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Cover Page - USD ($)	12 Months Ended
Cover Page - USD ($)	Dec. 31, 2019	Mar. 12, 2020	Jun. 30, 2019
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	FY
Entity Registrant Name	CATALYST PHARMACEUTICALS, INC.
Entity Central Index Key	0001369568
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity Filer Category	Accelerated Filer
Trading Symbol	CPRX
Entity Emerging Growth Company	false
Entity Small Business	true
Entity Address, State or Province	FL
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		103,408,699
Entity Public Float			$ 367,949,157

Consolidated Balance Sheets - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Current Assets:
Cash and cash equivalents	$ 89,511,710	$ 16,559,400
Short-term investments	5,007,050	36,922,213
Accounts receivable, net	10,536,997
Inventory	1,956,792	56,012
Prepaid expenses and other current assets	4,351,074	1,649,781
Total current assets	111,363,623	55,187,406
Investments	0	5,008,243
Operating lease right-of-use asset	793,252
Property and equipment, net	210,467	245,425
Deposits	8,888	8,888
Total assets	112,376,230	60,449,962
Current Liabilities:
Accounts payable	4,117,447	2,337,367
Accrued expenses and other liabilities	19,981,295	7,173,987
Total current liabilities	24,098,742	9,511,354
Accrued expenses and other liabilities, non-current	0	154,799
Operating lease liability, net of current portion	647,532
Total liabilities	24,746,274	9,666,153
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at December 31, 2019 and 2018	0
Common stock, $0.001 par value, 150,000,000 shares authorized; 103,397,033 shares and 102,739,257 shares issued and outstanding at December 31, 2019 and 2018, respectively	103,397	102,739
Additional paid-in capital	216,205,678	211,265,279
Accumulated deficit	(128,688,624)	(160,563,961)
Accumulated other comprehensive income (loss)	9,505	(20,248)
Total stockholders' equity	87,629,956	50,783,809
Total liabilities and stockholders' equity	$ 112,376,230	$ 60,449,962

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2019	Dec. 31, 2018
Statement of Financial Position [Abstract]
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	103,397,033	102,739,257
Common stock, shares outstanding	103,397,033	102,739,257

Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Revenues:
Revenues	$ 102,306,337
Revenues		$ 500,000
Operating costs and expenses:
Cost of sales	14,759,139
Research and development	18,842,752	19,919,204
Selling, general and administrative	36,881,187	15,875,961
Total operating costs and expenses	70,483,078	35,795,165
Other income, net	1,585,774	1,291,651
Operating income (loss)	31,823,259	(35,295,165)
Net income (loss) before income taxes	33,409,033	(34,003,514)
Provision for income taxes	1,533,696
Net income (loss)	$ 31,875,337	$ (34,003,514)
Net income (loss) per share:
Basic	$ 0.31	$ (0.33)
Diluted	$ 0.30	$ (0.33)
Weighted average shares outstanding:
Basic	102,944,316	102,633,884
Diluted	106,020,936	102,633,884
Net income (loss)	$ 31,875,337	$ (34,003,514)
Other comprehensive income (loss):
Unrealized gain (loss) on available-for-sale securities	29,753	(20,248)
Comprehensive income (loss)	31,905,090	(34,023,762)
Product [Member]
Revenues:
Revenues	102,306,337
Collaborative Arrangement Product Agreement [Member]
Revenues:
Revenues	$ 0
Revenues		$ 500,000

Consolidated Statement of Changes in Stockholders' Equity - USD ($)	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Gain (Loss) [Member]
Beginning Balance at Dec. 31, 2017	$ 80,963,812	$ 102,549	$ 207,421,710	$ (126,560,447)
Issuance of common stock, net	10,549	3	10,546
Issuance of stock options for services	3,535,647		3,535,647
Exercise of stock options for common stock	297,563	187	297,376
Other comprehensive gain (loss)	(20,248)				$ (20,248)
Net income (loss)	(34,003,514)			(34,003,514)
Ending Balance at Dec. 31, 2018	50,783,809	102,739	211,265,279	(160,563,961)	(20,248)
Issuance of stock options for services	3,780,086		3,780,086
Exercise of stock options for common stock	1,116,242	658	1,115,584
Amortization of restricted stock for services	44,729		44,729
Other comprehensive gain (loss)	29,753				29,753
Net income (loss)	31,875,337			31,875,337
Ending Balance at Dec. 31, 2019	$ 87,629,956	$ 103,397	$ 216,205,678	$ (128,688,624)	$ 9,505

- Definition

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

+ References + Details

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
Consolidated Statements of Cash Flows - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Operating Activities:
Net income (loss)	$ 31,875,337	$ (34,003,514)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation	54,327	37,978
Amortization of right-of-use asset	243,399
Stock-based compensation	3,824,815	3,550,644
Change in accrued interest and accretion of discount on investments	(290,805)	(443,139)
(Increase) decrease in:
Accounts receivable, net	(10,536,997)
Inventory	(1,900,780)	(56,012)
Prepaid expenses and other current assets and deposits	(2,701,293)	(476,037)
Increase (decrease) in:
Accounts payable	1,780,080	391,792
Accrued expenses and other liabilities	12,540,197	4,850,743
Operating lease liability	(276,807)
Net cash provided by (used in) operating activities	34,611,473	(26,147,545)
Investing Activities:
Purchases of property and equipment	(19,369)	(92,018)
Purchases of investments	(34,725,401)	(36,790,854)
Proceeds from maturities and sales of investments	71,969,365	21,800,000
Net cash provided by (used in) investing activities	37,224,595	(15,082,872)
Financing Activities:
Payment of employee withholding tax related to stock-based compensation	0	(4,448)
Proceeds from exercise of stock options	1,116,242	297,563
Net cash provided by (used in) financing activities	1,116,242	293,115
Net increase (decrease) in cash and cash equivalents	72,952,310	(40,937,302)
Cash and cash equivalents - beginning of period	16,559,400	57,496,702
Cash and cash equivalents - end of period	89,511,710	16,559,400
Non-cash investing and financing activities:
Unrealized gain (loss) on available-for-sale securities	$ 29,753	$ (20,248)

Organization and Description of Business

12 Months Ended

Dec. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Description of Business

1.	Organization and Description of Business.

Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the “Company”) is a biopharmaceutical company focused on developing and commercializing innovati

therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), Anti-MuSK antibody positive myasthenia gravis (MuSK-MG), and Spinal Muscular Atrophy (SMA) Type 3. The Company (f/k/a Catalyst Pharmaceutical Partners, Inc.) was incorporated in Delaware in July 2006. It is the successor by merger to Catalyst Pharmaceutical Partners, Inc., a Florida corporation, which commenced operations in January 2002.

On November 28, 2018, the U.S. Food and Drug Administration, or FDA, granted approval of Firdapse

for the treatment of adults with LEMS (ages 17 and above). On January 15, 2019, the Company launched its first product, Firdapse

, in the United States for the treatment of adults with LEMS.

Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets, raising capital, and selling its product. The Company incurred operating losses in each period from inception, and started reporting operating income during the year ended December 31, 2019. The Company has been able to fund its cash needs to date through several public and private offerings of its securities and from revenues from its product sales. See Note 11 (Stockholders’ Equity).

Capital Resources

While there can be no assurance, based on currently available information, the Company estimates that it currently has sufficient resources to support its operations for at least the next 12 months from the issuance date of this Form

10-K.

The Company may raise required funds in the future through public or private equity offerings, debt financings, corporate collaborations, governmental research grants or other means. The Company may also seek to raise new capital to fund additional product development efforts, even if it has sufficient funds for its planned operations. Any sale by the Company of additional equity or convertible debt securities could result in dilution to the Company’s current stockholders. There can be no assurance that any required additional funding will be available to the Company at all or available on terms acceptable to the Company. Further, to the extent that the Company raises additional funds through collaborative arrangements, it may be necessary to relinquish some rights to the Company’s drug candidates or grant sublicenses on terms that are not favorable to the Company. If the Company is not able to secure additional funding when needed, the Company may have to delay, reduce the scope of, or eliminate one or more research and development programs, which could have an adverse effect on the Company’s business.

Basis of Presentation and Significant Accounting Policies

12 Months Ended

Dec. 31, 2019

Accounting Policies [Abstract]

Basis of Presentation and Significant Accounting Policies

2.	Basis of Presentation and Significant Accounting Policies.

PRINCIPLES OF CONSOLIDATION

. The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiary

Catalyst Pharmaceuticals Ireland, Ltd. (“Catalyst Ireland”). All intercompany accounts and transactions have been eliminated in consolidation. Catalyst Ireland was organized in 2017.

USE OF ESTIMATES.

The preparation of financial statements in conformity with

accounting

principles

generally accepted in the U.S

(U.S. GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.

CASH AND CASH EQUIVALENTS.

The Company considers all highly liquid instruments, purchased with an original maturity of three months or less, to be cash equivalents. Cash equivalents consist mainly of money market funds and U.S. Treasuries. The Company has substantially all of its cash and cash equivalents deposited with one financial institution. These amounts at times may exceed federally insured limits.

INVESTMENTS.

The Company invests in high credit-quality funds in order to obtain higher yields on its cash and investments pending the use of those funds in its business. At December 31, 2019, investments consisted of U.S. Treasuries. At December 31, 2018, investments consisted of a short-term bond fund and U.S. Treasuries. Such investments are not insured by the Federal Deposit Insurance Corporation.

Short-Term Bond Fund

The short-term bond fund

was

classified as

trading secur

ity

. Trading securities are recorded at fair value based on the closing market price of the security. For trading securities, the Company recognizes realized gains and losses and unrealized gains and losses to earnings. At December 31, 2019, there were no investments classified as trading securities. At December 31, 2018, the only investment classified as trading securities was the short-term bond fund. Realized gains on trading securities were $80,045 for the year ended December 31, 2019. There were no sales of trading securities for the year ended December 31, 2018. Unrealized gain (loss) on trading securities was $0 and ($29,430), respectively, for the years ended December 31, 2019, and 2018 and is included in other income, net in the accompanying consolidated statements of operations.

U.S. Treasuries

U.S. Treasuries are classified as

available-for-sale

securities. The Company classifies

available-for-sale

securities with stated maturities of greater than three months and less than one year as short-term investments.

Available-for-sale

securities with stated maturities greater than one year are classified as

non-current

investments in the accompanying consolidated balance sheets. The Company records

available-for-sale

securities at fair value with unrealized gains and losses in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in other income, net in the consolidated statements of operations and

comprehensive

income (loss)

and

are derived using the specific identification method for determining the cost of securities sold. Interest income is recognized when earned and is included in other income, net in the consolidated statements of operations

and comprehensive income (loss).

The Company recognizes a charge when the declines in the fair value below the amortized cost basis of its

available-for-sale

securities are judged to be other-than-temporary. The Company considers various factors in determining whether to recognize an other-than-temporary charge, including whether the Company intends to sell the security or whether it is more likely than not that the Company would be required to sell the security before recovery of the amortized cost basis. The Company has not recorded any other-than-temporary impairment charges on its

available-for-sale

securities. See Note 3

(

Investments).

ACCOUNTS RECEIVABLE, NET.

Accounts receivable are recorded net of customer allowance for distribution fees, trade discounts, prompt payment discounts, chargebacks and doubtful accounts. Allowances for distribution fees,

trade discounts

prompt payment discounts and chargebacks are based on contractual terms. The Company estimates the allowance for doubtful accounts based on existing contractual payment terms, actual payment patterns of its customer and individual customer circumstances. At December 31, 2019, the Company determined that an allowance for doubtful accounts was not required. No accounts were written off during the periods presented.

INVENTORY.

