Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | May 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | CATALYST PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001369568 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Filer Category | 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 | 106,076,959 | |
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 Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-33057 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 148,247 | $ 298,395 |
Accounts receivable, net | 33,402 | 10,439 |
Inventory | 10,328 | 6,805 |
Prepaid expenses and other current assets | 6,934 | 5,167 |
Total current assets | 198,911 | 320,806 |
Operating lease right-of-use asset | 2,706 | 2,770 |
Property and equipment, net | 1,285 | 847 |
License and acquired intangibles, net | 184,083 | 32,471 |
Deferred tax assets, net | 20,242 | 18,736 |
Total assets | 407,227 | 375,630 |
Current Liabilities: | ||
Accounts payable | 3,391 | 3,975 |
Accrued expenses and other liabilities | 53,318 | 53,613 |
Total current liabilities | 56,709 | 57,588 |
Operating lease liability, net of current portion | 3,468 | 3,557 |
Other non-current liabilities | 13,389 | 14,064 |
Total liabilities | 73,566 | 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 March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value, 200,000,000 shares authorized; 105,938,292 shares and 105,263,031 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 106 | 105 |
Additional paid-in capital | 254,114 | 250,430 |
Retained earnings | 79,430 | 49,862 |
Accumulated other comprehensive income | 11 | 24 |
Total stockholders' equity | 333,661 | 300,421 |
Total liabilities and stockholders' equity | $ 407,227 | $ 375,630 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 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 | 105,938,292 | 105,263,031 |
Common stock, shares outstanding | 105,938,292 | 105,263,031 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | ||
Revenues: | |||
Total revenues | $ 85,366 | $ 43,089 | |
Operating costs and expenses: | |||
Cost of sales | [1] | 9,946 | 5,890 |
Research and development | 3,562 | 3,403 | |
Selling, general and administrative | [1] | 29,718 | 16,430 |
Amortization of intangible assets | 6,531 | 0 | |
Total operating costs and expenses | 49,757 | 25,723 | |
Operating income | 35,609 | 17,366 | |
Other income, net | 1,704 | 93 | |
Net income before income taxes | 37,313 | 17,459 | |
Income tax provision | 7,745 | 4,218 | |
Net income | $ 29,568 | $ 13,241 | |
Net income per share: | |||
Basic | $ 0.28 | $ 0.13 | |
Diluted | $ 0.26 | $ 0.12 | |
Weighted average shares outstanding: | |||
Basic | 105,561,229 | 102,781,771 | |
Diluted | 113,986,129 | 109,041,096 | |
Net income | $ 29,568 | $ 13,241 | |
Other comprehensive income: | |||
Unrealized gain (loss) on available-for-sale securities, net of tax of $5 and $94, respectively | (13) | (305) | |
Comprehensive income | 29,555 | 12,936 | |
Product revenue, net [Member] | |||
Revenues: | |||
Total revenues | 85,304 | 43,033 | |
License and other revenue [Member] | |||
Revenues: | |||
Total revenues | $ 62 | $ 56 | |
[1]exclusive of amortization of intangible assets |
CONSOLIDATED STATEMENTS OF OP_2
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net of tax impact | $ 5 | $ 94 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Gain (Loss) [Member] |
Beginning Balance at Dec. 31, 2021 | $ 206,831 | $ 103 | $ 233,186 | $ (26,310) | $ (148) |
Beginning Balance (shares) at Dec. 31, 2021 | 102,993,000 | ||||
Issuance of stock options for services | 1,623 | 1,623 | |||
Exercise of stock options for common stock | 1,102 | $ 0 | 1,102 | ||
Exercise of stock options for common stock (shares) | 364,000 | ||||
Amortization of restricted stock for services | 280 | 280 | |||
Repurchase of common stock (shares) | (400,000) | ||||
Repurchase of common stock | (2,551) | $ 0 | (2,551) | ||
Other comprehensive gain (loss) | (305) | (305) | |||
Net income | 13,241 | 13,241 | |||
Ending Balance at Mar. 31, 2022 | 220,221 | $ 103 | 236,191 | (15,620) | (453) |
Ending Balance (shares) at Mar. 31, 2022 | 102,957,000 | ||||
Beginning Balance at Dec. 31, 2022 | 300,421 | $ 105 | 250,430 | 49,862 | 24 |
Beginning Balance (shares) at Dec. 31, 2022 | 105,263,000 | ||||
Issuance of stock options for services | 2,177 | 2,177 | |||
Exercise of stock options for common stock | 1,270 | $ 1 | 1,269 | ||
Exercise of stock options for common stock (shares) | 548,000 | ||||
Amortization of restricted stock for services | 715 | 715 | |||
Issuance of common stock upon vesting of restricted stock units, net | (477) | (477) | |||
Issuance of common stock upon vesting of restricted stock units, net (Share) | 127,000 | ||||
Repurchase of common stock (shares) | 0 | ||||
Other comprehensive gain (loss) | (13) | (13) | |||
Net income | 29,568 | 29,568 | |||
Ending Balance at Mar. 31, 2023 | $ 333,661 | $ 106 | $ 254,114 | $ 79,430 | $ 11 |
Ending Balance (shares) at Mar. 31, 2023 | 105,938,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Activities: | ||
Net income | $ 29,568 | $ 13,241 |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||
Depreciation | 69 | 34 |
Stock-based compensation | 2,892 | 1,903 |
Amortization of intangible assets | 6,531 | |
Deferred taxes | (1,519) | 1,901 |
Change in accrued interest and accretion of discount on investments | (2) | |
Reduction in the carrying amount of right-of-use asset | 64 | 60 |
Acquired inventory samples expensed from asset acquisition | 130 | |
(Increase) decrease in: | ||
Accounts receivable, net | (22,963) | (3,933) |
Inventory | 577 | 43 |
Prepaid expenses and other current assets | (191) | (563) |
Increase (decrease) in: | ||
Accounts payable | (584) | 2,371 |
Accrued expenses and other liabilities | (2,422) | (6,504) |
Operating lease liability | (82) | (73) |
Net cash provided by (used in) operating activities | 12,070 | 8,478 |
Investing Activities: | ||
Purchases of property and equipment | (74) | |
Payment in connection with asset acquisition | (162,293) | |
Net cash provided by (used in) investing activities | (162,367) | |
Financing Activities: | ||
Payment of employee withholding tax related to stock-based compensation | (477) | |
Proceeds from exercise of stock options | 1,270 | 1,000 |
Repurchase of common stock | 0 | (2,551) |
Payment of liabilities arising from asset acquisition | (644) | |
Net cash provided by (used in) financing activities | 149 | (1,551) |
Net increase (decrease) in cash and cash equivalents | (150,148) | 6,927 |
Cash and cash equivalents – beginning of period | 298,395 | 171,445 |
Cash and cash equivalents – end of period | 148,247 | 178,372 |
