ACORDA THERAPEUTICS INC, 10-Q filed on 11/14/2022
Quarterly Report
v3.22.2.2
Document and Entity Information - shares
9 Months Ended
Sep. 30, 2022
Nov. 10, 2022
Cover [Abstract]    
Entity Registrant Name ACORDA THERAPEUTICS, INC.  
Entity Central Index Key 0001008848  
Document Type 10-Q  
Document Period End Date Sep. 30, 2022  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity Filer Category Non-accelerated Filer  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Document Quarterly Report true  
Document Transition Report false  
Document Fiscal Year Focus 2022  
Document Fiscal Period Focus Q3  
Trading Symbol ACOR  
Title of each class Common Stock $0.001 par value per share  
Name of each exchange on which registered NASDAQ  
Entity Common Stock, Shares Outstanding   24,337,814
Entity File Number 001-31938  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 13-3831168  
Entity Address, Address Line One 2 Blue Hill Plaza  
Entity Address, Address Line Two 3rd Floor  
Entity Address, City or Town Pearl River  
Entity Address, State or Province NY  
Entity Address, Postal Zip Code 10965  
City Area Code 914  
Local Phone Number 347-4300  
v3.22.2.2
Consolidated Balance Sheets - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Current assets:    
Cash and cash equivalents $ 20,696 $ 45,634
Restricted cash 13,232 13,400
Trade accounts receivable, net of allowances of $888 and $1,012, as of September 30, 2022 and December 31, 2021, respectively 14,690 17,002
Prepaid expenses 5,111 6,574
Inventory, net 15,252 18,548
Other current assets 2,711 999
Total current assets 71,692 102,157
Property and equipment, net of accumulated depreciation 2,825 4,382
Intangible assets, net of accumulated amortization 312,779 335,980
Right of use asset, net of accumulated amortization 5,541 6,751
Restricted cash 255 6,189
Other assets 247 11
Total assets 393,339 455,470
Current liabilities:    
Accounts payable 11,505 10,845
Accrued expenses and other current liabilities 26,705 28,605
Current portion of liability related to sale of future royalties   4,460
Current portion of lease liabilities 1,454 8,186
Current portion of acquired contingent consideration 2,359 1,929
Total current liabilities 42,023 54,025
Convertible senior notes 162,760 151,025
Derivative liability   37
Non-current portion of acquired contingent consideration 35,241 47,671
Non-current portion of lease liabilities 4,612 4,086
Non-current portion of loans payable 24,929 27,645
Deferred tax liability 42,228 13,930
Other non-current liabilities 5,780 5,914
Commitments and contingencies
Stockholders’ equity:    
Preferred stock, $0.001 par value per share. Authorized 1,000,000 shares at September 30, 2022 and December 31, 2021; no shares issued as of September 30, 2022 and December 31, 2021, respectively
Common stock, $0.001 par value per share. Authorized 61,666,666 shares at September 30, 2022 and December 31, 2021; issued 24,338,195 and 13,249,802 shares, including those held in treasury, as of September 30, 2022 and December 31, 2021, respectively 24 13
Treasury stock at cost (5,543 shares at September 30, 2022 and December 31, 2021) (638) (638)
Additional paid-in capital 1,029,705 1,023,136
Accumulated deficit (955,415) (870,357)
Accumulated other comprehensive loss 2,090 (1,017)
Total stockholders’ equity 75,766 151,137
Total liabilities and stockholders’ equity $ 393,339 $ 455,470
v3.22.2.2
Consolidated Balance Sheets (Parenthetical) - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Statement Of Financial Position [Abstract]    
Trade accounts receivable, allowances (in dollars) $ 888 $ 1,012
Preferred stock, par value (in dollars per share) $ 0.001 $ 0.001
Preferred stock, Authorized shares 1,000,000 1,000,000
Preferred stock, issued shares 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, Authorized shares 61,666,666 61,666,666
Common stock, issued shares 24,338,195 13,249,802
Treasury stock, shares 5,543 5,543
v3.22.2.2
Consolidated Statements of Operations - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Revenues:        
Total net revenues $ 33,511 $ 31,456 $ 87,096 $ 92,104
Costs and expenses:        
Cost of sales 11,005 13,303 25,772 36,589
Research and development 1,383 1,931 4,602 9,054
Selling, general and administrative 22,997 29,623 80,002 95,959
Amortization of intangible assets 7,691 7,691 23,073 23,073
Change in fair value of derivative liability   (288) (37) (868)
Changes in fair value of acquired contingent consideration (4,576) 2,205 (10,709) (4,224)
Total operating expenses 38,500 54,465 122,703 159,583
Operating loss (4,989) (23,009) (35,607) (67,479)
Other income (expense), net:        
Interest and amortization of debt discount expense (7,465) (7,167) (22,501) (22,697)
Interest income 17 1 38 4
Other income (expense)     1,250 1
Realized loss on foreign currency transactions (1) (1) (1) (4)
Total other expense, net (7,449) (7,167) (21,214) (22,696)
Loss before taxes (12,438) (30,176) (56,821) (90,175)
(Provision for) benefit from income taxes (1,416) 3,105 (28,237) 6,788
Net loss $ (13,854) $ (27,071) $ (85,058) $ (83,387)
Net loss per share—basic $ (0.57) $ (2.43) $ (4.69) $ (8.17)
Net loss per share—diluted $ (0.57) $ (2.43) $ (4.69) $ (8.17)
Weighted average common shares outstanding used in computing net loss per share—basic 24,290 11,131 18,148 10,204
Weighted average common shares outstanding used in computing net loss per share—diluted 24,290 11,131 18,148 10,204
Net Product Revenues        
Revenues:        
Total net revenues $ 29,964 $ 27,851 $ 76,023 $ 81,297
Royalty Revenues        
Revenues:        
Total net revenues 3,047 $ 3,605 10,573 $ 10,807
License Revenue        
Revenues:        
Total net revenues $ 500   $ 500  
v3.22.2.2
Consolidated Statements of Comprehensive Income (Loss) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Statement Of Income And Comprehensive Income [Abstract]        
Net loss $ (13,854) $ (27,071) $ (85,058) $ (83,387)
Other comprehensive income (loss), net of tax:        
Foreign currency translation adjustment 1,352 276 3,107 1,246
Other comprehensive income (loss), net of tax 1,352 276 3,107 1,246
Comprehensive income (loss) $ (12,502) $ (26,795) $ (81,951) $ (82,141)
v3.22.2.2
Consolidated Statements of Changes in Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Total
Common stock
Treasury stock
Additional paid-in capital
Accumulated deficit
Accumulated other comprehensive (loss) income
Balance at Dec. 31, 2020 $ 237,955 $ 9 $ (638) $ 1,007,790 $ (766,403) $ (2,803)
Balance (in shares) at Dec. 31, 2020   9,476        
Compensation expense for issuance of stock options to employees 483     483    
Compensation expense for issuance of restricted stock to employees 224     224    
Other comprehensive income (loss), net of tax 1,069         1,069
Net income (loss) (33,451)       (33,451)  
Balance at Mar. 31, 2021 206,279 $ 9 (638) 1,008,497 (799,854) (1,734)
Balance (in shares) at Mar. 31, 2021   9,476        
Balance at Dec. 31, 2020 237,955 $ 9 (638) 1,007,790 (766,403) (2,803)
Balance (in shares) at Dec. 31, 2020   9,476        
Net income (loss) (83,387)          
Balance at Sep. 30, 2021 164,475 $ 11 (638) 1,016,448 (849,789) (1,557)
Balance (in shares) at Sep. 30, 2021   11,194        
Balance at Mar. 31, 2021 206,279 $ 9 (638) 1,008,497 (799,854) (1,734)
Balance (in shares) at Mar. 31, 2021   9,476        
Compensation expense for issuance of stock options to employees 498     498    
Compensation expense for issuance of restricted stock to employees 456     456    
Interest payment for convertible notes 6,210 $ 2   6,208    
Interest payment for convertible notes (in shares)   1,636        
Other comprehensive income (loss), net of tax (99)         (99)
Net income (loss) (22,864)       (22,864)  
Balance at Jun. 30, 2021 190,481 $ 11 (638) 1,015,659 (822,718) (1,833)
Balance (in shares) at Jun. 30, 2021   11,112        
Compensation expense for issuance of stock options to employees 455     455    
Compensation expense for issuance of restricted stock to employees 334     334    
Compensation expense for issuance of restricted stock to employees (in shares)   82        
Other comprehensive income (loss), net of tax 276         276
Net income (loss) (27,071)       (27,071)  
Balance at Sep. 30, 2021 164,475 $ 11 (638) 1,016,448 (849,789) (1,557)
Balance (in shares) at Sep. 30, 2021   11,194        
Balance at Dec. 31, 2021 151,137 $ 13 (638) 1,023,136 (870,357) (1,017)
Balance (in shares) at Dec. 31, 2021   13,250        
Compensation expense for issuance of stock options to employees 181     181    
Compensation expense for issuance of restricted stock to employees 304     304    
Compensation expense for issuance of restricted stock to employees (in shares)   35        
Other comprehensive income (loss), net of tax 449         449
Net income (loss) (24,522)       (24,522)  
Balance at Mar. 31, 2022 127,549 $ 13 (638) 1,023,621 (894,879) (568)
Balance (in shares) at Mar. 31, 2022   13,285        
Balance at Dec. 31, 2021 151,137 $ 13 (638) 1,023,136 (870,357) (1,017)
Balance (in shares) at Dec. 31, 2021   13,250        
Net income (loss) (85,058)          
Balance at Sep. 30, 2022 75,766 $ 24 (638) 1,029,705 (955,415) 2,090
Balance (in shares) at Sep. 30, 2022   24,338        
Balance at Mar. 31, 2022 127,549 $ 13 (638) 1,023,621 (894,879) (568)
Balance (in shares) at Mar. 31, 2022   13,285        
Compensation expense for issuance of stock options to employees 471     471    
Interest payment for convertible notes 5,263 $ 11   5,252    
Interest payment for convertible notes (in shares)   10,992        
Other comprehensive income (loss), net of tax 1,306         1,306
Net income (loss) (46,682)       (46,682)  
Balance at Jun. 30, 2022 87,907 $ 24 (638) 1,029,344 (941,561) 738
Balance (in shares) at Jun. 30, 2022   24,277        
Compensation expense for issuance of stock options to employees 364     364    
Compensation expense for issuance of restricted stock to employees (3)     (3)    
Compensation expense for issuance of restricted stock to employees (in shares)   61        
Other comprehensive income (loss), net of tax 1,352         1,352
Net income (loss) (13,854)       (13,854)  
Balance at Sep. 30, 2022 $ 75,766 $ 24 $ (638) $ 1,029,705 $ (955,415) $ 2,090
Balance (in shares) at Sep. 30, 2022   24,338        
v3.22.2.2
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Cash flows from operating activities:    
Net income (loss) $ (85,058) $ (83,387)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:    
Share-based compensation expense 1,320 2,515
Amortization of debt discount and debt issuance costs 12,356 12,672
Depreciation and amortization expense 24,770 25,482
Change in acquired contingent consideration obligation (10,709) (4,224)
Non-cash royalty revenue (4,762) (8,889)
Deferred tax provision (benefit) 28,300 (6,788)
Change in derivative liability (37) (868)
Changes in assets and liabilities:    
Decrease in accounts receivable 2,312 6,606
(Increase) decrease in prepaid expenses and other current assets (258) 2,629
Decrease in inventory 3,297 5,813
Increase in other assets (237)  
(Decrease) increase in accounts payable, accrued expenses and other current liabilities (844) 4,875
Decrease in other non-current liabilities (439) (1,024)
Net cash used in operating activities (29,990) (44,588)
Cash flows from investing activities:    
Proceeds from sale of Chelsea facility, net   73,969
Purchases of property and equipment (136) (164)
Purchases of intangible assets (123) (26)
Net cash (used in) provided by investing activities (259) 73,779
Cash flows from financing activities:    
Repayment of Convertible Senior Notes Due 2021   (69,000)
Repayment of loans payable   (655)
Net cash used in financing activities   (69,655)
Effect of exchange rate changes on cash, cash equivalents and restricted cash (790) (511)
Net decrease in cash, cash equivalents and restricted cash (31,040) (40,975)
Cash, cash equivalents and restricted cash at beginning of period 65,223 102,895
Cash, cash equivalents and restricted cash at end of period 34,183 61,920
Supplemental disclosure:    
Cash paid for interest 947 6
Cash paid for taxes $ 133 $ 46
v3.22.2.2
Organization and Business Activities
9 Months Ended
Sep. 30, 2022
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Organization and Business Activities

(1) Organization and Business Activities

Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders.

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information, Accounting Standards Codification (ASC) Topic 270-10 and with the instructions to Form 10-Q. Accordingly, these financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, all adjustments considered necessary for a fair presentation have been included in the interim periods presented and all adjustments are of a normal recurring nature. The Company has evaluated subsequent events through the date of this filing. Operating results for the three- and nine-month periods ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. When used in these notes, the terms “Acorda” or “the Company” mean Acorda Therapeutics, Inc. The December 31, 2021 consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. You should read these unaudited interim condensed consolidated financial statements in conjunction with the consolidated financial statements and footnotes included in the Company's Annual Report on Form 10-K, for the year ended December 31, 2021.

v3.22.2.2
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2022
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

(2) Summary of Significant Accounting Policies

The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2021. Effective January 1, 2021, the Company adopted ASU 2019-12, “Simplifying the Accounting for Income Taxes” (Topic 740). Effective January 1, 2022, the Company adopted ASU 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options”. The Company’s significant accounting policies have not changed materially from December 31, 2021.

Basis of Presentation

The Company reclassified the net proceeds from the sale of the Chelsea facility of $74.0 million for the nine-month period ended September 30, 2021 from financing activities to investing activities in the accompanying Consolidated Statement of Cash Flows.

