Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 26, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | CATALYST PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 0001369568 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Large Accelerated Filer | ||
Trading Symbol | CPRX | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | false | ||
Entity Address, State or Province | FL | ||
Entity Interactive Data Current | Yes | ||
Title of 12(b) Security | Common Stock | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 117,863,258 | ||
Entity Tax Identification Number | 76-0837053 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 355 Alhambra Circle | ||
Entity Address, Address Line Two | Suite 801 | ||
Entity Address, City or Town | Coral Gables | ||
Entity Address, Postal Zip Code | 33134 | ||
City Area Code | 305 | ||
Local Phone Number | 420-3200 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-33057 | ||
Entity Public Float | $ 1,341,304,702 | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | GRANT THORNTON LLP | ||
Auditor Firm ID | 248 | ||
Auditor Location | Miami, Florida | ||
Document Financial Statement Error Correction [Flag] | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 137,636 | $ 298,395 |
Accounts receivable, net | 53,514 | 10,439 |
Inventory | 15,644 | 6,805 |
Prepaid expenses and other current assets | 12,535 | 5,167 |
Total current assets | 219,329 | 320,806 |
Operating lease right-of-use asset | 2,508 | 2,770 |
Property and equipment, net | 1,195 | 847 |
License and acquired intangibles, net | 194,049 | 32,471 |
Deferred tax assets, net | 36,544 | 18,736 |
Investment in equity securities | 16,489 | 0 |
Total assets | 470,114 | 375,630 |
Current Liabilities: | ||
Accounts payable | 14,795 | 3,975 |
Accrued expenses and other liabilities | 61,268 | 53,613 |
Total current liabilities | 76,063 | 57,588 |
Operating lease liability, net of current portion | 3,188 | 3,557 |
Other non-current liabilities | 2,982 | 14,064 |
Total liabilities | 82,233 | 75,209 |
Commitments and contingencies (Note 12) | ||
Stockholders' Equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at December 31, 2023 and 2022 | 0 | 0 |
Common stock, $0.001 par value, 200,000,000 shares authorized; 107,121,549 shares and 105,263,031 shares issued and outstanding at December 31, 2023 and 2022, respectively | 107 | 105 |
Additional paid-in capital | 266,488 | 250,430 |
Retained earnings | 121,272 | 49,862 |
Accumulated other comprehensive income (Note 4) | 14 | 24 |
Total stockholders' equity | 387,881 | 300,421 |
Total liabilities and stockholders' equity | $ 470,114 | $ 375,630 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 107,121,549 | 105,263,031 |
Common stock, shares outstanding | 107,121,549 | 105,263,031 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||
Revenues: | ||||
Total revenues | $ 398,204 | $ 214,203 | $ 140,833 | |
Operating costs and expenses: | ||||
Cost of sales | [1] | 51,967 | 34,393 | 21,884 |
Research and development | 93,150 | 19,789 | 16,936 | |
Selling, general and administrative | [1] | 133,710 | 57,085 | 49,628 |
Amortization of intangible assets | 32,565 | 1,098 | 0 | |
Total operating costs and expenses | 311,392 | 112,365 | 88,448 | |
Operating income | 86,812 | 101,838 | 52,385 | |
Other income, net | 7,699 | 2,881 | 282 | |
Net income before income taxes | 94,511 | 104,719 | 52,667 | |
Income tax provision | 23,101 | 21,640 | 13,185 | |
Net income | $ 71,410 | $ 83,079 | $ 39,482 | |
Net income per share: | ||||
Basic | $ 0.67 | $ 0.8 | $ 0.38 | |
Diluted | $ 0.63 | $ 0.75 | $ 0.37 | |
Weighted average shares outstanding: | ||||
Basic | 106,279,736 | 103,374,606 | 103,379,349 | |
Diluted | 113,753,154 | 111,375,631 | 107,795,585 | |
Net income | $ 71,410 | $ 83,079 | $ 39,482 | |
Other comprehensive income (Note 4): | ||||
Unrealized gain (loss) on available-for-sale securities, net of tax of $4, ($54) and $46, respectively | (10) | 172 | (179) | |
Comprehensive income | 71,400 | 83,251 | 39,303 | |
Product revenue, net [Member] | ||||
Revenues: | ||||
Total revenues | 396,502 | 213,938 | 137,997 | |
License and other revenue [Member] | ||||
Revenues: | ||||
Total revenues | $ 1,702 | $ 265 | $ 2,836 | |
[1]exclusive of amortization of intangible assets |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | |||
Net of tax impact | $ 4 | $ (54) | $ 46 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings (Accumulated Deficit) [Member] | Accumulated Other Comprehensive Gain (Loss) [Member] |
Beginning Balance at Dec. 31, 2020 | $ 169,598 | $ 104 | $ 223,168 | $ (53,705) | $ 31 |
Beginning Balance (shares) at Dec. 31, 2020 | 103,782,000 | ||||
Stock-based compensation | 6,073 | 6,073 | |||
Exercise of stock options for common stock | 4,099 | $ 1 | 4,098 | ||
Exercise of stock options for common stock (shares) | 1,328,000 | ||||
Issuance of common stock upon vesting of restricted stock units, net | (153) | (153) | |||
Issuance of common stock upon vesting of restricted stock units, net (Share) | 91,000 | ||||
Repurchase of common stock (shares) | (2,208,292) | ||||
Repurchase of common stock | (12,089) | $ (2) | (12,087) | ||
Other comprehensive gain (loss) | (179) | (179) | |||
Net income | 39,482 | 39,482 | |||
Ending Balance at Dec. 31, 2021 | 206,831 | $ 103 | 233,186 | (26,310) | (148) |
Ending Balance (shares) at Dec. 31, 2021 | 102,993,000 | ||||
Stock-based compensation | 7,907 | 7,907 | |||
Exercise of stock options for common stock | 9,569 | $ 2 | 9,567 | ||
Exercise of stock options for common stock (shares) | 3,172,000 | ||||
Issuance of common stock upon vesting of restricted stock units, net | (230) | (230) | |||
Issuance of common stock upon vesting of restricted stock units, net (Share) | 98,000 | ||||
Repurchase of common stock (shares) | (1,000,000) | ||||
Repurchase of common stock | (6,907) | (6,907) | |||
Other comprehensive gain (loss) | 172 | 172 | |||
Net income | 83,079 | 83,079 | |||
Ending Balance at Dec. 31, 2022 | 300,421 | $ 105 | 250,430 | 49,862 | 24 |
Ending Balance (shares) at Dec. 31, 2022 | 105,263,000 | ||||
Stock-based compensation | 14,250 | 14,250 | |||
Exercise of stock options for common stock | $ 2,792 | $ 2 | 2,790 | ||
Exercise of stock options for common stock (shares) | 1,651,345 | 1,652,000 | |||
Issuance of common stock upon vesting of restricted stock units, net | $ (982) | (982) | |||
Issuance of common stock upon vesting of restricted stock units, net (Share) | 207,000 | ||||
Repurchase of common stock (shares) | 0 | ||||
Other comprehensive gain (loss) | (10) | (10) | |||
Net income | 71,410 | 71,410 | |||
Ending Balance at Dec. 31, 2023 | $ 387,881 | $ 107 | $ 266,488 | $ 121,272 | $ 14 |
Ending Balance (shares) at Dec. 31, 2023 | 107,122,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Activities: | |||
Net income | $ 71,410,000 | $ 83,079,000 | $ 39,482,000 |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |||
Depreciation | 316,000 | 141,000 | 192,000 |
Stock-based compensation | 14,250,000 | 7,907,000 | 6,073,000 |
Amortization of intangible assets | 32,565,000 | 1,098,000 | 0 |
Deferred taxes | (17,818,000) | 4,937,000 | 9,316,000 |
Accretion of discount | 1,320,000 | 17,000 | (5,000) |
Reduction in the carrying amount of right-of-use asset | 262,000 | 247,000 | 292,000 |
Realized loss on sale of available-for-sale securities | 762,000 | ||
Acquired research and development inventory expensed from asset acquisition | 4,130,000 | ||
Acquired inventory samples expensed from asset acquisition | 130,000 | ||
Acquired in-process research and development | 81,513,000 | ||
Change in fair value of equity securities | (3,024,000) | 0 | 0 |
(Increase) decrease in: | |||
Accounts receivable, net | (43,075,000) | (3,820,000) | (632,000) |
Inventory | (4,739,000) | 1,065,000 | (3,219,000) |
Prepaid expenses and other current assets | (5,792,000) | (807,000) | 3,977,000 |
Increase (decrease) in: | |||
Accounts payable | 10,820,000 | 1,207,000 | (1,488,000) |
Accrued expenses and other liabilities | 5,800,000 | 16,391,000 | 5,520,000 |
Operating lease liability | (338,000) | (307,000) | 864,000 |
Net cash provided by (used in) operating activities | 143,600,000 | 116,047,000 | 60,372,000 |
Investing Activities: | |||
Purchases of property and equipment | (231,000) | (29,000) | (1,021,000) |
Purchases of investments | (10,000,000) | ||
Proceeds from sale of available-for-sale securities | 19,238,000 | ||
Payments in connection with asset acquisitions | (198,293,000) | (10,000,000) | |
Acquisition of in-process research and development | (81,513,000) | ||
Purchase of equity securities | (13,465,000) | ||
Net cash provided by (used in) investing activities | (293,502,000) | 9,209,000 | (11,021,000) |
Financing Activities: | |||
Payment of employee withholding tax related to stock-based compensation | (982,000) | (230,000) | (153,000) |
Proceeds from exercise of stock options | 2,792,000 | 9,569,000 | 4,099,000 |
Repurchase of common stock | (6,907,000) | (12,089,000) | |
Payment of liabilities arising from asset acquisition | (12,667,000) | (738,000) | |
Net cash provided by (used in) financing activities | (10,857,000) | 1,694,000 | (8,143,000) |
Net increase (decrease) in cash and cash equivalents | (160,759,000) | 126,950,000 | 41,208,000 |
Cash and cash equivalents – beginning of period | 298,395,000 | 171,445,000 | 130,237,000 |
Cash and cash equivalents – end of period | 137,636,000 | 298,395,000 | 171,445,000 |
Supplemental disclosures of cash flow information: | |||
Cash paid for income taxes | 50,458,000 | 7,667,000 | 3,000,000 |
Cash paid for interest | 705,000 | ||
Non-cash investing and financing activities: | |||
Operating lease liabilities arising from obtaining right-of-use assets | $ 3,309,000 | ||
Liabilities arising from asset acquisition | $ 1,915,000 | $ 27,699,000 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business. Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the Company) is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, best-in-class The Company’s New Drug Application (NDA) for FIRDAPSE ® ® ® ® ® On December 17, 2022, the Company entered into an asset purchase agreement with Eisai Co., Ltd. (Eisai) for the acquisition of the United States rights to FYCOMPA ® ® ® In July 2023, the Company completed its acquisition from Santhera Pharmaceuticals Holdings (Santhera) of an exclusive license for North America for AGAMREE ® ® ® ® Since inception, the Company has devoted substantially all its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, raising capital, and selling its products. The Company has been able to fund its cash needs to date through offerings of its securities and from revenues from sales of its products. See Note 15 (Stockholders’ Equity). Capital Resources Based on forecasts of available cash, the Company believes that it has sufficient resources to support the currently anticipated operations for at least the next 12 months from the date of this report. The Company may raise funds in the future through public or private equity offerings, debt financings, corporate collaborations, governmental research grants or other means. The Company may also seek to raise new capital to fund additional business development activities, even if it has sufficient funds for its planned operations. Any sale by the Company of additional equity or convertible debt securities could result in dilution to the Company’s current stockholders. There can be no assurance that any required additional funding will be available to the Company at all or available on terms acceptable to the Company. Further, to the extent that the Company raises additional funds through collaborative arrangements, it may be necessary to relinquish some rights to the Company’s drug candidates or grant sublicenses on terms that are not favorable to the Company. If the Company is not able to secure additional funding when needed, the Company may have to delay, reduce the scope of, or eliminate one or more research and development programs, which could have an adverse effect on the Company’s business. Subsequent to year-end, See Note 18 (Subsequent Events). Risks and Uncertainties The Company is subject to risks and adversities that could affect its business in unforeseen ways. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of Presentation and Significant Accounting Policies. a. PRINCIPLES OF CONSOLIDATION. b. USE OF ESTIMATES. c. CASH AND CASH EQUIVALENTS. d. INVESTMENTS. The Company invests in high credit-quality instruments in order to obtain higher yields on its cash available for investments. At December 31, 2023, investments consisted of U.S. Treasuries and an investment in equity securities. At December 31, 2022, investments consisted of U.S. Treasuries. Such investments are not insured by the Federal Deposit Insurance Corporation. The U.S. Treasuries held at December 31, 2023 and December 31, 2022 are classified as available-for-sale non-current There are no short-term investments as of December 31, 2023 and December 31, 2022. The Company records available-for-sale available-for-sale available-for-sale available-for-sale In July 2023, the Company made a strategic equity investment into Santhera by acquiring 1,414,688 of Santhera’s post reverse-split ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares following the transaction) . e. ACCOUNTS RECEIVABLE, NET. f. INVENTORY work-in-process first-in, Products that have been approved by the FDA or other regulatory authorities, such as FIRDAPSE ® ® ® ® ® ® The Company evaluates for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage. g. PREPAID EXPENSES AND OTHER CURRENT ASSETS. co-pay pre-clinical h. PROPERTY AND EQUIPMENT, NET. three five five i BUSINESS COMBINATIONS AND ASSET ACQUISITIONS 805-50, See Notes 12 (Commitments and Contingencies) and 13 (Agreements) for further discussion on the Company’s exclusive license agreement with Jacobus Pharmaceutical Company, Inc . ® ASC 805-50. ® ® 805-50. j. INTANGIBLE ASSETS, NET. The Company reviews intangible assets with finite lives for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist, an impairment test is performed to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are deemed not recoverable, the Company would estimate the fair value of the assets and record an impairment loss. k. FAIR VALUE OF FINANCIAL INSTRUMENTS. l. FAIR VALUE MEASUREMENTS. Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Fair Value Measurements at Reporting Date Using (in thousands) Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 18,256 $ 18,256 $ — $ — U.S. Treasuries $ 94,523 $ 94,523 $ — $ — Investment in equity securities: Equity securities $ 16,489 $ 16,489 $ — $ — Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 168,853 $ 168,853 $ — $ — U.S. Treasuries $ 105,442 $ 105,442 $ — $ — m. OPERATING LEASES. right-of-use non-lease n. SHARE REPURCHASES. The Company accounts for share repurchases by charging the excess of the repurchase price over the repurchased common stock’s par value entirely to retained earnings. All repurchased shares are retired and become authorized but unissued shares. The Company accrues for the shares purchased under the share repurchase plan based on the trade date. The Company may terminate or modify its share repurchase program at any time. o. REVENUE RECOGNITION. Product Revenues: To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification (ASC) Topic 606 – Revenue from Contracts with Customers (Topic 606), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company assesses the goods or services promised within each contract and determines those that are performance obligations by assessing whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net below. The Company also may generate revenues from payments received under collaborative and license agreements. Collaborative and license agreement payments may include nonrefundable fees at the inception of the agreements, contingent payments for specific achievements designated in the agreements, and/or net profit-sharing payments on sales of products resulting from the collaborative and license arrangements. For a complete discussion of accounting for collaborative and licensing arrangements, see Revenues from Collaboration and Licensing Arrangements below. The Company recognizes revenue when its customer for FIRDAPSE ® ® ® ® ® ® ® Product Revenue, Net: Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales. If taxes should be collected from the Customer relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the years ended December 31, 2023, 2022 and 2021. During the years ended December 31, 2023, 2022 and 2021, substantially all of the Company’s product revenues were from sales to customers in the United States. The following table summarizes the Company’s net product revenue disaggregated by product (in thousands): For the Years Ended December 31, 2023 2022 2021 FIRDAPSE ® $ 258,426 $ 213,938 $ 137,997 FYCOMPA ® 138,076 — — Total product revenue, net $ 396,502 $ 213,938 $ 137,997 Reserves for Variable Consideration: These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2023 and, therefore, the transaction price was not reduced further during the years ended December 31, 2023, 2022 and 2021. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts, Allowances and Wholesaler Fees: Prompt Payment Discounts: Funded Co-pay co-pay co-pay Product Returns: ® Provider Chargebacks and Discounts: ® ® ® These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue, net and accounts receivable, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by the customer or at the time of a resale to a FYCOMPA ® Government Rebates: ® The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor Rebates: Bridge and Patient Assistance Programs: ® pre-established ® ® ® ® ® ® The Company provides FYCOMPA ® pre-established ® ® The Company does not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations and comprehensive income. Revenues from Collaboration and Licensing Arrangements: The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration (Topic 808), to assess whether such arrangements, or transactions between arrangement participants, involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities or are more akin to a vendor-customer relationship. In making this evaluation, the Company considers whether the activities of the collaboration are considered to be distinct and deemed to be within the scope of the collaborative arrangement guidance or if they are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For elements of collaboration arrangements that are not accounted for pursuant to guidance in Topic 606, an appropriate recognition method is determined and applied consistently, generally by analogy to the revenue from contracts with customers guidance. The Company evaluates the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. Goods or services that meet these criteria are considered distinct performance obligations. The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. The agreements provide for milestone payments upon achievement of development and regulatory events. The Company accounts for milestone payments as variable consideration in accordance with Topic 606. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of potential transaction price and the likelihood that the transaction price will be received. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and, if so, these options are considered performance obligations. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the overall transaction price is allocated to the performance obligations based on the same methodology used at contract inception. The Company recognizes sales-based royalties or net profit-sharing when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty or net profit-sharing has been allocated has been satisfied. Payments to and from the collaborator are presented in the statement of operations based on the nature of the Company’s business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments. Refer to Note 11 (Collaborative and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements. p. RESEARCH AND DEVELOPMENT. q. ADVERTISING EXPENSE. C r. STOCK-BASED COMPENSATION. s. CONCENTRATION OF RISK. The Company sells its product, FIRDAPSE ® ® As of December 31, 2023, the Company had three FDA approved products, which makes it difficult to evaluate its current business, predict its future prospects, and forecast financial performance and growth. The Company had invested a significant portion of its efforts and financial resources in the development and commercialization of its lead product, FIRDAPSE®. The Company expects FIRDAPSE® and the recently acquired products FYCOMPA® and AGAMREE® to constitute virtually all of the Company’s product revenue for the foreseeable future. The Company relies exclusively on third parties to formulate and manufacture FIRDAPSE®, FYCOMPA®, AGAMREE® and any future drug candidates. The commercialization of FIRDAPSE®, FYCOMPA®, AGAMREE® and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and for the commercialization of FIRDAPSE®. It also relies on Eisai as its sole source of supply for FYCOMPA® and on Santhera as its sole source of supply for AGAMREE®. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of its drugs. t. ROYALTIES. Royalties incurred in connection with the Company’s license agreement for RUZURGI ® $ million are included in the purchase price of the agreement. u. INCOME TAXES. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not v. COMPREHENSIVE INCOME. available-for-sale w. NET INCOME PER COMMON SHARE. Diluted net income per common share is computed by dividing net income by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period. The following table reconciles basic and diluted weighted average common shares: For the Years Ended December 31, 2023 2022 2021 Basic weighted average common shares outstanding 106,279,736 103,374,606 103,379,349 Effect of dilutive securities 7,473,418 8,001,025 4,416,236 Diluted weighted average common shares outstanding 113,753,154 111,375,631 107,795,585 Outstanding common stock equivalents totaling approximately million, million and million, were excluded from the calculation of diluted net income per common share for the years ended December 31, 2023, 2022 and 2021, respectively, as their effect would be anti-dilutive. Potentially dilutive options to purchase common stock as of December 31, 2023, 2022 and 2021 had exercise prices ranging from $ to $ , $ to $ and $ to $ , respectively. x. SEGMENT INFORMATION. y. RECLASSIFICATIONS. z. RECENTLY ISSUED ACCOUNTING STANDARDS. accounting In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Investments
Investments | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 3. Investments. Available-for-sale investments by security type were as follows (in thousands): Estimated Gross Gross Amortized At December 31, 2023: U.S. Treasuries - Cash equivalents $ 94,523 $ 18 $ — $ 94,505 Total $ 94,523 $ 18 $ — $ 94,505 At December 31, 2022: U.S. Treasuries - Cash equivalents $ 105,442 $ 32 $ — $ 105,410 Total $ 105,442 $ 32 $ — $ 105,410 There were no realized gains or losses from available-for-sale available-for-sale The estimated fair values of available-for-sale 2023 Due in one year or less $ 94,523 For the Years Ended 2023 2022 2021 Equity securities: Net gains (losses) recognized during the period on equity securities $ 3,024 $ — $ — Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date $ 3,024 $ — $ — There were no sales of equity securities during the years ended December 31, 2023, 2022 and 2021. Unrealized net gains (losses) recognized during the periods on equity securities are included in other income, net in the consolidated statements of operations. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) | 12 Months Ended |
Dec. 31, 2023 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract] | |
Accumulated Other Comprehensive Income (Loss) | 4. Accumulated Other Comprehensive Income (loss). The following table summarizes the changes in accumulated other comprehensive income (loss), net of tax from unrealized gains (losses) on available-for-sale The amount reclassified out of accumulated other comprehensive income (loss), net of tax and into net income during the year ended December 31, 2022, was solely due to a realized loss from sale of available-for-sale 1 Total Accumulated Balance at December 31, 2021 $ (148 ) Other comprehensive gain (loss) before reclassifications (590 ) Amount reclassified from accumulated other comprehensive income (loss) 762 Net current period other comprehensive gain 172 Balance at December 31, 2022 $ 24 Other comprehensive gain (loss) before reclassifications (10 ) Net current period other comprehensive gain (10 ) Balance at December 31, 2023 $ 14 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory. Inventory consists of the following ( i n thousands): December 31, 2023 December 31, 2022 Raw materials $ 1,910 $ — Work-in-process 4,573 5,543 Finished goods 9,161 1,262 Total inventory $ 15,644 $ 6,805 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2023 | |
Text Block [Abstract] | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets. Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2023 December 31, 2022 Prepaid manufacturing costs $ 2,005 $ 1,147 Prepaid tax 1,238 44 Prepaid insurance 1,332 1,224 Prepaid subscriptions fees 1,299 808 Prepaid research fees 1,500 178 Prepaid commercialization expenses 3,038 592 Due from collaborative and licensing arrangements 138 354 Prepaid conference and travel expenses 771 234 Prepaid co-pay 863 97 Other 351 489 Total prepaid expenses and other current assets $ 12,535 $ 5,167 |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2023 | |
Operating Lease, Lease Income [Abstract] | |
Operating Leases | 7. Operating Leases. The Company has an operating lease agreement for its corporate office. The lease includes an option to extend the lease for up to 5 years and options to terminate the lease within 6 The Company entered into an agreement in May 2020 that amended its lease for its office facilities. Under the amended lease, the Company’s leased space increased from approximately 7,800 square feet of space to approximately 10,700 square feet of space. The amended lease commenced in March 2021 when construction of the asset was completed and space became available for use. The components of lease expense were as follows (in thousands): For the Years Ended 2023 2022 Operating lease cost $ 431 $ 431 Supplemental cash flow information related to lease was as follows (in thousands): For the Years Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 506 $ 492 Right-of-use Operating lease $ 89 $ 89 Supplemental balance sheet information related to lease was as follows (in thousands): December 31, 2023 December 31, 2022 Operating lease right-of-use $ 2,508 $ 2,770 Other current liabilities $ 369 $ 337 Operating lease liabilities, net of current portion 3,188 3,557 Total operating lease liabilities $ 3,557 $ 3,894 As of December 31, 2023 and December 31, 2022, the weighted average remaining lease term was 7.3 years and 8.3 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 4.51 % as of December 31, 2023 and 2022. Remaining payments of lease liabilities as of December 31, 2023 were as follows (in thousands): 2024 $ 522 2025 537 2026 553 2027 570 2028 587 Thereafter 1,440 Total lease payments 4,209 Less: imputed interest (652 ) Total $ 3,557 Rent expense was $0.4 million for the years ended December 31, 2023, 2022 and 2021. |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | 8. Property and Equipment, Net. Property and equipment, net consists of the following (in thousands): December 31, 2023 December 31, 2022 Furniture and equipment $ 494 $ 273 Leasehold improvements 991 980 Software 433 — Less: Accumulated depreciation (723 ) (406 ) Total property and equipment, net $ 1,195 $ 847 |
