0001193125-23-055176 | 10-K | XBRL Viewer | Intracellular Therapies INC

Cover Page - USD ($) $ in Billions	12 Months Ended
Cover Page - USD ($) $ in Billions	Dec. 31, 2022	Feb. 27, 2023	Jun. 30, 2021
Cover [Abstract]
Amendment Flag	false
Document Type	10-K
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Document Annual Report	true
Entity Central Index Key	0001567514
Document Transition Report	false
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	Yes
Entity Voluntary Filers	No
Document Period End Date	Dec. 31, 2022
Entity Registrant Name	Intra-Cellular Therapies, Inc.
Trading Symbol	ITCI
Entity Filer Category	Large Accelerated Filer
Entity Emerging Growth Company	false
Entity Small Business	false
Entity Interactive Data Current	Yes
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity File Number	001-36274
Entity Tax Identification Number	36-4742850
Entity Incorporation, State or Country Code	DE
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
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		95,280,003
Entity Public Float			$ 5.3
ICFR Auditor Attestation Flag	true
Auditor Name	Ernst & Young LLP
Auditor Firm ID	42
Auditor Location	Baltimore, Maryland

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 148,615	$ 92,365
Investment securities, available-for-sale	443,290	319,968
Restricted cash	1,750	1,400
Accounts receivable, net	75,189	20,156
Inventory	23,920	7,948
Prepaid expenses and other current assets	45,193	25,444
Total current assets	737,957	467,281
Property and equipment, net	1,913	1,791
Right of use assets, net	14,824	20,764
Other assets	86	86
Total assets	754,780	489,922
Current liabilities:
Accounts payable	10,395	8,691
Accrued and other current liabilities	19,657	11,073
Accrued Customer Programs	25,621	5,964
Accrued employee benefits	22,996	20,897
Operating lease liabilities	4,567	6,732
Total current liabilities	83,236	53,357
Operating lease liabilities, non-current	15,474	18,675
Total liabilities	98,710	72,032
Stockholders' equity:
Common stock, $0.0001 par value: 175,000,000 shares authorized at December 31, 2022 and December 31, 2021, respectively; 94,829,794 and 81,886,965 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively	9	8
Additional paid-in capital	2,137,737	1,639,476
Accumulated deficit	(1,477,486)	(1,221,230)
Accumulated comprehensive loss	(4,190)	(364)
Total stockholders' equity	656,070	417,890
Total liabilities and stockholders' equity	$ 754,780	$ 489,922

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	175,000,000	175,000,000
Common stock, shares issued	94,829,794	81,886,965
Common stock, shares outstanding	94,829,794	81,886,965

Consolidated Statements of Operations - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Revenue	$ 250,314	$ 83,803	$ 22,813
Operating expenses:
Cost of product sales	20,443	8,035	1,895
Selling, general and administrative	358,782	272,611	186,364
Research and development	134,715	88,845	65,782
Total operating expenses	513,940	369,491	254,041
Loss from operations	(263,626)	(285,688)	(231,228)
Interest income	7,376	1,568	4,236
Loss before provision for income taxes	(256,250)	(284,120)	(226,992)
Income tax expense	(6)	(6)	(14)
Net loss	$ (256,256)	$ (284,126)	$ (227,006)
Net loss per common share:
Basic	$ (2.72)	$ (3.5)	$ (3.23)
Diluted	$ (2.72)	$ (3.5)	$ (3.23)
Weighted average number of common shares:
Basic	94,046,670	81,253,394	70,364,800
Diluted	94,046,670	81,253,394	70,364,800
Product sales, net [Member]
Revenue	$ 249,132	$ 81,708	$ 22,531
Grant revenue [Member]
Revenue	$ 1,182	$ 2,095	$ 282

Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Statement of Comprehensive Income [Abstract]
Net loss	$ (256,256)	$ (284,126)	$ (227,006)
Other comprehensive loss:
Unrealized (loss) gain on investment securities	(3,826)	(845)	353
Comprehensive loss	$ (260,082)	$ (284,971)	$ (226,653)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Accumulated Comprehensive Gain (Loss) [Member]
Balance at Dec. 31, 2019	$ 195,007	$ 6	$ 904,971	$ (710,098)	$ 128
Balance, shares at Dec. 31, 2019		55,507,497
Common shares issued	652,712	$ 2	652,710
Common shares issued, shares		23,409,458
Exercise of stock options and issuances of restricted stock (Value)	11,465	$ 0	11,465
Exercise of stock options and issuances of restricted stock (Shares)		1,536,797
Stock issued for services	214	$ 0	214
Stock issued for services, shares		9,337
Share-based compensation	24,115		24,115
Net loss	(227,006)			(227,006)
Other comprehensive income (loss)	353				353
Balance at Dec. 31, 2020	656,860	$ 8	1,593,475	(937,104)	481
Balance, shares at Dec. 31, 2020		80,463,089
Exercise of stock options and issuances of restricted stock (Value)	11,519	$ 0	11,519
Exercise of stock options and issuances of restricted stock (Shares)		1,419,331
Stock issued for services	179		179
Stock issued for services, shares		4,545
Share-based compensation	34,303		34,303
Net loss	(284,126)			(284,126)
Other comprehensive income (loss)	(845)				(845)
Balance at Dec. 31, 2021	417,890	$ 8	1,639,476	(1,221,230)	(364)
Balance, shares at Dec. 31, 2021		81,886,965
Common shares issued	433,718	$ 1	433,717
Common shares issued, shares		10,952,381
Exercise of stock options and issuances of restricted stock (Value)	21,441	$ 0	21,441
Exercise of stock options and issuances of restricted stock (Shares)		1,988,775
Stock issued for services	90		90
Stock issued for services, shares		1,673
Share-based compensation	43,013		43,013
Net loss	(256,256)			(256,256)
Other comprehensive income (loss)	(3,826)				(3,826)
Balance at Dec. 31, 2022	$ 656,070	$ 9	$ 2,137,737	$ (1,477,486)	$ (4,190)
Balance, shares at Dec. 31, 2022		94,829,794

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Cash flows used in operating activities
Net loss	$ (256,256)	$ (284,126)	$ (227,006)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	656	533	528
Share-based compensation	43,013	34,303	24,115
Stock issued for services	90	179	214
Amortization of premiums and accretion of discounts on investment securities, net	447	(4,080)	(648)
Changes in operating assets and liabilities:
Accounts receivable, net	(55,033)	(9,391)	(10,765)
Inventory	(15,972)	(892)	(7,056)
Prepaid expenses and other assets	(19,749)	(11,208)	(7,922)
Long term deferred tax asset, net	0	0	265
Accounts payable	1,704	3,189	(1,923)
Accrued and other current liabilities	8,584	3,177	(8,242)
Accrued customer programs	19,657	2,958	5,435
Accrued employee benefits	2,099	5,989	3,005
Lease liabilities, net	574	(175)	(73)
Net cash used in operating activities	(270,186)	(259,544)	(230,073)
Cash flows (used in) provided by investing activities
Purchases of investments	(759,209)	(224,575)	(755,629)
Maturities of investments	631,614	505,244	275,601
Purchases of property and equipment	(778)	(325)	(267)
Net cash (used in) provided by investing activities	(128,373)	280,344	(480,295)
Cash flows provided by financing activities
Proceeds of public offerings, net	433,718	0	652,712
Proceeds from exercise of stock options	21,441	11,519	11,465
Net cash provided by financing activities	455,159	11,519	664,177
Net increase (decrease) in cash, cash equivalents, and restricted cash	56,600	32,319	(46,191)
Cash, cash equivalents, and restricted cash at beginning of period	93,765	61,446	107,637
Cash, cash equivalents, and restricted cash at end of period	150,365	93,765	61,446
Cash paid for taxes	6	6	2
Vehicle Fleet Lease [Member]
Non-cash investing and financing activities
Right of use assets under operating leases	$ 419	$ 108	$ 8,918

Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Statement of Cash Flows [Abstract]
Cash and cash equivalents	$ 148,615	$ 92,365	$ 60,046
Restricted cash	1,750	1,400	1,400
Total cash, cash equivalents and restricted cash	$ 150,365	$ 93,765	$ 61,446	$ 107,637

Organization	12 Months Ended
Organization	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization	1. 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 neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms within the central nervous system. In December 2019, CAPLYTA ® (lumateperone) was approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia in adults (42mg/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 (42mg/day). The Company initiated the commercial launch of CAPLYTA for the treatment of bipolar depression in December 2021. Additionally, in April 2022, the FDA approved two new 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 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 Consolidated Financial Statements, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults and 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. Lumateperone is in Phase 3 clinical development as a novel treatment for major depressive disorder. On January 7, 2022, the Company completed a public offering of common stock in which the Company sold 10,952,381 shares of common stock at a public offering price of $42.00 per share for aggregate gross proceeds of $460.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $433.7 million. In order to further its commercial activities and research projects and support its collaborations, the Company may require additional financing until such time, if ever, that revenue streams are sufficient to generate consistent positive cash flow from operations. The Company currently projects that its cash, cash equivalents and investments will be sufficient to fund operating expenses and capital expenditures for at least one year from the date that these financial statements are filed with the Securities and Exchange Commission (the “SEC”). Possible sources of funds include public or private sales of the Company’s equity securities, sales of debt or convertible debt securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s products, product candidates and technology and, to a much lesser extent, grant funding.

Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own 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 for the treatment of neurological and psychiatric disorders.

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.

Reclassifications

Certain amounts reported in prior periods have been reclassified to conform to current period financial statement presentation. These reclassifications have no material effect on previously reported financial position, cash flows, or results of operations.

