Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 05, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
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 | 102,978,461 | |
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 | Jun. 30, 2021 | Dec. 31, 2020 |
Current Assets: | ||
Cash and cash equivalents | $ 135,295 | $ 130,237 |
Short-term investments | 19,980 | 10,041 |
Accounts receivable, net | 6,292 | 5,987 |
Inventory | 7,097 | 4,651 |
Prepaid expenses and other current assets | 7,641 | 8,328 |
Total current assets | 176,305 | 159,244 |
Operating lease right-of-use asset | 3,201 | |
Property and equipment, net | 914 | 130 |
Deferred tax assets | 28,701 | 32,971 |
Deposits | 9 | 9 |
Total assets | 209,130 | 192,354 |
Current Liabilities: | ||
Accounts payable | 2,924 | 4,256 |
Accrued expenses and other liabilities | 13,211 | 18,500 |
Total current liabilities | 16,135 | 22,756 |
Operating lease liability, net of current portion | 4,051 | |
Total liabilities | 20,186 | 22,756 |
Commitments and contingencies (Note 10) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at June 30, 2021 and December 31, 2020 | 0 | |
Common stock, $0.001 par value, 200,000,000 shares authorized; 103,162,041 shares and 103,781,641 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 103 | 104 |
Additional paid-in capital | 226,699 | 223,168 |
Accumulated deficit | (37,821) | (53,705) |
Accumulated other comprehensive income (loss) | (37) | 31 |
Total stockholders' equity | 188,944 | 169,598 |
Total liabilities and stockholders' equity | $ 209,130 | $ 192,354 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
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 | 103,162,041 | 103,781,641 |
Common stock, shares outstanding | 103,162,041 | 103,781,641 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 36,365 | $ 29,605 | $ 66,570 | $ 58,741 |
Operating costs and expenses: | ||||
Cost of sales | $ 4,545 | $ 4,140 | $ 9,226 | $ 8,291 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 4,450 | $ 4,350 | $ 7,457 | $ 8,573 |
Selling, general and administrative | 11,532 | 10,833 | 24,248 | 20,896 |
Total operating costs and expenses | 20,527 | 19,323 | 40,931 | 37,760 |
Operating income | 15,838 | 10,282 | 25,639 | 20,981 |
Other income, net | 62 | 111 | 143 | 448 |
Net income before income taxes | 15,900 | 10,393 | 25,782 | 21,429 |
Provision for income taxes | 3,719 | 613 | 5,938 | 1,223 |
Net income | $ 12,181 | $ 9,780 | $ 19,844 | $ 20,206 |
Net income per share: | ||||
Basic | $ 0.12 | $ 0.09 | $ 0.19 | $ 0.20 |
Diluted | $ 0.11 | $ 0.09 | $ 0.18 | $ 0.19 |
Weighted average shares outstanding: | ||||
Basic | 103,407,803 | 103,414,523 | 103,610,138 | 103,410,881 |
Diluted | 107,734,924 | 106,730,423 | 107,299,262 | 106,433,862 |
Net income | $ 12,181 | $ 9,780 | $ 19,844 | $ 20,206 |
Other comprehensive income: | ||||
Unrealized gain (loss) on available-for-sale securities | 8 | (85) | (68) | (11) |
Comprehensive income | 12,189 | 9,695 | 19,776 | 20,195 |
Product Revenue, Net [Member] | ||||
Revenues: | ||||
Total revenues | 33,636 | $ 29,605 | 63,841 | $ 58,741 |
License and other [Member] | ||||
Revenues: | ||||
Total revenues | $ 2,729 | $ 2,729 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (unaudited) - 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, 2019 | $ 87,630 | $ 103 | $ 216,206 | $ (128,689) | $ 10 |
Beginning Balance (shares) at Dec. 31, 2019 | 103,397,000 | ||||
Issuance of stock options for services | 1,384 | 1,384 | |||
Exercise of stock options for common stock | 26 | 26 | |||
Exercise of stock options for common stock (shares) | 12,000 | ||||
Amortization of restricted stock for services | 136 | 136 | |||
Other comprehensive gain (loss) | 74 | 74 | |||
Net income | 10,426 | 10,426 | |||
Ending Balance at Mar. 31, 2020 | 99,676 | $ 103 | 217,752 | (118,263) | 84 |
Ending Balance (shares) at Mar. 31, 2020 | 103,409,000 | ||||
Beginning Balance at Dec. 31, 2019 | 87,630 | $ 103 | 216,206 | (128,689) | 10 |
Beginning Balance (shares) at Dec. 31, 2019 | 103,397,000 | ||||
Net income | 20,206 | ||||
Ending Balance at Jun. 30, 2020 | 111,201 | $ 103 | 219,582 | (108,483) | (1) |
Ending Balance (shares) at Jun. 30, 2020 | 103,422,000 | ||||
Beginning Balance at Mar. 31, 2020 | 99,676 | $ 103 | 217,752 | (118,263) | 84 |
Beginning Balance (shares) at Mar. 31, 2020 | 103,409,000 | ||||
Issuance of stock options for services | 1,627 | 1,627 | |||
Exercise of stock options for common stock | 36 | 36 | |||
Exercise of stock options for common stock (shares) | 13,000 | ||||
Amortization of restricted stock for services | 167 | 167 | |||
Other comprehensive gain (loss) | (85) | (85) | |||
Net income | 9,780 | 9,780 | |||
Ending Balance at Jun. 30, 2020 | 111,201 | $ 103 | 219,582 | (108,483) | (1) |
Ending Balance (shares) at Jun. 30, 2020 | 103,422,000 | ||||
Beginning Balance at Dec. 31, 2020 | 169,598 | $ 104 | 223,168 | (53,705) | 31 |
Beginning Balance (shares) at Dec. 31, 2020 | 103,782,000 | ||||
Issuance of stock options for services | 1,442 | 1,442 | |||
Exercise of stock options for common stock | 188 | 188 | |||
Exercise of stock options for common stock (shares) | 90,000 | ||||
Amortization of restricted stock for services | 129 | 129 | |||
Repurchase of common stock | (293) | (293) | |||
Repurchase of common stock (shares) | (67,000) | ||||
Other comprehensive gain (loss) | (76) | (76) | |||
Net income | 7,663 | 7,663 | |||
Ending Balance at Mar. 31, 2021 | 178,651 | $ 104 | 224,927 | (46,335) | (45) |
Ending Balance (shares) at Mar. 31, 2021 | 103,805,000 | ||||
Beginning Balance at Dec. 31, 2020 | $ 169,598 | $ 104 | 223,168 | (53,705) | 31 |
Beginning Balance (shares) at Dec. 31, 2020 | 103,782,000 | ||||
Repurchase of common stock (shares) | (800,000) | ||||
Net income | $ 19,844 | ||||
Ending Balance at Jun. 30, 2021 | 188,944 | $ 103 | 226,699 | (37,821) | (37) |
Ending Balance (shares) at Jun. 30, 2021 | 103,162,000 | ||||
Beginning Balance at Mar. 31, 2021 | 178,651 | $ 104 | 224,927 | (46,335) | (45) |
Beginning Balance (shares) at Mar. 31, 2021 | 103,805,000 | ||||
Issuance of stock options for services | 1,388 | 1,388 | |||