License and Acquired Intangible
License and Acquired Intangibles, Net | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License and Acquired Intangibles, Net | 9. License and Acquired Intangibles, Net. The following table presents the Company’s intangible assets at December 31, 2023 (in thousands): Gross Carrying Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 3,418 $ 30,151 License and acquired intangibles for FYCOMPA ® 158,143 29,673 128,470 License and acquired intangibles for AGAMREE ® 36,000 572 35,428 Total $ 227,712 $ 33,663 $ 194,049 The following table presents the Company’s intangible assets at December 31, 2022 (in thousands): Gross Carrying Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 1,098 $ 32,471 Total $ 33,569 $ 1,098 $ 32,471 The Company amortizes its definite-lived intangible assets using the straight-line method, which is considered the best estimate of economic benefit, over its estimated useful life. The estimated useful life used for this purpose for RUZURGI ® ® ® years, years and years, respectively. The Company recorded approximately $2.3 ® ® ® million in amortization expense related to the licensed and acquired intangibles for RUZURGI ® amortization expense was recorded during the year ended December 31, 2021. Amortization of the FYCOMPA ® ® ® The following table presents future amortization expense the Company expects for its intangible assets (in thousands): 2024 $ 37,378 2025 37,378 2026 37,378 2027 37,378 2028 7,705 Thereafter 36,832 Total $ 194,049 At December 31, 2023 and December 31, 2022, the weighted average amortization period remaining for intangible assets was 6.5 years and 14.0 years, respectively. If all or a portion of the intangible assets are deemed not recoverable, the Company would estimate the fair value of the assets and record an impairment loss. There were no impairment charges recognized on definite-lived intangibles for the years ended December 31, 2023, 2022 or 2021. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | 10. Accrued Expenses and Other Liabilities. Accrued expenses and other liabilities consist of the following as of December 31 (in thousands): 2023 2022 Accrued preclinical and clinical trial expenses $ 1,015 $ 479 Accrued professional fees 4,730 1,619 Accrued compensation and benefits 8,883 5,132 Accrued license fees 24,437 20,444 Accrued purchases 192 154 Operating lease liability 369 337 Accrued variable consideration 6,877 3,381 Accrued income tax 729 8,702 Due to licensor 12,540 13,127 Accrued interest payable 1,031 — Other 465 238 Current accrued expenses and other liabilities 61,268 53,613 Lease liability – non-current 3,188 3,557 Due to licensor – non-current 2,497 14,064 Other – non-current 485 — Non-current 6,170 17,621 Total accrued expenses and other liabilities $ 67,438 $ 71,234 |
Collaborative and Licensing Arr
Collaborative and Licensing Arrangements | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative and Licensing Arrangements | 11. Collaborative and Licensing Arrangements. Endo In December 2018, the Company entered into a collaboration and license agreement (Collaboration) with Endo, for the further development and commercialization of generic Sabril ® ® In October 2023, Endo informed the Company that it is discontinuing work on the Collaboration for development and commercialization of vigabatrin and that it wished to terminate the arrangement. As the Company proceeds with the termination process, the Company does not expect the end of the collaboration to have a material impact on the Company’s consolidated financial statements. KYE Pharmaceuticals Inc. In August 2020, the Company entered into a collaboration and license agreement with KYE Pharmaceuticals Inc. (KYE), for the commercialization of FIRDAPSE ® Under the agreement, Catalyst granted KYE an exclusive license to commercialize and market FIRDAPSE ® ® Under the terms of the agreement, the Company will receive an up-front ® mid-double-digit ® This agreement is in form identified as a collaborative agreement and the Company has concluded for accounting purposes that it also represents a contract with a customer. This is because the Company grants to KYE a license and provides supply of FIRDAPSE ® The collaborative agreement included a nonrefundable upfront license fee that was recognized upon transfer of the license based on a determination that the right is provided as the intellectual property exists at the point in time in which the license is granted. Revenue from sales of FIRDAPSE ® Revenues from the arrangement with KYE for the years ended December 31, 2023, 2022 and 2021 were not material. Revenue is included in product revenue, net and license and other revenue in the accompanying consolidated statements of operations and comprehensive income. Expenses incurred, net have been included in selling, general and administrative expenses in the accompanying consolidated statements of operations and comprehensive income. DyDo Pharma, Inc. On June 28, 2021, the Company entered into a license agreement with DyDo Pharma, Inc. (DyDo), for the development and commercialization of FIRDAPSE ® Under the agreement, DyDo has joint rights to develop FIRDAPSE ® Under the terms of the agreement, the Company has earned an up-front ® The Company has concluded that this license agreement will be accounted for pursuant to Topic 606. The agreement included a nonrefundable upfront license fee that was recognized upon the effective date of the agreement as the intellectual property exists at the point in time in which the right to the license is granted. The Company determined the granting of the right to the license is distinct from the supply of FIRDAPSE ® The agreement includes milestones that are considered a sales-based royalty in which the license is deemed to be the predominant item to which these milestones relate. Revenue will be recognized when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty has been allocated has been satisfied. Additionally, the agreement includes regulatory milestone payments which represent variable consideration, and due to uncertainty are fully constrained and only recognized when the uncertainty is subsequently resolved. For clinical and commercial supply of the product, the Company will recognize revenue when the Customer obtains control of the Company’s product, which will occur at a point in time which is generally at time of shipment. There was $1.9 million in revenue from the arrangement with DyDo for the year ended December 31, 2023, of which $0.5 million is included in product revenue, net in the accompanying consolidated statements of operations and comprehensive income and $1.4 million related to a regulatory filing milestone in Japan is included in licensing and other revenue in the accompanying consolidated statements of operations and comprehensive income. There was $0.5 million in revenue from the arrangement with DyDo for the year ended December 31, 2022, which is included in product revenue, net in the accompanying consolidated statements of operations and comprehensive income. Revenues from the arrangement with DyDo for the year ended December 31, 2021 were approximately $2.9 million, which primarily consisted of a $2.7 million nonrefundable upfront license fee, which is included in licensing and other revenue in the accompanying consolidated statements of operations and comprehensive income. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies. In May 2019, the FDA approved a NDA for RUZURGI ® (3,4-DAP), ® ® On July 30, 2020, the Magistrate Judge considering this lawsuit filed a Report and Recommendation in which she recommended to the District Judge handling the case that she grant the FDA’s and Jacobus’ motions for summary judgment and deny the Company’s motion for summary judgment. On September 29, 2020, the District Judge adopted the Report and Recommendation of the Magistrate Judge, granted the FDA’s and Jacobus’ motions for summary judgment, and dismissed the Company’s case. The Company appealed the District Court’s decision to the U.S. Court of Appeals for the 11 th On September 30, 2021, a three-judge panel of 11 th ® th th th th th ® 7-year ® On July 11, 2022, the Company settled certain of its disputes with Jacobus. In connection with the settlement, the Company licensed the rights to develop and commercialize RUZURGI ® ® ® ® know-how ® ® ® non-competition In connection with the settlement with Jacobus, the Company agreed to pay the following consideration to Jacobus: • $30 million of cash, of which $10 million was paid at the closing of the settlement on July 11, 2022, $10 million was paid on the first anniversary of closing , • An annual royalty on our net sales (as defined in the License and Asset Purchase Agreement between Catalyst and Jacobus) of amifampridine products in the United States equal to: (a) for calendar years 2022 through 2025, 1.5% (with a minimum annual royalty of $3.0 million per year), and (b) for calendar years 2026 through the expiration of the last to expire of the Company’s FIRDAPSE® patents in the United States, 2.5% (with a minimum annual royalty of $5 million per year); provided, however, that the royalty rate may be reduced and the minimum annual royalty may be eliminated under certain circumstances; and • If the Company were to receive a priority review voucher for FIRDAPSE® or RUZURGI® in the future, 50% of the consideration paid by a third-party to acquire that voucher will be paid to Jacobus. The Company’s New Drug Submission filin g ® ® ® ® ® ® in 2023 ® In January 2023, the Company received Paragraph IV Certification Notice Letters from three generic drug manufacturers advising that they had each submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE ® ® Further , i O cto Nov ® ® On February 20, 2023, the Company received a Paragraph IV Certification Notice Letter from a company that appears to have filed the first ANDA for the oral suspension formulation for FYCOMPA ® ® non-infringement, non-validity, ® ® ® ® Additionally, from time to time the Company may become involved in legal proceedings arising in the ordinary course of business. Except as set forth above, the Company believes that there is no other litigation pending at this time that could have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition, or cash flows. |
Agreements
Agreements | 12 Months Ended |
Dec. 31, 2023 | |
Text Block [Abstract] | |
Agreements | 13. Agreements. a. LICENSE AGREEMENT FOR FIRDAPSE ® ® ® ® On May 29, 2019, the Company and BioMarin entered into an amendment to the Company’s license agreement for FIRDAPSE ® ® ® On December 18, 2023, DyDo filed a Japan NDA with the PMDA, which was accepted for filing upon its submission. As a result, the Company’s territory automatically expanded on that date to include most of Asia, as well as Latin America. In January 2020, the Company was advised that BioMarin has transferred substantially all of its rights under the license agreement to SERB S.A., and SERB S.A. is now the Company’s licensor under the license agreement. b. LICENSE AGREEMENT FOR RUZURGI ® July 11, 2022 ® Pursuant to the terms of the license agreement, the Company paid Jacobus a million up-front payment on the Effective Date and also paid an additional million on the first annual anniversary of the Effective Date (July 11, 2023). The Company is obligated to pay an additional million on the second annual anniversary of the Effective Date (July 11, 2024). The Company is also obligated to pay tiered royalty payments on net sales (as defined in the license agreement) of all of the Company’s products in the United States that range from based on whether there is a competing product or generic version of FIRDAPSE ® A minimum royalty payment exists annually for calendar years from the Effective Date through 2025 of $3 million, provided that such minimum annual royalty payment shall be prorated in the first calendar year of the agreement. As these minimum payments are both probable and estimable, they are included in the purchase price of the agreement and any royalties in excess of this amount will be charged to cost of sales as revenue from product sales is recognized. A minimum royalty payment exists annually for calendar years from 2026 through the expiration of the royalty term (which ends when there is no valid claim under the Company’s FIRDAPSE ® ® Assets acquired as part of the license agreement include among other intellectual property rights, Jacobus’ U.S. patents related to RUZURGI ® ® ® ® know-how ® Additionally, the Company also purchased from Jacobus approximately $4.1 million of RUZURGI ® Under business combination guidance, the screen test states that if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the set is not considered a business and is accounted for as an asset acquisition. The Company has determined that the screen test was not met. However, the Company determined that the acquisition did not meet the definition of a business under ASC 805, Business Combination. The Company