Restricted Cash

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows:

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

(In thousands)

Beginning of period

 

 

End of period

 

 

Beginning of period

 

 

End of period

 

Cash and cash equivalents

$

45,634

 

 

$

20,696

 

 

$

71,369

 

 

$

36,168

 

Restricted cash

 

13,400

 

 

 

13,232

 

 

 

12,917

 

 

 

13,353

 

Restricted cash non-current

 

6,189

 

 

 

255

 

 

 

18,609

 

 

 

12,399

 

Total Cash, cash equivalents and restricted cash per statement of cash flows

$

65,223

 

 

$

34,183

 

 

$

102,895

 

 

$

61,920

 

 

 

Restricted cash represents an escrow account with funds to maintain the interest payments for an amount equal to all remaining scheduled interest payments on the outstanding convertible senior secured notes due 2024 through the interest payment date of June 1, 2023; and a bank account with funds to cover the Company’s self-funded employee health insurance. At September 30, 2022, the Company also held $0.3 million of restricted cash related to cash collateralized standby letters of credit in connection with obligations under facility leases. See Note 10 to the Company’s Consolidated Financial Statements included in this report for a discussion of interest payments on the outstanding convertible senior secured notes due to 2024.

Inventory

The following table provides the major classes of inventory:

(In thousands)

 

September 30, 2022

 

 

December 31, 2021

 

Raw materials

 

$

3,333

 

 

$

3,338

 

Finished goods

 

 

11,919

 

 

 

15,210

 

Total

 

$

15,252

 

 

$

18,548

 

The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. On February 10, 2021, the Company completed the sale of its Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. In connection with the sale of the manufacturing operations, the Company transferred approximately $2.3 million of raw materials to Catalent. See Note 12 to the Company’s Consolidated Financial Statements included in this report for a discussion of assets transferred upon the sale. Additionally, in reviewing the inventory for slow moving or obsolete amounts the Company recorded a charge of $1.3 million for the remaining work-in-progress inventory that was scrapped or discarded during the nine-month period ended September 30, 2021.

Foreign Currency Translation

The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations.

Segment and Geographic Information

The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Ampyra and Inbrija in the U.S. for the three- and nine-month periods ended September 30, 2022 and 2021.

Impairment of Long-Lived Assets

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer and significant negative economic trends. The decline in the trading price of the Company's common stock

during the nine-month period ended September 30, 2022, and related decrease in the Company's market capitalization, was determined to be a triggering event in connection with the Company's review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2022. The Company performed a recoverability test as of September 30, 2022 using the undiscounted cash flows, which are the sum of the future undiscounted cash flows expected to be derived from the direct use of the long-lived assets to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s own assumptions about its own use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2022, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets.

Liquidity

The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, and obtain additional financing. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing its convertible senior secured notes due 2024, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether.

At September 30, 2022, the Company had $20.7 million of cash and cash equivalents, compared to $45.6 million at December 31, 2021. The Company’s September 30, 2022 cash and cash equivalents balance does not include $12.4 million of restricted cash that is currently held in escrow under the terms of its convertible senior secured notes due 2024, which may potentially be released from escrow if the Company pays interest on those notes using shares of its common stock (the amount released would correspond to the amount of interest paid using shares). The Company incurred a net loss of $85.1 million for the nine-month period ended September 30, 2022. On October 18, 2022, the Company announced that it will not use common stock to make the approximately $6.2 million interest payment due on December 1, 2022. In addition, in October 2022, the Company received $16.5 million following a final decision of an arbitration panel regarding a dispute over licensing royalties relating to Ampyra.

The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, “Presentation of Financials Statements—Going Concern” (“ASC Topic 205-40”), which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim consolidated financial statements are issued. Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgement by management. The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements contained in this report are issued.

On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10

consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankruptcy or liquidation. On November 11, 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market, which forms the basis of the Company’s long-term strategic planning.

The Company believes that its existing cash and cash equivalents will be sufficient to cover its cash flow requirements for at least the next twelve months from the issuance date of these financial statements. However, the Company’s future requirements may change and will depend on numerous factors, some of which may be beyond the Company’s control.

Subsequent Events

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were subsequent events that required disclosure or adjustment in these financial statements. See Note 15 to the Company’s Consolidated Financial Statements included in this report for a discussion of subsequent events.

Accounting Pronouncements Adopted

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted. The Company adopted this guidance effective January 1, 2021. The adoption of this guidance did not have a significant impact on the consolidated financial statements.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The FASB is issuing this update to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this guidance effective January 1, 2022. The adoption of this guidance did not have a significant impact on the consolidated financial statements.

Accounting Pronouncements Not Yet Adopted

In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments”: The amendments in this update are to clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2020-03 are not expected to have a significant effect on current accounting practices. The ASU improves various financial instrument topics in the Codification to increase stakeholder awareness of the amendments and to expedite the improvement process by making the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. The ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022 with early application permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This update simplifies the accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature models which require separate accounting for embedded conversion features. This update also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions and requires the application of the if-converted method for calculating diluted earnings per share. ASU 2020-06 is effective for smaller reporting companies for fiscal periods beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In March, 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses: Troubled Debt Restructurings and Vintage Disclosures. The amendments in this Update eliminate the accounting guidance for Troubled Debt Restructurings by creditors in Subtopic 310-40, Receivables—Troubled Debt Restructurings by Creditors, while enhancing disclosure requirements for certain loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty. This update also includes amendments which require that an entity disclose current-period gross writeoffs by year of origination for financing receivables and net investments in leases within the scope of Subtopic 326-20, Financial Instruments—Credit Losses—Measured at Amortized Cost. The ASU is effective for entities that have adopted the amendments in Update 2016-13 for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In September, 2022, the FASB issued ASU 2022-04, Liabilities – Supplier Finance Programs: Disclosure of Supplier Finance Program Obligations. The amendments in this update address investor and other financial statement user requests for additional information about the use of supplier finance programs (the programs) by the buyer party to understand the effect of those programs on an entity’s working capital, liquidity, and cash flows. The ASU requires that a buyer in a supplier finance program disclose sufficient information about the program to allow a user of financial statements to understand the program’s nature, activity during the period, changes from period to period, and potential magnitude. The ASU is effective for entities that have fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

v3.22.2.2
Revenue
9 Months Ended
Sep. 30, 2022
Revenue From Contract With Customer [Abstract]  
Revenue

(3) Revenue

In accordance with ASC 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for the good or service. ASC 606 requires entities to record a contract asset when a performance obligation has been satisfied or partially satisfied, but the amount of consideration has not yet been received because the receipt of the consideration is conditioned on something other than the passage of time. ASC 606 also requires an entity to present a revenue contract as a contract liability in instances when a customer pays consideration, or an entity has a right to an amount of consideration that is unconditional (e.g., receivable), before the entity transfers a good or service to the customer.

As of September 30, 2022, the Company had contract liabilities of $6.1 million, as compared to $5.9 million as of December 31, 2021, which is the upfront payment received as part of the Esteve Germany distribution agreement entered into in 2021, and pre-payment of product ordered as part of the Esteve Spain supply agreement entered into in 2021. The Company did not have any contract liabilities as of September 30, 2021. The Company did not have any contract assets as of September 30, 2022 or 2021. The Company entered into distribution and supply agreements with Esteve Pharmaceuticals, which launched Inbrija in Germany in June 2022. The Company recognized $2.9 million of revenues during the period ended September 30, 2022 from the supply agreement with Esteve Pharmaceuticals.

The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen. See Note 9 for additional information on the Company’s related payment obligation to HealthCare Royalty Partners, or HCRP, in connection with a 2017 royalty purchase agreement with HCRP.

 

 

(In thousands)

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ampyra

$

21,110

 

 

$

20,026

 

 

$

54,192

 

 

$

62,035

 

Inbrija U.S.

 

7,848

 

 

 

7,804

 

 

 

18,957

 

 

 

19,240

 

Inbrija ex-U.S.

 

1,006

 

 

 

 

 

 

2,874

 

 

 

 

Other

 

 

 

 

21

 

 

 

 

 

 

22

 

Total net product revenues

 

29,964

 

 

 

27,851

 

 

 

76,023

 

 

 

81,297

 

Royalty Revenue

 

3,047

 

 

 

3,605

 

 

 

10,573

 

 

 

10,807

 

License Revenue

 

500

 

 

 

 

 

 

500

 

 

 

 

Total net revenues

$

33,511

 

 

$

31,456

 

 

$

87,096

 

 

$

92,104

 

 

v3.22.2.2
Share-based Compensation
9 Months Ended
Sep. 30, 2022
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]  
Share-based Compensation

(4) Share-based Compensation

During the three‑month periods ended September 30, 2022 and 2021, the Company recognized share-based compensation expense of $0.4 million and $0.9 million, respectively. During the nine-month periods ended September 30, 2022 and 2021, the Company recognized share-based compensation expense of $1.3 and $2.5 million, respectively. Activity in options and restricted stock during the nine-month period ended September 30, 2022 and related balances outstanding as of that date are reflected below. The weighted average fair value per share of options granted to employees for the three-month periods ended September 30, 2022 and 2021 were approximately $0.31 and $2.56, respectively. The weighted average fair value per share of options granted to employees for the nine-month periods ended September 30, 2022 and 2021 were approximately $0.84 and $2.58, respectively.

The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations:

 

 

 

For the three-month period ended September 30,

 

 

For the nine-month period ended September 30,

 

(In thousands)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Research and development expense

 

$

14

 

 

$

225

 

 

$

66

 

 

$

599

 

Selling, general and administrative expense

 

 

351

 

 

 

627

 

 

 

1,254

 

 

 

1,898

 

Cost of Sales

 

 

(1

)

 

 

2

 

 

 

0

 

 

 

18

 

Total

 

$

364

 

 

$

854

 

 

$

1,320

 

 

$

2,515

 

 

A summary of share-based compensation activity for the nine-month period ended September 30, 2022 is presented below:

Stock Option Activity

 

 

 

Number of

Shares

(In thousands)

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term

 

 

Intrinsic

Value

(In thousands)

 

Balance at January 1, 2022

 

 

1,186

 

 

$

94.38

 

 

 

 

 

 

 

 

 

Granted

 

 

97

 

 

 

1.19

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(230

)

 

 

128.93

 

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2022

 

 

1,053

 

 

$

78.24

 

 

 

6.0

 

 

$

 

Vested and expected to vest at

    September 30, 2022

 

 

1,053

 

 

$

78.24

 

 

 

6.0

 

 

$

 

Vested and exercisable at

    September 30, 2022

 

 

713

 

 

$

113.62

 

 

 

4.5

 

 

$

 

 

Restricted Stock and Performance Stock Unit Activity

 

(In thousands)

 

 

 

 

Restricted Stock and Performance Stock Units

 

Number of Shares

 

Nonvested at January 1, 2022

 

 

116

 

Granted

 

 

 

Vested

 

 

(103

)

Forfeited

 

 

(7

)

Nonvested at September 30, 2022

 

 

6

 

 

Unrecognized compensation cost for unvested stock options, restricted stock awards, and restricted stock units as of September 30, 2022 totaled $0.8 million and is expected to be recognized over a weighted average period of approximately 2.7 years.

During the nine‑month periods ended September 30, 2022, the Company did not make any repurchases of shares.

v3.22.2.2
Loss Per Share
9 Months Ended
Sep. 30, 2022
Earnings Per Share [Abstract]  
Loss Per Share

(5) Loss Per Share

The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2022 and 2021:

 

(In thousands, except per share data)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss—basic

 

$

(13,854

)

 

$

(27,071

)

 

$

(85,058

)

 

$

(83,387

)

Net income (loss)—diluted

 

$

(13,854

)

 

$

(27,071

)

 

$

(85,058

)

 

$

(83,387

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used in computing net loss per share—basic

 

 

24,290

 

 

 

11,131

 

 

 

18,148

 

 

 

10,204

 

Plus: net effect of dilutive stock options and restricted common shares

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used in computing net loss per share—diluted

 

 

24,290

 

 

 

11,131

 

 

 

18,148

 

 

 

10,204

 

Net loss per share—basic

 

$

(0.57

)

 

$

(2.43

)

 

$

(4.69

)

 

$

(8.17

)

Net loss per share—diluted

 

$

(0.57

)

 

$

(2.43

)

 

$

(4.69

)

 

$

(8.17

)

 

Securities that could potentially be dilutive are excluded from the computation of diluted loss per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts.

The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options and restricted common shares

 

 

1,134

 

 

 

1,370

 

 

 

1,089

 

 

 

1,368

 

 

Performance share units are excluded from the calculation of net loss per diluted share as the performance criteria has not been met for the three- and nine-month periods ended September 30, 2022 and 2021. Additionally, the impact of the convertible senior notes was determined to be anti-dilutive and excluded from the calculation of net loss per diluted share for the three- and nine-month periods ended September 30, 2022 and 2021.

v3.22.2.2
Income Taxes
9 Months Ended
Sep. 30, 2022
Income Tax Disclosure [Abstract]  
Income Taxes

(6) Income Taxes

The Company’s effective income tax rate differs from the U.S. statutory rate primarily due to an increase in the valuation allowance and expense recorded on the equity forfeiture.

For the three-month periods ended September 30, 2022 and 2021, the Company recorded a provision of $1.4 million and a benefit of $3.1 million for income taxes, respectively. The effective income tax rates for the Company for the three-month periods ended September 30, 2022 and 2021 were (11.3)% and 10.2%, respectively. The variances in the effective tax rates for the three-month period ended September 30, 2022, as compared to the three-month period ended September 30, 2021, was primarily due to an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, which increase includes the valuation allowance due to a deemed ownership change described below.

For the nine-month periods ended September 30, 2022 and 2021, the Company recorded a provision from income taxes of $28.2 million and a benefit of $6.8 million, respectively. The effective income tax rates for the nine-month periods ended September 30, 2022 and 2021 were (49.69)% and 7.53%, respectively. The variance in the effective tax rates for the nine-month period ended September 30, 2022 as compared to the nine-month period ended September 30, 2021 was due primarily to forfeitures of equity of which no tax deduction is recorded and an increase in the existing valuation allowance recorded on the Company’s deferred tax assets for which no tax benefit can be recognized, which increase includes the valuation allowance due to a deemed ownership change described below.

