Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 05, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-36274 | |
Entity Registrant Name | INTRA-CELLULAR THERAPIES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4742850 | |
Entity Address, Address Line One | 430 East 29th Street | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10016 | |
City Area Code | 646 | |
Local Phone Number | 440-9333 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ITCI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 105,666,925 | |
Entity Central Index Key | 0001567514 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 693,306 | $ 147,767 |
Investment securities, available-for-sale | 329,601 | 350,174 |
Restricted cash | 1,750 | 1,750 |
Accounts receivable, net | 145,714 | 114,018 |
Inventory | 20,082 | 11,647 |
Prepaid expenses and other current assets | 73,798 | 42,443 |
Total current assets | 1,264,251 | 667,799 |
Property and equipment, net | 1,445 | 1,654 |
Right of use assets, net | 14,507 | 12,928 |
Inventory, non-current | 32,562 | 38,621 |
Other assets | 7,739 | 7,293 |
Total assets | 1,320,504 | 728,295 |
Current liabilities: | ||
Accounts payable | 17,548 | 11,452 |
Accrued and other current liabilities | 39,713 | 27,944 |
Accrued customer programs | 77,971 | 53,173 |
Accrued employee benefits | 22,372 | 27,364 |
Operating lease liabilities | 4,171 | 3,612 |
Total current liabilities | 161,775 | 123,545 |
Operating lease liabilities, non-current | 14,117 | 13,326 |
Total liabilities | 175,892 | 136,871 |
Stockholders’ equity: | ||
Common stock, $0.0001 par value: 175,000,000 shares authorized at June 30, 2024 and December 31, 2023, respectively; 105,624,902 and 96,379,811 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 11 | 10 |
Additional paid-in capital | 2,793,896 | 2,208,470 |
Accumulated deficit | (1,648,627) | (1,617,160) |
Accumulated comprehensive (loss) income | (668) | 104 |
Total stockholders’ equity | 1,144,612 | 591,424 |
Total liabilities and stockholders’ equity | $ 1,320,504 | $ 728,295 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 175,000,000 | 175,000,000 |
Common stock, shares issued (in shares) | 105,624,902 | 96,379,811 |
Common stock, shares outstanding (in shares) | 105,624,902 | 96,379,811 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Total revenues, net | $ 161,388 | $ 110,792 | $ 306,254 | $ 206,098 |
Operating expenses: | ||||
Cost of product sales | 11,354 | 7,163 | 21,254 | 13,914 |
Selling, general and administrative | 121,574 | 101,014 | 234,659 | 199,937 |
Research and development | 56,183 | 49,794 | 99,016 | 87,818 |
Total operating expenses | 189,111 | 157,971 | 354,929 | 301,669 |
Loss from operations | (27,723) | (47,179) | (48,675) | (95,571) |
Interest income | 11,560 | 4,530 | 17,624 | 8,879 |
Loss before provision for income taxes | (16,163) | (42,649) | (31,051) | (86,692) |
Income tax expense | (57) | (135) | (416) | (145) |
Net loss | $ (16,220) | $ (42,784) | $ (31,467) | $ (86,837) |
Net loss per common share: | ||||
Basic (in dollars per share) | $ (0.16) | $ (0.45) | $ (0.31) | $ (0.91) |
Diluted (in dollars per share) | $ (0.16) | $ (0.45) | $ (0.31) | $ (0.91) |
Weighted average number of common shares: | ||||
Basic (in shares) | 103,723,007 | 95,948,063 | 100,299,141 | 95,543,626 |
Diluted (in share) | 103,723,007 | 95,948,063 | 100,299,141 | 95,543,626 |
Product sales, net | ||||
Total revenues, net | $ 161,276 | $ 110,128 | $ 306,119 | $ 204,859 |
Grant revenue | ||||
Total revenues, net | $ 112 | $ 664 | $ 135 | $ 1,239 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (16,220) | $ (42,784) | $ (31,467) | $ (86,837) |
Other comprehensive (loss) gain: | ||||
Unrealized (loss) gain on investment securities | (238) | 430 | (772) | 1,922 |
Comprehensive loss | $ (16,458) | $ (42,354) | $ (32,239) | $ (84,915) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive (Loss) Income |
Beginning balance (in shares) at Dec. 31, 2022 | 94,829,794 | ||||
Beginning balance at Dec. 31, 2022 | $ 656,070 | $ 9 | $ 2,137,737 | $ (1,477,486) | $ (4,190) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and issuances of restricted stock (in shares) | 849,827 | ||||
Exercise of stock options and issuances of restricted stock | 3,640 | $ 1 | 3,639 | ||
Stock issued for services (in shares) | 408 | ||||
Stock issued for services | 22 | 22 | |||
Share-based compensation | 10,439 | 10,439 | |||
Net loss | (44,053) | (44,053) | |||
Other comprehensive gain (loss) | 1,492 | 1,492 | |||
Ending balance (in shares) at Mar. 31, 2023 | 95,680,029 | ||||
Ending balance at Mar. 31, 2023 | 627,610 | $ 10 | 2,151,837 | (1,521,539) | (2,698) |
Beginning balance (in shares) at Dec. 31, 2022 | 94,829,794 | ||||
Beginning balance at Dec. 31, 2022 | 656,070 | $ 9 | 2,137,737 | (1,477,486) | (4,190) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (86,837) | ||||
Ending balance (in shares) at Jun. 30, 2023 | 96,083,387 | ||||
Ending balance at Jun. 30, 2023 | 607,090 | $ 10 | 2,173,671 | (1,564,323) | (2,268) |
Beginning balance (in shares) at Mar. 31, 2023 | 95,680,029 | ||||
Beginning balance at Mar. 31, 2023 | 627,610 | $ 10 | 2,151,837 | (1,521,539) | (2,698) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and issuances of restricted stock (in shares) | 402,994 | ||||
Exercise of stock options and issuances of restricted stock | 8,585 | 8,585 | |||
Stock issued for services (in shares) | 364 | ||||
Stock issued for services | 23 | 23 | |||
Share-based compensation | 13,226 | 13,226 | |||
Net loss | (42,784) | (42,784) | |||
Other comprehensive gain (loss) | 430 | 430 | |||
Ending balance (in shares) at Jun. 30, 2023 | 96,083,387 | ||||
Ending balance at Jun. 30, 2023 | 607,090 | $ 10 | 2,173,671 | (1,564,323) | (2,268) |
Beginning balance (in shares) at Dec. 31, 2023 | 96,379,811 | ||||
Beginning balance at Dec. 31, 2023 | 591,424 | $ 10 | 2,208,470 | (1,617,160) | 104 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Exercise of stock options and issuances of restricted stock (in shares) | 1,097,668 | ||||
Exercise of stock options and issuances of restricted stock | 9,989 | 9,989 | |||
Stock issued for services (in shares) | 339 | ||||
Stock issued for services | 23 | 23 | |||