believes that the licensing agreement and other assets acquired from Jacobus are similar and considered them all to be intangible assets with the exception of the inventory acquired. As the screen test was not met, further determination was required to determine that the Company had not acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business, and therefore, determined that this was an asset acquisition. The Company accounted for the Jacobus license agreement as an asset acquisition under ASC 805-50, The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands): License and acquired intangibles $ 33,569 Acquired research and development inventory expensed from asset acquisition 4,130 Total purchase price $ 37,699 The straight-line method is used to amortize the license and acquired intangibles, as disclosed in Note 9 (License and Acquired Intangibles, Net). c. ACQUISITION OF U.S. RIGHTS FOR FYCOMPA ® . ® million in cash, including the reimbursement of certain liabilities and the payment of transaction costs. Eisai was eligible to receive a contingent payment of $25 million if a certain regulatory milestone was met. As meeting the regulatory milestone was not probable, the Company did not recognize any amount related to the milestone payments in the purchase price. Additionally, after the loss of patent exclusivity for FYCOMPA ® ® Royalties commencing on loss of exclusivity for each calendar year during the royalty term equal to 12% on net sales greater than $10 million and less than $100 million, 17% on net sales of greater than $100 million and less than $125 million and 22% on net sales greater than $125 million prior to the date of generic entry. Royalties equal to 6% on net sales greater than $10 million and less than $100 million, 8.5% on net sales of greater than $100 million and less than $125 million and 11% on net sales greater than $125 million after the date of generic entry. The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of FYCOMPA ® Base cash payment $ 160,000 Cash paid for pro-rated 1,576 Reimbursement on base purchase price (i) (3,238 ) Transaction costs (ii) 5,870 Total purchase consideration $ 164,208 (i) Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023. (ii) As of December 31, 2023 , The acquisition of FYCOMPA ® 805-50. The ® ® ® at-market 805-10-55-5A The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands): Inventory $ 4,100 Prepaid expenses and other current assets (samples) 130 Prepaid commercialization expenses 1,576 Property and equipment, net 433 License and acquired intangibles for FYCOMPA ® 158,143 Accrued preclinical and clinical trial expenses (174 ) Total purchase consideration $ 164,208 The straight-line method is used to amortize the license and acquired intangibles, as disclosed in Note 9 (License and Acquired Intangibles, Net). d. LICENSE AGREEMENT FOR AGAMREE ® In July 2023, the Company completed its acquisition from Santhera of an exclusive license for North America for AGAMREE ® ® all-cash $ million at the closing of the acquisition to acquire the license. Simultaneously, the Company made a strategic equity investment into Santhera by acquiring 1,414,688 of Santhera’s post reverse-split ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares following the transaction), which are traded on the SIX Swiss Exchange, at an investment price of CHF 9.477 per share (corresponding to a mutually agreed volume-weighted average price prior to signing), with the funds invested into Santhera to be used by Santhera for Phase IV studies in DMD and further development of additional indications for AGAMREE ® The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of AGAMREE ® Initial cash payment $ 75,000 Investment in Santhera 13,465 Transaction costs 6,513 Total purchase consideration $ 94,978 The transaction has been accounted for as an asset acquisition in accordance with ASC 805-50. ® ® 805-10-55-5A non-financial The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands): License and acquired intangibles for AGAMREE ® $ 81,513 Investment in Santhera (i) 13,465 Total purchase consideration $ 94,978 (i) The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023. In accordance with FASB ASC 730-10-25, ® Following the approval of the NDA for AGAMREE ® The strategic equity investment in Santhera is accounted for as an investment in equity securities, and is recognized as a non-current e. AGREEMENTS FOR DRUG MANUFACTURING, DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes. The Company is subject to income taxes in the U.S. federal jurisdiction and various states jurisdictions. The income tax expense for the years ended December 31, 2023, 2022, and 2021 consists of (in thousands): 2023 2022 2021 Current - Federal $ 34,975 $ 12,858 $ 2,455 Current - State 5,931 3,877 1,414 Deferred - Federal (16,093 ) 4,739 8,620 Deferred - State (1,712 ) 166 696 $ 23,101 $ 21,640 $ 13,185 The reconciliation of income tax expense computed at the statutory federal income tax rate of 21% to amounts included in the statements of operations is as follows: 2023 2022 2021 Statutory rate 21.0 % 21.0 % 21.0 % State tax 3.1 % 3.1 % 3.4 % Executive compensation limitation 2.6 % 3.6 % 1.1 % Tax credit — (1.9 )% (0.6 )% Stock compensation windfall (4.4 )% (5.6 )% (0.6 )% Other 2.1 % 0.5 % 0.7 % 24.4 % 20.7 % 25.0 % Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryovers and the temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets/(liabilities) as of December 31, 2023 and 2022 are as follows (in thousands): 2023 2022 Deferred tax assets: Start-up $ — $ 9,771 Deferred compensation 6,473 4,706 Inventory 448 296 Intangible assets 24,847 52 Accrued expenses 788 — Operating lease liability 854 953 Capitalized research 4,927 4,255 Total deferred tax assets 38,337 20,033 Deferred tax liabilities: Prepaid expenses (1,023 ) (481 ) Right-of (759 ) (860 ) Other (11 ) 44 Total deferred tax liabilities (1,793 ) (1,297 ) Deferred tax assets, net $ 36,544 $ 18,736 The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As of December 31, 2023, the Company determined that there is sufficient positive evidence to conclude that it is more likely than not that the above deferred taxes of approximately $37 million are realizable. The An immaterial amount of interest and penalties were accrued through December 31, 2023 a nd |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 15. Stockholders’ Equity. Preferred Stock The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share, at December 31, 2023 and 2022. No shares of preferred stock were outstanding at December 31, 2023 and 2022. Common Stock The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At December 31, 2023 and 2022, 107,121,549 and 105,263,031 shares, respectively, of common stock were issued and outstanding. Each holder of common stock is entitled to one vote of each share of common stock held of record on all matters on which stockholders generally are entitled to vote. See Note 18 (Subsequent Events). Share Repurchases In March 2021, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $40 million of the Company’s common stock, pursuant to a repurchase plan under Rule 10b-18 2020 Shelf Registration Statement On July 23, 2020, the Company filed a shelf registration statement with the SEC to sell up to $200 million of common stock, preferred stock, warrants to purchase common stock, debt securities and units consisting of one or more of such securities (the “2020 Shelf Registration Statement”). The 2020 Shelf Registration Statement (file no. 333-240052) was declared effective by the SEC on July 31, 2020. The Company’s 2020 Shelf Registration Statement expired on July 31, 2023. 2023 Shelf Registration Statement On September 8, 2023, the Company filed a shelf registration statement with the SEC to sell up to $500 million of common stock, preferred stock, warrants to purchase common stock, debt securities and units consisting of one or more of such securities (the “2023 Shelf Registration Statement”). The 2023 Shelf Registration Statement (file no. 333-274427) |
Stock Compensation
Stock Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock Compensation | 16. Stock Compensation. For the years ended December 31, 2023, 2022 and 2021, the Company recorded stock-based compensation expense as follows (in thousands): 2023 2022 2021 Research and development $ 1,481 $ 1,729 $ 1,611 Selling, general and administrative 12,769 6,178 4,462 Total stock-based compensation $ 14,250 $ 7,907 $ 6,073 The Company may issue stock options, restricted stock, stock appreciation rights and restricted stock units (collectively, the “Awards”) to employees, directors, and consultants of the Company under the 2014 and 2018 Stock Incentive Plans (the 2014 Plan and the 2018 Plan or collectively, the Plans). At December 31, 2023, no shares remain available for future issuance under the 2014 Plan. Under the 2018 Plan, 18,000,000 shares are reserved for issuance and as of December 31, 2023, 1,801,949 shares remain available for future issuance. Stock Options The Company has granted stock options to employees, officers, directors, and consultants generally at exercise prices equal to the market price of the common stock at grant date. Option awards generally vest over a period of 1 to 3 years of continuous service and have contractual terms of 7 years. Certain awards provide for accelerated vesting if there is a change in control. The Company issues new shares as shares are required to be delivered upon exercise of outstanding stock options. During the years ended December 31, 2023, 2022 and 202 1 During the years ended December 31, 2023, 2022 and 2021 the Company recorded non-cash During the years ended December 31, 2023, 2022 and 2021, the Company granted seven-year options to purchase an aggregate of 3,598,535, 1,386,500 and 2,330,000 shares, respectively, of the Company’s common stock to certain of the Company’s officers, employees, directors, and consultants. Stock option activity under the Company’s Plans for the year ended December 31, 2023 is summarized as follows: Number of Weighted Weighted Aggregate Outstanding at beginning of year 12,309,108 $ 4.93 Granted 3,598,535 14.62 Exercised or released (1,651,345 ) 1.69 Forfeited or cancelled (78,810 ) 11.83 Expired — — Outstanding at end of year 14,177,488 $ 7.73 4.05 $ 130,966 Exercisable at end of year 8,891,904 $ 4.45 2.78 $ 110,488 Other information pertaining to stock option activity during the years ended December 31, 2023, 2022 and 2021 was as follows: 2023 2022 2021 Weighted–average fair value of granted stock options $ 8.66 $ 8.52 $ 3.24 Total fair value of vested stock options (in thousands) $ 8,278 $ 6,096 $ 6,421 Total intrinsic value of exercised stock options (in thousands) $ 22,265 $ 31,881 $ 3,623 As of December 31, 2023, there was approximately $36.3 million of unrecognized compensation expense related to non-vested The Company utilizes the Black-Scholes option-pricing model to determine the fair value of stock options on the date of grant. This model derives the fair value of stock options based on certain assumptions related to the expected stock price volatility, expected option life, risk-free interest rate and dividend yield. Expected volatility is based on reviews of historical volatility of the Company’s common stock. The Company estimates the expected option life for options granted to employees and directors based upon the simplified method. Under this method, the expected life is presumed to be the mid-point Assumptions used during the years were as follows: 2023 2022 2021 Risk free interest rate 3.55% to 4.92% 1.27% to 4.07% 0.34% to 1.18% Expected term 4.5 to 5.2 years 4.5 years 4.5 to 4.8 years Expected volatility 68.0% to 71.0% 68.4% to 69.5% 68.6% to 72.8% Expected dividend yield — % — % — % Expected forfeiture rate — % — % — % Restricted Stock Units Under the 2018 Plan, participants may be granted restricted stock units, each of which represents a conditional right to receive shares of common stock in the future. The restricted stock units granted under this plan generally vest ratably over a three-year period. Upon vesting, the restricted stock units will convert into an equivalent number of shares of common stock. The amount of expense relating to the restricted stock units is based on the closing market price of the Company’s common stock on the date of grant and is amortized on a straight-line basis over the requisite service period. Restricted stock unit activity for the year ended December 31, 2023 was as follows: Number of Weighted Average Nonvested balance at beginning of year 752,500 $ 11.46 Granted 370,117 13.67 Vested (268,158 ) 11.25 Forfeited — — Nonvested balance at end of year 854,459 $ 12.48 During the year ended December 31, 2023, 2022 and 2021, the Company recorded non-cash |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Benefit Plan | 17. Benefit Plan. The Company maintains an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code covering all eligible employees. Subject to certain dollar limits, eligible employees may contribute up to 15% of their pre-tax |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events. On January 9, 2024, the Company completed a public offering of 10 million shares of its authorized but unissued common stock, raising net proceeds of approximately |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
PRINCIPLES OF CONSOLIDATION | a. PRINCIPLES OF CONSOLIDATION. |
USE OF ESTIMATES | b. USE OF ESTIMATES. |
CASH AND CASH EQUIVALENTS | c. CASH AND CASH EQUIVALENTS. |
