0000950170-24-122282 | 10-Q | XBRL Viewer | Catalyst Pharmaceuticals INC

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2024

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets.

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


	September 30, 2024		December 31, 2023
Prepaid manufacturing costs	$	180	$	2,005
Prepaid tax		6,166		1,238
Prepaid insurance		489		1,332
Prepaid subscriptions fees		1,870		1,299
Prepaid research fees		1,833		1,500
Prepaid commercialization expenses		4,543		3,038
Due from collaborative and licensing arrangements		—		138
Prepaid conference and travel expenses		1,233		771
Prepaid co-pay assistance program		1,561		863
Other		509		351
Total prepaid expenses and other current assets	$	18,384	$	12,535

Stockholders' Equity	9 Months Ended
Sep. 30, 2024
Equity [Abstract]
Stockholders' Equity	15. Stockholders’ Equity. Preferred Stock The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share. At September 30, 2024 and December 31, 2023, no shares of preferred stock were outstanding. Common Stock The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At September 30, 2024 and December 31, 2023, 119,266,561 and 107,121,549 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. No shares were repurchased during the three and nine months ended September 30, 2024 and 2023. 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. The Company’s 2020 Shelf Registration Statement expired on July 31, 2023. 2023 Shelf Registration Statement On September 8, 2023, the Company filed a shelf registration statement with the SEC to sell up to $500 million of common stock, preferred stock, warrants to purchase common stock, debt securities and units consisting of one or more of such securities (the “2023 Shelf Registration Statement”). The 2023 Shelf Registration Statement (file no. 333-274427) became effective upon filing. On January 9, 2024, the Company completed a public offering of 10 million shares of its common stock, raising net proceeds of approximately $140.7 million under the Company’s 2023 Shelf Registration Statement.

Stockholders' Equity

9 Months Ended

Sep. 30, 2024

Equity [Abstract]

Stockholders' Equity

15.

Stockholders’ Equity.

Preferred Stock

The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share. At September 30, 2024 and December 31, 2023, no shares of preferred stock were outstanding.

Common Stock

The Company has 200,000,000 shares of authorized common stock, par value $0.001 per share. At September 30, 2024 and December 31, 2023, 119,266,561 and 107,121,549 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. No shares were repurchased during the three and nine months ended September 30, 2024 and 2023.

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. The Company’s 2020 Shelf Registration Statement expired on July 31, 2023.

2023 Shelf Registration Statement

On September 8, 2023, the Company filed a shelf registration statement with the SEC to sell up to $500 million of common stock, preferred stock, warrants to purchase common stock, debt securities and units consisting of one or more of such securities (the “2023 Shelf Registration Statement”). The 2023 Shelf Registration Statement (file no. 333-274427) became effective upon filing. On January 9, 2024, the Company completed a public offering of 10 million shares of its common stock, raising net proceeds of approximately $140.7 million under the Company’s 2023 Shelf Registration Statement.

- Definition

The entire disclosure for equity.

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+ Details

Operating Leases - Additional Information (Detail) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) ft²	Sep. 30, 2023 USD ($)	Dec. 31, 2023
Lessee, Lease, Description [Line Items]
Finance lease obligations \| $	$ 0		$ 0
Lessee, Operating Lease, Option to Extend			5 years
Before agreement of company leased spaces \| ft²			7,800
After agreement of company leased spaces \| ft²			10,700
Weighted average remaining lease term	6 years 7 months 6 days		6 years 7 months 6 days		7 years 3 months 18 days
Weighted average discount rate	4.51%		4.51%		4.51%
Rent expense \| $	$ 108	$ 108	$ 323	$ 323
Maximum [Member]
Lessee, Lease, Description [Line Items]
Lessee, Operating Lease, Option to Terminate			7.6 years
Minimum [Member]
Lessee, Lease, Description [Line Items]
Lessee, Operating Lease, Option to Terminate			6 years

Collaborative and Licensing Arrangements - Additional Information (Detail) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Collaborative Arrangement [Member] \| Dydo Pharma Inc [Member]
Collaborative Arrangements [Line Items]
Revenues	$ 2.1	$ 0.0	$ 2.1	$ 0.5