Cash and Cash Equivalents

The Company considers all highly liquid investments with a maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents consist of checking accounts, money market accounts, money market mutual funds, and certificates of deposit with a maturity date of three months or less. The carrying values of cash and cash equivalents approximate the fair market value. Certificates of deposit, commercial paper, corporate notes and corporate bonds with a maturity date of more than three months are classified separately on the consolidated balance sheets.

Investment Securities

Investment securities may consist of investments in U.S. Treasuries, various U.S. governmental agency debt securities, corporate bonds, certificates of deposit, and other fixed income securities with an average maturity of approximately twelve months or less. Management classifies the Company’s investments as

available-for-sale.

Such securities are carried at estimated fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive loss, which is a separate component of stockholders’ equity. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any

available-for-sale

security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income are recognized as interest income on the consolidated statements of operations when earned. The cost of securities sold is calculated using the specific identification method.

The Company monitors its investment portfolio for overall risk, specifically credit loss, quarterly or more frequently if circumstances warrant. The Company has estimated the expected credit loss over the lifetime of the asset and has determined an allowance for credit losses is not material with respect to the investment portfolio.

Fair Value Measurements

The Company applies the fair value method under ASC Topic 820,

Fair Value Measurements and Disclosures

. ASC Topic 820 defines fair value, establishes a fair value hierarchy for assets and liabilities measured at fair value and requires expanded disclosures about fair value measurements. 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 evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the ASC Topic 820 hierarchy.

Financial Instruments

The Company considers the recorded costs of its financial assets and liabilities, which consist of cash equivalents, restricted cash, accounts receivable, prepaid expenses, right of use asset, net, other assets, accounts payable, accrued liabilities, accrued employee benefits, and operating lease liabilities, current, to approximate their fair value because of their relatively short maturities at December 31, 2022 and 2021. Management believes that the risks associated with the Company’s financial instruments are minimal as the counterparties are various corporations, financial institutions and government agencies of high credit standing.

Restricted Cash

Restricted cash is collateral used under the letter of credit arrangement for the Company’s vehicle lease agreement (see Note 7). The Company adopted ASU

No. 2016-18,

“Restricted Cash” (“ASU

2016-18”)

and now includes restricted cash balances within the cash, cash equivalents and restricted cash balance on the statement of cash flows.

Accounts Receivable, net

The Company’s accounts receivable, net, primarily arise from product sales. They are generally stated at the invoiced amount and do not bear interest. Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and which result primarily from chargebacks, prompt pay discounts, and distribution fees. All customers have standard payment terms which generally require payment within 60 days.

The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in the customers’ credit profiles. The Company reserves against accounts receivable for estimated losses that may arise from a Customer’s inability to pay and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The reserve amount for estimated collectability losses was not significant as of December 31, 2022 and 2021.

We are also subject to credit risk from our accounts receivable related to our product sales. We monitor our exposure within accounts receivable and record a credit loss reserve against uncollectible accounts receivable as necessary. We extend credit primarily to pharmaceutical wholesale distributors. Customer creditworthiness is monitored and collateral is not required. Historically, we have not experienced credit losses on our accounts receivable. As of December 31, 2022 and 2021, our credit loss reserve on receivables was not significant.

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 equivalent and investments held at financial institutions. For the years ended December 31, 2022 and 2021, 97% and 96% of product sales were generated from three major industry wholesalers, respectively.

Three individual customers accounted for approximately 39%, 30%, and 28% and 40%, 28%, and 28% of product sales for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the Company believes that these customers are of high credit quality.

Cash equivalents are held with major financial institutions in the United States. Certificates of deposit, cash and cash equivalents held with banks may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand and, therefore, bear minimal risk.

Inventory

The Company values its inventories at the lower of cost or estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a

first-in,

first-out

(“FIFO”) basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated net realizable value in the period in which the impairment is first identified. Such impairment charges, if they occur, are recorded within cost of product sales.

The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired and manufactured prior to receipt of regulatory approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory that is used in the production of sample product is reclassified to prepaid and other current assets and is then expensed to selling, general and administrative expenses when the sample product is distributed.

Shipping and handling costs for product shipments to customers are recorded as part of cost of product sales along with costs associated with manufacturing the product, and any inventory write-downs.

Property and Equipment

Property and equipment is stated at cost and depreciated on a straight-line basis over estimated useful lives ranging from three to five years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the assets or the term of the related lease. Expenditures for maintenance and repairs are charged to operations as incurred.

When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic No. 360,

Property, Plant and Equipment

. The Company considers historical performance and anticipated future results in its evaluation of potential impairment. The Company evaluates the carrying value of those assets in relation to the operating performance of the business and undiscounted cash flows expected to result from the use of those assets. Impairment losses are recognized when carrying value exceeds the undiscounted cash flows, in which case management must determine the fair value of the underlying asset. No such impairment losses have been recognized to date.

Leases

In accordance with ASC 842, the Company elected the package of practical expedients, which permit the Company not to reassess under the new standard the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of the consolidated balance sheets. The Company also elected the lessee component election, allowing the Company to account for the lease and

non-lease

components as a single lease component.

To determine whether a contract contains a lease, asset and service agreements are assessed at onset and upon modification for criteria of specifically identified assets, control and economic benefit. Payments for identified leases are recognized in the consolidated statements of operations on a straight-line basis over the lease term. The Company uses the rate implicit in the contract whenever possible when determining the applicable discount rate. As the majority of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments.

Revenue Recognition

In accordance with ASC Topic 606, the Company recognizes revenue when the customer obtains control of a promised good or service, in an amount that reflects the consideration that the Company expects to receive in exchange for the good or service. The reported results for the years ended December 31, 2022 and 2021 reflect the application of ASC Topic 606.

To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 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 ASC 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 ASC 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 additional discussion of accounting for product sales, see

Product Sales, net

(below).

To date, the Company’s only source of product sales has been from sales of CAPLYTA in the United States, which the Company began shipping to customers in March 2020.

Product Sales, net

The Company sells CAPLYTA to a limited number of customers which include a number of national and select regional distributors. These customers subsequently resell the Company’s products to specialty pharmacy providers, as well as other retail pharmacies and certain medical centers or hospitals. In addition to distribution agreements with customers, the Company enters into arrangements with health care providers and payers that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. 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). Product revenues are recorded net of applicable reserves for variable consideration, including rebates, discounts and allowances, among others. If taxes should be collected from customers relating to product sales and remitted to governmental authorities, they will be excluded from revenue.

Reserves for Variable Consideration

Revenues are calculated based on the wholesale acquisition cost that the Company charges to distributors for CAPLYTA less variable consideration for which reserves are established. Components of variable consideration may include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payer rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payers, and other indirect customers relating to the Company’s sales of its product.

These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, include the Company’s best estimates that take into consideration a range of possible outcomes which are considered more likely in accordance with the expected value method in ASC Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, and forecasted customer buying and payment patterns. The Company’s estimates utilizing payer mix are based on CAPLYTA’s actual channel mix in 2022. 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 contemplated application of the constraint in accordance with the guidance, under which it determined it was probable that a significant reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2022 and 2021, therefore, the transaction price was not reduced further during the years ended December 31, 2022 and 2021. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product sales and earnings in the period such variances become known.

Trade Discounts and Allowances

— The Company generally provides customers with discounts which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of product sales, net within the consolidated statements of operations for the years ended December 31, 2022 and 2021, as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Product Returns

— Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date, which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as accrued expenses and other current liabilities on the consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has not received significant expired product returns to date.

Provider Chargebacks and Discounts

— Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to customers who purchase the product directly from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivable, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting

period-end

that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.

Government Rebates

— The Company is subject to discount obligations under state Medicaid and Medicare programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability

under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.

Payer Rebates

— The Company contracts with certain private payer organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its product. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability recorded as an accrued expenses and other current liabilities on the consolidated balance sheets.

Other Incentives

— Other incentives which the Company offers include voluntary patient assistance programs, such as the

co-pay

assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug

co-payments

required by payers. The calculation of the accrual for

co-pay

assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. The Company also has a voucher program whereby a patient can receive a prescription at no cost and whereby the Company reimburses the pharmacy for 100% of the sales price of the prescription. The Company applies the claims for vouchers for product that is in the distribution channel and reduces recognized revenue accordingly.

The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the consolidated balance sheets.

Chargebacks, discounts, fees, and returns are recorded as reductions of trade receivables, net on the consolidated balance sheets. Government and other rebates are recorded as a component of accrued expenses and other current liabilities on the consolidated balance sheets.

Cost of Product Sales

Our cost of product sales relates to sales of CAPLYTA. Cost of product sales primarily includes product royalty fees, overhead, and direct costs (inclusive of material, shipping, and manufacturing costs).

For the product royalty fees, the Company entered into an exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), for which the Company is obliged to make tiered single digit percentage royalty payments ranging between

5-9%

on sales of licensed products. The related royalties are recorded within cost of product sales on the statement of operations.

Prior to the FDA approval of CAPLYTA, the Company expensed all costs associated with the manufacturing of lumateperone as part of research and development expenses. The cost of product sales in the years ended December 31, 2022, 2021 and 2020 are lower than incurred because of previously expensed inventory.

Research and Development, Including Clinical Trial Expenses

The Company recognizes its research and development expenses as the services are incurred. Research and development costs primarily consist of salaries and related expenses for personnel and resources and the costs of clinical trials. Other research and development expenses include nonclinical analytical testing, manufacturing of drug product for use in clinical and nonclinical trials, outside services, providers, materials and consulting fees.

Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors, among other factors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be.

