122,703 |
Operating loss | (2,519) | (4,989) | (17,627) | (35,607) |
Other income (expense), net: | ||||
Interest and amortization of debt discount expense | (7,984) | (7,465) | (23,328) | (22,501) |
Interest income | 157 | 17 | 308 | 38 |
Realized gain (loss) on foreign currency transactions | 288 | (1) | 287 | (1) |
Other income (expense) | 115 | 209 | 1,250 | |
Total other expense, net | (7,424) | (7,449) | (22,524) | (21,214) |
Loss before taxes | (9,943) | (12,438) | (40,151) | (56,821) |
Benefit from (provision for) income taxes | 1,055 | (1,416) | 5,058 | (28,237) |
Net loss | $ (8,888) | $ (13,854) | $ (35,093) | $ (85,058) |
Net loss per share—basic | $ (7.16) | $ (11.17) | $ (28.25) | $ (97.66) |
Net loss per share—diluted | $ (7.16) | $ (11.17) | $ (28.25) | $ (97.66) |
Weighted average common shares outstanding used in computing net loss per share-basic | 1,242 | 1,240 | 1,242 | 871 |
Weighted average common shares outstanding used in computing net loss per share-diluted | 1,242 | 1,240 | 1,242 | 871 |
Net Product Revenues | ||||
Revenues: | ||||
Total net revenues | $ 25,179 | $ 29,964 | $ 69,863 | $ 76,023 |
Royalty Revenues | ||||
Revenues: | ||||
Total net revenues | 2,502 | 3,047 | 9,717 | 10,573 |
License revenues | ||||
Revenues: | ||||
Total net revenues | $ 34 | $ 500 | $ 68 | $ 500 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (8,888) | $ (13,854) | $ (35,093) | $ (85,058) |
Other comprehensive income (loss), net of tax: | ||||
Foreign currency translation adjustment | (163) | 1,352 | 89 | 3,107 |
Other comprehensive income (loss), net of tax | (163) | 1,352 | 89 | 3,107 |
Comprehensive income (loss) | $ (9,051) | $ (12,502) | $ (35,004) | $ (81,951) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) shares in Thousands, $ in Thousands | Total | Common stock | Treasury stock | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive (loss) income |
Balance at Dec. 31, 2021 | $ 151,137 | $ 13 | $ (638) | $ 1,023,136 | $ (870,357) | $ (1,017) |
Balance (in shares) at Dec. 31, 2021 | 13,250 | |||||
Compensation expense for issuance of stock options to employees | 181 | 181 | ||||
Compensation expense for issuance of restricted stock to employees | 304 | 304 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 35 | |||||
Other comprehensive income (loss), net of tax | 449 | 449 | ||||
Net loss | (24,522) | (24,522) | ||||
Balance at Mar. 31, 2022 | 127,549 | $ 13 | (638) | 1,023,621 | (894,879) | (568) |
Balance (in shares) at Mar. 31, 2022 | 13,285 | |||||
Balance at Dec. 31, 2021 | 151,137 | $ 13 | (638) | 1,023,136 | (870,357) | (1,017) |
Balance (in shares) at Dec. 31, 2021 | 13,250 | |||||
Net loss | (85,058) | |||||
Balance at Sep. 30, 2022 | 75,766 | $ 24 | (638) | 1,029,705 | (955,415) | 2,090 |
Balance (in shares) at Sep. 30, 2022 | 24,338 | |||||
Balance at Mar. 31, 2022 | 127,549 | $ 13 | (638) | 1,023,621 | (894,879) | (568) |
Balance (in shares) at Mar. 31, 2022 | 13,285 | |||||
Compensation expense for issuance of stock options to employees | 471 | 471 | ||||
Other comprehensive income (loss), net of tax | 1,306 | 1,306 | ||||
Net loss | (46,682) | (46,682) | ||||
Interest payment for convertible notes | 5,263 | $ 11 | 5,252 | |||
Interest payment for convertible notes (in shares) | 10,992 | |||||
Balance at Jun. 30, 2022 | 87,907 | $ 24 | (638) | 1,029,344 | (941,561) | 738 |
Balance (in shares) at Jun. 30, 2022 | 24,277 | |||||
Compensation expense for issuance of stock options to employees | 364 | 364 | ||||
Compensation expense for issuance of restricted stock to employees | (3) | (3) | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 61 | |||||
Other comprehensive income (loss), net of tax | 1,352 | 1,352 | ||||
Net loss | (13,854) | (13,854) | ||||
Balance at Sep. 30, 2022 | 75,766 | $ 24 | (638) | 1,029,705 | (955,415) | 2,090 |
Balance (in shares) at Sep. 30, 2022 | 24,338 | |||||
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 | 71 | 71 | ||||
Other comprehensive income (loss), net of tax | 91 | 91 | ||||
Net loss | (16,824) | (16,824) | ||||
Balance at Mar. 31, 2023 | 76,960 | $ 24 | (638) | 1,029,952 | (953,097) | 719 |
Balance (in shares) at Mar. 31, 2023 | 1,242 | |||||
Balance at Dec. 31, 2022 | 93,622 | $ 24 | (638) | 1,029,881 | (936,273) | 628 |
Balance (in shares) at Dec. 31, 2022 | 1,242 | |||||
Net loss | (35,093) | |||||
Balance at Sep. 30, 2023 | 58,957 | $ 1 | (638) | 1,030,243 | (971,366) | 717 |
Balance (in shares) at Sep. 30, 2023 | 1,242 | |||||
Balance at Mar. 31, 2023 | 76,960 | $ 24 | (638) | 1,029,952 | (953,097) | 719 |
Balance (in shares) at Mar. 31, 2023 | 1,242 | |||||
Compensation expense for issuance of stock options to employees | 128 | 128 | ||||
Reverse Stock Split Adjustment | $ (23) | 23 | ||||
Other comprehensive income (loss), net of tax | 161 | 161 | ||||
Net loss | (9,381) | (9,381) | ||||
Balance at Jun. 30, 2023 | 67,868 | $ 1 | (638) | 1,030,103 | (962,478) | 880 |
Balance (in shares) at Jun. 30, 2023 | 1,242 | |||||
Compensation expense for issuance of stock options to employees | 140 | 140 | ||||
Other comprehensive income (loss), net of tax | (163) | (163) | ||||
Net loss | (8,888) | (8,888) | ||||
Balance at Sep. 30, 2023 | $ 58,957 | $ 1 | $ (638) | $ 1,030,243 | $ (971,366) | $ 717 |
Balance (in shares) at Sep. 30, 2023 | 1,242 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (35,093) | $ (85,058) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 340 | 1,320 |
Amortization of debt discount and debt issuance costs | 14,012 | 12,356 |
Depreciation and amortization expense | 23,743 | 24,770 |
Non-cash lease expense | (50) | |
Change in acquired contingent consideration obligation | (7,118) | (10,709) |
Non-cash royalty revenue | (4,762) | |
Deferred tax (benefit) provision | (5,021) | 28,300 |
Change in derivative liability | (37) | |
Changes in assets and liabilities: | ||
Decrease in accounts receivable | 1,889 | 2,312 |
Decrease (increase) in prepaid expenses and other current assets | 547 | (258) |
Decrease (increase) in inventory | (5,189) | 3,297 |
Increase in other assets | (3,401) | (237) |
Increase (decrease) in accounts payable, accrued expenses, and other current liabilities | 6,340 | (844) |
Increase (decrease) in other non-current liabilities | (1,965) | (439) |
Net cash used in operating activities | (10,966) | (29,990) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (220) | (136) |
Purchases of intangible assets | (123) | |
Net cash (used in) provided by investing activities | (220) | (259) |
Cash flows from financing activities: | ||
Effect of exchange rate changes on cash, cash equivalents, and restricted cash | 95 | (790) |
Net decrease in cash, cash equivalents, and restricted cash | (11,091) | (31,040) |
Cash, cash equivalents and restricted cash at beginning of period | 44,675 | 65,223 |
Cash, cash equivalents and restricted cash at end of period | 33,584 | 34,183 |
Supplemental disclosure: | ||
Cash paid for interest | 6,210 | 947 |
Cash paid for taxes | $ 788 | $ 133 |
Organization and Business Activ
Organization and Business Activities | 9 Months Ended |
Sep. 30, 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. The Company markets Inbrija (levodopa inhalation powder), which is approved in the U.S. for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa. Inbrija is for as needed use and utilizes the Company’s ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation that the Company believes has potential to be used in the development of a variety of inhaled medicines. The Company has entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, and is in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S. The Company also markets branded Ampyra (dalfampridine) Extended Release Tablets, 10 mg to improve walking in adults with multiple sclerosis. Ampyra is marketed as Fampyra outside the U.S. by Biogen International GmbH, or Biogen, under a license and collaboration agreement that the Company entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia, and the Americas. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies 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. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information, Accounting Standards Codification (“ASC”) Topic 270-10, and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated potential subsequent events through the date of this filing. Operating results for the three- and nine-month periods ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2022 consolidated balance sheet data was derived from the Company’s audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2022. Effective January 1, 2022, the Company adopted ASU 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” The Company’s significant accounting policies have not changed materially from December 31, 2022. Restricted Cash At September 30, 2023, the Company held restricted cash consisting of $ 0.3 million related to cash collateralized standby letters of credit in connection with obligations under facility leases and $ 0.9 million to cover the Company’s self-funded employee health insurance. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 32,468 $ 45,634 $ 20,696 Restricted cash 6,884 861 13,400 13,232 Restricted cash non-current 255 255 6,189 255 Total Cash, cash equivalents, and restricted cash per statement of cash flows $ 44,675 $ 33,584 $ 65,223 $ 34,183 Investments Short-term investments consist primarily of high-grade commercial paper and corporate bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period is longer than one year. The Company classifies all its investments as available-for-sale. Available-for-sale securities are recorded at the fair value of the investments based on quoted market prices. Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive loss. Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective‑interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income are included in interest income. Realized gains and losses are included in other income. There were no investments classified as short-term or long-term at September 30, 2023 or December 31, 2022. Inventory The following table provides the major classes of inventory: (In thousands) September 30, 2023 December 31, 2022 Raw materials $ 10,537 $ 6,212 Finished goods 7,405 6,540 Total $ 17,942 $ 12,752 The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. Foreign Currency Translation The functional currency of operations outside the U.S. is deemed to be the currency of the local country, unless otherwise determined that the U.S. 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 subsidiaries are translated into U.S. dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations. Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Inbrija and Ampyra in the U.S. Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer, and significant negative economic trends. The decline in the trading price of the Company’s common stock during the nine-month period ended September 30, 2023, and related decrease in the Company’s market capitalization, was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2023. The Company performed a recoverability test as of September 30, 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 compared to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s assumptions about its use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2023, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets. Liquidity The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, obtain additional financing and repay or restructure outstanding indebtedness. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing the 2024 Notes, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness, in particular the 2024 Notes that mature on December 1, 2024, will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether. At September 30 , 2023, the Company had $ 32.5 million of cash and cash equivalents, compared to $ 37.5 million at December 31, 2022. The Company’s September 30, 2023 cash and cash equivalents balance does not include $ 1.2 million of restricted cash, of which $ 0.9 million is related to self-funded employee health insurance and $ 0.3 million is related to collateralized standby letters of credit. The Company incurred a net loss of $ 35.1 million for the nine-month period ended September 30, 2023. 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 be sufficient to cover its cash flow requirements for the next twelve months from the issuance date of these financial statements. However, the 2024 Notes mature on December 1, 2024 and, unless earlier converted in accordance with their terms, the Company will be required to pay all outstanding principal and any accrued and unpaid interest on the notes on the maturity date. At September 30, 2023, the principal balance outstanding under the 2024 Notes was $ 207.0 million. The Company is evaluating its options to raise additional capital and repay or restructure all or a portion of the 2024 Notes, but its ability to do so will depend on numerous factors, some of which are beyond the Company’s control. The Company can provide no assurance that such efforts will be successful. Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events that required disclosure in these financial statements. Accounting Pronouncements Not Yet Adopted In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 that 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. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | (3) Revenue In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has no t yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g., receivable), before the entity transfers a good or service to the customer. As of September 30, 2023, the Company had contract liabilities of $ 8.2 million, as compared to $ 6.1 million as of September 30, 2022 , which are comprised of 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. As of September 30, 2023, approximately $ 0.5 million of the contract liability balance is expected to be recognized as revenue from the remaining performance obligations over the next 12 months for the Esteve Germany agreement as goods are shipped. The Company expects to recognize the remaining balance over the next 9 years. The Company will re-evaluate the transaction price in each reporting period and as certain events are resolved or other changes in circumstances occur. The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen and the royalties payable from Neurelis Inc. for sales of Valtoco. No further royalties from sales of Valtoco are expected. (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Revenues: Net product revenues: Ampyra $ 15,725 $ 21,110 $ 45,244 $ 54,192 Inbrija 8,092 7,848 21,923 18,957 Inbrija ex-U.S. 1,362 1,006 2,696 2,874 Total net product revenues 25,179 29,964 69,863 76,023 Royalty revenues 2,502 3,047 9,717 10,573 License Revenue 34 500 68 500 Total net revenues $ 27,715 $ 33,511 $ 79,648 $ 87,096 |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share-Based Compensation | (4) Share-Based Compensation During the three‑month periods ended September 30, 2023 and 2022, the Company recognized share-based compensation expense o f $ 0.1 m illion and $ 0.4 million, respectively. During the nine-month periods ended September 30, 2023 and 2022, the Company recognized share-based compensation expense of $ 0.3 million and $ 1.3 million, respectively. Activity in options and restricted stock during the nine-month period ended September 30, 2023 and related balances outstanding as of that date are reflected below. The weighted average fair value p er share of options granted to employees for the three-month periods ended September 30, 2023 and 2022 were approximately $ 9.97 an d $ 6.10 , respectively. The weighted average fair value per share of options granted to employees for the nine-month periods ended September 30, 2023 and 2022 were approximately $ 9.86 and $ 16.80 , respectively. The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: For the three-month period ended September 30, For the nine-month period ended September 30, (In thousands) 2023 2022 2023 2022 Research and development expense $ 3 $ 14 $ 8 $ 66 Selling, general and administrative expense 137 351 331 1,254 Cost of Sales — ( 1 ) — — Total $ 140 $ 364 $ 339 $ 1,320 A summary of share-based compensation activity for the nine-month period ended September 30, 2023 is presented below: Stock Option Activity Number of thousands) Weighted Weighted Intrinsic thousands) Balance at January 1, 2023 52 $ 1,571.06 — — Granted 62 12.32 — — Cancelled ( 8 ) 2,740.73 — — Exercised — — — — Balance at September 30, 2023 106 $ 568.54 7.8 $ 181,812 Vested and expected to vest at 106 $ 568.54 7.8 $ 181,812 Vested and exercisable at 51 $ 1,161.97 6.2 $ 55,689 Unrec ognized compensation cost for unvested stock options, restricted stock awards, and restricted stock units as of September 30, 2023 totaled $ 0.6 million and is expected to be recognized over a weighted average period of approximately 1.4 years. During the nine‑month period ended September 30, 2023, the Company did no t make any repurchases of shares. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Loss Per Share | (5) Loss Per Share The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2023 and 2022: (In thousands, except per share data) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Basic and diluted Net loss—basic $ ( 8,888 ) $ ( 13,854 ) $ ( 35,093 ) $ ( 85,058 ) Net income (loss)—diluted $ ( 8,888 ) $ ( 13,854 ) $ ( 35,093 ) $ ( 85,058 ) Weighted average common shares outstanding used in 1,242 1,240 1,242 871 Plus: net effect of dilutive stock options and restricted — — — — Weighted average common shares outstanding used in 1,242 1,240 1,242 871 Net loss per share—basic $ ( 7.16 ) $ ( 11.17 ) $ ( 28.25 ) $ ( 97.66 ) Net loss per share—diluted $ ( 7.16 ) $ ( 11.17 ) $ ( 28.25 ) $ ( 97.66 ) Securities that could potentially be dilutive are excluded from the computation of diluted loss per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts. The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Denominator Stock options and restricted common shares 105 57 105 55 Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the three- and nine-month periods ended September 30, 2023 and 2022. Additionally, the impact of the 2024 Notes was determined to be anti-dilutive and excluded from the calculation of net loss per diluted share for the three- and nine-month periods ended September 30, 2023 and 2022. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (6) Income Taxes For the three-month periods ended September 30, 2023 and 2022, the Company recorded a benefit of $ 1.1 million and a provision of ($ 1.4 ) million for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended September 30, 2023 and 2022 were 10.6 % and ( 11.3 %), respectively. The variances in the effective tax rates for the three-month period ended September 30, 2023, as compared to the three-month period ended September 30, 2022, was primarily due to an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, as a result of the deemed ownership that occurred in the prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax attributes and the forfeitures of equity of which no tax deduction is recorded. For the nine-month periods ended September 30, 2023 and 2022, the Company recorded a benefit of $ 5.1 million and a provision of ($ 28.2 ) million for income taxes, respectively. The effective income tax rates for the Company for the nine-month periods ended September 30, 2023 and 2022 were 12.6 % and ( 49.7 %), respectively. The variances in the effective tax rates for the nine-month period ended September 30, 2023, as compared to the nine-month period ended September 30, 2022, was primarily due to an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, as a result of the deemed ownership that occurred in the prior year under IRS Section 382 which required a valuation allowance to be recorded on the Company’s tax attributes and the forfeitures of equity of which no tax deduction is recorded. The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits, and the regulatory approval of products under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company’s income taxes. The Massachusetts income tax examination for the tax years 2018 and 2019 was finalized during the third quarter of 2023 with no adjustment. The New Jersey income tax examination was finalized during the first quarter of 2023 for tax years 2015 through 2018 with no adjustments. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (7) 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. The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. 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 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 Therapeutics, Inc. (“Civitas”) which are valued using a probability weighted discounted cash flow valuation approach. For assets and liabilities not accounted for at fair value, the carrying values of these accounts approximates their fair values at September 30, 2023, except for the fair value of the Company’s 2024 Notes, which was approximately $ 157.3 million as of September 30, 2023. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2). (In thousands) Level 1 Level 2 Level 3 September 30, 2023 Assets Carried at Fair Value: Money market funds $ — $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 32,800 December 31, 2022 Assets Carried at Fair Value: Money market funds $ 15,322 $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 41,200 The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value. Acquired contingent consideration (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Acquired contingent consideration: Balance, beginning of period $ 38,500 $ 42,900 $ 41,200 $ 49,600 Fair value change to contingent consideration ( 5,203 ) ( 4,576 ) ( 7,118 ) ( 10,709 ) Royalty payments ( 497 ) ( 724 ) ( 1,282 ) ( 1,291 ) Balance, end of period $ 32,800 $ 37,600 $ 32,800 $ 37,600 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), a U.S. Food and Drug Administration (“FDA”) approved drug for the treatment of OFF periods in 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 payments ranged from $ 0 million to $ 16.2 million f or Inbrija. The discount rate used in the valuation was 23 % for the three- and nine-month periods ended September 30, 2023 and 2022. The valuation is performed quarterly and changes in the fair value of the contingent consideration are included in the statement of operations. For the nine-month periods ended September 30, 2023 and 2022, changes in the fair value of the acquired contingent consideration were primarily due to change in projected revenue and the recalculation of cash flows for the passage of time. 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 2024 Notes: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 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 2024 Notes (See Note 10 to the Consolidated Financial Statements included in this report for more information on the 2024 Notes). 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 2024 Notes, (3) historical volatility of the share price, and (4) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the derivative liability was determined using a binomial model that calculates the fair value of the 2024 Notes with the conversion feature as compared to the fair value of the 2024 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 2024 Notes that did not meet the conditions for equity classification at the time of issuance. As a result, these features were aggregated 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 September 30, 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 nine-month period ended September 30, 2023. |
Investments
Investments | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | (8) Investments There were no available-for-sale investments at September 30, 2023 and December 31, 2022, respectively. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 9 Months Ended |
Sep. 30, 2023 | |
Deferred Revenue Disclosure [Abstract] | |
Liability Related to Sale of Future Royalties | (9) Liability Related to Sale of Future Royalties In October 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 collaboration and licensing agreement with the Company up to an agreed upon threshold of royalties. This threshold was met during the second quarter of 2022 and the Company’s obligations to HCRP expired upon Biogen’s payment of royalties for that quarter. The Royalty Agreement has been accounted for as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. The Company recorded the receipt of the $ 40 million payment from HCRP and established a corresponding liability in the amount of $ 40 million, net of transaction costs of approximately $ 2.2 million. The net liability is classified between the current and non-current portion of liability related to the sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments to be received by HCRP in the 12 months following the financial statement reporting date. The total net royalties to be paid, less the net proceeds received, is recorded to interest expense using the effective interest method over the life of the Royalty Agreement. The Company did no t have a liability related to the sale of future royalties for the periods ending September 30, 2023 and 2022, respectively. The following table shows the activity within the liability account for the nine-month period ended September 30, 2023 and 2022, respectively: (In thousands) September 30, 2023 September 30, 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 $ — $ — |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | (10) Debt Convertible Senior Secured Notes Due 2024 On December 24, 2019, the Company completed the private exchange of $ 276.0 million aggregate principal amount of its then outstanding 1.75 % Convertible Senior Notes due 2021 for the 2024 Notes and cash. The Company issued $ 207.0 million aggregate principal amount of the 2024 Notes and paid approximate $ 55.2 million in cash to participating holders. The 2024 Notes were issued pursuant to an Indenture, dated as of December 23, 2019, among the Company, its wholly owned subsidiary, Civitas (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. The 2024 Notes will mature on December 1, 2024 unless earlier converted in accordance with their terms. 