Share-based compensation | 13,843 | 13,843 | |||
Net loss | (15,247) | (15,247) | |||
Other comprehensive gain (loss) | (534) | (534) | |||
Ending balance (in shares) at Mar. 31, 2024 | 97,477,818 | ||||
Ending balance at Mar. 31, 2024 | 599,498 | $ 10 | 2,232,325 | (1,632,407) | (430) |
Beginning balance (in shares) at Dec. 31, 2023 | 96,379,811 | ||||
Beginning balance at Dec. 31, 2023 | 591,424 | $ 10 | 2,208,470 | (1,617,160) | 104 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (31,467) | ||||
Ending balance (in shares) at Jun. 30, 2024 | 105,624,902 | ||||
Ending balance at Jun. 30, 2024 | 1,144,612 | $ 11 | 2,793,896 | (1,648,627) | (668) |
Beginning balance (in shares) at Mar. 31, 2024 | 97,477,818 | ||||
Beginning balance at Mar. 31, 2024 | 599,498 | $ 10 | 2,232,325 | (1,632,407) | (430) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Common shares issued (in shares) | 7,876,713 | ||||
Common shares issued | 543,086 | $ 1 | 543,085 | ||
Exercise of stock options and issuances of restricted stock (in shares) | 270,026 | ||||
Exercise of stock options and issuances of restricted stock | 2,093 | 2,093 | |||
Stock issued for services (in shares) | 345 | ||||
Stock issued for services | 23 | 23 | |||
Share-based compensation | 16,370 | 16,370 | |||
Net loss | (16,220) | (16,220) | |||
Other comprehensive gain (loss) | (238) | (238) | |||
Ending balance (in shares) at Jun. 30, 2024 | 105,624,902 | ||||
Ending balance at Jun. 30, 2024 | $ 1,144,612 | $ 11 | $ 2,793,896 | $ (1,648,627) | $ (668) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows used in operating activities | ||
Net loss | $ (31,467) | $ (86,837) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 261 | 257 |
Share-based compensation | 30,213 | 23,665 |
Stock issued for services | 46 | 45 |
Amortization of premiums and accretion of discounts on investment securities, net | (4,196) | (3,670) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (31,696) | (20,775) |
Inventory | (2,376) | (17,975) |
Prepaid expenses and other assets | (31,801) | (417) |
Accounts payable | 6,096 | (2,662) |
Accrued and other current liabilities | 11,769 | 7,799 |
Accrued customer programs | 24,798 | 6,089 |
Accrued employee benefits | (4,992) | (1,373) |
Operating lease liabilities, net | (229) | (1,014) |
Net cash used in operating activities | (33,574) | (96,868) |
Cash flows provided by investing activities | ||
Purchases of investments | (169,570) | (174,411) |
Maturities of investments | 193,568 | 252,697 |
Purchases of property and equipment | (53) | 0 |
Net cash provided by investing activities | 23,945 | 78,286 |
Cash flows provided by financing activities | ||
Proceeds from exercise of stock options | 12,082 | 12,225 |
Proceeds from sale of common stock, net | 543,086 | 0 |
Net cash provided by financing activities | 555,168 | 12,225 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 545,539 | (6,357) |
Cash, cash equivalents, and restricted cash at beginning of period | 149,517 | 150,365 |
Cash, cash equivalents, and restricted cash at end of period | 695,056 | 144,008 |
Non-cash investing and financing activities | ||
Right of use assets under operating leases | 2,548 | 0 |
Supplemental cash flow information | ||
Cash paid for taxes | $ 1,364 | $ 6 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Cash Flows [Abstract] | ||||
Cash and cash equivalents | $ 693,306 | $ 147,767 | $ 142,258 | |
Restricted cash | 1,750 | 1,750 | 1,750 | |
Total cash, cash equivalents and restricted cash | $ 695,056 | $ 149,517 | $ 144,008 | $ 150,365 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiary, ITI, Inc. (“ITI”), is a biopharmaceutical company focused on the discovery, clinical development and commercialization of innovative, small molecule drugs that address underserved medical needs primarily in psychiatric and neurological disorders. In December 2019, CAPLYTA® (lumateperone) was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia in adults (42 mg/day) and the Company initiated the commercial launch of CAPLYTA in March 2020. In December 2021, CAPLYTA was approved by the FDA for the treatment of bipolar depression in adults (42 mg/day) and the Company initiated the commercial launch of CAPLYTA for the treatment of bipolar depression. Additionally, in April 2022, the FDA approved two additional dosage strengths of CAPLYTA, 10.5 mg and 21 mg capsules, to provide dosage recommendations for patients concomitantly taking strong or moderate CYP3A4 inhibitors, and 21 mg capsules for patients with moderate or severe hepatic impairment (Child-Pugh class B or C). The commercial launch of these special population doses occurred in August 2022. As used in these Notes to Condensed Consolidated Financial Statements, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults and for the treatment of bipolar depression in adults, and “lumateperone” refers to, where applicable, CAPLYTA as well as lumateperone for the treatment of indications beyond schizophrenia and bipolar depression. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly owned subsidiary have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States GAAP set forth in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). All intercompany accounts and transactions have been eliminated in consolidation. The Company currently operates in one operating segment. Operating segments are defined as components of an enterprise about which separate discrete information is available for the chief operating decision maker, or decision making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business in one segment, which is discovering, developing and commercializing drugs primarily in psychiatric and neurological disorders. Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures , requiring public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are also required to apply the disclosure requirements. The standard is effective for annual reporting periods beginning after December 15, 2023, and for interim reporting periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential impact that this new standard will have on its consolidated financial statements and related disclosures. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Although actual results could differ from those estimates, management does not believe that such differences would be material. Significant Accounting Policies The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist of accounts receivable, net from customers and cash, cash equivalents and investments held at financial institutions. For the six-month period ended June 30, 2024, 97% of product sales were generated from three major industry wholesalers. Three individual customers accounted for approximately 35%, 26%, and 36% as well as 37%, 30%, and 29% of product sales for the six-month periods ended June 30, 2024 and 2023, respectively. As of June 30, 2024, the Company continues to believe that such customers are of high credit quality. |
