0001193125-20-288507 | 10-Q | XBRL Viewer | Intracellular Therapies INC

Cover Page - shares	9 Months Ended
Cover Page - shares	Sep. 30, 2020	Nov. 06, 2020
Cover [Abstract]
Amendment Flag	false
Document Type	10-Q
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Document Quarterly Report	true
Entity Central Index Key	0001567514
Document Transition Report	false
Current Fiscal Year End Date	--12-31
Document Period End Date	Sep. 30, 2020
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		80,157,554

Condensed Consolidated Balance Sheets - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 300,988,981	$ 107,636,849
Investment securities, available-for-sale	420,958,509	116,373,335
Restricted cash	1,400,000
Accounts receivable, net	7,480,604
Inventory	2,947,138
Prepaid expenses and other current assets	11,090,774	6,313,785
Total current assets	744,866,006	230,323,969
Property and equipment, net	2,049,552	2,259,740
Right of use assets, net	24,292,167	18,252,074
Deferred tax asset, net		264,609
Other assets	86,084	86,084
Total assets	771,293,809	251,186,476
Current liabilities:
Accounts payable	8,569,148	7,425,024
Accrued and other current liabilities	12,186,380	16,138,909
Lease liabilities, short-term	5,267,258	3,187,435
Accrued employee benefits	12,005,931	9,472,651
Total current liabilities	38,028,717	36,224,019
Lease liabilities	23,869,557	19,955,186
Total liabilities	61,898,274	56,179,205
Stockholders' equity:
Common stock, $0.0001 par value: 100,000,000 shares authorized; 80,142,797 and 55,507,497 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	8,014	5,551
Additional paid-in capital	1,585,023,637	904,971,772
Accumulated deficit	(876,404,854)	(710,098,369)
Accumulated comprehensive income	768,738	128,317
Total stockholders' equity	709,395,535	195,007,271
Total liabilities and stockholders' equity	$ 771,293,809	$ 251,186,476

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	80,142,797	55,507,497
Common stock, shares outstanding	80,142,797	55,507,497

Condensed Consolidated Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Revenue	$ 7,368,594		$ 10,358,709
Operating expenses:
Cost of product sales	556,107		753,957
Research and development	10,275,368	$ 21,339,792	51,483,551	$ 70,059,113
Selling, general and administrative	52,473,573	15,036,444	128,015,496	42,184,078
Total operating expenses	63,305,048	36,376,236	180,253,004	112,243,191
Loss from operations	(55,936,454)	(36,376,236)	(169,894,295)	(112,243,191)
Interest income	752,829	1,513,837	3,591,091	5,105,464
Loss before provision for income taxes	(55,183,625)	(34,862,399)	(166,303,204)	(107,137,727)
Income tax expense			3,281	1,600
Net loss	$ (55,183,625)	$ (34,862,399)	$ (166,306,485)	$ (107,139,327)
Net loss per common share:
Basic & Diluted	$ (0.79)	$ (0.63)	$ (2.48)	$ (1.94)
Weighted average number of common shares:
Basic & Diluted	69,530,039	55,207,400	67,030,991	55,155,854
Product sales, net [Member]
Revenue	$ 7,368,594		$ 10,126,999
Grant revenue [Member]
Revenue			$ 231,710

Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Statement of Comprehensive Income [Abstract]
Net loss	$ (55,183,625)	$ (34,862,399)	$ (166,306,485)	$ (107,139,327)
Other comprehensive income (loss):
Unrealized gain (loss) on investment securities	(399,361)	(33,396)	640,421	866,805
Comprehensive loss	$ (55,582,986)	$ (34,895,795)	$ (165,666,064)	$ (106,272,522)

- 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

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Accumulated Comprehensive Income (Loss) [Member]
Balance at Dec. 31, 2018	$ 317,714,881	$ 5,490	$ 880,753,339	$ (562,376,191)	$ (667,757)
Balance, shares at Dec. 31, 2018		54,895,295
Exercise of stock options and issuances of restricted stock (Value)	442,826	$ 34	442,792
Exercise of stock options and issuances of restricted stock (Shares)		338,054
Stock issued for services	145,691	$ 1	145,690
Stock issued for services, shares		14,230
Share-based compensation	14,849,409		14,849,409
Net loss	(107,139,327)			(107,139,327)
Other comprehensive gain (loss)	866,805				866,805
Balance at Sep. 30, 2019	226,880,285	$ 5,525	896,191,230	(669,515,518)	199,048
Balance, shares at Sep. 30, 2019		55,247,579
Balance at Jun. 30, 2019	256,768,362	$ 5,519	891,183,518	(634,653,119)	232,444
Balance, shares at Jun. 30, 2019		55,186,745
Exercise of stock options and issuances of restricted stock (Value)	152,379	$ 6	152,373
Exercise of stock options and issuances of restricted stock (Shares)		54,332
Stock issued for services	48,571		48,571
Stock issued for services, shares		6,502
Share-based compensation	4,806,768		4,806,768
Net loss	(34,862,399)			(34,862,399)
Other comprehensive gain (loss)	(33,396)				(33,396)
Balance at Sep. 30, 2019	226,880,285	$ 5,525	896,191,230	(669,515,518)	199,048
Balance, shares at Sep. 30, 2019		55,247,579
Balance at Dec. 31, 2019	195,007,271	$ 5,551	904,971,772	(710,098,369)	128,317
Balance, shares at Dec. 31, 2019		55,507,497
Common shares issued	652,712,011	$ 2,341	652,709,670
Common shares issued, shares		23,409,458
Exercise of stock options and issuances of restricted stock (Value)	7,829,584	$ 121	7,829,463
Exercise of stock options and issuances of restricted stock (Shares)		1,218,188
Stock issued for services	160,583	$ 1	160,582
Stock issued for services, shares		7,654
Share-based compensation	19,352,150		19,352,150
Net loss	(166,306,485)			(166,306,485)
Other comprehensive gain (loss)	640,421				640,421
Balance at Sep. 30, 2020	709,395,535	$ 8,014	1,585,023,637	(876,404,854)	768,738
Balance, shares at Sep. 30, 2020		80,142,797
Balance at Jun. 30, 2020	379,529,868	$ 6,678	1,199,576,320	(821,221,229)	1,168,099
Balance, shares at Jun. 30, 2020		66,777,737
Common shares issued	370,138,616	$ 1,318	370,137,298
Common shares issued, shares		13,179,458
Common shares receivable collected	5,705,186		5,705,186
Exercise of stock options and issuances of restricted stock (Value)	2,650,605	$ 18	2,650,587
Exercise of stock options and issuances of restricted stock (Shares)		183,516
Stock issued for services	53,527	$ 0	53,527
Stock issued for services, shares		2,086
Share-based compensation	6,900,719		6,900,719
Net loss	(55,183,625)			(55,183,625)
Other comprehensive gain (loss)	(399,361)				(399,361)
Balance at Sep. 30, 2020	$ 709,395,535	$ 8,014	$ 1,585,023,637	$ (876,404,854)	$ 768,738
Balance, shares at Sep. 30, 2020		80,142,797

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Cash flows used in operating activities
Net loss	$ (166,306,485)	$ (107,139,327)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	402,146	335,461
Share-based compensation	19,352,150	14,849,409
Stock issued for services	160,583	145,691
Amortization of premiums and discounts on investment securities, net	(177,374)	(871,412)
Changes in operating assets and liabilities:
Accounts receivable, net	(7,480,604)
Inventory	(2,947,138)
Prepaid expenses and other assets	(4,776,989)	4,020,430
Long term deferred tax asset, net	264,609
Accounts payable	1,144,124	(7,730,137)
Accrued liabilities and other	(1,419,249)	3,462,560
Lease liabilities, net	(45,899)
Net cash used in operating activities	(161,830,126)	(92,927,325)
Cash flows (used in) provided by investing activities
Purchases of investments	(488,524,539)	(58,332,886)
Maturities of investments	184,757,160	199,383,553
Purchases of property and equipment	(191,958)	(1,350,688)
Net cash (used in) provided by investing activities	(303,959,337)	139,699,979
Cash flows provided by financing activities
Proceeds from exercise of stock options	7,829,584	442,826
Proceeds of public offering, net	652,712,011
Net cash provided by financing activities	660,541,595	442,826
Net increase in cash, cash equivalents, and restricted cash	194,752,132	47,215,480
Cash, cash equivalents, and restricted cash at beginning of period	107,636,849	54,947,502
Cash, cash equivalents, and restricted cash at end of period	302,388,981	102,162,982
Vehicle Fleet Lease [Member]
Non-cash investing and financing activities
Right of use assets under operating	$ 7,750,959
Real Estate Lease [Member]
Non-cash investing and financing activities
Right of use assets under operating		$ 219,703