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

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+ Details

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Accumulated Other Comprehensive Income [Member]
Beginning Balance at Dec. 31, 2022	$ 300,421	$ 105	$ 250,430	$ 49,862	$ 24
Beginning Balance (shares) at Dec. 31, 2022		105,263,000
Stock-based compensation	2,892		2,892
Exercise of stock options for common stock	1,270	$ 1	1,269
Exercise of stock options for common stock (shares)		548,000
Issuance of common stock upon vesting of restricted stock units, net	(477)		(477)
Issuance of common stock upon vesting of restricted stock units, net (Share)		127,000
Other comprehensive gain (loss)	(13)				(13)
Net income (loss)	29,568			29,568
Ending Balance at Mar. 31, 2023	333,661	$ 106	254,114	79,430	11
Ending Balance (shares) at Mar. 31, 2023		105,938,000
Beginning Balance at Dec. 31, 2022	300,421	$ 105	250,430	49,862	24
Beginning Balance (shares) at Dec. 31, 2022		105,263,000
Net income (loss)	36,566
Ending Balance at Sep. 30, 2023	348,548	$ 107	261,998	86,428	15
Ending Balance (shares) at Sep. 30, 2023		106,605,000
Beginning Balance at Mar. 31, 2023	333,661	$ 106	254,114	79,430	11
Beginning Balance (shares) at Mar. 31, 2023		105,938,000
Stock-based compensation	3,298		3,298
Exercise of stock options for common stock	617	$ 1	616
Exercise of stock options for common stock (shares)		557,000
Issuance of common stock upon vesting of restricted stock units, net	(52)		(52)
Issuance of common stock upon vesting of restricted stock units, net (Share)		6,000
Other comprehensive gain (loss)	8				8
Net income (loss)	37,762			37,762
Ending Balance at Jun. 30, 2023	375,294	$ 107	257,976	117,192	19
Ending Balance (shares) at Jun. 30, 2023		106,501,000
Stock-based compensation	3,810		3,810
Exercise of stock options for common stock	212		212
Exercise of stock options for common stock (shares)		92,000
Issuance of common stock upon vesting of restricted stock units, net (Share)		12,000
Other comprehensive gain (loss)	(4)				(4)
Net income (loss)	(30,764)			(30,764)
Ending Balance at Sep. 30, 2023	348,548	$ 107	261,998	86,428	15
Ending Balance (shares) at Sep. 30, 2023		106,605,000
Beginning Balance at Dec. 31, 2023	387,881	$ 107	266,488	121,272	14
Beginning Balance (shares) at Dec. 31, 2023		107,122,000
Issuance of common stock, net	140,704	$ 10	140,694
Issuance of common stock, net (shares)		10,000,000
Stock-based compensation	8,248		8,248
Exercise of stock options for common stock	1,522	$ 1	1,521
Exercise of stock options for common stock (shares)		664,000
Issuance of common stock upon vesting of restricted stock units, net	(204)		(204)
Issuance of common stock upon vesting of restricted stock units, net (Share)		244,000
Other comprehensive gain (loss)	(14)				(14)
Net income (loss)	23,275			23,275
Ending Balance at Mar. 31, 2024	561,412	$ 118	416,747	144,547
Ending Balance (shares) at Mar. 31, 2024		118,030,000
Beginning Balance at Dec. 31, 2023	387,881	$ 107	266,488	121,272	$ 14
Beginning Balance (shares) at Dec. 31, 2023		107,122,000
Net income (loss)	107,953
Ending Balance at Sep. 30, 2024	660,941	$ 119	431,597	229,225
Ending Balance (shares) at Sep. 30, 2024		119,267,000
Beginning Balance at Mar. 31, 2024	561,412	$ 118	416,747	144,547
Beginning Balance (shares) at Mar. 31, 2024		118,030,000
Issuance of common stock, net	10		10
Issuance of common stock, net (shares)		0
Stock-based compensation	4,408		4,408
Exercise of stock options for common stock	2,031	$ 1	2,030
Exercise of stock options for common stock (shares)		491,000
Net income (loss)	40,794			40,794
Ending Balance at Jun. 30, 2024	608,655	$ 119	423,195	185,341
Ending Balance (shares) at Jun. 30, 2024		118,521,000
Stock-based compensation	4,424		4,424
Exercise of stock options for common stock	3,978		3,978
Exercise of stock options for common stock (shares)		746,000
Net income (loss)	43,884			43,884
Ending Balance at Sep. 30, 2024	$ 660,941	$ 119	$ 431,597	$ 229,225
Ending Balance (shares) at Sep. 30, 2024		119,267,000

Commitments and Contingencies

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

12.

Commitments and Contingencies.

In May 2019, the FDA approved a NDA for RUZURGI®, Jacobus Pharmaceuticals’ version of amifampridine (3,4-DAP), for the treatment of pediatric LEMS patients (ages 6 to under 17). In June 2019 the Company filed suit against the FDA and several related parties challenging this approval and related drug labeling. Jacobus later 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 vacating the FDA’s approval of RUZURGI®.

On July 30, 2020, the Magistrate Judge considering this lawsuit filed a Report and Recommendation in which the Magistrate Judge recommended to the District Judge handling the case that the District Judge 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 Company’s case. The Company appealed the District Court’s decision to the U.S. Court of Appeals for the 11th Circuit. The case was fully briefed in early 2021, 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.

On July 11, 2022, the Company settled certain of its disputes with Jacobus. In connection with the settlement, the Company licensed the rights to develop and commercialize RUZURGI® in the U.S. and Mexico (the Territory). Simultaneously, the Company purchased, among other intellectual property rights, Jacobus’ U.S. patents related to RUZURGI®, its new drug applications in the U.S. for RUZURGI®, and certain RUZURGI® inventory previously manufactured by Jacobus. At the same time, the Company received a license from Jacobus for use of its know-how related to the manufacture of RUZURGI®. Further, the Company settled its patent case against Jacobus, which was dismissed without prejudice. Finally, Jacobus agreed that until the later of (i) the expiration of the royalty term or (ii) December 31, 2034, Jacobus and its affiliates, will not, directly or indirectly, research, develop, manufacture, commercialize, distribute, use or otherwise exploit any product competitive to FIRDAPSE® or RUZURGI® in the Territory, and Laura Jacobus, the sole shareholder of Jacobus, and two of Jacobus’ other officers, also signed individual non-competition agreements containing the same terms.