Investment Securities
Investment Securities | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Investment Securities | Investment Securities Investment securities consisted of the following (in thousands): June 30, 2024 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 91,148 $ 5 $ (142) $ 91,011 FDIC Certificates of Deposit 1,470 — (1) 1,469 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 33,669 — (19) 33,650 Corporate Notes/Bonds 163,982 6 (517) 163,471 $ 350,269 $ 11 $ (679) $ 349,601 December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 150,651 $ 148 $ (204) $ 150,595 FDIC Certificates of Deposit 4,410 2 (12) 4,400 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 78,610 59 (27) 78,642 Corporate Notes/Bonds 118,899 281 (143) 119,037 $ 412,570 $ 490 $ (386) $ 412,674 The Company has classified all of its investment securities as available-for-sale, including those with maturities beyond one year, as current assets on the condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of June 30, 2024 and December 31, 2023, the Company held $110.7 million and $77.8 million, respectively, of available-for-sale investment securities with contractual maturity dates more than one year and less than two years, with the remainder of the available-for-sale investment securities having contractual maturity dates less than one year. Accrued interest receivable from investment securities as of June 30, 2024 and December 31, 2023 was $2.7 million and $2.3 million, respectively, and are included within prepaid expenses and other current assets. The aggregate related fair value of investments with unrealized losses as of June 30, 2024 was $274.7 million, which consisted of $81.0 million of U.S. government agency securities, $1.5 million of certificates of deposit, $33.7 million of commercial paper, and $158.5 million of corporate notes/bonds. $16.2 million of the aggregate fair value of investments with unrealized losses as of June 30, 2024 has been held in a continuous unrealized loss position for over 12 months, with the remaining $258.5 million held in a continuous unrealized loss position for less than 12 months. As of December 31, 2023, the aggregate related fair value of investments with unrealized losses was $165.2 million. $70.1 million of the aggregate fair value of investments with unrealized losses as of December 31, 2023 had been held in a continuous unrealized loss position for more than 12 months, with the remaining $95.1 million held in a continuous unrealized loss position for less than 12 months. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company applies the fair value method under ASC Topic 820, Fair Value Measurements and Disclosures . The ASC Topic 820 hierarchy ranks the quality and reliability of inputs, or assumptions, used in the determination of fair value and requires assets and liabilities carried at fair value to be classified and disclosed in one of the following categories based on the lowest level input used that is significant to a particular fair value measurement: • Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. • Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. • Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. The Company had no assets or liabilities that were measured using prices with significant unobservable inputs (Level 3 assets and liabilities) as of June 30, 2024 and December 31, 2023. The carrying value of cash held in money market funds of $81.9 million as of June 30, 2024 and $10.7 million as of December 31, 2023 is included in cash and cash equivalents on the condensed consolidated balance sheets and approximates market value based on quoted market prices or Level 1 inputs. The carrying value of cash held in certificates of deposit of $20.0 million as of June 30, 2024 is included in cash and cash equivalents. The carrying value of cash held in U.S. government agency securities of $2.5 million and certificates of deposit of $60.0 million as of December 31, 2023 is included in cash and cash equivalents. The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at June 30, Quoted Prices Significant Significant Money Market Funds $ 81,940 $ 81,940 $ — $ — U.S. Government Agency Securities 91,011 — 91,011 — FDIC Certificates of Deposit 1,469 — 1,469 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 33,650 — 33,650 — Corporate Notes/Bonds 163,471 — 163,471 — $ 431,541 $ 81,940 $ 349,601 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 10,698 $ 10,698 $ — $ — U.S. Government Agency Securities 150,595 — 150,595 — FDIC Certificates of Deposit 4,400 — 4,400 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 78,642 — 78,642 — Corporate Notes/Bonds 119,037 — 119,037 — $ 423,372 $ 10,698 $ 412,674 $ — |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consists of the following (in thousands): June 30, December 31, Raw materials $ 32,562 $ 38,621 Work in process 12,151 4,277 Finished goods 7,931 7,370 Total 52,644 50,268 Less: Current portion (20,082) (11,647) Total inventory, non-current $ 32,562 $ 38,621 As of June 30, 2024 and December 31, 2023, the Company has recorded $8.0 million and $7.7 million, respectively, in inventory on the condensed consolidated balance sheets which is subject to supplemental regulatory procedures but the Company believes it is probable that such inventory has future economic benefit. |
Prepaid and Other Assets
Prepaid and Other Assets | 6 Months Ended |