As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account various clinical information provided by vendors and discussion with applicable personnel and external service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations, clinical sites and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period.

Advertising Expense

Advertising costs are expensed when services are rendered. The Company incurred $85.8 million, $82.5 million and $36.3 million in advertising costs during the years ended December 31, 2022, 2021, and 2020, respectively, related to its marketed product, CAPLYTA.

Income Taxes

Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled.

The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce net deferred tax assets to the amount expected to be realized. Income tax expense is the tax payable for the period and the change during the period in deferred tax assets and liabilities. The Company accounts for uncertain tax positions pursuant to ASC Topic 740,

Income Taxes

. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a

more-likely-than-not

threshold of that position being sustained. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes.

The Company’s effective tax rate for the years ended December 31, 2022, 2021 and 2020 was approximately 0%. This effective tax rate is substantially lower than the U.S. statutory rate of 21% due to valuation allowances recorded on current year losses where the Company is not more likely than not to recognize a future tax benefit.

On March 27, 2020, the United States enacted The Coronavirus Aid, Relief and Economic Security (“CARES”) Act which includes several significant business tax provisions, of which the immediate relevance to the Company is the acceleration of refunds of previously generated corporate Alternative Minimum Tax (“AMT”) credits. The CARES Act also adds an employee retention credit to encourage employers to maintain headcounts even if employees cannot report to work because of issues related to the coronavirus, and a temporary provision allowing companies to defer remitting to the government the employee share of some payroll taxes, among other things. On August 9, 2022, the United States enacted the CHIPS and Science Act which provides an investment tax credit for 25% of qualified investments primarily used for manufacturing of semiconductors and related equipment in the U.S. On August 16, 2022, the United States enacted the Inflation Reduction Act (“IRA”) which includes a provision for a 15% corporate alternative minimum tax on companies with average annual adjusted financial statement income over $1 billion effective for tax years ending after December 31, 2022. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the year ended December 31, 2022.

On December 31, 2022, ITI Limited, our wholly-owned Bermuda subsidiary, was merged into Intra-Cellular Therapies, Inc., a Delaware corporation. The intellectual property rights associated with lumateperone were transferred to the Delaware corporation as a result of this merger. This merger and the subsequent liquidation of ITI Limited does not have any material impact from a U.S. or Bermuda income tax perspective.

Comprehensive Loss

All components of comprehensive loss, including net loss, are reported in the financial statements in the period in which they are incurred. Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from

non-owner

sources. In accordance with accounting guidance, the Company presents the impact of any unrealized gains or losses on its investment securities in a separate statement of comprehensive loss for each period.

Share-Based Compensation

Share-based payments are accounted for in accordance with the provisions of ASC Topic 718,

Compensation—Stock Compensation

. The fair value of share-based payments related to stock options is estimated, on the date of grant, using the Black-Scholes-Merton option-pricing model (the “Black-Scholes Model”). The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option.

For all awards granted with time-based vesting conditions, expense is amortized using the straight-line attribution method. Share-based compensation expense recognized in the statements of operations for the years ended December 31, 2022, 2021 and 2020 accounts for forfeitures as they occur.

The Company utilizes the Black-Scholes Model for estimating fair value of its stock options granted. Option valuation models, including the Black-Scholes Model, require the input of subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility and the expected life of the award.

The expected volatility rates are based entirely on the historical volatility of the Company’s common stock. The expected life of stock options is the period of time for which the stock options are expected to be outstanding. Given the limited historical exercise data, the expected life is determined using the “simplified method,” which defines expected life as the midpoint between the vesting date and the end of the contractual term.

he risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception and does not plan to pay cash dividends in the foreseeable future. Therefore, the Company has assumed an expected dividend rate of zero. For stock options granted, the exercise price was determined by using the closing market price of the Company’s common stock on the date of grant.

A restricted stock unit (“RSU”) is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the fair market value of the Company’s common stock on the date of grant. In each fiscal year beginning in 2016, the Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company. In each fiscal year beginning in 2020, the Company has granted select employees performance based RSUs which vest upon the Board’s approval at the end of the three year service period based on the achievement of select clinical development performance milestones and comparative shareholder returns against the Company’s peers.

Under ASC Topic 718, the cumulative amount of compensation cost recognized for instruments classified as equity that ordinarily would result in a future tax deduction under existing tax law is considered to be a deductible difference in applying ASC Topic 740,

Income Taxes

. The deductible temporary difference is based on the compensation cost recognized for financial reporting purposes; however, these provisions currently do not impact the Company, as all the deferred tax assets have a full valuation allowance.

Equity instruments issued to

non-employees

for services are accounted for under the provisions of ASC Topic 718 and ASC Topic

505-50,

Equity/Equity-Based Payments to

Non-Employees

. Accordingly, the estimated fair value of the equity instrument is recorded on the earlier of the performance commitment date or the date the required services are completed and are marked to market during the service period.

In 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive Plan (the “Amended 2018 Plan”) pursuant to which 6,500,000 additional shares of common stock were reserved for future equity grants. In December 2019, the Company adopted the 2019 Inducement Award Plan (the “2019 Inducement Plan”) for the grant of equity awards of up to 1,000,000 shares of common stock to newly hired employees.

Loss Per Share

Basic net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period. The treasury stock method is used to determine the dilutive effect of the Company’s stock option grants and RSUs.

Recently Issued Accounting Standards

The Company considers the applicability and impact of any recent ASU issued by the FASB. Based on our assessment, there are no recent accounting pronouncements that have or are expected to have a material impact on the Company’s consolidated financial statements or related disclosures.

Investment Securities

12 Months Ended

Dec. 31, 2022

Investments, Debt and Equity Securities [Abstract]

Investment Securities

3. Investment Securities

Investment securities consisted of the following (in thousands):


	December 31, 2022
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	188,465	$	14	$	(1,729	)	$	186,750
FDIC Certificates of Deposit		4,155		3		(72	)		4,086
Certificates of Deposit		7,500		—		—			7,500
Commercial Paper		100,711		3		(269	)		100,445
Corporate Notes/Bonds		189,588		1		(2,141	)		187,448

	$	490,419	$	21	$	(4,211	)	$	486,229


	December 31, 2021
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	71,752	$	—	$	(100	)	$	71,652
Certificates of Deposit		26,232		1		—			26,233
Commercial Paper		55,955		—		(36	)		55,919
Corporate Notes/Bonds		166,394		19		(249	)		166,164

	$	320,333	$	20	$	(385	)	$	319,968

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 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 December 31, 2022 and 2021, the Company held $71.5 million and $67.2 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.

The aggregate related fair value of investments with unrealized losses as of December 31, 2022 was $438.3 million, which consisted of $153.1 million from U.S. government agency securities, $3.1 million of certificates of deposit, $96.6 million of commercial paper, and $185.5 million of corporate notes/bonds. $49.1 million of the aggregate fair value of investments with unrealized losses as of December 31, 2022 has been held in a continuous unrealized loss position for over than 12 months, with the remaining $389.2 million held in a continuous unrealized loss position for less than 12 months. As of December 31, 2022, $14.9 million of the commercial paper balance

, $20.5 million of the U.S. Government Agency Securities balance, and $7.5 million of the certificates of deposit balance are

listed as cash equivalents. As of December 31, 2021, the aggregate related fair value of investments with unrealized losses was $263.5 million. $9.5 million of the aggregate fair value of investments with unrealized losses as of December 31, 2021 has been held in a continuous unrealized loss position for over than 12 months, with the remaining $254.1 million held in a continuous unrealized loss position for less than 12 months.

The Company reviewed all of the investments which were in a loss position at the respective balance sheet dates, as well as the remainder of the portfolio. The Company has analyzed the unrealized losses and determined that market conditions were the primary factor driving these changes. After analyzing the securities in an unrealized loss position, the portion of these losses that relate to changes in credit quality is insignificant. The Company does not intend to sell these securities, nor is it more likely than not that the Company will be required to sell them prior to the end of their contractual terms. Furthermore, the Company does not believe that these securities expose the Company to undue market risk or counterparty credit risk.

Fair Value Measurements

12 Months Ended

Dec. 31, 2022

Fair Value Disclosures [Abstract]

Fair Value Measurements

4. Fair Value Measurements

The Company has no assets or liabilities that were measured for significant unobservable inputs (Level 3 assets and liabilities) as of December 31, 2022 and 2021. The carrying value of cash held in money market funds of approximately $12.2 million as of December 31, 2022 and $56.5 million as of December 31, 2021 is included in cash and cash equivalents and approximates market value based on quoted market price or Level 1 inputs. The carrying value of cash held in commercial paper of approximately $14.9 million

.S. Government Agency Securities of $20.5 million,

and certificates of deposit of $7.5

million

as of December 31, 2022

are included in cash and cash equivalents. The carrying value of cash held in investment securities of $0 as of

December 31, 2021 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 Reporting Date Using
	December 31, 2022		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	12,203	$	12,203	$	—	$	—
U.S. Government Agency Securities		186,750		—		186,750		—
FDIC Certificates of Deposit		4,086		—		4,086		—
Certificates of Deposit		7,500		—		7,500		—
Commercial Paper		100,445		—		100,445		—
Corporate Notes/Bonds		187,448		—		187,448		—

	$	498,432	$	12,203	$	486,229	$	—


			Fair Value Measurements at Reporting Date Using
	December 31, 2021		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	56,539	$	56,539	$	—	$	—
U.S. Government Agency Securities		71,652		—		71,652		—
Certificates of Deposit		26,233		—		26,233		—
Commercial Paper		55,919		—		55,919		—
Corporate Notes/Bonds		166,164		—		166,164		—

	$	376,507	$	56,539	$	319,968	$	—

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Inventory

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Inventory

5. Inventory

Inventory consists of the following (in thousands):


	December 31, 2022		December 31, 2021
Raw materials	$	17,227	$	2,484
Work in process		2,594		2,407
Finished goods		4,099		3,057

	$	23,920	$	7,948

Property and Equipment

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment

6. Property and Equipment

Property and equipment consist of the following (in thousands):


	December 31, 2022			December 31, 2021
Computer equipment	$	409		$	409
Furniture and fixtures		423			423
Scientific equipment		5,065			4,287
Leasehold improvements		1,240			1,240

		7,137			6,359
Less accumulated depreciation		(5,224	)		(4,568	)

	$	1,913		$	1,791

Depreciation expense for the year ended December 31, 2022, 2021 and 2020 was $0.7

million, $0.5

million

and $0.5 million, respectively.

