0001193125-22-077228 | 10-K | XBRL Viewer | Catalyst Pharmaceuticals INC

Consolidated Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current Assets:
Cash and cash equivalents	$ 171,445	$ 130,237
Short-term investments	19,821	10,041
Accounts receivable, net	6,619	5,987
Inventory	7,870	4,651
Prepaid expenses and other current assets	4,351	8,328
Total current assets	210,106	159,244
Operating lease right-of-use asset	3,017	0
Property and equipment, net	959	130
Deferred tax assets, net	23,697	32,971
Deposits	9	9
Total assets	237,788	192,354
Current Liabilities:
Accounts payable	2,768	4,256
Accrued expenses and other liabilities	24,295	18,500
Total current liabilities	27,063	22,756
Operating lease liability, net of current portion	3,894	0
Total liabilities	30,957	22,756
Commitments and contingencies (Note 10)
Stockholders' equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at December 31, 2021 and 2020	0
Common stock, $0.001 par value, 200,000,000 shares authorized; 102,992,913 shares and 103,781,641 shares issued and outstanding at December 31, 2021 and 2020, respectively	103	104
Additional paid-in capital	233,186	223,168
Accumulated deficit	(26,310)	(53,705)
Accumulated other comprehensive income (loss)	(148)	31
Total stockholders' equity	206,831	169,598
Total liabilities and stockholders' equity	$ 237,788	$ 192,354

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
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	200,000,000	200,000,000
Common stock, shares issued	102,992,913	103,781,641
Common stock, shares outstanding	102,992,913	103,781,641

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Revenues:
Total revenues	$ 140,833	$ 119,073	$ 102,306
Operating costs and expenses:
Cost of sales	$ 21,884	$ 17,039	$ 14,759
Cost, Product and Service [Extensible List]	us-gaap:ProductMember	us-gaap:ProductMember	us-gaap:ProductMember
Research and development	$ 16,936	$ 16,497	$ 18,843
Selling, general and administrative	49,628	44,234	36,881
Total operating costs and expenses	88,448	77,770	70,483
Operating income	52,385	41,303	31,823
Other income, net	282	587	1,586
Net income before income taxes	52,667	41,890	33,409
Income tax provision (benefit)	13,185	(33,093)	1,534
Net income	$ 39,482	$ 74,983	$ 31,875
Net income per share:
Basic	$ 0.38	$ 0.72	$ 0.31
Diluted	$ 0.37	$ 0.71	$ 0.30
Weighted average shares outstanding:
Basic	103,379,349	103,512,913	102,944,316
Diluted	107,795,585	106,242,273	106,020,936
Net income	$ 39,482	$ 74,983	$ 31,875
Other comprehensive income:
Unrealized gain (loss) on available-for-sale securities	(179)	22	30
Comprehensive income	39,303	75,005	31,905
Product Revenue Net [Member]
Revenues:
Total revenues	137,997	118,790	102,306
License and other revenue [Member]
Revenues:
Total revenues	$ 2,836	$ 283	$ 0

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Parenthetical) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Statement of Comprehensive Income [Abstract]
Net of tax impact	$ 46	$ 0	$ 0

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Accumulated Deficit [Member]	Accumulated Other Comprehensive Gain (Loss) [Member]
Beginning Balance at Dec. 31, 2018	$ 50,785	$ 103	$ 211,265	$ (160,563)	$ (20)
Beginning Balance (shares) at Dec. 31, 2018		102,739,000
Issuance of stock options for services	3,780		3,780
Exercise of stock options for common stock	1,116	$ 1	1,115
Exercise of stock options for common stock (shares)		658,000
Amortization of restricted stock for services	45		45
Other comprehensive gain (loss)	29				29
Net income	31,875			31,875
Ending Balance at Dec. 31, 2019	87,630	$ 104	216,205	(128,688)	9
Ending Balance (shares) at Dec. 31, 2019		103,397,000
Issuance of stock options for services	5,694		5,694
Exercise of stock options for common stock	758		758
Exercise of stock options for common stock (shares)		282,000
Amortization of restricted stock for services	567		567
Issuance of common stock upon vesting of restricted stock units, net	(56)		(56)
Issuance of common stock upon vesting of restricted stock units, net (Share)		103,000
Other comprehensive gain (loss)	22				22
Net income	74,983			74,983
Ending Balance at Dec. 31, 2020	169,598	$ 104	223,168	(53,705)	31
Ending Balance (shares) at Dec. 31, 2020		103,782,000
Issuance of stock options for services	5,550		5,550
Exercise of stock options for common stock	$ 4,099	$ 1	4,098
Exercise of stock options for common stock (shares)	1,328,936	1,328,000
Amortization of restricted stock for services	$ 523		523
Issuance of common stock upon vesting of restricted stock units, net	(153)		(153)
Issuance of common stock upon vesting of restricted stock units, net (Share)		91,000
Repurchase of common stock (shares)		(2,208,292)
Repurchase of common stock	(12,089)	$ (2)		(12,087)
Other comprehensive gain (loss)	(179)				(179)
Net income	39,482			39,482
Ending Balance at Dec. 31, 2021	$ 206,831	$ 103	$ 233,186	$ (26,310)	$ (148)
Ending Balance (shares) at Dec. 31, 2021		102,993,000

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Operating Activities:
Net income	$ 39,482	$ 74,983	$ 31,875
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
Depreciation	192	92	55
Stock-based compensation	6,073	6,261	3,825
Deferred taxes	9,316	(32,971)
Change in accrued interest and accretion of discount on investments	(5)	(12)	(291)
Reduction in the carrying amount of right-of-use asset	292	793	244
(Increase) decrease in:
Accounts receivable, net	(632)	4,549	(10,537)
Inventory	(3,219)	(2,694)	(1,901)
Prepaid expenses and other current assets and deposits	3,977	(3,977)	(2,701)
Increase (decrease) in:
Accounts payable	(1,488)	138	1,780
Accrued expenses and other liabilities	5,520	(1,209)	12,540
Operating lease liability	864	(919)	(277)
Net cash provided by (used in) operating activities	60,372	45,034	34,612
Investing Activities:
Purchases of property and equipment	(1,021)	(11)	(19)
Purchases of investments	(10,000)	(10,000)	(34,725)
Proceeds from maturities and sales of investments	0	5,000	71,969
Net cash provided by (used in) investing activities	(11,021)	(5,011)	37,225
Financing Activities:
Payment of employee withholding tax related to stock-based compensation	(153)	(56)	0
Proceeds from exercise of stock options	4,099	758	1,116
Repurchase of common stock	(12,089)
Net cash provided by (used in) financing activities	(8,143)	702	1,116
Net increase in cash and cash equivalents	41,208	40,725	72,953
Cash and cash equivalents – beginning of period	130,237	89,512	16,559
Cash and cash equivalents – end of period	171,445	130,237	$ 89,512
Supplemental disclosures of cash flow information:
Cash paid for income taxes	3,000	$ 2,785
Non-cash investing and financing activities:
Operating lease liabilities arising from obtaining right-of-use assets	$ 3,309

Organization and Description of Business

12 Months Ended

Dec. 31, 2021

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 commercial-stage biopharmaceutical company focused on

in-licensing,

developing and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge,

best-in-class

medicines for rare diseases. 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 Lambert-Eaton Myasthenic Syndrome (“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.

On August 6, 2020, the Company announced that Canada’s national healthcare regulatory agency, Health Canada, had approved FIRDAPSE

for the treatment of patients in Canada with LEMS. On October 28, 2020, the Company launched FIRDAPSE

in Canada for the treatment of patients with LEMS through a license and supply agreement with KYE Pharmaceuticals.

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 offerings of its securities and from revenues from sales of its product. See Note 13 (Stockholders’ Equity).

Capital Resources

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

The Company may raise 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 drug 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.

Risks and Uncertainties

There are numerous aspects of the coronavirus

(COVID-19)

pandemic that have adversely affected the Company’s business since the beginning of the pandemic. The Company closely monitors the impact of the pandemic on all aspects of its business and takes steps, wherever possible, to lessen those impacts. However, the Company is unable to predict the impact that the coronavirus pandemic will have on its business in future periods.

Basis of Presentation and Significant Accounting Policies

12 Months Ended

Dec. 31, 2021

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 exceed federally insured limits.

INVESTMENTS.

The Company invests in high credit-quality instruments in order to obtain higher yields on its cash available for investments. At December 31, 2021 and 2020, investments consisted of short-term bond funds and U.S. Treasuries. Such investments are not insured by the Federal Deposit Insurance Corporation.

The short-term bond funds and U.S. Treasuries held at December 31, 2021 are classified as

available-for-sale

securities. The short-term bond funds are classified as current assets, which reflects management’s intention to use the proceeds from the sale of these investments to fund the Company’s operations, as necessary. The Company classifies U.S. Treasuries with stated maturities of greater than three months and less than one year in short-term investments, U.S Treasuries with stated maturities greater than one year are classified as

non-current

investments in its consolidated balance sheets. There are no

non-current

investments as of December 31, 2021 and 2020.