In connection with the settlement with Jacobus, the Company agreed to pay the following consideration to Jacobus:

•

$30 million of cash, of which $10 million was paid at the closing of the settlement on July 11, 2022, $10 million was paid on the first anniversary of the closing, and the remaining $10 million was paid on the second anniversary of the closing;

•

An annual royalty on the Company's net sales (as defined in the License and Asset Purchase Agreement between Catalyst and Jacobus) of amifampridine products in the U.S. equal to: (a) for calendar years 2022 through 2025, 1.5% (with a minimum annual royalty of $3.0 million per year), and (b) for calendar years 2026 through the expiration of the last to expire of the Company’s FIRDAPSE® patents in the U.S., 2.5% (with a minimum annual royalty of $5 million per year); provided, however, that the royalty rate may be reduced and the minimum annual royalty may be eliminated under certain circumstances; and

•

If the Company were to receive a priority review voucher for FIRDAPSE® or RUZURGI® in the future, 50% of the consideration paid by a third-party to acquire that voucher will be paid to Jacobus.

12.

Commitments and Contingencies (continued).

The Company’s New Drug Submission filing for FIRDAPSE® for the symptomatic treatment of LEMS was approved when Health Canada issued a Notice of Compliance, or NOC, on July 31, 2020. In August 2020, the Company entered into a license agreement with KYE Pharmaceuticals, or KYE, pursuant to which the Company licensed to KYE the Canadian rights for FIRDAPSE® for the treatment of LEMS. On August 10, 2020, Health Canada issued a NOC to Medunik (Jacobus’ licensee in Canada for RUZURGI®) for the treatment of LEMS. Shortly thereafter, 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 due to Medunik’s use of the Company’s protected data in its application. After two decisions by the trial judge to quash the RUZURGI® approval and remand the matter back to Health Canada, the Canadian Federal Appellate Court overturned the trial judge’s decision. The Minister subsequently reapproved RUZURGI®’s NOC for Canada in 2023. The Company does not expect the approval of RUZURGI® in Canada to have a material impact on the Company’s consolidated financial statements.

In January 2023, the Company received Paragraph IV Certification Notice Letters from three generic drug manufacturers (Teva, Hetero and Lupin) advising that they had each submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE® in the U.S. The notice letters each alleged that the six patents listed in the FDA Orange Book covering FIRDAPSE® are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in these ANDA submissions. Under the FDCA, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, the Company had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA from approving any ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first. In that regard, after conducting the necessary due diligence, the Company filed lawsuits on March 1, 2023 in the U.S. District Court for the District of New Jersey against each of the three generic drug manufacturers who notified the Company of their ANDA submissions, thus triggering the stay. In June 2024, Lupin converted five of its Paragraph IV Certifications in its ANDA to Paragraph III certifications acknowledging the validity and their ANDA’s infringement of five of those patents, the latest ending in 2034. The Company subsequently dismissed all of its claims against Lupin related to those five patents but maintains its claims against Lupin for the remaining Paragraph IV certification for United States Patent No. 10,626,088 which is the patent expiring in 2037, so the litigation continues. Further, the litigation with Teva and Hetero continues with respect to all six patents.

Further, in October 2023, the Company received a Paragraph IV Certification Notice Letter from a fourth generic drug manufacturer (Inventia), and the Company filed a similar lawsuit against that manufacturer in November 2023. On July 30, 2024, the Company settled its patent litigation with Inventia for FIRDAPSE®. In that settlement, Inventia acknowledged both the validity of the Company's FIRDAPSE® patents and also the infringement by the ANDA filer's product of the Company's patents. As part of the settlement, Inventia also agreed not to commercialize its product until the earlier of all FIRDAPSE® patents expiration scheduled for February 2037, or the earlier entry into the market of another ANDA product meeting certain conditions.

The outcome of patent litigation with Paragraph IV challengers is always uncertain and there can be no assurance that the Company will prevail in this litigation. However, the Company is vigorously defending its intellectual property for FIRDAPSE® in this litigation and believes that its patent estate will protect FIRDAPSE® from generic competition for the life of its patents.