Jun. 30, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid and Other Assets | Prepaid and Other Assets Prepaid expenses and other assets consist of the following (in thousands): June 30, December 31, Prepaid operating expenses $ 27,990 $ 19,465 Production campaign deposits 24,202 15,127 Clinical trial advances 24,778 11,630 Prefunded customer programs 4,567 3,514 Total 81,537 49,736 Less: Current portion (73,798) (42,443) Total other assets $ 7,739 $ 7,293 |
Right of Use Assets and Lease L
Right of Use Assets and Lease Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Right of Use Assets and Lease Liabilities | Right of Use Assets and Lease Liabilities In 2014, the Company entered into a long-term lease with a related party, which, as amended, provided for a lease of useable laboratory and office space located in New York, New York. A member of the Company’s board of directors is the Executive Chairman of the parent company to the landlord under this lease. Concurrent with this lease, the Company entered into a license agreement to occupy certain vivarium-related space in the same facility for the same term and rent escalation provisions as the lease. This license has the primary characteristics of a lease and is characterized as a lease in accordance with ASC Topic 842, Leases, for accounting purposes. In September 2018, the Company further amended the lease to obtain an additional office space beginning October 1, 2018 and to extend the term of the lease for previously acquired space. The lease, as amended, has a term of 14.3 years ending in May 2029. In May 2024, the Company entered into a long-term lease of office space in Bedminster, New Jersey. The lease has a term of 5.7 years ending in February 2030. The Company has also entered into an agreement (the “Vehicle Lease”) with a company (the “Lessor”) to acquire motor vehicles for certain employees. The Vehicle Lease provides for individual vehicle leases, which at each lease commencement was determined to qualify for operating lease treatment. The contractual period of each lease is 12 months, followed by month-to-month renewal periods. The Company estimates the lease term for each vehicle to be 12 months. Leases which the Company determined to have a lease term of 12 months or less will be treated as short-term in accordance with the accounting policy election and are not recognized on the balance sheet. Each lease permits either party to terminate the lease at any time via written notice to the other party. The Company neither acquires ownership of, nor has the option to purchase the vehicles at any time. The Company is required to maintain an irrevocable $1.75 million letter of credit that the Lessor may draw upon in the event the Company defaults on the Vehicle Lease, which has been recorded as restricted cash on the condensed consolidated balance sheets. The following table presents the weighted average remaining lease term, and the weighted average discount rates related to leases as of June 30, 2024 and December 31, 2023: June 30, 2024 December 31, 2023 Other information Weighted average remaining lease term 4.9 years 5.3 years Weighted average discount rate 8.83 % 9.07 % The following table presents the lease cost for the six-month periods ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Lease cost Operating lease cost $ 1,974 $ 2,003 Variable lease cost 844 724 Short-term lease cost 1,216 599 $ 4,034 $ 3,326 Maturity analysis under the lease agreements is as follows (in thousands): Six months ending December 31, 2024 $ 2,165 Year ending December 31, 2025 4,436 Year ending December 31, 2026 4,513 Year ending December 31, 2027 4,573 Year ending December 31, 2028 4,707 Thereafter 2,351 Total 22,745 Less: Present value discount (4,457) Total operating lease liability 18,288 Less: Current portion (4,171) Operating lease liabilities, non-current $ 14,117 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies License and Royalty Commitments On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which the Company holds a license to certain patents and know-how of BMS relating to lumateperone and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop or commercialize lumateperone and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the agreement to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds. Under the agreement, the Company has made payments of $10.8 million to BMS related to milestones achieved to date for lumateperone. Possible milestone payments remaining total $5.0 million. Under the agreement, the Company may be obliged to make other milestone payments to BMS for each licensed product of up to an aggregate of approximately $14.75 million. The Company is also obliged to make tiered single digit percentage royalty payments ranging between 5 – 9% on sales of licensed products. The Company is obliged to pay to BMS a percentage of non-royalty payments made in consideration of any sublicense. The agreement extends, and royalties are payable, on a country-by-country and product-by-product basis, through the later of 10 years after first commercial sale of a licensed product in such country, expiration of the last licensed patent covering a licensed product, its method of manufacture or use, or the expiration of other government grants providing market exclusivity, subject to certain rights of the parties to terminate the agreement on the occurrence of certain events. On termination of the agreement, the Company may be obliged to convey to BMS rights in developments relating to a licensed compound or licensed product, including regulatory filings, research results and other intellectual property rights. Purchase Commitments |
Share-Based Compensation