Inventories are stated at the lower of cost or net realizable value with cost determined under the first-in-first-out (FIFO) cost method. Inventories consist of raw materials and supplies, work in process and finished goods. Costs to be capitalized as inventories primarily include third party manufacturing costs and other overhead costs. The Company began capitalizing inventories post FDA approval of Firdapse

on November 28, 2018 as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to the FDA approval of Firdapse

were recorded as research and development expenses in prior years’ consolidated statements of operations and comprehensive income (loss). If information becomes available that suggests that inventories may not be realizable, the Company may be required to expense a portion or all of the previously capitalized inventories. As of December 31, 2019 inventory consisted mainly of raw materials, work-in-process and finished goods. As of December 31, 2018, inventory consisted mainly of packaging and labeling costs.

Products that have been approved by the FDA or other regulatory authorities, such as Firdapse

, are also used in clinical programs to assess the safety and efficacy of the products for usage in treating diseases that have not been approved by the FDA or other regulatory authorities. The form of Firdapse

utilized for both commercial and clinical programs is identical and, as a result, the inventory has an “alternative future use” as defined in authoritative guidance. Raw materials associated with clinical development programs are included in inventory and charged to research and development expense when the product enters the research and development process and no longer can be used for commercial purposes and, therefore, does not have an “alternative future use”.

The Company evaluates for potential excess inventory by analyzing current and future product demand relative to the remaining product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage.

PREPAID EXPENSES AND OTHER CURRENT ASSETS.

Prepaid expenses and other current assets consist primarily of prepaid research fees, prepaid insurance, prepaid commercialization expenses, prepaid subscription fees and prepaid manufacturing. Prepaid research fees consist of advances for the Company’s product development activities, including contracts for

pre-clinical

studies, clinical trials and studies, regulatory affairs and consulting. Prepaid manufacturing consists of advances for the Company’s drug manufacturing activities. Such advances are recorded as expense as the related goods are received or the related services are performed.

PROPERTY AND EQUIPMENT

NET

Property and equipment are recorded at cost. Depreciation is calculated to amortize the depreciable assets over their useful lives using the straight-line method and commences when the asset is placed in service. Leasehold improvements are amortized on a straight-line basis over the term of the lease or the estimated life of the improvement, whichever is shorter. Useful lives generally range from three to five years for computer equipment to five years for furniture and equipment, and from four to seven years for leasehold improvements. Expenditures for repairs and maintenance are charged to expenses as incurred.

FAIR VALUE OF FINANCIAL INSTRUMENTS.

The Company’s financial instruments consist of cash and cash equivalents, investments, accounts receivable, accounts payable, and accrued expenses and other liabilities. At December 31, 2019 and 2018, the fair value of these instruments approximated their carrying value.

FAIR VALUE MEASUREMENTS.

Current Financial Accounting Standards Board (FASB) fair value guidance emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, current FASB guidance establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions that it believes market participants would use in pricing assets or liabilities (unobservable inputs classified within Level 3 of the hierarchy).

Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability.


	Fair Value Measurements at Reporting Date Using
	Balances as of December 31, 2019		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	23,963,617	$	23,963,617	$	—	$	—

U.S. Treasuries	$	59,932,200	$		$	59,932,200	$

Short-term investments :
U.S. Treasuries	$	5,007,050	$	—	$	5,007,050	$	—


	Balances as of December 31, 2018		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	14,462,087	$	14,462,087	$	—	$	—

Short-term investments:
Short-term bond fund	$	26,541,349	$	26,541,349	$	—	$	—

U.S. Treasuries	$	10,380,864	$	—	$	10,380,864	$	—

Investments:
U.S. Treasuries	$	5,008,243	$	—	$	5,008,243	$	—

OPERATING LEASES.

Effective January 1, 2019, the Company determined if an arrangement is a lease at inception. Operating leases are included in operating lease

right-of-use

(“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.

Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of future payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives and initial direct costs incurred. The Company’s lease terms do not include options to extend or terminate the lease as it is not reasonably certain that it will exercise these options. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company has lease agreements with lease and

non-lease

components, which are generally accounted for separately. Refer to Note 2.v. for discussion on adoption method.

REVENUE RECOGNITION.

Prior to the January 2019 launch of Firdapse

, the Company did not generate any product revenue. Therefore, on January 1, 2019, the Company adopted Accounting Standards Codification (“ASC”) Topic 606 – Revenue from Contracts with Customers (“Topic 606”). This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, collaborative arrangements and financial instruments. Under Topic 606, an entity recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled in exchange for these goods or services. The Company had no contracts with customers until the FDA approved Firdapse

in November 2018. Subsequent to receiving FDA approval, the Company entered into an arrangement with one distributor (the “Customer”), who is the exclusive distributor of Firdapse

in the United States. The Customer subsequently resells Firdapse

to a small group of exclusive specialty pharmacies (“SPs”) whose dispensing activities for patients with specific payors may result in government-mandated or privately negotiated rebate obligations for the Company with respect to the purchase of Firdapse

To determine revenue recognition for arrangements that are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for product revenue, see Product Revenue, Net below.

The Company also

may

generate revenues from payments received under a collaborative agreement. Collaborative agreement payments may include nonrefundable fees at the inception of the agreements, milestone and event-based payments for specific achievements designated in the collaborative agreements, and/or royalties on sales of products resulting from a collaborative arrangement. For a complete discussion of accounting for collaborative arrangements, see Revenues from Collaborative Arrangement below.

Product Revenue, Net:

The Company sells Firdapse

the

Customer (its exclusive distributor) who subsequently resells Firdapse

to both a small group of SPs who have exclusive contracts with the Company to distribute the Company’s products to patients and potentially to medical centers or hospitals on an emergency basis. In addition to the distribution agreement with its Customer, the Company enters into arrangements with health care providers and payors 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 revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. The Company’s payment terms range between 15 and 30 days.

Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales.

If taxes should be collected from the Customer relating to product sales and remitted to governmental authorities, they will be excluded from revenue. The Company expenses incremental costs of obtaining a contract when incurred, if the expected amortization period of the asset that the Company would have recognized is one year or less. However, no such costs were incurred during the year ended December 31, 2019.

As of December 31, 2019, all of the Company’s sales are to its Customer.

Reserves for Variable Consideration:

Revenue from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customer, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than a customer). These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also 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 December 31, 2019 and, therefore, the transaction price was not reduced further during the year ended December 31, 2019. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

Trade Discounts and Allowances:

The Company provides its Customer with a discount that is explicitly stated in its contract and is recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company receives sales order management, data and distribution services from the Customer. To the extent the services received are distinct from the sale of Firdapse

to the Customer, these payments are classified in selling, general and administrative expenses in the Company’s consolidated statement of operations and comprehensive income (loss). However, if the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer, these payments have been recorded as a reduction of revenue within the

cons

lidated

statement of operations and comprehensive income (loss) through December 31, 2019, as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Funded

Co-pay

Assistance Program:

The Company contracts with a third-party to manage the

co-pay

assistance program intended to provide financial assistance to qualified

commercially-insured

patients. 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 Firdapse

that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. These payments are considered payable to the

ustomer and the related reserve is 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 in the consolidated balance sheets.

Product Returns:

Consistent with industry practice, the Company offers the SPs and its distributor limited product return rights for damaged and expiring product, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company estimates the amount of its product sales that may be returned by its Customer and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net on the consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has an insignificant amount of returns to date and believes that returns of its products will continue to be minimal.

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 the Customer who directly purchases the product from the Company. The Customer charges 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

net

and accounts receivable, net. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by the Customer, 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 principally of chargebacks that the Customer has claimed, but for which the Company has not yet issued a credit.

Government Rebates:

The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.

Bridge and Patient Assistance Programs:

The Company provides free Firdapse

to uninsured patients who satisfy

pre-established

criteria for either the Bridge Program or the Patient Assistance Program. Patients who meet the Bridge Program eligibility criteria and are transitioning from investigational product while they are waiting for a coverage determination, or later, for patients whose access is threatened by the complications arising from a change of insurer may receive a temporary supply of free Firdapse

while the Company is determining the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Firdapse

. The Patient Assistance Program provides free Firdapse

for longer periods of time for those who are uninsured or functionally uninsured with respect to Firdapse

because they are unable to obtain coverage from their payer despite having health insurance

to the extent allowed

applicable

law

. The Company does not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations.

Revenues from Collaborative Arrangement:

The Company has entered into a collaboration agreement for the further development and commercialization of generic Sabril

(vigabatrin) tablets. Pursuant to the terms of this agreement, collaborators could be required to make various payments to the Company, including upfront license fees, milestone payments based on achievement of regulatory approvals, and royalties on sales of products resulting from

the

collaborative agreement.

Nonrefundable upfront license fees are recognized upon receipt as persuasive evidence of an arrangement exists, the price to the collaborator is fixed or determinable and collectability is reasonably assured.

The collaborative agreement provides for a milestone payment upon achievement of development and regulatory events

The Company accounts for milestone payments in accordance with the provisions of Accounting Standards Update (ASU)

No. 2010-17,

Revenue Recognition – Milestone Method (“Milestone Method of Accounting”)

. The Company recognizes consideration that is contingent upon the achievement of a milestone in its entirety as revenue in the period in which the milestone is achieved only if the milestone is substantive in its entirety. A milestone is considered substantive when it meets all of the following criteria:

The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone;

The consideration relates solely to past performance; and

The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the vendor.

The Company believes that achievement of the milestone will be substantive and there will be no substantive uncertainty once the milestone is achieved.

Since the Company will receive royalty reports 60 days after quarter end, royalty revenue from sales of collaboration products by our collaborators will be recognized in the quarter following the quarter in which the corresponding sales occurred. As of December 31, 2019 and 2018, there was no royalty

revenue from sales of the collaborative product.

Refer to Note 7

(

Collaborative Arrangement

)

, for further discussion on the Company’s collaborative arrangement.

RESEARCH AND DEVELOPMENT.

Costs incurred in connection with research and development activities are expensed as incurred. These costs consist of direct and indirect costs associated with specific projects

as well as fees paid to various entities that perform research related services for the Company.

STOCK-BASED COMPENSATION

. The Company recognizes expense in the consolidated statements of operations for the fair value of all stock-based payments to employees, directors, scientific advisors and consultants, including grants of stock options and other share-based awards. For stock options, the Company uses the Black-Scholes option valuation model, the single-option award approach, and the straight-line attribution method. Using this approach, compensation cost is amortized on a straight-line basis over the vesting period of each respective stock option, generally one to five years. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.

CONCENTRATION OF RISK.

The financial instruments that potentially subject the Company to concentration of credit risk are cash equivalents (i.e., money market funds), investments and accounts receivable, net. The Company places its cash

and cash

equivalents with high-credit quality financial institutions. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in these accounts.

The Company sells its product in the United States through an exclusive distributor (its Customer) to specialty pharmacies. Therefore, its distributor and specialty pharmacies account for all of its trade receivables and net product revenues. The creditworthiness of its Customer is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for doubtful accounts primarily based on the credit worthiness of its Customer, historical payment patterns, aging of receivable balances and general economic conditions.

The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, Firdapse

, and expects Firdapse

to constitute virtually all of product revenue for the foreseeable future. The Company’s success depends on its ability to effectively commercialize Firdapse

The Company relies exclusively on third parties to formulate and manufacture Firdapse

and its drug candidates. The commercialization of Firdapse

and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. The Company is using the same third-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and for the commercialization of Firdapse

. If the Company is unable to continue its relationships with one or more of these third-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on one or more third-party contractors to manufacture the commercial supply of its drugs.

ROYALTIES.

Royalties incurred in connection

with

the Company’s license agreement, as disclosed in Note 9

(

Agreements

)

, are expensed to cost of sales as revenue from product sales is recognized.

INCOME TAXES

. The Company utilizes the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the

more-likely-than-not

threshold, the amount recognized in the financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company is subject to income taxes in the U.S. federal jurisdiction and various state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. The Company is not subject to U.S. federal, state and local tax examinations by tax authorities for years before

2016

. If the Company were to subsequently record an unrecognized tax benefit, associated penalties and tax related interest expense would be reported as a component of income tax expense.