On February 20, 2023, the Company received a Paragraph IV Certification Notice Letter from a company that appears to have filed the first ANDA for the oral suspension formulation for FYCOMPA®. The same company sent a similar letter to the Company later in February with a similar certification for the tablet formulation for FYCOMPA®, the fourth such certification for this formulation. Both of these letters were paragraph IV certifications of non-infringement, non-validity, and unenforceability to the ‘497 patent for FYCOMPA® but each application, like the previous Paragraph IV notices from ANDA filers, for FYCOMPA® tablets does not challenge the ‘571 patent. Similar to the actions with the FIRDAPSE® Paragraph IV Certifications described above, after due diligence the Company filed lawsuits on April 5, 2023, in the U.S. District Court for the District of New Jersey against the drug manufacturer who notified the Company of their ANDA submissions for both FYCOMPA® formulations, thus triggering the 30-month stay for each application. This lawsuit was settled in June 2024. As part of this settlement, this Paragraph IV filer agreed not to commercialize their proposed ANDA products for both the oral suspension formulation of FYCOMPA® and for FYCOMPA® tablets until at least December 15, 2025.

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.

Property and Equipment, Net - Property and Equipment, Net (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Property, Plant and Equipment [Line Items]
Less: Accumulated depreciation	$ (1,006)	$ (723)
Total property and equipment, net	1,380	1,195
Furniture and equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	962	494
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	991	991
Software [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, gross	$ 433	$ 433

License and Acquired Intangibles, Net (Tables)

9 Months Ended

Sep. 30, 2024

Finite-Lived Intangible Assets, Net [Abstract]

Schedule of Finite-Lived Intangible Assets

The following table presents the Company’s intangible assets at September 30, 2024 (in thousands):


	Gross Carrying Value		Accumulated Amortization		Net Carrying Value
Intangible assets:
License and acquired intangibles for RUZURGI®	$	33,569	$	5,158	$	28,411
License and acquired intangibles for FYCOMPA®		158,143		53,395		104,748
License and acquired intangibles for AGAMREE®		36,000		3,143		32,857
Total	$	227,712	$	61,696	$	166,016

The following table presents the Company’s intangible assets at December 31, 2023 (in thousands):


	Gross Carrying Value		Accumulated Amortization		Net Carrying Value
Intangible assets:
License and acquired intangibles for RUZURGI®	$	33,569	$	3,418	$	30,151
License and acquired intangibles for FYCOMPA®		158,143		29,673		128,470
License and acquired intangibles for AGAMREE®		36,000		572		35,428
Total	$	227,712	$	33,663	$	194,049

Schedule of Finite-Lived, Future Amortization Expense

The following table presents future amortization expense the Company expects for its intangible assets (in thousands):


2024 (remaining three months)	$	9,345
2025		37,378
2026		37,378
2027		37,378
2028		7,705
Thereafter		36,832
Total	$	166,016

Agreements - Summary of total purchase price allocated (Detail)
$ in Thousands

1 Months Ended

Jul. 31, 2023

USD ($)

Asset Acquisition [Line Items]

Total purchase consideration

$ 94,978

Vamorolone [Member]

Asset Acquisition [Line Items]

License and acquired intangibles for vamorolone (IPR&D)

81,513

Investment in Santhera

13,465

^[1]

Total purchase consideration

$ 94,978

[1]	The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023.

Agreements - Summary of Aggregate Amount Paid for the Assets Acquired (Detail) - USD ($)
$ in Thousands

1 Months Ended

9 Months Ended

Jul. 31, 2023

Jan. 31, 2023

Sep. 30, 2024

Asset Acquisition [Line Items]

Total purchase consideration

$ 94,978

U.S. Rights for FYCOMPA [Member]

Asset Acquisition [Line Items]

Base cash payment

$ 160,000

Cash paid for pro-rated prepaid expenses

1,576

Reimbursement on base purchase price

^[1]

(3,238)

Transaction costs

5,870

^[2]

$ 5,900

Total purchase consideration

$ 164,208

[1]	Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023.
[2]	As of September 30, 2024, the full $5.9 million has been paid in cash.

License and Acquired Intangibles, Net

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

License and Acquired Intangibles, Net

License and Acquired Intangibles, Net.

The following table presents the Company’s intangible assets at September 30, 2024 (in thousands):


	Gross Carrying Value		Accumulated Amortization		Net Carrying Value
Intangible assets:
License and acquired intangibles for RUZURGI®	$	33,569	$	5,158	$	28,411
License and acquired intangibles for FYCOMPA®		158,143		53,395		104,748
License and acquired intangibles for AGAMREE®		36,000		3,143		32,857
Total	$	227,712	$	61,696	$	166,016

The following table presents the Company’s intangible assets at December 31, 2023 (in thousands):


	Gross Carrying Value		Accumulated Amortization		Net Carrying Value
Intangible assets:
License and acquired intangibles for RUZURGI®	$	33,569	$	3,418	$	30,151
License and acquired intangibles for FYCOMPA®		158,143		29,673		128,470
License and acquired intangibles for AGAMREE®		36,000		572		35,428
Total	$	227,712	$	33,663	$	194,049

The Company amortizes its definite-lived intangible assets using the straight-line method, which is considered the best estimate of economic benefit, over its estimated useful life. The estimated useful life used for this purpose for RUZURGI®, FYCOMPA® and AGAMREE® was approximately 14.5 years, 5 years and 10.5 years, respectively.