Exercise of stock options for common stock | 271 | 271 | |||
Exercise of stock options for common stock (shares) | 83,000 | ||||
Amortization of restricted stock for services | 130 | 130 | |||
Repurchase of common stock | $ (3,668) | $ (1) | (3,667) | ||
Repurchase of common stock (shares) | (732,951) | (733,000) | |||
Issuance of common stock upon vesting of restricted stock units, net | $ (17) | (17) | |||
Issuance of common stock upon vesting of restricted stock units, net (shares) | 7,000 | ||||
Other comprehensive gain (loss) | 8 | 8 | |||
Net income | 12,181 | 12,181 | |||
Ending Balance at Jun. 30, 2021 | $ 188,944 | $ 103 | $ 226,699 | $ (37,821) | $ (37) |
Ending Balance (shares) at Jun. 30, 2021 | 103,162,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Operating Activities: | ||
Net income | $ 19,844 | $ 20,206 |
Adjustments to reconcile net income to net cash provided by (used in) operating activities: | ||
Depreciation | 128 | 43 |
Stock-based compensation | 3,089 | 3,314 |
Deferred taxes | 4,270 | |
Change in accrued interest and accretion of discount on investments | (6) | (4) |
Reduction in the carrying amount of right-of-use asset | 108 | 721 |
(Increase) decrease in: | ||
Accounts receivable, net | (305) | 3,775 |
Inventory | (2,446) | 129 |
Prepaid expenses and other current assets and deposits | 687 | (3,170) |
Increase (decrease) in: | ||
Accounts payable | (1,332) | 1,687 |
Accrued expenses and other liabilities | (5,490) | (5,473) |
Operating lease liability | 942 | (750) |
Net cash provided by (used in) operating activities | 19,489 | 20,478 |
Investing Activities: | ||
Purchases of property and equipment | (912) | |
Purchases of investments | (10,000) | |
Proceeds from maturities and sales of investments | 5,000 | |
Net cash provided by (used in) investing activities | (10,912) | 5,000 |
Financing Activities: | ||
Payment of employee withholding tax related to stock-based compensation | (17) | |
Proceeds from exercise of stock options | 459 | 62 |
Repurchase of common stock | (3,961) | |
Net cash provided by (used in) financing activities | (3,519) | 62 |
Net increase (decrease) in cash and cash equivalents | 5,058 | 25,540 |
Cash and cash equivalents—beginning of period | 130,237 | 89,512 |
Cash and cash equivalents—end of period | 135,295 | 115,052 |
Supplemental disclosures of cash flow information: | ||
Cash paid for income taxes | 341 | 50 |
Non-cash investing and financing activities: | ||
Unrealized gain (loss) on available-for-sale securities | (68) | $ (11) |
Operating lease liabilities arising from obtaining right-of-use assets | $ 3,309 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the “Company”) is a commercial-stage patient-centric biopharmaceutical company focused on in-licensing, On November 28, 2018, the U.S. Food and Drug Administration, or FDA, granted approval of Firdapse ® ® On August 6, 2020, the Company announced that Canada’s national healthcare regulatory agency, Health Canada, has approved Firdapse ® ® Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, raising capital, and selling its product. The Company incurred operating losses in each period from inception until the second quarter of 2019, when it started reporting net income. The Company has been able to fund its cash needs to date through offerings of its securities and revenues from sales of its product. See Note 13 (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 planned operations for at least the next 12 months from the issuance date of this Form 10-Q. 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 drug development efforts, 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 and if 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 | 6 Months Ended |
Jun. 30, 2021 | |
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, 2020 included in the 2020 Annual Report on Form 10-K b. PRINCIPLES OF CONSOLIDATION c. USE OF ESTIMATES. d. CASH AND CASH EQUIVALENTS. e. INVESTMENTS The short-term bond funds and U.S. Treasuries held at June 30, 2021 are classified as available-for-sale non-current non-current The Company records available-for-sale available-for-sale available-for-sale f. ACCOUNTS RECEIVABLE, NET. g. INVENTORY. work-in-process first-in, ® ® work-in work-in-process 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. FAIR VALUE OF FINANCIAL INSTRUMENTS. j. 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 Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 68,663 $ 68,663 $ — $ — U.S. Treasuries $ 49,996 $ 49,996 $ — $ — Short-term investments: Short-term bond funds $ 19,980 $ 19,980 $ — $ — Balances Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 15,674 $ 15,674 $ — $ — U.S. Treasuries $ 104,994 $ — $ 104,994 $ — Short-term investments: Short-term bond funds $ 10,041 $ 10,041 $ — $ — k. OPERATING LEASES. right-of-use non-lease l. SHARE REPURCHASES. The Company accounts for share repurchases by charging the excess of the m. REVENUE RECOGNITION. Product Revenues: The Company recognizes revenue when its customer obtains title of the promised goods, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for these goods. The Company had no contracts with customers until the FDA approved Firdapse ® ® ® ® 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 only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses 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. 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 and six months ended June 30, 2021 and 2020. During the three and six months ended June 30, 2021 and 2020, all of the Company’s sales of Firdapse ® 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 June 30, 2021 and, therefore, the transaction price was not reduced further during the three and six months ended June 30, 2021 and 2020. 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 and Allowances: ® June 30, Prompt Payment Discounts: Funded Co-pay co-pay co-pay ® Product Returns: Provider Chargebacks and Discounts: Government Rebates: Bridge and Patient Assistance Programs: ® pre-established ® ® ® ® Revenues from Collaboration and Licensing Arrangements: The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration, (“ASC 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 FASB ASC Topic 606, Revenue from Contracts with Customers. 