Supplemental disclosures of cash flow information: | ||
Cash paid for income taxes | 0 | 41 |
Non-cash investing and financing activities: | ||
Proceeds from exercise of stock options not yet settled at end of period | $ 102 | |
Liabilities arising from asset acquisition | $ 1,915 |
Organization and Description of
Organization and Description of Business | 3 Months Ended |
Mar. 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 biopharmaceutical company focused on in-licensing, first-in-class Catalyst’s New Drug Application 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 ® ® ® 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 incurred operating losses in each period from inception and started reporting operating income during the year ended December 31, 2019. 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 While there can be no assurance, based on currently available information, the Company estimates that it has sufficient resources to support its operations for at least the next 12 months from the issuance 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. Risks and Uncertainties There are numerous aspects of the coronavirus (COVID-19) |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of Presentation and Significant Accounting Policies. a. INTERIM FINANCIAL STATEMENTS. 10-Q In the opinion of management, the accompanying unaudited interim consolidated financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2022 included in the 2022 Annual Report on Form 10-K b. PRINCIPLES OF CONSOLIDATION. The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiary, Catalyst Pharmaceuticals Ireland, Ltd. (Catalyst Ireland). All intercompany accounts and transactions have been eliminated in consolidation. Catalyst Ireland was organized in 2017. c. USE OF ESTIMATES. d. CASH AND CASH EQUIVALENTS. e. INVESTMENTS. The U.S. Treasuries held at March 31, 2023 are classified as available-for-sale non-current short-term or non-current investments as of March 31, 2023 and December 31, 2022. The Company records available-for-sale ) available-for-sale available-for-sale available-for-sale f. ACCOUNTS RECEIVABLE, NET. g. INVENTORY Inventories are stated at the lower of cost or net realizable value. Inventories consist of raw materials, work-in-process and finished goods. Costs to be capitalized as inventories primarily include third party manufacturing costs and other overhead costs. Cost is determined using a standard cost method, which approximates actual cost, and assumes a first-in, first out (FIFO) flow of goods. If information becomes available that suggests that inventories may not be realizable, the Company may be required to expense a portion or all of the previously capitalized inventories. 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. h. PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-clinical i. PROPERTY AND EQUIPMENT, NET. three five five j BUSINESS COMBINATIONS AND ASSET ACQUISITIONS 805-50, Refer to Notes 12 (Commitments and Contingencies) and 13 (Agreements) for further discussion on the Company’s exclusive license agreement with Jacobus Pharmaceutical Company, Inc (Jacobus), for the rights to develop and commercialize RUZURGI ® ASC 805-50. ® 805-50. k. 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. l. FAIR VALUE OF FINANCIAL INSTRUMENTS. m. 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 prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. 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 $ 12,373 $ 12,373 $ — $ — U.S. Treasuries $ 115,785 $ 115,785 $ — $ — 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 $ — $ — n. OPERATING LEASES. right-of-use xercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Com non-lease o. SHARE REPURCHASES. 40 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 (accumulated deficit). 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. p. 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 and FYCOMPA ® ® ® ® ® ® ® ® Product Revenue, Net: ® ® ® ® The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time (upon delivery or upon dispense to patient). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 15 and 30 days. 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 three months ended March 31, 2023 and 2022. During the three months ended March 31, 2023 and 2022, 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 Three Months Ended 2023 2022 FIRDAPSE ® $ 57,526 $ 43,033 FYCOMPA ® 27,778 — Total product revenue, net $ 85,304 $ 43,033 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 March 31, 2023 and, therefore, the transaction price was not reduced further during the three months ended March 31, 2023 and 2022. 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. 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 arrangeme n q. RESEARCH AND DEVELOPMENT. r. ADVERTISING EXPENSE. C s s. STOCK-BASED COMPENSATION. one t. CONCENTRATION OF RISK. The Company sells its product, FIRDAPSE ® As of March 31, 2023, the Company had two 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 relies exclusively on third parties to formulate and manufacture FIRDAPSE ® ® ® ® ® u. ROYALTIES. ® Royalties incurred in connection with the Company’s license agreement for RUZURGI ® v. 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 w. COMPREHENSIVE INCOME. available-for-sale x. 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 Three Months Ended 2023 2022 Basic weighted average common shares outstanding 105,561,229 102,781,771 Effect of dilutive securities 8,424,900 6,259,325 Diluted weighted average common shares outstanding 113,986,129 109,041,096 Outstanding common stock equivalents totaling approximately 1.3 million and 2.3 million, were excluded from the calculation of diluted net income per common share for the three months ended March 31, 2023 and 2022, respectively, as their effect would be anti-dilutive. y. SEGMENT INFORMATION. z. RECLASSIFICATIONS. aa. RECENTLY ISSUED ACCOUNTING STANDARDS. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 3. Investments. Available-for-sale Estimated Gross Gross Amortized At March 31, 2023: U.S. Treasuries - Cash equivalents $ 115,785 $ 14 $ — $ 115,771 Total $ 115,785 $ 14 $ — $ 115,771 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 The estimated fair values of available-for-sale March 31, Due in one year or less $ 115,785 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 3 Months Ended |
Mar. 31, 2023 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract] | |