Condensed Consolidated Statements of Cash Flows (Unaudited) (Parenthetical) - USD ($)	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2019	Dec. 31, 2018
Statement of Cash Flows [Abstract]
Cash and cash equivalents	$ 300,988,981	$ 107,636,849	$ 102,162,982
Restricted cash	1,400,000
Total cash, cash equivalents and restricted cash	$ 302,388,981	$ 107,636,849	$ 102,162,982	$ 54,947,502

Organization	9 Months Ended
Organization	Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization	1. Organization Intra-Cellular Therapies, Inc. (the “Company”), through its wholly-owned operating subsidiaries, ITI, Inc. (“ITI”) and ITI Limited, 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 (“CNS”). In December 2019, the Company announced that CAPLYTA TM (lumateperone) had been approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of schizophrenia in adults (42mg/day). The Company initiated the commercial launch of CAPLYTA in late March 2020. As used in these Notes to Condensed Consolidated Financial Statements, “CAPLYTA” refers to lumateperone approved by the FDA for the treatment of schizophrenia in adults, and “lumateperone” refers to, where applicable, CAPLYTA as well as lumateperone for the treatment of indications beyond schizophrenia. Lumateperone is in Phase 3 clinical development as a novel treatment for bipolar depression. On January 10, 2020, the Company completed a public offering of common stock in which the Company sold 10,000,000 shares of common stock at an offering price of $29.50 per share for aggregate gross proceeds of $295.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $277.0 million. On September 15, 2020 , the Company completed a public offering of common stock in which the Company sold 12,666,667 shares of common stock at an offering price of $30.00 per share for aggregate gross proceeds of $380.0 million. After deducting underwriting discounts, commissions and offering expenses, the net proceeds to the Company were approximately $357.8 million. In order to further its commercial activities and research projects and support its collaborations, the Company will 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 securities, the incurrence of debt from commercial lenders, strategic collaborations, licensing a portion or all of the Company’s product candidates and technology and, to a lesser extent, grant funding. On August 30, 2019, the Company filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on September 12, 2019, on which the Company registered for sale up to $350 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, which includes up to $75 million of common stock that the Company may issue and sell from time to time, through SVB Leerink LLC acting as its sales agent, pursuant to the sale agreement that the Company entered into with SVB Leerink on August 29, 2019 for the Company’s “at-the-market” equity program. On September 10, 2020, the Company terminated the “at-the-market” equity program sales agreement with SVB Leerink LLC. Through the date of the termination of the sales agreement on September 10, 2020, the Company had issued an aggregate 742,791 shares of common stock under the Company’s “at-the-market” equity program which resulted in the Company receiving net proceeds of $17.9 million. In addition, on January 6, 2020, the Company filed an automatic shelf registration statement on Form S-3 with the SEC, which became effective upon filing, on which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights, and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continues to satisfy the requirements of a “well-known seasoned issuer” under SEC rules. These registration statements will remain in effect for up to three years from the respective dates they became effective.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements of Intra-Cellular Therapies, Inc. and its wholly own subsidiaries have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. 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 for the treatment of neurological and psychiatric disorders.

Use of Estimates

The preparation of financial statements in conformity with U.S. 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.

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 condensed consolidated balance sheets.

Investment Securities

Investment securities consisted of the following (in thousands):


	September 30, 2020
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
	(Unaudited)
U.S. Government Agency Securities	$	159,237	$	12	$	(32	)	$	159,217
Certificates of Deposit		10,500		—		—			10,500
Commercial Paper		78,788		138		(2	)		78,924
Corporate Notes/Bonds		171,665		782		(129	)		172,318

	$	420,190	$	932	$	(163	)	$	420,959


	December 31, 2019
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	35,462	$	35	$	(3	)	$	35,494
Certificates of Deposit		3,000		—		—			3,000
Commercial Paper		39,013		10		(5	)		39,018
Corporate Notes/Bonds		38,770		91		—			38,861

	$	116,245	$	136	$	(8	)	$	116,373

The Company has classified all of its investment securities as

available-for-sale,

including those with maturities beyond one year, as current assets on the condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. As of September 30, 2020, and December 31, 2019, the Company held $197.3 million and $3.0 million, respectively, of

available-for-sale

investment securities with contractual maturity dates more than one year and less than two years.

The Company monitors its investment portfolio for overall risk, specifically credit risk loss, quarterly or more frequently if circumstances warrant. The Company would estimate the expected credit loss over the lifetime of the asset and record an allowance for the portion of the amortized cost basis of the financial asset that the Company does not expect to collect.

The aggregate related fair value of investments with unrealized losses as of September 30, 2020 was $192.8 million, which consisted of $110.4 million from U.S. government agency securities, $10.0 million of commercial paper, and $72.4 million of corporate notes/bonds. The aggregate amount of unrealized losses as of September 30, 2020 was approximately $163,000, which consisted of $32,000 from U.S. government agency securities, $2,000 from commercial paper, and $129,000 from corporate notes/bonds. The $192.8 million aggregate fair value of investments with unrealized losses as of September 30, 2020 has been held in a continuous unrealized loss position for less than 12 months. As of December 31, 2019, the Company had approximately $29.6 million of investments with a continuous unrealized loss for 12 months or longer of which approximately $12.5 million had been held in a continuous loss position for 12 months or longer.

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.

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.

The Company has no assets or liabilities that were measured using quoted prices for significant unobservable inputs (Level 3 assets and liabilities) as of September 30, 2020 or December 31, 2019. The carrying value of cash held in money market funds of approximately $224.2 million as of September 30, 2020 and $49.9 million as of December 31, 2019 is included in cash and cash equivalents on the condensed consolidated balance sheet and approximates market value based on quoted market prices or Level 1 inputs. The carrying value of certificates of deposit of approximately

47.6 million as of December 31, 2019 is also included in cash and cash equivalents on the condensed consolidated balance sheet and approximates market value based on quoted market prices or Level 2 inputs. The carrying value of commercial paper of approximately $3.0 million as of December 31, 2019 is included in cash and cash equivalents on the condensed consolidated balance sheet and approximates market value based on quoted market prices or Level 2 inputs.

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
	September 30, 2020		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	224,239	$	224,239	$	—	$	—
U.S. Government Agency Securities		159,217		—		159,217		—
Certificates of Deposit		10,500		—		10,500		—
Commercial Paper		78,924		—		78,924		—
Corporate Notes/Bonds		172,318		—		172,318		—

	$	645,198	$	224,239	$	420,959	$	—


			Fair Value Measurements at Reporting Date Using
	December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	49,882	$	49,882	$	—	$	—
U.S. Government Agency Securities		35,494		—		35,494		—
Certificates of Deposit		50,622		—		50,622		—
Commercial Paper		42,015		—		42,015		—
Corporate Notes/Bonds		38,861		—		38,861		—

	$	216,874	$	49,882	$	166,992	$	—

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, other assets, accounts payable, accrued liabilities, accrued employee benefits and lease liabilities, short-term, to approximate their fair value because of their relatively short maturities at September 30, 2020 and December 31, 2019. Management believes that the risks associated with its 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 vehicle lease agreement. 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 from chargebacks, prompt pay discounts, and distribution fees.

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. For the three and nine months ended September 30, 2020, 96% of sales were generated from three major industry wholesalers, respectively.

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 nine months ended September 30, 2020, all of the Company’s accounts receivable, net arose from product sales in the U.S. and all customers have standard payment terms which generally require payment within 90 days. Three individual customers accounted for approximately 39%, 29%, and 28% of product sales for the three months ended September 30, 2020 as well as accounted for approximately 41%, 27% and 27% of product sales for the nine months ended September 30, 2020. As of September 30, 2020, the Company believes that such 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 incurred in 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 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.

Revenue Recognition

Effective January 1, 2018, the Company adopted FASB ASC Topic 606,

Revenue from Contracts with Customers

(“ASC Topic 606”). The Company did not generate any product related revenue prior to January 1, 2020, and therefore the adoption of ASC Topic 606 did not have an impact in the Company’s financial statements for any prior periods. 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 three and nine months ended September 30, 2020 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 U.S., 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 estimates that take into consideration a range of possible outcomes which are either considered more likely or probability-weighted 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, forecasted customer buying and payment patterns. The Company’s estimates regarding the payer mix for CAPLYTA and historical industry information regarding the payer mix for comparable pharmaceutical products and product portfolios, in particular, historical information related to similar products in their initial launch stages. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts after considering whether revenue should be constrained under ASC 606.

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 a material reversal of revenue would not occur in a future period for the estimates detailed below as of September 30, 2020 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2020. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product 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 net sales within the condensed consolidated statements of operations through September 30, 2020, as well as a reduction to trade receivables, net on the condensed 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 condensed 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 any 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 directly purchase the product 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 receivables, 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. For the three and nine months ended September 30, 2020, these amounts were not significant.

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 condensed 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 condensed 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 estimates the number of claims through vouchers for product that is in the distribution channel inventories 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 condensed consolidated balance sheets.