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 Pursuant to Topic 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. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset. 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 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 9 (Collaboration and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements. n. RESEARCH AND DEVELOPMENT. o. STOCK-BASED COMPENSATION. one p. CONCENTRATION OF RISK. The Company sells its product in the United States through an exclusive distributor (its Customer) to SPs. Therefore, its distributor and SPs account for all of its trade receivables and net product revenues. The creditworthiness of its Customer is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for expected credit loss primarily based on the credit worthiness of its Customer, historical payment patterns, aging of receivable balances and general economic conditions. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse ® ® ® The Company relies exclusively on third parties to formulate and manufacture Firdapse ® ® ® q. ROYALTIES. r. INCOME 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 s. COMPREHENSIVE INCOME. available-for-sale t. 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 For the Six Months Ended 2021 2020 2021 2020 Basic weighted average common shares outstanding 103,407,803 103,414,523 103,610,138 103,410,881 Effect of dilutive securities 4,327,121 3,315,900 3,689,124 3,022,981 Diluted weighted average common shares outstanding 107,734,924 106,730,423 107,299,262 106,433,862 Outstanding common stock equivalents totaling approximately 4.9 million and 5.1 million, were excluded from the calculation of diluted net income per common share for the three and six months ended June 30, 2021 as their effect would be anti-dilutive. For the three and six months ended June 30, 2020, approximately 3.5 million and 4.8 million shares of common stock equivalents were excluded from the calculation of diluted net income per common share as their effect would be anti-dilutive. u. RECLASSIFICATIONS. v. RECENTLY ISSUED ACCOUNTING STANDARDS. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes step-up |
Investments
Investments | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 3. Investments. Available-for-sale Estimated Gross Gross Amortized At June 30, 2021: U.S. Treasuries – Cash equivalents $ 49,996 $ — $ (1 ) $ 49,997 Short-term bond funds 19,980 — (36 ) 20,016 Total $ 69,976 $ — $ (37 ) $ 70,013 At December 31, 2020: U.S. Treasuries – Cash equivalents $ 104,994 $ 2 $ — $ 104,992 Short-term bond funds 10,041 29 — 10,012 Total $ 115,035 $ 31 $ — $ 115,004 There were no realized gains or losses from available-for-sale The estimated fair values of available-for-sale June 30, 2021 Due in one year or less $ 69,976 |
Inventory, net
Inventory, net | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory, net | 4. Inventory, net. Inventory, net consists of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 1,117 $ — Work-in-process 5,168 3,555 Finished goods 812 1,096 Total inventory, net $ 7,097 $ 4,651 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2021 | |
Text Block [Abstract] | |
Prepaid Expenses and Other Current Assets | 5. Prepaid Expenses and Prepaid expenses and other current assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Prepaid manufacturing costs $ 2,646 $ 3,328 Prepaid tax 93 1,368 Prepaid insurance 623 1,285 Prepaid subscription fees 530 729 Prepaid research fees 391 453 Prepaid commercialization expenses 120 199 Due from collaborative and licensing arrangements 2,917 437 Other 321 529 Total prepaid expenses and other current assets $ 7,641 $ 8,328 |
Operating Leases
Operating Leases | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure of Operating Leases [Abstract] | |
Operating Leases | 6. Operating Lease. The Company has an operating lease agreement for its corporate office. The lease includes an option to extend the lease for up to 5 years and options to terminate the lease within 6 and 7.6 years. There are no obligations under finance leases. 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 Q1 2021. The components of lease expense were as follows (in thousands): For the three June 30, 2021 For the six June 30, 2021 Operating lease cost $ 108 $ 164 Supplemental cash flow information related to leases was as follows: June 30, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 29 Right-of-use Operating leases $ 36 Supplemental balance sheet information related to leases was as follows: Operating lease right-of-use $ 3,201 Other current liabilities $ 200 Operating lease liabilities, net of current portion 4,051 Total operating lease liabilities $ 4,251 Remaining lease term 9.8 years Discount rate 4.51 % Remaining payments of lease liabilities as of June 30, 2021 were as follows (in thousands): 2021 (remaining six $ 80 2022 492 2023 506 2024 522 2025 537 Thereafter 3,150 Total lease payments 5,287 Less imputed interest (1,036 ) Total $ 4,251 Rent expense was approximately $0.1 million and $0.2 million for the three and six months ended June 30, 2021 , respec tively, , respectively. |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 7. Property and Equipment, net. Property and equipment, net consists of the following (in thousands): June 30, 2021 December 31, 2020 Computer equipment $ 51 $ 51 Furniture and equipment 135 242 Leasehold improvements 939 177 Less: Accumulated depreciation (211 ) (340 ) Total property and equipment, net $ $ 130 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | 8. Accrued Expenses and Other Liabilities. Accrued expenses and other liabilities consist of the following (in thousands): June 30, 2021 December 31, 2020 Accrued preclinical and clinical trial expenses $ 530 $ 585 Accrued professional fees 1,229 1,884 Accrued compensation and benefits 2,014 3,991 Accrued license fees 6,382 10,373 Accrued purchases 1,343 258 Accrued contributions — 310 Operating lease liability 200 29 Accrued variable consideration 1,331 964 Accrued income tax 70 — Other 112 106 Current accrued expenses and other liabilities 13,211 18,500 Lease liability—non-current 4,051 — Non-current 4,051 — Total accrued expenses and other liabilities $ 17,262 $ 18,500 |