Accumulated Other Comprehensive Income | 4. Accumulated Other Comprehensive Income. The following table summarizes the changes in accumulated other comprehensive income, net of tax from unrealized gains (losses) on available-for-sale There were no reclassifications out of accumulated other comprehensive income during the three months ended March 31, 2023 or 2022. Total Accumulated Balance at December 31, 2022 $ 24 Other comprehensive gain (loss) before reclassifications (13 ) Amount reclassified from accumulated other comprehensive income — Net current period other comprehensive gain (loss) (13 ) Balance at March 31, 2023 $ 11 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | 5. Inventory. Inventory consists of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ — $ — Work-in-process 5,642 5,543 Finished goods 4,686 1,262 Total inventory $ 10,328 $ 6,805 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 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): March 31, 2023 December 31, 2022 Prepaid manufacturing costs $ 1,147 $ 1,147 Prepaid tax 44 44 Prepaid insurance 871 1,224 Prepaid subscriptions fees 1,057 808 Prepaid research fees 157 178 Prepaid commercialization expenses 2,585 592 Due from collaborative and licensing arrangements 213 354 Prepaid conference and travel expenses 525 234 Other 335 586 Total prepaid expenses and other current assets $ 6,934 $ 5,167 |
Operating Leases
Operating Leases | 3 Months Ended |
Mar. 31, 2023 | |
Operating Lease, Lease Income [Abstract] | |
Operating Leases | 7. Operating Leases. The Company has an operating lease agreement 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. Consequently, the Company recorded the effects of the amended lease during the first quarter of 2021 . The components of lease expense were as follows (in thousands): For the Three Months Ended 2023 2022 Operating lease cost $ 108 $ 108 Supplemental cash flow information related to lease was as follows (in thousands): For the Three Months Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 125 $ 121 Right-of-use Operating lease $ 22 $ 22 Supplemental balance sheet information related to lease was as follows (in thousands): March 31, 2023 December 31, 2022 Operating lease right-of-use $ 2,706 $ 2,770 Other current liabilities $ 345 $ 337 Operating lease liabilities, net of current portion 3,468 3,557 Total operating lease liabilities $ 3,813 $ 3,894 As of March 31, 2023 and December 31, 2022, the weighted average remaining lease term was 8.1 years and 8.3 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 4.51% as of March 31, 2023 and December 31, 2022. Remaining payments of lease liabilities as of March 31, 2023 were as follows (in thousands): 2023 (remaining nine months) $ 382 2024 522 2025 537 2026 553 2027 570 Thereafter 2,027 Total lease payments 4,591 Less: imputed interest (778 ) Total $ 3,813 Rent expense was approximately $0.1 million for each of |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 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): March 31, 2023 December 31, 2022 Computer equipment $ 51 $ 51 Furniture and equipment 296 222 Leasehold improvements 980 980 Software 433 — Less: Accumulated depreciation (475 ) (406 ) Total property and equipment, net $ 1,285 $ 847 |
License and Acquired Intangible
License and Acquired Intangibles, Net | 3 Months Ended |
Mar. 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 March 31, 2023 (in thousands): Gross Carrying Value Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 1,678 $ 31,891 License and acquired intangibles for FYCOMPA ® 158,143 5,951 152,192 Total $ 191,712 $ 7,629 $ 184,083 The following table presents the Company’s intangible assets at December 31, 2022 (in thousands): Gross Carrying Value 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 useful life for RUZURGI ® ® ® ® cost of sales. Amortization of both the FYCOMPA ® and RUZURGI ® intangible assets are reported together as The following table presents future amortization expense the Company expects for its intangible assets (in thousands): 2023 (remaining nine months) $ 25,462 2024 33,949 2025 33,949 2026 33,949 2027 33,949 Thereafter 22,825 Total $ 184,083 At March 31, 2023 and December 31, 2022, the weighted average amortization period remaining for intangible assets was years and 14.0 years, respectively. If all or a portion of the |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 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 (in thousands): March 31, 2023 December 31, 2022 Accrued preclinical and clinical trial expenses $ 290 $ 479 Accrued professional fees 5,626 1,619 Accrued compensation and benefits 2,043 5,132 Accrued license fees 7,614 20,444 Accrued purchases 146 154 Operating lease liability 345 337 Accrued variable consideration 4,748 3,381 Accrued contributions 1,350 — Accrued income tax 17,949 8,702 Due to licensor 12,928 13,127 Other 279 238 Current accrued expenses and other liabilities 53,318 53,613 Lease liability – non-current 3,468 3,557 Due to licensor – non-current 13,389 14,064 Non-current 16,857 17,621 Total accrued expenses and other liabilities $ 70,175 $ 71,234 |
Collaborative and Licensing Arr
Collaborative and Licensing Arrangements | 3 Months Ended |
Mar. 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 ® ® Under the terms of the Collaboration, the Company has received an up-front mid-double ® The Company evaluated the license agreement with Endo to determine whether it is a collaborative arrangement for purposes of Topic 808. As the Company shares in the significant risks and rewards, the Company has concluded that this is a collaborative arrangement. As developing a final finished dosage form of a generic product in exchange for consideration is not an output of the Company’s ongoing activities, Endo does not represent a contract with a customer. However, Topic 808 does not provide guidance on the recognition of consideration exchanged or accounting for the obligations that may arise between the parties. The Company concluded that ASC Topic 730, Research and Development The collaborative agreement included a nonrefundable upfront license fee that was recognized upon receipt following execution of the collaborative arrangement for vigabatrin tablets. The collaborative agreement provides for a $2.0 million milestone payment on the commercial launch of the product by Endo/Par. As of March 31, 2023 and 2022, no milestone payments have been earned. There were no revenues from this collaborative arrangement for the three months ended March 31, 2023 or 2022. There were no expenses incurred, net, in connection with the collaborative arrangement for the three months ended March 31, 2023 or 2022. 