The Internal Revenue Code of 1986 contains certain provisions that can limit a taxpayer's ability to utilize net operating loss and tax credit carryforwards in any given year resulting from cumulative changes in ownership interests in excess of 50 percent over a three-year period (“ownership change”). In the event of such a deemed ownership change, Section 382 imposes an annual limitation on pre-ownership change tax attributes. In the nine-month period ended September 30, 2022, the Company experienced an ownership change under Section 382 due to cumulative changes in the Company’s ownership over three years. Accordingly, the Company's ability to utilize NOL’s and tax credit carryforwards attributable to periods prior to the deemed ownership change is subject to the annual limitation. As a result of the impact of this limitation, the Company recorded a cumulative tax provision of approximately $25.0 million, which is reflected in the increase to the valuation allowance on deferred tax assets in the nine-month period ended September 30, 2022, with respect to the Section 382 impact.

The Company continues to evaluate the realizability of its deferred tax assets on a quarterly basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any changes to the valuation allowance or deferred tax assets and liabilities in the future would impact the Company's income taxes.

The Company has ongoing state examinations in Massachusetts and New Jersey which cover multiple years. There have been no proposed adjustments at this stage of the examination. The Minnesota examination was finalized during the second quarter of 2022 for years 2018 and 2019 with no adjustments.

v3.22.2.2
Fair Value Measurements
9 Months Ended
Sep. 30, 2022
Fair Value Disclosures [Abstract]  
Fair Value Measurements

(7) Fair Value Measurements

The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 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 which are valued using a probability weighted discounted cash flow valuation approach and derivative liabilities related to conversion options for the convertible senior notes due December

2024 which are valued using a binomial model. For assets and liabilities not accounted for at fair value, the carrying values of these accounts approximates their fair values at September 30, 2022, except for the fair value of the Company’s convertible senior notes due December 2024, which was approximately $157.3 million as of September 30, 2022. The Company estimates the fair value of its notes utilizing market quotations for the debt (Level 2).

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

September 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

2,216

 

 

$

 

 

$

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

37,600

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,192

 

 

$

 

 

$

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

49,600

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

37

 

 

The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value.

Acquired contingent consideration

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Acquired contingent consideration:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

 

$

42,900

 

 

$

41,200

 

 

$

49,600

 

 

$

48,200

 

Fair value change to contingent consideration

   included in the statement of operations

 

 

(4,576

)

 

 

2,205

 

 

 

(10,709

)

 

 

(4,224

)

Royalty payments

 

 

(724

)

 

 

(405

)

 

 

(1,291

)

 

 

(976

)

Balance, end of period

 

$

37,600

 

 

$

43,000

 

 

$

37,600

 

 

$

43,000

 

 

The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from Inbrija (levodopa inhalation powder), an FDA approved drug 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 $18.1 million for Inbrija. The discount rate used in the valuation was 23% for the three- and nine-month periods ended September 30, 2022, as compared to 20.5% for the three- and nine-month periods ended September 30, 2021. 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, 2022 and 2021, 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-Conversion Option

The following table represents a reconciliation of the derivative liability recorded in connection with the issuance of the convertible senior secured notes due 2024:

(In thousands)

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Derivative Liability-Conversion Option

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

$

 

 

$

613

 

 

$

37

 

 

$

1,193

 

Fair value adjustment

 

 

 

 

(288

)

 

 

(37

)

 

 

(868

)

Balance, end of period

$

 

 

$

325

 

 

$

 

 

$

325

 

During 2019, a derivative liability was initially recorded as a result of the issuance of the 6.00% Convertible Senior Secured Notes due 2024 (See Note 10 to the Consolidated Financial Statements included in this report for more information on the Convertible Senior Notes due 2024). The fair value measurement of the derivative liability is classified as Level 3 under the fair value hierarchy as it has been valued using certain unobservable inputs. These inputs include: (1) share price as of the valuation date, (2) assumed timing of conversion of the Notes, (3) historical volatility of the share price, and (4) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in a significantly lower or higher fair value measurement. The fair value of the derivative liability was determined using a binomial model that calculates the fair value of the Notes with the conversion feature as compared to the fair value of the Notes without the conversion feature, with the difference representing the value of the conversion feature, or the derivative liability. There are several embedded features within the Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as a derivative liability conversion option. 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, 2022. 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, 2022.

v3.22.2.2
Investments
9 Months Ended
Sep. 30, 2022
Investments Debt And Equity Securities [Abstract]  
Investments

(8) Investments

There were no available-for-sale investments at September 30, 2022 and December 31, 2021, respectively. 

Short-term investments with maturities of three months or less from date of purchase have been classified as cash equivalents, and amounted to approximately $2.2 million and $12.2 million as of September 30, 2022 and December 31, 2021, respectively. There were no short-term investments with original maturities of greater than 3 months but less than 1 year as of September 30, 2022 and December 31, 2021, respectively. Additionally, there were no short-term investments in an unrealized loss position as of September 30, 2022 and December 31, 2021, respectively. Long-term investments have original maturities of greater than 1 year. There were no investments classified as long-term at September 30, 2022 or December 31, 2021. The Company has determined that there were no other-than-temporary declines in the fair values of its investments as of September 30, 2022 as the Company does not have any short or long-term investments as of September 30, 2022.

v3.22.2.2
Liability Related to Sale of Future Royalties
9 Months Ended
Sep. 30, 2022
Deferred Revenue Disclosure [Abstract]  
Liability Related to Sale of Future Royalties

(9) Liability Related to Sale of Future Royalties

On October 1, 2017, the Company completed a royalty purchase agreement with HealthCare Royalty Partners, or HCRP (the “Royalty Agreement”). In exchange for the payment of $40 million to the Company, HCRP obtained the right to receive Fampyra royalties payable by Biogen under the Biogen Collaboration Agreement up to an agreed upon threshold of royalties. This threshold was met during the second quarter of 2022 and our obligations to HCRP expired upon Biogen’s payment of royalties for that quarter.

Since the Company maintained rights under the Biogen Collaboration Agreement, therefore, the Royalty Agreement has been accounted for as a liability that will be amortized using the effective interest method over the life of the arrangement, in accordance with the relevant accounting guidance. The Company recorded the receipt of the $40 million payment from HCRP and established a corresponding liability in the amount of $40 million, net of transaction costs of approximately $2.2 million. The net liability is classified between the current and non-current portion of liability related to the sale of future royalties in the consolidated balance sheets based on the recognition of the interest and principal payments to be received by HCRP in the 12 months following the financial statement reporting date. The total net royalties to be paid, less the net proceeds received, is recorded to interest expense using the effective interest method over the life of the Royalty Agreement. The Company estimates the payments to be made to HCRP over the term of the Royalty Agreement based on forecasted royalties and calculates the interest rate required to discount such payments back to the liability balance. Over the course of the Royalty Agreement, the actual interest rate will be affected by the amount and timing of net royalty revenue recognized and changes in forecasted revenue. On a quarterly basis, the Company reassess the effective interest rate and adjust the rate prospectively as necessary.

The Company has a liability related to the sale of future royalties of $0 and $7.5 million for the periods ending September 30, 2022 and 2021, respectively.

The following table shows the activity within the liability account for the nine-month period ended September 30, 2022 and 2021, respectively:

 

(In thousands)

 

September 30, 2022

 

 

September 30, 2021

 

Liability related to sale of future royalties - beginning balance

 

$

4,460

 

 

$

15,257

 

Deferred transaction costs amortized

 

 

33

 

 

 

193

 

Non-cash royalty revenue payable to HCRP

 

 

(4,739

)

 

 

(8,889

)

Non-cash interest expense recognized

 

 

246

 

 

 

891

 

Liability related to sale of future royalties - ending balance

 

$

 

 

$

7,452

 

 

 

 

 

 

 

 

 

 

 

 

v3.22.2.2
Debt
9 Months Ended
Sep. 30, 2022
Debt Disclosure [Abstract]  
Debt

(10) Debt

Convertible Senior Secured Notes Due 2024

On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of its outstanding 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”) for a combination of newly issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. For each $1,000 principal amount of exchanged 2021 Notes, the Company issued $750 principal amount of the 2024 Notes and made a cash payment of $200 (the “Exchange”). In the aggregate, the Company issued approximately $207.0 million aggregate principal amount of the 2024 Notes and paid approximate $55.2 million in cash to participating holders. The Exchange was conducted with a limited number of institutional holders of the 2021 Notes pursuant to Exchange Agreements dated as of December 20, 2019. The 2021 Notes received by the Company in the Exchange were cancelled in accordance with their terms. Accordingly, upon completion of the Exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand.

The 2024 Notes were issued pursuant to an Indenture, dated as of December 23, 2019, among the Company, its wholly owned subsidiary, Civitas Therapeutics, Inc. (along with any domestic subsidiaries acquired or formed after the date of issuance, the “Guarantors”), and Wilmington Trust, National Association, as trustee and collateral agent (the “2024 Indenture”). The 2024 Notes are senior obligations of the Company and the Guarantors, secured by a first priority security interest in substantially all of the assets of the Company and the Guarantors, subject to certain exceptions described in the Security Agreement, dated as of December 23, 2019, between the grantors party thereto and Wilmington Trust, National Association, as collateral agent.

The 2024 Notes will mature on December 1, 2024 unless earlier converted in accordance with their terms prior to such date. Interest on the 2024 Notes is payable semi-annually in arrears at a rate of 6.00% per annum on each June 1 and December 1, beginning on June 1, 2020. Under the 2024 Indenture, the Company may elect to pay interest in cash or shares of the Company’s common stock, subject to the satisfaction of certain conditions. If the Company elects to pay interest in shares of common stock, such common stock will have a per share value equal to 95% of the daily volume-weighted average price for the 10 trading days ending on and including the trading day immediately preceding the relevant interest payment date. Based on the current market price of the Company’s common stock and the Company’s remaining authorized shares of common stock that are not reserved for other purposes, the Company believes that for the foreseeable future interest payments on the 2024 notes will have to be made in cash.

The 2024 Notes are convertible at the option of the holder into shares of common stock of the Company at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. The adjusted conversion rate for the 2024 Notes is 47.6190 shares of the Company’s common stock per $1,000 principal amount of 2024 Notes, representing an adjusted conversion price of approximately $21.00 per share of common stock. The conversion rate was adjusted to reflect the 1-for-6 reverse stock split effected on December 31, 2020 and is subject to additional adjustments in certain circumstances as described in the 2024 Indenture.

The Company may elect to settle conversions of the 2024 Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Holders who convert their 2024 Notes prior to June 1, 2023 (other than in connection with a make-whole fundamental change) will also be entitled to an interest make-whole payment equal to the sum of all regularly scheduled stated interest payments, if any, due on such 2024 Notes on each interest payment date occurring after the conversion date for such conversion and on or before June 1, 2023. In addition, the Company will have the right to cause all 2024 Notes then outstanding to be converted automatically if the volume-weighted average price per share of the Company’s common stock equals or exceeds 130% of the adjusted conversion price for a specified period of time and certain other conditions are satisfied.

Holders of the 2024 Notes will have the right, at their option, to require the Company to purchase their 2024 Notes if a fundamental change (as defined in the 2024 Indenture) occurs, such as a delisting of the Company’s common stock from the Nasdaq Global Select Market, in each case, at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. If a make-whole fundamental change occurs, as described in the 2024 Indenture, and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the adjusted conversion rate as described in the 2024 Indenture.

Subject to a number of exceptions and qualifications, the 2024 Indenture restricts the ability of the Company and certain of its subsidiaries to, among other things, (i) pay dividends or make other payments or distributions on their capital stock, or purchase, redeem, defease or otherwise acquire or retire for value any capital stock, (ii) make certain investments, (iii) incur indebtedness or issue preferred stock, other than certain forms of permitted debt, which includes, among other items, indebtedness incurred to refinance the 2021 Notes, (iv) create liens on their assets, (v) sell their assets, (vi) enter into certain transactions with affiliates or (vii) merge, consolidate or sell of all or substantially all of their assets. The 2024 Indenture also requires the Company to make an offer to repurchase the 2024 Notes upon the occurrence of certain asset sales.

The 2024 Indenture provides that a number of events will constitute an event of default, including, among other things, (i) a failure to pay interest for 30 days, (ii) failure to pay the 2024 Notes when due at maturity, upon any required repurchase, upon declaration of acceleration or otherwise, (iii) failure to convert the 2024 Notes in accordance with the 2024 Indenture and the failure continues for five business days, (iv) not issuing certain notices required by the 2024 Indenture within a timely manner, (v) failure to comply with the other covenants or agreements in the 2024 Indenture for 60 days following the receipt of a notice of non-compliance, (vi) a default or other failure by the Company to make required payments under other indebtedness of the Company or certain subsidiaries having an outstanding principal amount of $30.0 million or more, (vii) failure by the Company or certain subsidiaries to pay final judgments aggregating in excess of $30.0 million, (viii) certain events of bankruptcy or insolvency and (ix) the commercial launch in the United States of a product determined by the U.S. FDA to be bioequivalent to Inbrija. In the case of an event of default arising from certain events of bankruptcy or insolvency with respect to the Company, all outstanding 2024 Notes will become due and payable immediately without further action or notice. If any other event of default occurs and is continuing, the trustee or the holders of at least 25% in aggregate principal amount of the then outstanding 2024 Notes may declare all the notes to be due and payable immediately.

The Company determined that the exchange of the 2021 Notes for 2024 Notes qualified for a debt extinguishment and recognized a gain on extinguishment of $55.1 million for the year ended December 31, 2019, representing the difference between the fair value of the liability component immediately before the exchange and the carrying value of the debt. The Company recorded an adjustment of $38.4 million to additional paid-in capital to adjust the equity component of 2021 Notes in connection with the extinguishment.