Collaboration and Licensing Arr
Collaboration and Licensing Arrangements | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration and Licensing Arrangements | 9. Collaboration 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 Collaboration, Endo assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the collaboration, while the Company is responsible for exercising commercially reasonable efforts to develop, or cause the development of, a final finished, stable dosage form 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 ASC 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 Par. As of June 30, 2021 and 2020, no milestone payments have been earned. There were no revenues from this collaborative arrangement for the three or six months ended June 30, 2021 or 2020. Total expenses incurred, net, in connection with the collaborative agreement for the three and six months ended June 30, 2021 were approximately $45,000. Total expenses incurred, net, in connection with the collaborative agreement for three and six months ended June 30, 2020 were approximately $8,554 and $4,206, respectively. These expenses have been included in research and development expenses in the accompanying consolidated statements of operations and comprehensive income. KYE Pharmaceuticals 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 ® Although this agreement is in form identified as a collaborative agreement, the Company has concluded for accounting purposes that it 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 the collaborator. Revenue from sales of collaboration products by the Company’s collaborator will be recognized in the quarter in which the sales occurred. Revenues June 30, 2021 were not material. 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 will have joint rights to develop Firdapse ® a 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 ASC 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 ® Additionally, the agreement includes sales-based milestones 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 satisfied. Variable consideration related to regulatory milestones is 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. Revenue from the arrangement with DyDo for the three and six months ended June 30, 2021 was approximately $2.7 million relating to the nonrefundable upfront license fee, and is included in license and other revenue in the accompanying consolidated statements of operations and comprehensive income. As of June 30, 2021, no milestone payments have been earned and there has been no clinical or commercial supply of Firdapse ® |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. Commitments and Contingencies. In May 2019, the FDA approved a New Drug Application (NDA) for Jacobus Pharmaceuticals for Ruzurgi ® (3,4-DAP), ® ® ® ® off-label ® off-label The Company believes that the FDA’s approval of Ruzurgi ® ® ® On July 30, 2020, the Magistrate Judge considering the Company’s lawsuit against the FDA 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’s motions for summary judgment, and dismissed the Company’s case. The Company has appealed the District Court’s decision to the Eleventh Circuit Court of Appeals. There can be no assurance as to the outcome of the Company’s appeal. On August 10, 2020, Health Canada issued a Notice of Compliance (NOC) to Medunik for Ruzurgi ® ® ® ® On June 3, 2021, the Company announced a positive decision in this proceeding that quashed the NOC previously issued for Ruzurgi ® ® ® re-issued ® 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 | 6 Months Ended |
Jun. 30, 2021 | |
Text Block [Abstract] | |
Agreements | 11. Agreements. a. LICENSE AGREEMENT FOR FIRDAPSE ® On ® ® ® 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. AGREEMENTS FOR DRUG MANUFACTURING, DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 12. Income Taxes. The Company’s effective income tax rate was 23.0% and 5.7% for the six ended June 30, 2021 and 2020, respectively. The difference in the effective rates between periods is driven by the release of the Company’s valuation allowance against deferred taxes in the third quarter of 2020. Differences in the effective tax and the statutory federal income tax rate of 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 June 30, 2021 and December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 13. Stockholders’ Equity. Preferred Stock The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share, at June 30, 2021 and December 31, 2020. No shares of preferred stock were outstanding at June 30, 2021 and December 31, 2020. Common Stock The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At June 30, 2021 and December 31, 2020, 103,162,041 and 103,781,641 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 See Note 15 (Subsequent Events). 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) |
Stock Compensation
Stock Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock Compensation | 14. Stock Compensation. For the three and six months ended June 30, 2021 and 2020, the Company recorded stock-based compensation expense as follows (in thousands): Three months ended Six months ended 2021 2020 2021 2020 Research and development $ 376 $ 421 $ 765 $ 839 Selling, general and administrative 1,142 1,373 2,324 2,475 Total stock-based compensation $ 1,518 $ 1,794 $ 3,089 $ 3,314 Stock Options As of June 30, 2021, there were outstanding stock options to purchase 13,759,670 shares of common stock, of which stock options to purchase 8,765,623 shares of common stock were exercisable as of June 30, 2021. During the three and six months ended June 30, 2021, the Company granted seven-year term options to purchase an aggregate of 70,000 and 630,000 shares, respectively, of the Company’s common stock to employees. The Company recorded stock-based compensation related to stock options totaling $1.4 million and $2.8 million, respectively, during the three and six months ended June 30, 2021. During the three and six months