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. Under the arrangement, the Company will receive profit-sharing reports within nine days after quarter end from KYE. Revenue from sales of FIRDAPSE ® Revenues from the arrangement with KYE for the three months ended March 31, 2023 and 2022 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 $0.2 million and $0 in revenue from the arrangement with DyDo for the three months ended March 31, 2023 and 2022, respectively, which is included in product revenue, net in the accompanying consolidated statements of operations and comprehensive income. As of March 31, 2023, no milestone payments have been earned. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies. In May 2019, the FDA approved a New Drug Application (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 and the balance of which will be paid over the next two years, on the first and second 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 Catalyst’s FIRDAPSE ® • If Catalyst were to receive a priority review voucher for FIRDAPSE ® ® Royalties will be trued up at the end of the year to the extent that royalties on net sales are below the minimum royalty. The Company’s New Drug Submission filing for FIRDAPSE ® ® ® ® ® ® On June 3, 2021, the Company announced a positive decision in this proceeding that quashed the NOC previously issued for RUZURGI ® ® ® re-issued ® On March 11, 2022, the Company announced that the Company had received a favorable decision from the Canadian court setting aside, for the second time, the decision of Health Canada approving RUZURGI ® ® ® ® ® 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 ® ® ccurs first. In that regard, after conducting the necessary due diligence, the Company filed lawsuits on March 1, 2023 in the U.S. District Court for the District of New Jersey against each of the three generic drug manufacturers who notified the Company of their ANDA submissions, thus triggering the sta y. 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 | 3 Months Ended |
Mar. 31, 2023 | |
Text Block [Abstract] | |
Agreements | 13. Agreements. a. LICENSE AGREEMENT FOR FIRDAPSE ® ® ® 7 100 10 100 ® 7 3.5 On May 29, 2019, the Company and BioMarin entered into an amendment to the Company’s license agreement for FIRDAPSE ® ® In January 2020, the Company was advised that BioMarin has transferred certain rights under the license agreement to SERB S.A. b. LICENSE AGREEMENT FOR RUZURGI ® (the Effective Date), ® Pursuant to the terms of the license agreement, the Company paid Jacobus a $10 million up-front ® ® ® If these minimum payments become probable in the future, the Company would recognize a contingent liability at that time with an offset to the value of the intangible asset acquired. Any royalties in excess of this amount will be charged to cost of sales as revenue from product sales is recognized. Royalties over the minimum, if any, will be paid based on the agreement terms on a quarterly basis. 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 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 ® . the Company acquired the U.S. Rights for FYCOMPA® (perampanel) CIII a commercial stage epilepsy asset, from Eisai Co., Ltd. (Eisai). The aggregate consideration for the acquisition was $ Eisai is also eligible to receive a contingent payment of $25 million if certain regulatory milestones are met. As the regulatory milestones are 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®, the Company may be obligated to pay certain royalties to Eisai on net sales of FYCOMPA®. As the Transaction is accounted for as an asset acquisition under U.S. GAAP, the Company opted to recognize the royalty payments in cost of sales as revenue from product sales is recognized. 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 March 31, 2023 (ii) $1.9 million of transaction expenses are recorded in a abili in the accompanying consolidated balance sheet as of March 31, 2023 The acquisition of FYCOMPA ® 805-50. ® ® ® 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. AGREEMENTS FOR DRUG MANUFACTURING, DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes. The Company’s effective income tax rate was 20.8% and 24.2% for the three months ended March 31, 2023 and 2022, respectively. Differences in the effective tax and the statutory federal income tax rate of 21% are driven by state income taxes and anticipated annual permanent differences and offset by the orphan drug credit claimed. The Company had no uncertain tax positions as of March 31, 2023 and December 31, 2022. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 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 March 31, 2023 and December 31, 2022. No shares of preferred stock were outstanding at March 31, 2023 and December 31, 2022. Common Stock The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At March 31, 2023 and December 31, 2022, 105,938,292 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. 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. As of the date of this report, no offerings have been completed under the Company’s 2020 Shelf Registration Statement. |
Stock Compensation
Stock Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock Compensation | 16. Stock Compensation. For the three months ended March 31, 2023 and 2022, the Company recorded stock-based compensation expense as follows (in thousands): 2023 2022 Research and development $ 339 $ 432 Selling, general and administrative 2,553 1,471 Total stock-based compensation $ 2,892 $ 1,903 Stock Options As of March 31, 2023, there were outstanding stock options to purchase 12,082,183 shares of common stock, of which stock options to purchase 8,442,955 shares of common stock were exercisable as of March 31, 2023. During the three months ended March 31, 2023 and 2022, the Company granted seven-year term options to purchase an aggregate of 340,500 and 410,000 shares, respectively, of the Company’s common stock to employees. The Company recorded stock-based compensation related to stock options totaling $2.2 million and $1.6 million, respectively, during the three months ended March 31, 2023 and 2022. During the three months ended March 31, 2023 and 2022, options to purchase 547,957 shares and 363,772 shares, respectively, of the Company’s common stock were exercised, with proceeds of $1.3 million and $1.1 million respectively, to the Company. As of March 31, 2023, there was approximately $18.0 million of unrecognized compensation expense related to non-vested Restricted Stock Units The Company granted no restricted stock units and 474,500 restricted stock units during the three months ended March 31, 2023 and 2022, respectively. During the three months ended March 31, 2023 and 2022, the Company recorded non-cash As of March 31, 2023, there was approximately $6.8 million of unrecognized compensation expense related to non-vested |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