The Company records

available-for-sale

securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in other income, net 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. 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 as a result of a credit loss. The Company considers various factors in determining whether to recognize an allowance for credit losses 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. If the unrealized loss of an

available-for-sale

debt security is determined to be a result of a credit loss the Company would recognize an allowance and the corresponding credit loss would be included in the consolidated statements of operations and comprehensive income. The Company has not recorded an allowance for credit loss on its

available-for-sale

securities. See Note 3 (Investments).

ACCOUNTS RECEIVABLE, NET.

Accounts receivable is recorded net of customer allowance for distribution fees, trade discounts, prompt payment discounts, chargebacks and expected credit losses. Allowances for distribution fees, trade discounts, prompt payment discounts and chargebacks are based on contractual terms. The Company estimates the allowance for expected credit losses based on existing contractual payment terms, actual payment patterns of its customers and individual customer circumstances. At December 31, 2021 and 2020, the Company determined that an allowance for expected credit losses 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. Inventories consist of raw materials,

work-in-process

and finished goods. Costs to be capitalized as inventories primarily include third party manufacturing costs and other overhead costs. Cost is determined using a standard cost method, which approximates actual cost, and assumes a

first-in,

first out (FIFO) flow of goods. 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. 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.

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 manufacturing, prepaid tax, prepaid insurance, prepaid subscription fees, prepaid research fees, prepaid commercialization expenses, amounts due from collaborative and license arrangements and prepaid conference and travel expenses. 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

less accumulated depreciation.

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 five to ten 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, 2021 and 2020, 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 (in thousands)
	Balances as of December 31, 2021		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	$	10,990	$	10,990	$	—	$	—

U.S. Treasuries	$	140,995	$	140,995	$	—	$	—

Short-term investments:
Short-term bond funds	$	19,821	$	19,821	$	—	$	—

	Balances as of December 31, 2020		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	$	15,674	$	15,674	$	—	$	—

U.S. Treasuries	$	104,994	$	—	$	104,994	$	—

Short-term investments:
Short-term bond funds	$	10,041	$	10,041	$	—	$	—

OPERATING LEASES.

The Company determines 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 lease does 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 term includes options to extend or terminate the lease, however, these options are not considered in the lease term as the Company 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 a lease agreement with lease and

non-lease

components, which are accounted for separately.

SHARE REPURCHASES.

In March

2021

, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $

million of the Company’s common stock.

The Company accounts for share repurchases by charging the excess of the repurchase price over the repurchased common stock’s par value entirely to accumulated deficit. All repurchased shares are retired

and

become authorized but unissued shares. The Company accrues

for the shares purchased under the share repurchase plan based on the trade date. The Company may terminate or modify its share repurchase program at any time.

REVENUE RECOGNITION.

Product Revenues:

The Company recognizes revenue when its customer obtains title of the promised goods, in an amount that reflects the consideration to which the Company expects to be entitled in exchange for these goods. 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”), which 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 Accounting Standards Codification (“ASC”) Topic 606 – Revenue from Contracts with Customers (“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 assesses the goods or services promised within each contract and determines those that are performance obligations by assessing 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 collaborative and license agreements. Collaborative and license agreement payments may include nonrefundable fees at the inception of the agreements, contingent payments for specific achievements designated in the agreements, and/or net profit-sharing payments on sales of products resulting from the collaborative and license arrangements. For a complete discussion of accounting for collaborative and licensing arrangements, see Revenues from Collaboration and Licensing Arrangements below.

Product Revenue, Net:

The Company sells FIRDAPSE

to 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 or upon dispense to patient). 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 years ended December 31, 2021, 2020 and 2019.

During the years ended December 31, 2021, 2020 and 2019, principally all of the Company’s sales of FIRDAPSE

in the United States were to its Customer.

Reserves for Variable Consideration:

Revenue from product sales is 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, prompt payment discounts, 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 contemplates 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, 2021 and, therefore, the transaction price was not reduced further during the years ended December 31, 2021, 2020 and 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, transactional 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. However, if the Company has determined such services received 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 consolidated statement of operations and comprehensive income through December 31, 2021, 2020 and 2019, as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Prompt Payment Discounts:

The Company provides its Customer with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The prompt payment discount reserve is based on actual invoice sales and contractual discount rates. Reserves for prompt payment discounts are included in 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 third-party vendor 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. 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. These payments are considered payable to the third-party vendor 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. 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 primarily 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 FIRDAPSE

free of charge 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 FIRDAPSE

free of charge 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 payor despite having health insurance, to the extent allowed by 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 and comprehensive income.

Revenues from Collaboration and Licensing Arrangements:

The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration, (“Topic 808”) to assess whether such arrangements, or transactions between arrangement participants, involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities or are more akin to a vendor-customer relationship. In making this evaluation, the Company considers whether the activities of the collaboration are considered to be distinct and deemed to be within the scope of the collaborative arrangement guidance or if they are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement.

For elements of collaboration arrangements that are not accounted for pursuant to guidance in Topic 606, an appropriate recognition method is determined and applied consistently, generally by analogy to the revenue from contracts with customers guidance.

The Company evaluates the performance obligations promised in the contract that are based on goods and services that will be transferred to the customer and determines whether those obligations are both (i) capable of being distinct and (ii) distinct in the context of the contract. Goods or services that meet these criteria are considered distinct performance obligations. The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration or variable consideration.

The agreements provide for milestone payments upon achievement of development and regulatory events. The Company accounts for milestone payments as variable consideration in accordance with Topic 606. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of potential transaction price and the likelihood that the transaction price will be received. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and, if so, these options are considered performance obligations.

After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the overall transaction price is allocated to the performance obligations based on the same methodology used at contract inception.

The Company recognizes sales-based royalties or net profit-sharing when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty or net profit-sharing has been allocated has been satisfied.

Payments to and from the collaborator are presented in the statement of operations based on the nature of the Company’s business operations, the nature of the arrangement, including the contractual terms, and the nature of the payments.

Refer to Note 9 (Collaborati

and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements

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.

ADVERTISING EXPENSE.

In connection with the FDA approval and commercial launch of FIRDAPSE

in 2019, the Company began to incur advertising costs. Advertising costs are expensed as incurred. The company incurred $2.9 million, $2.5 million and $3.3 million in advertising costs during the years ended December 31, 2021, 2020 and 2019, respectively, which are included in selling, general and administrative expenses in the Company’s consolidated statement of operations and comprehensive income.

STOCK-BASED COMPENSATION.

The Company recognizes expense in the consolidated statements of operations for the

grant date

fair value of all stock-based payments to employees, directors 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 three 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 SPs. Therefore, its distributor and SPs account for principally 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 expected credit loss 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 11 (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 2018. 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.

COMPREHENSIVE INCOME.

U.S. GAAP requires that all components of comprehensive income be reported in the financial statements in the period in which they are recognized. Comprehensive income is net income, plus certain other items that are recorded directly into stockholders’ equity. The Company’s comprehensive income is shown on the consolidated statements of operations and comprehensive income for the years ended December 31, 2021, 2020 and 2019, and is comprised of net unrealized gains (losses) on the Company’s

available-for-sale

securities.

NET INCOME PER COMMON SHARE.

Basic net income per share is computed by dividing net income 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 per common share is computed by dividing net income 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,
	2021		2020		2019


Basic weighted average common shares outstanding		103,379,349		103,512,913		102,944,316
Effect of dilutive securities		4,416,236		2,729,360		3,076,620

Diluted weighted average common shares outstanding		107,795,585		106,242,273		106,020,936

Outstanding common stock equivalents totaling approximately 4.3 million, 7.1 million and 4.6 million, were excluded from the calculation of diluted net income per common share for the years ended December 31, 2021, 2020 and 2019, respectively, as their effect would be anti-dilutive. Potentially dilutive options to purchase common stock as of December 31, 2021, 2020 and 2019 had exercise prices ranging from $0.79 to $4.64, $0.79 to $3.95 and $0.79 to $4.20, respectively.

SEGMENT INFORMATION.

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

drug

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 December 2019, the FASB issued ASU

2019-12,

Income Taxes: Simplifying the Accounting for Income Taxes

, a new standard intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new standard also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a

step-up

in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within, with early adoption permitted. Adoption of the standard requires certain changes to be made prospectively, with some changes to be made retrospectively. The Company adopted the new standard on January 1, 2021. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Investments

12 Months Ended

Dec. 31, 2021

Investments, Debt and Equity Securities [Abstract]

Investments

3.	Investments.

Available-for-sale

investments by security type were as follows (in thousands):


	Estimated Fair Value		Gross Unrealized Gains		Gross Unrealized Losses			Amortized Cost
At December 31, 2021:
U.S. Treasuries - Cash equivalents	$	140,995	$	2	$	—		$	140,993
Short-term bond funds		19,821		—		(196	)		20,017

Total	$	160,816	$	2	$	(196	)	$	161,010

At December 31, 2020:
U.S. Treasuries - Cash equivalents	$	104,994	$	2	$	—		$	104,992
Short-term bond funds		10,041		29		—			10,012

Total	$	115,035	$	31	$	—		$	115,004

There were no realized gains or losses from

available-for-sale

securities for the years ended December 31, 2021, 2020 or 2019.