INVESTMENTS | d. INVESTMENTS. The Company invests in high credit-quality instruments in order to obtain higher yields on its cash available for investments. At December 31, 2023, investments consisted of U.S. Treasuries and an investment in equity securities. At December 31, 2022, investments consisted of U.S. Treasuries. Such investments are not insured by the Federal Deposit Insurance Corporation. The U.S. Treasuries held at December 31, 2023 and December 31, 2022 are classified as available-for-sale non-current There are no short-term investments as of December 31, 2023 and December 31, 2022. The Company records available-for-sale available-for-sale available-for-sale available-for-sale In July 2023, the Company made a strategic equity investment into Santhera by acquiring 1,414,688 of Santhera’s post reverse-split ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares following the transaction) . |
ACCOUNTS RECEIVABLE, NET | e. ACCOUNTS RECEIVABLE, NET. |
INVENTORY | f. INVENTORY work-in-process first-in, Products that have been approved by the FDA or other regulatory authorities, such as FIRDAPSE ® ® ® ® ® ® The Company evaluates for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage. |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | g. PREPAID EXPENSES AND OTHER CURRENT ASSETS. co-pay pre-clinical |
PROPERTY AND EQUIPMENT, NET | h. PROPERTY AND EQUIPMENT, NET. three five five |
BUSINESS COMBINATIONS AND ASSET ACQUISITIONS | i BUSINESS COMBINATIONS AND ASSET ACQUISITIONS 805-50, See Notes 12 (Commitments and Contingencies) and 13 (Agreements) for further discussion on the Company’s exclusive license agreement with Jacobus Pharmaceutical Company, Inc . ® ASC 805-50. ® ® 805-50. |
INTANGIBLE ASSETS, NET | j. INTANGIBLE ASSETS, NET. The Company reviews intangible assets with finite lives for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist, an impairment test is performed to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are deemed not recoverable, the Company would estimate the fair value of the assets and record an impairment loss. |
FAIR VALUE OF FINANCIAL INSTRUMENTS | k. FAIR VALUE OF FINANCIAL INSTRUMENTS. |
FAIR VALUE MEASUREMENTS | l. FAIR VALUE MEASUREMENTS. Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Fair Value Measurements at Reporting Date Using (in thousands) Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 18,256 $ 18,256 $ — $ — U.S. Treasuries $ 94,523 $ 94,523 $ — $ — Investment in equity securities: Equity securities $ 16,489 $ 16,489 $ — $ — Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 168,853 $ 168,853 $ — $ — U.S. Treasuries $ 105,442 $ 105,442 $ — $ — |
OPERATING LEASES | m. OPERATING LEASES. right-of-use non-lease |
SHARE REPURCHASES | n. SHARE REPURCHASES. The Company accounts for share repurchases by charging the excess of the repurchase price over the repurchased common stock’s par value entirely to retained earnings. All repurchased shares are retired and become authorized but unissued shares. The Company accrues for the shares purchased under the share repurchase plan based on the trade date. The Company may terminate or modify its share repurchase program at any time. |
REVENUE RECOGNITION | o. REVENUE RECOGNITION. Product Revenues: To determine revenue recognition for arrangements that are within the scope of Accounting Standards Codification (ASC) Topic 606 – Revenue from Contracts with Customers (Topic 606), the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company assesses the goods or services promised within each contract and determines those that are performance obligations by assessing whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net below. The Company also may generate revenues from payments received under collaborative and license agreements. Collaborative and license agreement payments may include nonrefundable fees at the inception of the agreements, contingent payments for specific achievements designated in the agreements, and/or net profit-sharing payments on sales of products resulting from the collaborative and license arrangements. For a complete discussion of accounting for collaborative and licensing arrangements, see Revenues from Collaboration and Licensing Arrangements below. The Company recognizes revenue when its customer for FIRDAPSE ® ® ® ® ® ® ® Product Revenue, Net: Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales. If taxes should be collected from the Customer relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the years ended December 31, 2023, 2022 and 2021. During the years ended December 31, 2023, 2022 and 2021, substantially all of the Company’s product revenues were from sales to customers in the United States. The following table summarizes the Company’s net product revenue disaggregated by product (in thousands): For the Years Ended December 31, 2023 2022 2021 FIRDAPSE ® $ 258,426 $ 213,938 $ 137,997 FYCOMPA ® 138,076 — — Total product revenue, net $ 396,502 $ 213,938 $ 137,997 Reserves for Variable Consideration: These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2023 and, therefore, the transaction price was not reduced further during the years ended December 31, 2023, 2022 and 2021. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Trade Discounts, Allowances and Wholesaler Fees: Prompt Payment Discounts: Funded Co-pay co-pay co-pay Product Returns: ® Provider Chargebacks and Discounts: ® ® ® These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue, net and accounts receivable, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by the customer or at the time of a resale to a FYCOMPA ® Government Rebates: ® The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor Rebates: Bridge and Patient Assistance Programs: ® pre-established ® ® ® ® ® ® The Company provides FYCOMPA ® pre-established ® ® The Company does not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations and comprehensive income. Revenues from Collaboration and Licensing Arrangements: The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration (Topic 808), to assess whether such arrangements, or transactions between arrangement participants, involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities or are more akin to a vendor-customer relationship. In making this evaluation, the Company considers whether the activities of the collaboration are considered to be distinct and deemed to be within the scope of the collaborative arrangement guidance or if they are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For elements of collaboration arrangements that are not accounted for pursuant to guidance in Topic 606, an appropriate recognition method is determined and applied consistently, generally by analogy to the revenue from contracts with customers guidance. The Company evaluates the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. Goods or services that meet these criteria are considered distinct performance obligations. The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration. The agreements provide for milestone payments upon achievement of development and regulatory events. The Company accounts for milestone payments as variable consideration in accordance with Topic 606. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of potential transaction price and the likelihood that the transaction price will be received. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and, if so, these options are considered performance obligations. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the overall transaction price is allocated to the performance obligations based on the same methodology used at contract inception. The Company recognizes sales-based royalties or net profit-sharing when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty or net profit-sharing has been allocated has been satisfied. Payments to and from the collaborator are presented in the statement of operations based on the nature of the Company’s business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments. Refer to Note 11 (Collaborative and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements. |
RESEARCH AND DEVELOPMENT | p. RESEARCH AND DEVELOPMENT. |
ADVERTISING EXPENSE | q. ADVERTISING EXPENSE. C |
STOCK-BASED COMPENSATION | r. STOCK-BASED COMPENSATION. |
CONCENTRATION OF RISK | s. CONCENTRATION OF RISK. The Company sells its product, FIRDAPSE ® ® As of December 31, 2023, the Company had three FDA approved products, which makes it difficult to evaluate its current business, predict its future prospects, and forecast financial performance and growth. The Company had invested a significant portion of its efforts and financial resources in the development and commercialization of its lead product, FIRDAPSE®. The Company expects FIRDAPSE® and the recently acquired products FYCOMPA® and AGAMREE® to constitute virtually all of the Company’s product revenue for the foreseeable future. The Company relies exclusively on third parties to formulate and manufacture FIRDAPSE®, FYCOMPA®, AGAMREE® and any future drug candidates. The commercialization of FIRDAPSE®, FYCOMPA®, AGAMREE® and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and for the commercialization of FIRDAPSE®. It also relies on Eisai as its sole source of supply for FYCOMPA® and on Santhera as its sole source of supply for AGAMREE®. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of its drugs. |
ROYALTIES | t. ROYALTIES. Royalties incurred in connection with the Company’s license agreement for RUZURGI ® $ million are included in the purchase price of the agreement. |
INCOME TAXES | u. INCOME TAXES. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not |
COMPREHENSIVE INCOME | v. COMPREHENSIVE INCOME. available-for-sale |
NET INCOME PER COMMON SHARE | w. NET INCOME PER COMMON SHARE. Diluted net income per common share is computed by dividing net income by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period. The following table reconciles basic and diluted weighted average common shares: For the Years Ended December 31, 2023 2022 2021 Basic weighted average common shares outstanding 106,279,736 103,374,606 103,379,349 Effect of dilutive securities 7,473,418 8,001,025 4,416,236 Diluted weighted average common shares outstanding 113,753,154 111,375,631 107,795,585 Outstanding common stock equivalents totaling approximately million, million and million, were excluded from the calculation of diluted net income per common share for the years ended December 31, 2023, 2022 and 2021, respectively, as their effect would be anti-dilutive. Potentially dilutive options to purchase common stock as of December 31, 2023, 2022 and 2021 had exercise prices ranging from $ to $ , $ to $ and $ to $ , respectively. |
SEGMENT INFORMATION | x. SEGMENT INFORMATION. |
RECLASSIFICATIONS | y. RECLASSIFICATIONS. |
RECENTLY ISSUED ACCOUNTING STANDARDS | z. RECENTLY ISSUED ACCOUNTING STANDARDS. accounting In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Fair Value Measurement Specific to Assets or Liability | Fair Value Measurements at Reporting Date Using (in thousands) Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 18,256 $ 18,256 $ — $ — U.S. Treasuries $ 94,523 $ 94,523 $ — $ — Investment in equity securities: Equity securities $ 16,489 $ 16,489 $ — $ — Balances as of Quoted Prices in Significant Other Significant Cash and cash equivalents: Money market funds $ 168,853 $ 168,853 $ — $ — U.S. Treasuries $ 105,442 $ 105,442 $ — $ — |
Basic and Dilutive Weighted Average Common Shares | The following table reconciles basic and diluted weighted average common shares: For the Years Ended December 31, 2023 2022 2021 Basic weighted average common shares outstanding 106,279,736 103,374,606 103,379,349 Effect of dilutive securities 7,473,418 8,001,025 4,416,236 Diluted weighted average common shares outstanding 113,753,154 111,375,631 107,795,585 |
Summary of Disaggregated Product Revenue | The following table summarizes the Company’s net product revenue disaggregated by product (in thousands): For the Years Ended December 31, 2023 2022 2021 FIRDAPSE ® $ 258,426 $ 213,938 $ 137,997 FYCOMPA ® 138,076 — — Total product revenue, net $ 396,502 $ 213,938 $ 137,997 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Investments by Security type | Available-for-sale investments by security type were as follows (in thousands): Estimated Gross Gross Amortized At December 31, 2023: U.S. Treasuries - Cash equivalents $ 94,523 $ 18 $ — $ 94,505 Total $ 94,523 $ 18 $ — $ 94,505 At December 31, 2022: U.S. Treasuries - Cash equivalents $ 105,442 $ 32 $ — $ 105,410 Total $ 105,442 $ 32 $ — $ 105,410 |
Estimated Fair Values of Available for Sale Securities | The estimated fair values of available-for-sale 2023 Due in one year or less $ 94,523 |
Summary Of Net Gains And Losses On Equity Securities | For the Years Ended 2023 2022 2021 Equity securities: Net gains (losses) recognized during the period on equity securities $ 3,024 $ — $ — Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date $ 3,024 $ — $ — |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract] | |
Summary of Reclassifications out of Accumulated Other Comprehensive Income | The following table summarizes the changes in accumulated other comprehensive income (loss), net of tax from unrealized gains (losses) on available-for-sale The amount reclassified out of accumulated other comprehensive income (loss), net of tax and into net income during the year ended December 31, 2022, was solely due to a realized loss from sale of available-for-sale 1 Total Accumulated Balance at December 31, 2021 $ (148 ) Other comprehensive gain (loss) before reclassifications (590 ) Amount reclassified from accumulated other comprehensive income (loss) 762 Net current period other comprehensive gain 172 Balance at December 31, 2022 $ 24 Other comprehensive gain (loss) before reclassifications (10 ) Net current period other comprehensive gain (10 ) Balance at December 31, 2023 $ 14 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of current inventory | Inventory consists of the following ( i n thousands): December 31, 2023 December 31, 2022 Raw materials $ 1,910 $ — Work-in-process 4,573 5,543 Finished goods 9,161 1,262 Total inventory $ 15,644 $ 6,805 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Text Block [Abstract] | |
Prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following (in thousands): December 31, 2023 December 31, 2022 Prepaid manufacturing costs $ 2,005 $ 1,147 Prepaid tax 1,238 44 Prepaid insurance 1,332 1,224 Prepaid subscriptions fees 1,299 808 Prepaid research fees 1,500 178 Prepaid commercialization expenses 3,038 592 Due from collaborative and licensing arrangements 138 354 Prepaid conference and travel expenses 771 234 Prepaid co-pay 863 97 Other 351 489 Total prepaid expenses and other current assets $ 12,535 $ 5,167 |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Disclosure of Operating Leases [Abstract] | |
Lease, Cost | The components of lease expense were as follows (in thousands): For the Years Ended 2023 2022 Operating lease cost $ 431 $ 431 |
Schedule of Supplemental Cash Flow Information Related To Lease | Supplemental cash flow information related to lease was as follows (in thousands): For the Years Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 506 $ 492 Right-of-use Operating lease $ 89 $ 89 |
Schedule of Supplemental Balance Sheet related To Lease | Supplemental balance sheet information related to lease was as follows (in thousands): December 31, 2023 December 31, 2022 Operating lease right-of-use $ 2,508 $ 2,770 Other current liabilities $ 369 $ 337 Operating lease liabilities, net of current portion 3,188 3,557 Total operating lease liabilities $ 3,557 $ 3,894 |
Lessee, Operating Lease, Liability, Maturity | Remaining payments of lease liabilities as of December 31, 2023 were as follows (in thousands): 2024 $ 522 2025 537 2026 553 2027 570 2028 587 Thereafter 1,440 Total lease payments 4,209 Less: imputed interest (652 ) Total $ 3,557 Rent expense was $0.4 million for the years ended December 31, 2023, 2022 and 2021. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and equipment, net consists of the following (in thousands): December 31, 2023 December 31, 2022 Furniture and equipment $ 494 $ 273 Leasehold improvements 991 980 Software 433 — Less: Accumulated depreciation (723 ) (406 ) Total property and equipment, net $ 1,195 $ 847 |
License and Acquired Intangib_2
License and Acquired Intangibles, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Finite-Lived Intangible Assets, Net [Abstract] | |
Schedule of Finite-Lived Intangible Assets | The following table presents the Company’s intangible assets at December 31, 2023 (in thousands): Gross Carrying Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 3,418 $ 30,151 License and acquired intangibles for FYCOMPA ® 158,143 29,673 128,470 License and acquired intangibles for AGAMREE ® 36,000 572 35,428 Total $ 227,712 $ 33,663 $ 194,049 The following table presents the Company’s intangible assets at December 31, 2022 (in thousands): Gross Carrying Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 1,098 $ 32,471 Total $ 33,569 $ 1,098 $ 32,471 |
Schedule of Finite-Lived, Future Amortization Expense | The following table presents future amortization expense the Company expects for its intangible assets (in thousands): 2024 $ 37,378 2025 37,378 2026 37,378 2027 37,378 2028 7,705 Thereafter 36,832 Total $ 194,049 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following as of December 31 (in thousands): 2023 2022 Accrued preclinical and clinical trial expenses $ 1,015 $ 479 Accrued professional fees 4,730 1,619 Accrued compensation and benefits 8,883 5,132 Accrued license fees 24,437 20,444 Accrued purchases 192 154 Operating lease liability 369 337 Accrued variable consideration 6,877 3,381 Accrued income tax 729 8,702 Due to licensor 12,540 13,127 Accrued interest payable 1,031 — Other 465 238 Current accrued expenses and other liabilities 61,268 53,613 Lease liability – non-current 3,188 3,557 Due to licensor – non-current 2,497 14,064 Other – non-current 485 — Non-current 6,170 17,621 Total accrued expenses and other liabilities $ 67,438 $ 71,234 |
Agreements (Tables)
Agreements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Asset Acquisition [Line Items] | |
Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values | License and acquired intangibles $ 33,569 Acquired research and development inventory expensed from asset acquisition 4,130 Total purchase price $ 37,699 |
Summary of Aggregate Amount Paid for the Assets Acquired | The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of FYCOMPA ® Base cash payment $ 160,000 Cash paid for pro-rated 1,576 Reimbursement on base purchase price (i) (3,238 ) Transaction costs (ii) 5,870 Total purchase consideration $ 164,208 (i) Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023. (ii) As of December 31, 2023 , |
Summary of Total Purchase Price Allocated to Acquired Assets | The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands): Inventory $ 4,100 Prepaid expenses and other current assets (samples) 130 Prepaid commercialization expenses 1,576 Property and equipment, net 433 License and acquired intangibles for FYCOMPA ® 158,143 Accrued preclinical and clinical trial expenses (174 ) Total purchase consideration $ 164,208 |
Vamorolone [Member] | |
Asset Acquisition [Line Items] | |
Summary of Aggregate Amount Paid for the Assets Acquired | The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of AGAMREE ® Initial cash payment $ 75,000 Investment in Santhera 13,465 Transaction costs 6,513 Total purchase consideration $ 94,978 |
Summary of Total Purchase Price Allocated to Acquired Assets | The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands): License and acquired intangibles for AGAMREE ® $ 81,513 Investment in Santhera (i) 13,465 Total purchase consideration $ 94,978 (i) The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of income tax expense | The income tax expense for the years ended December 31, 2023, 2022, and 2021 consists of (in thousands): 2023 2022 2021 Current - Federal $ 34,975 $ 12,858 $ 2,455 Current - State 5,931 3,877 1,414 Deferred - Federal (16,093 ) 4,739 8,620 Deferred - State (1,712 ) 166 696 $ 23,101 $ 21,640 $ 13,185 |
Reconciliation of income tax expense computed at statutory federal income tax rate | The reconciliation of income tax expense computed at the statutory federal income tax rate of 21% to amounts included in the statements of operations is as follows: 2023 2022 2021 Statutory rate 21.0 % 21.0 % 21.0 % State tax 3.1 % 3.1 % 3.4 % Executive compensation limitation 2.6 % 3.6 % 1.1 % Tax credit — (1.9 )% (0.6 )% Stock compensation windfall (4.4 )% (5.6 )% (0.6 )% Other 2.1 % 0.5 % 0.7 % 24.4 % 20.7 % 25.0 % |
Components of deferred tax assets | 2023 2022 Deferred tax assets: Start-up $ — $ 9,771 Deferred compensation 6,473 4,706 Inventory 448 296 Intangible assets 24,847 52 Accrued expenses 788 — Operating lease liability 854 953 Capitalized research 4,927 4,255 Total deferred tax assets 38,337 20,033 Deferred tax liabilities: Prepaid expenses (1,023 ) (481 ) Right-of (759 ) (860 ) Other (11 ) 44 Total deferred tax liabilities (1,793 ) (1,297 ) Deferred tax assets, net $ 36,544 $ 18,736 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | For the years ended December 31, 2023, 2022 and 2021, the Company recorded stock-based compensation expense as follows (in thousands): 2023 2022 2021 Research and development $ 1,481 $ 1,729 $ 1,611 Selling, general and administrative 12,769 6,178 4,462 Total stock-based compensation $ 14,250 $ 7,907 $ 6,073 |
Stock option activity under the Company's Plans | Stock option activity under the Company’s Plans for the year ended December 31, 2023 is summarized as follows: Number of Weighted Weighted Aggregate Outstanding at beginning of year 12,309,108 $ 4.93 Granted 3,598,535 14.62 Exercised or released (1,651,345 ) 1.69 Forfeited or cancelled (78,810 ) 11.83 Expired — — Outstanding at end of year 14,177,488 $ 7.73 4.05 $ 130,966 Exercisable at end of year 8,891,904 $ 4.45 2.78 $ 110,488 |
Schedule of Other Information Pertaining to Stock Option Activity | Other information pertaining to stock option activity during the years ended December 31, 2023, 2022 and 2021 was as follows: 2023 2022 2021 Weighted–average fair value of granted stock options $ 8.66 $ 8.52 $ 3.24 Total fair value of vested stock options (in thousands) $ 8,278 $ 6,096 $ 6,421 Total intrinsic value of exercised stock options (in thousands) $ 22,265 $ 31,881 $ 3,623 |
Summary of Stock Options Awards Based on Certain Assumptions | Assumptions used during the years were as follows: 2023 2022 2021 Risk free interest rate 3.55% to 4.92% 1.27% to 4.07% 0.34% to 1.18% Expected term 4.5 to 5.2 years 4.5 years 4.5 to 4.8 years Expected volatility 68.0% to 71.0% 68.4% to 69.5% 68.6% to 72.8% Expected dividend yield — % — % — % Expected forfeiture rate — % — % — % |
Summary of Restricted Stock Unit Activity | Restricted stock unit activity for the year ended December 31, 2023 was as follows: Number of Weighted Average Nonvested balance at beginning of year 752,500 $ 11.46 Granted 370,117 13.67 Vested (268,158 ) 11.25 Forfeited — — Nonvested balance at end of year 854,459 $ 12.48 |
Organization and Description _2
Organization and Description of Business - Additional Information (Detail) - 2023 Shelf Registration Statement - Subsequent Event [Member] $ in Millions | Jan. 09, 2024 USD ($) shares |
Stock issued during the period shares new issues | shares | 10,000,000 |
Proceeds from issuance of common stock | $ | $ 140.1 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Jul. 11, 2025 USD ($) | Jul. 11, 2024 USD ($) | Jul. 11, 2023 USD ($) | Jul. 31, 2023 shares | Dec. 31, 2023 USD ($) Segment $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Mar. 31, 2021 USD ($) | |
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Maximum maturity period of cash and cash equivalent | three months | |||||||
Maximum amortization period of compensation cost on straight line basis | 3 years | |||||||
Stock option exercise price range, Minimum | $ / shares | $ 0.79 | $ 0.79 | $ 0.79 | |||||
Stock option exercise price range, Maximum | $ / shares | $ 7.1 | $ 7.07 | $ 4.64 | |||||
Potential equivalent common stock excluded | shares | 4,500,000 | 1,000,000 | 4,300,000 | |||||
Number of operating segments | Segment | 1 | |||||||
Short-term investments | $ 0 | $ 0 | ||||||
Asset acquisition equity interests issued or issuable number of shares issued | shares | 1,414,688 | |||||||
Asset acquisition percentage of outstanding ordinary shares | 11.26% | |||||||
Share Purchase Program [Member] | Common Stock [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Share repurchase program, authorised | $ 40,000 | |||||||
License Agreement For RUZURGI [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Minimum royalty | $ 3,000 | $ 3,000 | $ 3,000 | |||||
Selling, General and Administrative Expenses [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Advertising expense | $ 9,100 | $ 3,300 | $ 2,900 | |||||
Minimum [Member] | Furniture and Equipment [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 5 years | |||||||
Minimum [Member] | Computer Equipment [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 3 years | |||||||
Minimum [Member] | Leasehold Improvements [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 5 years | |||||||
Maximum [Member] | Furniture and Equipment [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 7 years | |||||||
Maximum [Member] | Computer Equipment [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 5 years | |||||||
Maximum [Member] | Leasehold Improvements [Member] | ||||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||||
Useful life of assets | 10 years |
Basis of Presentation and Sig_5
Basis of Presentation and Significant Accounting Policies - Fair Value Measurement Specific to Assets or Liability (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | $ 16,489 | $ 0 |
U.S. Treasuries [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 94,523 | 105,442 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 18,256 | 168,853 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity securities | 16,489 | |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | U.S. Treasuries [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 94,523 | 105,442 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 18,256 | $ 168,853 |
Basis of Presentation and Sig_6
Basis of Presentation and Significant Accounting Policies - Summary of Disaggregated Product Revenue (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation of Revenue [Line Items] | |||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 398,204 | $ 214,203 | $ 140,833 |
FIRDAPSE [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Revenue from Contract with Customer, Excluding Assessed Tax | 258,426 | 213,938 | 137,997 |
FYCOMPA [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Revenue from Contract with Customer, Excluding Assessed Tax | 138,076 | 0 | 0 |
Product revenue, net [Member] | |||
Disaggregation of Revenue [Line Items] | |||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 396,502 | $ 213,938 | $ 137,997 |
Basis of Presentation and Sig_7
Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | |||