ended June 30, 2020, the Company granted seven-year term options to purchase an aggregate of 260,000 and 995,000 shares, respectively, of the Company’s common stock to employees. The Company recorded stock-based compensation related to stock options totaling $1.6 million and $3.0 million, respectively, during the three and six months ended June 30, 2020. During the three and six months ended June 30, 2021, options to purchase 83,332 shares and 173,330 shares, respectively, of the Company’s common stock were exercised, with proceeds of $270,523 and $458,818 respectively, to the Company. During the three and six months ended June 30, 2020, options to purchase 13,333 shares and 24,999 shares, respectively, of the Company’s common stock were exercised, with proceeds of $36,201 and $62,350 respectively, to the Company. As of June 30, 2021, there was approximately $8.3 million of unrecognized compensation expense related to non-vested Restricted Stock Units There were no grants of restricted stock units to employees or directors during the three or six months ended June 30, 2021. During the three and six months ended June 30, 2020, 30,000 restricted stock units were granted. During the three and six months ended June 30, 2021, the Company recorded non-cash non-cash As of June 30, 2021, there was approximately $0.8 million of unrecognized compensation expense related to non-vested |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Subsequent to June 30, 2021, 199,746 shares of the Company’s common stock were repurchased under the Company’s stock repurchase plan. The shares were purchased at an average price of $5.48 per share for a total cost of $1.1 million. During July 2021, as a result of Health Canada re-issuing ® ® |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
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, 2020 included in the 2020 Annual Report on Form 10-K |
PRINCIPLES OF CONSOLIDATION. | b. PRINCIPLES OF CONSOLIDATION |
USE OF ESTIMATES | c. USE OF ESTIMATES. |
CASH AND CASH EQUIVALENTS | d. CASH AND CASH EQUIVALENTS. |
INVESTMENTS | e. INVESTMENTS The short-term bond funds and U.S. Treasuries held at June 30, 2021 are classified as available-for-sale non-current non-current The Company records available-for-sale available-for-sale available-for-sale |
ACCOUNTS RECEIVABLE, NET | f. ACCOUNTS RECEIVABLE, NET. |
INVENTORY | g. INVENTORY. work-in-process first-in, ® ® work-in work-in-process 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 |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | h. PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-clinical |
FAIR VALUE OF FINANCIAL INSTRUMENTS | i. FAIR VALUE OF FINANCIAL INSTRUMENTS. |
FAIR VALUE MEASUREMENTS | j. 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 Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 68,663 $ 68,663 $ — $ — U.S. Treasuries $ 49,996 $ 49,996 $ — $ — Short-term investments: Short-term bond funds $ 19,980 $ 19,980 $ — $ — Balances Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 15,674 $ 15,674 $ — $ — U.S. Treasuries $ 104,994 $ — $ 104,994 $ — Short-term investments: Short-term bond funds $ 10,041 $ 10,041 $ — $ — |
OPERATING LEASES | k. OPERATING LEASES. right-of-use non-lease |
SHARE REPURCHASES | l. SHARE REPURCHASES. The Company accounts for share repurchases by charging the excess of the |
REVENUE RECOGNITION | m. REVENUE RECOGNITION. Product Revenues: The Company recognizes revenue when its customer obtains title of the promised goods, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for these goods. The Company had no contracts with customers until the FDA approved Firdapse ® ® ® ® 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 only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses 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. 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 and six months ended June 30, 2021 and 2020. During the three and six months ended June 30, 2021 and 2020, all of the Company’s sales of Firdapse ® 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 June 30, 2021 and, therefore, the transaction price was not reduced further during the three and six months ended June 30, 2021 and 2020. 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 and Allowances: ® June 30, Prompt Payment Discounts: Funded Co-pay co-pay co-pay ® Product Returns: Provider Chargebacks and Discounts: Government Rebates: Bridge and Patient Assistance Programs: ® pre-established ® ® ® ® Revenues from Collaboration and Licensing Arrangements: The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration, (“ASC 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 FASB ASC Topic 606, Revenue from Contracts with Customers. 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 Pursuant to Topic 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. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset. 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 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 9 (Collaboration and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements. |
RESEARCH AND DEVELOPMENT | n. RESEARCH AND DEVELOPMENT. |
STOCK-BASED COMPENSATION | o. STOCK-BASED COMPENSATION. one |
CONCENTRATION OF RISK | p. CONCENTRATION OF RISK. The Company sells its product in the United States through an exclusive distributor (its Customer) to SPs. Therefore, its distributor and SPs account for all of its trade receivables and net product revenues. The creditworthiness of its Customer is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for expected credit loss primarily based on the credit worthiness of its Customer, historical payment patterns, aging of receivable balances and general economic conditions. The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse ® ® ® The Company relies exclusively on third parties to formulate and manufacture Firdapse ® ® ® |
ROYALTIES | q. ROYALTIES. |
INCOME TAXES | r. INCOME 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 | s. COMPREHENSIVE INCOME. available-for-sale |