Share-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation Total share-based compensation expense related to all of the Company's share-based awards, including stock options and restricted stock units (“RSUs”), granted to employees and directors recognized during the six-month periods ended June 30, 2024 and 2023, was comprised of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Inventoriable costs $ 491 $ 420 $ 908 $ 762 Selling, general and administrative 10,808 8,725 20,025 15,705 Research and development 5,071 4,081 9,280 7,198 Total share-based compensation expense $ 16,370 $ 13,226 $ 30,213 $ 23,665 Information regarding the stock options activity, including with respect to grants to employees and directors under the Amended and Restated 2018 Equity Incentive Plan (the Amended 2018 Plan) and 2019 Inducement Award Plan (the 2019 Inducement Plan) as of June 30, 2024, and changes during the six-month period then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2023 4,239,982 $ 28.22 5.2 years Options granted 2024 17,288 Options exercised 2024 (574,301) Options canceled or expired 2024 (9,347) Outstanding at June 30, 2024 3,673,622 $ 29.38 5.1 years Vested and expected to vest at June 30, 2024 3,673,622 $ 29.38 Exercisable at June 30, 2024 3,320,956 $ 26.94 4.7 years The fair value of the time-based RSUs is based on the closing price of the Company’s common stock on the date of grant. Information regarding the time-based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan, and changes during the six-month period ended June 30, 2024 is summarized as follows: Number of Weighted-Average Weighted- Outstanding at December 31, 2023 1,645,130 $ 48.92 1.0 year Time-based RSUs granted in 2024 1,033,819 Time-based RSUs vested in 2024 (719,864) Time-based RSUs cancelled in 2024 (29,622) Outstanding at June 30, 2024 1,929,463 $ 59.99 1.4 years |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share The following share-based awards were excluded in the calculation of diluted net loss per common share because their effect could be anti-dilutive as applied to the loss from operations for the three and six-month periods ended June 30, 2024 and 2023: Three and Six Months Ended June 30, 2024 2023 Stock options 3,673,622 4,515,188 RSUs 2,153,965 1,841,855 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net loss | $ (16,220) | $ (15,247) | $ (42,784) | $ (44,053) | $ (31,467) | $ (86,837) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 shares | Jun. 30, 2024 shares | |
Trading Arrangements, by Individual | ||
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Michael I. Halstead [Member] | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | • On May 22, 2024, Sharon Mates, Ph.D., Chairman and Chief Executive Officer, adopted a Rule 10b5-1 Sales Plan having an end date of December 31, 2024. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of up to an aggregate of 286,998 shares of our common stock, including the potential sale of up to 216,998 shares of our common stock upon the exercise of stock options with an exercise expiration date of January 1, 2025. On May 28, 2024, Dr. Mates adopted a subsequently commencing Rule 10b5-1 Sales Plan with a start date of January 2, 2025 and an end date of March 31, 2025. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of (i) an aggregate of 96,247 shares of our common stock upon the vesting of restricted stock units and (ii) all shares issuable upon the vesting of performance restricted stock units for up to 30,847 shares of our common stock at maximum achievement of the performance vesting conditions. • On June 4, 2024, Suresh Durgam, M.D., Executive Vice President, Chief Medical Officer, adopted a Rule 10b5-1 Sales Plan having an end date of March 31, 2025. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of an indeterminate number of shares of our common stock sufficient to cover Dr. Durgam’s tax liability (i) upon the vesting of restricted stock units for an aggregate of 29,220 shares of our common stock and (ii) upon the vesting of performance restricted stock units for up to 11,017 shares of our common stock at maximum achievement of the performance vesting conditions. • On June 7, 2024, Mark Neumann, Executive Vice President, Chief Commercial Officer, adopted a Rule 10b5-1 Sales Plan having an end date of March 31, 2025. The plan is intended to satisfy the affirmative defense of Rule 10b5-1(c) and provides for the sale of (i) an aggregate of 29,200 shares of our common stock upon the vesting of restricted stock units and (ii) all shares issuable upon the vesting of performance restricted stock units for up to 11,017 shares of our common stock at maximum achievement of the performance vesting conditions. | |
Sharon Mates, Ph.D [Member] | ||
Trading Arrangements, by Individual | ||
Arrangement Duration | 223 days | |
Suresh Durgam, M.D [Member] | ||
Trading Arrangements, by Individual | ||
Name | Suresh Durgam, M.D | |
Title | Executive Vice President, Chief Medical Officer, | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | June 4, 2024 | |
Expiration Date | March 31, 2025 | |
Arrangement Duration | 300 days | |
Aggregate Available | 29,220 | 29,220 |
Mark Neumann [Member] | ||
Trading Arrangements, by Individual | ||
Name | Mark Neumann | |
Title | Executive Vice President, Chief Commercial Officer, | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | June 7, 2024 | |
Expiration Date | March 31, 2025 | |
Arrangement Duration | 480 days | |
Aggregate Available | 29,200 | 29,200 |
Dr. Mates [Member] | ||
Trading Arrangements, by Individual | ||
Arrangement Duration | 88 days | |
Sharon Mates, Ph.D Trading Arrangement, May 22 Plan [Member] | Sharon Mates, Ph.D [Member] | ||
Trading Arrangements, by Individual | ||
Name | Sharon Mates, Ph.D. | |
Title | Chairman and Chief Executive Officer, | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | May 22, 2024 | |
Expiration Date | December 31, 2024 | |
Aggregate Available | 286,998 | 286,998 |
Sharon Mates, Ph.D Trading Arrangement, May 28 Plan [Member] | Sharon Mates, Ph.D [Member] | ||
Trading Arrangements, by Individual | ||
Name | Dr. Mates | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | May 28, 2024 | |
Expiration Date | March 31, 2025 | |
Aggregate Available | 96,247 | 96,247 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures |
Use of Estimates | Use of Estimates |
Significant Accounting Policies | Significant Accounting Policies |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist of accounts receivable, net from customers and cash, cash equivalents and investments held at financial institutions. For the six-month period ended June 30, 2024, 97% of product sales were generated from three major industry wholesalers. |
Investment Securities (Tables)