INTERIM FINANCIAL STATEMENTS | a. INTERIM FINANCIAL STATEMENTS. 10-Q In the opinion of management, the accompanying unaudited interim consolidated financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2022 included in the 2022 Annual Report on Form 10-K |
PRINCIPLES OF CONSOLIDATION | b. PRINCIPLES OF CONSOLIDATION. The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiary, Catalyst Pharmaceuticals Ireland, Ltd. (Catalyst Ireland). All intercompany accounts and transactions have been eliminated in consolidation. Catalyst Ireland was organized in 2017. |
USE OF ESTIMATES | c. USE OF ESTIMATES. |
CASH AND CASH EQUIVALENTS | d. CASH AND CASH EQUIVALENTS. |
INVESTMENTS | e. INVESTMENTS. The U.S. Treasuries held at March 31, 2023 are classified as available-for-sale non-current short-term or non-current investments as of March 31, 2023 and December 31, 2022. The Company records available-for-sale ) available-for-sale available-for-sale available-for-sale |
ACCOUNTS RECEIVABLE, NET | f. ACCOUNTS RECEIVABLE, NET. |
INVENTORY | g. INVENTORY Inventories are stated at the lower of cost or net realizable value. Inventories consist of raw materials, work-in-process and finished goods. Costs to be capitalized as inventories primarily include third party manufacturing costs and other overhead costs. Cost is determined using a standard cost method, which approximates actual cost, and assumes a first-in, first out (FIFO) flow of goods. If information becomes available that suggests that inventories may not be realizable, the Company may be required to expense a portion or all of the previously capitalized inventories. 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 | h. PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-clinical |
PROPERTY AND EQUIPMENT, NET | i. PROPERTY AND EQUIPMENT, NET. three five five |
BUSINESS COMBINATIONS AND ASSET ACQUISITIONS | j BUSINESS COMBINATIONS AND ASSET ACQUISITIONS 805-50, Refer to Notes 12 (Commitments and Contingencies) and 13 (Agreements) for further discussion on the Company’s exclusive license agreement with Jacobus Pharmaceutical Company, Inc (Jacobus), for the rights to develop and commercialize RUZURGI ® ASC 805-50. ® 805-50. |
INTANGIBLE ASSETS, NET | k. 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 | l. FAIR VALUE OF FINANCIAL INSTRUMENTS. |
FAIR VALUE MEASUREMENTS | m. 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 prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. 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 $ 12,373 $ 12,373 $ — $ — U.S. Treasuries $ 115,785 $ 115,785 $ — $ — 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 | n. OPERATING LEASES. right-of-use xercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Com non-lease |
SHARE REPURCHASES | o. SHARE REPURCHASES. 40 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 (accumulated deficit). 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 | p. 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 and FYCOMPA ® ® ® ® ® ® ® ® Product Revenue, Net: ® ® ® ® The Company recognizes revenue on product sales when the Customer obtains control of the Company’s product, which occurs at a point in time (upon delivery or upon dispense to patient). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 15 and 30 days. 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 three months ended March 31, 2023 and 2022. During the three months ended March 31, 2023 and 2022, 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 Three Months Ended 2023 2022 FIRDAPSE ® $ 57,526 $ 43,033 FYCOMPA ® 27,778 — Total product revenue, net $ 85,304 $ 43,033 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 March 31, 2023 and, therefore, the transaction price was not reduced further during the three months ended March 31, 2023 and 2022. 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. 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 arrangeme n |
RESEARCH AND DEVELOPMENT | q. RESEARCH AND DEVELOPMENT. |
ADVERTISING EXPENSE | r. ADVERTISING EXPENSE. C s |
STOCK-BASED COMPENSATION | s. STOCK-BASED COMPENSATION. one |
CONCENTRATION OF CREDIT RISK | t. CONCENTRATION OF RISK. The Company sells its product, FIRDAPSE ® As of March 31, 2023, the Company had two 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 relies exclusively on third parties to formulate and manufacture FIRDAPSE ® ® ® ® ® |
ROYALTIES | u. ROYALTIES. ® Royalties incurred in connection with the Company’s license agreement for RUZURGI ® |
INCOME TAXES | v. 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 | w. COMPREHENSIVE INCOME. available-for-sale |
NET INCOME PER COMMON SHARE | x. 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 Three Months Ended 2023 2022 Basic weighted average common shares outstanding 105,561,229 102,781,771 Effect of dilutive securities 8,424,900 6,259,325 Diluted weighted average common shares outstanding 113,986,129 109,041,096 Outstanding common stock equivalents totaling approximately 1.3 million and 2.3 million, were excluded from the calculation of diluted net income per common share for the three months ended March 31, 2023 and 2022, respectively, as their effect would be anti-dilutive. |
SEGMENT INFORMATION | y. SEGMENT INFORMATION. |
RECLASSIFICATIONS | z. RECLASSIFICATIONS. |
RECENTLY ISSUED ACCOUNTING STANDARDS | aa. RECENTLY ISSUED ACCOUNTING STANDARDS. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 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 $ 12,373 $ 12,373 $ — $ — U.S. Treasuries $ 115,785 $ 115,785 $ — $ — 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 Three Months Ended 2023 2022 Basic weighted average common shares outstanding 105,561,229 102,781,771 Effect of dilutive securities 8,424,900 6,259,325 Diluted weighted average common shares outstanding 113,986,129 109,041,096 |
Summary of Disaggregated Product Revenue | The following table summarizes the Company’s net product revenue disaggregated by product (in thousands): For the Three Months Ended 2023 2022 FIRDAPSE ® $ 57,526 $ 43,033 FYCOMPA ® 27,778 — Total product revenue, net $ 85,304 $ 43,033 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Investments by Security type | Available-for-sale Estimated Gross Gross Amortized At March 31, 2023: U.S. Treasuries - Cash equivalents $ 115,785 $ 14 $ — $ 115,771 Total $ 115,785 $ 14 $ — $ 115,771 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 March 31, Due in one year or less $ 115,785 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 3 Months Ended |