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

expensed all

costs associated with the manufacturing of lumateperone as part of research and development expenses

From December 20, 2019, the date of approval of CAPLYTA, through December 31, 2019 there was no production and no inventory costs were incurred. Therefore, at December 31, 2019, no inventory costs had been capitalized. The cost of product sales in the nine months ended September 30, 2020 are lower than incurred because of previously expensed inventory.

Research and Development, Including Clinical Trial Expenses

Except for payments made in advance of services, the Company expenses its research and development costs as incurred. For payments made in advance, the Company recognizes research and development expense as the services are rendered. 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 preclinical 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 with respect to their actual costs incurred, among other factors. 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. For the nine-months ended September 30, 2020, the Company recorded a change in estimate of approximately $3.3 million of accrued expenses for clinical trials related to the first and second quarter of 2020 which resulted in an increase of clinical trial expense in the nine month period ending September 30, 2020. For the three and nine months ended September 30, 2020 and 2019, there were no material adjustments to the Company’s prior year estimates of accrued expenses for clinical trials.

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 (previously included in FASB Interpretation No. 48,

Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No.

109

). 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 three and nine months ended September 30, 2020 and 2019 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, a temporary provision allowing companies to defer remitting to the government the employee share of some payroll taxes, among other things. The Company reviewed the provisions and there was not a material tax impact on its financial statements for the three and nine months ended September 30, 2020. The Company did reclassify its deferred tax asset related to the AMT tax credit carryforward of $265,000 to a current tax receivable in the first quarter of 2020 upon the filing of its tax return for year ended December 31, 2019 and received the refund in July 2020.

Comprehensive Income (Loss)

All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are incurred. Comprehensive income (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 income (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 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 three and nine months ended September 30, 2020 and 2019 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.

Expected volatility rates for quarterly periods prior to December 31, 2019 were based on a combination of the historical volatility of the common stock of comparable publicly traded entities and the limited historical information about the Company’s common stock. In the fourth quarter of 2019, 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.

The 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. The Company has granted RSUs that vest in three equal annual installments provided that the employee remains employed with the Company.

In the first quarter of each fiscal year beginning in 2016, the Company granted time based RSUs that vest in three equal annual installments. In the first quarter of 2017, the Company granted performance-based RSUs, which vest based on the achievement of certain milestones that include (i) the submission of a new drug application (“NDA”) to the FDA for lumateperone for the treatment of schizophrenia, (ii) the approval of the NDA by the FDA (together, the “Milestone RSUs”) and (iii) the achievement of certain comparative shareholder returns against the Company’s peers (the “TSR RSUs”). The Milestone RSUs related to the NDA submission were fully amortized on December 31, 2018. The NDA submission milestone was achieved in the third quarter of 2018, so the Milestone RSUs related to the NDA submission vested on December 31, 2018. The Milestone RSU’s related to the NDA approval was achieved in the fourth quarter of 2019, so the RSU’s vested on December 31, 2019. The Milestone RSUs related to the approval of the NDA were fully amortized on December 31, 2019. The TSR RSUs were valued using the Monte Carlo Simulation method and were amortized over the life of the RSUs based on the agreements which vested on January 24, 2020.

In the first quarter of 2020, the Company granted performance-based RSUs for 86,000 shares of common stock, which vest based on the achievement of certain milestones that include (i) the approval of a planned NDA by the FDA and (ii) the achievement of certain comparative shareholder returns against the Company’s peers (the “2020 TSR RSUs”). The 2020 TSR RSUs were valued using the Monte Carlo Simulation method and will be amortized over the life of the RSUs based on the agreements.

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.

Since the Company has losses and also maintains a full valuation allowance to cover its deferred tax assets as of September 30, 2020 and 2019, excess tax benefits, if any, recognized for the tax deductions related to share-based awards will add to the Company’s net operating loss deferred tax asset and covered by valuation allowances.

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 June 2018, the Company’s stockholders approved the Company’s 2018 Equity Incentive Plan pursuant to which 4,750,000 additional shares of common stock were reserved for future equity grants. In May 2020, the Company’s stockholders approved the Company’s 2018 Amended and Restated Equity Incentive 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 Intra-Cellular Therapies, Inc. 2019 Inducement Award Plan (the “2019 Inducement Plan”) without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Pursuant to the 2019 Inducement Plan, the Company may grant stock options, RSUs, stock awards and other share-based awards for up to a total of 1,000,000 shares of common stock to new employees of the Company. As of September 30, 2020, stock options and RSUs for 314,138 shares have been granted under the 2019 Inducement Plan. The Company does not intend to make additional grants under the 2019 Inducement Plan.

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.

The following awards were excluded in the calculation of diluted loss per share because their effect could be anti-dilutive as applied to the loss from operations for the three and nine months ended September 30, 2020 and 2019:


	Three and Nine Months Ended September 30,
	2020		2019
Stock options		5,964,135		6,330,914
RSUs		1,702,538		1,425,459
TSR RSUs		43,022		134,170

Recently Issued Accounting Standards

In June 2016, the FASB issued ASU

No. 2016-13,

“Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU

2016-13”).

This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. For

available-for-sale

debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction to the carrying value of the asset. For trade receivables, loans and

held-to-maturity

debt securities, entities will be required to estimate lifetime expected credit losses. The Company adopted this standard on January 1, 2020. The Company evaluated the implications of the new standard, inclusive of the applicable financial statement disclosures required, as well as to its internal controls, business processes, and accounting policies, noting there was no significant impact to the financial statements as of January 1, 2020 and for the three and nine month period ended September 30, 2020.

Inventory

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Inventory

3. Inventory

Inventory consists of the following:


	September 30, 2020
Raw materials	$	—
Work in process		1,597,413

Finished goods		1,349,725

	$	2,947,138

Inventory acquired prior to receipt of the FDA approval on December 20, 2019 for CAPLYTA was expensed as research and development expense as incurred. No inventory was produced from the FDA approval date through the end of 2019; therefore, no inventory was capitalized on the consolidated balance sheet as of December 31, 2019.

Property and Equipment

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Property and Equipment

4. Property and Equipment

Property and equipment consist of the following:


	September 30, 2020			December 31, 2019
Computer equipment	$	243,532		$	243,532
Furniture and fixtures		423,097			423,097
Scientific equipment		4,053,185			3,861,227
Leasehold improvements		1,240,315			1,240,315

		5,960,129			5,768,171
Less accumulated depreciation		(3,910,577	)		(3,508,431	)

	$	2,049,552		$	2,259,740

Depreciation expense for the three and nine months ended September 30, 2020 was $121,044 and $402,146, respectively, as compared to approximately $129,052 and $335,461, respectively, for the three and nine months ended September 30, 2019.

Right of Use Assets and Lease Liabilities

9 Months Ended

Sep. 30, 2020

Leases [Abstract]

Right of Use Assets and Lease Liabilities

5. Right of Use Assets and Lease Liabilities

Real Estate Leases

In 2014, the Company entered into a long-term lease with a related party which, as amended, provides 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 additional office space beginning October 1, 2018 and to extend the term of the lease for previously acquired space. The lease, as amended, has a term of 14.3 years ending in May 2029. In February 2019, the Company entered into a long-term lease for office space in Towson, Maryland beginning March 1, 2019. The lease has a term of 3.2 years ending in April 2022 and includes limited rent abatement and escalation provisions.

In adopting ASU

2016-02

as of January 1, 2019, 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 condensed 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. In determining 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. The Company recognized those lease payments 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. On the lease commencement dates, the Company estimated the lease liabilities and the right of use assets at present value using its applicable incremental borrowing rates of its two long-term leases of 7.2% for the Company’s Maryland lease of 3.2 years and 9.1% for the Company’s New York leases of 14.3 years. On January 1, 2019, upon adoption of ASU

2016-02,

the Company recorded right of use assets of approximately $20.2 million, lease liabilities of $23.4 million and eliminated deferred rent of $3.2 million. At the execution of the Maryland lease in 2019, the Company recorded a right of use asset and a lease liability of $0.2 million, which represented a

non-cash

transaction.

aturity analysis under the lease agreements are as follows:


Three months ending December 31, 2020	$	845,566
Year ending December 31, 2021		3,448,323
Year ending December 31, 2022		3,491,166
Year ending December 31, 2023		3,566,466
Year ending December 31, 2024		3,675,196
Thereafter		17,627,040

Total		32,653,757
Less: Present value discount		(10,463,196	)

Total Lease liability		22,190,561

Less: Current portion		(3,259,966	)

Long-term lease liabilities	$	18,930,595

Lease expense for the three and nine months ended September 30, 2020 was approximately $0.8 million and $2.5 million, respectively, as compared to approximately $0.8 million and $2.5

million

, respectively, for the three and nine months ended September 30, 2019.