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. On June 1, 2023, the Company made a cash interest payment of approximately $ 6.2 million in satisfaction of the interest payment due on June 1, 2023 which was made out of restricted cash. 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. 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 of approximately $ 420 per share for a specified period of time and certain other conditions are satisfied. Holders of the 2024 Notes will have the right, at their option, to require the Company to purchase their 2024 Notes if a fundamental change (as defined in the 2024 Indenture) occurs, such as a delisting of the Company’s common stock from the Nasdaq Global Select Market, in each case, at a repurchase price equal to 100 % of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. If a make-whole fundamental change occurs, as described in the 2024 Indenture, and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the adjusted conversion rate as described in the 2024 Indenture. Subject to a number of exceptions and qualifications, the 2024 Indenture restricts the ability of the Company and certain of its subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, (iv) create liens on their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or (vii) merge, consolidate, or sell all or substantially all of their assets. The 2024 Indenture also requires the Company to make an offer to repurchase the 2024 Notes upon the occurrence of certain asset sales. The 2024 Indenture provides that a number of events will constitute an event of default, including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by the Company to make required payments under other indebtedness of the Company or certain subsidiaries having an outstanding principal amount of $ 30.0 million or more, (vii) failure by the Company or certain subsidiaries to pay final judgments aggregating in excess of $ 30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the U.S. of a product determined by the 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 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 that did not meet the conditions for equity classification at the time of issuance. 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 such 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 September 30, 2023. The outstanding 2024 Notes balances as of September 30, 2023 and December 31, 2022 consisted of the following: (In thousands) September 30, 2023 December 31, 2022 Liability component: Principal 207,000 $ 207,000 Less: debt discount and debt issuance costs, net ( 25,957 ) ( 39,969 ) Net carrying amount $ 181,043 $ 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 three and nine-month periods ended September 30, 2023, the Company recognized $ 8.0 million and $ 23.3 million, respectively, 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 September 30, 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 three- and nine-month periods ended September 30, 2023 and 2022: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Contractual interest expense $ 3,105 $ 3,105 $ 9,315 $ 9,315 Amortization of debt issuance costs 347 291 995 834 Amortization of debt discount 4,532 3,797 13,018 10,902 Total interest expense $ 7,984 $ 7,193 $ 23,328 $ 21,051 Non-Convertible Capital Loans The Company’s subsidiary, Biotie Therapies Ltd., received several non-convertible capital loans from Business Finland for research and development of specific drug candidates, with an aggregate adjusted acquisition-date fair value of $ 20.5 million. The loans were to be repaid only when the consolidated retained earnings of Biotie Therapies Ltd. from the development of specific product candidates was sufficient to fully repay the loans. The Company filed an application with Business Finland for waiver of the loans and accrued interest. In July 2022, Business Finland granted the waiver request, which became effective in December 2022. The Company recorded a gain on extinguishment of debt of $ 27.1 million for the carrying amount of the loans including accrued interest in December 2022. In October 2023, the Company dissolved its Biotie Therapies, Ltd. subsidiary, resulting in no financial impact to the Company. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | (11) Leases In February 2016, the FASB issued ASU 2016-02, “Leases” Topic 842, which amends the guidance in former ASC Topic 840, Leases . The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. 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. Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 3.3 years to 4.8 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 previously leased a facility in Ardsley, New York with approximately 160,000 square feet of space for its corporate headquarters. The Company exercised 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 for its corporate headquarters. The Company has no opt ions to extend the term of the sublease. The Pearl River sublease provides for monthly payments of rent during the lease term. The base rent commencing on January 1, 2023 is $ 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, Massachusetts. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $ 1.2 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 will recognize on a straight line basis sublease rental income of $ 0.3 million in 2023 and $ 0.7 million per year beginning in 2024 until lease expiration in December 2026. The Company’s leases have remaining lease terms of 3.3 years to 4.8 years , which reflects the exercise of the early termination of the Company’s Ardsley, New York lease as described above. The weighted-average remaining lease term for the Company’s operating leases was 3.6 years at September 30, 2023. The weighted-average discount rate was 8 % at September 30, 2023. ROU assets and lease liabilities related to the Company’s operating leases are as follows: (In thousands) Balance Sheet Classification September 30, 2023 December 31, 2022 Right-of-use assets Right of use assets $ 4,496 $ 5,287 Current lease liabilities Current portion of lease liabilities 1,578 1,545 Non-current lease liabilities Non-current portion of lease liabilities 3,468 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: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Operating lease cost $ 448 $ 431 $ 1,342 $ 3,390 Variable lease cost 205 132 409 1,960 Short-term lease cost 0 1 1 7 Total lease cost $ 653 $ 564 $ 1,752 $ 5,357 Future minimum commitments under all non-cancelable operating leases are as follows: (In thousands) 2023 (excluding the three months ended September 30, 2023) $ 386 2024 1,588 2025 1,633 2026 1,678 2027 357 Later years 182 Total lease payments 5,824 Less: Imputed interest ( 779 ) Present value of lease liabilities $ 5,045 Supplemental cash flow information related to the Company’s operating leases are as follows: (In thousands) Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 386 $ 295 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (12) Commitments and Contingencies In February 2021, the Company sold its Chelsea manufacturing operations to Catalent Pharma Solutions (“Catalent”) . In connection with the sale, the Company entered into a long-term, global manufacturing services (supply) agreement (the “2021 MSA”) with Catalent for the manufacture of Inbrija. The 2021 MSA provided that the Company would purchase Inbrija exclusively from Catalent and 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 entered into an amendment of the 2021 MSA that adjusted 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 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, to terminate the 2021 MSA. In connection with the termination of the 2021 MSA, the Company is obligated to pay a $ 4 million termination fee to Catalent, payable in April 2024 and included in Accounts Payable as of September 30, 2023. 