Mar. 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, net of tax from unrealized gains (losses) on available-for-sale There were no reclassifications out of accumulated other comprehensive income during the three months ended March 31, 2023 or 2022. Total Accumulated Balance at December 31, 2022 $ 24 Other comprehensive gain (loss) before reclassifications (13 ) Amount reclassified from accumulated other comprehensive income — Net current period other comprehensive gain (loss) (13 ) Balance at March 31, 2023 $ 11 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of current inventory | Inventory consists of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ — $ — Work-in-process 5,642 5,543 Finished goods 4,686 1,262 Total inventory $ 10,328 $ 6,805 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Text Block [Abstract] | |
Prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following (in thousands): March 31, 2023 December 31, 2022 Prepaid manufacturing costs $ 1,147 $ 1,147 Prepaid tax 44 44 Prepaid insurance 871 1,224 Prepaid subscriptions fees 1,057 808 Prepaid research fees 157 178 Prepaid commercialization expenses 2,585 592 Due from collaborative and licensing arrangements 213 354 Prepaid conference and travel expenses 525 234 Other 335 586 Total prepaid expenses and other current assets $ 6,934 $ 5,167 |
Operating Leases (Tables)
Operating Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Disclosure of Operating Leases [Abstract] | |
Lease, Cost | The components of lease expense were as follows (in thousands): For the Three Months Ended 2023 2022 Operating lease cost $ 108 $ 108 |
Schedule of Supplemental Cash Flow Information Related To Lease | Supplemental cash flow information related to lease was as follows (in thousands): For the Three Months Ended 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 125 $ 121 Right-of-use Operating lease $ 22 $ 22 |
Schedule of Supplemental Balance Sheet related To Lease | Supplemental balance sheet information related to lease was as follows (in thousands): March 31, 2023 December 31, 2022 Operating lease right-of-use $ 2,706 $ 2,770 Other current liabilities $ 345 $ 337 Operating lease liabilities, net of current portion 3,468 3,557 Total operating lease liabilities $ 3,813 $ 3,894 |
Lessee, Operating Lease, Liability, Maturity | Remaining payments of lease liabilities as of March 31, 2023 were as follows (in thousands): 2023 (remaining nine months) $ 382 2024 522 2025 537 2026 553 2027 570 Thereafter 2,027 Total lease payments 4,591 Less: imputed interest (778 ) Total $ 3,813 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and equipment, net consists of the following (in thousands): March 31, 2023 December 31, 2022 Computer equipment $ 51 $ 51 Furniture and equipment 296 222 Leasehold improvements 980 980 Software 433 — Less: Accumulated depreciation (475 ) (406 ) Total property and equipment, net $ 1,285 $ 847 |
License and Acquired Intangib_2
License and Acquired Intangibles, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Finite-Lived Intangible Assets, Net [Abstract] | |
Schedule of Finite-Lived Intangible Assets | The following table presents the Company’s intangible assets at March 31, 2023 (in thousands): Gross Carrying Value Accumulated Net Carrying Value Intangible assets: License and acquired intangibles for RUZURGI ® $ 33,569 $ 1,678 $ 31,891 License and acquired intangibles for FYCOMPA ® 158,143 5,951 152,192 Total $ 191,712 $ 7,629 $ 184,083 The following table presents the Company’s intangible assets at December 31, 2022 (in thousands): Gross Carrying Value 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): 2023 (remaining nine months) $ 25,462 2024 33,949 2025 33,949 2026 33,949 2027 33,949 Thereafter 22,825 Total $ 184,083 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following (in thousands): March 31, 2023 December 31, 2022 Accrued preclinical and clinical trial expenses $ 290 $ 479 Accrued professional fees 5,626 1,619 Accrued compensation and benefits 2,043 5,132 Accrued license fees 7,614 20,444 Accrued purchases 146 154 Operating lease liability 345 337 Accrued variable consideration 4,748 3,381 Accrued contributions 1,350 — Accrued income tax 17,949 8,702 Due to licensor 12,928 13,127 Other 279 238 Current accrued expenses and other liabilities 53,318 53,613 Lease liability – non-current 3,468 3,557 Due to licensor – non-current 13,389 14,064 Non-current 16,857 17,621 Total accrued expenses and other liabilities $ 70,175 $ 71,234 |
Agreements (Tables)
Agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Text Block [Abstract] | |
Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values | 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 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 March 31, 2023 (ii) $1.9 million of transaction expenses are recorded in a abili in the accompanying consolidated balance sheet as of March 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 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | For the three months ended March 31, 2023 and 2022, the Company recorded stock-based compensation expense as follows (in thousands): 2023 2022 Research and development $ 339 $ 432 Selling, general and administrative 2,553 1,471 Total stock-based compensation $ 2,892 $ 1,903 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) $ in Thousands, shares in Millions | 3 Months Ended | |||||
Jul. 11, 2025 USD ($) | Jul. 11, 2024 USD ($) | Jul. 11, 2023 USD ($) | Mar. 31, 2023 USD ($) Segment shares | Mar. 31, 2022 USD ($) shares | Dec. 31, 2022 USD ($) | |
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||
Maximum maturity period of cash and cash equivalent | three months | |||||
Non current investments | $ 0 | $ 0 | ||||
Minimum amortization period of compensation cost on straight line basis | 1 year | |||||
Maximum Amortization Period Of Compensation Cost On Straight Line Basis | 3 years | |||||
Potential equivalent common stock excluded | shares | 1.3 | 2.3 | ||||
Number of operating segments | Segment | 1 | |||||
License Agreement For RUZURGI [Member] | Subsequent Event [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 | $ 1,700 | $ 700 | ||||
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 | Mar. 31, 2023 | Dec. 31, 2022 |
U.S. Treasuries [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 115,785 | $ 105,442 |
Money market funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 12,373 | 168,853 |
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 | 115,785 | 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 | $ 12,373 | $ 168,853 |