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to

(1) reducing the U.S. federal corporate tax rate from 35 to 21 percent; (2) requiring companies to pay a

one-time

transition tax on certain repatriated earnings of foreign subsidiaries; (3) generally eliminating U.S. federal income taxes on dividends from foreign subsidiaries; (4) requiring a current inclusion in U.S. federal taxable income earnings of controlled foreign corporations; (5) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (6) creating the base erosion anti-abuse tax (BEAT), a new minimum tax; (7) creating a new limitation on deductible interest expense, and (8) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017.

COMPREHENSIVE INCOME (LOSS).

U.S. GAAP requires that all components of comprehensive income (loss) be reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is net income (loss), plus certain other items that are recorded directly into stockholders’ equity. The Company’s comprehensive income (loss) is shown on the consolidated statements of operations and comprehensive income (loss) for the years ended December 31, 2019 and 2018, and is comprised of net unrealized gains (losses) on the Company’s

available-for-sale

securities.

NET INCOME (LOSS) PER COMMON SHARE

. Basic net income (loss) per share is computed by dividing net income (loss) for the period by the weighted average number of common shares outstanding during the period. With regard to common stock subject to vesting requirements, the calculation includes only the vested portion of such stock and units.

Diluted net income

(

loss

)

per common share is computed by dividing net income

(

loss

)

by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period.

The following table reconciles basic and diluted weighted average common shares:


	For the Years Ended December 31,
	2019		2018
Basic weighted average common shares outstanding		102,944,316		102,633,884
Effect of dilutive securities:
Common stock issuable upon the exercise of stock options		3,076,620		—

Diluted weighted average common shares outstanding		106,020,936		102,633,884

Outstanding common stock equivalents totaling approximately 4.6 million, were excluded from the calculation of diluted net income (loss) per common share for the year ended December 31, 2019 as their effect would be anti-dilutive. For the year ended December 31, 2018, approximately 10.5 million shares of outstanding stock options were excluded from the calculation of diluted net loss per common share because a net loss was reported in this period and therefore their effect was anti-dilutive. Potentially dilutive options to purchase common stock as of December 31, 2019 had exercise prices ranging from $0.79 to $4.20. Potentially dilutive options to purchase common stock as of December 31, 2018 had exercise prices ranging from $0.79 to $4.64.

SEGMENT INFORMATION.

Management has determined that the Company operates in one reportable segment, which is the development and commercialization of pharmaceutical products.

RECLASSIFICATIONS.

Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year presentation.

RECENTLY ISSUED ACCOUNTING STANDARDS.

In February 2016, the FASB issued ASU

No. 2016-02,

Leases (Topic 842), which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU

No.

2016-02

also requires new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU

2016-02

is effective for fiscal years beginning after December 15, 2018. The Company adopted the standard as of January 1, 2019, using the modified retrospective approach in which prior comparative periods are not adjusted. The Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carry forward historical lease classification. The Company has operating leases for its office facilities, which expire on November 30, 2022. As of January 1, 2019, the Company recognized an additional

right-of-use

asset and corresponding operating lease liability related to its facility lease on the consolidated balance sheet. No cumulative effect adjustment was recognized as the amount was not material. The standard did not materially impact the Company’s consolidated statement of operations or cash flows. See Note 5

(

perating

ases)

for the financial position impact and additional disclosures.

In June 2018, the FASB issued ASU

No. 2018-07,

Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting that largely aligns the accounting for share-based payment awards issued to employees and nonemployees. Under ASU

No. 2018-07

, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. ASU

2018-07

is effective for all entities for annual reporting periods beginning after December 15, 2018, including interim reporting periods within each annual reporting period, with early adoption permitted. The Company adopted this standard as of January 1, 2019. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

In June 2016, the FASB issued ASU

No. 2016-13,

Financial Instruments — Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments. The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. For

available-for-sale

debt securities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company

adopted

the new standard on January 1, 2020.

The adoption of this standard did not have a material impact on the Company’s consolidated financial statements

Investments

12 Months Ended

Dec. 31, 2019

Investments, Debt and Equity Securities [Abstract]

Investments

3.	Investments.

Available-for-sale

investments by security type were as follows:


	Estimated Fair Value		Gross Unrealized Gains		Gross Unrealized Losses			Amortized Cost
At December 31, 2019:
U.S. Treasuries - Cash equivalents	$	59,932,200	$	2,042	$	—		$	59,930,158
U.S. Treasuries - S T		5,007,050		7,463		—			4,999,587

Total	$	64,939,250	$	9,505	$	—		$	64,929,745

At December 31, 2018:
U.S. Treasuries - ST	$	10,380,864	$	—	$	(1,835	)	$	10,382,699
U.S. Treasuries - LT		5,008,243		—		(18,413	)		5,026,656

Total	$	15,389,107	$	—	$	(20,248	)	$	15,409,355

There were no realized gains or losses from

available-for-sale

securities for the years ended December 31, 2019 or 2018.

The Company did not hold any securities in an unrealized loss position for more than 12 months as of December 31, 2019.

The estimated fair values of

available-for-sale

securities at December 31, 2019, by contractual maturity, are summarized as follows:


	2019
Due in one year or less	$	64,939,250

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2019

Text Block [Abstract]

Prepaid Expenses and Other Current Assets

4.	Prepaid Expenses and Other Current Assets.

Prepaid expenses and other current assets consist of the following as of December 31:


	2019		2018
Prepaid manufacturing costs	$	1,526,013	$	—
Prepaid insurance		1,263,129		800,261
Prepaid subscriptions fees		501,251		170,552
Prepaid research fees		481,057		358,209
Prepaid commercialization expenses		62,959		17,030
Other		516,665		303,729

Total prepaid expenses and other current assets	$	4,351,074	$	1,649,781

Operating Leases

12 Months Ended

Dec. 31, 2019

Disclosure of Operating Leases [Abstract]

Operating Leases

5.	Operating Leases.

The Company has operating lease agreements for its corporate office. The leases include options to extend the leases for up to 1 year and options to terminate the lease within 1 year. There are no obligations under finance leases.

The components of lease expense were as follows:


	For the Year Ended December 31, 2019
Operating lease cost	$	296,316

Supplemental cash flow information related to leases was as follows:


	December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	329,725
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	21,220

Supplemental balance sheet information related to leases was as follows:


	December 31, 2019
Operating lease right-of-use assets	$	793,252

Other current liabilities	$	300,518
Operating lease liabilities, net of current portion		647,532

Total operating lease liabilities	$	948,050


Weighted average remaining lease term			2.9 years
Weighted average discount rate			4.81 %

Remaining payments

lease liabilities as of December 31, 2019 were as follows:


2020	$	339,605
2021		349,788
2022		329,662

Total lease payments		1,019,055
Less imputed interest		(71,005	)

Total	$	948,050

Rent expense was $242,155 for the year ended December 31, 2018.

Accrued Expenses and Other Liabilities

12 Months Ended

Dec. 31, 2019

Payables and Accruals [Abstract]

Accrued Expenses and Other Liabilities

6.	Accrued Expenses and Other Liabilities.

Accrued expenses and other liabilities consist of the following as of December 31:


	2019		2018
Accrued preclinical and clinical trial expenses	$	1,183,513	$	821,633
Accrued professional fees		1,241,526		1,311,061
Accrued compensation and benefits		3,064,645		1,941,449
Accrued license fees		8,751,991		3,000,000
Accrued purchases		1,313,310		—
Accrued contributions		1,535,000		—
Operating lease liability		300,518		—
Accrued variable consideration		884,764		—
Deferred rent and lease incentive		—		33,408
Income tax payable		1,533,696		—
Other		172,332		66,436

Current accrued expenses and other liabilities		19,981,295		7,173,987

Lease liability – non-current		647,532		—
Deferred rent and lease incentive—non-current		—		154,799

Non-current accrued expenses and other liabilities		647,532		154,799

Total accrued expenses and other liabilities	$	20,628,827	$	7,328,786

Collaborative Arrangement

12 Months Ended

Dec. 31, 2019

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Collaborative Arrangement

7.	Collaborative Arrangement.

In December 2018, the Company entered into a collaboration and license agreement (

ollaboration) with Endo Ventures Limited (Endo), for the further development and commercialization of generic Sabril

(vigabatrin) tablets through Endo’s U.S. Generic Pharmaceuticals segment, doing business as Par Pharmaceutical.

Under the Collaboration, Endo assumes all development, manufacturing, clinical, regulatory, sales and marketing costs under the collaboration, while the Company is responsible for exercising commercially reasonable efforts to develop, or cause the development of, a final finished, stable dosage form of generic Sabril

tablets.

Under the terms of the Collaboration, the Company has received an

up-front

payment, and will receive

a milestone payment, and a sharing of defined net profits upon commercialization from Endo consisting of a

mid-double

digit percent of net sales of generic Sabril

. The Company has also agreed to a sharing of certain development expenses. Unless terminated earlier in accordance with its terms, the collaboration continues in effect until the date that is

ten years following the commercial launch of the product.

The collaborative agreement provides for

$2.0

million milestone payment on the commercial launch of the product by Par

. As of December 31, 2019 and 2018, no milestone payments have been earned.

Revenues from collaborative arrangement were $0 and

$500,000

(for upfront license fees) for the years ended December 31, 2019 and 2018, respectively. Total expenses incurred, net, in connection with the collaboration agreement for the years ended December 31, 2019 and December 31, 2018 were $65,061 and $0, and have been included in research and development expenses in the accompanying consolidated statements of operations.

Commitments and Contingencies

12 Months Ended

Dec. 31, 2019

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

8.	Commitments and Contingencies.

In 2018, the Company became aware that certain patents granted to Northwestern University (which patents have been licensed by Northwestern to a third party) for a new GABA aminotransferase inhibitor were developed from

CPP-115,

which had previously been licensed to the Company by Northwestern. As a result, on October 26, 2018, the Company terminated the license agreement for

CPP-115

and commenced an arbitration proceeding against Northwestern seeking damages for alleged breaches of the license agreement. Shortly thereafter, Northwestern filed counterclaims against the Company in the arbitration action seeking damages for alleged breaches by the Company of the license agreement. On May 21, 2019, the Company entered into a settlement agreement with Northwestern that resolved all pending disputes between the parties with no admission of liability by either party, released all claims of liability or wrongdoing between the Company and Northwestern, and dismissed the pending arbitration. Under the settlement agreement, the Company received a $100,000 payment on May 21, 2019, which is reported as income in other income, net in the consolidated statement of operations. The Company is also entitled to receive certain contingent compensation that will be reported when and if received.

In May 2019, the FDA approved an NDA for Jacobus Pharmaceuticals for Ruzurgi

, their version of amifampridine

(3,4-DAP),

for the treatment of pediatric LEMS patients (ages 6 to under 17). The Company believes that Jacobus is offering Ruzurgi

at a lower price than the Company is offering Firdapse

. In addition, while the NDA for Ruzurgi

only covers pediatric patients, the Company believes Ruzurgi

is being prescribed off label to adult LEMS patients. If Jacobus is able to successfully sell Ruzurgi

off-label

to adult LEMS patients, it could have a material adverse effect on the Company’s business, financial condition and results of operations.

The Company believes that the FDA’s approval of Ruzurgi

violated its statutory rights and was in multiple other respects arbitrary, capricious and contrary to law. As a result, in June 2019 the Company filed suit against the FDA and several related parties challenging this approval and related drug labeling. The Company’s complaint, which was filed in the federal district court for the Southern District of Florida, alleges that the FDA’s approval of Ruzurgi

violated multiple provisions of FDA regulations regarding labeling, resulting in misbranding in violation of the Federal Food, Drug, and Cosmetic Act (FDCA); violated its statutory rights to Orphan Drug Exclusivity and New Chemical Entity Exclusivity under the FDCA; and was in multiple other respects arbitrary, capricious, and contrary to law, in violation of the Administrative Procedure Act. Among other remedies, the suit seeks an order vacating the FDA’s approval of Ruzurgi

. Jacobus has intervened in the case. Each party has filed a cross motion for summary judgement. There can be no assurance as to the outcome of this lawsuit.