Basic weighted average common shares outstanding | 106,279,736 | 103,374,606 | 103,379,349 |
Effect of dilutive securities | 7,473,418 | 8,001,025 | 4,416,236 |
Diluted weighted average common shares outstanding | 113,753,154 | 111,375,631 | 107,795,585 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |||
Realized gains losses from available for sale securities | $ 0 | $ 0 | |
Realized losses from sale of available-for-sale securities | $ 762 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net Investment Income [Line Items] | ||
Estimated Fair Value | $ 94,523 | $ 105,442 |
Gross Unrealized Gains | 18 | 32 |
Gross Unrealized Losses | 0 | 0 |
Amortized cost | 94,505 | 105,410 |
U.S. Treasuries - Cash equivalents [Member] | ||
Net Investment Income [Line Items] | ||
Estimated Fair Value | 94,523 | 105,442 |
Gross Unrealized Gains | 18 | 32 |
Gross Unrealized Losses | 0 | 0 |
Amortized cost | $ 94,505 | $ 105,410 |
Investments - Estimated Fair Va
Investments - Estimated Fair Values of Available for Sale Securities (Detail) $ in Thousands | Dec. 31, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due in one year or less | $ 94,523 |
Investments - Summary Of Net Ga
Investments - Summary Of Net Gains And Losses On Equity Securities (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |||
Net gains (losses) recognized during the period on equity securities | $ 3,024 | $ 0 | $ 0 |
Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date | $ 3,024 | $ 0 | $ 0 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Loss) - Summary of Reclassifications out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Beginning balance | $ 24 | $ (148) | |
Other comprehensive gain (loss) before reclassifications | (10) | (590) | |
Amount reclassified from accumulated other comprehensive income (loss) | 762 | ||
Net current period other comprehensive gain | (10) | 172 | $ (179) |
Ending balance | $ 14 | $ 24 | $ (148) |
Inventory - Summary of current
Inventory - Summary of current inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,910 | $ 0 |
Work-in-process | 4,573 | 5,543 |
Finished goods | 9,161 | 1,262 |
Total inventory | $ 15,644 | $ 6,805 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid manufacturing costs | $ 2,005 | $ 1,147 |
Prepaid tax | 1,238 | 44 |
Prepaid insurance | 1,332 | 1,224 |
Prepaid subscriptions fees | 1,299 | 808 |
Prepaid research fees | 1,500 | 178 |
Prepaid commercialization expenses | 3,038 | 592 |
Due from collaborative and licensing arrangements | 138 | 354 |
Prepaid conference and travel expenses | 771 | 234 |
Prepaid co-pay assistance program | 863 | 97 |
Other | 351 | 489 |
Total prepaid expenses and other current assets | $ 12,535 | $ 5,167 |
Operating Leases - Operating Le
Operating Leases - Operating Leases (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disclosure of Operating Leases [Abstract] | |||
Operating lease cost | $ 431 | $ 431 | $ 400 |
Operating Leases - Schedule of
Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows | $ 506 | $ 492 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating leases | $ 89 | $ 89 |
Operating Leases - Schedule o_2
Operating Leases - Schedule of Supplemental Balance Sheet related To Lease (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Disclosure of Operating Leases [Line Items] | ||
Operating lease right-of-use assets | $ 2,508 | $ 2,770 |
Other current liabilities | $ 369 | $ 337 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Liabilities, Current | Liabilities, Current |
Operating lease liabilities, net of current portion | $ 3,188 | $ 3,557 |
Total operating lease liabilities | $ 3,557 | $ 3,894 |
Operating Leases - Lessee, Oper
Operating Leases - Lessee, Operating Lease, Liability, Maturity (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Disclosure of Operating Leases [Line Items] | ||
2024 | $ 522 | |
2025 | 537 | |
2026 | 553 | |
2027 | 570 | |
2028 | 587 | |
Thereafter | 1,440 | |
Total lease payments | 4,209 | |
Less: imputed interest | (652) | |
Total | $ 3,557 | $ 3,894 |
Operating Leases - Additional
Operating Leases - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Disclosure of Operating Leases [Line Items] | |||
Finance Lease Obligations | $ | $ 0 | ||
Lessee, Operating Lease, Option to Extend | 5 years | ||
Before agreement of company leased spaces | ft² | 7,800 | ||
After agreement of company leased spaces | ft² | 10,700 | ||
Weighted average remaining lease term | 7 years 3 months 18 days | 8 years 3 months 18 days | |
Weighted average discount rate | 4.51% | 4.51% | |
Rent expense | $ | $ 431 | $ 431 | $ 400 |
Maximum [Member] | |||
Disclosure of Operating Leases [Line Items] | |||
Lessee, Operating Lease, Option to Terminate | 7.6 years | ||
Minimum [Member] | |||
Disclosure of Operating Leases [Line Items] | |||
Lessee, Operating Lease, Option to Terminate | 6 years |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (723) | $ (406) |
Total property and equipment, net | 1,195 | 847 |
Furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 494 | 273 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 991 | 980 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 433 | $ 0 |
License and Acquired Intangib_3
License and Acquired Intangibles, Net - Schedule of Finite Lived Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 227,712 | $ 33,569 |
Accumulated Amortization | 33,663 | 1,098 |
Net Carrying Value | 194,049 | 32,471 |
License and Acquired Intangibles for RUZURGI [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 33,569 | 33,569 |
Accumulated Amortization | 3,418 | 1,098 |
Net Carrying Value | 30,151 | $ 32,471 |
License and Acquired Intangibles for FYCOMPA [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 158,143 | |
Accumulated Amortization | 29,673 | |
Net Carrying Value | 128,470 | |
Licensed And Acquired Intangibles For AGAMREE [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 36,000 | |
Accumulated Amortization | 572 | |
Net Carrying Value | $ 35,428 |
License and Acquired Intangib_4
License and Acquired Intangibles, Net - Schedule of Finite-Lived, Future Amortization Expense (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2024 | $ 37,378 | |
2025 | 37,378 | |
2026 | 37,378 | |
2027 | 37,378 | |
2028 | 7,705 | |
Thereafter | 36,832 | |
Total | $ 194,049 | $ 32,471 |
License and Acquired Intangib_5
License and Acquired Intangibles, Net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ 32,565,000 | $ 1,098,000 | $ 0 |
Impairment charges recognized on definite-lived intangibles | $ 0 | $ 0 | $ 0 |
Finite-Lived Intangible Assets, Remaining Amortization Period | 6 years 6 months | 14 years | |
License and Acquired Intangibles for RUZURGI [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Finite-lived intangible asset, useful life | 14 years 6 months | ||
Amortization of intangible assets | $ 2,300,000 | $ 1,100,000 | |
License and Acquired Intangibles for FYCOMPA [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Finite-lived intangible asset, useful life | 5 years | ||
Amortization of intangible assets | $ 29,700,000 | ||
Licensed And Acquired Intangibles For AGAMREE [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Finite-lived intangible asset, useful life | 10 years 6 months | ||
Amortization of intangible assets | $ 600,000 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued preclinical and clinical trial expenses | $ 1,015 | $ 479 |
Accrued professional fees | 4,730 | 1,619 |
Accrued compensation and benefits | 8,883 | 5,132 |
Accrued license fees | 24,437 | 20,444 |
Accrued purchases | 192 | 154 |
Operating lease liability | 369 | 337 |
Accrued variable consideration | 6,877 | 3,381 |
Accrued income tax | 729 | 8,702 |
Due to licensor | 12,540 | 13,127 |
Accrued interest payable | 1,031 | 0 |
Other | 465 | 238 |
Current accrued expenses and other liabilities | 61,268 | 53,613 |
Lease liability – non-current | 3,188 | 3,557 |
Due to licensor – non-current | 2,497 | 14,064 |
Other – non-current | 485 | 0 |
Non-current accrued expenses and other liabilities | 6,170 | 17,621 |
Total accrued expenses and other liabilities | $ 67,438 | $ 71,234 |
Collaborative and Licensing A_2
Collaborative and Licensing Arrangements - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
KYE Pharmaceuticals [Member] | Selling, General and Administrative Expenses [Member] | |||
Collaborative Arrangements [Line Items] | |||
Expenses incurred in connection with collaboration agreement | $ 0 | $ 0 | $ 0 |
Dydo Pharma Inc [Member] | |||
Collaborative Arrangements [Line Items] | |||
Revenues | 2,900,000 | ||
Dydo Pharma Inc [Member] | Non Refundable Upfront License Fees [Member] | |||
Collaborative Arrangements [Line Items] | |||
Revenues | $ 2,700,000 | ||
Collaborative Arrangement [Member] | Product revenue, net [Member] | |||
Collaborative Arrangements [Line Items] | |||
Revenues | 500,000 | $ 500,000 | |
Collaborative Arrangement [Member] | Regulatory Filing Milestone [Member] | |||
Collaborative Arrangements [Line Items] | |||
Revenues | 1,400,000 | ||
Collaborative Arrangement [Member] | Dydo Pharma Inc [Member] | |||
Collaborative Arrangements [Line Items] | |||
Revenues | $ 1,900,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | |||
Jul. 11, 2022 | Jan. 31, 2023 | Jul. 11, 2024 | Jul. 11, 2023 | |
Commitments [Line Items] | ||||
Number of trading days from receipt of the notice letter | 45 days | |||
License And Asset Purchase Agreement Payment | $ 10 | $ 10 | ||
Subsequent Event [Member] | ||||
Commitments [Line Items] | ||||
License And Asset Purchase Agreement Payment | $ 10 | |||
License and Asset Purchase Agreement [Member] | ||||
Commitments [Line Items] | ||||
Purchase price of an asset acquisition | $ 30 | |||
Percentage of the consideration paid by a third party to acquire that voucher | 50% | |||
License and Asset Purchase Agreement [Member] | Calendar Years 2022 Through 2025 [Member] | ||||
Commitments [Line Items] | ||||
Percentage of annual royalty on the Company's net sales | 1.50% | |||
Minimum royalty amount | $ 3 | |||
License and Asset Purchase Agreement [Member] | Calendar Year 2026 [Member] | ||||
Commitments [Line Items] | ||||
Percentage of annual royalty on the Company's net sales | 2.50% | |||
Minimum royalty amount | $ 5 |
Agreements - Additional Informa
Agreements - Additional Information (Detail) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||
Jul. 11, 2025 USD ($) | Jul. 11, 2024 USD ($) | Jul. 19, 2023 SFr / shares | Jul. 11, 2023 USD ($) | Jul. 11, 2022 USD ($) | Jul. 31, 2023 SFr / shares shares | Dec. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Oct. 26, 2023 USD ($) | |
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 3.50% | ||||||||||
Research and development expenses | $ 93,150 | $ 19,789 | $ 16,936 | ||||||||
Asset acquisition equity interests issued or issuable number of shares issued | shares | 1,414,688 | ||||||||||
Asset Acquisition Percentage Of Outstanding Ordinary Shares | 11.26% | ||||||||||
U.S. Rights for FYCOMPA [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Date on which strategic collaboration is entered into | Jan. 24, 2023 | ||||||||||
Payments to acquire productive assets | $ 164,200 | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 6% | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 12% | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 8.50% | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 17% | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred And Twenty Five Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 11% | ||||||||||
Net sales royalty threshold | $ 125,000 | ||||||||||
U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred And Twenty Five Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 22% | ||||||||||
Net sales royalty threshold | $ 125,000 | ||||||||||
Vamorolone [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Payments to acquire productive assets | $ 75,000 | ||||||||||
Asset acquisition equity interests issued or issuable number of shares issued | shares | 1,414,688 | ||||||||||
Asset Acquisition Percentage Of Outstanding Ordinary Shares | 11.26% | ||||||||||
Asset Acquisition Investment Share Price | SFr / shares | SFr 9.477 | ||||||||||
Closing Market Price | SFr / shares | SFr 8.25 | ||||||||||
Foreign Currency Exchange Rate, Translation | 1.1537 | ||||||||||
Collaborative arrangement, milestone payment obligation | $ 36,000 | ||||||||||
Payment on milestone payment | $ 36,000 | ||||||||||
Capitalized amortized Cost | $ 36,000 | ||||||||||
Finite-lived intangible asset, useful life | 10 years 6 months | 10 years 6 months | |||||||||
Minimum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | $ 10,000 | ||||||||||
Minimum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 10,000 | ||||||||||
Minimum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 100,000 | ||||||||||
Minimum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 100,000 | ||||||||||
Maximum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 100,000 | ||||||||||
Maximum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Ten Million And Less Than Hundred Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 100,000 | ||||||||||
Maximum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | 125,000 | ||||||||||
Maximum [Member] | U.S. Rights for FYCOMPA [Member] | Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] | Royalty Agreement Terms [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Net sales royalty threshold | $ 125,000 | ||||||||||
License Agreement with BioMarin [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Date on which strategic collaboration is entered into | Oct. 26, 2012 | ||||||||||