The Company assessed all terms and features of the 2024 Notes in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the 2024 Notes, including the conversion, put and call features. The Company concluded the conversion features required bifurcation as a derivative. The fair value of the conversion features derivative was determined based on the difference between the fair value of the 2024 Notes with the conversion options and the fair value of the 2024 Notes without the conversion options using a binomial model. The Company determined that the fair value of the derivative upon issuance of the 2024 Notes was $59.4 million and recorded this amount as a derivative liability with an offsetting amount as a debt discount as a reduction to the carrying value of the 2024 Notes on the closing date, or December 24, 2019. There are several embedded features within the 2024 Notes which, upon issuance, did not meet the conditions for equity classification. As a result, these features were aggregated together and recorded as the derivative liability conversion option. The conversion feature is measured at fair value on a quarterly basis and the changes in the fair value of the conversion feature for the period will be recognized in the consolidated statements of operations. 

The Company received stockholder approval on August 28, 2020 to increase the number of authorized shares of the Company’s common stock from 13,333,333 shares to 61,666,666 shares. As a result of the share approval, the Company determined that multiple embedded conversion options met the conditions for equity classification. The Company performed a valuation of these conversion options as of September 17, 2020, which was the date the Company completed certain securities registration obligations for the shares underlying the 2024 Notes. The resulting fair value of these conversion options was $18.3 million, which was reclassified to equity and presented in the statement of stockholder’s equity as of September 30, 2020, net of the $4.4 million tax impact. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The Company performed a valuation of the derivative liability related to certain embedded conversion features that are precluded from equity classification. The fair value of these conversion features was calculated to be negligible as of September 30, 2022.

The outstanding 2024 Note balances as of September 30, 2022 and December 31, 2021 consisted of the following:

 

(In thousands)

 

September 30, 2022

 

 

December 31, 2021

 

Liability component:

 

 

 

 

 

 

 

 

Principal

 

 

207,000

 

 

$

207,000

 

Less: debt discount and debt issuance costs, net

 

 

(44,240

)

 

 

(55,975

)

Net carrying amount

 

$

162,760

 

 

$

151,025

 

Equity component

 

$

18,257

 

 

$

18,257

 

Derivative liability-conversion option

 

$

 

 

$

37

 

 

The Company determined that the expected life of the 2024 Notes was equal to the period through December 1, 2024 as this represents the point at which the 2024 Notes will mature unless earlier converted in accordance with their terms prior to such date. 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, 2022, the Company recognized $7.2 million and $21.1 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, 2022.

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, 2022 and 2021:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Contractual interest expense

 

$

3,105

 

 

$

3,105

 

 

$

9,315

 

 

$

9,315

 

Amortization of debt issuance costs

 

 

291

 

 

 

243

 

 

 

834

 

 

 

698

 

Amortization of debt discount

 

 

3,797

 

 

 

3,179

 

 

 

10,902

 

 

 

9,130

 

Total interest expense

 

$

7,193

 

 

$

6,527

 

 

$

21,051

 

 

$

19,143

 

 

Convertible Senior Notes Due 2021

On June 17, 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the “2021 Notes”). On December 24, 2019, the Company completed the private exchange of $276.0 million aggregate principal amount of its then-outstanding 2021 Notes for a combination of newly issued 6.00% Convertible Senior Secured Notes due 2024 (the “2024 Notes”) and cash. The 2021 Notes received by the Company in the exchange were cancelled in accordance with their terms. Accordingly, upon completion of the exchange, $69.0 million of the 2021 Notes remained outstanding. On June 15, 2021, the Company repaid the outstanding balance of the 2021 Notes at their maturity date using cash on hand.

In accounting for the issuance of the 2021 Notes, the Company separated the 2021 Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the 2021 Notes as a whole. The equity component is not re-measured as long as it continues to meet the conditions for equity classification.

 

In connection with the issuance of the 2021 Notes, the Company incurred approximately $7.5 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $7.5 million of debt issuance costs, $1.3 million were allocated to the equity component and recorded as a reduction to additional paid-in capital and $6.2 million were allocated to the liability component and recorded as a reduction in the carrying amount of the debt liability on the balance

sheet. The portion allocated to the liability component is amortized to interest expense over the expected life of the 2021 Notes using the effective interest method. The Company wrote off $1.2 million of issuance cost associated with the exchange of the 2021 Notes.

The following table sets forth total interest expense recognized related to the 2021 Notes for the three- and nine-month periods ended September 30, 2022 and 2021:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Contractual interest expense

 

$

 

 

$

 

 

$

 

 

$

428

 

Amortization of debt issuance costs

 

 

 

 

 

 

 

 

 

 

 

95

 

Amortization of debt discount

 

 

 

 

 

 

 

 

 

 

 

934

 

Total interest expense

 

$

 

 

$

 

 

$

 

 

$

1,457

 

 

Non-Convertible Capital Loans

 

Our Biotie subsidiary received fourteen non-convertible capital loans granted by Business Finland (formerly Tekes) for research and development of specific drug candidates, with an aggregate adjusted acquisition-date fair value of $20.5 million (€18.2 million) and an aggregate carrying value of $24.9 million as of September 30, 2022. The loans are to be repaid only when the consolidated retained earnings of Biotie from the development of specific loan-funded product candidates is sufficient to fully repay the loans. In light of the status of the loan-funded product candidates, we filed an application with Business Finland for waiver of the loans and accrued interest. In July 2022, Business Finland granted these waivers, which will become effective upon Biotie’s compliance with specified conditions to be completed, including a residual payment of approximately $50,000 for one of the loans. As of September 30, 2022, Biotie had approximately $14.5 million in cash.

v3.22.2.2
Leases
9 Months Ended
Sep. 30, 2022
Leases [Abstract]  
Leases

(11) Leases

In February 2016, the FASB issued ASU 2016-02, “Leases” Topic 842, which amends the guidance in former ASC Topic 840, Leases.

The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 4.25 years to 5.75 years. The Company has exercised the option to terminate the Ardsley lease with a termination date of June 22, 2022. 

Operating Leases

The Company leases certain office space, manufacturing and warehouse space under arrangements classified as leases under ASC 842. Leases with an initial term of 12 months or less are not recorded on the balance sheet; the Company recognizes lease expense for these leases on a straight-line basis over the lease term.

Ardsley, New York

The Company was previously headquartered at a leased facility in Ardsley, New York with approximately 160,000 square feet of space. In September 2021, the Company sent the landlord notice of exercise of its early termination option under the lease, which was effective on June 22, 2022. In connection with the lease termination, the Company paid an early termination fee of approximately $4.7 million. Concurrent with the Ardsley lease termination, in June 2022, the Company relocated its corporate headquarters to a substantially smaller subleased office in Pearl River, New York, described below.

Pearl River, New York

In June 2022, the Company entered into a 6-year sublease for an aggregate of approximately 21,000 square feet of space in Pearl River, New York. The Company has no options to extend the term of the sublease. The Pearl River sublease provides for monthly payments of rent during the lease term. The base rent is currently $0 through December 31, 2022, with payments commencing on January 1, 2023 with a base rent of $0.3 million per year, subject to an annual 2.0% escalation factor in each subsequent year thereafter.

Chelsea, Massachusetts

The Company’s Civitas subsidiary leased a manufacturing facility in Chelsea, Massachusetts which it used to manufacture Inbrija through February 10, 2021. On February 10, 2021, the Company completed the sale of its Chelsea manufacturing operations to Catalent Pharma Solutions and assigned the lease of the Chelsea facility to a Catalent affiliate.

In 2018, the Company initiated a renovation and expansion of a building within the Chelsea manufacturing facility that increased the size of the facility to approximately 95,000 square feet. The project added a new size 7 spray dryer manufacturing production line for Inbrija and other ARCUS products that has greater capacity than the existing size 4 spray dryer manufacturing production line, and created additional warehousing space for manufactured product. All costs to renovate and expand the facility through the date of assignment to Catalent were borne by the Company. Since the February 10, 2021 sale of the manufacturing operations, Catalent has been responsible for finalizing the expansion, including obtaining needed regulatory approvals. However, given the potential importance of the expansion to the Company’s business, in December 2021 the Company agreed to fund $1.5 million of Catalent’s costs to complete the size 7 spray dryer expansion, which will be payable by the Company in four quarterly installments after the later of January 1, 2024 or FDA qualification and approval for use of the size 7 spray dryer.

Additional Facilities

In October 2016, the Company entered into a 10-year lease agreement with a term commencing January 1, 2017, for approximately 26,000 square feet of lab and office space in Waltham, MA. The lease provides for monthly rental payments over the lease term. The base rent under the lease is currently $1.2 million per year.

The Company’s leases have remaining lease terms of 4.25 years to 5.75 years, which reflects the exercise of the early termination of the Company’s Ardsley, NY lease as described above. The weighted-average remaining lease term for the Company’s operating leases was 4.6 years at September 30, 2022. The weighted-average discount rate was 7.89% at September 30, 2022.

ROU assets and lease liabilities related to the Company’s operating leases are as follows:

 

(In thousands)

 

Balance Sheet Classification

 

September 30, 2022

 

 

December 31, 2021

 

Right-of-use assets

 

Right of use assets

 

$

5,541

 

 

$

6,751

 

Current lease liabilities

 

Current portion of lease liabilities

 

 

1,454

 

 

 

8,186

 

Non-current lease liabilities

 

Non-current portion of lease liabilities

 

 

4,612

 

 

 

4,086

 

 

The Company has lease agreements that contain both lease and non-lease components. The Company accounts for lease components together with non-lease components (e.g., common-area maintenance). The components of lease costs were as follows:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Operating lease cost

 

$

431

 

 

$

1,600

 

 

$

3,390

 

 

$

4,593

 

Variable lease cost

 

 

132

 

 

 

948

 

 

 

1,960

 

 

 

3,283

 

Short-term lease cost

 

 

1

 

 

 

339

 

 

 

7

 

 

 

829

 

Total lease cost

 

$

564

 

 

$

2,887

 

 

$

5,357

 

 

$

8,705

 

 

 

Future minimum commitments under all non-cancelable operating leases are as follows:

 

(In thousands)

 

 

 

 

2022 (excluding the three months ended September 30, 2022)

 

$

295

 

2023

 

 

1,546

 

2024

 

 

1,588

 

2025

 

 

1,633

 

2026

 

 

1,678

 

Later years

 

 

539

 

Total lease payments

 

 

7,279

 

Less: Imputed interest

 

 

(1,213

)

Present value of lease liabilities

 

$

6,066

 

 

Supplemental cash flow information related to the Company’s operating leases are as follows:

 

(In thousands)

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Operating cash flow information:

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities

 

$

295

 

 

$

4,605

 

 

v3.22.2.2
Disposal of Assets
9 Months Ended
Sep. 30, 2022
Property Plant And Equipment [Abstract]  
Disposal of Assets

(12) Disposal of Assets

On January 12, 2021 the Company and Catalent entered into an asset purchase agreement, pursuant to which the Company agreed to sell to Catalent certain assets related to the Company’s manufacturing activities located at the facilities situated in Chelsea, Massachusetts (the “Chelsea Facility”) and Waltham, Massachusetts (the “Waltham Facility”), for a purchase price of $80 million, plus an additional $2.3 million for raw materials transferred, and the assumption by Catalent of certain liabilities relating to such manufacturing activities. The Company closed the transaction on February 10, 2021. The Company determined that the criterion to classify the Chelsea manufacturing operations as assets held for sale within the Company’s consolidated balance sheet effective December 31, 2020 were met. Accordingly, the assets were classified as current assets held for sale at December 31, 2020 as the Company, at that time, expected to divest the Chelsea manufacturing operations within the next twelve months.

The classification to assets held for sale impacted the net book value of the assets expected to be transferred upon sale. The estimated fair value of the Chelsea manufacturing operations was determined using the purchase price in the purchase agreement along with estimated broker, accounting, legal, and other selling expenses, which resulted in a fair value less costs to sell of approximately $71.8 million. The carrying value of the assets classified as held for sale was approximately $129.7 million, which included property and equipment of $129.6 million and prepaid expenses of $0.1 million. As a result, the Company recorded a loss on assets held for sale of $57.9 million against the Chelsea manufacturing operations. Upon completion of the divestiture, final net proceeds were $74.0 million. Additionally, the expected divestiture of the Chelsea manufacturing operations was not deemed to represent a fundamental strategic shift that would have a major effect on the Company’s operations, and accordingly, the operating results of the Chelsea manufacturing operations were not reported as discontinued operations in the Company’s consolidated statement of income as of December 31, 2020.

The Company closed the transaction on February 10, 2021. In addition to the property and equipment, prepaid expenses, and raw materials, the Company also assigned the lease of the Chelsea Facility to a Catalent affiliate, which had a net carrying value of $(0.5) million as of the close date. During the three-month period ended March 31, 2021, the Company recorded a gain on disposal of approximately $0.5 million based on the net assets transferred and final net proceeds received at the close.

v3.22.2.2
Corporate Restructuring
9 Months Ended
Sep. 30, 2022
Restructuring And Related Activities [Abstract]  
Corporate Restructuring

(13) Corporate Restructuring

In January 2021 and September 2021, the Company announced corporate restructurings to reduce costs, more closely align operating expenses with expected revenue, and focus its resources on Inbrija. As part of the January 2021 restructuring, the Company reduced headcount by approximately 16% through a reduction in force (excluding the employees that transferred to Catalent at the closing of the sale of the Company’s Chelsea manufacturing operations). All of the reduction in personnel in connection with the January 2021 restructuring took place during the three-month period ended March 31, 2021.

As part of the September 2021 restructuring, the Company reduced headcount by approximately 15% through a reduction in force. Most of this reduction in force took place in September 2021, and was materially completed as of March 31, 2022, with negligible expenses incurred in the second quarter of 2022.

During the nine-month period ended September 30, 2022, the Company incurred $0.3 million of restructuring charges, substantially all of which were cash expenditures for severance and other employee separation-related costs. All of the restructuring charges were recorded in selling, general and administrative expenses for the nine-month period ended September 30, 2022.