Additionally, from time to time the Company may become involved in legal proceedings arising in the ordinary course of business. Except as set forth above, the Company believes that there is no other litigation pending at this time that could have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or cash flows.

Agreements

12 Months Ended

Dec. 31, 2019

Text Block [Abstract]

Agreements

9.	Agreements.

LICENSE AGREEMENT WITH BIOMARIN (FIRDAPSE

)

. On October 26, 2012, the Company entered into a license agreement with BioMarin Pharmaceutical, Inc. (BioMarin) for the North American rights to Firdapse

. Under the license agreement, the Company pays: (i) royalties to

the

licensor

for

seven years from the first commercial sale of Firdapse

equal to 7% of net sales (as defined in the license agreement) in North America for any calendar year for sales up to $100 million, and 10% of net sales in North America in any calendar year in excess of $100 million; and (ii) royalties to the third-party licensor of the rights sublicensed to the Company for seven years from the first commercial sale of Firdapse

equal to 7% of net sales (as defined in the license agreement between BioMarin and the third-party licensor) in any calendar year.

On May 29, 2019,

the Company entered into an amendment to its license agreement for Firdapse

. Under the amendment, the Company has expanded its commercial territory for Firdapse

, which originally was comprised of North America, to include Japan. Additionally, the Company has an option to further expand its territory under the license agreement to include most of Asia, as well as Central and South America, upon the achievement of certain milestones in Japan. Under the amendment, the Company will pay royalties on net sales in Japan of a similar percentage to the royalties that the Company is currently paying under its original license agreement for North America.

Subsequent to

year-end,

during January 2020, the Company was advised that BioMarin has transferred certain rights under the license agreement to SERB S.A.

AGREEMENTS FOR DRUG MANUFACTURING, DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES.

The Company has entered into agreements with contract manufacturers for the manufacture of commercial drug and drug and study placebo for the Company’s trials and studies, with contract research organizations (CRO) to conduct and monitor the Company’s trials and studies and with various entities for laboratories and other testing related to the Company’s trials and studies. The contractual terms of the agreements vary, but most require certain advances as well as payments based on the achievement of milestones. Further, most of these agreements are cancellable at any time, but obligate the Company to reimburse the providers for any time or costs incurred through the date of termination.

Income Taxes

12 Months Ended

Dec. 31, 2019

Income Tax Disclosure [Abstract]

Income Taxes

10.	Income Taxes.

Due to the Company’s historical operating losses and the inability to recognize any income tax benefit, there was no provision for income taxes in the preceding period presented in these financial statements. Commencing in 2019, the Company has recorded income taxes on their pretax income using an e

ffective

tax rate.

The income tax expense for the years ended December 31, 2019 and 2018 consist

of:


	2019		2018
Current	$	1,533,696	$	—
Deferred		—		—

	$	1,533,696	$	—

The reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate of 21% to amounts included in the statements of operations is as follows:


	2019			2018
Statutory rate		21.0	%		21.0	%
State tax		6.5	%		4.2	%
Valuation allowance		(20.9	) %		(25.9	)%
Federal rate change		0.0	%		0.0	%
Tax credit		(2.5	) %		1.4	%
Other		0.5	%		(0.7	)%

		4.6	%		0.0	%

Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryovers and the temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are as follows:


	2019			2018
Net operating loss	$	10,645,128		$	19,867,591
Start-up cost s		12,894,926			13,861,147
Tax credits		14,320,860			12,625,275
Deferred compensation		3,183,767			1,919,434
Inventory		229,050			—
Other		355,023			109,779

Gross deferred tax asset		41,628,754			48,383,226

Valuation allowance		(41,628,754	)		(48,383,226	)

Net deferred tax assets	$	—		$	—

The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As of December 31, 2019, and December 31, 2018, based on the Company’s history of operating losses, the Company has concluded that it is more likely than not that the benefit of its deferred tax assets will not be realized. Accordingly, the Company has provided a full valuation allowance for deferred tax assets including NOL and tax credit carryover as of December 31, 2019 and December 31, 2018. The valuation allowance

decreased by

$6.8

million and increased

$9.2

million during 2019 and 2018, respectively.

At December 31, 2019 and 2018, respectively, the Company had net operating

loss carryforwards and other credits of

approximately $41.5 million and $79.0 million

available to reduce future taxable income, if any. The net operating loss carryforwards will expire at various dates beginning in 20

and ending in 2037, the amount of net operating loss generated in 2018 will have an infinite life, but will be limited to utilization per year

of 80% of taxable income.

Beginning in 2010, the Company has received several orphan drug designations by the FDA for products currently under development. The orphan drug designations allow the Company to claim increased federal tax credits for certain research and development activities. The tax credit carryforwards will expire at various dates beginning in 2032 and ending in 2040.

Utilization of certain of the Company’s NOL and tax credit carryforwards in the United States is subject to annual limitation due to the ownership change limitations provided by Sections 382 and 383 of the Internal Revenue Code and similar state provisions. Such an annual limitation may result in the expiration of certain NOLs and tax credits before future utilization.

The Company is currently conducting a study of the availability for use of its net operating loss carryforwards and other credits under Section 382 of the Internal Revenue Code. The results of this study could impact the amounts of net operating losses and other credits that the Company has available for use in future periods and the timing of their use.

No interest or penalties were accrued through December 31, 201

. The Company’s policy is to recognize any related interest or penalties in income tax expense. The Company is not subject to U.S. federal, state and local tax examinations by tax authorities for any years before

2016. However, authorities can examine net operating loss carryforwards incurred prior to 2016 to the extent utilized in subsequent periods with open statutes. The Company is not currently under income tax examinations by any tax authorities.

Stockholders' Equity

12 Months Ended

Dec. 31, 2019

Equity [Abstract]

Stockholders' Equity

11.	Stockholders’ Equity.

Preferred Stock

The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share

at December 31, 2019 and 2018. No shares of preferred stock were outstanding at December 31, 2019 and 2018.

Common Stock

The Company has 150,000,000 shares of authorized common stock, par value $0.001 per share. At December 31, 2019 and 2018, 103,397,033 and 102,739,257 shares, respectively, of common stock were issued and outstanding. Each holder of common stock is entitled to one vote of each share of common stock held of record on all matters on which stockholders generally are entitled to vote.

2016 Shelf Registration Statement

On December 23, 2016, the Company filed a shelf Registration Statement on Form

S-3

(the 2016 Shelf Registration Statement) with the SEC to sell up to approximately $33.8 million of common stock. The 2016 Shelf Registration Statement (file

No. 333-215315)

was declared effective by the SEC on January 9, 2017. No sales have been conducted to date under the 2016 Shelf Registration Statement.

On January 9, 2020, the 2016 Shelf Registration Statement expired.

2017 Shelf Registration Statement

On July 12, 2017, the Company filed a universal shelf Registration Statement on Form

S-3

(the 2017 Shelf Registration Statement) with the SEC to sell up to $150 million of common stock, preferred stock, warrants to purchase common stock, or debt securities (including debt securities that may be convertible or exchangeable for common stock or other securities), which securities may be offered separately or together in units or multiple series. The 2017 Shelf Registration Statement (file

No. 333-219259)

was declared effective by the SEC on July 26, 2017.

On November 28, 2017, the Company filed a prospectus supplement and offered for sale 16,428,572 shares of its common stock at a price of $3.50 per share in an underwritten public offering under the 2017 Shelf Registration. The Company received gross proceeds in the public offering of approximately $57.5 million before underwriting commission and incurred expenses of approximately $3.7 million.

At December 31, 2019, there is approximately $92.5 million available for future sale under the 2017 Shelf Registration Statement.

Stockholder Rights Plan

On September 20, 2011, the Board of Directors approved the Company’s adoption of a Stockholder Rights Plan. Under the

Stockholders’ Rights Plan, a dividend of one preferred share purchase right (a Right) was declared for each share of common stock of the Company that was outstanding on

October 7, 2011. Each Right entitles the holder to purchase from the Company one

one-hundredth

of a share of Series A Junior Preferred Stock at a purchase price of $7.80, subject to adjustment.

The Rights trade automatically with the common stock and will not be exercisable until a person or group has become an “acquiring person” by acquiring 17.5% or more of the Company’s outstanding common stock, or a person or group commences, or publicly announces a tender offer that will result in such a person or group owning 17.5% or more of the Company’s outstanding common stock. Upon announcement that any person or group has become an acquiring person, each Right will entitle all rightholders (other than the acquiring person) to purchase, for the exercise price of $7.80, a number of shares of the Company’s common stock having a market value equal to twice the exercise price. Rightholders would also be entitled to purchase common stock of the acquiring person having a value of twice the exercise price if, after a person had become an acquiring person, the Company were to enter into certain mergers or other transactions. If any person becomes an acquiring person, the Board of Directors may, at its option and subject to certain limitations, exchange one share of common stock for each Right.

The Rights have certain anti-takeover effects, in that they would cause substantial dilution to a person or group that attempts to acquire a significant interest in the Company on terms not approved by the Board of Directors. In the event that the Board of Directors determines a transaction to be in the best interests of the Company and its stockholders, the Board of Directors may redeem the Rights for $0.001 per share at any time prior to a person or group becoming an acquiring person.

On September 19, 2016, the Board of Directors unanimously approved, and on the same date the Company entered into Amendment No. 1 to the Stockholders Rights Plan (the “Amendment”). Under the terms of the Amendment, the outside expiration date of the rights plan has been extended from September 20, 2016 to September 20, 2019. Additionally, as part of the Amendment, the Board adopted a Certificate of Designation, Preferences and Rights of Series A Junior Participating Preferred Stock of the Company to increase the number of shares of Series A Junior Participating Preferred Stock of the Company available for issuance under the Rights Plan from 500,000 shares to 1.5 million shares.

On August 28, 2019, the Board of Directors unanimously adopted Amendment No. 2 to the Stockholders’ Rights Plan extending the outside expiration date of the rights plan to September 20, 2022.

Stock Compensation

12 Months Ended

Dec. 31, 2019

Share-based Payment Arrangement [Abstract]

Stock Compensation

12.	Stock Compensation.

For the years ended December 31, 2019 and 2018, the Company recorded stock-based compensation expense as follows:


	2019		2018
Research and development	$	1,137,596	$	1,079,230
Selling, general and administrative		2,687,219		2,471,414

Total stock-based compensation	$	3,824,815	$	3,550,644

The Company may issue stock options, restricted stock, stock appreciation rights and restricted stock units (collectively, the “Awards”) to employees, directors, and consultants of the Company under the 2014 and 2018 Stock Incentive Plans (the 2014 Plan and the 2018 Plan or collectively, the Plans). At December 31, 2019, no shares remain available for future issuance under the 2014 Plan. Under the 2018 Plan, 7,500,000 shares were reserved for issuance and as of December 31, 2019, 1,596,271 shares remain available for future issuance.

Stock Options

The Company has granted stock options to employees, officers, directors, and consultants generally at exercise prices equal to the market price of the common stock at grant date. Option awards generally vest over a period of 1 to 5 years of continuous service and have contractual terms from 5 to 7 years. Certain awards provide for accelerated vesting if there is a change in control. The Company issues new shares as shares are required to be delivered upon exercise of outstanding stock options.

During the years ended December 31, 2019 and 2018, options to purchase 654,332 and 186,665 shares of the Company’s common stock were exercised with gross proceeds to the Company of $1,116,242 and $297,563, respectively. Further, during the year ended December 31, 2019, options to purchase 6,666 shares of the Company’s common stock were exercised on a “cashless” basis, resulting in the issuance of an aggregate of 3,444 shares of the Company’s common stock, respectively. During the year ended December 31, 2018, no options to purchase shares of the Company’s common stock were exercised on a “cashless” basis.