Right of Use Assets and Lease Liabilities

12 Months Ended

Dec. 31, 2022

Leases [Abstract]

Right of Use Assets and Lease Liabilities

7. 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 ASU

2016-02

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.

On May 17, 2019, the Company 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 leases for the vehicles, which at each lease commencement was determined to qualify for operating lease treatment. The Company began leasing vehicles under the Vehicle Lease in March 2020.

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

between 12 and 30 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.

The 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 consolidated balance sheets.

The following tables present the lease balances within the consolidated balance sheet, operating cash outflows, weighted average remaining lease term, and the weighted average discount rates related to leases as of December 31, 2022 and 2021 (in thousands, except years and percentages):


	December 31, 2022			December 31, 2021
Operating lease balance sheet classification
Right of use assets, net	$	14,824		$	20,764

Lease liabilities, short term		4,567			6,732
Lease liabilities, noncurrent		15,474			18,675

Total lease liabilities	$	20,041		$	25,407

Lease cost
Operating lease cost	$	4,719		$	5,774
Variable lease cost		1,612			2,676
Short-term lease cost		873			—

	$	7,204		$	8,450

Other information
Weighted average remaining lease term		5.9 years			6.1 years
Weighted average discount rate		8.76	%		8.46	%

Maturity analysis under the lease agreements are as follows:


Year ending December 31, 2023	$	4,741
Year ending December 31, 2024		3,792
Year ending December 31, 2025		3,907
Year ending December 31, 2026		3,974
Year ending December 31, 2027		4,022
Thereafter		5,915

Total		26,351
Less: Present value discount		(6,310	)

Total Lease liability		20,041
Less: Current portion		(4,567	)

Long-term lease liabilities	$	15,474

Share-Based Compensation

12 Months Ended

Dec. 31, 2022

Disclosure of Compensation Related Costs, Share-based Payments [Abstract]

Share-Based Compensation

8. Share-Based Compensation

The Board of Directors determines who will receive options, the vesting periods (which are generally one to three years) and the exercise prices of such options. Options have a maximum term of 10 years. The exercise price of stock options granted under the Amended 2018 Plan and the 2019 Inducement Plan must be at least equal to the fair market value of the common stock on the date of grant.

Total share-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs granted to employees and directors recognized during the years ended December 31, 2022, 2021, and 2020, was comprised of the following (in thousands):


	Years Ended December 31,
	2022		2021		2020
Inventoriable costs	$	1,791	$	1,624	$	1,342
Research and development		15,387		9,832		7,073
Selling, general and administrative		25,835		22,847		15,700

Total share-based compensation expense	$	43,013	$	34,303	$	24,115

The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2022, 2021 and 2020:


	2022			2021			2020
Dividend yield		0	%		0	%		0	%
Expected volatility		78.7%-88.7	%		89.4-94.9	%		91.6-95.5	%
Weighted-average risk-free interest rate		2.22	%		0.87	%		1.29	%
Expected term (in years)		5.9			5.9			6.0

Information regarding the stock options activity, including with respect to grants to employees, directors and consultants under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2022, and changes during the year then ended, are summarized as follows:


	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2021		5,451,398		$	21.09		6.1 years
Options granted 2022		612,945		$	56.65
Options exercised 2022		(1,219,421	)	$	17.58
Options canceled 2022		(56,792	)	$	41.01
Options expired 2022		(2,158	)	$	12.73

Outstanding at December 31, 2022		4,785,972		$	26.27		5.8 years

Vested and expected to vest at December 31, 2022		4,785,972		$	26.27

Exercisable at December 31, 2022		3,628,867		$	20.38		5.0 years

The weighted-average grant date fair value for awards granted during the years ended December 31, 2022, 2021 and 2020 was $41.71, $29.01 and $17.98 per share, respectively. The total intrinsic value of the options exercised during the years ended December 31, 2022, 2021 and 2020 was $48.3 million, $19.6 million and $11.1 million, respectively. The total intrinsic value of the options outstanding as of December 31, 2022 was $130.1 million. The total intrinsic value of the options exercisable as of December 31, 2022 was $118.3 million. The total fair value of shares vested during the years ended December 31, 2022, 2021 and 2020 was $17.1 million, $10.6 million and $13.4 million, respectively.

The unrecognized share-based compensation expense related to stock option awards at December 31, 2022 was $23.6 million, and will be recognized over a weighted-average period of 1.3 years.

Information regarding time based RSU activity, including with respect to grants to employees under the Amended 2018 Plan and 2019 Inducement Plan as of December 31, 2022, and changes during the year then ended, is summarized as follows:


	Number of Shares			Weighted- Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2021		1,529,652		$	26.95		1.5 years
Time based RSUs granted in 2022		601,055		$	57.53
Time based RSUs vested in 2022		(769,355	)	$	23.23
Time based RSUs cancelled in 2022		(86,688	)	$	39.73

Outstanding at December 31, 2022		1,274,664		$	42.76		0.8 years

The total intrinsic value of the time based RSUs vested during the years ended December 31, 2022, 2021 and 2020 was $40.7 million, $25.0 million and $14.6 million, respectively. The total intrinsic value of the time based RSU’s outstanding as of December 31, 2022 was $67.5 million. The total fair value of time based RSUs vested during the years ended December 31, 2022, 2021 and 2020 was $17.9 million, $12.4 million and $7.2 million, respectively. The fair value of time based RSUs is based on the closing price of the Company’s common stock on the date of grant.

The Company did not issue any options or RSUs under the 2019 Inducement Plan in 2022 or 2021. As of December 31, 2022, there was approximately $0.3 million of unrecognized compensation costs related to unvested options and RSUs under the 2019 Inducement Plan, and $1.2 million was recognized during 2022 under this plan. As of December 31, 2022, 11,126 options and 64,302 RSUs are expected to vest in the future.

As of D

ecember 31, 2022, there was $34.7 million of unrecognized compensation costs related to unvested time based RSUs which will be recognized over a weighted-average period of 1.4 years.

Loss per Share

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Loss per Share

9. Loss per Share

The following common stock equivalents were excluded in the calculation of diluted loss per share because their effect could be anti-dilutive as applied to the net loss for the years ended December 31, 2022, 2021 and 2020:


	Year Ended December 31,
	2022		2021		2020
Stock options		4,785,972		5,451,398		5,517,622
RSUs		1,469,678		1,666,848		1,636,422

Income Taxes

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Income Taxes

10. Income Taxes

Loss before income taxes is as follows (in thousands):


	2022			2021			2020
U.S.	$	(223,465	)	$	(221,216	)	$	(155,616	)
Non-U.S.		(32,785	)		(62,904	)		(71,376	)

Total loss before taxes	$	(256,250	)	$	(284,120	)	$	(226,992	)

Total income tax expense for the years ended December 31, 2022, 2021 and 2020 is allocated as follows:


	2022			2021			2020
Current	$	6		$	6		$	14
Deferred		(52,789	)		(53,070	)		(40,049	)
Valuation allowance		52,789			53,070			40,049

Provision for income taxes	$	6		$	6		$	14

A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2022, 2021 and 2020 is as follows:


	December 31,
	2022			2021			2020
Income tax at statutory federal rate		21.00	%		21.00	%		21.00	%
Executive and share-based compensation		1.92			0.60			(1.01	)
Subpart F Inclusion		(3.38	)		0.0			0.0
Foreign rate differential		(2.69	)		(4.63	)		(6.60	)
Change in effective state tax rates		0.17			(0.31	)		1.12
State income tax expense		3.58			2.04			3.14
Change in valuation allowance		(20.60	)		(18.70	)		(17.65	)

Provision for income taxes		0.0	%		0.0	%		0.0	%

Deferred income taxes reflect the net tax effect of temporary differences that exist between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, using enacted tax rates in effect for the year in which the differences are expected to reverse. As of December 31, 2022, the Company had $663.2 million of federal net operating loss carryforwards, of which $131.1 million expire at various dates through 2037 and $532.1 million do not expire. The gross amount of the state net operating loss carryforwards is equal to or less than the federal net operating loss carryforwards and expires over various periods based on individual state tax law. In general, businesses with U.S. net operating losses (“NOLs”) are considered loss corporations for U.S. federal income tax purposes. Pursuant to Section 382 of the Code, loss corporations that undergo an ownership change, as defined under the Code, may be subject to an annual limitation on the amount of NOLs (and certain other tax attributes) available to offset taxable income earned after such ownership change. For the years ended December 31, 2015 through 2022, the Company performed a Section 382 ownership analysis and determined that an ownership change occurred (within the meaning of Section 382 of the Code) in 2015 but not in subsequent periods. Based on the analysis performed through December 31, 2022, however, the Company does not believe that the Section 382 annual limitation will impact the Company’s ability to utilize the tax attributes that existed as of the date of the ownership change in a material manner. If the Company experiences an ownership change in the future, the tax benefits related to the NOLs and tax credit carryforwards may be further limited or lost.