NET INCOME PER COMMON SHARE | t. 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 For the Six Months Ended 2021 2020 2021 2020 Basic weighted average common shares outstanding 103,407,803 103,414,523 103,610,138 103,410,881 Effect of dilutive securities 4,327,121 3,315,900 3,689,124 3,022,981 Diluted weighted average common shares outstanding 107,734,924 106,730,423 107,299,262 106,433,862 Outstanding common stock equivalents totaling approximately 4.9 million and 5.1 million, were excluded from the calculation of diluted net income per common share for the three and six months ended June 30, 2021 as their effect would be anti-dilutive. For the three and six months ended June 30, 2020, approximately 3.5 million and 4.8 million shares of common stock equivalents were excluded from the calculation of diluted net income per common share as their effect would be anti-dilutive. |
RECLASSIFICATIONS | u. RECLASSIFICATIONS. v. RECENTLY ISSUED ACCOUNTING STANDARDS. 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes step-up |
RECENTLY ISSUED ACCOUNTING STANDARDS |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Fair Value Measurement Specific to Assets or Liability | Fair Value Measurements at Reporting Date Using (in thousands) Balances Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 68,663 $ 68,663 $ — $ — U.S. Treasuries $ 49,996 $ 49,996 $ — $ — Short-term investments: Short-term bond funds $ 19,980 $ 19,980 $ — $ — Balances Quoted Prices in Significant Significant Cash and cash equivalents: Money market funds $ 15,674 $ 15,674 $ — $ — U.S. Treasuries $ 104,994 $ — $ 104,994 $ — Short-term investments: Short-term bond funds $ 10,041 $ 10,041 $ — $ — |
Basic and Dilutive Weighted Average Common Shares | The following table reconciles basic and diluted weighted average common shares: For the Three Months Ended For the Six Months Ended 2021 2020 2021 2020 Basic weighted average common shares outstanding 103,407,803 103,414,523 103,610,138 103,410,881 Effect of dilutive securities 4,327,121 3,315,900 3,689,124 3,022,981 Diluted weighted average common shares outstanding 107,734,924 106,730,423 107,299,262 106,433,862 |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available-for-Sale Investments by Security type | Available-for-sale Estimated Gross Gross Amortized At June 30, 2021: U.S. Treasuries – Cash equivalents $ 49,996 $ — $ (1 ) $ 49,997 Short-term bond funds 19,980 — (36 ) 20,016 Total $ 69,976 $ — $ (37 ) $ 70,013 At December 31, 2020: U.S. Treasuries – Cash equivalents $ 104,994 $ 2 $ — $ 104,992 Short-term bond funds 10,041 29 — 10,012 Total $ 115,035 $ 31 $ — $ 115,004 |
Estimated Fair Values of Available for Sale Securities | The estimated fair values of available-for-sale June 30, 2021 Due in one year or less $ 69,976 |
Inventory, net (Tables)
Inventory, net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Summary of current inventory | Inventory, net consists of the following (in thousands): June 30, 2021 December 31, 2020 Raw materials $ 1,117 $ — Work-in-process 5,168 3,555 Finished goods 812 1,096 Total inventory, net $ 7,097 $ 4,651 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Text Block [Abstract] | |
Prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Prepaid manufacturing costs $ 2,646 $ 3,328 Prepaid tax 93 1,368 Prepaid insurance 623 1,285 Prepaid subscription fees 530 729 Prepaid research fees 391 453 Prepaid commercialization expenses 120 199 Due from collaborative and licensing arrangements 2,917 437 Other 321 529 Total prepaid expenses and other current assets $ 7,641 $ 8,328 |
Operating Leases (Tables)
Operating Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure of Operating Leases [Abstract] | |
Lease, Cost | The components of lease expense were as follows (in thousands): For the three June 30, 2021 For the six June 30, 2021 Operating lease cost $ 108 $ 164 |
Schedule of Supplemental Cash Flow Information Related To Lease | Supplemental cash flow information related to leases was as follows: June 30, 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 29 Right-of-use Operating leases $ 36 |
Schedule of Supplemental Balance Sheet related To Lease | Supplemental balance sheet information related to leases was as follows: Operating lease right-of-use $ 3,201 Other current liabilities $ 200 Operating lease liabilities, net of current portion 4,051 Total operating lease liabilities $ 4,251 Remaining lease term 9.8 years Discount rate 4.51 % |
Lessee, Operating Lease, Liability, Maturity | Remaining payments of lease liabilities as of June 30, 2021 were as follows (in thousands): 2021 (remaining six $ 80 2022 492 2023 506 2024 522 2025 537 Thereafter 3,150 Total lease payments 5,287 Less imputed interest (1,036 ) Total $ 4,251 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, net | Property and equipment, net consists of the following (in thousands): June 30, 2021 December 31, 2020 Computer equipment $ 51 $ 51 Furniture and equipment 135 242 Leasehold improvements 939 177 Less: Accumulated depreciation (211 ) (340 ) Total property and equipment, net $ $ 130 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following (in thousands): June 30, 2021 December 31, 2020 Accrued preclinical and clinical trial expenses $ 530 $ 585 Accrued professional fees 1,229 1,884 Accrued compensation and benefits 2,014 3,991 Accrued license fees 6,382 10,373 Accrued purchases 1,343 258 Accrued contributions — 310 Operating lease liability 200 29 Accrued variable consideration 1,331 964 Accrued income tax 70 — Other 112 106 Current accrued expenses and other liabilities 13,211 18,500 Lease liability—non-current 4,051 — Non-current 4,051 — Total accrued expenses and other liabilities $ 17,262 $ 18,500 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation Expense | For the three and six months ended June 30, 2021 and 2020, the Company recorded stock-based compensation expense as follows (in thousands): Three months ended Six months ended 2021 2020 2021 2020 Research and development $ 376 $ 421 $ 765 $ 839 Selling, general and administrative 1,142 1,373 2,324 2,475 Total stock-based compensation $ 1,518 $ 1,794 $ 3,089 $ 3,314 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($) shares in Millions | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2021 | Dec. 31, 2020 | |