Vehicle Fleet Lease

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 30 months based on industry standards. 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 $1.4 million letter of credit that the Lessor may draw upon in the event the Company defaults on the Vehicle Lease. The $1.4 million is recorded as restricted cash on the condensed consolidated balance sheet.

The nature of the lease is one commonly referred to as “TRAC” lease, as it contains a terminal rental adjustment clause, or “TRAC” clause.” The TRAC clause limits lessee

exposure, or likelihood of having a variable lease payment

due at lease termination. This variable lease payment amount would be any difference between the vehicle stipulated (capitalized) cost and the sum of the reserve and net proceeds from disposal as described in the Vehicle Lease. Further, the Lessor guarantees that the net proceeds will not be less than 20% of the vehicle capitalized cost in the first 12 months, and 30% of the vehicle capitalized cost at the beginning of subsequent

12-month

period increments.

Right of use asset and lease liability for the vehicle fleet lease were approximately $6.9 million and $6.9 million, respectively, as of September 30, 2020. The vehicle leases entered into since March 2020 represent

non-cash

transactions. The total operating lease cost for the nine months ended September 30, 2020 was $585,490. The operating cash outflows related to vehicle fleet operating lease obligations for the nine months ended September 30, 2020 were $585,490.

The following table presents the Vehicle Lease balances within the condensed consolidated balance sheet, weighted average remaining fleet lease term, and the weighted average discount rates related to the Vehicle Lease as of September 30, 2020:


Lease Assets and Liabilities – Fleet	Classification		September 30, 2020
Assets
Right of use assets, net		Operating lease right of use assets	$	6,946,254

			$	6,946,254

Liabilities
Current
Lease liabilities, short-term		Operating lease liabilities	$	2,007,292
Non-Current
Lease liabilities		Non-current operating lease liabilities		4,938,962

Total lease liabilities			$	6,946,254

Weighted average remaining lease term				2.2 years
Weighted average discount rate				1.85	%

The following table presents the maturity of the Company’s fleet lease liability as of

September

30, 2020:

Time

Period


Three months ending December 31, 2020	$	530,799
Year ending December 31, 2021		2,112,506
Year ending December 31, 2022		3,207,898
Year ending December 31, 2023		1,273,867
Thereafter		—

Total		7,125,070
Less: Present value discount		(178,816	)

Total operating lease liabilities		6,946,254

Less: Current portion		(2,007,292	)

Long-term lease liabilities	$	4,938,962

Right of use assets and lease liabilities for

all

operating leases were approximately $24.3 million and $29.1 million, respectively, as of September 30, 2020.

Share-Based Compensation

9 Months Ended

Sep. 30, 2020

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

Share-Based Compensation

6. Share-Based Compensation

On June 18, 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”). The 2018 Plan provided for the granting of share-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. On May 27, 2020, the Company’s stockholders approved the Amended and Restated 2018 Equity Incentive Plan (the “Amended 2018 Plan”), which amended and restated the 2018 Plan. The Amended 2018 Plan provides for the granting of up to

6,500,000

additional share-based awards, such as stock options, restricted common stock, RSUs and stock appreciation rights to employees, directors and consultants as determined by the Board of Directors. 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.

As of December 31, 2019, the total number of shares reserved under all equity plans was 11,287,390 and the Company had 2,208,317 shares available for future issuance under the Amended 2018 Plan and the 2019 Inducement Plan. Stock options granted under the 2018 Plan and the 2019 Inducement Plan may be either incentive stock options (“ISOs”) as defined by the

Internal Revenue Code of 1986, as amended

, or

non-qualified

stock options. 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

-based compensation expense related to all of the Company’s share-based awards, including stock options and RSUs to employees, directors and consultants, recognized during the three and nine months ended September 30, 2020 and 2019, was comprised of the following:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Inventoriable costs	$	345,460	$	—	$	996,802	$	—
Research and development		2,402,865		2,023,700		6,792,498	$	6,785,280
General and administrative		4,152,394		2,783,068		11,562,850		8,064,129

Total share-based compensation expense	$	6,900,719	$	4,806,768	$	19,352,150	$	14,849,409

The following table describes the weighted-average assumptions used for calculating the value of options granted during the nine months ended September 30, 2020 and 2019:


	2020	2019
Dividend yield	0%	0%
Expected volatility	91.6%-92.7%	83.7%-85.7%
Weighted-average risk-free interest rate	1.31%	2.32%
Expected term (in years)	6.0	6.0

Information regarding stock option awards under the 2019 Inducement Plan, including with respect to grants to employees as of September 30, 2020, and changes during the nine month period then ended, are summarized as follows:


	Number of Shares		Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2019		—	$	—
Options granted in 2020		39,728	$	17.18		9.5 years

Outstanding at September 30, 2020		39,728	$	17.18		9.5 years

Vested or expected to vest at September 30, 2020		39,728	$	17.18

Exercisable at September 30, 2020		—	$	—

Information regarding RSU awards under the 2019 Inducement Plan during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted- Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		—		$	—
Time based RSUs granted in 2020		274,410		$	16.01		2.6 years
Time based RSUs cancelled in 2020		(15,064	)	$	15.81		2.5 years

Outstanding at September 30, 2020		259,346		$	16.01		2.6 years

Vested or expected to vest at September 30, 2020		259,346		$	16.01

Exercisable at September 30, 2020		—		$	—

As of September 30, 2020, the Company issued options and time based RSUs totaling 314,138 shares in the 2019 Inducement Plan. The Company does not intend to issue any additional equity awards under the 2019 Inducement Plan.

Information regarding the stock options activity, including with respect to grants to employees, directors and consultants as of September 30, 2020, and changes during the nine month period then ended, are summarized as follows:


	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2019		6,039,945		$	16.81		7.0 years
Options granted		742,509		$	23.85		9.4 years
Options exercised		(696,936	)	$	12.79		4.8 years
Options canceled or expired		(161,111	)	$	21.70		7.9 years

Outstanding at September 30, 2020		5,924,407		$	18.03		6.8 years

Vested or expected to vest at September 30, 2020		5,924,407		$	18.03

Exercisable at September 30, 2020		3,620,984		$	18.85		5.7 years

The fair value of the time based RSUs and the Milestone RSUs is based on the closing price of the Company’s common stock on the date of grant.

The fair value of the TSR RSUs was determined using the Monte Carlo simulation method. Information

regarding the time based RSU activity and changes during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted-Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		1,268,679		$	13.60		1.7 years
Time based RSUs granted in 2020		728,596		$	23.05		2.7 years
Time based RSUs vested in 2020		(506,546	)	$	13.78		0.9 years
Time based RSUs cancelled in 2020		(90,559	)	$	17.03		1.5 years

Outstanding at September 30, 2020		1,400,170		$	18.69		1.9 years

Information related to the Company’s Milestone RSUs and TSR RSUs during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted-Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		67,080		$	17.08		0.2 years
Milestone RSUs and TSR RSUs granted in 2020		86,044		$	32.56		2.4 years
Milestone RSUs and TSR RSUs vested in 2020		(67,080	)	$	17.08		0.2 years

Outstanding at September 30, 2020		86,044		$	32.56		2.4 years

The weighted average estimated fair value per share of the TSR RSUs granted in 2017 was $17.08, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.6%, and expected volatility of 95.4%. The TSR RSUs granted in 2017 entitled the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ended and vested on December 31, 2019, provided the grantee remained in the service of the Company on the settlement date. The Company expensed the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs was settled was a percentage of shares for which the award was targeted and depended on the Company’s total shareholder return (as defined below), expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group (as defined below). The number of shares for which the TSR RSUs were settled varied depending on the level of achievement of the goal. Total shareholder return was determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2020 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2017, with a deemed reinvestment of any dividends declared during the performance period.

The Company’s peer group originally included 223 companies that comprised the Nasdaq Biotechnology Index at December 31, 2018, which was selected by the Compensation Committee of the Company’s Board of Directors and included a range of biotechnology companies operating in several business segments.

The weighted average estimated fair value per share of the TSR RSUs granted in 2020 was $32.56, which was derived from a Monte Carlo simulation. Significant assumptions utilized in estimating the value of the awards granted include an expected dividend yield of 0%, a risk free rate of 1.4%, and expected volatility of 91.3%. The TSR RSUs granted in 2020 will entitle the grantee to receive a number of shares of the Company’s common stock determined over a three-year performance period ending and vesting on December 31, 2022, provided the grantee remained in the service of the Company on the settlement date. The Company is expensing the cost of these awards ratably over the requisite service period. The number of shares for which the TSR RSUs will be settled is a percentage of shares for which the award is targeted and depends on the Company’s total shareholder return, expressed as a percentile ranking of the Company’s total shareholder return as compared to the Company’s peer group, which is consistent with the TSR RSUs granted in 2017. The number of shares for which the TSR RSUs will be settled will vary depending on the level of achievement of the goal. Total shareholder return will be determined by dividing the average share value of the Company’s common stock over the 30 trading days preceding January 1, 2023 by the average share value of the Company’s common stock over the 30 trading days beginning on January 1, 2020, with a deemed reinvestment of any dividends declared during the performance period.