Royalty agreement period | 7 years | ||||||||||
Net sales royalty threshold | $ 100,000 | ||||||||||
License Agreement with BioMarin [Member] | Minimum [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 7% | ||||||||||
License Agreement with BioMarin [Member] | Maximum [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of royalty on net sales | 10% | ||||||||||
License Agreement For RUZURGI [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Date on which strategic collaboration is entered into | Jul. 11, 2022 | ||||||||||
Minimum royalty | $ 3,000 | $ 3,000 | $ 3,000 | ||||||||
Research and development expenses | $ 4,100 | ||||||||||
Up front payment | $ 10,000 | ||||||||||
Asset acquisition purchase price consideration | $ 10,000 | $ 10,000 | |||||||||
License Agreement For RUZURGI [Member] | Minimum [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of minimum royalty payable to net sales | 1.25% | ||||||||||
License Agreement For RUZURGI [Member] | Maximum [Member] | |||||||||||
License Agreement [Line Items] | |||||||||||
Percentage of maximum royalty payable to net sales | 2.50% |
Agreements - Schedule Of Total
Agreements - Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values (Detail) - License Agreement For RUZURGI [Member] $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values [Line Items] | |
License and acquired intangibles | $ 33,569 |
Acquired research and development inventory expensed from asset acquisition | 4,130 |
Total purchase price | $ 37,699 |
Agreements - Summary of Aggrega
Agreements - Summary of Aggregate Amount Paid for the Assets Acquired (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) | ||
Asset Acquisition [Line Items] | ||
Total purchase consideration | $ 94,978 | |
U.S. Rights for FYCOMPA [Member] | ||
Asset Acquisition [Line Items] | ||
Base cash payment | 160,000 | |
Cash paid for pro-rated prepaid expenses | 1,576 | |
Reimbursement on base purchase price | (3,238) | [1] |
Transaction costs | 5,870 | [2] |
Total purchase consideration | $ 164,208 | |
[1]Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023[2]As of December 31, 2023 the full $5.9 million has been paid in cash |
Agreements - Summary of Aggre_2
Agreements - Summary of Aggregate Amount Paid for the Assets Acquired (Parenthetical) (Detail) - U.S. Rights for FYCOMPA [Member] $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) | ||
Asset Acquisition [Line Items] | ||
Transaction expenses | $ 5,870 | [1] |
Cash [Member] | ||
Asset Acquisition [Line Items] | ||
Transaction expenses | $ 5,900 | |
[1]As of December 31, 2023 the full $5.9 million has been paid in cash |
Agreements - Summary of Total P
Agreements - Summary of Total Purchase Price Allocated to Acquired Assets (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Asset Acquisition [Line Items] | |
Total purchase consideration | $ 94,978 |
U.S. Rights for FYCOMPA [Member] | |
Asset Acquisition [Line Items] | |
Inventory | 4,100 |
Prepaid expenses and other current assets (samples) | 130 |
Prepaid commercialization expenses | 1,576 |
Property and equipment, net | 433 |
License and acquired intangibles for FYCOMPA® | 158,143 |
Accrued preclinical and clinical trial expenses | (174) |
Total purchase consideration | $ 164,208 |
Agreements - Summary of aggre_3
Agreements - Summary of aggregate amount paid for the assets (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) | ||
Asset Acquisition [Line Items] | ||
Investment in Santhera | $ 13,465 | [1] |
Total purchase consideration | 94,978 | |
Vamorolone [Member] | ||
Asset Acquisition [Line Items] | ||
Initial cash payment | 75,000 | |
Investment in Santhera | 13,465 | |
Transaction costs | 6,513 | |
Total purchase consideration | $ 94,978 | |
[1]The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023. |
Agreements - Summary of total_2
Agreements - Summary of total purchase price allocated (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 USD ($) | ||
Asset Acquisition [Line Items] | ||
Investment in Santhera | $ 13,465 | [1] |
Total purchase consideration | 94,978 | |
Vamorolone [Member] | ||
Asset Acquisition [Line Items] | ||
License and acquired intangibles for AGAMREE® (vamorolone) (IPR&D) | 81,513 | |
Investment in Santhera | 13,465 | |
Total purchase consideration | $ 94,978 | |
[1]The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023. |
Income Taxes - Schedule of inco
Income Taxes - Schedule of income tax expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Current - Federal | $ 34,975 | $ 12,858 | $ 2,455 |
Current - State | 5,931 | 3,877 | 1,414 |
Deferred - Federal | (16,093) | 4,739 | 8,620 |
Deferred - State | (1,712) | 166 | 696 |
Total income tax expense | $ 23,101 | $ 21,640 | $ 13,185 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Line Items] | ||
Deferred tax assets, net | $ 36,544 | $ 18,736 |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Income Tax Expense Computed at Statutory Federal Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Statutory rate | 21% | 21% | 21% |
State tax | 3.10% | 3.10% | 3.40% |
Executive compensation limitation | 2.60% | 3.60% | 1.10% |
Tax credit | 0% | (1.90%) | (0.60%) |
Stock compensation windfall | (4.40%) | (5.60%) | (0.60%) |
Other | 2.10% | 0.50% | 0.70% |
Reconciliation of income tax expense | 24.40% | 20.70% | 25% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Tax Assets [Abstract] | ||
Start-up costs | $ 0 | $ 9,771 |
Deferred compensation | 6,473 | 4,706 |
Inventory | 448 | 296 |
Intangible assets | 24,847 | 52 |
Accrued expenses | 788 | 0 |
Operating lease liability | 854 | 953 |
Capitalized research | 4,927 | 4,255 |
Total deferred tax assets | 38,337 | 20,033 |
Deferred tax liabilities: | ||
Prepaid expenses | (1,023) | (481) |
Right-of use asset | (759) | (860) |
Other | (11) | 44 |
Total deferred tax liabilities | (1,793) | (1,297) |
Deferred tax assets, net | $ 36,544 | $ 18,736 |
Stockholders' Equity (Preferred
Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail) | Dec. 31, 2023 Vote $ / shares shares | Dec. 31, 2022 $ / shares shares |
Stockholders Equity [Line Items] | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 |
Common stock, shares issued | 107,121,549 | 105,263,031 |
Common stock, shares outstanding | 107,121,549 | 105,263,031 |
Number of votes entitled for each share of common stock | Vote | 1 |
Stockholders' Equity ( Share Re
Stockholders' Equity ( Share Repurchases ) - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | |
Stockholders Equity [Line Items] | ||||
Aggregate purchase price | $ 6,907 | $ 12,089 | ||
Average price per share | $ 6.91 | $ 5.47 | ||
Common Stock [Member] | ||||
Stockholders Equity [Line Items] | ||||
Aggregate share repurchased | 0 | (1,000,000) | (2,208,292) | |
Share Purchase Program [Member] | Common Stock [Member] | ||||
Stockholders Equity [Line Items] | ||||
Share repurchase program, authorised | $ 40,000 |
Stockholders' Equity (2020 Shel
Stockholders' Equity (2020 Shelf Registration Statement) - Additional Information (Detail) $ in Millions | Jul. 23, 2020 USD ($) |
2020 Shelf Registration Statement [Member] | |
Stockholders' Equity [Line Items] | |
Maximum dollar amount of common stock to be issued under shelf registration statement | $ 200 |
Stockholders' Equity (2023 Shel
Stockholders' Equity (2023 Shelf Registration Statement) - Additional Information (Detail) - 2023 Shelf Registration Statement [Member] - USD ($) | Jan. 09, 2024 | Sep. 08, 2023 |
Stockholders' Equity [Line Items] | ||
Maximum dollar amount of common stock to be issued under shelf registration statement | $ 500,000,000 | |
Subsequent Event [Member] | ||
Stockholders' Equity [Line Items] | ||
Stock issued during the period shares new issues | 10,000,000 | |
Gross proceeds from issuance of common stock | $ 140,100,000 |
Stock Compensation - Stock-Base
Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation | $ 14,250 | $ 7,907 | $ 6,073 |
Research and Development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation | 1,481 | 1,729 | 1,611 |
Selling, General and Administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation | $ 12,769 | $ 6,178 | $ 4,462 |
Stock Compensation - Additional
Stock Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options exercised | 1,651,345 | ||
Proceeds from exercise of stock options | $ 2,792 | $ 9,569 | $ 4,099 |
Common stock unit granted | 3,598,535 | ||
Expected dividend rate | 0% | 0% | 0% |
Stock Option [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock option contractual term | 7 years | ||
Stock Option [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 1 year | ||
Stock Option [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 3 years | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $ 3,200 | $ 1,600 | $ 500 |
Two Thousand Eighteen Stock Incentive Plan [Member] | Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares reserved for issuance under the Plan | 18,000,000 | ||
Common stock shares available for future issuance under the Plan | 1,801,949 | ||
Two Thousand Eighteen Stock Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 3 years | ||
Options to Purchase Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options exercised | 1,651,345 | 3,172,342 | 1,328,936 |
Proceeds from exercise of stock options | $ 2,800 | $ 9,600 | $ 4,100 |
Stock option granted, contractual term | 7 years | 7 years | 7 years |
Common stock unit granted | 3,598,535 | 1,386,500 | 2,330,000 |
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan | $ 36,300 | ||
Expected remaining weighted average vesting period | 3 years 1 month 9 days | ||
Non-cash stock-based compensation expense | $ 11,100 | $ 6,300 | $ 5,500 |
Expected dividend rate | 0% |
Stock Compensation - Summary of
Stock Compensation - Summary of Stock Option Activity under the Company's Plan (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Share-based Payment Arrangement [Abstract] | |
Number of options, Outstanding at beginning of year | shares | 12,309,108 |
Number of options, Granted | shares | 3,598,535 |
Number of options, Exercised or released | shares | (1,651,345) |
Number of options, Forfeited or cancelled | shares | (78,810) |
Number of options, Expired | shares | 0 |
Number of options, Outstanding at end of year | shares | 14,177,488 |
Number of options, Exercisable at end of year | shares | 8,891,904 |
Weighted average exercise price, Outstanding at beginning of year | $ / shares | $ 4.93 |
Weighted average exercise price, Granted | $ / shares | 14.62 |
Weighted average exercise price, Exercised or released | $ / shares | 1.69 |
Weighted average exercise price, Forfeited or cancelled | $ / shares | 11.83 |
Weighted average exercise price, Expired | $ / shares | 0 |
Weighted average exercise price, Outstanding at end of year | $ / shares | 7.73 |
Weighted average exercise price, Exercisable at end of year | $ / shares | $ 4.45 |
Weighted Average Remaining Contractual Term (Years), Outstanding at end of year | 4 years 18 days |
Weighted Average Remaining Contractual Term (Years), Exercisable at end of year | 2 years 9 months 10 days |
Aggregate Intrinsic value, Outstanding at end of year | $ | $ 130,966 |
Aggregate Intrinsic value, Exercisable at end of year | $ | $ 110,488 |
Stock Compensation - Schedule o
Stock Compensation - Schedule of Other Information Pertaining to Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |||
Weighted-average fair value of granted stock options | $ 8.66 | $ 8.52 | $ 3.24 |
Total fair value of vested stock options | $ 8,278 | $ 6,096 | $ 6,421 |
Total intrinsic value of exercised stock options | $ 22,265 | $ 31,881 | $ 3,623 |
Stock Compensation - Summary _2
Stock Compensation - Summary of Stock Options Awards Based on Certain Assumptions (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk free interest rate, Minimum | 3.55% | 1.27% | 0.34% |
Risk free interest rate, Maximum | 4.92% | 4.07% | 1.18% |
Expected dividend yield | 0% | 0% | 0% |
Expected forfeiture rate | 0% | 0% | 0% |
Expected term | 4 years 6 months | ||
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 68% | 68.40% | 68.60% |
Expected term | 4 years 6 months | 4 years 6 months | |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 71% | 69.50% | 72.80% |
Expected term | 5 years 2 months 12 days | 4 years 9 months 18 days |
Stock Compensation - Summary _3
Stock Compensation - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Schedule Of Restricted Stock Activity [Line Items] | |
Nonvested balance at beginning of year | shares | 752,500 |
Granted | shares | 370,117 |
Vested | shares | (268,158) |
Forfeited | shares | 0 |
Nonvested balance at end of year | shares | 854,459 |
Nonvested Weighted Average Grant Date Fair Value balance at beginning of year | $ / shares | $ 11.46 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 13.67 |
Weighted Average Grant Date Fair Value, Vested | $ / shares | 11.25 |
Weighted Average Grant Date Fair Value, Forfeited | $ / shares | 0 |
Nonvested Weighted Average Grant Date Fair Value balance at end of year | $ / shares | $ 12.48 |
Benefit Plan - Additional Infor
Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |||
Employees contribution of pre-tax annual compensation | 15% | ||
Discretionary matching contributions of employee contributions of an employee's gross salary | 4% | ||
Contributions | $ 0.7 | $ 0.5 | $ 0.5 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - Two Thousand Twenty Three Shelf Registration Statement [Member] $ in Millions | Jan. 09, 2024 USD ($) shares |
Subsequent Event [Line Items] | |
Stock issued during the period shares new issues | shares | 10,000,000 |
Gross proceeds from issuance of common stock | $ | $ 140.1 |