The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2022 and 2021, respectively (in thousands):


	December 31,
	2022			2021
Deferred tax assets:
Net operating loss carryforwards	$	168,606		$	137,561
Accrued expenditures		9,169			2,723
Research and development credit, net		9,321			9,321
Research and development expenditures		13,525			—
Share-based compensation		17,085			15,947
Other		1,466			93
Capital lease		4,980			6,178
Deferred tax liabilities:
Right of use asset—capital lease		(3,684	)		(5,049	)
Depreciation		(154	)		(201	)

Net deferred tax asset before valuation allowance		220,314			166,573
Valuation allowance		(220,314	)		(166,573	)

Net deferred tax asset	$	—		$	—

Based upon the Company’s historical operating performance and the reported cumulative net losses to date, the Company presently does not have sufficient objective evidence to support the recovery of its net deferred tax assets. Accordingly, the Company has established a full valuation allowance against its net deferred tax assets in 2022 and 2021, for financial reporting purposes because it is not more likely than not that these deferred tax assets will be realized.

The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The open years subject to tax audits vary depending on the tax jurisdictions. In the U.S. federal jurisdiction, we are no longer subject to income tax audits by taxing authorities for years before 201

The total amount of unrecognized tax benefits was $1.7 million as of December 31, 2022 and 2021. If recognized, none of these tax benefits would affect the effective tax rate due to valuation allowances.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Commitments and Contingencies	12 Months Ended
Commitments and Contingencies	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	11. 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, 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 made an upfront payment of $1.0 million to BMS in 2005, a milestone payment of $1.25 million in December 2013, and a milestone payment of $1.5 million in December 2014 following the initiation of the Company’s first Phase 3 clinical trial for lumateperone for patients with exacerbated schizophrenia. Upon FDA acceptance of an NDA filing for lumateperone, the Company was obligated to pay BMS a $ 2.0 million milestone payment, which was paid in January 2019. The FDA approved the NDA filing on December 20, 2019 and as a result the Company accrued an additional milestone liability of $5.0 million in the fourth quarter of 2019 which was paid in January 2020. 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. In September 2016, the Company transferred certain of its rights under the BMS agreement to its wholly owned subsidiary, ITI Limited. However, in December 2022, ITI Limited merged into Intra-Cellular Therapies, Inc. The Company expensed approximately $12.5 million , $4.1 million, and $1.1 million in cost of product sales to satisfy its obligation under the BMS agreement for the years ended December 31, 2022 , 202 1 and 202 0 , respectively. Purchase Commitments The Company enters into certain other long-term commitments for goods and services that are outstanding for periods greater than one year. The Company recently amended the significant manufacturing service agreements with Siegfried Evionnaz SA and Lonza Ltd, committing to certain minimum annual purchase commitments which the Company anticipates making payments for within the years 2025 through 2029. As of December 31, 2022, the Company has committed to purchasing production campaigns for various raw materials including active pharmaceutical ingredients (API) and its intermediates from each of its supply vendors. The campaigns are expected to be received into inventory during 2023 and 2024. The Company has paid deposits of $21.6 million and $9.5 million as of December 31, 2022 and 2021, respectively, for the various campaigns, which are recorded within prepaid expenses and other current assets. Over the course of the vendors’ manufacturing period, the Company will remit payments to each vendor based on the payment plan within the executed agreements. Retirement savings plan 401(k) contributions The Company sponsors a defined contribution 401(k) plan covering all full-time employees. Participants may elect to contribute their annual pre-tax earnings up to the federally allowed maximum limits. The Company made a matching contribution of 100% on the first 6% of contributions made by participants in the year ended December 31, 2022, 2021 and 2020. Participant and company contributions vest immediately. During the years ended December 31, 2022, 2021 and 2020, the Company recorded matching contribution expense of $3.9 million, $3.0 million and $1.8 million, respectively. Contingencies During the normal course of our business, we are occasionally involved with various claims and litigation. Reserves are established in connection with such matters when a loss is probable and the amount of such loss can be reasonably estimated. At December 31, 2022 and 2021, no material reserves were recorded. The determination of probability and the estimation of the actual amount of any such loss are inherently unpredictable, and it is therefore possible that the eventual outcome of such claims and litigation could exceed the estimated reserves, if any. However, we believe that the likelihood that any such excess might have a material adverse effect on our financial statements is remote.

Unaudited Quarterly Financial Information

12 Months Ended

Dec. 31, 2022

Quarterly Financial Information Disclosure [Abstract]

Unaudited Quarterly Financial Information

12. Unaudited Quarterly Financial Information

The tables herein set forth the Company’s unaudited condensed consolidated 2022 and 2021 quarterly statements of operations.

The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2022 quarters ended (in thousands):


2022 Quarter Ended	December 31,			September 30,			June 30,			March 31,
Revenue, net	$	87,869		$	71,870		$	55,579		$	34,996
Operating expenses		(135,281	)		(127,499	)		(143,502	)		(107,658	)
Interest income		3,386			2,122			1,320			548
Income tax expense		—			(1	)		—			(5	)

Net loss		(44,026	)		(53,508	)		(86,603	)		(72,119	)

Basic and diluted net loss per share	$	(0.45	)	$	(0.57	)	$	(0.92	)	$	(0.78	)

The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2021 quarters ended (in thousands):


2021 Quarter Ended	December 31,			September 30,			June 30,			March 31,
Revenue, net	$	25,671		$	22,207		$	20,047		$	15,878
Operating expenses		(111,675	)		(99,531	)		(89,188	)		(69,097	)
Interest income		270			393			421			484
Income tax benefit (expense)		—			23			(24	)		(5	)

Net loss		(85,734	)		(76,908	)		(68,744	)		(52,740	)

Basic and diluted net loss per share	$	(1.05	)	$	(0.95	)	$	(0.85	)	$	(0.65	)

Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2022

Accounting Policies [Abstract]

Basis of Presentation

Use of Estimates

Reclassifications

Cash and Cash Equivalents

Investment Securities

available-for-sale.

available-for-sale

Fair Value Measurements

The Company applies the fair value method under ASC Topic 820,

Fair Value Measurements and Disclosures

•

Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities.

•

Financial Instruments

Restricted cash

Restricted Cash

Restricted cash is collateral used under the letter of credit arrangement for the Company’s vehicle lease agreement (see Note 7). The Company adopted ASU

No. 2016-18,

“Restricted Cash” (“ASU

2016-18”)

and now includes restricted cash balances within the cash, cash equivalents and restricted cash balance on the statement of cash flows.

Accounts Receivable, net

Concentration of Credit Risk

Inventory

first-in,

first-out

Shipping and handling costs for product shipments to customers are recorded as part of cost of product sales along with costs associated with manufacturing the product, and any inventory write-downs.

Property and Equipment

When indicators of possible impairment are identified, the Company evaluates the recoverability of the carrying value of its long-lived assets based on the criteria established in ASC Topic No. 360,

Property, Plant and Equipment

Leases

non-lease

components as a single lease component.

Revenue Recognition

Product Sales, net

(below).

To date, the Company’s only source of product sales has been from sales of CAPLYTA in the United States, which the Company began shipping to customers in March 2020.

Product Sales, net

Reserves for Variable Consideration

Trade Discounts and Allowances

Product Returns

Provider Chargebacks and Discounts

period-end

that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.

Government Rebates

Payer Rebates

Other Incentives

— Other incentives which the Company offers include voluntary patient assistance programs, such as the

co-pay

assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug

co-payments

required by payers. The calculation of the accrual for

co-pay

Cost of product sales

Cost of Product Sales

5-9%

on sales of licensed products. The related royalties are recorded within cost of product sales on the statement of operations.

Research and Development, including Clinical trial expenses

Research and Development, Including Clinical Trial Expenses

Advertising Expense

Income Taxes

. Financial statement recognition of a tax position taken or expected to be taken in a tax return is determined based on a

more-likely-than-not

Comprehensive Loss

non-owner

Share-Based Compensation

Share-based payments are accounted for in accordance with the provisions of ASC Topic 718,

Compensation—Stock Compensation

Income Taxes

Equity instruments issued to

non-employees

for services are accounted for under the provisions of ASC Topic 718 and ASC Topic

505-50,

Equity/Equity-Based Payments to

Non-Employees

Loss Per Share

Recently Issued Accounting Standards

Investment Securities (Tables)

12 Months Ended

Dec. 31, 2022

Investments, Debt and Equity Securities [Abstract]

Schedule of Investment Securities

Investment securities consisted of the following (in thousands):


	December 31, 2022
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	188,465	$	14	$	(1,729	)	$	186,750
FDIC Certificates of Deposit		4,155		3		(72	)		4,086
Certificates of Deposit		7,500		—		—			7,500
Commercial Paper		100,711		3		(269	)		100,445
Corporate Notes/Bonds		189,588		1		(2,141	)		187,448

	$	490,419	$	21	$	(4,211	)	$	486,229


	December 31, 2021
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	71,752	$	—	$	(100	)	$	71,652
Certificates of Deposit		26,232		1		—			26,233
Commercial Paper		55,955		—		(36	)		55,919
Corporate Notes/Bonds		166,394		19		(249	)		166,164

	$	320,333	$	20	$	(385	)	$	319,968

Fair Value Measurements (Tables)