Basis of Presentation and Sig_6
Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||
Basic weighted average common shares outstanding | 105,561,229 | 102,781,771 |
Effect of dilutive securities | 8,424,900 | 6,259,325 |
Dilutive weighted average common shares outstanding | 113,986,129 | 109,041,096 |
Basis of Presentation and Sig_7
Basis of Presentation and Significant Accounting Policies - Summary of Disaggregated Product Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 85,366 | $ 43,089 |
FIRDAPSE [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Excluding Assessed Tax | 57,526 | 43,033 |
FYCOMPA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Excluding Assessed Tax | 27,778 | 0 |
Product revenue, net [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 85,304 | $ 43,033 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | ||
Realized gains losses from available for sale securities | $ 0 | $ 0 |
Investment - Summary of Availab
Investment - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Net Investment Income [Line Items] | ||
Estimated Fair Value | $ 115,785 | $ 105,442 |
Gross Unrealized Gains | 14 | 32 |
Gross Unrealized Losses | 0 | 0 |
Amortized cost | 115,771 | 105,410 |
U.S. Treasuries - Cash equivalents [Member] | ||
Net Investment Income [Line Items] | ||
Estimated Fair Value | 115,785 | 105,442 |
Gross Unrealized Gains | 14 | 32 |
Gross Unrealized Losses | 0 | 0 |
Amortized cost | $ 115,771 | $ 105,410 |
Investment - Estimated Fair Val
Investment - Estimated Fair Values of Available for Sale Securities (Detail) $ in Thousands | Mar. 31, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due in one year or less | $ 115,785 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income - Summary of Reclassifications out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||
Beginning balance | $ 24 | |
Other comprehensive gain (loss) before reclassifications | (13) | |
Amount reclassified from accumulated other comprehensive income | 0 | |
Net current period other comprehensive gain (loss) | (13) | $ (305) |
Ending balance | $ 11 |
Inventory - Summary of current
Inventory - Summary of current inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 0 | $ 0 |
Work-in-process | 5,642 | 5,543 |
Finished goods | 4,686 | 1,262 |
Total inventory | $ 10,328 | $ 6,805 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid manufacturing costs | $ 1,147 | $ 1,147 |
Prepaid tax | 44 | 44 |
Prepaid insurance | 871 | 1,224 |
Prepaid subscriptions fees | 1,057 | 808 |
Prepaid research fees | 157 | 178 |
Prepaid commercialization expenses | 2,585 | 592 |
Due from collaborative and licensing arrangements | 213 | 354 |
Prepaid conference and travel expenses | 525 | 234 |
Other | 335 | 586 |
Total prepaid expenses and other current assets | $ 6,934 | $ 5,167 |
Operating Leases - Operating Le
Operating Leases - Operating Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disclosure of Operating Leases [Abstract] | ||
Operating lease cost | $ 108 | $ 108 |
Operating Leases - Schedule of
Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows | $ 125 | $ 121 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating leases | $ 22 | $ 22 |
Operating Leases - Schedule o_2
Operating Leases - Schedule of Supplemental Balance Sheet related To Lease (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Disclosure of Operating Leases [Line Items] | ||
Operating lease right-of-use assets | $ 2,706 | $ 2,770 |
Other current liabilities | $ 345 | $ 337 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Liabilities, Current | Liabilities, Current |
Operating lease liabilities, net of current portion | $ 3,468 | $ 3,557 |
Total operating lease liabilities | $ 3,813 | $ 3,894 |
Operating Leases - Lessee, Oper
Operating Leases - Lessee, Operating Lease, Liability, Maturity (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Disclosure of Operating Leases [Line Items] | ||
2023 (remaining nine months) | $ 382 | |
2024 | 522 | |
2025 | 537 | |
2026 | 553 | |
2027 | 570 | |
Thereafter | 2,027 | |
Total lease payments | 4,591 | |
Less: imputed interest | (778) | |
Total | $ 3,813 | $ 3,894 |
Operating Leases - Additional
Operating Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 USD ($) ft² | Mar. 31, 2022 USD ($) | Dec. 31, 2022 | |
Disclosure of Operating Leases [Line Items] | |||
Finance Lease Obligations | $ | $ 0 | ||
Lessee, Operating Lease, Option to Extend | 5 | ||
Rent expense | $ | $ 108 | $ 108 | |
Before agreement of company leased spaces | ft² | 7,800 | ||
After agreement of company leased spaces | ft² | 10,700 | ||
Weighted average remaining lease term | 8 years 1 month 6 days | 8 years 3 months 18 days | |
Weighted average discount rate | 4.51% | ||
Maximum [Member] | |||
Disclosure of Operating Leases [Line Items] | |||
Lessee, Operating Lease, Option to Terminate | 7.6 | ||
Minimum [Member] | |||
Disclosure of Operating Leases [Line Items] | |||
Lessee, Operating Lease, Option to Terminate | 6 |
Property and Equipment, Net - P
Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (475) | $ (406) |
Total property and equipment, net | 1,285 | 847 |
Computer equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 51 | 51 |
Furniture and equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 296 | 222 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 980 | 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 | Mar. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 191,712 | $ 33,569 |
Accumulated Amortization | 7,629 | 1,098 |
Net Carrying Value | 184,083 | 32,471 |
License and Acquired Intangibles for RUZURGI [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 33,569 | 33,569 |
Accumulated Amortization | 1,678 | 1,098 |
Net Carrying Value | 31,891 | $ 32,471 |
License and Acquired Intangibles for FYCOMPA [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 158,143 | |
Accumulated Amortization | 5,951 | |
Net Carrying Value | $ 152,192 |
License and Acquired Intangib_4
License and Acquired Intangibles, Net - Schedule of Finite-Lived, Future Amortization Expense (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2023 (remaining nine months) | $ 25,462 | |
2024 | 33,949 | |
2025 | 33,949 | |
2026 | 33,949 | |
2027 | 33,949 | |
Thereafter | 22,825 | |
Total | $ 184,083 | $ 32,471 |
License and Acquired Intangib_5
License and Acquired Intangibles, Net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ 6,531 | ||
Impairment charges recognized on definite-lived intangibles | $ 0 | $ 0 | |
Finite-Lived Intangible Assets, Remaining Amortization Period | 6 years 8 months 12 days | 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 | $ 600 | 0 | |