A summary of the restructuring charges for the nine-month period ended September 30, 2022 is as follows:

(In thousands)

 

Restructuring Costs

 

Restructuring Liability as of December 31, 2021

 

$

1,851

 

Q1 Restructuring Costs

 

 

226

 

Q1 Restructuring Payments

 

 

(1,700

)

Restructuring Liability as of March 31, 2022

 

$

377

 

Q2 Restructuring Costs

 

 

25

 

Q2 Restructuring Payments

 

 

(145

)

Restructuring Liability as of June 30, 2022

 

$

257

 

Q3 Restructuring Costs

 

 

 

Q3 Restructuring Payments

 

 

(257

)

Restructuring Liability as of September 30, 2022

 

$

(0

)

 

v3.22.2.2
Commitments and Contingencies
9 Months Ended
Sep. 30, 2022
Commitments And Contingencies Disclosure [Abstract]  
Commitments and Contingencies

(14) Commitments and Contingencies

On November 9, 2020, Drug Royalty III, L.P., and LSRC III S.ar.l. (collectively, “DRI”) filed an arbitration claim against the Company with the American Arbitration Association under a September 26, 2003 License Agreement that it originally entered into with Rush-Presbyterian St. Luke’s Medical Center (“Rush”). DRI previously purchased license royalty rights under the license agreement from Rush. DRI alleged a dispute over the last-to-expire patent covering sales of the drug Ampyra under the license agreement, and claimed damages based on unpaid license royalties of $6 million plus interest. On June 28, 2022, the Company settled DRI’s claim in exchange for a payment by the Company to DRI of $750,000 expressly without any admission of wrongdoing. Although the Company believed it had valid defenses to this claim, it also believed that the settlement was in the best interests of the Company and its stockholders to avoid the future expense and distraction associated with continuing the arbitration. The Company recorded a liability of $2 million for the year ended December 31, 2020 in accrued expense and other current liabilities related to the dispute. As a result of the settlement, during the quarter ended September 30, 2022, this accrual was reduced to the $750,000 settlement amount and a corresponding gain of $1.3 million was recorded in the consolidated statement of operations as other income.

From time to time the Company is involved in litigation or other legal proceedings relating to claims arising out of operations in the normal course of business. The Company has assessed all litigation and legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for these other matters. Litigation expenses are expensed as incurred.

On February 10, 2021, the Company sold its Chelsea manufacturing operations to Catalent Pharma Solutions. In connection with the sale, the Company entered into a long-term, global manufacturing services (supply) agreement with a Catalent affiliate pursuant to which they have agreed to manufacture Inbrija for the Company at the Chelsea facility. The manufacturing services agreement provides that Catalent will manufacture Inbrija, to the Company’s specifications, and the Company will purchase Inbrija exclusively from Catalent during the term of the manufacturing services agreement; provided that such exclusivity requirement will not apply to Inbrija intended for sale in China. Under the Company’s agreement with Catalent, it is obligated to make minimum inventory purchase commitments for Inbrija through the expiration of the agreement on December 31, 2030.

During the quarter ended September 30, 2022, the Company incurred approximately $7.7 million of purchase commitments with Catalent, of which $3.9 million are recognized as inventory within the Company’s balance sheet and $3.8 million are recognized as cost of sales within the Company’s consolidated statement of operations for the period. As of September 30, 2022, the minimum remaining purchase commitment to Catalent was $4.5 million through December 31, 2022, and $18.0 million annually each year thereafter. 

v3.22.2.2
Subsequent Events
9 Months Ended
Sep. 30, 2022
Subsequent Events [Abstract]  
Subsequent Events

(15) Subsequent Events

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were no subsequent events that required disclosure or adjustment in these financial statements except for the following disclosure:

Alkermes Arbitration

On October 16, 2022, the Company issued a press release announcing that a three-judge arbitration panel has issued a final decision in a dispute regarding licensing royalties relating to AMPYRA. The Company was awarded $15 million plus prejudgment interest of $1.5 million from Alkermes. In addition, as a result of the panel’s ruling, the Company will be permitted to cease paying Alkermes a double-digit percentage of net sales for the license and supply of AMPYRA, and the Company is now free to use alternative sources for supply of AMPYRA, which the Company has already secured. On October 21, 2022, we made a submission to the arbitration panel to correct the award to include an additional $1.6 million that was inadvertently omitted from the initial award calculation, which amount Alkermes does not dispute. We are awaiting the arbitration tribunal’s decision on this corrected award amount and the amount of pre-judgment interest to be applied to this corrected award amount.

Shareholder Vote

On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankruptcy or liquidation. On November 11, 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market, which forms the basis of the Company’s long-term strategic planning.

v3.22.2.2
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2022
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

The Company reclassified the net proceeds from the sale of the Chelsea facility of $74.0 million for the nine-month period ended September 30, 2021 from financing activities to investing activities in the accompanying Consolidated Statement of Cash Flows.

Restricted Cash

Restricted Cash

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows:

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

(In thousands)

Beginning of period

 

 

End of period

 

 

Beginning of period

 

 

End of period

 

Cash and cash equivalents

$

45,634

 

 

$

20,696

 

 

$

71,369

 

 

$

36,168

 

Restricted cash

 

13,400

 

 

 

13,232

 

 

 

12,917

 

 

 

13,353

 

Restricted cash non-current

 

6,189

 

 

 

255

 

 

 

18,609

 

 

 

12,399

 

Total Cash, cash equivalents and restricted cash per statement of cash flows

$

65,223

 

 

$

34,183

 

 

$

102,895

 

 

$

61,920

 

 

 

Restricted cash represents an escrow account with funds to maintain the interest payments for an amount equal to all remaining scheduled interest payments on the outstanding convertible senior secured notes due 2024 through the interest payment date of June 1, 2023; and a bank account with funds to cover the Company’s self-funded employee health insurance. At September 30, 2022, the Company also held $0.3 million of restricted cash related to cash collateralized standby letters of credit in connection with obligations under facility leases. See Note 10 to the Company’s Consolidated Financial Statements included in this report for a discussion of interest payments on the outstanding convertible senior secured notes due to 2024.

Inventory

Inventory

The following table provides the major classes of inventory:

(In thousands)

 

September 30, 2022

 

 

December 31, 2021

 

Raw materials

 

$

3,333

 

 

$

3,338

 

Finished goods

 

 

11,919

 

 

 

15,210

 

Total

 

$

15,252

 

 

$

18,548

 

The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected product sales volume and provides reserves against the carrying amount of inventory as appropriate. On February 10, 2021, the Company completed the sale of its Chelsea, Massachusetts manufacturing operations to Catalent Pharma Solutions. In connection with the sale of the manufacturing operations, the Company transferred approximately $2.3 million of raw materials to Catalent. See Note 12 to the Company’s Consolidated Financial Statements included in this report for a discussion of assets transferred upon the sale. Additionally, in reviewing the inventory for slow moving or obsolete amounts the Company recorded a charge of $1.3 million for the remaining work-in-progress inventory that was scrapped or discarded during the nine-month period ended September 30, 2021.

Foreign Currency Translation

Foreign Currency Translation

The functional currency of operations outside the United States of America is deemed to be the currency of the local country, unless otherwise determined that the United States dollar would serve as a more appropriate functional currency given the economic operations of the entity. Accordingly, the assets and liabilities of the Company’s foreign subsidiary, Biotie, are translated into United States dollars using the period-end exchange rate; and income and expense items are translated using the average exchange rate during the period; and equity transactions are translated at historical rates. Cumulative translation adjustments are reflected as a separate component of equity. Foreign currency transaction gains and losses are charged to operations and reported in other income (expense) in consolidated statements of operations.

Segment and Geographic Information

Segment and Geographic Information

The Company is managed and operated as one business which is focused on developing therapies that restore function and improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information to allocate resources to separate products or product candidates or by location. Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported are substantially derived from the sales of Ampyra and Inbrija in the U.S. for the three- and nine-month periods ended September 30, 2022 and 2021.

Impairment of Long-Lived Assets

Impairment of Long-Lived Assets

The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets, including identifiable intangible assets subject to amortization and property plant and equipment, may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Factors the Company considers important that could trigger an impairment review include significant changes in the use of any assets, changes in historical trends in operating performance, changes in projected operating performance, stock price, loss of a major customer and significant negative economic trends. The decline in the trading price of the Company's common stock

during the nine-month period ended September 30, 2022, and related decrease in the Company's market capitalization, was determined to be a triggering event in connection with the Company's review of the recoverability of its long-lived assets for the nine-month period ended September 30, 2022. The Company performed a recoverability test as of September 30, 2022 using the undiscounted cash flows, which are the sum of the future undiscounted cash flows expected to be derived from the direct use of the long-lived assets to the carrying value of the long-lived assets. Estimates of future cash flows were based on the Company’s own assumptions about its own use of the long-lived assets. The cash flow estimation period was based on the long-lived assets’ estimated remaining useful life to the Company. After performing the recoverability test, the Company determined that the undiscounted cash flows exceeded the carrying value and the long-lived assets were not impaired. Changes in these assumptions and resulting valuations could result in future long-lived asset impairment charges. During the nine-month period ended September 30, 2022, no other impairment indicators were noted by the Company. Management will continue to monitor any changes in circumstances for indicators of impairment. Any write‑downs are treated as permanent reductions in the carrying amount of the assets.

Liquidity

Liquidity

The Company’s ability to meet its future operating requirements, repay its liabilities, meet its other obligations, and continue as a going concern are dependent upon a number of factors, including its ability to generate cash from product sales, reduce expenditures, and obtain additional financing. If the Company is unable to generate sufficient cash flow from the sale of its products, the Company will be required to adopt one or more alternatives, subject to the restrictions contained in the indenture governing its convertible senior secured notes due 2024, such as further reducing expenses, selling assets, restructuring debt, or obtaining additional equity capital on terms that may be onerous and which are likely to be highly dilutive. Also, the Company’s ability to raise additional capital and repay or restructure its indebtedness will depend on the capital markets and its financial condition at such time, among other factors. In addition, financing may not be available when needed, at all, on terms acceptable to the Company or in accordance with the restrictions described above. As a result of these factors, the Company may not be able to engage in any of the alternative activities, or engage in such activities on desirable terms, which could harm the Company’s business, financial condition and results of operations, as well as result in a default on the Company’s debt obligations. If the Company is unable to take these actions, it may be forced to significantly alter its business strategy, substantially curtail its current operations, or cease operations altogether.

At September 30, 2022, the Company had $20.7 million of cash and cash equivalents, compared to $45.6 million at December 31, 2021. The Company’s September 30, 2022 cash and cash equivalents balance does not include $12.4 million of restricted cash that is currently held in escrow under the terms of its convertible senior secured notes due 2024, which may potentially be released from escrow if the Company pays interest on those notes using shares of its common stock (the amount released would correspond to the amount of interest paid using shares). The Company incurred a net loss of $85.1 million for the nine-month period ended September 30, 2022. On October 18, 2022, the Company announced that it will not use common stock to make the approximately $6.2 million interest payment due on December 1, 2022. In addition, in October 2022, the Company received $16.5 million following a final decision of an arbitration panel regarding a dispute over licensing royalties relating to Ampyra.

The Company assesses and determines its ability to continue as a going concern in accordance with the provisions of ASC Topic 205-40, “Presentation of Financials Statements—Going Concern” (“ASC Topic 205-40”), which requires the Company to evaluate whether there are conditions or events that raise substantial doubt about its ability to continue as a going concern within one year after the date that its annual and interim consolidated financial statements are issued. Certain additional financial statement disclosures are required if such conditions or events are identified. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting. Determining the extent, if any, to which conditions or events raise substantial doubt about the Company’s ability to continue as a going concern, or the extent to which mitigating plans sufficiently alleviate any such substantial doubt, as well as whether or not liquidation is imminent, requires significant judgement by management. The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements contained in this report are issued.

On June 22, 2022, the Company received notice that it is no longer in compliance with Nasdaq’s continued listing requirements because the trading price of its common stock had fallen below $1.00 for a period of more than 30 consecutive business days. The Company has 180 days, or until December 19, 2022, in order to regain compliance with this requirement in order to avoid potential delisting of its common stock, which would have significant adverse consequences both for the liquidity of the Company’s common stock and under the Indenture governing the 2024 Notes. To regain compliance with the Minimum Bid Requirement, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10

consecutive business days during this 180-day period, unless the Staff exercises its discretion to extend this period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company’s common stock is delisted, holders of the 2024 Notes would have the right to require the Company to repurchase the 2024 Notes for 100% of their principal amount. If holders representing a significant amount of the 2024 Notes were to exercise this repurchase right, the Company would be unable to pay, which would result in a default under the Indenture. Such a default could, in turn, result in the Company’s bankruptcy or liquidation. On November 11, 2022, the Company held a special meeting of stockholders in order authorize the Company’s Board of Directors to approve the amendment and restatement of the Company’s Certificate of Incorporation to effect a reverse stock split at a ratio of any whole number in the range of 1-for-2 to 1-for-20 within one year following the conclusion of the special meeting. At the special meeting, the Company’s stockholders voted to authorize the Board of Directors to effect a reverse stock split. The Company believes that this approval by stockholders of the reverse stock split proposal, will, if necessary as determined by the Board of Directors, enable the Company to maintain its listing on the Nasdaq Global Select Market, which forms the basis of the Company’s long-term strategic planning.

The Company believes that its existing cash and cash equivalents will be sufficient to cover its cash flow requirements for at least the next twelve months from the issuance date of these financial statements. However, the Company’s future requirements may change and will depend on numerous factors, some of which may be beyond the Company’s control.

Subsequent Events

Subsequent Events

Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined there were subsequent events that required disclosure or adjustment in these financial statements. See Note 15 to the Company’s Consolidated Financial Statements included in this report for a discussion of subsequent events.

Accounting Pronouncements Adopted

Accounting Pronouncements Adopted

In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted. The Company adopted this guidance effective January 1, 2021. The adoption of this guidance did not have a significant impact on the consolidated financial statements.

In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt – Modifications and Extinguishments (Subtopic 470-50), Compensation – Stock Compensation (Topic 718), and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. The FASB is issuing this update to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. The amendments in this update are effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this guidance effective January 1, 2022. The adoption of this guidance did not have a significant impact on the consolidated financial statements.