12 Months Ended

Dec. 31, 2022

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 Reporting Date Using
	December 31, 2022		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	12,203	$	12,203	$	—	$	—
U.S. Government Agency Securities		186,750		—		186,750		—
FDIC Certificates of Deposit		4,086		—		4,086		—
Certificates of Deposit		7,500		—		7,500		—
Commercial Paper		100,445		—		100,445		—
Corporate Notes/Bonds		187,448		—		187,448		—

	$	498,432	$	12,203	$	486,229	$	—


			Fair Value Measurements at Reporting Date Using
	December 31, 2021		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	56,539	$	56,539	$	—	$	—
U.S. Government Agency Securities		71,652		—		71,652		—
Certificates of Deposit		26,233		—		26,233		—
Commercial Paper		55,919		—		55,919		—
Corporate Notes/Bonds		166,164		—		166,164		—

	$	376,507	$	56,539	$	319,968	$	—

Inventory (Tables)

12 Months Ended

Dec. 31, 2022

Inventory Disclosure [Abstract]

Schedule of Inventory, Current

Inventory consists of the following (in thousands):


	December 31, 2022		December 31, 2021
Raw materials	$	17,227	$	2,484
Work in process		2,594		2,407
Finished goods		4,099		3,057

	$	23,920	$	7,948

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2022

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and equipment consist of the following (in thousands):


	December 31, 2022			December 31, 2021
Computer equipment	$	409		$	409
Furniture and fixtures		423			423
Scientific equipment		5,065			4,287
Leasehold improvements		1,240			1,240

		7,137			6,359
Less accumulated depreciation		(5,224	)		(4,568	)

	$	1,913		$	1,791

Right of Use Assets and Lease Liabilities (Tables)

12 Months Ended

Dec. 31, 2022

Schedule Of Maturity Analysis Under Lease Agreements

Maturity analysis under the lease agreements are as follows:


Year ending December 31, 2023	$	4,741
Year ending December 31, 2024		3,792
Year ending December 31, 2025		3,907
Year ending December 31, 2026		3,974
Year ending December 31, 2027		4,022
Thereafter		5,915

Total		26,351
Less: Present value discount		(6,310	)

Total Lease liability		20,041
Less: Current portion		(4,567	)

Long-term lease liabilities	$	15,474

Schedule Of Quantitative Information About Operating Leases


	December 31, 2022			December 31, 2021
Operating lease balance sheet classification
Right of use assets, net	$	14,824		$	20,764

Lease liabilities, short term		4,567			6,732
Lease liabilities, noncurrent		15,474			18,675

Total lease liabilities	$	20,041		$	25,407

Lease cost
Operating lease cost	$	4,719		$	5,774
Variable lease cost		1,612			2,676
Short-term lease cost		873			—

	$	7,204		$	8,450

Other information
Weighted average remaining lease term		5.9 years			6.1 years
Weighted average discount rate		8.76	%		8.46	%

Share-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2022

Total Stock-Based Compensation Expense


	Years Ended December 31,
	2022		2021		2020
Inventoriable costs	$	1,791	$	1,624	$	1,342
Research and development		15,387		9,832		7,073
Selling, general and administrative		25,835		22,847		15,700

Total share-based compensation expense	$	43,013	$	34,303	$	24,115

Assumptions Used for Calculating Value of Options Granted

The following table describes the assumptions used for calculating the value of options granted during the years ended December 31, 2022, 2021 and 2020:


	2022			2021			2020
Dividend yield		0	%		0	%		0	%
Expected volatility		78.7%-88.7	%		89.4-94.9	%		91.6-95.5	%
Weighted-average risk-free interest rate		2.22	%		0.87	%		1.29	%
Expected term (in years)		5.9			5.9			6.0

Stock Option Activity


	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2021		5,451,398		$	21.09		6.1 years
Options granted 2022		612,945		$	56.65
Options exercised 2022		(1,219,421	)	$	17.58
Options canceled 2022		(56,792	)	$	41.01
Options expired 2022		(2,158	)	$	12.73

Outstanding at December 31, 2022		4,785,972		$	26.27		5.8 years

Vested and expected to vest at December 31, 2022		4,785,972		$	26.27

Exercisable at December 31, 2022		3,628,867		$	20.38		5.0 years

Time Based Restricted Stock Units [Member]

Summary of Information Regarding RSU Activity


	Number of Shares			Weighted- Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2021		1,529,652		$	26.95		1.5 years
Time based RSUs granted in 2022		601,055		$	57.53
Time based RSUs vested in 2022		(769,355	)	$	23.23
Time based RSUs cancelled in 2022		(86,688	)	$	39.73

Outstanding at December 31, 2022		1,274,664		$	42.76		0.8 years

Loss per Share (Tables)

12 Months Ended

Dec. 31, 2022

Earnings Per Share [Abstract]

Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share


	Year Ended December 31,
	2022		2021		2020
Stock options		4,785,972		5,451,398		5,517,622
RSUs		1,469,678		1,666,848		1,636,422

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2022

Income Tax Disclosure [Abstract]

Summary of Loss Before Income Taxes

Loss before income taxes is as follows (in thousands):


	2022			2021			2020
U.S.	$	(223,465	)	$	(221,216	)	$	(155,616	)
Non-U.S.		(32,785	)		(62,904	)		(71,376	)

Total loss before taxes	$	(256,250	)	$	(284,120	)	$	(226,992	)

Total Income Tax Expense

Total income tax expense for the years ended December 31, 2022, 2021 and 2020 is allocated as follows:


	2022			2021			2020
Current	$	6		$	6		$	14
Deferred		(52,789	)		(53,070	)		(40,049	)
Valuation allowance		52,789			53,070			40,049

Provision for income taxes	$	6		$	6		$	14

Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate

A reconciliation of the difference between the statutory federal income tax rate and the effective income tax rate for the years ended December 31, 2022, 2021 and 2020 is as follows:


	December 31,
	2022			2021			2020
Income tax at statutory federal rate		21.00	%		21.00	%		21.00	%
Executive and share-based compensation		1.92			0.60			(1.01	)
Subpart F Inclusion		(3.38	)		0.0			0.0
Foreign rate differential		(2.69	)		(4.63	)		(6.60	)
Change in effective state tax rates		0.17			(0.31	)		1.12
State income tax expense		3.58			2.04			3.14
Change in valuation allowance		(20.60	)		(18.70	)		(17.65	)

Provision for income taxes		0.0	%		0.0	%		0.0	%

Deferred Tax Assets and Liabilities

The following summarizes the significant components of the Company’s deferred tax assets and liabilities as of December 31, 2022 and 2021, respectively (in thousands):


	December 31,
	2022			2021
Deferred tax assets:
Net operating loss carryforwards	$	168,606		$	137,561
Accrued expenditures		9,169			2,723
Research and development credit, net		9,321			9,321
Research and development expenditures		13,525			—
Share-based compensation		17,085			15,947
Other		1,466			93
Capital lease		4,980			6,178
Deferred tax liabilities:
Right of use asset—capital lease		(3,684	)		(5,049	)
Depreciation		(154	)		(201	)

Net deferred tax asset before valuation allowance		220,314			166,573
Valuation allowance		(220,314	)		(166,573	)

Net deferred tax asset	$	—		$	—

Unaudited Quarterly Financial Information (Tables)

12 Months Ended

Dec. 31, 2022

Quarterly Financial Information Disclosure [Abstract]

Schedule of Quarterly Financial Information

The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2022 quarters ended (in thousands):


2022 Quarter Ended	December 31,			September 30,			June 30,			March 31,
Revenue, net	$	87,869		$	71,870		$	55,579		$	34,996
Operating expenses		(135,281	)		(127,499	)		(143,502	)		(107,658	)
Interest income		3,386			2,122			1,320			548
Income tax expense		—			(1	)		—			(5	)

Net loss		(44,026	)		(53,508	)		(86,603	)		(72,119	)

Basic and diluted net loss per share	$	(0.45	)	$	(0.57	)	$	(0.92	)	$	(0.78	)

The following table sets forth the Company’s unaudited condensed consolidated statements of operations for the 2021 quarters ended (in thousands):


2021 Quarter Ended	December 31,			September 30,			June 30,			March 31,
Revenue, net	$	25,671		$	22,207		$	20,047		$	15,878
Operating expenses		(111,675	)		(99,531	)		(89,188	)		(69,097	)
Interest income		270			393			421			484
Income tax benefit (expense)		—			23			(24	)		(5	)

Net loss		(85,734	)		(76,908	)		(68,744	)		(52,740	)

Basic and diluted net loss per share	$	(1.05	)	$	(0.95	)	$	(0.85	)	$	(0.65	)

Organization - Additional Information (Detail) $ / shares in Units, $ in Millions	Jan. 07, 2022 USD ($) $ / shares shares
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Initial public offering, Number of shares \| shares	10,952,381
Initial public offering, Price per share \| $ / shares	$ 42
IPO [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Initial public offering, Gross proceeds	$ 460.0
Initial public offering, Net proceeds	$ 433.7