Investment Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Investment Securities | Investment securities consisted of the following (in thousands): June 30, 2024 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 91,148 $ 5 $ (142) $ 91,011 FDIC Certificates of Deposit 1,470 — (1) 1,469 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 33,669 — (19) 33,650 Corporate Notes/Bonds 163,982 6 (517) 163,471 $ 350,269 $ 11 $ (679) $ 349,601 December 31, 2023 Amortized Unrealized Unrealized Estimated U.S. Government Agency Securities $ 150,651 $ 148 $ (204) $ 150,595 FDIC Certificates of Deposit 4,410 2 (12) 4,400 Certificates of Deposit 60,000 — — 60,000 Commercial Paper 78,610 59 (27) 78,642 Corporate Notes/Bonds 118,899 281 (143) 119,037 $ 412,570 $ 490 $ (386) $ 412,674 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities | The fair value measurements of the Company’s cash equivalents and available-for-sale investment securities are identified in the following tables (in thousands): Fair Value Measurements at June 30, Quoted Prices Significant Significant Money Market Funds $ 81,940 $ 81,940 $ — $ — U.S. Government Agency Securities 91,011 — 91,011 — FDIC Certificates of Deposit 1,469 — 1,469 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 33,650 — 33,650 — Corporate Notes/Bonds 163,471 — 163,471 — $ 431,541 $ 81,940 $ 349,601 $ — Fair Value Measurements at December 31, Quoted Prices Significant Significant Money Market Funds $ 10,698 $ 10,698 $ — $ — U.S. Government Agency Securities 150,595 — 150,595 — FDIC Certificates of Deposit 4,400 — 4,400 — Certificates of Deposit 60,000 — 60,000 — Commercial Paper 78,642 — 78,642 — Corporate Notes/Bonds 119,037 — 119,037 — $ 423,372 $ 10,698 $ 412,674 $ — |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consists of the following (in thousands): June 30, December 31, Raw materials $ 32,562 $ 38,621 Work in process 12,151 4,277 Finished goods 7,931 7,370 Total 52,644 50,268 Less: Current portion (20,082) (11,647) Total inventory, non-current $ 32,562 $ 38,621 |
Prepaid and Other Assets (Table
Prepaid and Other Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Assets | Prepaid expenses and other assets consist of the following (in thousands): June 30, December 31, Prepaid operating expenses $ 27,990 $ 19,465 Production campaign deposits 24,202 15,127 Clinical trial advances 24,778 11,630 Prefunded customer programs 4,567 3,514 Total 81,537 49,736 Less: Current portion (73,798) (42,443) Total other assets $ 7,739 $ 7,293 |
Right of Use Assets and Lease_2
Right of Use Assets and Lease Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Schedule of Quantitative Information About Operating Leases | The following table presents the weighted average remaining lease term, and the weighted average discount rates related to leases as of June 30, 2024 and December 31, 2023: June 30, 2024 December 31, 2023 Other information Weighted average remaining lease term 4.9 years 5.3 years Weighted average discount rate 8.83 % 9.07 % The following table presents the lease cost for the six-month periods ended June 30, 2024 and 2023 (in thousands): Six Months Ended June 30, 2024 2023 Lease cost Operating lease cost $ 1,974 $ 2,003 Variable lease cost 844 724 Short-term lease cost 1,216 599 $ 4,034 $ 3,326 |
Schedule Of Maturity Analysis Under Lease Agreements | Maturity analysis under the lease agreements is as follows (in thousands): Six months ending December 31, 2024 $ 2,165 Year ending December 31, 2025 4,436 Year ending December 31, 2026 4,513 Year ending December 31, 2027 4,573 Year ending December 31, 2028 4,707 Thereafter 2,351 Total 22,745 Less: Present value discount (4,457) Total operating lease liability 18,288 Less: Current portion (4,171) Operating lease liabilities, non-current $ 14,117 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount | Total share-based compensation expense related to all of the Company's share-based awards, including stock options and restricted stock units (“RSUs”), granted to employees and directors recognized during the six-month periods ended June 30, 2024 and 2023, was comprised of the following (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Inventoriable costs $ 491 $ 420 $ 908 $ 762 Selling, general and administrative 10,808 8,725 20,025 15,705 Research and development 5,071 4,081 9,280 7,198 Total share-based compensation expense $ 16,370 $ 13,226 $ 30,213 $ 23,665 |
Stock Option Activity | Information regarding the stock options activity, including with respect to grants to employees and directors under the Amended and Restated 2018 Equity Incentive Plan (the Amended 2018 Plan) and 2019 Inducement Award Plan (the 2019 Inducement Plan) as of June 30, 2024, and changes during the six-month period then ended, are summarized as follows: Number of Weighted- Weighted- Outstanding at December 31, 2023 4,239,982 $ 28.22 5.2 years Options granted 2024 17,288 Options exercised 2024 (574,301) Options canceled or expired 2024 (9,347) Outstanding at June 30, 2024 3,673,622 $ 29.38 5.1 years Vested and expected to vest at June 30, 2024 3,673,622 $ 29.38 Exercisable at June 30, 2024 3,320,956 $ 26.94 4.7 years |
Summary of Information Regarding RSU Activity | Information regarding the time-based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan, and changes during the six-month period ended June 30, 2024 is summarized as follows: Number of Weighted-Average Weighted- Outstanding at December 31, 2023 1,645,130 $ 48.92 1.0 year Time-based RSUs granted in 2024 1,033,819 Time-based RSUs vested in 2024 (719,864) Time-based RSUs cancelled in 2024 (29,622) Outstanding at June 30, 2024 1,929,463 $ 59.99 1.4 years |
Loss Per Share - (Tables)
Loss Per Share - (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Earnings Per Share [Abstract] | |
Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share | The following share-based awards were excluded in the calculation of diluted net loss per common share because their effect could be anti-dilutive as applied to the loss from operations for the three and six-month periods ended June 30, 2024 and 2023: Three and Six Months Ended June 30, 2024 2023 Stock options 3,673,622 4,515,188 RSUs 2,153,965 1,841,855 |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | |
Apr. 30, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Shares sold (in shares) | 7,876,713 | ||
Offering price (in dollars per share) | $ 73 | ||
Aggregate gross proceeds | $ 575,000 | ||
Proceeds from sale of common stock, net | $ 543,100 | $ 543,086 | $ 0 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - segment | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Significant Accounting Policies [Line Items] | ||
Number of operating segments | 1 | |
Revenue Benchmark | Customer Concentration Risk | Three Major Wholesalers | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk (as a percent) | 97% | |
Revenue Benchmark | Customer Concentration Risk | Customer One | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk (as a percent) | 35% | 37% |
Revenue Benchmark | Customer Concentration Risk | Customer Two | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk (as a percent) | 26% | 30% |
Revenue Benchmark | Customer Concentration Risk | Customer Three | ||
Significant Accounting Policies [Line Items] | ||
Concentration risk (as a percent) | 36% | 29% |
Investment Securities - Summary
Investment Securities - Summary of Investment Securities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | $ 350,269 | $ 412,570 |
Unrealized Gains | 11 | 490 |
Unrealized (Losses) | (679) | (386) |
Estimated Fair Value | 349,601 | 412,674 |
U.S. Government Agency Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 91,148 | 150,651 |
Unrealized Gains | 5 | 148 |
Unrealized (Losses) | (142) | (204) |
Estimated Fair Value | 91,011 | 150,595 |
FDIC Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 1,470 | 4,410 |
Unrealized Gains | 0 | 2 |
Unrealized (Losses) | (1) | (12) |
Estimated Fair Value | 1,469 | 4,400 |
Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 60,000 | 60,000 |
Unrealized Gains | 0 | 0 |
Unrealized (Losses) | 0 | 0 |
Estimated Fair Value | 60,000 | 60,000 |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 33,669 | 78,610 |
Unrealized Gains | 0 | 59 |
Unrealized (Losses) | (19) | (27) |
Estimated Fair Value | 33,650 | 78,642 |
Corporate Notes/Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Amortized Cost | 163,982 | 118,899 |
Unrealized Gains | 6 | 281 |
Unrealized (Losses) | (517) | (143) |
Estimated Fair Value | $ 163,471 | $ 119,037 |
Investment Securities - Additio
Investment Securities - Additional Information (Detail) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Debt Securities, Available-for-Sale [Line Items] | ||
Investment securities, available for sale, noncurrent | $ 110.7 | $ 77.8 |
Aggregate related fair value of investments with unrealized losses | 274.7 | 165.2 |
Aggregate fair value of investments with unrealized losses | 16.2 | 70.1 |
Continuous unrealized losses, value remaining | 258.5 | 95.1 |
Debt Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Accrued interest receivable | 2.7 | $ 2.3 |
U.S. Government Agency Securities | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 81 | |
Certificates of Deposit | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 1.5 | |
Commercial Paper | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | 33.7 | |
Corporate Notes/Bonds | ||
Debt Securities, Available-for-Sale [Line Items] | ||
Aggregate related fair value of investments with unrealized losses | $ 158.5 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Carrying value of cash held in money market funds | $ 81,900,000 | $ 10,700,000 |
Cash and Cash Equivalents | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Certificates of deposits | 20,000,000 | 60,000,000 |
Carrying value of cash held in commercial paper, government securities | 2,500,000 | |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Liabilities measured using quoted prices | 0 | 0 |
Assets measured using quoted prices | $ 0 | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value Measurements of Cash Equivalents (Detail) - USD ($) | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 431,541,000 | $ 423,372,000 |
Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 81,940,000 | 10,698,000 |
Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 91,011,000 | 150,595,000 |
Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 1,469,000 | 4,400,000 |
Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 60,000,000 | 60,000,000 |
Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 33,650,000 | 78,642,000 |
Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 163,471,000 | 119,037,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 81,940,000 | 10,698,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 81,940,000 | 10,698,000 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 349,601,000 | 412,674,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 91,011,000 | 150,595,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 1,469,000 | 4,400,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 60,000,000 | 60,000,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 33,650,000 | 78,642,000 |
Significant Other Observable Inputs (Level 2) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 163,471,000 | 119,037,000 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | U.S. Government Agency Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | FDIC Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Certificates of Deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | Fair Value, Measurements, Recurring | Corporate Notes/Bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investment securities | $ 0 | $ 0 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 32,562 | $ 38,621 |
Work in process | 12,151 | 4,277 |
Finished goods | 7,931 | 7,370 |
Total | 52,644 | 50,268 |
Less: Current portion | (20,082) | (11,647) |
Total inventory, non-current | 32,562 | 38,621 |
Inventory subject to supplemental regulatory procedures | $ 8,000 | $ 7,700 |
Prepaid and Other Assets (Detai
Prepaid and Other Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid operating expenses | $ 27,990 | $ 19,465 |
Production campaign deposits | 24,202 | 15,127 |
Clinical trial advances | 24,778 | 11,630 |
Prefunded customer programs | 4,567 | 3,514 |
Total | 81,537 | 49,736 |
Less: Current portion | (73,798) | (42,443) |
