Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
|---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
|
| Total revenue | $ 2,474 | $ 1,501 | $ 5,768 | $ 3,082 |
| Operating costs and expenses: | ||||
| Cost of goods sold | 205 | 200 | 435 | 486 |
| Research and development | 97,161 | 77,297 | 189,987 | 155,315 |
| Selling, general and administrative | 75,565 | 52,411 | 141,273 | 98,888 |
| Total operating costs and expenses | 172,931 | 129,908 | 331,695 | 254,689 |
| Loss from operations | (170,457) | (128,407) | (325,927) | (251,607) |
| Interest income, net | 10,173 | 2,102 | 19,003 | 3,270 |
| Other income (expense), net | (41) | 45 | (229) | 22 |
| Net loss | $ (160,325) | $ (126,260) | $ (307,153) | $ (248,315) |
| Net loss per share—basic | $ (2.68) | $ (2.13) | $ (5.14) | $ (4.2) |
| Net loss per share—diluted | $ (2.68) | $ (2.13) | $ (5.14) | $ (4.2) |
| Weighted average number of common shares outstanding— basic | 59,769,640 | 59,266,322 | 59,722,147 | 59,148,246 |
| Weighted average number of common shares outstanding— diluted | 59,769,640 | 59,266,322 | 59,722,147 | 59,148,246 |
| Comprehensive loss: | ||||
| Net loss | $ (160,325) | $ (126,260) | $ (307,153) | $ (248,315) |
| Other comprehensive items: | ||||
| Unrealized gain (loss) on marketable securities | (556) | (2,671) | 4,562 | (11,212) |
| Total other comprehensive gain (loss) | (556) | (2,671) | 4,562 | (11,212) |
| Total comprehensive loss | (160,881) | (128,931) | (302,591) | (259,527) |
| Product Revenue [Member] | ||||
| Total revenue | 2,460 | $ 1,501 | 5,754 | $ 3,082 |
| Collaboration Revenue [Member] | ||||
| Total revenue | $ 14 | $ 14 | ||
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- Definition Cost of sales. No definition available.
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- Definition Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The net amount of nonoperating interest income (expense). No definition available.
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- Definition The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- References No definition available.
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- Definition Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
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- Definition The net result for the period of deducting operating expenses from operating revenues. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount after tax and reclassification adjustments of other comprehensive income (loss). Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- References No definition available.
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- Definition Amount, after tax and before adjustment, of unrealized holding gain (loss) on investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale). Excludes unrealized gain (loss) on investment in debt security measured at amortized cost (held-to-maturity) from transfer to available-for-sale. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of income (expense) related to nonoperating activities, classified as other. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The aggregate costs incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, including the costs of developing computer software up to the point in time of achieving technological feasibility, and costs allocated in accounting for a business combination to in-process projects deemed to have no alternative future use. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss). Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition The aggregate total costs related to selling a firm's product and services, as well as all other general and administrative expenses. Direct selling expenses (for example, credit, warranty, and advertising) are expenses that can be directly linked to the sale of specific products. Indirect selling expenses are expenses that cannot be directly linked to the sale of specific products, for example telephone expenses, Internet, and postal charges. General and administrative expenses include salaries of non-sales personnel, rent, utilities, communication, etc. Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
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- Definition The average number of shares or units issued and outstanding that are used in calculating diluted EPS or earnings per unit (EPU), determined based on the timing of issuance of shares or units in the period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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- Definition Number of [basic] shares or units, after adjustment for contingently issuable shares or units and other shares or units not deemed outstanding, determined by relating the portion of time within a reporting period that common shares or units have been outstanding to the total time in that period. Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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