During the years ended December 31, 2019 and 2018 the Company recorded

non-cash

stock-based compensation expense related to stock options totaling $3,780,086 and $3,535,647, respectively.

During the years ended December 31, 2019 and 2018, the Company granted seven-year options to purchase an aggregate of 2,183,500 and 5,882,500 shares, respectively, of the Company’s common stock to certain of the Company’s officers, employees, directors, and consultants.

Stock option activity under the Company’s Plans for the year ended December 31, 2019 is summarized as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at beginning of year		10,532,500		$	2.54
Granted		2,183,500			4.54
Exercised or released		(660,998	)		1.72
Forfeited or cancelled		(511,668	)		2.73
Expired		(65,000	)		3.90

Outstanding at end of year		11,478,334		$	2.95		4.89	$	11,590,899

Exercisable at end of year		5,844,819		$	2.41		3.87	$	8,084,671

Other information pertaining to stock option activity during the years ended December 31, 2019 and 2018 was as follows:


	2019		2018
Weighted–average fair value of granted stock options	$	2.69	$	1.93
Total fair value of vested stock options	$	3,864,995	$	2,193,294
Total intrinsic value of exercised stock options	$	1,899,862	$	274,864

The following table summarizes information about the Company’s options outstanding at December 31, 2019:


	Options Outstanding						Options Exercisable
Range of Exercise Prices	Number Outstanding		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price		Number Exercisable		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price
$0.79 to $2.17		2,139,000		3.83	$	1.05		1,757,332		3.73	$	1.01
$2.18 to $2.43		2,350,000		5.97	$	2.25		983,324		5.97	$	2.24
$2.44 to $3.38		2,345,334		3.07	$	2.88		1,919,996		2.46	$	2.86
$3.39 to $4.07		2,592,500		5.17	$	3.82		1,019,167		5.11	$	3.85
$4.08 to $6.63		2,051,500		6.54	$	4.74		165,000		2.48	$	4.18

		11,478,334		4.89	$	2.95		5,844,819		3.87	$	2.41

As of December 31, 2019, there was approximately $9.9 million of unrecognized compensation expense related to

non-vested

stock option awards granted under the Plans. That cost is expected to be recognized over a weighted average period of approximately 2.33 years.

The Company utilizes the Black-Scholes option-pricing model to determine the fair value of stock options on the date of grant. This model derives the fair value of stock options based on certain assumptions related to the expected stock price volatility, expected option life, risk-free interest rate and dividend yield. Expected volatility is based on reviews of historical volatility of the Company’s common stock. The estimated expected option life is based upon estimated employee exercise patterns and considers whether and the extent to which the options are

in-the-money.

The Company estimates the expected option life for options granted to employees and directors based upon the simplified method. Under this method, the expected life is presumed to be the

mid-point

between the vesting date and the end of the contractual term. The Company will continue to use the simplified method until it has sufficient historical exercise data to estimate the expected life of the options. The risk-free interest rate assumption is based upon the U.S. Treasury yield curve appropriate for the estimated life of the stock options awards. The expected dividend rate is zero. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.

Assumptions used during the years were as follows:


	December 31, 2019			December 31, 2018
Risk free interest rate		1.51% to 2.53	%		2.09% to 2.88	%
Expected term		4.5 years			0 to 7 years
Expected volatility		75.5	%		82	%
Expected dividend yield		—	%		—	%
Expected forfeiture rate		—	%		—	%

Restricted Stock Units

Under the 2018 Plan, participants may be granted restricted stock units, each of which represents a conditional right to receive shares of common stock in the future. The restricted stock units granted under this plan generally vest ratably over a three-year period. Upon vesting, the restricted stock units will convert into an equivalent number of shares of common stock. The amount of expense relating to the restricted stock units is based on the closing market price of the Company’s common stock on the date of grant and is amortized on a straight-line basis over the requisite service period. Restricted stock unit activity during 2019 was as follows:


	2019
	Number of Restricted Stock Units		Weighted Average Grant Date Fair Value
Nonvested balance at beginning of year		—	$	—
Granted		352,500		4.64
Vested		—		—
Forfeited		—		—

Nonvested balance at end of year		352,500	$	4.64

No restricted stock units were granted

outstanding

during 2018.

During the year ended December 31, 2019, the Company recorded

non-cash

stock-based compensation expense related to restricted stock units totaling $44,729. No stock-based compensation related to restricted stocks was recorded during 2018.

Common Stock

No shares of common stock were granted during the year ended December 31, 2019. During the year ended December 31, 2018, the Company granted 3,094 net shares of common stock to an employee as compensation. The Company recorded stock-based compensation related to common stock issued to an employee totaling approximately $15,000, during the year ended December 31, 2018.

Benefit Plan

12 Months Ended

Dec. 31, 2019

Retirement Benefits [Abstract]

Benefit Plan

13.	Benefit Plan.

The Company maintains an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code covering all eligible employees. Subject to certain dollar limits, eligible employees may contribute up to 15% of their

pre-tax

annual compensation to the plan. The Company has elected to make discretionary matching contributions of employee contributions up to 4% of an employee’s gross salary. For the years ended December 31, 2019 and 2018, the Company’s matching contributions were approximately $268,000 and $123,000, respectively.

Quarterly Financial Information (unaudited)

12 Months Ended

Dec. 31, 2019

Quarterly Financial Information Disclosure [Abstract]

Quarterly Financial Information (unaudited)

14.	Quarterly Financial Information (unaudited).

The following table presents unaudited supplemental quarterly financial information for the years ended December 31, 2019 and 2018:


	Quarter Ended
	March 31, 2019			June 30, 2019		September 30, 2019		December 31, 2019
Revenues	$	12,448,438		$	28,837,900	$	30,897,444	$	30,122,555
Income (loss) from operations	$	(987,769	)	$	10,959,189	$	13,845,152	$	8,006,687
Net income (loss)	$	(644,503	)	$	10,959,948	$	13,630,179	$	7,929,713
Net income (loss) per share – basic	$	(0.01	)	$	0.11	$	0.13	$	0.08
Net income (loss) per share – diluted	$	(0.01	)	$	0.10	$	0.13	$	0.07


	Quarter Ended
	March 31, 2018			June 30, 2018			September 30, 2018			December 31, 2018
Revenues	$	—		$	—		$	—		$	500,000
Loss from operations	$	(5,933,440	)	$	(6,335,855	)	$	(8,182,603	)	$	(14,843,267	)
Net loss	$	(5,699,892	)	$	(5,965,140	)	$	(7,838,873	)	$	(14,499,609	)
Net loss per share – basic and diluted	$	(0.06	)	$	(0.06	)	$	(0.08	)	$	(0.14	)

Quarterly basic and diluted net income (loss) per common share were computed independently for each quarter and do not necessarily total to the full year basic and diluted net income (loss) per common share.

Basis of Presentation and Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2019

Accounting Policies [Abstract]

PRINCIPLES OF CONSOLIDATION.

PRINCIPLES OF CONSOLIDATION

. The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiary

Catalyst Pharmaceuticals Ireland, Ltd. (“Catalyst Ireland”). All intercompany accounts and transactions have been eliminated in consolidation. Catalyst Ireland was organized in 2017.

USE OF ESTIMATES

USE OF ESTIMATES.

The preparation of financial statements in conformity with

accounting

principles

generally accepted in the U.S

CASH AND CASH EQUIVALENTS

CASH AND CASH EQUIVALENTS.

INVESTMENTS

INVESTMENTS.

Short-Term Bond Fund

The short-term bond fund

was

classified as

trading secur

ity

U.S. Treasuries

U.S. Treasuries are classified as

available-for-sale

securities. The Company classifies

available-for-sale

securities with stated maturities of greater than three months and less than one year as short-term investments.

Available-for-sale

securities with stated maturities greater than one year are classified as

non-current

investments in the accompanying consolidated balance sheets. The Company records

available-for-sale

comprehensive

income (loss)

and

and comprehensive income (loss).

The Company recognizes a charge when the declines in the fair value below the amortized cost basis of its

available-for-sale

securities. See Note 3

(

Investments).

ACCOUNTS RECEIVABLE, NET

ACCOUNTS RECEIVABLE, NET.

Accounts receivable are recorded net of customer allowance for distribution fees, trade discounts, prompt payment discounts, chargebacks and doubtful accounts. Allowances for distribution fees,

trade discounts

INVENTORY

INVENTORY.

on November 28, 2018 as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to the FDA approval of Firdapse

Products that have been approved by the FDA or other regulatory authorities, such as Firdapse

PREPAID EXPENSES AND OTHER CURRENT ASSETS

PREPAID EXPENSES AND OTHER CURRENT ASSETS.

pre-clinical

PROPERTY AND EQUIPMENT, NET

PROPERTY AND EQUIPMENT

NET

FAIR VALUE OF FINANCIAL INSTRUMENTS

FAIR VALUE OF FINANCIAL INSTRUMENTS.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS.


	Fair Value Measurements at Reporting Date Using
	Balances as of December 31, 2019		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	23,963,617	$	23,963,617	$	—	$	—

U.S. Treasuries	$	59,932,200	$		$	59,932,200	$

Short-term investments :
U.S. Treasuries	$	5,007,050	$	—	$	5,007,050	$	—


	Balances as of December 31, 2018		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	14,462,087	$	14,462,087	$	—	$	—

Short-term investments:
Short-term bond fund	$	26,541,349	$	26,541,349	$	—	$	—

U.S. Treasuries	$	10,380,864	$	—	$	10,380,864	$	—

Investments:
U.S. Treasuries	$	5,008,243	$	—	$	5,008,243	$	—

OPERATING LEASES

OPERATING LEASES.

Effective January 1, 2019, the Company determined if an arrangement is a lease at inception. Operating leases are included in operating lease

right-of-use

(“ROU”) assets, other current liabilities, and operating lease liabilities on its consolidated balance sheets.

non-lease

components, which are generally accounted for separately. Refer to Note 2.v. for discussion on adoption method.

REVENUE RECOGNITION

REVENUE RECOGNITION.

Prior to the January 2019 launch of Firdapse

in November 2018. Subsequent to receiving FDA approval, the Company entered into an arrangement with one distributor (the “Customer”), who is the exclusive distributor of Firdapse

in the United States. The Customer subsequently resells Firdapse

The Company also

may

Product Revenue, Net:

The Company sells Firdapse

the

Customer (its exclusive distributor) who subsequently resells Firdapse

Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods, and are recorded in cost of sales.

As of December 31, 2019, all of the Company’s sales are to its Customer.

Reserves for Variable Consideration:

Trade Discounts and Allowances:

cons

lidated

statement of operations and comprehensive income (loss) through December 31, 2019, as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Funded

Co-pay

Assistance Program:

The Company contracts with a third-party to manage the

co-pay

assistance program intended to provide financial assistance to qualified

commercially-insured

patients. 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 Firdapse

that has been recognized as revenue, but remains in the distribution channel at the end of each reporting period. These payments are considered payable to the

Product Returns:

Provider Chargebacks and Discounts:

net

Government Rebates:

Bridge and Patient Assistance Programs:

The Company provides free Firdapse

to uninsured patients who satisfy

pre-established

while the Company is determining the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Firdapse

. The Patient Assistance Program provides free Firdapse

for longer periods of time for those who are uninsured or functionally uninsured with respect to Firdapse

because they are unable to obtain coverage from their payer despite having health insurance

to the extent allowed

applicable

law

Revenues from Collaborative Arrangement:

The Company has entered into a collaboration agreement for the further development and commercialization of generic Sabril

the

collaborative agreement.

The collaborative agreement provides for a milestone payment upon achievement of development and regulatory events

The Company accounts for milestone payments in accordance with the provisions of Accounting Standards Update (ASU)

No. 2010-17,

Revenue Recognition – Milestone Method (“Milestone Method of Accounting”)

The consideration relates solely to past performance; and

The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.