The Company’s peer group included companies that compromised the Nasdaq Biotechnology Index at December 31, 2019.

The Company recognized

non-cash

hare

-based compensation expense related to time based RSU’s for the three and nine months ended September 30, 2020 of approximately $3.2 million and $8.9 million, respectively, as compared to $1.7 million and $5.6 million for the three and nine months ended September 30, 2019, respectively. Total expense for all RSUs, including the time based

and performance based RSUs, is $3.4 million and $9.2 million for the three and nine months ended September 30, 2020, respectively, as

compared to $1.9 million and $6.1 million for the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, there was $21.6 million of unrecognized compensation costs related to unvested time based RSUs. As of September 30, 2020, there was $1.0 million and $1.1 million of unrecognized compensation costs related to unvested Milestone RSUs and TSR RSUs, respectively.

Collaborations and License Agreements	9 Months Ended
Collaborations and License Agreements	Sep. 30, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Collaborations and License Agreements	7. Collaborations and License Agreements The Bristol-Myers Squibb License Agreement On May 31, 2005, the Company entered into a worldwide, exclusive License Agreement with Bristol-Myers Squibb Company (“BMS”), pursuant to which the Company holds a license to certain patents and know-how of BMS relating to lumateperone and other specified compounds. The agreement was amended on November 3, 2010. The licensed rights are exclusive, except BMS retains rights in specified compounds in the fields of obesity, diabetes, metabolic syndrome and cardiovascular disease. However, BMS has no right to use, develop or commercialize lumateperone and other specified compounds in any field of use. The Company has the right to grant sublicenses of the rights conveyed by BMS. The Company is obliged under the agreement to use commercially reasonable efforts to develop and commercialize the licensed technology. The Company is also prohibited from engaging in the clinical development or commercialization of specified competitive compounds. Under the agreement, the Company 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 23, 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. In connection with the transfer, the Company guaranteed ITI Limited’s performance of its obligations under the BMS agreement. With the initial recognition of product sales revenue in the nine months ended September 30, 2020, the Company expensed approximately $506,000 in cost of product sales to satisfy its obligation under the BMS agreement.

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation

Use of Estimates

Cash and Cash Equivalents

Investment Securities, available-for-sale

Investment Securities

Investment securities consisted of the following (in thousands):


	September 30, 2020
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
	(Unaudited)
U.S. Government Agency Securities	$	159,237	$	12	$	(32	)	$	159,217
Certificates of Deposit		10,500		—		—			10,500
Commercial Paper		78,788		138		(2	)		78,924
Corporate Notes/Bonds		171,665		782		(129	)		172,318

	$	420,190	$	932	$	(163	)	$	420,959


	December 31, 2019
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	35,462	$	35	$	(3	)	$	35,494
Certificates of Deposit		3,000		—		—			3,000
Commercial Paper		39,013		10		(5	)		39,018
Corporate Notes/Bonds		38,770		91		—			38,861

	$	116,245	$	136	$	(8	)	$	116,373

The Company has classified all of its investment securities as

available-for-sale,

available-for-sale

investment securities with contractual maturity dates more than one year and less than two years.

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.

•

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
	September 30, 2020		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	224,239	$	224,239	$	—	$	—
U.S. Government Agency Securities		159,217		—		159,217		—
Certificates of Deposit		10,500		—		10,500		—
Commercial Paper		78,924		—		78,924		—
Corporate Notes/Bonds		172,318		—		172,318		—

	$	645,198	$	224,239	$	420,959	$	—


			Fair Value Measurements at Reporting Date Using
	December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	49,882	$	49,882	$	—	$	—
U.S. Government Agency Securities		35,494		—		35,494		—
Certificates of Deposit		50,622		—		50,622		—
Commercial Paper		42,015		—		42,015		—
Corporate Notes/Bonds		38,861		—		38,861		—

	$	216,874	$	49,882	$	166,992	$	—

Financial Instruments

Restricted Cash

Restricted cash is collateral used under the letter of credit arrangement for the vehicle lease agreement. 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

(“FIFO”) basis. The

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 360,

Property, Plant and Equipment

Revenue Recognition

Effective January 1, 2018, the Company adopted FASB ASC Topic 606,

Revenue from Contracts with Customers

Product Sales, net

(below).

To date, the Company’s only source of product sales has been from sales of CAPLYTA in the U.S., 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

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

Prior to FDA approval of CAPLYTA, the Company

expensed all

costs associated with the manufacturing of lumateperone as part of research and development expenses

Research and Development, including Clinical trial expenses

Research and Development, Including Clinical Trial Expenses

Income Taxes

Accounting for Uncertainty in Income Taxes—an Interpretation of FASB Statement No.

109

). 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 Income (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


	Three and Nine Months Ended September 30,
	2020		2019
Stock options		5,964,135		6,330,914
RSUs		1,702,538		1,425,459
TSR RSUs		43,022		134,170

Recently Issued Accounting Standards

In June 2016, the FASB issued ASU

No. 2016-13,

“Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU

2016-13”).

This guidance applies to all entities and impacts how entities account for credit losses for most financial assets and other instruments. For

available-for-sale

debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction to the carrying value of the asset. For trade receivables, loans and

held-to-maturity

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Schedule of Investment Securities

Investment Securities

Investment securities consisted of the following (in thousands):


	September 30, 2020
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
	(Unaudited)
U.S. Government Agency Securities	$	159,237	$	12	$	(32	)	$	159,217
Certificates of Deposit		10,500		—		—			10,500
Commercial Paper		78,788		138		(2	)		78,924
Corporate Notes/Bonds		171,665		782		(129	)		172,318

	$	420,190	$	932	$	(163	)	$	420,959


	December 31, 2019
	Amortized Cost		Unrealized Gains		Unrealized (Losses)			Estimated Fair Value
U.S. Government Agency Securities	$	35,462	$	35	$	(3	)	$	35,494
Certificates of Deposit		3,000		—		—			3,000
Commercial Paper		39,013		10		(5	)		39,018
Corporate Notes/Bonds		38,770		91		—			38,861

	$	116,245	$	136	$	(8	)	$	116,373

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
	September 30, 2020		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	224,239	$	224,239	$	—	$	—
U.S. Government Agency Securities		159,217		—		159,217		—
Certificates of Deposit		10,500		—		10,500		—
Commercial Paper		78,924		—		78,924		—
Corporate Notes/Bonds		172,318		—		172,318		—

	$	645,198	$	224,239	$	420,959	$	—


			Fair Value Measurements at Reporting Date Using
	December 31, 2019		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Money Market Funds	$	49,882	$	49,882	$	—	$	—
U.S. Government Agency Securities		35,494		—		35,494		—
Certificates of Deposit		50,622		—		50,622		—
Commercial Paper		42,015		—		42,015		—
Corporate Notes/Bonds		38,861		—		38,861		—

	$	216,874	$	49,882	$	166,992	$	—

Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share


	Three and Nine Months Ended September 30,
	2020		2019
Stock options		5,964,135		6,330,914
RSUs		1,702,538		1,425,459
TSR RSUs		43,022		134,170

Inventory (Tables)

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Schedule of Inventory, Current

Inventory consists of the following:


	September 30, 2020
Raw materials	$	—
Work in process		1,597,413

Finished goods		1,349,725

	$	2,947,138

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Property and Equipment

Property and equipment consist of the following:


	September 30, 2020			December 31, 2019
Computer equipment	$	243,532		$	243,532
Furniture and fixtures		423,097			423,097
Scientific equipment		4,053,185			3,861,227
Leasehold improvements		1,240,315			1,240,315

		5,960,129			5,768,171
Less accumulated depreciation		(3,910,577	)		(3,508,431	)

	$	2,049,552		$	2,259,740

Right of Use Assets and Lease Liabilities (Tables)

9 Months Ended

Sep. 30, 2020

Schedule Of Maturity Analysis Under Lease Agreements

aturity analysis under the lease agreements are as follows:


Three months ending December 31, 2020	$	845,566
Year ending December 31, 2021		3,448,323
Year ending December 31, 2022		3,491,166
Year ending December 31, 2023		3,566,466
Year ending December 31, 2024		3,675,196
Thereafter		17,627,040

Total		32,653,757
Less: Present value discount		(10,463,196	)

Total Lease liability		22,190,561

Less: Current portion		(3,259,966	)

Long-term lease liabilities	$	18,930,595

Vehicle Fleet Lease [Member]

Schedule Of Quantitative Information About Operating Leases


Lease Assets and Liabilities – Fleet	Classification		September 30, 2020
Assets
Right of use assets, net		Operating lease right of use assets	$	6,946,254