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||
Maximum maturity period of cash and cash equivalent | three months | |||||
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 | 4.9 | 3.5 | 5.1 | 4.8 | ||
Non current investments | $ 0 | $ 0 | $ 0 | |||
Common Stock [Member] | Share Purchase Program [Member] | ||||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | ||||||
Share repurchase authorized amount | $ 40,000,000 |
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 | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 19,980 | $ 10,041 |
Short-Term Bond Fund [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 19,980 | 10,041 |
U.S. Treasuries [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 49,996 | 104,994 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 68,663 | 15,674 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | Short-Term Bond Fund [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 19,980 | 10,041 |
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 | 49,996 | |
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 | $ 68,663 | 15,674 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. Treasuries [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | $ 104,994 |
Basis of Presentation and Sig_6
Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Weighted Average Number of Shares Outstanding Reconciliation [Abstract] | ||||
Basic weighted average common shares outstanding | 103,407,803 | 103,414,523 | 103,610,138 | 103,410,881 |
Effect of dilutive securities | 4,327,121 | 3,315,900 | 3,689,124 | 3,022,981 |
Dilutive weighted average common shares outstanding | 107,734,924 | 106,730,423 | 107,299,262 | 106,433,862 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||||
Realized gains losses from available for sale securities | $ 0 | $ 0 | $ 0 | $ 0 |
Investment - Summary of Availab
Investment - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Net Investment Income [Line Items] | ||
Amortized cost | $ 70,013 | $ 115,004 |
Gross Unrealized Gains | 0 | 31 |
Gross Unrealized Losses | (37) | |
Estimated Fair Value | 69,976 | 115,035 |
U.S. Treasuries – Cash equivalents [Member] | ||
Net Investment Income [Line Items] | ||
Amortized cost | 49,997 | 104,992 |
Gross Unrealized Gains | 0 | 2 |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 49,996 | 104,994 |
Short-term bond funds [Member] | ||
Net Investment Income [Line Items] | ||
Amortized cost | 20,016 | 10,012 |
Gross Unrealized Gains | 29 | |
Gross Unrealized Losses | (36) | |
Estimated Fair Value | $ 19,980 | $ 10,041 |
Investment - Estimated Fair Val
Investment - Estimated Fair Values of Available for Sale Securities (Detail) $ in Thousands | Jun. 30, 2021USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due in one year or less | $ 69,976 |
Inventory, net - Summary Of Cur
Inventory, net - Summary Of Current Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory [Line Items] | ||
Raw materials | $ 1,117 | |
Work-in-process | 5,168 | $ 3,555 |
Finished goods | 812 | 1,096 |
Total inventory, net | $ 7,097 | $ 4,651 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid manufacturing costs | $ 2,646 | $ 3,328 |
Prepaid tax | 93 | 1,368 |
Prepaid insurance | 623 | 1,285 |
Prepaid subscription fees | 530 | 729 |
Prepaid research fees | 391 | 453 |
Prepaid commercialization expenses | 120 | 199 |
Due from collaborative arrangements | 2,917 | 437 |
Other | 321 | 529 |
Total prepaid expenses and other current assets | $ 7,641 | $ 8,328 |
Operating Leases - Operating Le
Operating Leases - Operating Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Disclosure of Operating Leases [Abstract] | ||
Operating lease cost | $ 108 | $ 164 |
Operating Leases - Schedule of
Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows | $ 29 |
Right-of-use assets obtained in exchange for lease obligations: | |
Operating leases | $ 36 |
Operating Leases -Schedule of S
Operating Leases -Schedule of Supplemental Balance Sheet related To Lease (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Disclosure of Operating Leases [Line Items] | ||
Operating lease right-of-use assets | $ 3,201 | |
Other current liabilities | 200 | $ 29 |
Operating lease liabilities, net of current portion | 4,051 | |
Total operating lease liabilities | $ 4,251 | |
Remaining lease term | 9 years 9 months 18 days | |
Discount rate | 4.51% |
Operating Leases -Lessee, Opera
Operating Leases -Lessee, Operating Lease, Liability, Maturity (Detail) $ in Thousands | Jun. 30, 2021USD ($) |
Disclosure of Operating Leases [Line Items] | |
2021 (remaining six months) | $ 80 |
2022 | 492 |
2023 | 506 |
2024 | 522 |
2025 | 537 |
Thereafter | 3,150 |
Total lease payments | 5,287 |
Less imputed interest | (1,036) |
Total | $ 4,251 |
Operating Leases - Additional
Operating Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)ft² | Jun. 30, 2020USD ($) | |
Disclosure of Operating Leases [Line Items] | ||||
Finance Lease Obligations | $ | $ 0 | $ 0 | ||
Lessor, Operating Lease, Option to Extend | 5 years | |||
Rent expense | $ | $ 100 | $ 100 | $ 200 | $ 200 |
Before agreement of company leased spaces | ft² | 7,800 | |||
After agreement of company leased spaces | ft² | 10,700 | |||
Maximum [Member] | ||||
Disclosure of Operating Leases [Line Items] | ||||
Lessor, Operating Lease, Option to Terminate | 7.6 | |||
Minimum [Member] | ||||
Disclosure of Operating Leases [Line Items] | ||||
Lessor, Operating Lease, Option to Terminate | 6 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary Of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Less: Accumulated depreciation | $ (211) | $ (340) |
Total property and equipment, net | 914 | 130 |
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 | 135 | 242 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 939 | $ 177 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued preclinical and clinical trial expenses | $ 530 | $ 585 |
Accrued professional fees | 1,229 | 1,884 |
Accrued compensation and benefits | 2,014 | 3,991 |
Accrued license fees | 6,382 | 10,373 |
Accrued purchases | 1,343 | 258 |
Accrued contributions | 310 | |
Operating lease liability | 200 | 29 |