The estimated fair values of

available-for-sale

securities at December 31, 2021, by contractual maturity, are summarized as follows (in thousands):


	2021
Due in one year or less	$	160,816

Inventory

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Inventory

4.	Inventory .

Inventory consists of the following (in thousands):


	December 31, 2021		December 31, 2020
Raw materials	$	1,769	$	—
Work-in-process		5,172		3,555
Finished goods		929		1,096

Total inventory	$	7,870	$	4,651

Prepaid Expenses and Other Current Assets

12 Months Ended

Dec. 31, 2021

Text Block [Abstract]

Prepaid Expenses and Other Current Assets

5.	Prepaid Expenses and Other Current Assets.

Prepaid expenses and other current assets consist of the following as of December 31 (in thousands):


	2021		2020
Prepaid manufacturing costs	$	307	$	3,328
Prepaid tax		564		1,368
Prepaid insurance		1,213		1,285
Prepaid subscriptions fees		909		729
Prepaid research fees		452		453
Prepaid commercialization expenses		195		199
Due from collaborative and licensing arrangements		105		437
Prepaid conference and travel expenses		279		83
Other		327		446

Total prepaid expenses and other current assets	$	4,351	$	8,328

Operating Leases

12 Months Ended

Dec. 31, 2021

Operating Lease, Lease Income [Abstract]

Operating Leases

6.	Operating Leases.

The Company has an operating lease agreement for its corporate office. The lease includes an option to extend the lease for up to

years and options to terminate the lease within 6 and 7.6 years. There are no obligations under finance leases.

The Company entered into an agreement in May 2020 that amended its lease for its office facilities. Under the amended lease, the Company’s leased space increased from approximately 7,800 square feet of space to approximately 10,700 square feet of space. The amended lease commenced in March 2021 when construction of the asset was completed and space became available for use. Consequently, the Company recorded the effects of the amended lease during Q1 2021.

The components of lease expense were as follows (in thousands):


	For the Year Ended December 31, 2021
Operating lease cost	$	379

Supplemental cash flow information related to lease was as follows (in thousands):


	December 31, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	109
Right-of-use assets obtained in exchange for lease obligations:
Operating lease	$	80

Supplemental balance sheet information related to lease was as follows (in thousands


	December 31, 2021

Operating lease right-of-use assets	$	3,017
Other current liabilities	$	308
Operating lease liabilities, net of current portion		3,894
Total operating lease liabilities	$	4,202

As of December 31, 2021, the weighted average remaining lease term was 9.3 years and the weighted average discount rate used to determine the operating lease liabilities was 4.51%.

Remaining payments of lease liabilities as of December 31, 2021 were as follows (in thousands):



2022	$	492
2023		506
2024		522
2025		537
2026		553
Thereafter		2,597
Total lease payments		5,207
Less: imputed interest		(1,005	)
Total	$	4,202

Rent expense was $0.4 million, $0.3 million and $0.3 million for the years ended December 31, 2021, 2020 and 2019.

Property and Equipment, Net

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

7.	Property and Equipment, N et.

Property and equipment, net consists of the following (in thousands):


	December 31, 2021			December 31, 2020
Computer equipment	$	51		$	51
Furniture and equipment		203			242
Leasehold improvements		980			177
Less: Accumulated depreciation		(275	)		(340	)
Total property and equipment, net	$	959		$	130

Accrued Expenses and Other Liabilities

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Accrued Expenses and Other Liabilities

8.	Accrued Expenses and Other Liabilities.

Accrued expenses and other liabilities consist of the following as of December 31 (in thousands):


	2021		2020
Accrued preclinical and clinical trial expenses	$	659	$	585
Accrued professional fees		2,391		1,884
Accrued compensation and benefits		4,035		3,991
Accrued license fees		12,819		10,373
Accrued purchases		2,045		258
Accrued contributions		—		310
Operating lease liability		308		29
Accrued variable consideration		1,716		964
Accrued income tax		79		—
Other		243		106
Current accrued expenses and other liabilities		24,295		18,500
Lease liability – non-current		3,894		—
Non-current accrued expenses and other liabilities		3,894		—
Total accrued expenses and other liabilities	$	28,189	$	18,500

Collaborative and Licensing Arrangements

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Collaborative and Licensing Arrangements

9.	Collaborative and Licensing Arrangements.

Endo

In December 2018, the Company entered into a collaboration and license agreement (Collaboration) with 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 (Par). 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 Company evaluated the license agreement with Endo to determine whether it is a collaborative arrangement for purposes of Topic 808. As the Company shares in the significant risks and rewards, the Company has concluded that this is a collaborative arrangement. As developing a final finished dosage form of a generic product in exchange for consideration is not an output of the Company’s ongoing activities, Endo does not represent a contract with a customer. However, Topic 808 does not provide guidance on the recognition of consideration exchanged or accounting for the obligations that may arise between the parties. The Company concluded that ASC Topic 730,

Research and Development

, should be applied by analogy to payments between the parties during the development activities and Topic 606

for the milestone payment and sharing of defined net profits upon commercialization.

The collaborative agreement included a nonrefundable upfront license fee that was recognized upon receipt following execution of the collaborative arrangement for vigabatrin tablets.

The collaborative agreement provides for a $

2.0

million milestone payment on the commercial launch of the product by Par. As of December 31, 2021, 2020 and 2019,

milestone payments have been earned.

There were no revenues from this collaborative arrangement for the years ended December 31, 2021, 2020 or 2019. Total expenses incurred, net, in connection with the collaborative agreement for the years ended December 31, 2021, 2020 and 2019 were approximately $45,000, $4,200 and $65,000, respectively. These expenses have been included in research and development expenses in the accompanying consolidated statements of operations and comprehensive income.

KYE Pharmaceuticals Inc.

In August 2020, the Company entered into a collaboration and license agreement with KYE Pharmaceuticals Inc. (KYE), for the commercialization of FIRDAPSE

in Canada.

Under the agreement, Catalyst granted KYE an exclusive license to commercialize and market FIRDAPSE

in Canada. KYE assumes all selling and marketing costs under the collaboration, while the Company is responsible for supply of FIRDAPSE

based on the collaboration partner’s purchase orders.

Under the terms of the agreement, the Company will receive an

up-front

payment, received payment upon transfer of Marketing Authorization and delivery of commercial product, received payment for supply of FIRDAPSE

, will receive milestone payments, and a sharing of defined net profits upon commercialization from KYE consisting of a

mid-double-digit

percent of net sales of FIRDAPSE

This agreement is in form identified as a collaborative agreement and the Company has concluded for accounting purposes that it also represents a contract with a customer. This is because the Company grants to KYE a license and provides supply of FIRDAPSE

in exchange for consideration, which are outputs of the Company’s ongoing activities. Accordingly, the Company has concluded that this collaborative arrangement will be accounted for pursuant to Topic 606.

The collaborative agreement included a nonrefundable upfront license fee that was recognized upon transfer of the license based on a determination that the right is provided as the intellectual property exists at the point in time in which the license is granted.

Under the arrangement, the Company will receive profit-sharing reports within nine days after quarter end from KYE. Revenue from sales of FIRDAPSE

by KYE will be recognized in the quarter in which the sales occurred.

Revenues from the arrangement with KYE for the year ended December 31, 2021 were not material. Revenue is included in product revenue, net and license and other revenue in the accompanying consolidated statements of operations and comprehensive income. Expenses incurred, net have been included in selling, general and administrative expenses in the accompanying consolidated statements of operations and comprehensive income.

DyDo Pharma, Inc.

On June 28, 2021, the Company entered into a license agreement with DyDo Pharma, Inc. (DyDo), for the development and commercialization of FIRDAPSE

in Japan.

Under the agreement, DyDo has joint rights to develop FIRDAPSE

, and exclusive rights to commercialize the product, in Japan. DyDo is responsible for funding all clinical, regulatory, marketing and commercialization activities in Japan, while the Company is responsible for clinical and commercial supply based on purchase orders, as well as providing support to DyDo in its efforts to obtain regulatory approval for the product from the Japanese regulatory authorities.

Under the terms of the agreement, the Company has earned an

up-front

payment and may earn further development and sales milestones for FIRDAPSE

, as well as revenue on product supplied to DyDo.

The Company has concluded that this license agreement will be accounted for pursuant to Topic 606. The agreement included a nonrefundable upfront license fee that was recognized upon the effective date of the agreement as the intellectual property exists at the point in time in which the right to the license is granted. The Company determined the granting of the right to the license is distinct from the supply of FIRDAPSE

and represents a separate performance obligation in the agreement.

The agreement includes milestones that are considered a sales-based royalty in which the license is deemed to be the predominant item to which these milestones relate. Revenue will be recognized when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty has been allocated has been satisfied. Additionally, the agreement includes regulatory milestone payments which represent variable consideration, and due to uncertainty are fully constrained and only recognized when the uncertainty is subsequently resolved. For clinical and commercial supply of the product, the Company will recognize revenue when the Customer obtains control of the Company’s product, which will occur at a point in time which is generally at time of shipment.