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 were delivered in the first quarter of 2023. Effective January 1, 2023, the Company entered into a new manufacturing services agreement with Catalent, which was subsequently amended in March 2023 (as amended in March 2023, the “New MSA”). Under the New MSA, Catalent will continue to manufacture Inbrija 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 will be subject to purchase commitments in 2023 and 2024 of 15 and 24 batches of Inbrija, respectively, at a total cost of $ 10.5 million and $ 15.5 million, respectively. 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 U.S. 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, and will provide up to $ 1 million in each of 2023 and 2024 for capital expenditures to assist in the capacity expansion efforts. In addition, the Company paid Catalent $ 2 million in 2023 in connection with certain activities relating to the operational readiness of the PSD-7. The New MSA, unless earlier terminated, will continue until December 31, 2030, and will be automatically extended for successive two-year periods unless either party 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. During the quarter ended September 30, 2023, the Company incurred approximately $ 6.3 million of purchase commitments with Catalent, of which $ 3.5 million was recognized as new purchases, and $ 2.8 million is recognized as other current assets. Additionally, approximately $ 1.4 million in purchases incurred in the prior quarter was previously recognized as other current assets and has been reclassified as inventory. The Company did not recognize any purchase commitments in cost of sales within its consolidated statement of operations for the period. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
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. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) for interim financial information, Accounting Standards Codification (“ASC”) Topic 270-10, and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated potential subsequent events through the date of this filing. Operating results for the three- and nine-month periods ended September 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2022 consolidated balance sheet data was derived from the Company’s audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2022. Effective January 1, 2022, the Company adopted ASU 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” The Company’s significant accounting policies have not changed materially from December 31, 2022. |
Restricted Cash | Restricted Cash At September 30, 2023, the Company held restricted cash consisting of $ 0.3 million related to cash collateralized standby letters of credit in connection with obligations under facility leases and $ 0.9 million to cover the Company’s self-funded employee health insurance. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows: Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 32,468 $ 45,634 $ 20,696 Restricted cash 6,884 861 13,400 13,232 Restricted cash non-current 255 255 6,189 255 Total Cash, cash equivalents, and restricted cash per statement of cash flows $ 44,675 $ 33,584 $ 65,223 $ 34,183 |
Investments | Investments Short-term investments consist primarily of high-grade commercial paper and corporate bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period is longer than one year. The Company classifies all its investments as available-for-sale. Available-for-sale securities are recorded at the fair value of the investments based on quoted market prices. Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive loss. Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective‑interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income are included in interest income. Realized gains and losses are included in other income. There were no investments classified as short-term or long-term at September 30, 2023 or December 31, 2022. |
Inventory | Inventory The following table provides the major classes of inventory: (In thousands) September 30, 2023 December 31, 2022 Raw materials $ 10,537 $ 6,212 Finished goods 7,405 6,540 Total $ 17,942 $ 12,752 The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. |
Foreign Currency Translation | Foreign Currency Translation The functional currency of operations outside the U.S. is deemed to be the currency of the local country, unless otherwise determined that the U.S. 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 subsidiaries are translated into U.S. dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations. |
Segment and Geographic Information | Segment and Geographic Information The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Inbrija and Ampyra in the U.S. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer, and significant negative economic trends. The decline in the trading price of the Company’s common stock during the nine-month period ended September 30, 2023, and related decrease in the Company’s market capitalization, was determined to be a triggering event in connection with the Company’s review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2023. The Company performed a recoverability test as of September 30, 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 compared to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s assumptions about its use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2023, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets. |
Liquidity | Liquidity The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, obtain additional financing and repay or restructure outstanding indebtedness. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing the 2024 Notes, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness, in particular the 2024 Notes that mature on December 1, 2024, will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether. At September 30 , 2023, the Company had $ 32.5 million of cash and cash equivalents, compared to $ 37.5 million at December 31, 2022. The Company’s September 30, 2023 cash and cash equivalents balance does not include $ 1.2 million of restricted cash, of which $ 0.9 million is related to self-funded employee health insurance and $ 0.3 million is related to collateralized standby letters of credit. The Company incurred a net loss of $ 35.1 million for the nine-month period ended September 30, 2023. 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 be sufficient to cover its cash flow requirements for the next twelve months from the issuance date of these financial statements. However, the 2024 Notes mature on December 1, 2024 and, unless earlier converted in accordance with their terms, the Company will be required to pay all outstanding principal and any accrued and unpaid interest on the notes on the maturity date. At September 30, 2023, the principal balance outstanding under the 2024 Notes was $ 207.0 million. The Company is evaluating its options to raise additional capital and repay or restructure all or a portion of the 2024 Notes, but its ability to do so will depend on numerous factors, some of which are beyond the Company’s control. The Company can provide no assurance that such efforts will be successful. |
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 no subsequent events that required disclosure in these financial statements. |
Accounting Pronouncements Not Yet Adopted | Accounting Pronouncements Not Yet Adopted In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 that 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 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: Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 (In thousands) Beginning of period End of period Beginning of period End of period Cash and cash equivalents $ 37,536 $ 32,468 $ 45,634 $ 20,696 Restricted cash 6,884 861 13,400 13,232 Restricted cash non-current 255 255 6,189 255 Total Cash, cash equivalents, and restricted cash per statement of cash flows $ 44,675 $ 33,584 $ 65,223 $ 34,183 |