The Company recorded approximately $0.5 million and $1.7 million in amortization expense related to the licensed and acquired intangibles for RUZURGI® during the three and nine months ended September 30, 2024, within selling, general and administrative expenses in the consolidated statements of operations and comprehensive income (loss). The Company recorded approximately $7.9 million and $23.7 million in amortization expense related to the licensed and acquired intangibles for FYCOMPA® during the three and nine months ended September 30, 2024, within cost of sales in the consolidated statements of operations and comprehensive income (loss). The Company recorded approximately $0.9 million and $2.6 million in amortization expense related to the licensed and acquired intangibles for AGAMREE® during the three and nine months ended September 30, 2024, within cost of sales in the consolidated statements of operations and comprehensive income (loss). The Company recorded approximately $0.6 million and $1.8 million in amortization expense related to the licensed and acquired intangibles for RUZURGI® during the three and nine months ended September 30, 2023, within selling, general and administrative expenses in the consolidated statements of operations and comprehensive income (loss). The Company recorded approximately $7.9 million and $21.8 million in amortization expense related to the licensed and acquired intangibles for FYCOMPA® during the three and nine months ended September 30, 2023, within cost of sales in the consolidated statements of operations and comprehensive income (loss). The Company recorded no amortization expense related to the licensed and acquired intangibles for AGAMREE® during the three and nine months ended September 30, 2023. Amortization of the FYCOMPA®, RUZURGI® and AGAMREE® intangible assets are reported together as amortization of intangible assets in the consolidated statements of operations and comprehensive income (loss).

The following table presents future amortization expense the Company expects for its intangible assets (in thousands):


2024 (remaining three months)	$	9,345
2025		37,378
2026		37,378
2027		37,378
2028		7,705
Thereafter		36,832
Total	$	166,016

At September 30, 2024 and December 31, 2023, the weighted average amortization period remaining for intangible assets was 5.7 years and 6.5 years, respectively.

If all or a portion of the intangible assets are deemed not recoverable, the Company would estimate the fair value of the assets and record an impairment loss. There were no impairment charges recognized on definite-lived intangibles for the three and nine months ended September 30, 2024 or 2023.

Basis of Presentation and Significant Accounting Policies - Summary of Disaggregated Product Revenue (Detail) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Disaggregation of Revenue [Line Items]

Revenue from Contract with Customer, Excluding Assessed Tax

$ 128,695

$ 102,688

$ 349,914

$ 287,636

FIRDAPSE [Member]

Disaggregation of Revenue [Line Items]

Revenue from Contract with Customer, Excluding Assessed Tax

79,303

66,224

223,517

188,648

FYCOMPA [Member]

Disaggregation of Revenue [Line Items]

Revenue from Contract with Customer, Excluding Assessed Tax

32,075

36,393

99,035

98,750

AGAMREE [Member]

Disaggregation of Revenue [Line Items]

Revenue from Contract with Customer, Excluding Assessed Tax

^[1]

15,046

24,966

Product revenue, net [Member]

Disaggregation of Revenue [Line Items]

Revenue from Contract with Customer, Excluding Assessed Tax

$ 126,424

$ 102,617

$ 347,518

$ 287,398

[1]	*AGAMREE® net product revenue for the nine months ended September 30, 2024 is for the period between March 13, 2024 (date of commercial launch) and September 30, 2024.

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 41
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-41

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 270
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482964/270-10-50-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (ee)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 4: http://fasb.org/us-gaap/role/ref/otherTransitionRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 5: http://fasb.org/us-gaap/role/ref/otherTransitionRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 32
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-32

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 924
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SAB Topic 11.L)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479941/924-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 5
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-5

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 30
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-30

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 42
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-42

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 40
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-40

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 280
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 22
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482810/280-10-50-22

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-4

+ Details

Agreements - Summary of Aggregate Amount Paid for the Assets Acquired (Parenthetical) (Detail) - USD ($)
$ in Thousands

1 Months Ended

9 Months Ended

Jan. 31, 2023

Sep. 30, 2024

U.S. Rights for FYCOMPA [Member]

Asset Acquisition [Line Items]

Transaction expenses

$ 5,870

^[1]

$ 5,900

[1]	As of September 30, 2024, the full $5.9 million has been paid in cash.

Inventory

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Inventory

Inventory.

Inventory consists of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	6,948	$	1,910
Work-in-process		3,826		4,573
Finished goods		9,243		9,161
Total inventory	$	20,017	$	15,644

Operating Leases - Lessee, Operating Lease, Liability, Maturity (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2024 (remaining three months)	$ 131
2025	537
2026	553
2027	570
2028	587
Thereafter	1,440
Total lease payments	3,818
Less: imputed interest	(536)
Total	$ 3,282	$ 3,557

Inventory (Tables)

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Summary of current inventory

Inventory consists of the following (in thousands):


	September 30, 2024		December 31, 2023
Raw materials	$	6,948	$	1,910
Work-in-process		3,826		4,573
Finished goods		9,243		9,161
Total inventory	$	20,017	$	15,644