			$	6,946,254

Liabilities
Current
Lease liabilities, short-term		Operating lease liabilities	$	2,007,292
Non-Current
Lease liabilities		Non-current operating lease liabilities		4,938,962

Total lease liabilities			$	6,946,254

Weighted average remaining lease term				2.2 years
Weighted average discount rate				1.85	%

Schedule Of Maturity Analysis Under Lease Agreements

The following table presents the maturity of the Company’s fleet lease liability as of

September

30, 2020:

Time

Period


Three months ending December 31, 2020	$	530,799
Year ending December 31, 2021		2,112,506
Year ending December 31, 2022		3,207,898
Year ending December 31, 2023		1,273,867
Thereafter		—

Total		7,125,070
Less: Present value discount		(178,816	)

Total operating lease liabilities		6,946,254

Less: Current portion		(2,007,292	)

Long-term lease liabilities	$	4,938,962

Share-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2020

Total Stock-Based Compensation Expense

Total


	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Inventoriable costs	$	345,460	$	—	$	996,802	$	—
Research and development		2,402,865		2,023,700		6,792,498	$	6,785,280
General and administrative		4,152,394		2,783,068		11,562,850		8,064,129

Total share-based compensation expense	$	6,900,719	$	4,806,768	$	19,352,150	$	14,849,409

Assumptions Used for Calculating Value of Options Granted

The following table describes the weighted-average assumptions used for calculating the value of options granted during the nine months ended September 30, 2020 and 2019:


	2020	2019
Dividend yield	0%	0%
Expected volatility	91.6%-92.7%	83.7%-85.7%
Weighted-average risk-free interest rate	1.31%	2.32%
Expected term (in years)	6.0	6.0

Stock Option Activity


	Number of Shares			Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2019		6,039,945		$	16.81		7.0 years
Options granted		742,509		$	23.85		9.4 years
Options exercised		(696,936	)	$	12.79		4.8 years
Options canceled or expired		(161,111	)	$	21.70		7.9 years

Outstanding at September 30, 2020		5,924,407		$	18.03		6.8 years

Vested or expected to vest at September 30, 2020		5,924,407		$	18.03

Exercisable at September 30, 2020		3,620,984		$	18.85		5.7 years

Time Based Restricted Stock Units [Member]

Summary of Information Regarding RSU Activity

The fair value of the TSR RSUs was determined using the Monte Carlo simulation method. Information

regarding the time based RSU activity and changes during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted-Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		1,268,679		$	13.60		1.7 years
Time based RSUs granted in 2020		728,596		$	23.05		2.7 years
Time based RSUs vested in 2020		(506,546	)	$	13.78		0.9 years
Time based RSUs cancelled in 2020		(90,559	)	$	17.03		1.5 years

Outstanding at September 30, 2020		1,400,170		$	18.69		1.9 years

Milestone and Total Shareholder Return Restricted Stock Units [Member]

Summary of Information Regarding RSU Activity

Information related to the Company’s Milestone RSUs and TSR RSUs during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted-Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		67,080		$	17.08		0.2 years
Milestone RSUs and TSR RSUs granted in 2020		86,044		$	32.56		2.4 years
Milestone RSUs and TSR RSUs vested in 2020		(67,080	)	$	17.08		0.2 years

Outstanding at September 30, 2020		86,044		$	32.56		2.4 years

Inducement Award Plan [Member]

Stock Option Activity


	Number of Shares		Weighted- Average Exercise Price		Weighted- Average Contractual Life
Outstanding at December 31, 2019		—	$	—
Options granted in 2020		39,728	$	17.18		9.5 years

Outstanding at September 30, 2020		39,728	$	17.18		9.5 years

Vested or expected to vest at September 30, 2020		39,728	$	17.18

Exercisable at September 30, 2020		—	$	—

Summary of Information Regarding RSU Activity

Information regarding RSU awards under the 2019 Inducement Plan during the nine month period ended September 30, 2020 are summarized as follows:


	Number of Shares			Weighted- Average Grant Date Fair Value Per Share		Weighted- Average Contractual Life
Outstanding at December 31, 2019		—		$	—
Time based RSUs granted in 2020		274,410		$	16.01		2.6 years
Time based RSUs cancelled in 2020		(15,064	)	$	15.81		2.5 years

Outstanding at September 30, 2020		259,346		$	16.01		2.6 years

Vested or expected to vest at September 30, 2020		259,346		$	16.01

Exercisable at September 30, 2020		—		$	—

Organization - Additional Information (Detail) - USD ($)					3 Months Ended	9 Months Ended
	Sep. 15, 2020	Sep. 10, 2020	Jan. 10, 2020	Sep. 12, 2019	Sep. 30, 2020	Sep. 30, 2020	Dec. 31, 2019
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Initial public offering, Number of shares	12,666,667		10,000,000
Initial public offering, Price per share	$ 30.00		$ 29.50
Net proceeds from the sale of common stock		$ 17,900,000				$ 652,712,011
Common stock issued, shares		742,791			80,142,797	80,142,797	55,507,497
Common Stock [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Initial public offering, Number of shares					13,179,458	23,409,458
IPO [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Initial public offering, Gross proceeds	$ 380,000,000.0		$ 295,000,000.0
Initial public offering, Net proceeds	$ 357,800,000		$ 277,000,000.0
Maximum [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Universal shelf registration statement, effective date value				$ 350,000,000
Net proceeds from the sale of common stock				75,000,000
Maximum [Member] \| Common Stock [Member]
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items]
Universal shelf registration statement, effective date value				$ 75,000,000

Summary of Significant Accounting Policies - Additional Information (Detail)			3 Months Ended	9 Months Ended
	Mar. 31, 2020 shares	Dec. 31, 2019 USD ($) shares	Sep. 30, 2020 USD ($) Customers shares	Sep. 30, 2020 USD ($) Segment Customers shares	Sep. 30, 2019	May 31, 2020 shares	Mar. 27, 2020 USD ($)	Jun. 30, 2018 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
Investment securities, available-for-sale		$ 116,373,335	$ 420,958,509	$ 420,958,509
Aggregate related fair value of investments with unrealized losses		29,600,000	192,800,000	192,800,000
Investment securities aggregate amount of unrealized loss			163,000	163,000
Investment securities, held in continuous unrealized loss position for 12 months or longer		12,500,000
Carrying value of cash held in money market funds		49,900,000	$ 224,200,000	224,200,000
Impairment losses recognized				$ 0
Manufacturing Costs		0
Inventory Costs		0
Effective tax rate				0.00%
US statutory rate				21.00%
Assumed expected dividend rate				0.00%	0.00%
Commercial Paper [Member]
Significant Accounting Policies [Line Items]
Carrying value of commercial paper		3,000,000.0
AMT Tax Credit [Member]
Significant Accounting Policies [Line Items]
Deferred Tax Assets, Gross							$ 265,000
Accounts Receivable [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage				96.00%
Accounts Receivable [Member] \| Customer one [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			39.00%	41.00%
Accounts Receivable [Member] \| Customer two [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			29.00%	27.00%
Accounts Receivable [Member] \| Customer three [Member]
Significant Accounting Policies [Line Items]
Concentration Risk, Percentage			28.00%	27.00%
Accounts Receivable [Member] \| Customer Concentration Risk [Member]
Significant Accounting Policies [Line Items]
Number of customers \| Customers			3	3
U.S. Government Agency Securities [Member]
Significant Accounting Policies [Line Items]
Investment securities, available-for-sale		35,494,000	$ 159,217,000	$ 159,217,000
Aggregate related fair value of investments with unrealized losses			110,400,000	110,400,000
Investment securities aggregate amount of unrealized loss			32,000	32,000
Commercial Paper [Member]
Significant Accounting Policies [Line Items]
Investment securities, available-for-sale		39,018,000	78,924,000	78,924,000
Aggregate related fair value of investments with unrealized losses			10,000,000.0	10,000,000.0
Investment securities aggregate amount of unrealized loss			2,000	2,000
Corporate Notes/Bonds [Member]
Significant Accounting Policies [Line Items]
Investment securities, available-for-sale		38,861,000	172,318,000	172,318,000
Aggregate related fair value of investments with unrealized losses			72,400,000	72,400,000
Investment securities aggregate amount of unrealized loss			129,000	129,000
Cash and Cash Equivalents [Member]
Significant Accounting Policies [Line Items]
Carrying value of cash held in certificates of deposit		47,600,000
Significant Unobservable Inputs (Level 3) [Member]
Significant Accounting Policies [Line Items]
Assets measured using quoted prices		0	0	0
Liabilities measured using quoted prices		0	0	0
Contractual Maturity Dates More Than One Year and Less Than Two Years [Member]
Significant Accounting Policies [Line Items]
Investment securities, available-for-sale		$ 3,000,000.0	$ 197,300,000	$ 197,300,000
2018 Equity Incentive Plan [Member]
Significant Accounting Policies [Line Items]
Additional shares of common stock reserved for future equity grants \| shares						6,500,000		4,750,000
ITCI Inducement Award Plan [Member]
Significant Accounting Policies [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant \| shares			314,138	314,138
Performance Based Restricted Stock Units [Member]
Significant Accounting Policies [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period \| shares	86,000
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] \| ITCI Inducement Award Plan [Member]
Significant Accounting Policies [Line Items]
Issuance of shares, Inducement Award Plan \| shares		1,000,000