The Company believes that achievement of the milestone will be substantive and there will be no substantive uncertainty once the milestone is achieved.

revenue from sales of the collaborative product.

Refer to Note 7

(

Collaborative Arrangement

)

, for further discussion on the Company’s collaborative arrangement.

RESEARCH AND DEVELOPMENT

RESEARCH AND DEVELOPMENT.

Costs incurred in connection with research and development activities are expensed as incurred. These costs consist of direct and indirect costs associated with specific projects

as well as fees paid to various entities that perform research related services for the Company.

STOCK-BASED COMPENSATION

CONCENTRATION OF CREDIT RISK

CONCENTRATION OF RISK.

and cash

equivalents with high-credit quality financial institutions. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in these accounts.

, and expects Firdapse

to constitute virtually all of product revenue for the foreseeable future. The Company’s success depends on its ability to effectively commercialize Firdapse

The Company relies exclusively on third parties to formulate and manufacture Firdapse

and its drug candidates. The commercialization of Firdapse

ROYALTIES

ROYALTIES.

Royalties incurred in connection

with

the Company’s license agreement, as disclosed in Note 9

(

Agreements

)

, are expensed to cost of sales as revenue from product sales is recognized.

INCOME TAXES

more-likely-than-not

2016

. If the Company were to subsequently record an unrecognized tax benefit, associated penalties and tax related interest expense would be reported as a component of income tax expense.

(1) reducing the U.S. federal corporate tax rate from 35 to 21 percent; (2) requiring companies to pay a

one-time

COMPREHENSIVE INCOME (LOSS)

COMPREHENSIVE INCOME (LOSS).

available-for-sale

securities.

NET INCOME (LOSS) PER COMMON SHARE

SEGMENT INFORMATION

SEGMENT INFORMATION.

Management has determined that the Company operates in one reportable segment, which is the development and commercialization of pharmaceutical products.

RECLASSIFICATIONS

RECLASSIFICATIONS.

Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year presentation.

RECENTLY ISSUED ACCOUNTING STANDARDS

RECENTLY ISSUED ACCOUNTING STANDARDS.

In February 2016, the FASB issued ASU

No. 2016-02,

Leases (Topic 842), which requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU

No.

2016-02

right-of-use

(

perating

ases)

for the financial position impact and additional disclosures.

Basis of Presentation and Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2019

Accounting Policies [Abstract]

Fair Value Measurement Specific to Assets or Liability


	Fair Value Measurements at Reporting Date Using
	Balances as of December 31, 2019		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	23,963,617	$	23,963,617	$	—	$	—

U.S. Treasuries	$	59,932,200	$		$	59,932,200	$

Short-term investments :
U.S. Treasuries	$	5,007,050	$	—	$	5,007,050	$	—


	Balances as of December 31, 2018		Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)
Cash and cash equivalents:
Money market funds	$	14,462,087	$	14,462,087	$	—	$	—

Short-term investments:
Short-term bond fund	$	26,541,349	$	26,541,349	$	—	$	—

U.S. Treasuries	$	10,380,864	$	—	$	10,380,864	$	—

Investments:
U.S. Treasuries	$	5,008,243	$	—	$	5,008,243	$	—

Basic and Dilutive Weighted Average Common Shares

The following table reconciles basic and diluted weighted average common shares:


	For the Years Ended December 31,
	2019		2018
Basic weighted average common shares outstanding		102,944,316		102,633,884
Effect of dilutive securities:
Common stock issuable upon the exercise of stock options		3,076,620		—

Diluted weighted average common shares outstanding		106,020,936		102,633,884

Investments (Tables)

12 Months Ended

Dec. 31, 2019

Investments, Debt and Equity Securities [Abstract]

Summary of Available-for-Sale Investments by Security type

Available-for-sale

investments by security type were as follows:


	Estimated Fair Value		Gross Unrealized Gains		Gross Unrealized Losses			Amortized Cost
At December 31, 2019:
U.S. Treasuries - Cash equivalents	$	59,932,200	$	2,042	$	—		$	59,930,158
U.S. Treasuries - S T		5,007,050		7,463		—			4,999,587

Total	$	64,939,250	$	9,505	$	—		$	64,929,745

At December 31, 2018:
U.S. Treasuries - ST	$	10,380,864	$	—	$	(1,835	)	$	10,382,699
U.S. Treasuries - LT		5,008,243		—		(18,413	)		5,026,656

Total	$	15,389,107	$	—	$	(20,248	)	$	15,409,355

Estimated Fair Values of Available for Sale Securities

The estimated fair values of

available-for-sale

securities at December 31, 2019, by contractual maturity, are summarized as follows:


	2019
Due in one year or less	$	64,939,250

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2019

Text Block [Abstract]

Prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following as of December 31:


	2019		2018
Prepaid manufacturing costs	$	1,526,013	$	—
Prepaid insurance		1,263,129		800,261
Prepaid subscriptions fees		501,251		170,552
Prepaid research fees		481,057		358,209
Prepaid commercialization expenses		62,959		17,030
Other		516,665		303,729

Total prepaid expenses and other current assets	$	4,351,074	$	1,649,781

Operating Leases (Tables)

12 Months Ended

Dec. 31, 2019

Disclosure of Operating Leases [Abstract]

Lease, Cost

The components of lease expense were as follows:


	For the Year Ended December 31, 2019
Operating lease cost	$	296,316

Schedule of Supplemental Cash Flow Information Related To Lease

Supplemental cash flow information related to leases was as follows:


	December 31, 2019
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	329,725
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$	21,220

Schedule of Supplemental Balance Sheet related To Lease

Supplemental balance sheet information related to leases was as follows:


	December 31, 2019
Operating lease right-of-use assets	$	793,252

Other current liabilities	$	300,518
Operating lease liabilities, net of current portion		647,532

Total operating lease liabilities	$	948,050


Weighted average remaining lease term			2.9 years
Weighted average discount rate			4.81 %

Lessee, Operating Lease, Liability, Maturity

Remaining payments

lease liabilities as of December 31, 2019 were as follows:


2020	$	339,605
2021		349,788
2022		329,662

Total lease payments		1,019,055
Less imputed interest		(71,005	)

Total	$	948,050

Accrued Expenses and Other Liabilities (Tables)

12 Months Ended

Dec. 31, 2019

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following as of December 31:


	2019		2018
Accrued preclinical and clinical trial expenses	$	1,183,513	$	821,633
Accrued professional fees		1,241,526		1,311,061
Accrued compensation and benefits		3,064,645		1,941,449
Accrued license fees		8,751,991		3,000,000
Accrued purchases		1,313,310		—
Accrued contributions		1,535,000		—
Operating lease liability		300,518		—
Accrued variable consideration		884,764		—
Deferred rent and lease incentive		—		33,408
Income tax payable		1,533,696		—
Other		172,332		66,436

Current accrued expenses and other liabilities		19,981,295		7,173,987

Lease liability – non-current		647,532		—
Deferred rent and lease incentive—non-current		—		154,799

Non-current accrued expenses and other liabilities		647,532		154,799

Total accrued expenses and other liabilities	$	20,628,827	$	7,328,786

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2019

Income Tax Disclosure [Abstract]

Schedule of income tax expense

The income tax expense for the years ended December 31, 2019 and 2018 consist

of:


	2019		2018
Current	$	1,533,696	$	—
Deferred		—		—

	$	1,533,696	$	—

Reconciliation of income tax expense (Benefit) computed at statutory federal income tax rate

The reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate of 21% to amounts included in the statements of operations is as follows:


	2019			2018
Statutory rate		21.0	%		21.0	%
State tax		6.5	%		4.2	%
Valuation allowance		(20.9	) %		(25.9	)%
Federal rate change		0.0	%		0.0	%
Tax credit		(2.5	) %		1.4	%
Other		0.5	%		(0.7	)%

		4.6	%		0.0	%

Components of deferred tax assets

Significant components of the Company’s deferred tax assets as of December 31, 2019 and 2018 are as follows:


	2019			2018
Net operating loss	$	10,645,128		$	19,867,591
Start-up cost s		12,894,926			13,861,147
Tax credits		14,320,860			12,625,275
Deferred compensation		3,183,767			1,919,434
Inventory		229,050			—
Other		355,023			109,779

Gross deferred tax asset		41,628,754			48,383,226

Valuation allowance		(41,628,754	)		(48,383,226	)

Net deferred tax assets	$	—		$	—

Stock Compensation (Tables)

12 Months Ended

Dec. 31, 2019

Share-based Payment Arrangement [Abstract]

Stock-Based Compensation Expense

For the years ended December 31, 2019 and 2018, the Company recorded stock-based compensation expense as follows:


	2019		2018
Research and development	$	1,137,596	$	1,079,230
Selling, general and administrative		2,687,219		2,471,414

Total stock-based compensation	$	3,824,815	$	3,550,644

Stock option activity under the Company's Plans

Stock option activity under the Company’s Plans for the year ended December 31, 2019 is summarized as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at beginning of year		10,532,500		$	2.54
Granted		2,183,500			4.54
Exercised or released		(660,998	)		1.72
Forfeited or cancelled		(511,668	)		2.73
Expired		(65,000	)		3.90

Outstanding at end of year		11,478,334		$	2.95		4.89	$	11,590,899

Exercisable at end of year		5,844,819		$	2.41		3.87	$	8,084,671

Schedule of Other Information Pertaining to Stock Option Activity

Other information pertaining to stock option activity during the years ended December 31, 2019 and 2018 was as follows:


	2019		2018
Weighted–average fair value of granted stock options	$	2.69	$	1.93
Total fair value of vested stock options	$	3,864,995	$	2,193,294
Total intrinsic value of exercised stock options	$	1,899,862	$	274,864

Summary of Company's Stock Options Outstanding

The following table summarizes information about the Company’s options outstanding at December 31, 2019:


	Options Outstanding						Options Exercisable
Range of Exercise Prices	Number Outstanding		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price		Number Exercisable		Weighted Average Remaining Contractual Life (Years)		Weighted Average Exercise Price
$0.79 to $2.17		2,139,000		3.83	$	1.05		1,757,332		3.73	$	1.01
$2.18 to $2.43		2,350,000		5.97	$	2.25		983,324		5.97	$	2.24
$2.44 to $3.38		2,345,334		3.07	$	2.88		1,919,996		2.46	$	2.86
$3.39 to $4.07		2,592,500		5.17	$	3.82		1,019,167		5.11	$	3.85
$4.08 to $6.63		2,051,500		6.54	$	4.74		165,000		2.48	$	4.18

		11,478,334		4.89	$	2.95		5,844,819		3.87	$	2.41

Summary of Stock Options Awards Based on Certain Assumptions

Assumptions used during the years were as follows:


	December 31, 2019			December 31, 2018
Risk free interest rate		1.51% to 2.53	%		2.09% to 2.88	%
Expected term		4.5 years			0 to 7 years
Expected volatility		75.5	%		82	%
Expected dividend yield		—	%		—	%
Expected forfeiture rate		—	%		—	%

Summary of Restricted Stock Unit Activity

Restricted stock unit activity during 2019 was as follows:


	2019
	Number of Restricted Stock Units		Weighted Average Grant Date Fair Value
Nonvested balance at beginning of year		—	$	—
Granted		352,500		4.64
Vested		—		—
Forfeited		—		—

Nonvested balance at end of year		352,500	$	4.64

Quarterly Financial Information (unaudited) (Tables)

12 Months Ended

Dec. 31, 2019

Quarterly Financial Information Disclosure [Abstract]

Schedule of Quarterly Financial Information

The following table presents unaudited supplemental quarterly financial information for the years ended December 31, 2019 and 2018:


	Quarter Ended
	March 31, 2019			June 30, 2019		September 30, 2019		December 31, 2019
Revenues	$	12,448,438		$	28,837,900	$	30,897,444	$	30,122,555
Income (loss) from operations	$	(987,769	)	$	10,959,189	$	13,845,152	$	8,006,687
Net income (loss)	$	(644,503	)	$	10,959,948	$	13,630,179	$	7,929,713
Net income (loss) per share – basic	$	(0.01	)	$	0.11	$	0.13	$	0.08
Net income (loss) per share – diluted	$	(0.01	)	$	0.10	$	0.13	$	0.07


	Quarter Ended
	March 31, 2018			June 30, 2018			September 30, 2018			December 31, 2018
Revenues	$	—		$	—		$	—		$	500,000
Loss from operations	$	(5,933,440	)	$	(6,335,855	)	$	(8,182,603	)	$	(14,843,267	)
Net loss	$	(5,699,892	)	$	(5,965,140	)	$	(7,838,873	)	$	(14,499,609	)
Net loss per share – basic and diluted	$	(0.06	)	$	(0.06	)	$	(0.08	)	$	(0.14	)

Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, shares in Millions	12 Months Ended
	Dec. 31, 2019 USD ($) Securities Segment $ / shares shares	Dec. 31, 2018 USD ($) $ / shares shares
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Maximum maturity period of cash and cash equivalent	three months
Minimum amortization period of compensation cost on straight line basis	1 year
Maximum Amortization Period Of Compensation Cost On Straight Line Basis	5 years
Stock option exercise price range, Minimum \| $ / shares	$ 0.79	$ 0.79
Stock option exercise price range, Maximum \| $ / shares	$ 4.20	$ 4.64
Lease Expiration Date	Nov. 30, 2022
Trading Securities, Realized Gain (Loss)	$ 80,045
Trading Securities Sales		$ 0
Potential equivalent common stock excluded \| shares	4.6	10.5
Number of trading securities \| Securities	0
Number of Reportable Segments \| Segment	1
Statutory rate	21.00%	21.00%
Generic Equivalent Commercially Sold [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Potential unearned milestone payment to be received	$ 2,000,000
Collaborative Arrangement Product Agreement [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Upfront license fees	$ 0	$ 500,000
U.S. federal corporate tax rate [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Statutory rate	21.00%
Furniture and Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	5 years
Other Income, Net [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Unrealized gain(loss),trading securities	$ 0	$ (29,430)
Minimum [Member] \| Computer Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	3 years
Minimum [Member] \| Leasehold Improvements [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	4 years
Maximum [Member] \| Computer Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	5 years
Maximum [Member] \| Leasehold Improvements [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	7 years

Basis of Presentation and Significant Accounting Policies - Fair Value Measurement Specific to Assets or Liability (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments	$ 0	$ 5,008,243
Short-Term Bond Fund [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments Fair Value Disclosure		26,541,349
U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments Fair Value Disclosure	59,932,200	10,380,864
Investments	5,007,050	5,008,243
Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Money market funds	23,963,617	14,462,087
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] \| Short-Term Bond Fund [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments Fair Value Disclosure		26,541,349
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Money market funds	23,963,617	14,462,087
Significant Other Observable Inputs (Level 2) [Member] \| U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Investments Fair Value Disclosure	59,932,200	10,380,864
Investments	5,007,050	$ 5,008,243
Significant Other Observable Inputs (Level 2) [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Money market funds	0
Significant Other Observable Inputs (Level 3) [Member] \| Money Market Funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Money market funds	$ 0

Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Details) - shares	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Accounting Policies [Abstract]
Basic weighted average common shares outstanding	102,944,316	102,633,884
Effect of dilutive securities:
Common stock issuable upon the exercise of stock options	3,076,620
Diluted weighted average common shares outstanding	106,020,936	102,633,884

Investments - Additional Information (Detail) - USD ($)	12 Months Ended
Investments - Additional Information (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Investments, Debt and Equity Securities [Abstract]
Realized gains losses from available for sale securities	$ 0	$ 0

Investment - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Net Investment Income [Line Items]
Amortized cost	$ 64,929,745	$ 15,409,355
Gross Unrealized Gains	9,505
Gross Unrealized Losses	0	(20,248)
Estimated Fair Value	64,939,250	15,389,107
U.S. Treasuries - ST [Member]
Net Investment Income [Line Items]
Amortized cost		10,382,699
Gross Unrealized Losses		(1,835)
Estimated Fair Value		10,380,864
U.S. Treasuries - LT [Member]
Net Investment Income [Line Items]
Amortized cost	4,999,587	5,026,656
Gross Unrealized Gains	7,463
Gross Unrealized Losses	0	(18,413)
Estimated Fair Value	5,007,050	$ 5,008,243
US Treasury Bond Securities Cash Equivalents [Member]
Net Investment Income [Line Items]
Amortized cost	59,930,158
Gross Unrealized Gains	2,042
Gross Unrealized Losses	0
Estimated Fair Value	$ 59,932,200

Investment - Estimated Fair Values of Available for Sale Securities (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Investments, Debt and Equity Securities [Abstract]
Estimated Fair Value	$ 64,939,250	$ 15,389,107

Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid manufacturing costs	$ 1,526,013
Prepaid insurance	1,263,129	$ 800,261
Prepaid subscriptions fees	501,251	170,552
Prepaid research fees	481,057	358,209
Prepaid commercialization expenses	62,959	17,030
Other	516,665	303,729
Total prepaid expenses and other current assets	$ 4,351,074	$ 1,649,781

Operating Leases - Operating Leases (Detail)	12 Months Ended
Operating Leases - Operating Leases (Detail)	Dec. 31, 2019 USD ($)
Disclosure of Operating Leases [Abstract]
Operating lease cost	$ 296,316

Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail)	12 Months Ended
	Dec. 31, 2019 USD ($)
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$ 329,725
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$ 21,220

Operating Leases -Schedule of Supplemental Balance Sheet related To Lease (Detail)	Dec. 31, 2019 USD ($)
Disclosure of Operating Leases [Line Items]
Operating lease right-of-use assets	$ 793,252
Other current liabilities	300,518
Operating lease liabilities, net of current portion	647,532
Total operating lease liabilities	$ 948,050
Weighted average remaining lease term	2 years 10 months 24 days
Weighted average discount rate	4.81%

Operating Leases -Lessee, Operating Lease, Liability, Maturity (Detail)	Dec. 31, 2019 USD ($)
Disclosure of Operating Leases [Line Items]
2020	$ 339,605
2021	349,788
2022	329,662
Total lease payments	1,019,055
Less imputed interest	(71,005)
Total	$ 948,050

Operating Leases - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Disclosure of Operating Leases [Line Items]
Finance Lease Obligations	$ 0
Lessor, Operating Lease, Option to Extend	1 year
Lessor, Operating Lease, Option to Terminate	1 year
Rent expense		$ 242,155

Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Payables and Accruals [Abstract]
Accrued preclinical and clinical trial expenses	$ 1,183,513	$ 821,633
Accrued professional fees	1,241,526	1,311,061
Accrued compensation and benefits	3,064,645	1,941,449
Accrued license fees	8,751,991	3,000,000
Accrued purchases	1,313,310
Accrued contributions	1,535,000
Operating lease liability	300,518
Accrued variable consideration	884,764
Deferred rent and lease incentive	0	33,408
Income tax payable	1,533,696
Other	172,332	66,436
Current accrued expenses and other liabilities	19,981,295	7,173,987
Lease liability - non-current	647,532
Deferred rent and lease incentive - non-current	0	154,799
Non-current accrued expenses and other liabilities	647,532	154,799
Total accrued expenses and other liabilities	$ 20,628,827	$ 7,328,786

Collaborative Arrangement - Additional Information (Detail) - USD ($)	3 Months Ended	12 Months Ended
	Dec. 31, 2018	Dec. 31, 2019	Dec. 31, 2018
Collaborative Arrangement [Line Items]
Period of collaboration agreement		10 years
Upfront License Fee	$ 500,000		$ 500,000
Expenses In Connection With Collaborative Arrangement		$ 18,842,752	19,919,204
Collaborative Arrangement [Member]
Collaborative Arrangement [Line Items]
Milestone payments		2,000,000
Milestone payments income		0	0
Upfront License Fee		0	500,000
Expenses In Connection With Collaborative Arrangement		$ 65,061	$ 0

Commitments and Contingencies - Additional Information (Detail)	1 Months Ended
	May 21, 2019 USD ($)
Settlement Agreement [Member] \| Other Income [Member]
Commitments [Line Items]
Litigation Settlement Received	$ 100,000

Agreements - Additional Information (Detail) - License Agreement with BioMarin [Member] $ in Millions	12 Months Ended
	Dec. 31, 2019 USD ($)
License Agreement [Line Items]
Date on which strategic collaboration is entered into	Oct. 26, 2012
Royalty agreement period	7 years
Net sales royalty threshold	$ 100
Minimum [Member]
License Agreement [Line Items]
Percentage of royalty on net sales	7.00%
Maximum [Member]
License Agreement [Line Items]
Percentage of royalty on net sales	10.00%

Income Taxes - Schedule of income tax expense (Detail)	12 Months Ended
Income Taxes - Schedule of income tax expense (Detail)	Dec. 31, 2019 USD ($)
Income Tax Disclosure [Abstract]
Current	$ 1,533,696
Deferred	0
Total income tax expense	$ 1,533,696

Income Taxes - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Increase (decrease) in valuation allowance on deferred tax assets	$ (6,800,000)	$ 9,200,000
Net operating loss carryforwards	$ 41,500,000	79,000,000
Net operating loss carryforwards expiration date	Beginning in 2024 and ending in 2037
Tax credit carryforwards expiration date	beginning in 2032 and ending in 2040
Percentage of limited utilization of taxable income per year	80.00%
Interest or penalties accrued		$ 0

Income Taxes - Schedule of Reconciliation of Income Tax Expense (Benefit) Computed at Statutory Federal Income Tax Rate (Detail)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Income Tax Disclosure [Abstract]
Statutory rate	21.00%	21.00%
State tax	6.50%	4.20%
Valuation allowance	(20.90%)	(25.90%)
Federal rate change	0.00%	0.00%
Tax credit	(2.50%)	1.40%
Other	0.50%	(0.70%)
Reconciliation of income tax expense (benefit)	4.60%	0.00%

Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($)	Dec. 31, 2019	Dec. 31, 2018
Components of Deferred Tax Assets [Abstract]
Net operating loss	$ 10,645,128	$ 19,867,591
Start-up costs	12,894,926	13,861,147
Tax credits	14,320,860	12,625,275
Deferred compensation	3,183,767	1,919,434
Inventory	229,050
Other	355,023	109,779
Gross deferred tax asset	41,628,754	48,383,226
Valuation allowance	(41,628,754)	(48,383,226)
Net deferred tax assets	$ 0	$ 0

Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail)	Dec. 31, 2019 Vote $ / shares shares	Dec. 31, 2018 $ / shares shares
Equity [Abstract]
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, par value \| $ / shares	$ 0.001	$ 0.001
Preferred stock, shares outstanding	0	0
Common stock, shares authorized	150,000,000	150,000,000
Common stock, par value \| $ / shares	$ 0.001	$ 0.001
Common stock, shares issued	103,397,033	102,739,257
Common stock, shares outstanding	103,397,033	102,739,257
Number of votes entitled for each share of common stock \| Vote	1

Stockholders' Equity (2016 Shelf Registration Statement) - Additional Information (Detail)	Dec. 23, 2016 USD ($)
2016 Shelf Registration Statement [Member]
Stockholders' Equity [Line Items]
Maximum dollar amount of common stock to be issued under shelf registration statement	$ 33,800,000