Summary of Significant Accounting Policies - Additional Information (Detail)			12 Months Ended
	Aug. 16, 2022	Aug. 09, 2022	Dec. 31, 2022 USD ($) Segment	Dec. 31, 2021 USD ($)	Dec. 31, 2020 USD ($) shares	Dec. 31, 2019 shares
Significant Accounting Policies [Line Items]
Number of operating segments \| Segment			1
Maturity of highly liquid investments			3 months
Maturity of certificates of deposit, commercial paper, corporate notes and corporate bonds			more than three months
Impairment losses recognized			$ 0
Assumed expected dividend rate			0.00%	0.00%	0.00%
Average Annual Adjusted Income			$ 1,000,000,000
Percentage Of Provision For Corporate Alternative Minimum Tax Rate	15.00%	25.00%
CAPLYTA [Member]
Significant Accounting Policies [Line Items]
Advertising costs			$ 85,800,000	$ 82,500,000	$ 36,300,000
Customer one [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			39.00%	40.00%
Customer two [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			30.00%	28.00%
Customer three [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			28.00%	28.00%
2018 Equity Incentive Plan [Member]
Significant Accounting Policies [Line Items]
Additional shares of common stock reserved for future equity grants \| shares					6,500,000
Minimum [Member]
Significant Accounting Policies [Line Items]
Property and equipment, estimated useful life			3 years
Minimum [Member] \| Product [Member] \| Bristol Myers Squibb Company [Member]
Significant Accounting Policies [Line Items]
Royalty Payment Percentage			5.00%
Maximum [Member]
Significant Accounting Policies [Line Items]
Property and equipment, estimated useful life			5 years
Maximum [Member] \| Product [Member] \| Bristol Myers Squibb Company [Member]
Significant Accounting Policies [Line Items]
Royalty Payment Percentage			9.00%
Maximum [Member] \| Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			97.00%	96.00%
Maximum [Member] \| Inducement Award Plan [Member]
Significant Accounting Policies [Line Items]
Issuance of shares, Inducement Award Plan \| shares						1,000,000

Investment Securities - Summary of Investment Securities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	$ 490,419	$ 320,333
Unrealized Gains	21	20
Unrealized (Losses)	(4,211)	(385)
Estimated Fair Value	486,229	319,968
U.S. Government Agency Securities [Member]
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	188,465	71,752
Unrealized Gains	14	0
Unrealized (Losses)	(1,729)	(100)
Estimated Fair Value	186,750	71,652
FDIC Certificates of Deposit [Member]
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	4,155
Unrealized Gains	3
Unrealized (Losses)	(72)
Estimated Fair Value	4,086
Certificates of Deposit [Member]
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	7,500	26,232
Unrealized Gains	0	1
Unrealized (Losses)	0	0
Estimated Fair Value	7,500	26,233
Commercial Paper [Member]
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	100,711	55,955
Unrealized Gains	3	0
Unrealized (Losses)	(269)	(36)
Estimated Fair Value	100,445	55,919
Corporate Notes/Bonds [Member]
Debt Securities, Available-for-sale [Line Items]
Amortized Cost	189,588	166,394
Unrealized Gains	1	19
Unrealized (Losses)	(2,141)	(249)
Estimated Fair Value	$ 187,448	$ 166,164

Investment Securities - Additional Information (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Debt Securities, Available-for-sale [Line Items]
Investment securities, available-for-sale	$ 443,290	$ 319,968
Aggregate related fair value of investments with unrealized losses	438,300	263,500
Debt Securities, Available-for-sale, Continuous Unrealized Loss Position, Less than 12 Months	389,200	254,100
Debt Securities, Available-for-sale, Continuous Unrealized Loss Position, 12 Months or Longer	49,100	9,500
Cash and Cash Equivalents [Member]
Debt Securities, Available-for-sale [Line Items]
Certificates of Deposit, at Carrying Value	7,500
US Government Agencies Securities, at Carrying Value	20,500
Commercial Paper, at Carrying Value	14,900
Contractual Maturity More Than One Year And Less Than Two Years [Member]
Debt Securities, Available-for-sale [Line Items]
Investment securities, available-for-sale	71,500	$ 67,200
US Government Agencies Debt Securities [Member]
Debt Securities, Available-for-sale [Line Items]
Aggregate related fair value of investments with unrealized losses	153,100
Commercial Paper [Member]
Debt Securities, Available-for-sale [Line Items]
Aggregate related fair value of investments with unrealized losses	96,600
Corporate Debt Securities [Member]
Debt Securities, Available-for-sale [Line Items]
Aggregate related fair value of investments with unrealized losses	185,500
Certificates of Deposit [Member]
Debt Securities, Available-for-sale [Line Items]
Aggregate related fair value of investments with unrealized losses	$ 3,100

Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions	Dec. 31, 2022	Dec. 31, 2021
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Carrying value of cash held in money market funds	$ 12.2	$ 56.5
Cash and Cash Equivalents [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investment Securities At Carrying Value		0.0
Certificates of Deposit, at Carrying Value	7.5
US Government Agencies Securities, at Carrying Value	20.5
Commercial Paper, at Carrying Value	14.9
Significant Unobservable Inputs (Level 3) [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Liabilities measured using quoted prices	0.0	0.0
Assets measured using quoted prices	$ 0.0	$ 0.0

Inventory - Schedule of Inventory, Current (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Inventory Disclosure [Abstract]
Raw materials	$ 17,227	$ 2,484
Work in process	2,594	2,407
Finished goods	4,099	3,057
Total inventories	$ 23,920	$ 7,948

Property and Equipment - Property and Equipment (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	$ 7,137	$ 6,359
Less accumulated depreciation	(5,224)	(4,568)
Property Plant and Equipment Net	1,913	1,791
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	409	409
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	423	423
Scientific Equipment [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	5,065	4,287
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	$ 1,240	$ 1,240

Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Abstract]
Depreciation	$ 656	$ 533	$ 528

Right of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Sep. 30, 2018
Term of long term lease	12 months
Minimum [Member]
Term of long term lease	12 months
Maximum [Member]
Term of long term lease	30 months
Vehicle Fleet Lease [Member]
Guarantee Obligations	$ 1,750
NEW YORK
Term of long term lease		14 years 3 months 18 days

Right of Use Assets and Lease Liabilities - Schedule Of Quantitative Information About Operating Leases (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Lessee, Lease, Description [Line Items]
Right of use assets, net	$ 14,824	$ 20,764
Lease liabilities, short term	4,567	6,732
Lease liabilities, noncurrent	15,474	18,675
Total Lease liability	20,041	25,407
Lease cost
Operating lease cost	4,719	5,774
Variable lease cost	1,612	2,676
Short-term lease cost	873	0
Lease, Cost	$ 7,204	$ 8,450
Other information
Weighted average remaining lease term	5 years 10 months 24 days	6 years 1 month 6 days
Weighted average discount rate	8.76%	8.46%

Right of Use Assets and Lease Liabilities - Maturity analysis of the Company's fleet lease liability (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Lessee, Lease, Description [Line Items]
Year ending December 31, 2023	$ 4,741
Year ending December 31, 2024	3,792
Year ending December 31, 2025	3,907
Year ending December 31, 2026	3,974
Year ending December 31, 2027	4,022
Thereafter	5,915
Total	26,351
Less: Present value discount	(6,310)
Total Lease liability	20,041	$ 25,407
Less: Current portion	(4,567)	(6,732)
Long-term lease liabilities	$ 15,474	$ 18,675

Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Inducement Award Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Awards granted	0
Share-Based Payment Arrangement, Expense	$ 1.2
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number	11,126
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount	$ 0.3
Time Based Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation costs related to unvested RSUs	$ 34.7
Unrecognized share-based compensation expense, weighted-average recognition period	1 year 4 months 24 days
RSUs [Member] \| Inducement Award Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based Compensation Arrangement by Share based Payment Award Equity Instruments Other than Options Vested and Expected to Vest Outstanding Number	64,302
Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, maximum term	10 years
Stock Options [Member] \| Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, vesting term	1 year
Stock Options [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, vesting term	3 years
Inducement Award Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value of stock options granted	$ 41.71	$ 29.01	$ 17.98
Total intrinsic value of the options exercised	$ 48.3	$ 19.6	$ 11.1
Total fair value of shares vested	$ 17.1	10.6	13.4
Unrecognized share-based compensation expense, weighted-average recognition period	1 year 3 months 18 days
Unrecognized share-based compensation expense related to employee stock option awards	$ 23.6
Total instrinsic value of stock units outstanding options	130.1
Total instrinsic value of stock units exercisable	118.3
Total instrinsic value of stock units vested,other than options	40.7	25.0	14.6
Total instrinsic value of stock units outstanding other than options	67.5
Total fair value of time based vested	$ 17.9	$ 12.4	$ 7.2
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number	4,785,972

Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	$ 43,013	$ 34,303	$ 24,115
Inventoriable Costs [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	1,791	1,624	1,342
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	15,387	9,832	7,073
Selling, General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	$ 25,835	$ 22,847	$ 15,700

Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Dividend yield	0.00%	0.00%	0.00%
Expected volatility, minimum	78.70%	89.40%	91.60%
Expected volatility, maximum	88.70%	94.90%	95.50%
Weighted-average risk-free interest rate	2.22%	0.87%	1.29%
Expected term (in years)	5 years 10 months 24 days	5 years 10 months 24 days	6 years

Share-Based Compensation - Stock Options Activity of Inducement Plan (Detail) - Inducement Award Plan [Member]	12 Months Ended
	Dec. 31, 2022 $ / shares shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of period, Number of Shares \| shares	5,451,398
Options granted, Number of Shares \| shares	612,945
Options exercised, Number of Shares \| shares	(1,219,421)
Options canceled Number of Shares \| shares	(56,792)
Options expired Number of Shares \| shares	(2,158)
Outstanding at end of period, Number of Shares \| shares	4,785,972
Vested or expected to vest at end of period, Number of Shares \| shares	4,785,972
Exercisable at end of period, Number of Shares \| shares	3,628,867
Outstanding at beginning of period, Weighted-Average Exercise Price \| $ / shares	$ 21.09
Options granted, exercise price \| $ / shares	56.65
Options exercised, Weighted-Average Exercise Price \| $ / shares	17.58
Options canceled Weighted-Average Exercise Price \| $ / shares	41.01
Options expired, Weighted-Average Exercise Price \| $ / shares	12.73
Outstanding at end of period, Weighted-Average Exercise Price \| $ / shares	26.27
Vested or expected to vest at end of period, Weighted-Average Exercise Price \| $ / shares	26.27
Exercisable at end of period, Weighted-Average Exercise Price \| $ / shares	$ 20.38
Options granted, Weighted-Average Contractual Life	6 years 1 month 6 days
Options exercised, Weighted-Average Contractual Life	5 years 9 months 18 days
Exercisable at end of period, Weighted-Average Contractual Life	5 years

Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of year, Number of Shares	1,529,652
Time based RSU's granted, Number of Shares	601,055
Time based RSU's vested, Number of Shares	(769,355)
Time based RSU's cancelled, Number of Shares	(86,688)
Outstanding at end of year, Number of Shares	1,274,664	1,529,652
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value	$ 26.95
Time based RSU's granted, Weighted-Average Grant Date Fair Value	57.53
Time based RSU's vested, Weighted-Average Grant Date Fair Value	23.23
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value	39.73
Outstanding at end of year, Weighted-Average Grant Date Fair Value	$ 42.76	$ 26.95
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms	9 months 18 days	1 year 6 months

Loss Per Share - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Stock Options [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of anti-dilutive securities excluded from computation of earnings per share	4,785,972	5,451,398	5,517,622
RSUs [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of anti-dilutive securities excluded from computation of earnings per share	1,469,678	1,666,848	1,636,422

Income Taxes - Additional Information (Detail) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Federal net operating loss carryforwards	$ 663.2
Federal net operating loss carryforwards expiration year	2037
Unrecognized tax benefits	$ 1.7	$ 1.7
Indefinite Period Carry Forward [Member]
Federal net operating loss carryforwards	532.1
Expire In 2037 [Member]
Federal net operating loss carryforwards	$ 131.1

Income Taxes - Loss before Income Taxes (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
U.S.	$ (223,465)	$ (221,216)	$ (155,616)
Non-U.S.	(32,785)	(62,904)	(71,376)
Loss before provision for income taxes	$ (256,250)	$ (284,120)	$ (226,992)

- Definition

Amount of income (loss) from continuing operations, including income (loss) from equity method investments, before deduction of income tax expense (benefit), and income (loss) attributable to noncontrolling interest.

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+ Details

Income Taxes - Total Income Tax Expense (Detail) - USD ($) $ in Thousands	3 Months Ended						12 Months Ended
	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Current							$ 6	$ 6	$ 14
Deferred							(52,789)	(53,070)	(40,049)
Valuation allowance							52,789	53,070	40,049
Provision for income taxes	$ (1)	$ 0	$ (5)	$ 23	$ (24)	$ (5)	$ 6	$ 6	$ 14

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Taxes - Reconciliation of Statutory Federal Income Tax Rate and the Effective Income Tax Rate (Detail)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Abstract]
Income tax at statutory federal rate	21.00%	21.00%	21.00%
Executive and share-based compensation	1.92%	0.60%	(1.01%)
Subpart F Inclusion	(3.38%)	0.00%	0.00%
Foreign rate differential	(2.69%)	(4.63%)	(6.60%)
Change in effective state tax rates	0.17%	(0.31%)	1.12%
State income tax expense	3.58%	2.04%	3.14%
Change in valuation allowance	(20.60%)	(18.70%)	(17.65%)
Provision for income taxes	0.00%	0.00%	0.00%

Income Taxes - Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Deferred tax assets:
Net operating loss carryforwards	$ 168,606	$ 137,561
Accrued expenditures	9,169	2,723
Research and development credit, net	9,321	9,321
Research and development expenditures	13,525	0
Share-based compensation	17,085	15,947
Other	1,466	93
Capital lease	4,980	6,178
Deferred tax liabilities:
Right of use asset—capital lease	(3,684)	(5,049)
Depreciation	(154)	(201)
Net deferred tax asset before valuation allowance	220,314	166,573
Valuation allowance	(220,314)	(166,573)
Net deferred tax asset	$ 0	$ 0

Commitments and Contingencies - Additional Information (Detail) - USD ($)			1 Months Ended		12 Months Ended
	Dec. 23, 2019	May 31, 2005	Dec. 31, 2014	Dec. 31, 2013	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Jan. 31, 2019
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Employer matching contribution					100.00%	100.00%	100.00%
Contributions made by participants for which the company makes matching contribution					6.00%	6.00%	6.00%
Contribution expense					$ 3,900,000	$ 3,000,000	$ 1,800,000
Purchase Commitment [Member] \| Siegfried Campaign and Lonza Campaign [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Cash paid					$ 21,600,000	9,500,000
Minimum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Purchase Obligation Year Of Payment					2025 years
Maximum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Purchase Obligation Year Of Payment					2029 years
Product [Member] \| Bristol-Myers Squibb Company [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Company made an upfront payment		$ 1,000,000
Company made milestone payment			$ 1,500,000	$ 1,250,000
Obliged to make milestone payments					$ 14,750,000			$ 2,000,000
License expiration period					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
Cost of product sales					$ 12,500,000	$ 4,100,000	1,100,000
Product [Member] \| Bristol-Myers Squibb Company [Member] \| Minimum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Royalty payment, percentage					5.00%
Product [Member] \| Bristol-Myers Squibb Company [Member] \| Maximum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Royalty payment, percentage					9.00%
Product [Member] \| Bristol-Myers Squibb Company [Member] \| National Democratic Alliance [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Company remaining milestone payment	$ 5,000,000
Product [Member] \| Bristol-Myers Squibb Company [Member] \| ITCI National Democratic Alliance [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Payment of milestone amount							$ 5,000,000

Unaudited Quarterly Financial Information - Schedule of Quarterly Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended								12 Months Ended
	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020
Quarterly Financial Information Disclosure [Abstract]
Revenue, net	$ 87,869	$ 71,870	$ 55,579	$ 34,996	$ 25,671	$ 22,207	$ 20,047	$ 15,878
Operating expenses	(135,281)	(127,499)	(143,502)	(107,658)	(111,675)	(99,531)	(89,188)	(69,097)	$ (513,940)	$ (369,491)	$ (254,041)
Interest income	3,386	2,122	1,320	548	270	393	421	484	7,376	1,568	4,236
Income tax benefit (expense)		(1)	0	(5)		23	(24)	(5)	6	6	14
Net loss	$ (44,026)	$ (53,508)	$ (86,603)	$ (72,119)	$ (85,734)	$ (76,908)	$ (68,744)	$ (52,740)	$ (256,256)	$ (284,126)	$ (227,006)
Earnings Per Share, Basic		$ (0.57)	$ (0.92)	$ (0.78)	$ (1.05)	$ (0.95)	$ (0.85)	$ (0.65)	$ (2.72)	$ (3.5)	$ (3.23)
Earnings Per Share, Diluted	$ (0.45)	$ (0.57)	$ (0.92)	$ (0.78)	$ (1.05)	$ (0.95)	$ (0.85)	$ (0.65)	$ (2.72)	$ (3.5)	$ (3.23)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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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.

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+ Details

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

- 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).

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+ Details

Fair Value Measurements - Schedule of Fair Value Measurements of Cash Equivalents (Detail) - USD ($) $ in Thousands	Dec. 31, 2022	Dec. 31, 2021
Fair Value, Measurements, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	$ 498,432	$ 376,507
Fair Value, Measurements, Recurring [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	12,203	56,539
Fair Value, Measurements, Recurring [Member] \| U.S. Government Agency Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	186,750	71,652
Fair Value, Measurements, Recurring [Member] \| FDIC Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	4,086
Fair Value, Measurements, Recurring [Member] \| Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	7,500	26,233
Fair Value, Measurements, Recurring [Member] \| Commercial Paper [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	100,445	55,919
Fair Value, Measurements, Recurring [Member] \| Corporate Notes/Bonds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	187,448	166,164
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Fair Value, Measurements, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	12,203	56,539
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Fair Value, Measurements, Recurring [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	12,203	56,539
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Fair Value, Measurements, Recurring [Member] \| U.S. Government Agency Securities [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| FDIC Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	0
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Fair Value, Measurements, Recurring [Member] \| Certificates of Deposit [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| Commercial Paper [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| Corporate Notes/Bonds [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	486,229	319,968
Significant Other Observable Inputs (Level 2) [Member] \| Fair Value, Measurements, Recurring [Member] \| Money Market Funds [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| U.S. Government Agency Securities [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	186,750	71,652
Significant Other Observable Inputs (Level 2) [Member] \| Fair Value, Measurements, Recurring [Member] \| FDIC Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	4,086
Significant Other Observable Inputs (Level 2) [Member] \| Fair Value, Measurements, Recurring [Member] \| Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	7,500	26,233
Significant Other Observable Inputs (Level 2) [Member] \| Fair Value, Measurements, Recurring [Member] \| Commercial Paper [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	100,445	55,919
Significant Other Observable Inputs (Level 2) [Member] \| Fair Value, Measurements, Recurring [Member] \| Corporate Notes/Bonds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	187,448	166,164
Significant Unobservable Inputs (Level 3) [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| Money Market Funds [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| U.S. Government Agency Securities [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| FDIC Certificates of Deposit [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	0
Significant Unobservable Inputs (Level 3) [Member] \| Fair Value, Measurements, Recurring [Member] \| Certificates of Deposit [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| Commercial Paper [Member]
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) [Member] \| Fair Value, Measurements, Recurring [Member] \| Corporate Notes/Bonds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Available-for-sale investment securities	$ 0	$ 0