Summary of Significant Accounting Policies - Schedule of Investment Securities (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	$ 420,190,000	$ 116,245,000
Unrealized Gains	932,000	136,000
Unrealized (Losses)	(163,000)	(8,000)
Estimated Fair Value	420,958,509	116,373,335
U.S. Government Agency Securities [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	159,237,000	35,462,000
Unrealized Gains	12,000	35,000
Unrealized (Losses)	(32,000)	(3,000)
Estimated Fair Value	159,217,000	35,494,000
Certificates of Deposit [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	10,500,000	3,000,000
Estimated Fair Value	10,500,000	3,000,000
Commercial Paper [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	78,788,000	39,013,000
Unrealized Gains	138,000	10,000
Unrealized (Losses)	(2,000)	(5,000)
Estimated Fair Value	78,924,000	39,018,000
Corporate Notes/Bonds [Member]
Schedule of Available-for-sale Securities [Line Items]
Amortized Cost	171,665,000	38,770,000
Unrealized Gains	782,000	91,000
Unrealized (Losses)	(129,000)
Estimated Fair Value	$ 172,318,000	$ 38,861,000

Summary of Significant Accounting Policies - Schedule of Fair Value Measurements of Cash Equivalents and Available-for-Sale Investment Securities (Detail) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	$ 645,198	$ 216,874
Money Market Funds [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	224,239	49,882
U.S. Government Agency Securities [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	159,217	35,494
Certificates of Deposit [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	10,500	50,622
Commercial Paper [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	78,924	42,015
Corporate Notes/Bonds [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	172,318	38,861
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	224,239	49,882
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] \| Money Market Funds [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	224,239	49,882
Significant Other Observable Inputs (Level 2) [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	420,959	166,992
Significant Other Observable Inputs (Level 2) [Member] \| U.S. Government Agency Securities [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	159,217	35,494
Significant Other Observable Inputs (Level 2) [Member] \| Certificates of Deposit [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	10,500	50,622
Significant Other Observable Inputs (Level 2) [Member] \| Commercial Paper [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	78,924	42,015
Significant Other Observable Inputs (Level 2) [Member] \| Corporate Notes/Bonds [Member]
Fair Value Of Assets And Liabilities Measured On Non Recurring Basis [Line Items]
Available-for-sale investment securities	$ 172,318	$ 38,861

Summary of Significant Accounting Policies - Common Stock Equivalents Excluded in Calculation of Diluted Loss Per Share (Detail) - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
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	5,964,135	6,330,914
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	1,702,538	1,425,459
Total Shareholder Return Restricted Stock Units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of anti-dilutive securities excluded from computation of earnings per share	43,022	134,170

Inventory - Schedule of Inventory, Current (Detail)	Sep. 30, 2020 USD ($)
Inventory Disclosure [Abstract]
Raw materials	$ 0
Work in process	1,597,413
Finished goods	1,349,725
Total inventories	$ 2,947,138

Property and Equipment - Property and Equipment (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	$ 5,960,129	$ 5,768,171
Less accumulated depreciation	(3,910,577)	(3,508,431)
Property Plant and Equipment Net	2,049,552	2,259,740
Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	243,532	243,532
Furniture and Fixtures [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	423,097	423,097
Scientific Equipment [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	4,053,185	3,861,227
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Property plant and equipment, gross	$ 1,240,315	$ 1,240,315

Property and Equipment - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Property, Plant and Equipment [Abstract]
Depreciation	$ 121,044	$ 129,052	$ 402,146	$ 335,461

Right of Use Assets and Lease Liabilities - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Feb. 28, 2019	Jan. 01, 2019	Sep. 30, 2018
Right of use assets, net	$ 24,292,167		$ 24,292,167		$ 18,252,074
Net lease liabilities	29,100,000		29,100,000
Operating lease expense	$ 800,000	$ 800,000	2,500,000	$ 2,500,000
Right of use assets obtained in exchange for operating lease liability					$ 200,000
Operating Lease, Cost			$ 585,490
Vehicle Fleet Lease [Member]
Operating lease discount rate	1.85%		1.85%
Right of use assets, net	$ 6,946,254		$ 6,946,254
Net lease liabilities	$ 6,946,254		$ 6,946,254
Term of long term lease	12 months		12 months
Operating Lease, Weighted Average Remaining Lease Term	2 years 2 months 12 days		2 years 2 months 12 days
Operating lease cash outflows			$ 585,490
Restricted Cash	$ 1,400,000		$ 1,400,000
Percentage Of Minimum Net Proceeds Of Capitalized Costs In First Twelve Months			20.00%
Percentage Of Minimum Net Proceeds Of Capitalized Costs Later Than Twelve Months			30.00%
Vehicle Fleet Lease [Member] \| Financial Standby Letter of Credit [Member]
Guarantee Obligations	$ 1,400,000		$ 1,400,000
Accounting Standards Update 2016-02 [Member]
Right of use assets, net							$ 20,200,000
Net lease liabilities							23,400,000
Eliminated deferred rent							$ 3,200,000
NEW YORK
Term of long term lease								14 years 3 months 18 days
NEW YORK \| Accounting Standards Update 2016-02 [Member]
Operating lease discount rate							7.20%
Operating Lease, Weighted Average Remaining Lease Term							3 years 2 months 12 days
MARYLAND
Term of long term lease						3 years 2 months 12 days
MARYLAND \| Accounting Standards Update 2016-02 [Member]
Operating lease discount rate							9.10%
Operating Lease, Weighted Average Remaining Lease Term							14 years 3 months 18 days

Right of Use Assets and Lease Liabilities - Maturity analysis under the lease agreements (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Total Lease liability	$ 29,100,000
Less: current portion	(5,267,258)	$ (3,187,435)
Long-term lease liabilities	23,869,557	$ 19,955,186
Real Estates Lease [Member]
Three months ending December 31, 2020	845,566
Year ending December 31, 2021	3,448,323
Year ending December 31, 2022	3,491,166
Year ending December 31, 2023	3,566,466
Year ending December 31, 2024	3,675,196
Thereafter	17,627,040
Total	32,653,757
Less: Present value discount	(10,463,196)
Total Lease liability	22,190,561
Less: current portion	(3,259,966)
Long-term lease liabilities	$ 18,930,595

Right Of Use Assets and Lease Liabilities - Schedule Of Quantitative Information About Operating Leases (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Lessee, Lease, Description [Line Items]
Right of use assets, net	$ 24,292,167	$ 18,252,074
Lease liabilities, short-term	5,267,258	3,187,435
Lease liabilities	23,869,557	$ 19,955,186
Total Lease liability	29,100,000
Vehicle Fleet Lease [Member]
Lessee, Lease, Description [Line Items]
Right of use assets, net	6,946,254
Lease liabilities, short-term	2,007,292
Lease liabilities	4,938,962
Total Lease liability	$ 6,946,254
Weighted average remaining lease term	2 years 2 months 12 days
Weighted average discount rate	1.85%

Right Of Use Assets and Lease Liabilities - Maturity analysis of the Company's fleet lease liability (Detail) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Lessee, Lease, Description [Line Items]
Total operating lease liabilities	$ 29,100,000
Less: current portion	(5,267,258)	$ (3,187,435)
Long-term lease liabilities	23,869,557	$ 19,955,186
Vehicle Fleet Lease [Member]
Lessee, Lease, Description [Line Items]
Three months ending December 31, 2020	530,799
Year ending December 31, 2021	2,112,506
Year ending December 31, 2022	3,207,898
Year ending December 31, 2023	1,273,867
Thereafter	0
Total	7,125,070
Less: Present value discount	(178,816)
Total operating lease liabilities	6,946,254
Less: current portion	(2,007,292)
Long-term lease liabilities	$ 4,938,962