Revenue from the arrangement with DyDo for the year ended December 31, 2021, was approximately $2.9 million, relating to the $2.7 million nonrefundable upfront license fee included in license and other revenue in the accompanying consolidated statements of operations and comprehensive income and the sale of FIRDAPSE

of $0.2 million included in product revenue, net within the accompanying consolidated statements of operations and comprehensive income. As of December 31, 2021, no milestone payments have been earned.

Commitments and Contingencies

12 Months Ended

Dec. 31, 2021

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

10.	Commitments and Contingencies.

In May 2019, the FDA approved a New Drug Application (NDA) for Ruzurgi

, another version of amifampridine

(3,4-DAP),

for the treatment of pediatric LEMS patients (ages 6 to under 17). While the NDA for Ruzurgi

only covers pediatric patients, the Company believes that Ruzurgi

is regularly being prescribed

off-label

to adult LEMS patients. The Company also believes that the FDA’s approval of Ruzurgi

violated the Company’s 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, and Jacobus Pharmaceuticals (Jacobus) intervened in the case. The Company’s complaint, which was filed in the federal district court for the Southern District of Florida, alleged 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 the Company’s 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 sought an order setting aside the FDA’s approval of Ruzurgi

On July 30, 2020, the Magistrate Judge considering the Company’s lawsuit against the FDA filed a Report and Recommendation in which she recommended to the District Judge handling the case that she grant the FDA’s and Jacobus’ motions for summary judgment and deny the Company’s motion for summary judgment. On September 29, 2020, the District Judge adopted the Report and Recommendation of the Magistrate Judge, granted the FDA’s and Jacobus’ motions for summary judgment, and dismissed the case. The Company appealed the District Court’s decision to the U.S. Circuit Court of Appeals for the 11th Circuit. By early 2021, the case was fully briefed, and oral argument was held in March 2021.

On September 30, 2021, a three-judge panel of 11th Circuit judges issued a unanimous decision overturning the District Court’s decision. The appellate court adopted the Company’s argument that the FDA’s approval of Ruzurgi

violated the Company’s rights to Orphan Drug Exclusivity and remanded the case to the District Court with orders to enter summary judgment in the Company’s favor. In November 2021, Jacobus filed a motion seeking rehearing of the case from the full 11th Circuit, which motion was denied in January 2022. Further, in January 2022, Jacobus filed motions with both the 11th Circuit and the U.S. Supreme Court seeking a stay of the 11th Circuit’s ruling indicating that it would seek a review of the 11th Circuit’s decision from the U.S. Supreme Court. Both stay motions were denied, and on January 28, 2022, the 11th Circuit issued a mandate directing the District Court to enter summary judgment in the Company’s favor. The District Court entered that order on January 31, 2022. On February 1, 2022, the FDA informed Jacobus that, consistent with the Court of Appeals for the 11th Circuit’s September 30, 2021, decision in favor of Catalyst, the final approval of the Ruzurgi

NDA was switched to a tentative approval until the

7-year

orphan-drug exclusivity (ODE) for Firdapse

has expired. See Note 16.

There can be no assurance as to whether Jacobus will seek U.S. Supreme Court review of the 11th Circuit’s decision, whether the U.S. Supreme Court will agree to hear the case, or whether, if the U.S. Supreme Court agrees to hear the case, Jacobus’ appeal to overturn the decision of the 11th Circuit will be successful. Similarly, there can be no assurance as to whether the U.S. Congress will pass, and the President will sign, legislation effectively overturning the 11th Circuit’s decision, and whether or not such legislation, if passed, would have any retroactive effect allowing the FDA to reinstate the approval of Ruzurgi

On August 10, 2020, Health Canada issued a Notice of Compliance (NOC) to Medunik for Ruzurgi

for the treatment of LEMS. The Company initiated a legal proceeding in Canada seeking judicial review of Health Canada’s decision to issue the NOC for Ruzurgi

as incorrect and unreasonable under Canadian law. Data protection, per Health Canada regulations, is supposed to prevent Health Canada from issuing a NOC to a drug that directly or indirectly references an innovative drug’s data, for eight years from the date of the innovative drug’s approval. The Ruzurgi

Product Monograph clearly references pivotal nonclinical carcinogenicity and reproductive toxicity data for amifampridine phosphate developed by the Company. As such, the Company believes that its data was relied upon to establish the nonclinical safety profile of Ruzurgi

needed to meet the standards of the Canadian Food and Drugs Act.

On June 3, 2021, the Company announced a positive decision in this proceeding that quashed the NOC previously issued for Ruzurgi

and remanded the matter to the Minister of Health to redetermine its decision to grant marketing authorization to Ruzurgi

in spite of FIRDAPSE

’s data protection rights. However, on June 28, 2021, the Company announced that Health Canada had

re-issued

a NOC for Ruzurgi

, once again allowing the product to be marketed in Canada for patients with LEMS. As a result, in early July 2021, the Company, along with its partner KYE, filed a second suit against Health Canada to overturn their most recent decision. That case was fully briefed in late 2021, with oral argument held in early December, and the Company is currently awaiting a decision from the court. There can be no assurance as to the outcome of this proceeding.

See Note 16.

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, 2021

Text Block [Abstract]

Agreements

11.	Agreements.

LICENSE AGREEMENT FOR 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 for the duration of any regulatory exclusivity within a territory and 3.5% for territories in any calendar year in territories without regulatory exclusivity.

On May 29, 2019, the Company and BioMarin entered into an amendment to the Company’s 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 to our licensor 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.

In 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, 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, 2021

Income Tax Disclosure [Abstract]

Income Taxes

12.	Income Taxes.

The Company is subject to income taxes in the U.S. federal jurisdiction and various states jurisdictions.

The income tax expense (benefit) for the years ended December 31, 2021, 2020, and 2019 consists of (in thousands):


	2021		2020			2019
Current	$	3,869	$	(122	)	$	1,534
Deferred		9,316		(32,971	)		—

	$	13,185	$	(33,093	)	$	1,534

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:


	2021			2020			2019
Statutory rate		21.0	%		21.0	%		21.0	%
State tax		3.4	%		2.2	%		6.5	%
Valuation allowance		—			(99.4	)%		(20.9	)%
Executive compensation limitation		1.1	%		—			0.1	%
Tax credit		(0.6	)%		(2.4	)%		(2.5	)%
Other		0.1	%		(0.4	)%		0.4	%

		25.0	%		(79.0	)%		4.6	%

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/(liabilities) as of December 31, 2021 and 2020 are as follows (in thousands):


	2021			2020
Deferred tax assets:
Net operating loss	$	1,218		$	2,320
Start-up costs		10,403			11,203
Tax credits		8,516			15,616
Deferred compensation		3,959			3,889
Inventory		163			212
Operating lease liability		1,003			—
Other		—			130
Total deferred tax assets		25,262			33,370
Deferred tax liabilities:
Prepaid expenses		(455	)		(399	)
Right-of use asset		(936	)		—
Other		(174	)		—

Total deferred tax liabilities		(1,565	)		(399	)

Deferred tax assets, net	$	23,697		$	32,971

The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. As of December 31, 202

, the Company determined that there is sufficient positive evidence to conclude that it is more likely than not that the above deferred taxes of approximately $24

million are realizable. The Company released the full valuation allowance for deferred tax assets including net operating loss and tax credit carryover as of December 31, 2020.

At December 31, 2021 and 2020 respectively, the Company had federal net operating loss carryforwards of approximately $0 million and $3 million to reduce future taxable income. The federal net operating loss carryforwards

were

utilized

in 2020

. Additionally, at December 31, 2021 and 2020, respectively, the Company had state net operating loss carryforwards of approximately $28 million and $42 million available to reduce future Florida taxable income. The state net operating loss carryforwards will expire at various dates beginning in 2034.

During 2020, the Company completed an analysis to determine whether, as a result of prior ownership changes, the utilization of certain net operating loss and orphan drug tax credit carryforwards would be subject to annual limitations under Sections 382 and 383 of the Internal Revenue Code and similar state provisions. In this analysis, the Company determined that the total net operating loss and orphan drug tax credit carryforwards are fully utilizable. Thus, the deferred tax assets were adjusted accordingly.

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 orphan drug credit carryforwards will expire at various dates beginning in 2035.

An immaterial amount of interest and no penalties were accrued through December 31, 2021. No interest or penalties were accrued through December 31, 2020. The Company’s policy is to recognize any related interest or penalties in income tax expense. The Company is not currently under income tax examinations by any tax authorities.

- Definition

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

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+ Details

Stockholders' Equity

12 Months Ended

Dec. 31, 2021

Equity [Abstract]

Stockholders' Equity

13.	Stockholders’ Equity.

Preferred Stock

The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share, at December 31, 2021 and 2020. No shares of preferred stock were outstanding at December 31, 2021 and 2020.