Basis of Presentation and Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Fair Value Measurement Specific to Assets or Liability


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of September 30, 2024		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	$	335,850	$	335,850	$	—	$	—
Investment in equity securities:
Equity securities	$	14,842	$	14,842	$	—	$	—


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of December 31, 2023		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	$	18,256	$	18,256	$	—	$	—
U.S. Treasuries	$	94,523	$	94,523	$	—	$	—
Investment in equity securities:
Equity securities	$	16,489	$	16,489	$	—	$	—

Summary of Disaggregated Product Revenue

The following table summarizes the Company’s net product revenue disaggregated by product (in thousands):


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
FIRDAPSE®	$	79,303	$	66,224	$	223,517	$	188,648
FYCOMPA®+		32,075		36,393		99,035		98,750
AGAMREE®*		15,046		—		24,966		—
Total product revenue, net	$	126,424	$	102,617	$	347,518	$	287,398

_________________

+FYCOMPA® net product revenue for the nine months ended September 30, 2023 is for the period between January 24, 2023 (date of acquisition) and September 30, 2023.

*AGAMREE® net product revenue for the nine months ended September 30, 2024 is for the period between March 13, 2024 (date of commercial launch) and September 30, 2024.

Summary of Percentage of the Company's Total Net Product Revenue

The following table illustrates the approximate percentage of the Company’s total net product revenue attributed to the Company’s largest customers for the periods presented:


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023
Customer A		74.6	%		64.5	%		71.5	%		65.6	%
Customer B*		—			35.5	%		—			34.4	%
Customer C		9.4	%		—			10.0	%		—
Total		84.0	%		100.0	%		81.5	%		100.0	%

*During 2023, the Company sold FYCOMPA® through a Transition Service Agreement with a U.S. subsidiary of Eisai. Effective January 1, 2024, FYCOMPA® is being sold and distributed through a third-party logistics (3PL) organization. Customers B and C both relate to sales of FYCOMPA®.

Basic and Dilutive Weighted Average Common Shares

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


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Basic weighted average common shares outstanding		118,931,153		106,568,137		117,976,056		106,133,077
Effect of dilutive securities		6,476,126		—		6,543,782		7,618,293
Diluted weighted average common shares outstanding		125,407,279		106,568,137		124,519,838		113,751,370

Insider Trading Arrangements	9 Months Ended
Insider Trading Arrangements	Sep. 30, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Investments - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Investments, Debt and Equity Securities [Abstract]
Realized gains losses from available for sale securities	$ 0	$ 0	$ 0	$ 0

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions		1 Months Ended
	Jul. 11, 2022	Jan. 31, 2023	Jul. 11, 2024	Jul. 11, 2023
Commitments [Line Items]
Number of trading days from receipt of the notice letter		45 days
License and asset purchase agreement payment made in first year	$ 10.0
License and asset purchase agreement payment made in second year				$ 10.0
License and asset purchase agreement payment made in third year			$ 10.0
License and Asset Purchase Agreement [Member]
Commitments [Line Items]
Purchase price of an asset acquisition	$ 30.0
Percentage of the consideration paid by a third party to acquire that voucher	50.00%
License and Asset Purchase Agreement [Member] \| Calendar Years 2022 Through 2025 [Member]
Commitments [Line Items]
Percentage of annual royalty on the Company's net sales	1.50%
Minimum royalty amount	$ 3.0
License and Asset Purchase Agreement [Member] \| Calendar Year 2026 [Member]
Commitments [Line Items]
Percentage of annual royalty on the Company's net sales	2.50%
Minimum royalty amount	$ 5.0

Accrued Expenses and Other Liabilities (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Schedule of Accrued Expenses and Other Liabilities

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


	September 30, 2024		December 31, 2023
Accrued preclinical and clinical trial expenses	$	869	$	1,015
Accrued professional fees		8,250		4,730
Accrued compensation and benefits		8,013		8,883
Accrued license fees		24,667		24,437
Accrued purchases		513		192
Operating lease liability		393		369
Accrued gross-to-net revenue liabilities*		47,455		6,877
Accrued income tax		—		729
Due to licensor		2,871		12,540
Accrued interest payable		352		1,031
Other		449		465
Current accrued expenses and other liabilities		93,832		61,268
Lease liability – non-current		2,889		3,188
Due to licensor – non-current		610		2,497
Other – non-current		2,175		485
Non-current accrued expenses and other liabilities		5,674		6,170
Total accrued expenses and other liabilities	$	99,506	$	67,438

* During 2023, the Company sold FYCOMPA® through a Transition Service Agreement with Eisai. Effective January 1, 2024, FYCOMPA® is being sold and distributed through a 3PL organization.