Share-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	3 Months Ended				9 Months Ended
	Sep. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Mar. 31, 2017	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares of common stock reserved for issuance							11,287,390
Expected dividend yield					0.00%	0.00%
Risk free interest rate					1.31%	2.32%
2018 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares of common stock reserved for issuance							2,208,317
Additional Stock- based awards, grant					6,500,000
Time Based Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation costs related to unvested RSUs	$ 21.6				$ 21.6
Non-cash stock-based compensation expense recognized	3.2		$ 1.7		8.9	$ 5.6
RSUs [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Non-cash stock-based compensation expense recognized	3.4		$ 1.9		$ 9.2	$ 6.1
Weighted average grant date fair value of stock options granted					$ 23.05
RSUs [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, vesting term					3 years
Milestone Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation costs related to unvested RSUs	$ 1.0				$ 1.0
Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options, maximum term					10 years
Inducement Award Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Issuance of shares, Inducement Award Plan	1,000,000				1,000,000
Awards granted	314,138				314,138
Weighted average grant date fair value of stock options granted					$ 16.01
Total Shareholder Return Restricted Stock Units [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted average grant date fair value of stock options granted				$ 17.08
Unrecognized compensation costs related to unvested RSUs	$ 1.1				$ 1.1
Expected dividend yield		0.00%		0.00%
Risk free interest rate		1.40%		1.60%
Expected volatility		91.30%		95.40%
Weighted average grant date fair value of stock options granted					$ 32.56

Share-Based Compensation - Total Stock-Based Compensation Expense (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	$ 6,900,719	$ 4,806,768	$ 19,352,150	$ 14,849,409
Inventoriable costs [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	345,460		996,802
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	2,402,865	2,023,700	6,792,498	6,785,280
General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total share-based compensation expense	$ 4,152,394	$ 2,783,068	$ 11,562,850	$ 8,064,129

Share-Based Compensation - Assumptions Used for Calculating Value of Options Granted (Detail)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Dividend yield	0.00%	0.00%
Expected volatility, minimum	91.60%	83.70%
Expected volatility, maximum	92.70%	85.70%
Weighted-average risk-free interest rate	1.31%	2.32%
Expected term (in years)	6 years	6 years

Share-Based Compensation - Stock Options Activity of Inducement Plan (Detail) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of period, Number of Shares	6,039,945
Options granted, Number of Shares	742,509
Outstanding at end of period, Number of Shares	5,924,407	6,039,945
Vested or expected to vest at end of period, Number of Shares	5,924,407
Exercisable at end of period, Number of Shares	3,620,984
Outstanding at beginning of period, Weighted-Average Exercise Price	$ 16.81
Options granted, exercise price	23.85
Outstanding at end of period, Weighted-Average Exercise Price	18.03	$ 16.81
Vested or expected to vest at end of period, Weighted-Average Exercise Price	18.03
Exercisable at end of period, Weighted-Average Exercise Price	$ 18.85
Options granted, Weighted-Average Contractual Life	9 years 4 months 24 days
Outstanding at end of period, Weighted-Average Contractual Life	6 years 9 months 18 days	7 years
Inducement Award Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of period, Number of Shares	0
Options granted, Number of Shares	39,728
Outstanding at end of period, Number of Shares	39,728	0
Vested or expected to vest at end of period, Number of Shares	39,728
Exercisable at end of period, Number of Shares	0
Outstanding at beginning of period, Weighted-Average Exercise Price	$ 0
Options granted, exercise price	17.18
Outstanding at end of period, Weighted-Average Exercise Price	17.18	$ 0
Vested or expected to vest at end of period, Weighted-Average Exercise Price	17.18
Exercisable at end of period, Weighted-Average Exercise Price	$ 0
Options granted, Weighted-Average Contractual Life	9 years 6 months
Outstanding at end of period, Weighted-Average Contractual Life	9 years 6 months

Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes Under the Inducement Plan (Detail) - Inducement Award Plan [Member]	9 Months Ended
	Sep. 30, 2020 $ / shares shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of year, Number of Shares \| shares	0
Time based RSU's granted, Number of Shares \| shares	274,410
Time based RSU's cancelled, Number of Shares \| shares	(15,064)
Outstanding at end of year, Number of Shares \| shares	259,346
Vested or expected to vest, Number of Shares \| shares	259,346
Exercisable, Number of Shares \| shares	0
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value \| $ / shares	$ 0
Time based RSU's granted, Weighted-Average Grant Date Fair Value \| $ / shares	16.01
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value \| $ / shares	15.81
Outstanding at end of year, Weighted-Average Grant Date Fair Value \| $ / shares	16.01
Vested or expected to vest, Weighted- Average Exercise Price \| $ / shares	16.01
Exercisable, Weighted- Average Exercise Price \| $ / shares	$ 0
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms	2 years 6 months
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms	2 years 7 months 6 days
Share Based Compensation By Share Based Payment Arrangement Other Than Options Weighted Average Contractual Term Of Instruments Forefeited	2 years 7 months 6 days

Share-Based Compensation - Stock Options Activity (Detail) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Outstanding at beginning of period, Number of Shares	6,039,945
Options granted, Number of Shares	742,509
Options exercised, Number of Shares	(696,936)
Options canceled or expired, Number of Shares	(161,111)
Outstanding at end of period, Number of Shares	5,924,407	6,039,945
Vested or expected to vest at end of period, Number of Shares	5,924,407
Exercisable at end of period, Number of Shares	3,620,984
Outstanding at beginning of period, Weighted-Average Exercise Price	$ 16.81
Options granted, Weighted-Average Exercise Price	23.85
Options exercised, Weighted-Average Exercise Price	12.79
Options canceled or expired, Weighted-Average Exercise Price	21.70
Outstanding at end of period, Weighted-Average Exercise Price	18.03	$ 16.81
Vested or expected to vest at end of period, Weighted-Average Exercise Price	18.03
Exercisable at end of period, Weighted-Average Exercise Price	$ 18.85
Options granted, Weighted-Average Contractual Life	9 years 4 months 24 days
Options exercised, Weighted-Average Contractual Life	4 years 9 months 18 days
Options canceled or expired, Weighted-Average Contractual Life	7 years 10 months 24 days
Outstanding at end of period, Weighted-Average Contractual Life	6 years 9 months 18 days	7 years
Exercisable at end of period, Weighted-Average Contractual Life	5 years 8 months 12 days

Share-Based Compensation - Summary of Information Regarding the Time Based RSU Activity and Changes (Detail) - RSUs [Member] - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of year, Number of Shares	1,268,679
Time based RSU's granted, Number of Shares	728,596
Time based RSU's vested, Number of Shares	(506,546)
Time based RSU's cancelled, Number of Shares	(90,559)
Outstanding at end of year, Number of Shares	1,400,170	1,268,679
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value	$ 13.60
Time based RSU's granted, Weighted-Average Grant Date Fair Value	23.05
Time based RSU's vested, Weighted-Average Grant Date Fair Value	13.78
Time based RSU's cancelled, Weighted-Average Grant Date Fair Value	17.03
Outstanding at end of year, Weighted-Average Grant Date Fair Value	$ 18.69	$ 13.60
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms	1 year 10 months 24 days	1 year 8 months 12 days
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Average Remaining Contractual Terms	2 years 8 months 12 days
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Vested Remaining Contractual Terms	10 months 24 days
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Forfeited Average Remaining Contractual Terms	1 year 6 months

Share-Based Compensation - Summary of Information Regarding Milestone RSU grants and TSR RSU grants (Detail) - Milestone and Total Shareholder Return Restricted Stock Units [Member] - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding at beginning of year, Number of Shares	67,080
Milestone RSUs and TSR RSUs granted, Number of Shares	86,044
Time based RSU's vested, Number of Shares	(67,080)
Outstanding at end of year, Number of Shares	86,044	67,080
Outstanding at beginning of year, Weighted-Average Grant Date Fair Value	$ 17.08
Milestone RSUs and TSR RSUs granted, Weighted- Average Grant Date Fair Value	32.56
Time based RSU's vested, Weighted-Average Grant Date Fair Value	17.08
Outstanding at end of year, Weighted-Average Grant Date Fair Value	$ 32.56	$ 17.08
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Outstanding, Weighted Average Remaining Contractual Terms	2 years 4 months 24 days	2 months 12 days
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Vested Remaining Contractual Terms	2 months 12 days
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Grants In Period Remaining Contractual Terms	2 years 4 months 24 days

Collaborations and License Agreements - Additional Information (Detail) - Product [Member] - Bristol-Myers Squibb Company [Member] - USD ($)			1 Months Ended		9 Months Ended
	Dec. 23, 2019	May 31, 2005	Dec. 31, 2014	Dec. 31, 2013	Sep. 30, 2020	Jan. 31, 2019
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Company made an upfront payment		$ 1,000,000.0
Company made milestone payment			$ 1,500,000	$ 1,250,000
Obliged to make milestone payments					$ 14,750,000	$ 2,000,000.0
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
Accrued Royalties					$ 506,000
Minimum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Royalty payment, percentage					5.00%
Maximum [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Royalty payment, percentage					9.00%
National Democratic Alliance [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Company remaining milestone payment	$ 5,000,000.0
ITCI National Democratic Alliance Member [Member]
Revenue Recognition, Multiple-deliverable Arrangements [Line Items]
Payment of milestone amount					$ 5,000,000.0