Stockholders' Equity (2017 Shelf Registration Statement) - Additional Information (Detail) - USD ($)		12 Months Ended
	Nov. 28, 2017	Dec. 31, 2019	Jul. 12, 2017
Underwritten Public Offering [Member]
Stockholders' Equity [Line Items]
Number of common stock sold in offering	16,428,572
Common stock issued, price per share	$ 3.50
Gross proceeds from issuance of common stock	$ 57,500,000
Offering expenses	$ 3,700,000
2017 Shelf Registration Statement [Member]
Stockholders' Equity [Line Items]
Maximum dollar amount of securities to be issued under shelf registration statement			$ 150,000,000
Value of common stock available for future sale		$ 92,500,000

Stockholders' Equity (Stockholder Rights Plan) - Additional Information (Detail) - $ / shares	Sep. 19, 2016	Sep. 20, 2011	Dec. 31, 2019
Series A Preferred Stock [Member]
Stockholders Equity [Line Items]
Preferred Stock Purchase Price		$ 7.80
Series A Preferred Stock [Member] \| Certificate Of Designation [Member]
Stockholders Equity [Line Items]
Junior participating preferred stock shares issued available for issuance under rights agreement, initial			500,000
Junior participating preferred stock shares issued available for issuance under rights agreement, amended			1,500,000
Stockholder Rights Plan [Member]
Stockholders Equity [Line Items]
Warrants exercise price		$ 7.80
Minimum percentage of outstanding stock acquired by a person or group to trigger Shareholder Rights Plan		17.50%
Stockholders Rights Plan redemption price of right		$ 0.001
Class of warrant or right expiration date	Sep. 20, 2016
Class of warrant or right expiration date, Extended	Sep. 20, 2019

Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 3,824,815	$ 3,550,644
Research and Development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	1,137,596	1,079,230
Selling, General and Administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 2,687,219	$ 2,471,414

Stock Compensation - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	660,998
Proceeds from exercise of stock options	$ 1,116,242	$ 297,563
Common stock unit granted	2,183,500
Stock option contractual term	3 years 10 months 13 days
Expected dividend rate	0.00%	0.00%
Employee [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock unit granted		3,094
Non-cash stock-based compensation expense		$ 15,000
Stock Option [Member] \| Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, vesting period	1 year
Stock option contractual term	5 years
Stock Option [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, vesting period	5 years
Stock option contractual term	7 years
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Non-cash stock-based compensation expense	$ 44,729	$ 0
Two Thousand Eighteen Stock Incentive Plan [Member] \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares reserved for issuance under the Plan	7,500,000
Common stock shares available for future issuance under the Plan	1,596,271
Two Thousand Eighteen Stock Incentive Plan [Member] \| Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, vesting period	3 years
2014 Stock Incentive Plan [Member] \| Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock shares available for future issuance under the Plan	0
Options to Purchase Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	654,332	186,665
Proceeds from exercise of stock options	$ 1,116,242	$ 297,563
Stock option granted, contractual term	7 years	7 years
Common stock unit granted	2,183,500	5,882,500
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan	$ 9,900,000
Expected remaining weighted average vesting period	2 years 3 months 29 days
Non-cash stock-based compensation expense	$ 3,780,086	$ 3,535,647
Expected dividend rate	0.00%
Options to Purchase Common Stock [Member] \| Cashless Basis [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	6,666	0
Shares issued for cashless option exercise	3,444

Stock Compensation - Summary of Stock Option Activity under the Company's Plan (Detail)	12 Months Ended
	Dec. 31, 2019 USD ($) $ / shares shares
Share-based Payment Arrangement [Abstract]
Number of options, Outstanding at beginning of year \| shares	10,532,500
Number of options, Granted \| shares	2,183,500
Number of options, Exercised or released \| shares	(660,998)
Number of options, Forfeited or cancelled \| shares	(511,668)
Number of options, Expired \| shares	(65,000)
Number of options, Outstanding at end of year \| shares	11,478,334
Number of options, Exercisable at end of year \| shares	5,844,819
Weighted average exercise price, Outstanding at beginning of year \| $ / shares	$ 2.54
Weighted average exercise price, Granted \| $ / shares	4.54
Weighted average exercise price, Exercised or released \| $ / shares	1.72
Weighted average exercise price, Forfeited or cancelled \| $ / shares	2.73
Weighted average exercise price, Expired \| $ / shares	3.90
Weighted average exercise price, Outstanding at end of year \| $ / shares	2.95
Weighted average exercise price, Exercisable at end of year \| $ / shares	$ 2.41
Weighted Average Remaining Contractual Term (Years), Outstanding at end of year	4 years 10 months 20 days
Weighted Average Remaining Contractual Term (Years), Exercisable at end of year	3 years 10 months 13 days
Aggregate Intrinsic value, Outstanding at end of year \| $	$ 11,590,899
Aggregate Intrinsic value, Exercisable at end of year \| $	$ 8,084,671

Stock Compensation - Schedule of Other Information Pertaining to Stock Option Activity (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Share-based Payment Arrangement [Abstract]
Weighted-average fair value of granted stock options	$ 2.69	$ 1.93
Total fair value of vested stock options	$ 3,864,995	$ 2,193,294
Total intrinsic value of exercised stock options	$ 1,899,862	$ 274,864

Stock Compensation - Summary of Company's Stock Options Outstanding (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	$ 0.79	$ 0.79
Range of Exercise Prices Upper Range	$ 4.20	$ 4.64
Number Outstanding, Options Outstanding	11,478,334
Weighted Average Remaining Contractual Life (Years), Options Outstanding	4 years 10 months 20 days
Weighted Average Exercise Price, Options Outstanding	$ 2.95
Number Exercisable Options Exercisable	5,844,819
Weighted Average Remaining Contractual Life (Years), Options Exercisable	3 years 10 months 13 days
Weighted Average Exercise Price, Options Exercisable	$ 2.41
$0.79 to $2.17 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	0.79
Range of Exercise Prices Upper Range	$ 2.17
Number Outstanding, Options Outstanding	2,139,000
Weighted Average Remaining Contractual Life (Years), Options Outstanding	3 years 9 months 29 days
Weighted Average Exercise Price, Options Outstanding	$ 1.05
Number Exercisable Options Exercisable	1,757,332
Weighted Average Remaining Contractual Life (Years), Options Exercisable	3 years 8 months 23 days
Weighted Average Exercise Price, Options Exercisable	$ 1.01
$2.18 to $2.43 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	2.18
Range of Exercise Prices Upper Range	$ 2.43
Number Outstanding, Options Outstanding	2,350,000
Weighted Average Remaining Contractual Life (Years), Options Outstanding	5 years 11 months 19 days
Weighted Average Exercise Price, Options Outstanding	$ 2.25
Number Exercisable Options Exercisable	983,324
Weighted Average Remaining Contractual Life (Years), Options Exercisable	5 years 11 months 19 days
Weighted Average Exercise Price, Options Exercisable	$ 2.24
$2.44 to $3.38 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	2.44
Range of Exercise Prices Upper Range	$ 3.38
Number Outstanding, Options Outstanding	2,345,334
Weighted Average Remaining Contractual Life (Years), Options Outstanding	3 years 25 days
Weighted Average Exercise Price, Options Outstanding	$ 2.88
Number Exercisable Options Exercisable	1,919,996
Weighted Average Remaining Contractual Life (Years), Options Exercisable	2 years 5 months 15 days
Weighted Average Exercise Price, Options Exercisable	$ 2.86
$3.39 to $4.07 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	3.39
Range of Exercise Prices Upper Range	$ 4.07
Number Outstanding, Options Outstanding	2,592,500
Weighted Average Remaining Contractual Life (Years), Options Outstanding	5 years 2 months 1 day
Weighted Average Exercise Price, Options Outstanding	$ 3.82
Number Exercisable Options Exercisable	1,019,167
Weighted Average Remaining Contractual Life (Years), Options Exercisable	5 years 1 month 9 days
Weighted Average Exercise Price, Options Exercisable	$ 3.85
$4.08 to $6.63 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Range of Exercise Prices Lower Range	4.08
Range of Exercise Prices Upper Range	$ 6.63
Number Outstanding, Options Outstanding	2,051,500
Weighted Average Remaining Contractual Life (Years), Options Outstanding	6 years 6 months 14 days
Weighted Average Exercise Price, Options Outstanding	$ 4.74
Number Exercisable Options Exercisable	165,000
Weighted Average Remaining Contractual Life (Years), Options Exercisable	2 years 5 months 23 days
Weighted Average Exercise Price, Options Exercisable	$ 4.18

Stock Compensation - Summary of Stock Options Awards Based on Certain Assumptions (Detail)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate, Minimum	1.51%	2.09%
Risk free interest rate, Maximum	2.53%	2.88%
Expected volatility	75.50%	82.00%
Expected dividend yield	0.00%	0.00%
Expected forfeiture rate	0.00%	0.00%
Expected term	4 years 6 months
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term		0 years
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term		7 years

Stock Compensation - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units (RSUs) [Member]	12 Months Ended
	Dec. 31, 2019 $ / shares shares
Schedule Of Restricted Stock Activity [Line Items]
Nonvested balance at beginning of year \| shares	0
Granted \| shares	352,500
Vested \| shares	0
Forfeited \| shares	0
Nonvested balance at end of year \| shares	352,500
Nonvested Weighted Average Grant Date Fair Value balance at beginning of year \| $ / shares	$ 0
Weighted Average Grant Date Fair Value, Granted \| $ / shares	4.64
Weighted Average Grant Date Fair Value, Vested \| $ / shares	0
Weighted Average Grant Date Fair Value, Forfeited \| $ / shares	0
Nonvested Weighted Average Grant Date Fair Value balance at end of year \| $ / shares	$ 4.64

Benefit Plan - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2019	Dec. 31, 2018
Retirement Benefits [Abstract]
Employees contribution of pre-tax annual compensation	15.00%
Discretionary matching contributions of employee contributions of an employee's gross salary	4.00%
Contributions	$ 268,000	$ 123,000

Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Detail) - USD ($)	3 Months Ended								12 Months Ended
	Dec. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Mar. 31, 2019	Dec. 31, 2018	Sep. 30, 2018	Jun. 30, 2018	Mar. 31, 2018	Dec. 31, 2019	Dec. 31, 2018
Quarterly Financial Information Disclosure [Abstract]
Revenues	$ 30,122,555	$ 30,897,444	$ 28,837,900	$ 12,448,438					$ 102,306,337
Revenues					$ 500,000					$ 500,000
Income (Loss) from operations	8,006,687	13,845,152	10,959,189	(987,769)	(14,843,267)	$ (8,182,603)	$ (6,335,855)	$ (5,933,440)	31,823,259	(35,295,165)
Net income (loss)	$ 7,929,713	$ 13,630,179	$ 10,959,948	$ (644,503)	$ (14,499,609)	$ (7,838,873)	$ (5,965,140)	$ (5,699,892)	$ 31,875,337	$ (34,003,514)
Net income (loss) per share - basic	$ 0.08	$ 0.13	$ 0.11	$ (0.01)					$ 0.31	$ (0.33)
Net income (loss) per share – diluted	$ 0.07	$ 0.13	$ 0.10	$ (0.01)					$ 0.30	$ (0.33)
Net loss per share – basic and diluted					$ (0.14)	$ (0.08)	$ (0.06)	$ (0.06)

- Definition

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

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+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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+ Details

- Definition

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

+ References + Details

Stock Compensation - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units (RSUs) [Member]	12 Months Ended
	Dec. 31, 2019 $ / shares shares
Schedule Of Restricted Stock Activity [Line Items]
Nonvested balance at beginning of year \| shares	0
Granted \| shares	352,500
Vested \| shares	0
Forfeited \| shares	0
Nonvested balance at end of year \| shares	352,500
Nonvested Weighted Average Grant Date Fair Value balance at beginning of year \| $ / shares	$ 0
Weighted Average Grant Date Fair Value, Granted \| $ / shares	4.64
Weighted Average Grant Date Fair Value, Vested \| $ / shares	0
Weighted Average Grant Date Fair Value, Forfeited \| $ / shares	0
Nonvested Weighted Average Grant Date Fair Value balance at end of year \| $ / shares	$ 4.64