Basis of Presentation and Significant Accounting Policies - Summary of Percentage of the Company's Total Net Product Revenue (Detail) - Revenue Benchmark [Member] - Customer Concentration Risk [Member]

3 Months Ended

9 Months Ended

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Customer A [Member]

Concentration Risk [Line Items]

Concentration risk, percentage

74.60%

64.50%

71.50%

65.60%

Customer B [Member]

Concentration Risk [Line Items]

Concentration risk, percentage

^[1]

0.00%

35.50%

0.00%

34.40%

Customer C [Member]

Concentration Risk [Line Items]

Concentration risk, percentage

9.40%

0.00%

10.00%

0.00%

Customer [Member]

Concentration Risk [Line Items]

Concentration risk, percentage

84.00%

100.00%

81.50%

100.00%

[1]	*During 2023, the Company sold FYCOMPA® through a Transition Service Agreement with a U.S. subsidiary of Eisai. Effective January 1, 2024, FYCOMPA® is being sold and distributed through a third-party logistics (3PL) organization. Customers B and C both relate to sales of FYCOMPA®.

Investments (Tables)

9 Months Ended

Sep. 30, 2024

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 September 30, 2024:
U.S. Treasuries - Cash equivalents	$	—	$	—	$	—	$	—
Total	$	—	$	—	$	—	$	—
At December 31, 2023:
U.S. Treasuries - Cash equivalents	$	94,523	$	18	$	—	$	94,505
Total	$	94,523	$	18	$	—	$	94,505

Summary Of Net Gains And Losses On Equity Securities


	For the Three Months Ended September 30,					For the Nine Months Ended September 30,
	2024		2023			2024			2023
Equity securities:
Net gains (losses) recognized during the period on equity securities	$	1,759	$	(568	)	$	(1,647	)	$	(568	)
Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date	$	1,759	$	(568	)	$	(1,647	)	$	(568	)

- Definition

Tabular disclosure of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-9

Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 6: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (aa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 7: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (aaa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 9: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 10: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 11: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

Reference 12: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-3

+ Details

Investments

9 Months Ended

Sep. 30, 2024

Investments, Debt and Equity Securities [Abstract]

Investments

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 September 30, 2024:
U.S. Treasuries - Cash equivalents	$	—	$	—	$	—	$	—
Total	$	—	$	—	$	—	$	—
At December 31, 2023:
U.S. Treasuries - Cash equivalents	$	94,523	$	18	$	—	$	94,505
Total	$	94,523	$	18	$	—	$	94,505

There were no realized gains or losses from available-for-sale securities during the three and nine months ended September 30, 2024 and 2023.


	For the Three Months Ended September 30,					For the Nine Months Ended September 30,
	2024		2023			2024			2023
Equity securities:
Net gains (losses) recognized during the period on equity securities	$	1,759	$	(568	)	$	(1,647	)	$	(568	)
Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date	$	1,759	$	(568	)	$	(1,647	)	$	(568	)

There were no sales of equity securities during the three and nine months ended September 30, 2024 and 2023.

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2024

Text Block [Abstract]

Prepaid expenses and other current assets

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


	September 30, 2024		December 31, 2023
Prepaid manufacturing costs	$	180	$	2,005
Prepaid tax		6,166		1,238
Prepaid insurance		489		1,332
Prepaid subscriptions fees		1,870		1,299
Prepaid research fees		1,833		1,500
Prepaid commercialization expenses		4,543		3,038
Due from collaborative and licensing arrangements		—		138
Prepaid conference and travel expenses		1,233		771
Prepaid co-pay assistance program		1,561		863
Other		509		351
Total prepaid expenses and other current assets	$	18,384	$	12,535

Inventory - Summary of current inventory (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Inventory Disclosure [Abstract]
Raw materials	$ 6,948	$ 1,910
Work-in-process	3,826	4,573
Finished goods	9,243	9,161
Total inventory	$ 20,017	$ 15,644

Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accrued preclinical and clinical trial expenses	$ 869	$ 1,015
Accrued professional fees	8,250	4,730
Accrued compensation and benefits	8,013	8,883
Accrued license fees	24,667	24,437
Accrued purchases	513	192
Operating lease liability	393	369
Accrued gross-to-net revenue liabilities	47,455	6,877
Accrued income tax	0	729
Due to licensor	2,871	12,540
Accrued interest payable	352	1,031
Other	449	465
Current accrued expenses and other liabilities	93,832	61,268
Lease liability – non-current	2,889	3,188
Due to licensor – non-current	610	2,497
Other – non-current	2,175	485
Non-current accrued expenses and other liabilities	5,674	6,170
Total accrued expenses and other liabilities	$ 99,506	$ 67,438

Agreements

9 Months Ended

Sep. 30, 2024

Text Block [Abstract]

Agreements

13.

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’s commercial territory will be expanded under the license agreement to include most of Asia, as well as Latin America, upon the acceptance by the Pharmaceuticals and Medical Devices Agency (PMDA) of a Japan MAA for FIRDAPSE® for LEMS. Under the amendment, the Company will pay royalties to its 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.

On December 18, 2023, DyDo filed a Japan NDA with the PMDA, which was accepted for filing upon its submission. As a result, the Company’s territory automatically expanded on that date to include most of Asia and Latin America.

In January 2020, the Company was advised that BioMarin has transferred substantially all of its rights under the license agreement to SERB S.A., and SERB S.A. is now the Company’s licensor under the license agreement.