Schedule of Major Classes of Inventory | The following table provides the major classes of inventory: (In thousands) September 30, 2023 December 31, 2022 Raw materials $ 10,537 $ 6,212 Finished goods 7,405 6,540 Total $ 17,942 $ 12,752 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue | The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen and the royalties payable from Neurelis Inc. for sales of Valtoco. No further royalties from sales of Valtoco are expected. (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Revenues: Net product revenues: Ampyra $ 15,725 $ 21,110 $ 45,244 $ 54,192 Inbrija 8,092 7,848 21,923 18,957 Inbrija ex-U.S. 1,362 1,006 2,696 2,874 Total net product revenues 25,179 29,964 69,863 76,023 Royalty revenues 2,502 3,047 9,717 10,573 License Revenue 34 500 68 500 Total net revenues $ 27,715 $ 33,511 $ 79,648 $ 87,096 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Schedule of Share-based Compensation Expense | The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: For the three-month period ended September 30, For the nine-month period ended September 30, (In thousands) 2023 2022 2023 2022 Research and development expense $ 3 $ 14 $ 8 $ 66 Selling, general and administrative expense 137 351 331 1,254 Cost of Sales — ( 1 ) — — Total $ 140 $ 364 $ 339 $ 1,320 |
Schedule of Stock Option Activity | A summary of share-based compensation activity for the nine-month period ended September 30, 2023 is presented below: Number of thousands) Weighted Weighted Intrinsic thousands) Balance at January 1, 2023 52 $ 1,571.06 — — Granted 62 12.32 — — Cancelled ( 8 ) 2,740.73 — — Exercised — — — — Balance at September 30, 2023 106 $ 568.54 7.8 $ 181,812 Vested and expected to vest at 106 $ 568.54 7.8 $ 181,812 Vested and exercisable at 51 $ 1,161.97 6.2 $ 55,689 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Loss per Share | The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2023 and 2022: (In thousands, except per share data) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Basic and diluted Net loss—basic $ ( 8,888 ) $ ( 13,854 ) $ ( 35,093 ) $ ( 85,058 ) Net income (loss)—diluted $ ( 8,888 ) $ ( 13,854 ) $ ( 35,093 ) $ ( 85,058 ) Weighted average common shares outstanding used in 1,242 1,240 1,242 871 Plus: net effect of dilutive stock options and restricted — — — — Weighted average common shares outstanding used in 1,242 1,240 1,242 871 Net loss per share—basic $ ( 7.16 ) $ ( 11.17 ) $ ( 28.25 ) $ ( 97.66 ) Net loss per share—diluted $ ( 7.16 ) $ ( 11.17 ) $ ( 28.25 ) $ ( 97.66 ) |
Schedule of Anti-dilutive Securities Excluded from Calculation of Net Loss per Diluted Share | The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Denominator Stock options and restricted common shares 105 57 105 55 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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 Basis | (In thousands) Level 1 Level 2 Level 3 September 30, 2023 Assets Carried at Fair Value: Money market funds $ — $ — $ — Liabilities Carried at Fair Value: Acquired contingent consideration — — 32,800 December 31, 2022 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) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Acquired contingent consideration: Balance, beginning of period $ 38,500 $ 42,900 $ 41,200 $ 49,600 Fair value change to contingent consideration ( 5,203 ) ( 4,576 ) ( 7,118 ) ( 10,709 ) Royalty payments ( 497 ) ( 724 ) ( 1,282 ) ( 1,291 ) Balance, end of period $ 32,800 $ 37,600 $ 32,800 $ 37,600 |
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 2024 Notes: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Derivative Liability-Conversion Option: Balance, beginning of period $ — $ — $ — $ 37 Fair value adjustment — — — ( 37 ) Balance, end of period $ — $ — $ — $ — |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 9 Months Ended |
Sep. 30, 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 nine-month period ended September 30, 2023 and 2022, respectively: (In thousands) September 30, 2023 September 30, 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 $ — $ — |
Debt (Tables)
Debt (Tables) - Convertible Senior Secured Notes due 2024 | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Outstanding Note Balances | The outstanding 2024 Notes balances as of September 30, 2023 and December 31, 2022 consisted of the following: (In thousands) September 30, 2023 December 31, 2022 Liability component: Principal 207,000 $ 207,000 Less: debt discount and debt issuance costs, net ( 25,957 ) ( 39,969 ) Net carrying amount $ 181,043 $ 167,031 Equity component $ 18,257 $ 18,257 Derivative liability-conversion option $ — $ — |
Schedule of Interest Expense Recognized Related to the Notes | The following table sets forth total interest expense recognized related to the 2024 Notes for the three- and nine-month periods ended September 30, 2023 and 2022: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Contractual interest expense $ 3,105 $ 3,105 $ 9,315 $ 9,315 Amortization of debt issuance costs 347 291 995 834 Amortization of debt discount 4,532 3,797 13,018 10,902 Total interest expense $ 7,984 $ 7,193 $ 23,328 $ 21,051 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 2023 December 31, 2022 Right-of-use assets Right of use assets $ 4,496 $ 5,287 Current lease liabilities Current portion of lease liabilities 1,578 1,545 Non-current lease liabilities Non-current portion of lease liabilities 3,468 4,341 |
Components of Lease Costs | The components of lease costs were as follows: (In thousands) Three-month period ended September 30, 2023 Three-month period ended September 30, 2022 Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Operating lease cost $ 448 $ 431 $ 1,342 $ 3,390 Variable lease cost 205 132 409 1,960 Short-term lease cost 0 1 1 7 Total lease cost $ 653 $ 564 $ 1,752 $ 5,357 |
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) 2023 (excluding the three months ended September 30, 2023) $ 386 2024 1,588 2025 1,633 2026 1,678 2027 357 Later years 182 Total lease payments 5,824 Less: Imputed interest ( 779 ) Present value of lease liabilities $ 5,045 |
Summary of Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to the Company’s operating leases are as follows: (In thousands) Nine-month period ended September 30, 2023 Nine-month period ended September 30, 2022 Operating cash flow information: Cash paid for amounts included in the measurement of lease liabilities $ 386 $ 295 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||||||||
Jun. 02, 2023 shares | Dec. 24, 2019 USD ($) | Sep. 30, 2023 USD ($) shares | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) Segment shares | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) shares | Sep. 17, 2020 shares | Aug. 28, 2020 shares | Dec. 31, 2019 shares | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||||
Common stock, Authorized shares | shares | 3,083,333 | 3,083,333 | 3,083,333 | 3,083,333 | 61,666,666 | 13,333,333 | 13,333,333 | |||||||
Investments | $ 0 | $ 0 | $ 0 | |||||||||||
Reverse stock split, description | 1-for-20 reverse stock split | |||||||||||||
Segment and Geographic Information | ||||||||||||||
Number of operating segments | Segment | 1 | |||||||||||||
Number of reportable operating segments | Segment | 1 | |||||||||||||
Net loss | (8,888,000) | $ (9,381,000) | $ (16,824,000) | $ (13,854,000) | $ (46,682,000) | $ (24,522,000) | $ (35,093,000) | $ (85,058,000) | ||||||
Previously Reported | ||||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||||
Common stock, Authorized shares | shares | 61,666,666 | |||||||||||||
Convertible Senior Secured Notes due 2024 | ||||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||||
Interest rate (as a percent) | 6% | |||||||||||||
Reverse stock split, description | 1-for-6 | |||||||||||||
Segment and Geographic Information | ||||||||||||||
Principal | $ 207,000,000 | 207,000,000 | $ 207,000,000 | |||||||||||
Notes maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||||||||||
VERSION A | ||||||||||||||
Segment and Geographic Information | ||||||||||||||
Cash and cash equivalents | 32,500,000 | $ 32,500,000 | $ 37,500,000 | |||||||||||
Restricted cash | 1,200,000 | 1,200,000 | ||||||||||||
Net loss | 35,100,000 | |||||||||||||
Self-Funded Employee Health Insurance | ||||||||||||||
Segment and Geographic Information | ||||||||||||||
Restricted cash | 900,000 | 900,000 | ||||||||||||
Self-Funded Employee Health Insurance | VERSION A | ||||||||||||||
Segment and Geographic Information | ||||||||||||||
Restricted cash | 900,000 | 900,000 | ||||||||||||
Letters of Credit | ||||||||||||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | ||||||||||||||
Restricted Cash and Cash Equivalents | 300,000 | 300,000 | ||||||||||||
Letters of Credit | VERSION A | ||||||||||||||
Segment and Geographic Information | ||||||||||||||
Restricted cash | $ 300,000 | $ 300,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 32,468 | $ 37,536 | $ 20,696 | $ 45,634 |
Restricted cash | 861 | 6,884 | 13,232 | 13,400 |
Restricted cash non-current | 255 | 255 | 255 | 6,189 |