Accounting Pronouncements Not Yet Adopted

Accounting Pronouncements Not Yet Adopted

In March 2020, the FASB issued ASU 2020-03, “Codification Improvements to Financial Instruments”: The amendments in this update are to clarify, correct errors in, or make minor improvements to a variety of ASC topics. The changes in ASU 2020-03 are not expected to have a significant effect on current accounting practices. The ASU improves various financial instrument topics in the Codification to increase stakeholder awareness of the amendments and to expedite the improvement process by making the Codification easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. The ASU is effective for smaller reporting companies for fiscal years beginning after December 15, 2022 with early application permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This update simplifies the accounting for convertible instruments by eliminating the cash conversion and beneficial conversion feature models which require separate accounting for embedded conversion features. This update also amends the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusions and requires the application of the if-converted method for calculating diluted earnings per share. ASU 2020-06 is effective for smaller reporting companies for fiscal periods beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In March, 2022, the FASB issued ASU 2022-02, Financial Instruments – Credit Losses: Troubled Debt Restructurings and Vintage Disclosures. The amendments in this Update eliminate the accounting guidance for Troubled Debt Restructurings by creditors in Subtopic 310-40, Receivables—Troubled Debt Restructurings by Creditors, while enhancing disclosure requirements for certain loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty. This update also includes amendments which require that an entity disclose current-period gross writeoffs by year of origination for financing receivables and net investments in leases within the scope of Subtopic 326-20, Financial Instruments—Credit Losses—Measured at Amortized Cost. The ASU is effective for entities that have adopted the amendments in Update 2016-13 for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

In September, 2022, the FASB issued ASU 2022-04, Liabilities – Supplier Finance Programs: Disclosure of Supplier Finance Program Obligations. The amendments in this update address investor and other financial statement user requests for additional information about the use of supplier finance programs (the programs) by the buyer party to understand the effect of those programs on an entity’s working capital, liquidity, and cash flows. The ASU requires that a buyer in a supplier finance program disclose sufficient information about the program to allow a user of financial statements to understand the program’s nature, activity during the period, changes from period to period, and potential magnitude. The ASU is effective for entities that have fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the impact the adoption of this guidance may have on its consolidated financial statements.

v3.22.2.2
Summary of Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2022
Accounting Policies [Abstract]  
Reconciliation of Cash, Cash Equivalents and Restricted Cash

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the statement of financial position that sum to the total of the same amounts shown in the statement of cash flows:

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

(In thousands)

Beginning of period

 

 

End of period

 

 

Beginning of period

 

 

End of period

 

Cash and cash equivalents

$

45,634

 

 

$

20,696

 

 

$

71,369

 

 

$

36,168

 

Restricted cash

 

13,400

 

 

 

13,232

 

 

 

12,917

 

 

 

13,353

 

Restricted cash non-current

 

6,189

 

 

 

255

 

 

 

18,609

 

 

 

12,399

 

Total Cash, cash equivalents and restricted cash per statement of cash flows

$

65,223

 

 

$

34,183

 

 

$

102,895

 

 

$

61,920

 

 

 

Schedule of Major Classes of Inventory

The following table provides the major classes of inventory:

(In thousands)

 

September 30, 2022

 

 

December 31, 2021

 

Raw materials

 

$

3,333

 

 

$

3,338

 

Finished goods

 

 

11,919

 

 

 

15,210

 

Total

 

$

15,252

 

 

$

18,548

 

v3.22.2.2
Revenue (Tables)
9 Months Ended
Sep. 30, 2022
Revenue From Contract With Customer [Abstract]  
Disaggregation of Revenue

The following table disaggregates the Company’s revenue by major source. The Company’s Royalty Revenue set forth below relates to Fampyra royalties payable under the Company’s License and Collaboration Agreement with Biogen. See Note 9 for additional information on the Company’s related payment obligation to HealthCare Royalty Partners, or HCRP, in connection with a 2017 royalty purchase agreement with HCRP.

 

 

(In thousands)

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net product revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ampyra

$

21,110

 

 

$

20,026

 

 

$

54,192

 

 

$

62,035

 

Inbrija U.S.

 

7,848

 

 

 

7,804

 

 

 

18,957

 

 

 

19,240

 

Inbrija ex-U.S.

 

1,006

 

 

 

 

 

 

2,874

 

 

 

 

Other

 

 

 

 

21

 

 

 

 

 

 

22

 

Total net product revenues

 

29,964

 

 

 

27,851

 

 

 

76,023

 

 

 

81,297

 

Royalty Revenue

 

3,047

 

 

 

3,605

 

 

 

10,573

 

 

 

10,807

 

License Revenue

 

500

 

 

 

 

 

 

500

 

 

 

 

Total net revenues

$

33,511

 

 

$

31,456

 

 

$

87,096

 

 

$

92,104

 

v3.22.2.2
Share-based Compensation (Tables)
9 Months Ended
Sep. 30, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Schedule of Share-based Compensation Expense

The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations:

 

 

 

For the three-month period ended September 30,

 

 

For the nine-month period ended September 30,

 

(In thousands)

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Research and development expense

 

$

14

 

 

$

225

 

 

$

66

 

 

$

599

 

Selling, general and administrative expense

 

 

351

 

 

 

627

 

 

 

1,254

 

 

 

1,898

 

Cost of Sales

 

 

(1

)

 

 

2

 

 

 

0

 

 

 

18

 

Total

 

$

364

 

 

$

854

 

 

$

1,320

 

 

$

2,515

 

Schedule of Stock Option Activity

A summary of share-based compensation activity for the nine-month period ended September 30, 2022 is presented below:

 

 

 

Number of

Shares

(In thousands)

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contractual

Term

 

 

Intrinsic

Value

(In thousands)

 

Balance at January 1, 2022

 

 

1,186

 

 

$

94.38

 

 

 

 

 

 

 

 

 

Granted

 

 

97

 

 

 

1.19

 

 

 

 

 

 

 

 

 

Cancelled

 

 

(230

)

 

 

128.93

 

 

 

 

 

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2022

 

 

1,053

 

 

$

78.24

 

 

 

6.0

 

 

$

 

Vested and expected to vest at

    September 30, 2022

 

 

1,053

 

 

$

78.24

 

 

 

6.0

 

 

$

 

Vested and exercisable at

    September 30, 2022

 

 

713

 

 

$

113.62

 

 

 

4.5

 

 

$

 

Restricted Stock and Performance Stock Unit  
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]  
Schedule of Restricted Stock and Performance Stock Unit Activity

 

(In thousands)

 

 

 

 

Restricted Stock and Performance Stock Units

 

Number of Shares

 

Nonvested at January 1, 2022

 

 

116

 

Granted

 

 

 

Vested

 

 

(103

)

Forfeited

 

 

(7

)

Nonvested at September 30, 2022

 

 

6

 

v3.22.2.2
Loss Per Share (Tables)
9 Months Ended
Sep. 30, 2022
Earnings Per Share [Abstract]  
Schedule of Computation of Basic and Diluted Loss per Share

The following table sets forth the computation of basic and diluted loss per share for the three- and nine-month periods ended September 30, 2022 and 2021:

 

(In thousands, except per share data)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss—basic

 

$

(13,854

)

 

$

(27,071

)

 

$

(85,058

)

 

$

(83,387

)

Net income (loss)—diluted

 

$

(13,854

)

 

$

(27,071

)

 

$

(85,058

)

 

$

(83,387

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used in computing net loss per share—basic

 

 

24,290

 

 

 

11,131

 

 

 

18,148

 

 

 

10,204

 

Plus: net effect of dilutive stock options and restricted common shares

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding used in computing net loss per share—diluted

 

 

24,290

 

 

 

11,131

 

 

 

18,148

 

 

 

10,204

 

Net loss per share—basic

 

$

(0.57

)

 

$

(2.43

)

 

$

(4.69

)

 

$

(8.17

)

Net loss per share—diluted

 

$

(0.57

)

 

$

(2.43

)

 

$

(4.69

)

 

$

(8.17

)

Schedule of Anti-dilutive Securities Excluded from Calculation of Net Loss per Diluted Share

The following amounts were not included in the calculation of net loss per diluted share because their effects were anti-dilutive:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock options and restricted common shares

 

 

1,134

 

 

 

1,370

 

 

 

1,089

 

 

 

1,368

 

v3.22.2.2
Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2022
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]  
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis

 

(In thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

September 30, 2022

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

2,216

 

 

$

 

 

$

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

37,600

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

 

 

 

 

 

 

 

 

 

Assets Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,192

 

 

$

 

 

$

 

Liabilities Carried at Fair Value:

 

 

 

 

 

 

 

 

 

 

 

 

Acquired contingent consideration

 

 

 

 

 

 

 

 

49,600

 

Derivative liability - conversion option

 

 

 

 

 

 

 

 

37

 

Contingent Consideration Liability  
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]  
Schedule of Contingent Liabilities

The following table presents additional information about liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value.

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Acquired contingent consideration:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

 

$

42,900

 

 

$

41,200

 

 

$

49,600

 

 

$

48,200

 

Fair value change to contingent consideration

   included in the statement of operations

 

 

(4,576

)

 

 

2,205

 

 

 

(10,709

)

 

 

(4,224

)

Royalty payments

 

 

(724

)

 

 

(405

)

 

 

(1,291

)

 

 

(976

)

Balance, end of period

 

$

37,600

 

 

$

43,000

 

 

$

37,600

 

 

$

43,000

 

 

Derivative Liability-Conversion Option  
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]  
Schedule of Fair Value Reconciliation of Derivative Liabilities

The following table represents a reconciliation of the derivative liability recorded in connection with the issuance of the convertible senior secured notes due 2024:

(In thousands)

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Derivative Liability-Conversion Option

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, beginning of period

$

 

 

$

613

 

 

$

37

 

 

$

1,193

 

Fair value adjustment

 

 

 

 

(288

)

 

 

(37

)

 

 

(868

)

Balance, end of period

$

 

 

$

325

 

 

$

 

 

$

325

 

v3.22.2.2
Liability Related to Sale of Future Royalties (Tables)
9 Months Ended
Sep. 30, 2022
Deferred Revenue Disclosure [Abstract]  
Schedule of Activity Within Liability Related to Sale of Future Royalties The following table shows the activity within the liability account for the nine-month period ended September 30, 2022 and 2021, respectively:

 

(In thousands)

 

September 30, 2022

 

 

September 30, 2021

 

Liability related to sale of future royalties - beginning balance

 

$

4,460

 

 

$

15,257

 

Deferred transaction costs amortized

 

 

33

 

 

 

193

 

Non-cash royalty revenue payable to HCRP

 

 

(4,739

)

 

 

(8,889

)

Non-cash interest expense recognized

 

 

246

 

 

 

891

 

Liability related to sale of future royalties - ending balance

 

$

 

 

$

7,452

 

 

 

 

 

 

 

 

 

 

 

 

v3.22.2.2
Debt (Tables)
9 Months Ended
Sep. 30, 2022
Convertible Senior Secured Notes due 2024  
Summary of Outstanding Note Balances

The outstanding 2024 Note balances as of September 30, 2022 and December 31, 2021 consisted of the following:

 

(In thousands)

 

September 30, 2022

 

 

December 31, 2021

 

Liability component:

 

 

 

 

 

 

 

 

Principal

 

 

207,000

 

 

$

207,000

 

Less: debt discount and debt issuance costs, net

 

 

(44,240

)

 

 

(55,975

)

Net carrying amount

 

$

162,760

 

 

$

151,025

 

Equity component

 

$

18,257

 

 

$

18,257

 

Derivative liability-conversion option

 

$

 

 

$

37

 

Schedule of Interest Expense Recognized Related to the Notes

The following table sets forth total interest expense recognized related to the 2024 Notes for the three- and nine-month periods ended September 30, 2022 and 2021:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Contractual interest expense

 

$

3,105

 

 

$

3,105

 

 

$

9,315

 

 

$

9,315

 

Amortization of debt issuance costs

 

 

291

 

 

 

243

 

 

 

834

 

 

 

698

 

Amortization of debt discount

 

 

3,797

 

 

 

3,179

 

 

 

10,902

 

 

 

9,130

 

Total interest expense

 

$

7,193

 

 

$

6,527

 

 

$

21,051

 

 

$

19,143

 

Convertible Senior Notes due 2021  
Schedule of Interest Expense Recognized Related to the Notes

The following table sets forth total interest expense recognized related to the 2021 Notes for the three- and nine-month periods ended September 30, 2022 and 2021:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Contractual interest expense

 

$

 

 

$

 

 

$

 

 

$

428

 

Amortization of debt issuance costs

 

 

 

 

 

 

 

 

 

 

 

95

 

Amortization of debt discount

 

 

 

 

 

 

 

 

 

 

 

934

 

Total interest expense

 

$

 

 

$

 

 

$

 

 

$

1,457

 

v3.22.2.2
Leases (Tables)
9 Months Ended
Sep. 30, 2022
Leases [Abstract]  
Schedule of ROU Assets and Lease Liabilities Related to Operating Leases

ROU assets and lease liabilities related to the Company’s operating leases are as follows:

 

(In thousands)

 

Balance Sheet Classification

 

September 30, 2022

 

 

December 31, 2021

 

Right-of-use assets

 

Right of use assets

 

$

5,541

 

 

$

6,751

 

Current lease liabilities

 

Current portion of lease liabilities

 

 

1,454

 

 

 

8,186

 

Non-current lease liabilities

 

Non-current portion of lease liabilities

 

 

4,612

 

 

 

4,086

 

 

Components of Lease Costs The components of lease costs were as follows:

 

(In thousands)

 

Three-month period ended September 30, 2022

 

 

Three-month period ended September 30, 2021

 

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Operating lease cost

 

$

431

 

 

$

1,600

 

 

$

3,390

 

 

$

4,593

 

Variable lease cost

 

 

132

 

 

 

948

 

 

 

1,960

 