Total other assets | $ 7,739 | $ 7,293 |
Right of Use Assets and Lease_3
Right of Use Assets and Lease Liabilities - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | May 31, 2024 | Sep. 30, 2018 |
Operating Leased Assets [Line Items] | |||
Term of long term lease | 12 months | ||
Vehicle Lease | |||
Operating Leased Assets [Line Items] | |||
Guarantor obligations, value | $ 1,750 | ||
NEW YORK | |||
Operating Leased Assets [Line Items] | |||
Term of long term lease | 14 years 3 months 18 days | ||
NEW JERSEY | |||
Operating Leased Assets [Line Items] | |||
Term of long term lease | 5 years 8 months 12 days |
Right of Use Assets and Lease_4
Right of Use Assets and Lease Liabilities - Schedule Of Quantitative Information About Operating Leases (Detail) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Other information | |||
Weighted average remaining lease term (in years) | 4 years 10 months 24 days | 5 years 3 months 18 days | |
Weighted average discount rate (as a percent) | 8.83% | 9.07% | |
Lease cost | |||
Operating lease cost | $ 1,974 | $ 2,003 | |
Variable lease cost | 844 | 724 | |
Short-term lease cost | 1,216 | 599 | |
Total lease cost | $ 4,034 | $ 3,326 |
Right of Use Assets and Lease_5
Right of Use Assets and Lease Liabilities - Maturity analysis under the lease agreements (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
Six months ending December 31, 2024 | $ 2,165 | |
Year ending December 31, 2025 | 4,436 | |
Year ending December 31, 2026 | 4,513 | |
Year ending December 31, 2027 | 4,573 | |
Year ending December 31, 2028 | 4,707 | |
Thereafter | 2,351 | |
Total | 22,745 | |
Less: Present value discount | (4,457) | |
Total operating lease liability | 18,288 | |
Less: Current portion | (4,171) | $ (3,612) |
Operating lease liabilities, non-current | $ 14,117 | $ 13,326 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | 229 Months Ended | ||
May 31, 2005 | Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Purchase Commitment | ||||
Purchase Commitment, Excluding Long-Term Commitment [Line Items] | ||||
Cash paid | $ 24,200 | $ 24,200 | $ 15,100 | |
Other current assets | 16,600 | 16,600 | 7,900 | |
Other assets | 7,600 | 7,600 | $ 7,200 | |
Product | Bristol-Myers Squibb Company | ||||
Purchase Commitment, Excluding Long-Term Commitment [Line Items] | ||||
Company made an upfront payment | 10,800 | |||
Payment of milestone amount | $ 5,000 | $ 5,000 | ||
Obliged to make milestone payments | $ 14,750 | |||
License expiration period | 10 years | |||
Product | Bristol-Myers Squibb Company | Minimum | ||||
Purchase Commitment, Excluding Long-Term Commitment [Line Items] | ||||
Royalty payment, percentage (as a percent) | 5% | |||
Product | Bristol-Myers Squibb Company | Maximum | ||||
Purchase Commitment, Excluding Long-Term Commitment [Line Items] | ||||
Royalty payment, percentage (as a percent) | 9% |
Share-Based Compensation - Tota
Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 16,370 | $ 13,226 | $ 30,213 | $ 23,665 |
Inventoriable costs | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 491 | 420 | 908 | 762 |
Selling, general and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 10,808 | 8,725 | 20,025 | 15,705 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 5,071 | $ 4,081 | $ 9,280 | $ 7,198 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Options Activity (Detail) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding [Roll Forward] | ||
Outstanding at beginning of period, Number of Shares (in shares) | 4,239,982 | |
Options granted, Number of Shares (in shares) | 17,288 | |
Options exercised, Number of Shares (in shares) | (574,301) | |
Options canceled or expired, Number of Shares (in shares) | (9,347) | |
Outstanding at end of period, Number of Shares (in shares) | 3,673,622 | 4,239,982 |
Vested or expected to vest at end of period, Number of Shares (in shares) | 3,673,622 | |
Exercisable at end of period, Number of Shares (in shares) | 3,320,956 | |
Weighted- Average Exercise Price | ||
Outstanding at beginning of period, Weighted-Average Exercise Price (in dollars per share) | $ 28.22 | |
Outstanding at end of period, Weighted-Average Exercise Price (in dollars per share) | 29.38 | $ 28.22 |
Vested or expected to vest at end of period, Weighted-Average Exercise Price (in dollars per share) | 29.38 | |
Exercisable at end of period, Weighted-Average Exercise Price (in dollars per share) | $ 26.94 | |
Outstanding at end of period, Weighted-Average Contractual Life (in years) | 5 years 1 month 6 days | 5 years 2 months 12 days |
Exercisable at end of period, Weighted-Average Contractual Life (in years) | 4 years 8 months 12 days |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Dec. 31, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Restricted Stock Units Activity [Roll Forward] | ||
Outstanding at beginning of year, Number of Shares (in shares) | 1,645,130 | |
Time based RSU's granted, Number of Shares (in shares) | 1,033,819 | |
Time based RSU's vested, Number of Shares (in shares) | (719,864) | |
Time based RSU's cancelled, Number of Shares (in shares) | (29,622) | |
Outstanding at end of year, Number of Shares (in shares) | 1,929,463 | 1,645,130 |
Weighted-Average Grant Date Fair Value Per Share | ||
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value (in dollars per share) | $ 48.92 | |
Outstanding at end of year, Weighted-Average Grant Date Fair Value (in dollars per share) | $ 59.99 | $ 48.92 |
Restricted stock outstanding, Weighted-Average Contractual Life (in years) | 1 year 4 months 24 days | 1 year |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) $ in Millions | Jun. 30, 2024 USD ($) |
Time Based Restricted Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation costs related to unvested RSUs | $ 99.6 |
Loss Per Share - Common Stock E
Loss Per Share - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares | 3 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of anti-dilutive securities excluded from computation of earnings per share (in shares) | 3,673,622 | 4,515,188 |
RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Number of anti-dilutive securities excluded from computation of earnings per share (in shares) | 2,153,965 | 1,841,855 |