Total Cash, cash equivalents and restricted cash per statement of cash flows | $ 33,584 | $ 44,675 | $ 34,183 | $ 65,223 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Major Classes of Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 10,537 | $ 6,212 |
Finished goods | 7,405 | 6,540 |
Total | $ 17,942 | $ 12,752 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Contract assets | $ 0 | $ 0 | ||
Revenues | 27,715,000 | $ 33,511,000 | 79,648,000 | $ 87,096,000 |
Royalty Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenues | 2,502,000 | 3,047,000 | 9,717,000 | 10,573,000 |
Valtoco [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Royalty revenue expected | 0 | |||
Esteve Pharmaceuticals [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from remaining performance obligations | $ 500,000 | $ 500,000 | ||
Esteve Pharmaceuticals [Member] | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-10-01 | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue from the remaining performance obligations term | 9 years | 9 years | ||
Esteve Pharmaceuticals And Hangzhou Chance Pharmaceuticals Co Ltd [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Contract Liabilities | $ 8,200,000 | $ 6,100,000 | $ 8,200,000 | $ 6,100,000 |
Revenue - Disaggregation of Rev
Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 27,715 | $ 33,511 | $ 79,648 | $ 87,096 |
Ampyra | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 15,725 | 21,110 | 45,244 | 54,192 |
Inbrija | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 8,092 | 7,848 | 21,923 | 18,957 |
Inbrija ex-U.S. | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 1,362 | 1,006 | 2,696 | 2,874 |
Net Product Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 25,179 | 29,964 | 69,863 | 76,023 |
Royalty Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | 2,502 | 3,047 | 9,717 | 10,573 |
License Revenue | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total net revenues | $ 34 | $ 500 | $ 68 | $ 500 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||
Share-based compensation expense recognized | $ 140 | $ 364 | $ 339 | $ 1,320 |
Weighted average fair value of options granted (in dollars per share) | $ 9.97 | $ 6.10 | $ 9.86 | $ 16.80 |
Unrecognized compensation costs for unvested stock options, restricted stock awards and restricted stock units | $ 600 | $ 600 | ||
Weighted average period | 1 year 4 months 24 days | |||
Purchase of Treasury Stock ,Shares | 0 |
Share-Based Compensation - Sche
Share-Based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 140 | $ 364 | $ 339 | $ 1,320 |
Research and development expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | 3 | 14 | 8 | 66 |
Selling, general, and administrative expense | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ 137 | 351 | $ 331 | $ 1,254 |
Cost of sales | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expense recognized | $ (1) |
Share-Based Compensation - Sc_2
Share-Based Compensation - Schedule of Stock Options Activity (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Stock Option Activity | |
Beginning balance (in shares) | shares | 52 |
Granted (in shares) | shares | 62 |
Cancelled (in shares) | shares | (8) |
Ending balance (in shares) | shares | 106 |
Vested and expected to vest at the end of the period | shares | 106 |
Vested and exercisable at the end of the period | shares | 51 |
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 | 12.32 |
Cancelled (in dollars per share) | $ / shares | 2,740.73 |
Balance at the end of the period (in dollars per share) | $ / shares | 568.54 |
Vested and expected to vest at the end of the period (in dollars per share) | $ / shares | 568.54 |
Vested and exercisable at the end of the period (in dollars per share) | $ / shares | $ 1,161.97 |
Weighted Average Remaining Contractual Term | |
Balance at the end of the period | 7 years 9 months 18 days |
Vested and expected to vest at the end of the period | 7 years 9 months 18 days |
Vested and exercisable at the end of the period | 6 years 2 months 12 days |
Intrinsic Value | |
Balance at the end of the period | $ | $ 181,812 |
Vested and expected to vest at the end of the period | $ | 181,812 |
Vested and exercisable at the end of the period | $ | $ 55,689 |
Loss Per Share - Schedule of Co
Loss Per Share - Schedule of Computation of Basic and Diluted Loss Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Basic and diluted | ||||||||
Net loss-basic | $ (8,888) | $ (9,381) | $ (16,824) | $ (13,854) | $ (46,682) | $ (24,522) | $ (35,093) | $ (85,058) |
Net income (loss)-diluted | $ (8,888) | $ (13,854) | $ (35,093) | $ (85,058) | ||||
Weighted average common shares outstanding used in computing net loss per share-basic | 1,242 | 1,240 | 1,242 | 871 | ||||
Weighted average common shares outstanding used in computing net loss per share—diluted | 1,242 | 1,240 | 1,242 | 871 | ||||
Net loss per share—basic | $ (7.16) | $ (11.17) | $ (28.25) | $ (97.66) | ||||
Net loss per share—diluted | $ (7.16) | $ (11.17) | $ (28.25) | $ (97.66) |
Loss Per Share - Schedule of An
Loss Per Share - Schedule of Antidilutive Securities Excluded from Calculation of Net Loss Per Diluted Share (Details) - shares shares in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock options and restricted common shares | ||||
Antidilutive Securities | ||||
Anti-dilutive securities excluded from computation of loss per share (in shares) | 105 | 57 | 105 | 55 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Benefit from (provision for) income taxes | $ 1,055 | $ (1,416) | $ 5,058 | $ (28,237) |
Effective income tax rate (as a percent) | 10.60% | (11.30%) | 12.60% | (49.70%) |
Tax deduction | 0% | 0% |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Millions | 9 Months Ended | |||||||
Sep. 17, 2020 USD ($) shares | Sep. 30, 2020 USD ($) | Sep. 30, 2023 USD ($) shares | Jun. 02, 2023 shares | Dec. 31, 2022 shares | Sep. 30, 2022 | Aug. 28, 2020 shares | Dec. 31, 2019 shares | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Common stock, Authorized shares | shares | 61,666,666 | 3,083,333 | 3,083,333 | 3,083,333 | 13,333,333 | 13,333,333 | ||
Derivative liability reclassified to equity | $ 18.3 | |||||||
Income tax effects on equity transactions | $ 4.4 | |||||||
Inbrija | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Milestone payment, minimum | $ 0 | |||||||
Milestone payment, maximum | 16.2 | |||||||
Fair Value, Inputs, Level 2 | Convertible Senior Secured Notes due 2024 | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Convertible senior notes | $ 157.3 | |||||||
Level 3 | Weighted Discounted Cash Flow Valuation Approach | Discount Rate | ||||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||||
Acquired contingent consideration, measurement input | 23 | 23 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Recurring basis - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Level 1 | Money Market Funds | ||
Assets Carried at Fair Value: | ||
Assets, Fair Value | $ 15,322 | |
Level 3 | ||
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | $ 32,800 | $ 41,200 |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Contingent Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||||
Balance, beginning of period | $ 38,500 | $ 42,900 | $ 41,200 | $ 49,600 |
Fair value change to contingent consideration included in the statement of operations | (5,203) | (4,576) | (7,118) | (10,709) |
Royalty payments | (497) | (724) | (1,282) | (1,291) |
Balance, end of period | $ 32,800 | $ 37,600 | $ 32,800 | $ 37,600 |
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 | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Fair Value Reconciliation Of Derivative Liability [Line Items] | |
Balance, beginning of period | $ 37 |
Fair value adjustment | (37) |
Balance, end of period | $ 0 |
Investments - Additional Inform
Investments - Additional Information (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Schedule Of Available For Sale Securities [Line Items] | ||
Available-for-sale investments | $ 0 | $ 0 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties - Additional Information (Details) - Royalty Purchase Agreement - USD ($) | 9 Months Ended | |||
Oct. 01, 2017 | Sep. 30, 2022 | Sep. 30, 2023 | Dec. 31, 2021 | |
Liability Related To Sale Of Future Royalties [Line Items] | ||||
Payment from royalties | $ 40,000,000 | |||
Royalty liability | 40,000,000 | |||
Net of transaction costs | $ 2,200,000 | $ 33,000 | ||
Liability related to sale of future royalties - ending balance | $ 0 | $ 0 | $ 4,460,000 |
Liability Related to Sale of _4
Liability Related to Sale of Future Royalties - Schedule of Activity Within Liability Related to Sale of Future Royalties (Details) - USD ($) | 9 Months Ended | |