 

 

3,283

 

Short-term lease cost

 

 

1

 

 

 

339

 

 

 

7

 

 

 

829

 

Total lease cost

 

$

564

 

 

$

2,887

 

 

$

5,357

 

 

$

8,705

 

 

 

Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases

Future minimum commitments under all non-cancelable operating leases are as follows:

 

(In thousands)

 

 

 

 

2022 (excluding the three months ended September 30, 2022)

 

$

295

 

2023

 

 

1,546

 

2024

 

 

1,588

 

2025

 

 

1,633

 

2026

 

 

1,678

 

Later years

 

 

539

 

Total lease payments

 

 

7,279

 

Less: Imputed interest

 

 

(1,213

)

Present value of lease liabilities

 

$

6,066

 

 

Summary of Supplemental Cash Flow Information Related to Operating Leases

Supplemental cash flow information related to the Company’s operating leases are as follows:

 

(In thousands)

 

Nine-month period ended September 30, 2022

 

 

Nine-month period ended September 30, 2021

 

Operating cash flow information:

 

 

 

 

 

 

 

 

Cash paid for amounts included in the measurement of lease liabilities

 

$

295

 

 

$

4,605

 

 

v3.22.2.2
Corporate Restructuring (Tables)
9 Months Ended
Sep. 30, 2022
Restructuring And Related Activities [Abstract]  
Summary of Restructuring Charges

A summary of the restructuring charges for the nine-month period ended September 30, 2022 is as follows:

(In thousands)

 

Restructuring Costs

 

Restructuring Liability as of December 31, 2021

 

$

1,851

 

Q1 Restructuring Costs

 

 

226

 

Q1 Restructuring Payments

 

 

(1,700

)

Restructuring Liability as of March 31, 2022

 

$

377

 

Q2 Restructuring Costs

 

 

25

 

Q2 Restructuring Payments

 

 

(145

)

Restructuring Liability as of June 30, 2022

 

$

257

 

Q3 Restructuring Costs

 

 

 

Q3 Restructuring Payments

 

 

(257

)

Restructuring Liability as of September 30, 2022

 

$

(0

)