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 | $ 6,000 | $ 0 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued preclinical and clinical trial expenses | $ 290 | $ 479 |
Accrued professional fees | 5,626 | 1,619 |
Accrued compensation and benefits | 2,043 | 5,132 |
Accrued license fees | 7,614 | 20,444 |
Accrued purchases | 146 | 154 |
Operating lease liability | 345 | 337 |
Accrued variable consideration | 4,748 | 3,381 |
Accrued contributions | 1,350 | |
Accrued income tax | 17,949 | 8,702 |
Due to licensor | 12,928 | 13,127 |
Other | 279 | 238 |
Current accrued expenses and other liabilities | 53,318 | 53,613 |
Lease liability – non-current | 3,468 | 3,557 |
Due to licensor – non-current | 13,389 | 14,064 |
Non-current accrued expenses and other liabilities | 16,857 | 17,621 |
Total accrued expenses and other liabilities | $ 70,175 | $ 71,234 |
Collaborative and Licensing A_2
Collaborative and Licensing Arrangements - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Collaborative Arrangements [Line Items] | ||
Period of collaboration agreement | 10 years | |
Research and development expenses | $ 3,562 | $ 3,403 |
Milestone payments income | 0 | 0 |
KYE Pharmaceuticals [Member] | Selling, General and Administrative Expenses [Member] | ||
Collaborative Arrangements [Line Items] | ||
Expenses incurred in connection with collaboration agreement | 0 | 0 |
Dydo Pharma Inc [Member] | ||
Collaborative Arrangements [Line Items] | ||
Milestone payments income | 0 | |
Collaborative Arrangement [Member] | ||
Collaborative Arrangements [Line Items] | ||
Milestone payments | 2,000 | |
Revenues | 0 | 0 |
Collaborative Arrangement [Member] | Product revenue, net [Member] | ||
Collaborative Arrangements [Line Items] | ||
Revenues | 200 | 0 |
Collaborative Arrangement [Member] | Research and Development Expense [Member] | ||
Collaborative Arrangements [Line Items] | ||
Research and development expenses | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | |
Jul. 11, 2022 | Jan. 31, 2023 | |
Commitments [Line Items] | ||
Number of trading days from receipt of the notice letter | 45 days | |
License and Asset Purchase Agreement [Member] | ||
Commitments [Line Items] | ||
Purchase price of an asset acquisition | $ 30 | |
Upfront payment related to asset acquisition | $ 10 | |
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) - USD ($) $ in Thousands | 3 Months Ended | |||||
Jul. 11, 2025 | Jul. 11, 2024 | Jul. 11, 2023 | Jul. 11, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
License Agreement [Line Items] | ||||||
Percentage of royalty on net sales | 3.50% | |||||
Research and development expenses | $ 3,562 | $ 3,403 | ||||
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 | |||||
Contingent payment | $ 25,000 | |||||
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 | |||||
Research and development expenses | $ 4,100 | |||||
Up front payment | $ 10,000 | |||||
License Agreement For RUZURGI [Member] | Subsequent Event [Member] | ||||||
License Agreement [Line Items] | ||||||
Minimum royalty | $ 3,000 | $ 3,000 | $ 3,000 | |||
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) $ in Thousands | 3 Months Ended |
Mar. 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) - U.S. Rights for FYCOMPA [Member] $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 USD ($) | ||
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 March 31, 2023[2]$1.9 million of transaction expenses are recorded in accrued expenses and other liabilities in the accompanying consolidated balance sheet as of March 31, 2023, the remaining $4.0 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 | 3 Months Ended | |
Mar. 31, 2023 USD ($) | ||
Asset Acquisition [Line Items] | ||
Transaction expenses | $ 5,870 | [1] |
Accrued expenses and other liabilities [Member] | ||
Asset Acquisition [Line Items] | ||
Transaction expenses | 1,900 | |
Cash [Member] | ||
Asset Acquisition [Line Items] | ||
Transaction expenses | $ 4,000 | |
[1]$1.9 million of transaction expenses are recorded in accrued expenses and other liabilities in the accompanying consolidated balance sheet as of March 31, 2023, the remaining $4.0 million has been paid in cash |
Agreements - Summary of Total P
Agreements - Summary of Total Purchase Price Allocated to Acquired Assets (Detail) - U.S. Rights for FYCOMPA [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
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 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Line Items] | |||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | $ 0 | $ 0 | |
Effective Income Tax Rate Reconciliation, Percent | 20.80% | 24.20% | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21% |
Stockholders' Equity (Preferred
Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail) | Mar. 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 | 105,938,292 | 105,263,031 |
Common stock, shares outstanding | 105,938,292 | 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 | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 31, 2021 | |
Stockholders Equity [Line Items] | |||
Aggregate purchase price | $ 0 | $ 2,551 | |
Average price per share | $ 0 | $ 6.38 | |
Common Stock [Member] | |||
Stockholders Equity [Line Items] | |||
Aggregate share repurchased | 0 | (400,000) | |
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 |
Stock Compensation - Stock-Base
Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 2,892 | $ 1,903 |
Research and Development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | 339 | 432 |
Selling, General and Administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation | $ 2,553 | $ 1,471 |
Stock Compensation - Additional
Stock Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Proceeds from exercise of stock options | $ 1,270 | $ 1,000 |
Number of options, Outstanding | 12,082,183 | |
Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan | $ 6,800 | |
Expected remaining weighted average vesting period | 2 years 6 months | |
Non-cash stock-based compensation expense | $ 700 | $ 300 |
Common stock granted | 0 | 474,500 |
Options to Purchase Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of stock options exercised | 547,957 | 363,772 |
Proceeds from exercise of stock options | $ 1,300 | $ 1,100 |
Stock option granted, contractual term | 7 years | 7 years |
Common stock unit granted | 340,500 | 410,000 |
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan | $ 18,000 | |
Expected remaining weighted average vesting period | 2 years 4 months 24 days | |
Non-cash stock-based compensation expense | $ 2,200 | $ 1,600 |
Stock options to purchase shares of common stock | 8,442,955 |