Common Stock

The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At December 31, 2021 and 2020, 102,992,913 and 103,781,641 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.

Share Repurchases

In March 2021, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $40 million of the Company’s common stock, pursuant to a repurchase plan under Rule

10b-18

of the Securities Act. The share repurchase program commenced on March 22, 2021 and, during the year ended December 31, 2021, 2,208,292 shares were repurchased for an aggregate purchase price of approximately $12.1 million ($5.47 average price per share).

2020 Shelf Registration Statement

On July 23, 2020, the Company filed a shelf registration statement with the SEC to sell up to $

200

million of common stock, preferred stock, warrants to purchase common stock, debt securities and units consisting of one or more of such securities (the “2020 Shelf Registration Statement”). The 2020 Shelf Registration Statement (file no.

333-240052)

was declared effective by the SEC on July 31, 2020. As of the date of this report, no offerings have been completed under the Company’s 2020 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 entitled 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 traded automatically with the common stock and were not exercisable until a person or group had become an “acquiring person” by acquiring 17.5% or more of the Company’s outstanding common stock, or a person or group commenced, or publicly announced a tender offer that would 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 had become an acquiring person, each Right would 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 had 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 was extended 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 further extending the outside expiration date of the rights plan to September 20, 2022.

On November 12, 2021, the Board of Directors terminated the Rights Plan. Despite the termination of the Rights Plan, the Board of Directors reserves the right to take all necessary actions it deems appropriate in the future to protect the interests of all of the Company’s stockholders.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

Stock Compensation

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Stock Compensation

14.	Stock Compensation.

For the years ended December 31, 2021, 2020 and 2019, the Company recorded stock-based compensation expense as follows (in thousands):


	2021		2020		2019
Research and development	$	1,611	$	1,585	$	1,138
Selling, general and administrative		4,462		4,676		2,687

Total stock-based compensation	$	6,073	$	6,261	$	3,825

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, 2021, no shares remain available for future issuance under the 2014 Plan. Under the 2018 Plan, 15,000,000 shares are reserved for issuance and as of December 31, 2021, 4,708,013 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 3 years of continuous service and have contractual terms of 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, 2021, 2020, and 2019, options to purchase 1,328,936, 281,762 and 654,332 shares, respectively, of the Company’s common stock were exercised with gross proceeds to the Company of approximately $4.1 million,

$0.8 million, and $1.1 million, respectively. During the years ended December 31, 2021 and 2020, no options to purchase shares of the Company’s common stock were exercised on a “cashless” basis. 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.

During the years ended December 31, 2021, 2020, and 2019 the Company recorded

non-cash

stock-based compensation expense related to stock options totaling approximately $5.5 million, $5.7 million, and $3.8 million, respectively.

During the years ended December 31, 2021, 2020, and 2019, the Company granted seven-year options to purchase an aggregate of 2,330,000, 2,715,000 and 2,183,500 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, 2021 is summarized as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at beginning of year		13,393,669		$	3.10
Granted		2,330,000			5.89
Exercised or released		(1,328,936	)		3.09
Forfeited or cancelled		(177,006	)		3.92
Expired		(9,999	)		5.12

Outstanding at end of year		14,207,728		$	3.55		4.15	$	46,168

Exercisable at end of year		9,473,196		$	2.87		3.21	$	36,958

Other information pertaining to stock option activity during the years ended December 31, 2021, 2020, and 2019 was as follows:


	2021		2020		2019
Weighted–average fair value of granted stock options	$	3.24	$	2.33	$	2.69
Total fair value of vested stock options (in thousands)	$	6,421	$	5,312	$	3,865
Total intrinsic value of exercised stock options (in thousands)	$	3,623	$	325	$	1,900

As of December 31, 2021, there was approximately $11.6 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 2.43 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 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 option 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:


	2021		2020		2019
Risk free interest rate		0.34% to 1.18 %		0.24% to 1.64 %		1.51% to 2.53 %
Expected term		4.5 – 4.8 years		4.5 years		4.5 years
Expected volatility		68.6% to 72.8 %		80.5% to 83.7 %		75.5 %
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 2021 and 2020 was as follows:


	2021					2020
	Number of Restricted Stock Units			Weighted Average Grant Date Fair Value		Number of Restricted Stock Units			Weighted Average Grant Date Fair Value
Nonvested balance at beginning of year		235,671		$	4.65		352,500		$	4.64
Granted		—			—		30,000			4.70
Vested		(112,832	)		4.65		(117,495	)		4.64
Forfeited		—			—		(29,334	)		4.64

Nonvested balance at end of year		122,839		$	4.65		235,671		$	4.65

During the year ended December 31, 2019, 352,500 restricted stock units were granted and outstanding and there were no vested or forfeited shares.

During the year ended December 31, 2021, 2020 and 2019, the Company recorded

non-cash

stock-based compensation expense related to restricted stock units totaling $0.5 million, $0.6 million and $0.1 million, respectively.

Benefit Plan

12 Months Ended

Dec. 31, 2021

Retirement Benefits [Abstract]

Benefit Plan

15.	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, 2021, 2020, and 2019, the Company’s matching contributions were approximately $0.5 million, $0.5 million and $0.3 million, respectively.

- Definition

The entire disclosure for retirement benefits.

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+ Details

Subsequent Events

12 Months Ended

Dec. 31, 2021

Subsequent Events [Abstract]

Subsequent Events

16.	Subsequent Events.

Subsequent to year end, in January 2022, Jacobus filed motions with both the 11th Circuit and the U.S. Supreme Court seeking a stay of the 11th Circuit’s ruling indicating that it would seek a review of the 11th Circuit’s decision from the U.S. Supreme Court. Both stay motions were denied, and on January 28, 2022, the 11th Circuit issued a mandate directing the District Court to enter summary judgment in the Company’s favor. The District Court entered that order on January 31, 2022. On February 1, 2022, the FDA informed Jacobus that, consistent with the Court of Appeals for the 11th Circuit’s September 30, 2021, decision in favor of Catalyst, the final approval of the Ruzurgi

NDA was switched to a tentative approval until the

7-year

orphan-drug exclusivity (ODE) for Firdapse

has expired. See Note 10.

Subsequent to year end, on March 11, 2022, the Company announced that it had received a favorable decision from the Canadian court setting aside, for the second time, the decision of Health Canada approving Ruzurgi

for the treatment of LEMS patients. In its ruling, the court determined that the Minister of Health’s approach to evaluating whether FIRDAPSE

’s data deserved protection based on FIRDAPSE

’s status as an innovative drug, which protects by regulation the use of such data as part of a submission seeking an NOC for eight years from approval of the innovative drug, was legally flawed and not supported by the evidence. As a result, the matter has, once again, been remanded to the Minister of Health to redetermine its decision in light of the court’s ruling. See Note 10.

Basis of Presentation and Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

PRINCIPLES OF CONSOLIDATION.

USE OF ESTIMATES

USE OF ESTIMATES.

CASH AND CASH EQUIVALENTS

CASH AND CASH EQUIVALENTS.

INVESTMENTS

INVESTMENTS.

The short-term bond funds and U.S. Treasuries held at December 31, 2021 are classified as

available-for-sale

non-current

investments in its consolidated balance sheets. There are no

non-current

investments as of December 31, 2021 and 2020.

The Company records

available-for-sale

securities. See Note 3 (Investments).

ACCOUNTS RECEIVABLE, NET

ACCOUNTS RECEIVABLE, NET.

INVENTORY

. Inventories are stated at the lower of cost or net realizable value. Inventories consist of raw materials,

work-in-process

first-in,

first out (FIFO) flow of goods. 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

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.

Property and equipment are recorded at cost

less accumulated depreciation.

FAIR VALUE OF FINANCIAL INSTRUMENTS

FAIR VALUE OF FINANCIAL INSTRUMENTS.

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS.


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of December 31, 2021		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	$	10,990	$	10,990	$	—	$	—

U.S. Treasuries	$	140,995	$	140,995	$	—	$	—

Short-term investments:
Short-term bond funds	$	19,821	$	19,821	$	—	$	—

	Balances as of December 31, 2020		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	$	15,674	$	15,674	$	—	$	—

U.S. Treasuries	$	104,994	$	—	$	104,994	$	—

Short-term investments:
Short-term bond funds	$	10,041	$	10,041	$	—	$	—

OPERATING LEASES

OPERATING LEASES.

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease

right-of-use

non-lease

components, which are accounted for separately.

SHARE REPURCHASES

SHARE REPURCHASES.

In March

2021

, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $

million of the Company’s common stock.

and

become authorized but unissued shares. The Company accrues

for the shares purchased under the share repurchase plan based on the trade date. The Company may terminate or modify its share repurchase program at any time.

REVENUE RECOGNITION

REVENUE RECOGNITION.

Product Revenues:

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

in the United States. The Customer subsequently resells FIRDAPSE

Product Revenue, Net:

The Company sells FIRDAPSE

to 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.

During the years ended December 31, 2021, 2020 and 2019, principally all of the Company’s sales of FIRDAPSE

in the United States were to its Customer.