Oct. 01, 2017 | Sep. 30, 2022 | |
Liability Related To Sale Of Future Royalties [Line Items] | ||
Non-cash royalty revenue payable to HCRP | $ (4,762,000) | |
Royalty Purchase Agreement | ||
Liability Related To Sale Of Future Royalties [Line Items] | ||
Liability related to sale of future royalties - beginning balance | 4,460,000 | |
Deferred transaction costs amortized | $ 2,200,000 | 33,000 |
Non-cash royalty revenue payable to HCRP | (4,739,000) | |
Non-cash interest expense recognized | 246,000 | |
Liability related to sale of future royalties - ending balance | $ 0 |
Debt - Additional Information (
Debt - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||||||
Jun. 02, 2023 shares | Jun. 01, 2023 USD ($) | Sep. 17, 2020 USD ($) shares | Dec. 24, 2019 USD ($) $ / shares | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares shares | Sep. 30, 2022 USD ($) | Sep. 30, 2020 USD ($) | Dec. 31, 2022 USD ($) shares | Aug. 28, 2020 shares | Dec. 31, 2019 shares | |
Debt Instrument [Line Items] | ||||||||||||
Cash interest payment | $ 6,200,000 | |||||||||||
Interest payment due date | June 1, 2023 | |||||||||||
Aggregate payment on debt exchange | $ 55,200,000 | |||||||||||
Stockholders' equity, reverse stock split | 1-for-20 reverse stock split | |||||||||||
Gain on debt extinguishment | $ 27,100,000 | |||||||||||
Common stock, Authorized shares | shares | 3,083,333 | 61,666,666 | 3,083,333 | 3,083,333 | 3,083,333 | 13,333,333 | 13,333,333 | |||||
Derivative liability reclassified to equity | $ 18,300,000 | |||||||||||
Income tax effects on equity transactions | $ 4,400,000 | |||||||||||
Interest expense | $ 7,984,000 | $ 7,465,000 | $ 23,328,000 | $ 22,501,000 | ||||||||
Non Convertible Debt | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Fair value of debt | 20,500,000 | 20,500,000 | ||||||||||
Convertible Senior Notes due 2021 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Principal amount of debt exchanged | $ 276,000,000 | |||||||||||
Interest rate (as a percent) | 1.75% | |||||||||||
Convertible Senior Secured Notes due 2024 | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate (as a percent) | 6% | |||||||||||
Principal | $ 207,000,000 | 207,000,000 | 207,000,000 | |||||||||
Debt instrument, principal amount outstanding | $ 207,000,000 | $ 207,000,000 | $ 207,000,000 | |||||||||
Notes maturity date | Dec. 01, 2024 | Dec. 01, 2024 | ||||||||||
Notes frequency of periodic payment | semi-annually in arrears | |||||||||||
Initial conversion rate of common stock | 2.381 | |||||||||||
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares | $ 420 | $ 420 | $ 420 | |||||||||
Principal amount of Notes or an integral multiple thereof in which holder may repurchase the Notes | $ 1,000 | $ 1,000 | ||||||||||
Stockholders' equity, reverse stock split | 1-for-6 | |||||||||||
Debt instrument conversion threshold stock price percentage | 130% | |||||||||||
Repurchase principal amount, Percentage | 100% | |||||||||||
Debt default, non payment of interest, period | 30 days | |||||||||||
Debt default, failure to convert notes, period | 5 days | |||||||||||
Debt default, non-compliance with covenants, period | 60 days | |||||||||||
Fair value of derivative liability | $ 59,400,000 | |||||||||||
Debt discount | $ 75,100,000 | |||||||||||
Interest expense | 8,000,000 | $ 23,300,000 | ||||||||||
Effective interest rate on liability component (as a percent) | 18.13% | |||||||||||
Debt fair value amount | 157,300,000 | 157,300,000 | ||||||||||
Debt issuance costs | $ 5,700,000 | $ 5,700,000 | ||||||||||
Convertible Senior Secured Notes due 2024 | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt default, non-payment of outstanding principal | $ 30,000,000 | |||||||||||
Debt default, failure to pay final judgements | $ 30,000,000 | |||||||||||
Debt default, percentage of principal outstanding required for immediate payment | 25% |
Debt - Summary of Outstanding N
Debt - Summary of Outstanding Note Balances (Details) - Convertible Senior Secured Notes due 2024 - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Dec. 24, 2019 |
Debt Instrument [Line Items] | |||
Principal | $ 207,000 | $ 207,000 | |
Less: debt discount and debt issuance costs, net | (25,957) | (39,969) | |
Net carrying amount | 181,043 | 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 | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Debt Instrument [Line Items] | ||||
Total interest expense | $ 7,984 | $ 7,465 | $ 23,328 | $ 22,501 |
Convertible Senior Secured Notes due December 2024 | ||||
Debt Instrument [Line Items] | ||||
Contractual interest expense | 3,105 | 3,105 | 9,315 | 9,315 |
Amortization of debt issuance costs | 347 | 291 | 995 | 834 |
Amortization of debt discount | 4,532 | 3,797 | 13,018 | 10,902 |
Total interest expense | $ 7,984 | $ 7,193 | $ 23,328 | $ 21,051 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Millions | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2023 USD ($) ft² | Dec. 31, 2024 USD ($) | Jul. 31, 2023 ft² | Jun. 30, 2022 ft² | Oct. 31, 2016 USD ($) ft² | |
Operating Lease Information | |||||
Operating lease description | Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 3.3 years to 4.8 years. | ||||
Operating lease renewal option | true | ||||
Operating lease termination option | true | ||||
Operating lease weighted-average remaining lease term | 3 years 7 months 6 days | ||||
Operating lease weighted-average discount rate | 8% | ||||
Sublease rental income recognized | $ 0.3 | ||||
Forecast | |||||
Operating Lease Information | |||||
Sublease rental income recognized | $ 0.7 | ||||
Ardsley, New York | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 160,000 | ||||
Termination option effective date | Jun. 22, 2022 | ||||
Termination Fee | $ 4.7 | ||||
Pearl River, New York | |||||
Operating Lease Information | |||||
Area of leased property | ft² | 21,000 | ||||
Lease term | 6 years | ||||
Operating sublease, existence of option to extend | false | ||||
Base rent payment commencing on January 1, 2023 | $ 0.3 | ||||
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 | |||||
Area of leased property | ft² | 26,000 | ||||
Lease term | 10 years | ||||
Base rent | $ 1.2 | ||||
Minimum | |||||
Operating Lease Information | |||||
Operating lease remaining lease term | 3 years 3 months 18 days | ||||
Maximum | |||||
Operating Lease Information | |||||
Operating lease remaining lease term | 4 years 9 months 18 days |
Leases - Schedule of ROU Assets
Leases - Schedule of ROU Assets and Lease Liabilities Related to Operating Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Right-of-use assets | $ 4,496 | $ 5,287 |
Current lease liabilities | 1,578 | 1,545 |
Non-current lease liabilities | $ 3,468 | $ 4,341 |
Leases - Components of Lease Co
Leases - Components of Lease Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Operating lease cost | $ 448 | $ 431 | $ 1,342 | $ 3,390 |
Variable lease cost | 205 | 132 | 409 | 1,960 |
Short-term lease cost | 0 | 1 | 1 | 7 |
Total lease cost | $ 653 | $ 564 | $ 1,752 | $ 5,357 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
2023 (excluding the three months ended June 30, 2023) | $ 386 |
2024 | 1,588 |
2025 | 1,633 |
2026 | 1,678 |
2027 | 357 |
Later years | 182 |
Total lease payments | 5,824 |
Less: Imputed interest | (779) |
Present value of lease liabilities | $ 5,045 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating cash flow information: | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 386 | $ 295 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Loss Contingencies [Line Items] | ||||
Cost of sales | $ 3,387 | $ 11,005 | $ 9,685 | $ 25,772 |
Catalent | ||||
Loss Contingencies [Line Items] | ||||
Termination fee payment | 4,000 | 4,000 | ||
Contribution of fund agreed | 2,000 | |||
Minimum purchase commitment | 6,300 | |||
Purchase commitment recognized as new purchase | 3,500 | 3,500 | ||
Purchase commitment reclassified as inventory | 1,400 | 1,400 | ||
Purchase commitment recognized as other current assets | 2,800 | 2,800 | ||
Catalent | Inbrija | ||||
Loss Contingencies [Line Items] | ||||
Purchase Obligation | 18,000 | 18,000 | ||
Purchase commitments in 2023 | 10,500 | 10,500 | ||
Purchase commitments in 2024 | 15,500 | 15,500 | ||
Cost of sales | 8,400 | |||
Maximum | ||||
Loss Contingencies [Line Items] | ||||
Capital expenditure provision in 2023 | 1,000 | |||
Capital expenditure provision in 2024 | 1,000 | |||
Minimum | Catalent | Inbrija | ||||
Loss Contingencies [Line Items] | ||||
Original Purchase Obligation | $ 17,000 | $ 17,000 |