Accrued variable consideration | 1,331 | 964 |
Accrued income tax | 70 | |
Other | 112 | 106 |
Current accrued expenses and other liabilities | 13,211 | 18,500 |
Lease liability__non-current | 4,051 | |
Non-current accrued expenses and other liabilities | 4,051 | |
Total accrued expenses and other liabilities | $ 17,262 | $ 18,500 |
Collaboration and Licensing A_2
Collaboration and Licensing Arrangements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Collaborative Arrangements [Line Items] | ||||
Period of collaboration agreement | 10 years | |||
Expenses In Connection With Collaborative Arrangement | $ 4,450,000 | $ 4,350,000 | $ 7,457,000 | $ 8,573,000 |
DyDo Pharma, Inc [Member] | ||||
Collaborative Arrangements [Line Items] | ||||
Milestone payments income | 0 | |||
Revenues | 2,700,000 | 2,700,000 | ||
Collaborative Arrangement [Member] | ||||
Collaborative Arrangements [Line Items] | ||||
Milestone payments | 2,000,000 | |||
Milestone payments income | 0 | 0 | ||
Expenses In Connection With Collaborative Arrangement | 8,554 | 4,206 | ||
Revenues | 0 | $ 0 | 0 | $ 0 |
Endo Collaboration [Member] | ||||
Collaborative Arrangements [Line Items] | ||||
Expenses In Connection With Collaborative Arrangement | 45,000 | 45,000 | ||
KYE Pharmaceuticals Collaboration [Member] | Selling, General and Administrative Expenses [Member] | ||||
Collaborative Arrangements [Line Items] | ||||
Expenses In Connection With Collaborative Arrangement | 2,000 | 40,000 | ||
Revenues from collaborative arrangements | $ 0 | $ 0 |
Agreements - Additional Informa
Agreements - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($) | |
License Agreement [Line Items] | |
Percentage of royalty on net sales | 3.50% |
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 |
License Agreement with BioMarin [Member] | Minimum [Member] | |
License Agreement [Line Items] | |
Percentage of royalty on net sales | 7.00% |
License Agreement with BioMarin [Member] | Maximum [Member] | |
License Agreement [Line Items] | |
Percentage of royalty on net sales | 10.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Tax Disclosure [Line Items] | |||
Unrecognized Tax Benefits that Would Impact Effective Tax Rate | $ 0 | $ 0 | $ 0 |
Effective Income Tax Rate Reconciliation, Percent | 23.00% | 5.70% | |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% |
Stockholders' Equity (Preferred
Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021USD ($)Vote$ / sharesshares | Mar. 31, 2021USD ($)shares | Jun. 30, 2021USD ($)Vote$ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Stockholders Equity [Line Items] | ||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | 5,000,000 | |
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred stock, shares outstanding | 0 | 0 | 0 | |
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | |
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares issued | 103,162,041 | 103,162,041 | 103,781,641 | |
Common stock, shares outstanding | 103,162,041 | 103,162,041 | 103,781,641 | |
Number of votes entitled for each share of common stock | Vote | 1 | 1 | ||
Share Repurchased During The Period Shares | 732,951 | 800,000 | ||
Average purchase price per share | $ / shares | $ 5 | $ 4.95 | ||
Payment to acquire shares | $ | $ 3,700 | $ 3,961 | ||
Common Stock [Member] | ||||
Stockholders Equity [Line Items] | ||||
Common stock, shares authorized | 200,000,000 | |||
Common stock, par value | $ / shares | $ 0.001 | |||
Common stock, shares issued | 103,162,041 | 103,162,041 | 103,781,641 | |
Common stock, shares outstanding | 103,162,041 | 103,162,041 | 103,781,641 | |
Share Repurchased During The Period Shares | 733,000 | 67,000 | ||
Share Purchase Program [Member] | Common Stock [Member] | ||||
Stockholders Equity [Line Items] | ||||
Share repurchase authorized amount | $ | $ 40,000 |
Stockholders' Equity (2020 Shel
Stockholders' Equity (2020 Shelf Registration Statement) - Additional Information (Detail) $ in Millions | Jul. 23, 2020USD ($) |
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 | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 1,518 | $ 1,794 | $ 3,089 | $ 3,314 |
Research and Development [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 376 | 421 | 765 | 839 |
Selling, General and Administrative [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 1,142 | $ 1,373 | $ 2,324 | $ 2,475 |
Stock Compensation - Additional
Stock Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Proceeds from exercise of stock options | $ 459,000 | $ 62,000 | ||
Stock options to purchase shares of common stock | 13,759,670 | 13,759,670 | ||
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options granted, expiration Period | 7 years | 7 years | 7 years | 7 years |
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 | $ 800,000 | $ 800,000 | ||
Expected remaining weighted average vesting period | 1 year 5 months 26 days | |||
Non-cash stock-based compensation expense | $ 100,000 | $ 200,000 | $ 300,000 | $ 300,000 |
Common stock granted | 0 | 30,000 | 0 | 30,000 |
Options to Purchase Common Stock [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of stock options exercised | 83,332 | 13,333 | 173,330 | 24,999 |
Proceeds from exercise of stock options | $ 270,523 | $ 36,201 | $ 458,818 | $ 62,350 |
Common stock unit granted | 70,000 | 260,000 | 630,000 | 995,000 |
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan | $ 8,300,000 | $ 8,300,000 | ||
Expected remaining weighted average vesting period | 2 years 29 days | |||
Non-cash stock-based compensation expense | $ 1,400,000 | $ 1,600,000 | $ 2,800,000 | $ 3,000,000 |
Stock options to purchase shares of common stock | 8,765,623 | 8,765,623 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Jul. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2021 | |
Subsequent Event [Line Items] | |||
Treasury Stock Acquired, Average Cost Per Share | $ 5 | $ 4.95 | |
Subsequent Event [Member] | Common Stock [Member] | |||
Subsequent Event [Line Items] | |||
Number of Shares Authorized to be Repurchased | 199,746 | ||
Treasury Stock Acquired, Average Cost Per Share | $ 5.48 | ||
Stock Repurchase Program, Authorized Amount | $ 1.1 |