v3.22.2.2
Summary of Significant Accounting Policies - Additional Information (Details)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 9 Months Ended
Nov. 11, 2022
Oct. 18, 2022
USD ($)
Jun. 22, 2022
$ / shares
Oct. 31, 2022
USD ($)
Sep. 30, 2022
USD ($)
Sep. 30, 2021
USD ($)
Sep. 30, 2022
USD ($)
Segment
Sep. 30, 2021
USD ($)
Dec. 31, 2021
USD ($)
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]                  
Proceeds from sale of facility             $ 74,000    
Transfer of raw material         $ 2,300   $ 2,300    
Charge for excess and obsolete inventory               $ 1,300  
Segment and Geographic Information                  
Number of operating segments | Segment             1    
Number of reportable operating segments | Segment             1    
Net loss         (13,854) $ (27,071) $ (85,058) (83,387)  
VERSION A                  
Segment and Geographic Information                  
Cash and cash equivalents         20,700   20,700   $ 45,600
Restricted cash         12,400   12,400    
Net loss             (85,100)    
Trading price of common stock | $ / shares     $ 1.00            
Consecutive days for complying with trading price of listed securities     30 days            
Number of additional days for complying with requirement of trading price of listed securities     180 days            
Cut off date on or before compliance with requirement of trading price of listed securities     Dec. 19, 2022            
Closing bid price of common stock | $ / shares     $ 1.00            
Consecutive days for complying with Minimum bid requirement     10 days            
Number of additional days for complying with minimum bid requirement     180 days            
VERSION A | 2024 Notes                  
Segment and Geographic Information                  
Repurchase principal amount, Percentage     100.00%            
Subsequent Event | VERSION A                  
Segment and Geographic Information                  
Common stock, interest payment   $ 6,200              
Licensing royalties received       $ 16,500          
Common stock, interest payment due date   December 1, 2022              
Stockholders' equity, reverse stock split 1-for-2 to 1-for-20                
Letters of Credit                  
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]                  
Restricted Cash and Cash Equivalents         $ 300   $ 300    
Chelsea Facility                  
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]                  
Proceeds from sale of facility               $ 74,000  
v3.22.2.2
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Sep. 30, 2021
Dec. 31, 2020
Accounting Policies [Abstract]        
Cash and cash equivalents $ 20,696 $ 45,634 $ 36,168 $ 71,369
Restricted cash 13,232 13,400 13,353 12,917
Restricted cash non-current 255 6,189 12,399 18,609
Total Cash, cash equivalents and restricted cash per statement of cash flows $ 34,183 $ 65,223 $ 61,920 $ 102,895
v3.22.2.2
Summary of Significant Accounting Policies - Schedule of Major Classes of Inventory (Details) - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Inventory Disclosure [Abstract]    
Raw materials $ 3,333 $ 3,338
Finished goods 11,919 15,210
Total $ 15,252 $ 18,548
v3.22.2.2
Revenue - Additional Information (Details) - USD ($)
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Dec. 31, 2021
Disaggregation Of Revenue [Line Items]          
Contract Liabilities $ 6,100,000 $ 0 $ 6,100,000 $ 0 $ 5,900,000
Contract assets 0 0 0 0  
Revenues $ 33,511,000 $ 31,456,000 87,096,000 $ 92,104,000  
Esteve Pharmaceuticals [Member]          
Disaggregation Of Revenue [Line Items]          
Revenues     $ 2,900,000    
v3.22.2.2
Revenue - Disaggregation of Revenue (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Disaggregation Of Revenue [Line Items]        
Total net revenues $ 33,511 $ 31,456 $ 87,096 $ 92,104
Ampyra        
Disaggregation Of Revenue [Line Items]        
Total net revenues 21,110 20,026 54,192 62,035
Inbrija U.S.        
Disaggregation Of Revenue [Line Items]        
Total net revenues 7,848 7,804 18,957 19,240
Inbrija ex-U.S.        
Disaggregation Of Revenue [Line Items]        
Total net revenues 1,006   2,874  
Other        
Disaggregation Of Revenue [Line Items]        
Total net revenues   21   22
Net Product Revenues        
Disaggregation Of Revenue [Line Items]        
Total net revenues 29,964 27,851 76,023 81,297
Royalty Revenues        
Disaggregation Of Revenue [Line Items]        
Total net revenues 3,047 $ 3,605 10,573 $ 10,807
License Revenue        
Disaggregation Of Revenue [Line Items]        
Total net revenues $ 500   $ 500  
v3.22.2.2
Share-based Compensation - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]        
Share-based compensation expense recognized $ 364 $ 854 $ 1,320 $ 2,515
Weighted average fair value of options granted (in dollars per share) $ 0.31 $ 2.56 $ 0.84 $ 2.58
Unrecognized compensation costs for unvested stock options, restricted stock awards and restricted stock units $ 800   $ 800  
Weighted average period     2 years 8 months 12 days  
Purchase of Treasury Stock ,Shares     0  
v3.22.2.2
Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Share-based compensation expense recognized $ 364 $ 854 $ 1,320 $ 2,515
Research and development expense        
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Share-based compensation expense recognized 14 225 66 599
Selling, general, and administrative expense        
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Share-based compensation expense recognized 351 627 1,254 1,898
Cost of sales        
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]        
Share-based compensation expense recognized $ (1) $ 2 $ 0 $ 18
v3.22.2.2
Share-based Compensation - Schedule of Stock Options Activity (Details)
shares in Thousands
9 Months Ended
Sep. 30, 2022
$ / shares
shares
Stock Option Activity  
Beginning balance (in shares) | shares 1,186
Granted (in shares) | shares 97
Cancelled (in shares) | shares (230)
Ending balance (in shares) | shares 1,053
Vested and expected to vest at the end of the period | shares 1,053
Vested and exercisable at the end of the period | shares 713
Weighted Average Exercise Price  
Balance at the beginning of the period (in dollars per share) | $ / shares $ 94.38
Granted (in dollars per share) | $ / shares 1.19
Cancelled (in dollars per share) | $ / shares 128.93
Balance at the end of the period (in dollars per share) | $ / shares 78.24
Vested and expected to vest at the end of the period (in dollars per share) | $ / shares 78.24
Vested and exercisable at the end of the period (in dollars per share) | $ / shares $ 113.62
Weighted Average Remaining Contractual Term  
Balance at the end of the period 6 years
Vested and expected to vest at the end of the period 6 years
Vested and exercisable at the end of the period 4 years 6 months
v3.22.2.2
Share-based Compensation - Schedule of Restricted Stock and Performance Stock Unit Activity (Details) - Restricted Stock and Performance Stock Unit
shares in Thousands
9 Months Ended
Sep. 30, 2022
shares
Restricted Stock and Performance Stock Units  
Nonvested at the beginning of the period (in shares) 116
Granted (in shares) 0
Vested (in shares) (103)
Forfeited (in shares) (7)
Nonvested at the end of the period (in shares) 6
v3.22.2.2
Loss Per Share - Schedule of Computation of Basic and Diluted Loss Per Share (Details) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Basic and diluted        
Net loss—basic $ (13,854) $ (27,071) $ (85,058) $ (83,387)
Net income (loss)—diluted $ (13,854) $ (27,071) $ (85,058) $ (83,387)
Weighted average common shares outstanding used in computing net loss per share—basic 24,290 11,131 18,148 10,204
Weighted average common shares outstanding used in computing net loss per share—diluted 24,290 11,131 18,148 10,204
Net loss per share—basic $ (0.57) $ (2.43) $ (4.69) $ (8.17)
Net loss per share—diluted $ (0.57) $ (2.43) $ (4.69) $ (8.17)
v3.22.2.2
Loss Per Share - Schedule of Antidilutive Securities Excluded from Calculation of Net Loss Per Diluted Share (Details) - shares
shares in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Stock options and restricted common shares        
Antidilutive Securities        
Anti-dilutive securities excluded from computation of loss per share (in shares) 1,134 1,370 1,089 1,368
v3.22.2.2
Income Taxes - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Income Tax Disclosure [Abstract]        
(Provision for) benefit from income taxes $ 1,416 $ (3,105) $ 28,237 $ (6,788)
Effective income tax rate (as a percent) (11.30%) 10.20% (49.69%) 7.53%
Change Of Control Ownership Percentage Threshold     50.00%  
Change Of Control Ownership Measurement Period     3 years  
Valuation allowance on deferred tax assets $ 25,000   $ 25,000  
v3.22.2.2
Fair Value Measurements - Additional Information (Details)
9 Months Ended
Sep. 17, 2020
USD ($)
shares
Dec. 24, 2019
Sep. 30, 2022
USD ($)
shares
Sep. 30, 2020
USD ($)
Dec. 31, 2021
shares
Sep. 30, 2021
Aug. 28, 2020
shares
Dec. 31, 2019
shares
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]                
Notes, interest rate   6.00%            
Common stock, Authorized shares | shares 61,666,666   61,666,666   61,666,666   13,333,333 13,333,333
Derivative liability reclassified to equity $ 18,300,000              
Income tax effects on equity transactions       $ 4,400,000        
Inbrija                
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]                
Milestone payment, minimum     $ 0          
Milestone payment, maximum     $ 18,100,000          
Convertible Senior Secured Notes due 2024                
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]                
Debt instrument maturity date     2024-12          
Notes, interest rate   6.00% 6.00%          
Notes, maturity date   Dec. 01, 2024 Dec. 01, 2024          
Fair Value, Inputs, Level 2 | Convertible Senior Secured Notes due 2024                
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]                
Convertible senior notes     $ 157,300,000          
Level 3 | Weighted Discounted Cash Flow Valuation Approach | Discount Rate                
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]                
Acquired contingent consideration, measurement input     23     20.5    
v3.22.2.2
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Liabilities Carried at Fair Value:    
Derivative liability   $ 37
Level 1 | Recurring basis | Money Market Funds    
Assets Carried at Fair Value:    
Assets, Fair Value $ 2,216 12,192
Level 3 | Recurring basis    
Liabilities Carried at Fair Value:    
Acquired contingent consideration $ 37,600 49,600
Derivative liability   $ 37
v3.22.2.2
Fair Value Measurements - Schedule of Contingent Liabilities (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs        
Balance, beginning of period $ 42,900 $ 41,200 $ 49,600 $ 48,200
Fair value change to contingent consideration included in the statement of operations (4,576) 2,205 (10,709) (4,224)
Royalty payments (724) (405) (1,291) (976)
Balance, end of period $ 37,600 $ 43,000 $ 37,600 $ 43,000
v3.22.2.2
Fair Value Measurements - Schedule of Fair Value Reconciliation of Derivative Liability (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Fair Value Reconciliation Of Derivative Liability [Line Items]      
Balance, beginning of period   $ 37  
Convertible Senior Secured Notes due 2024      
Fair Value Reconciliation Of Derivative Liability [Line Items]      
Balance, beginning of period $ 613 37 $ 1,193
Fair value adjustment (288) $ (37) (868)
Balance, end of period $ 325   $ 325
v3.22.2.2
Investments - Additional Information (Details) - USD ($)
Sep. 30, 2022
Dec. 31, 2021
Schedule Of Available For Sale Securities [Line Items]    
Available-for-sale investments $ 0 $ 0
Long-term investments 0 0
Short-term investments 0 0
Short Term Investments    
Schedule Of Available For Sale Securities [Line Items]    
Cash and cash equivalents $ 2,200,000 $ 12,200,000
v3.22.2.2
Liability Related to Sale of Future Royalties - Additional Information (Details) - Royalty Purchase Agreement - USD ($)
$ in Thousands
9 Months Ended
Oct. 01, 2017
Sep. 30, 2022
Sep. 30, 2021
Dec. 31, 2021
Dec. 31, 2020
Liability Related To Sale Of Future Royalties [Line Items]          
Payment from royalties $ 40,000        
Royalty liability 40,000        
Net of transaction costs $ 2,200 $ 33 $ 193    
Liability related to sale of future royalties - ending balance   $ 0 $ 7,452 $ 4,460 $ 15,257
v3.22.2.2
Liability Related to Sale of Future Royalties - Schedule of Activity Within Liability Related to Sale of Future Royalties (Details) - USD ($)
$ in Thousands
9 Months Ended
Oct. 01, 2017
Sep. 30, 2022
Sep. 30, 2021
Liability Related To Sale Of Future Royalties [Line Items]      
Non-cash royalty revenue payable to HCRP   $ (4,762) $ (8,889)
Royalty Purchase Agreement      
Liability Related To Sale Of Future Royalties [Line Items]      
Liability related to sale of future royalties - beginning balance   4,460 15,257
Deferred transaction costs amortized $ 2,200 33 193
Non-cash royalty revenue payable to HCRP   (4,739) (8,889)
Non-cash interest expense recognized   246 891
Liability related to sale of future royalties - ending balance   $ 0 $ 7,452
v3.22.2.2
Debt - Additional Information (Details)
$ / shares in Units, € in Millions
3 Months Ended 9 Months Ended 12 Months Ended
Sep. 17, 2020
USD ($)
shares
Dec. 24, 2019
USD ($)
TradingDay
Sep. 30, 2022
USD ($)
$ / shares
shares
Sep. 30, 2021
USD ($)
Sep. 30, 2022
USD ($)
Loan
$ / shares
shares
Sep. 30, 2021
USD ($)
Sep. 30, 2020
USD ($)
Dec. 31, 2019
USD ($)
shares
Sep. 30, 2022
EUR (€)
shares
Jul. 31, 2022
USD ($)
Dec. 31, 2021
USD ($)
shares
Aug. 28, 2020
shares
Jun. 17, 2014
USD ($)
Debt Instrument [Line Items]                          
Interest rate (as a percent)   6.00%                      
Cash payment made for exchange of notes   $ 200                      
Aggregate payment on debt exchange   55,200,000       $ 69,000,000              
Gain on debt extinguishment               $ 55,100,000          
Adjusted equity component of convertible notes exchange               $ 38,400,000          
Common stock, Authorized shares | shares 61,666,666   61,666,666   61,666,666     13,333,333 61,666,666   61,666,666 13,333,333  
Derivative liability reclassified to equity $ 18,300,000                        
Income tax effects on equity transactions             $ 4,400,000            
Interest expense     $ 7,465,000 $ 7,167,000 $ 22,501,000 $ 22,697,000              
Non Convertible Debt                          
Debt Instrument [Line Items]                          
Principal     24,900,000   24,900,000                
Fair value of debt     20,500,000   $ 20,500,000       € 18.2        
Number Of Loans | Loan         14                
Non Convertible Debt | Finland S Ministry Of Finance Rate                          
Debt Instrument [Line Items]                          
Residual payment amount                   $ 50,000,000      
Non Convertible Debt | Finland S Ministry Of Finance Rate | Biotie                          
Debt Instrument [Line Items]                          
Cash     14,500,000   $ 14,500,000                
Convertible Senior Notes due 2021                          
Debt Instrument [Line Items]                          
Principal amount of debt exchanged   $ 276,000,000.0                      
Interest rate (as a percent)   1.75%                     1.75%
Principal amount denomination for debt conversion   $ 1,000                      
Principal                         $ 345,000,000
Debt instrument, principal amount outstanding   $ 69,000,000.0 69,000,000.0   69,000,000.0                
Debt issuance costs     $ 7,500,000   7,500,000                
Reclassification of derivative liability to equity, net of tax         1,300,000                
Debt issuance costs allocated to liability component         6,200,000                
Debt issuance cost associated with exchange, written off         $ 1,200,000                
Convertible Senior Secured Notes due 2024                          
Debt Instrument [Line Items]                          
Interest rate (as a percent)   6.00% 6.00%   6.00%       6.00%        
Principal amount of debt issued for exchange   $ 750                      
Principal   $ 207,000,000.0                      
Debt instrument, principal amount outstanding     $ 207,000,000   $ 207,000,000           $ 207,000,000    
Notes maturity date   Dec. 01, 2024     Dec. 01, 2024                
Interest payment in shares, percentage of daily volume-weighted average price   95.00%                      
Notes frequency of periodic payment         semi-annually in arrears                
Interest in shares of common stock, threshold trading days | TradingDay   10                      
Initial conversion rate of common stock         47.6190                
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares     $ 21.00   $ 21.00                
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   130.00%                      
Repurchase principal amount, Percentage   100.00%                      
Debt default, non payment of interest, period   30 days                      
Debt default, failure to convert notes, period   5 days                      
Debt default, non-compliance with covenants, period   60 days                      
Fair value of derivative liability   $ 59,400,000                 $ 37,000    
Debt discount   $ 75,100,000                      
Interest expense     7,200,000   $ 21,100,000                
Effective interest rate on liability component (as a percent)   18.13%                      
Debt fair value amount     157,300,000   157,300,000                
Debt issuance costs     $ 5,700,000   $ 5,700,000                
Convertible Senior Secured Notes due 2024 | Minimum                          
Debt Instrument [Line Items]                          
Debt default, non-payment of outstanding principal   $ 30,000,000.0                      
Debt default, failure to pay final judgements   $ 30,000,000.0                      
Debt default, percentage of principal outstanding required for immediate payment   25.00%                      
v3.22.2.2
Debt - Summary of Outstanding Note Balances (Details) - Convertible Senior Secured Notes due 2024 - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Dec. 24, 2019
Debt Instrument [Line Items]      
Principal $ 207,000 $ 207,000  
Less: debt discount and debt issuance costs, net (44,240) (55,975)  
Net carrying amount 162,760 151,025  
Equity component $ 18,257 18,257  
Derivative liability-conversion option   $ 37 $ 59,400
v3.22.2.2
Debt - Schedule of Interest Expense Recognized Related to the Notes (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Debt Instrument [Line Items]        
Total interest expense $ 7,465 $ 7,167 $ 22,501 $ 22,697
Convertible Senior Secured Notes due December 2024        
Debt Instrument [Line Items]        
Contractual interest expense 3,105 3,105 9,315 9,315
Amortization of debt issuance costs 291 243 834 698
Amortization of debt discount 3,797 3,179 10,902 9,130
Total interest expense $ 7,193 $ 6,527 $ 21,051 19,143
Convertible Senior Notes due September 2021        
Debt Instrument [Line Items]        
Contractual interest expense       428
Amortization of debt issuance costs       95
Amortization of debt discount       934
Total interest expense       $ 1,457
v3.22.2.2
Leases - Additional Information (Details)
9 Months Ended 12 Months Ended
Sep. 30, 2022
USD ($)
ft²
Dec. 31, 2021
USD ($)
Jun. 30, 2022
ft²
Dec. 31, 2018
ft²
Oct. 31, 2016
USD ($)
ft²
Operating Lease Information          
Operating lease description Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred, if any. The Company’s leases have remaining lease terms of 4.25 years to 5.75 years. The Company has exercised the option to terminate the Ardsley lease with a termination date of June 22, 2022.         
Operating lease renewal option true        
Operating lease termination option true        
Operating lease termination date Jun. 22, 2022        
Operating lease weighted-average remaining lease term 4 years 7 months 6 days        
Operating lease weighted-average discount rate 7.89%        
Ardsley, New York          
Operating Lease Information          
Area of leased property | ft² 160,000        
Termination option effective date Jun. 22, 2022        
Termination Fee $ 4,700,000        
Pearl River, New York          
Operating Lease Information          
Area of leased property | ft²     21,000    
Lease term     6 years    
Operating sublease, existence of option to extend false        
Base rent $ 0        
Base rent payment commencing on January 1, 2023 $ 300,000        
Base rent subject to annual escalation percentage 2.00%        
Chelsea, Massachusetts | Manufacturing Facility          
Operating Lease Information          
Area of leased property | ft²       95,000  
Contribution Of Fund Agreed   $ 1,500,000      
Waltham, MA | Office and Laboratory Space          
Operating Lease Information          
Area of leased property | ft²         26,000
Lease term         10 years
Base rent         $ 1,200,000
Minimum          
Operating Lease Information          
Operating lease remaining lease term 4 years 3 months        
Maximum [Member]          
Operating Lease Information          
Operating lease remaining lease term 5 years 9 months        
v3.22.2.2
Leases - Schedule of ROU Assets and Lease Liabilities Related to Operating Leases (Details) - USD ($)
$ in Thousands
Sep. 30, 2022
Dec. 31, 2021
Leases [Abstract]    
Right-of-use assets $ 5,541 $ 6,751
Current lease liabilities 1,454 8,186
Non-current lease liabilities $ 4,612 $ 4,086
v3.22.2.2
Leases - Components of Lease Costs (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Leases [Abstract]        
Operating lease cost $ 431 $ 1,600 $ 3,390 $ 4,593
Variable lease cost 132 948 1,960 3,283
Short-term lease cost 1 339 7 829
Total lease cost $ 564 $ 2,887 $ 5,357 $ 8,705
v3.22.2.2
Leases - Schedule of Future Minimum Commitments under all Non-Cancelable Operating Leases (Details)
$ in Thousands
Sep. 30, 2022
USD ($)
Leases [Abstract]  
2022 (excluding the three months ended September 30, 2022) $ 295
2023 1,546
2024 1,588
2025 1,633
2026 1,678
Later years 539
Total lease payments 7,279
Less: Imputed interest (1,213)
Present value of lease liabilities $ 6,066
v3.22.2.2
Leases - Summary of Supplemental Cash Flow Information Related to Operating Leases (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2022
Sep. 30, 2021
Operating cash flow information:    
Cash paid for amounts included in the measurement of lease liabilities $ 295 $ 4,605
v3.22.2.2
Disposal of Assets - Additional Information (Details) - USD ($)
$ in Millions
1 Months Ended 3 Months Ended 9 Months Ended
Feb. 10, 2021
Jan. 12, 2021
Mar. 31, 2021
Sep. 30, 2022
Long Lived Assets Held For Sale [Line Items]        
Estimated fair value of assets held for sale       $ 71.8
Carrying value of the assets held for sale       129.7
Proceeds from completion of divestiture       74.0
Prepaid Expenses        
Long Lived Assets Held For Sale [Line Items]        
Carrying value of the assets held for sale       0.1
Property and Equipment        
Long Lived Assets Held For Sale [Line Items]        
Carrying value of the assets held for sale       129.6
Manufacturing Facility        
Long Lived Assets Held For Sale [Line Items]        
Loss on assets held for sale       $ 57.9
Catalent | Chelsea, Massachusetts        
Long Lived Assets Held For Sale [Line Items]        
Purchase price of assets related to manufacturing activities   $ 80.0    
Additional raw materials purchase price   $ 2.3    
Catalent | Leases        
Long Lived Assets Held For Sale [Line Items]        
Carrying value of the assets held for sale $ (0.5)      
Loss on assets held for sale     $ 0.5  
v3.22.2.2
Corporate Restructuring - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Jan. 31, 2021
Jun. 30, 2022
Mar. 31, 2022
Sep. 30, 2022
Sep. 30, 2021
Restructuring And Related Activities [Abstract]          
Approximate percentage of headcount reduction 16.00%       15.00%
Restructuring Charges For Severance And Other Employee Separation Related Cost   $ 25 $ 226 $ 300  
v3.22.2.2
Corporate Restructuring - Summary of Restructuring Charges (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2022
Jun. 30, 2022
Mar. 31, 2022
Sep. 30, 2022
Restructuring And Related Activities [Abstract]        
Restructuring Liability $ 257 $ 377 $ 1,851 $ 1,851
Restructuring Charges For Severance And Other Employee Separation Related Cost   25 226 300
Restructuring Payments (257) (145) (1,700)  
Restructuring Liability $ 0 $ 257 $ 377 $ 0
v3.22.2.2
Commitments and Contingencies - Additional Information (Detail) - USD ($)
3 Months Ended 9 Months Ended
Jun. 28, 2022
Sep. 30, 2022
Sep. 30, 2021
Sep. 30, 2022
Sep. 30, 2021
Dec. 31, 2021
Dec. 31, 2020
Loss Contingencies [Line Items]              
Commitments and contingencies        
Cost of sales   11,005,000 $ 13,303,000 25,772,000 $ 36,589,000    
Inventory, net   15,252,000   15,252,000   $ 18,548,000  
Catalent              
Loss Contingencies [Line Items]              
Cost of sales   3,800,000          
Inventory, net   3,900,000   3,900,000      
Minimum purchase commitment   7,700,000          
Purchase Commitment, Remaining Minimum Amount Committed   4,500,000   4,500,000      
Purchase Commitment Remaining Minimum Amount Committed There After   18,000,000.0   18,000,000.0      
Licensing Agreements              
Loss Contingencies [Line Items]              
Commitments and contingencies             $ 2,000,000
Unpaid license royalties   6,000,000   $ 6,000,000      
Payments for legal settlements $ 750,000 750,000          
Gain related to litigation settlement   $ 1,300,000          
v3.22.2.2
Subsequent Events - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Millions
Nov. 11, 2022
Oct. 21, 2022
Oct. 16, 2022
Jun. 22, 2022
VERSION A        
Subsequent Event [Line Items]        
Trading price of common stock       $ 1.00
Consecutive days for complying with trading price of listed securities       30 days
Number of additional days for complying with requirement of trading price of listed securities       180 days
Cut off date on or before compliance with requirement of trading price of listed securities       Dec. 19, 2022
Closing bid price of common stock       $ 1.00
Consecutive days for complying with Minimum bid requirement       10 days
Number of additional days for complying with minimum bid requirement       180 days
VERSION A | 2024 Notes        
Subsequent Event [Line Items]        
Repurchase principal amount, Percentage       100.00%
Subsequent Event | VERSION A        
Subsequent Event [Line Items]        
Stockholders' equity, reverse stock split 1-for-2 to 1-for-20      
Alkermes        
Subsequent Event [Line Items]        
Licensing royalties, Awarded amount     $ 15.0  
Licensing royalties, prejudgment interest     $ 1.5  
Licensing royalties, Additional awarded amount   $ 1.6