Reserves for Variable Consideration:

Trade Discounts and Allowances:

Prompt Payment Discounts:

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

Product Returns:

Provider Chargebacks and Discounts:

Government Rebates:

Bridge and Patient Assistance Programs:

The Company provides FIRDAPSE

free of charge 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 FIRDAPSE

free of charge for longer periods of time for those who are uninsured or functionally uninsured with respect to FIRDAPSE

Revenues from Collaboration and Licensing Arrangements:

RESEARCH AND DEVELOPMENT

RESEARCH AND DEVELOPMENT.

ADVERTISING EXPENSE

ADVERTISING EXPENSE.

In connection with the FDA approval and commercial launch of FIRDAPSE

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION.

The Company recognizes expense in the consolidated statements of operations for the

grant date

CONCENTRATION OF CREDIT RISK

CONCENTRATION OF RISK.

, 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 11 (Agreements), are expensed to cost of sales as revenue from product sales is recognized.

INCOME TAXES

INCOME TAXES.

more-likely-than-not

COMPREHENSIVE INCOME

COMPREHENSIVE INCOME.

available-for-sale

securities.

NET INCOME PER COMMON SHARE

NET INCOME PER COMMON SHARE.

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


	For the Years Ended December 31,
	2021		2020		2019


Basic weighted average common shares outstanding		103,379,349		103,512,913		102,944,316
Effect of dilutive securities		4,416,236		2,729,360		3,076,620

Diluted weighted average common shares outstanding		107,795,585		106,242,273		106,020,936

SEGMENT INFORMATION

SEGMENT INFORMATION.

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

drug

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 December 2019, the FASB issued ASU

2019-12,

Income Taxes: Simplifying the Accounting for Income Taxes

step-up

Basis of Presentation and Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Fair Value Measurement Specific to Assets or Liability


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of December 31, 2021		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	$	10,990	$	10,990	$	—	$	—

U.S. Treasuries	$	140,995	$	140,995	$	—	$	—

Short-term investments:
Short-term bond funds	$	19,821	$	19,821	$	—	$	—

	Balances as of December 31, 2020		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	$	15,674	$	15,674	$	—	$	—

U.S. Treasuries	$	104,994	$	—	$	104,994	$	—

Short-term investments:
Short-term bond funds	$	10,041	$	10,041	$	—	$	—

Basic and Dilutive Weighted Average Common Shares

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


	For the Years Ended December 31,
	2021		2020		2019


Basic weighted average common shares outstanding		103,379,349		103,512,913		102,944,316
Effect of dilutive securities		4,416,236		2,729,360		3,076,620

Diluted weighted average common shares outstanding		107,795,585		106,242,273		106,020,936

Investments (Tables)

12 Months Ended

Dec. 31, 2021

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 (in thousands):


	Estimated Fair Value		Gross Unrealized Gains		Gross Unrealized Losses			Amortized Cost
At December 31, 2021:
U.S. Treasuries - Cash equivalents	$	140,995	$	2	$	—		$	140,993
Short-term bond funds		19,821		—		(196	)		20,017

Total	$	160,816	$	2	$	(196	)	$	161,010

At December 31, 2020:
U.S. Treasuries - Cash equivalents	$	104,994	$	2	$	—		$	104,992
Short-term bond funds		10,041		29		—			10,012

Total	$	115,035	$	31	$	—		$	115,004

Estimated Fair Values of Available for Sale Securities

The estimated fair values of

available-for-sale

securities at December 31, 2021, by contractual maturity, are summarized as follows (in thousands):


	2021
Due in one year or less	$	160,816

Inventory (Tables)

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Summary of current inventory

Inventory consists of the following (in thousands):


	December 31, 2021		December 31, 2020
Raw materials	$	1,769	$	—
Work-in-process		5,172		3,555
Finished goods		929		1,096

Total inventory	$	7,870	$	4,651

Prepaid Expenses and Other Current Assets (Tables)

12 Months Ended

Dec. 31, 2021

Text Block [Abstract]

Prepaid expenses and other current assets

Prepaid expenses and other current assets consist of the following as of December 31 (in thousands):


	2021		2020
Prepaid manufacturing costs	$	307	$	3,328
Prepaid tax		564		1,368
Prepaid insurance		1,213		1,285
Prepaid subscriptions fees		909		729
Prepaid research fees		452		453
Prepaid commercialization expenses		195		199
Due from collaborative and licensing arrangements		105		437
Prepaid conference and travel expenses		279		83
Other		327		446

Total prepaid expenses and other current assets	$	4,351	$	8,328

Operating Leases (Tables)

12 Months Ended

Dec. 31, 2021

Disclosure of Operating Leases [Abstract]

Lease, Cost

The components of lease expense were as follows (in thousands):


	For the Year Ended December 31, 2021
Operating lease cost	$	379

Schedule of Supplemental Cash Flow Information Related To Lease

Supplemental cash flow information related to lease was as follows (in thousands):


	December 31, 2021
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	109
Right-of-use assets obtained in exchange for lease obligations:
Operating lease	$	80

Schedule of Supplemental Balance Sheet related To Lease

Supplemental balance sheet information related to lease was as follows (in thousands


	December 31, 2021

Operating lease right-of-use assets	$	3,017
Other current liabilities	$	308
Operating lease liabilities, net of current portion		3,894
Total operating lease liabilities	$	4,202

Lessee, Operating Lease, Liability, Maturity

Remaining payments of lease liabilities as of December 31, 2021 were as follows (in thousands):



2022	$	492
2023		506
2024		522
2025		537
2026		553
Thereafter		2,597
Total lease payments		5,207
Less: imputed interest		(1,005	)
Total	$	4,202

Property and Equipment, Net (Tables)

12 Months Ended

Dec. 31, 2021

Property, Plant and Equipment [Abstract]

Property and Equipment, net

Property and equipment, net consists of the following (in thousands):


	December 31, 2021			December 31, 2020
Computer equipment	$	51		$	51
Furniture and equipment		203			242
Leasehold improvements		980			177
Less: Accumulated depreciation		(275	)		(340	)
Total property and equipment, net	$	959		$	130

Accrued Expenses and Other Liabilities (Tables)

12 Months Ended

Dec. 31, 2021

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Liabilities

Accrued expenses and other liabilities consist of the following as of December 31 (in thousands):


	2021		2020
Accrued preclinical and clinical trial expenses	$	659	$	585
Accrued professional fees		2,391		1,884
Accrued compensation and benefits		4,035		3,991
Accrued license fees		12,819		10,373
Accrued purchases		2,045		258
Accrued contributions		—		310
Operating lease liability		308		29
Accrued variable consideration		1,716		964
Accrued income tax		79		—
Other		243		106
Current accrued expenses and other liabilities		24,295		18,500
Lease liability – non-current		3,894		—
Non-current accrued expenses and other liabilities		3,894		—
Total accrued expenses and other liabilities	$	28,189	$	18,500

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Schedule of income tax expense

The income tax expense (benefit) for the years ended December 31, 2021, 2020, and 2019 consists of (in thousands):


	2021		2020			2019
Current	$	3,869	$	(122	)	$	1,534
Deferred		9,316		(32,971	)		—

	$	13,185	$	(33,093	)	$	1,534

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:


	2021			2020			2019
Statutory rate		21.0	%		21.0	%		21.0	%
State tax		3.4	%		2.2	%		6.5	%
Valuation allowance		—			(99.4	)%		(20.9	)%
Executive compensation limitation		1.1	%		—			0.1	%
Tax credit		(0.6	)%		(2.4	)%		(2.5	)%
Other		0.1	%		(0.4	)%		0.4	%

		25.0	%		(79.0	)%		4.6	%

Components of deferred tax assets


	2021			2020
Deferred tax assets:
Net operating loss	$	1,218		$	2,320
Start-up costs		10,403			11,203
Tax credits		8,516			15,616
Deferred compensation		3,959			3,889
Inventory		163			212
Operating lease liability		1,003			—
Other		—			130
Total deferred tax assets		25,262			33,370
Deferred tax liabilities:
Prepaid expenses		(455	)		(399	)
Right-of use asset		(936	)		—
Other		(174	)		—

Total deferred tax liabilities		(1,565	)		(399	)

Deferred tax assets, net	$	23,697		$	32,971

Stock Compensation (Tables)

12 Months Ended

Dec. 31, 2021

Share-based Payment Arrangement [Abstract]

Stock-Based Compensation Expense

For the years ended December 31, 2021, 2020 and 2019, the Company recorded stock-based compensation expense as follows (in thousands):


	2021		2020		2019
Research and development	$	1,611	$	1,585	$	1,138
Selling, general and administrative		4,462		4,676		2,687

Total stock-based compensation	$	6,073	$	6,261	$	3,825

Stock option activity under the Company's Plans

Stock option activity under the Company’s Plans for the year ended December 31, 2021 is summarized as follows:


	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at beginning of year		13,393,669		$	3.10
Granted		2,330,000			5.89
Exercised or released		(1,328,936	)		3.09
Forfeited or cancelled		(177,006	)		3.92
Expired		(9,999	)		5.12

Outstanding at end of year		14,207,728		$	3.55		4.15	$	46,168

Exercisable at end of year		9,473,196		$	2.87		3.21	$	36,958

Schedule of Other Information Pertaining to Stock Option Activity

Other information pertaining to stock option activity during the years ended December 31, 2021, 2020, and 2019 was as follows:


	2021		2020		2019
Weighted–average fair value of granted stock options	$	3.24	$	2.33	$	2.69
Total fair value of vested stock options (in thousands)	$	6,421	$	5,312	$	3,865
Total intrinsic value of exercised stock options (in thousands)	$	3,623	$	325	$	1,900

Summary of Stock Options Awards Based on Certain Assumptions

Assumptions used during the years were as follows:


	2021		2020		2019
Risk free interest rate		0.34% to 1.18 %		0.24% to 1.64 %		1.51% to 2.53 %
Expected term		4.5 – 4.8 years		4.5 years		4.5 years
Expected volatility		68.6% to 72.8 %		80.5% to 83.7 %		75.5 %
Expected dividend yield		— %		— %		— %
Expected forfeiture rate		— %		— %		— %

Summary of Restricted Stock Unit Activity

Restricted stock unit activity during 2021 and 2020 was as follows:


	2021					2020
	Number of Restricted Stock Units			Weighted Average Grant Date Fair Value		Number of Restricted Stock Units			Weighted Average Grant Date Fair Value
Nonvested balance at beginning of year		235,671		$	4.65		352,500		$	4.64
Granted		—			—		30,000			4.70
Vested		(112,832	)		4.65		(117,495	)		4.64
Forfeited		—			—		(29,334	)		4.64

Nonvested balance at end of year		122,839		$	4.65		235,671		$	4.65

Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, $ in Thousands, shares in Millions	12 Months Ended
	Dec. 31, 2021 USD ($) Segment $ / shares shares	Dec. 31, 2020 USD ($) $ / shares shares	Dec. 31, 2019 USD ($) $ / shares shares
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Maximum maturity period of cash and cash equivalent	three months
Non current investments \| $	$ 0	$ 0
Minimum amortization period of compensation cost on straight line basis	1 year
Maximum Amortization Period Of Compensation Cost On Straight Line Basis	3 years
Stock option exercise price range, Minimum \| $ / shares	$ 0.79	$ 0.79	$ 0.79
Stock option exercise price range, Maximum \| $ / shares	$ 4.64	$ 3.95	$ 4.20
Potential equivalent common stock excluded \| shares	4.3	7.1	4.6
Number of Reportable Segments \| Segment	1
Furniture and Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets	5 years
Selling, General and Administrative Expenses [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Advertising Expense \| $	$ 2,900	$ 2,500	$ 3,300
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	5 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	10 years

Basis of Presentation and Significant Accounting Policies - Fair Value Measurement Specific to Assets or Liability (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	$ 19,821	$ 10,041
Short-term bond funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	19,821	10,041
U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents	140,995	104,994
Money market funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents	10,990	15,674
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] \| Short-term bond funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	19,821	10,041
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] \| U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents	140,995
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]
Cash and cash equivalents	$ 10,990	15,674
Significant Other Observable Inputs (Level 2) [Member] \| U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents		$ 104,994

Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Weighted Average Number of Shares Outstanding Reconciliation [Abstract]
Basic weighted average common shares outstanding	103,379,349	103,512,913	102,944,316
Effect of dilutive securities	4,416,236	2,729,360	3,076,620
Dilutive weighted average common shares outstanding	107,795,585	106,242,273	106,020,936

Investments - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Investments, Debt and Equity Securities [Abstract]
Realized gains losses from available for sale securities	$ 0	$ 0	$ 0

Investment - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Net Investment Income [Line Items]
Estimated Fair Value	$ 160,816	$ 115,035
Gross Unrealized Gains	2	31
Gross Unrealized Losses
Amortized cost	161,010	115,004
U.S Treasury Bond Securities Cash Equivalents [Member]
Net Investment Income [Line Items]
Estimated Fair Value	140,995	104,994
Gross Unrealized Gains	2	2
Amortized cost	140,993	104,992
Short Term Bond Funds [Member]
Net Investment Income [Line Items]
Estimated Fair Value	19,821	10,041
Gross Unrealized Gains		29
Gross Unrealized Losses	(196)
Amortized cost	$ 20,017	$ 10,012

Investment - Estimated Fair Values of Available for Sale Securities (Detail) $ in Thousands	Dec. 31, 2021 USD ($)
Investments, Debt and Equity Securities [Abstract]
Due in one year or less	$ 160,816

Inventory - Summary of current inventory (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Inventory Disclosure [Abstract]
Raw materials	$ 1,769
Work-in-process	5,172	3,555
Finished goods	929	1,096
Total inventory, net	$ 7,870	$ 4,651

Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid manufacturing costs	$ 307	$ 3,328
Prepaid tax	564	1,368
Prepaid insurance	1,213	1,285
Prepaid subscriptions fees	909	729
Prepaid research fees	452	453
Prepaid commercialization expenses	195	199
Due from collaborative arrangements	105	437
Prepaid conference and travel expenses	279	83
Other	327	446
Total prepaid expenses and other current assets	$ 4,351	$ 8,328

Operating Leases - Operating Leases (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Disclosure of Operating Leases [Abstract]
Operating lease cost	$ 379	$ 300	$ 300

Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$ 109
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$ 80

Operating Leases -Schedule of Supplemental Balance Sheet related To Lease (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Disclosure of Operating Leases [Line Items]
Operating lease right-of-use assets	$ 3,017	$ 0
Other current liabilities	$ 308	29
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Other Accrued Liabilities, Current
Operating lease liabilities, net of current portion	$ 3,894	$ 0
Total operating lease liabilities	$ 4,202

Operating Leases -Lessee, Operating Lease, Liability, Maturity (Detail) $ in Thousands	Dec. 31, 2021 USD ($)
Disclosure of Operating Leases [Line Items]
2022	$ 492
2023	506
2024	522
2025	537
2026	553
Thereafter	2,597
Total lease payments	5,207
Less imputed interest	(1,005)
Total	$ 4,202

Operating Leases - Additional Information (Detail) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($) ft²	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
Disclosure of Operating Leases [Line Items]
Finance Lease Obligations \| $	$ 0
Lessor, Operating Lease, Option to Extend	5 years
Rent expense \| $	$ 379	$ 300	$ 300
Before agreement of company leased spaces \| ft²	7,800
After agreement of company leased spaces \| ft²	10,700
Weighted average remaining lease term	9 years 3 months 18 days
Weighted average discount rate	4.51%
Maximum [Member]
Disclosure of Operating Leases [Line Items]
Lessee, Operating Lease, Option to Terminate	7.6 years
Minimum [Member]
Disclosure of Operating Leases [Line Items]
Lessee, Operating Lease, Option to Terminate	6 years

Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Property, Plant and Equipment [Line Items]
Less: Accumulated depreciation	$ (275)	$ (340)
Total property and equipment, net	959	130
Computer equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	51	51
Furniture and equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	203	242
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 980	$ 177

Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Payables and Accruals [Abstract]
Accrued preclinical and clinical trial expenses	$ 659	$ 585
Accrued professional fees	2,391	1,884
Accrued compensation and benefits	4,035	3,991
Accrued license fees	12,819	10,373
Accrued purchases	2,045	258
Accrued contributions		310
Operating lease liability	308	29
Accrued variable consideration	1,716	964
Accrued income tax	79
Other	243	106
Current accrued expenses and other liabilities	24,295	18,500
Lease liability - non-current	3,894	0
Total accrued expenses and other liabilities	$ 28,189	$ 18,500

Collaborative and Licensing Arrangements - Additional Information (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Collaborative Arrangements [Line Items]
Period of collaboration agreement	10 years
Total research and development expense	$ 16,936,000	$ 16,497,000	$ 18,843,000
Revenue	140,833,000	119,073,000	102,306,000
product revenue,net
Collaborative Arrangements [Line Items]
Revenue	137,997,000	118,790,000	102,306,000
Dydo Pharma Inc Member [Member]
Collaborative Arrangements [Line Items]
Milestone payments income	0
Revenues	2,700,000
Dydo Pharma Inc Member [Member] \| Non Refundable Upfront License Fees [Member]
Collaborative Arrangements [Line Items]
Revenues	2,900,000
Dydo Pharma Inc Member [Member] \| product revenue,net
Collaborative Arrangements [Line Items]
Revenue	200,000
Collaborative Arrangement [Member]
Collaborative Arrangements [Line Items]
Total research and development expense	45,000	4,200	65,000
Milestone payments	2,000,000.0
Milestone payments income	0	0	0
Revenues	$ 0	$ 0	$ 0

Agreements - Additional Information (Detail) $ in Millions	12 Months Ended
Agreements - Additional Information (Detail) $ in Millions	Dec. 31, 2021 USD ($)
License Agreement [Line Items]
Percentage of royalty on net sales	3.50%
License Agreement with BioMarin [Member]
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
License Agreement with BioMarin [Member] \| Minimum [Member]
License Agreement [Line Items]
Percentage of royalty on net sales	7.00%
License Agreement with BioMarin [Member] \| Maximum [Member]
License Agreement [Line Items]
Percentage of royalty on net sales	10.00%

Income Taxes - Schedule of income tax expense (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Income Tax Disclosure [Abstract]
Current	$ 3,869	$ (122)	$ 1,534
Deferred	9,316	(32,971)	0
Total income tax expense	$ 13,185	$ (33,093)	$ 1,534

- Definition

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

+ References + Details

Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Income Tax Disclosure [Line Items]
Deferred tax assets, net	$ 23,697	$ 32,971
Net operating loss carryforwards	$ 0	$ 3,000
Net operating loss carryforwards expiration date	beginning in 2034
Tax credit carryforwards expiration date		2035 years
Interest or penalties accrued		$ 0
Unrecognized tax benefits income tax penalties accrued	$ 0
State and Local Jurisdiction [Member]
Income Tax Disclosure [Line Items]
Net operating loss carryforwards	$ 28,000	$ 42,000

Income Taxes - Schedule of Reconciliation of Income Tax Expense (Benefit) Computed at Statutory Federal Income Tax Rate (Detail)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Income Tax Disclosure [Abstract]
Statutory rate	21.00%	21.00%	21.00%
State tax	3.40%	2.20%	6.50%
Valuation allowance	0.00%	(99.40%)	(20.90%)
Executive compensation limitation	1.10%	0.00%	0.10%
Tax credit	(0.60%)	(2.40%)	(2.50%)
Other	0.10%	(0.40%)	0.40%
Reconciliation of income tax expense (benefit)	25.00%	(79.00%)	4.60%

Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred Tax Assets [Abstract]
Net operating loss	$ 1,218	$ 2,320
Start-up costs	10,403	11,203
Tax credits	8,516	15,616
Deferred compensation	3,959	3,889
Inventory	163	212
Operating lease liability	1,003	0
Other	0	130
Total deferred tax assets	25,262	33,370
Deferred tax liabilities:
Prepaid expenses	(455)	(399)
Right-of use asset	(936)	0
Other	(174)	0
Total deferred tax liabilities	(1,565)	(399)
Deferred tax assets, net	$ 23,697	$ 32,971

Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail)	Dec. 31, 2021 Vote $ / shares shares	Dec. 31, 2020 $ / shares shares
Stockholders Equity [Line Items]
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	200,000,000	200,000,000
Common stock, par value \| $ / shares	$ 0.001	$ 0.001
Common stock, shares issued	102,992,913	103,781,641
Common stock, shares outstanding	102,992,913	103,781,641
Number of votes entitled for each share of common stock \| Vote	1

Stockholders' Equity ( Share Repurchases ) - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Mar. 31, 2021
Stockholders Equity [Line Items]
Aggregate purchase price	$ 12,089
Average price per share	$ 5.47
Common Stock [Member]
Stockholders Equity [Line Items]
Aggregate share repurchased	(2,208,292)
Share Purchase Program Member [Member] \| Common Stock [Member]
Stockholders Equity [Line Items]
Share repurchase program, authorised		$ 40,000

Stockholders' Equity (2020 Shelf Registration Statement) - Additional Information (Detail) $ in Millions	Jul. 23, 2020 USD ($)
2020 Shelf Registration Statement [Member]
Stockholders' Equity [Line Items]
Maximum dollar amount of common stock to be issued under shelf registration statement	$ 200

Stockholders' Equity (Stockholder Rights Plan) - Additional Information (Detail) - $ / shares	Sep. 19, 2016	Sep. 20, 2011	Dec. 31, 2021	Dec. 31, 2020
Series A Preferred Stock [Member]
Stockholders Equity [Line Items]
Preferred Stock Purchase Price		$ 7.80
Stockholder Rights Plan [Member]
Stockholders Equity [Line Items]
Minimum percentage of outstanding stock acquired by a person or group to trigger Shareholder Rights Plan		17.50%
Warrants exercise price		$ 7.80
Stockholders Rights Plan redemption price of right		$ 0.001
Class of warrant or right expiration date, Extended	Sep. 20, 2019
Certificate Of Designation [Member] \| Series A Preferred Stock [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

Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 6,073	$ 6,261	$ 3,825
Research and Development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	1,611	1,585	1,138
Selling, General and Administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 4,462	$ 4,676	$ 2,687

Stock Compensation - Additional Information (Detail) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	1,328,936
Proceeds from exercise of stock options	$ 4,099	$ 758	$ 1,116
Common stock unit granted	2,330,000
Expected dividend rate	0.00%	0.00%
Non Vested Outstanding			352,500
Non Vested granted			352,500
Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock option contractual term	7 years
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 [Member] \| Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share based compensation, vesting period	3 years
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Non-cash stock-based compensation expense	$ 500	$ 600	$ 100
Non Vested Outstanding	122,839	235,671	352,500
Non Vested granted	0	30,000
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	15,000,000
Common stock shares available for future issuance under the Plan	4,708,013
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
Options to Purchase Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	1,328,936	281,762	654,332
Proceeds from exercise of stock options	$ 4,100	$ 800	$ 1,100
Stock option granted, contractual term	7 years	7 years	7 years
Common stock unit granted	2,330,000	2,715,000	2,183,500
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan	$ 11,600
Expected remaining weighted average vesting period	2 years 5 months 4 days
Non-cash stock-based compensation expense	$ 5,500	$ 5,700	$ 3,800
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
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, 2021 USD ($) $ / shares shares
Share-based Payment Arrangement [Abstract]
Number of options, Outstanding at beginning of year \| shares	13,393,669
Number of options, Granted \| shares	2,330,000
Number of options, Exercised or released \| shares	(1,328,936)
Number of options, Forfeited or cancelled \| shares	(177,006)
Number of options, Expired \| shares	(9,999)
Number of options, Outstanding at end of year \| shares	14,207,728
Number of options, Exercisable at end of year \| shares	9,473,196
Weighted average exercise price, Outstanding at beginning of year \| $ / shares	$ 3.10
Weighted average exercise price, Granted \| $ / shares	5.89
Weighted average exercise price, Exercised or released \| $ / shares	3.09
Weighted average exercise price, Forfeited or cancelled \| $ / shares	3.92
Weighted average exercise price, Expired \| $ / shares	5.12
Weighted average exercise price, Outstanding at end of year \| $ / shares	3.55
Weighted average exercise price, Exercisable at end of year \| $ / shares	$ 2.87
Weighted Average Remaining Contractual Term (Years), Outstanding at end of year	4 years 1 month 24 days
Weighted Average Remaining Contractual Term (Years), Exercisable at end of year	3 years 2 months 15 days
Aggregate Intrinsic value, Outstanding at end of year \| $	$ 46,168
Aggregate Intrinsic value, Exercisable at end of year \| $	$ 36,958

Stock Compensation - Schedule of Other Information Pertaining to Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share-based Payment Arrangement [Abstract]
Weighted-average fair value of granted stock options	$ 3.24	$ 2.33	$ 2.69
Total fair value of vested stock options	$ 6,421	$ 5,312	$ 3,865
Total intrinsic value of exercised stock options	$ 3,623	$ 325	$ 1,900

Stock Compensation - Summary of Stock Options Awards Based on Certain Assumptions (Detail)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Risk free interest rate, Minimum	0.34%	0.24%	1.51%
Risk free interest rate, Maximum	1.18%	1.64%	2.53%
Expected volatility			75.50%
Expected dividend yield	0.00%	0.00%
Expected forfeiture rate	0.00%	0.00%
Expected term		4 years 6 months	4 years 6 months
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	68.60%	80.50%
Expected term	4 years 6 months
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	72.80%	83.70%
Expected term	4 years 9 months 18 days

Stock Compensation - Summary of Restricted Stock Unit Activity (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Schedule Of Restricted Stock Activity [Line Items]
Nonvested balance at beginning of year		352,500
Granted			352,500
Nonvested balance at end of year			352,500
Restricted Stock Units (RSUs) [Member]
Schedule Of Restricted Stock Activity [Line Items]
Nonvested balance at beginning of year	235,671	352,500
Granted	0	30,000
Vested	(112,832)	(117,495)
Forfeited	0	(29,334)
Nonvested balance at end of year	122,839	235,671	352,500
Nonvested Weighted Average Grant Date Fair Value balance at beginning of year	$ 4.65	$ 4.64
Weighted Average Grant Date Fair Value, Granted	0	4.70
Weighted Average Grant Date Fair Value, Vested	4.65	4.64
Weighted Average Grant Date Fair Value, Forfeited	0	4.64
Nonvested Weighted Average Grant Date Fair Value balance at end of year	$ 4.65	$ 4.65	$ 4.64

Benefit Plan - Additional Information (Detail) - USD ($) $ in Millions	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
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	$ 0.5	$ 0.5	$ 0.3