LICENSE AGREEMENT FOR RUZURGI®. On July 11, 2022 (the Effective Date), the Company entered into an exclusive license agreement with Jacobus Pharmaceutical Company, Inc. (Jacobus), for the rights to develop and commercialize RUZURGI® in the U.S. and Mexico.

Pursuant to the terms of the license agreement, the Company paid Jacobus a $10 million up-front payment on the Effective Date and also paid an additional $10 million on the first annual anniversary of the Effective Date (July 11, 2023). The Company paid the final $10 million installment on the second annual anniversary of the Effective Date (July 11, 2024). The Company is also obligated to pay tiered royalty payments on net sales (as defined in the license agreement) of all of the Company’s amifampridine products in the U.S. that range from 1.25% to 2.5% based on whether there is a competing product or generic version of FIRDAPSE® being marketed or sold in the U.S.

A minimum royalty payment exists annually for calendar years from the Effective Date through 2025 of $3 million, provided that such minimum annual royalty payment shall be prorated in the first calendar year of the agreement. As these minimum payments are both probable and estimable, they are included in the purchase price of the agreement and any royalties in excess of this amount will be charged to cost of sales as revenue from product sales is recognized. A minimum royalty payment exists annually for calendar years from 2026 through the expiration of the royalty term (which ends when there is no valid claim under the Company’s FIRDAPSE® patents in the U.S.) of $5 million unless a competing product or generic version of FIRDAPSE® is being marketed or sold in the U.S. If these minimum payments become probable in the future, the Company would recognize a contingent liability at that time with an offset to the value of the intangible asset acquired. Any royalties in excess of this amount will be charged to cost of sales as revenue from product sales is recognized. Royalties over the minimum, if any, will be paid based on the agreement terms on a quarterly basis.

Assets acquired as part of the license agreement include among other intellectual property rights, Jacobus’ U.S. patents related to RUZURGI®, its new drug applications in the U.S. for RUZURGI®, its U.S. Trademark for RUZURGI®, the Orphan Drug Designation for RUZURGI® and a license from Jacobus for use of its know-how related to the manufacture of RUZURGI®.

Additionally, the Company also purchased from Jacobus approximately $4.1 million of RUZURGI® inventory previously manufactured by Jacobus, which was recorded as an expense in research and development expenses in the consolidated statements of operations and comprehensive income (loss) for 2022.

13.

Agreements (continued).

Under business combination guidance, the screen test states that if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the set is not considered a business and is accounted for as an asset acquisition. The Company has determined that the screen test was not met. However, the Company determined that the acquisition did not meet the definition of a business under ASC 805, Business Combination. The Company believes that the licensing agreement and other assets acquired from Jacobus are similar and considered them all to be intangible assets with the exception of the inventory acquired. As the screen test was not met, further determination was required to determine that the Company had not acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business, and therefore, determined that this was an asset acquisition. The Company accounted for the Jacobus license agreement as an asset acquisition under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes consideration given.

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


License and acquired intangibles	$	33,569
Acquired research and development inventory expensed from asset acquisition		4,130
Total purchase price	$	37,699

The straight-line method is used to amortize the license and acquired intangibles, as disclosed in Note 9 (License and Acquired Intangibles, Net).

ACQUISITION OF U.S. RIGHTS FOR FYCOMPA®. On January 24, 2023, the Company acquired the U.S. Rights for FYCOMPA® (perampanel) CIII a commercial stage epilepsy asset, from Eisai. The aggregate consideration for the acquisition was $164.2 million in cash, including the reimbursement of certain liabilities and the payment of transaction costs.

Eisai was eligible to receive a contingent payment of $25 million if a certain regulatory milestone was met. As meeting the regulatory milestone was not probable, the Company did not recognize any amount related to the milestone payments in the purchase price. Additionally, after the loss of patent exclusivity for FYCOMPA®, the Company may be obligated to pay certain royalties to Eisai on net sales of FYCOMPA®. As the transaction is accounted for as an asset acquisition under U.S. GAAP, the Company will recognize the royalty payments in cost of sales as revenue from product sales is recognized.

Royalties commencing on loss of exclusivity for each calendar year during the royalty term equal to 12% on net sales greater than $10 million and less than $100 million, 17% on net sales of greater than $100 million and less than $125 million and 22% on net sales greater than $125 million prior to the date of generic entry. Royalties equal to 6% on net sales greater than $10 million and less than $100 million, 8.5% on net sales of greater than $100 million and less than $125 million and 11% on net sales greater than $125 million after the date of generic entry.

The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of FYCOMPA® (in thousands):


Base cash payment	$	160,000
Cash paid for pro-rated prepaid expenses		1,576
Reimbursement on base purchase price(i)		(3,238	)
Transaction costs(ii)		5,870
Total purchase consideration	$	164,208

(i)

Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023.

(ii)

As of September 30, 2024, the full $5.9 million has been paid in cash.

13.

Agreements (continued).

The acquisition of FYCOMPA® has been accounted for as an asset acquisition in accordance with FASB ASC 805-50. The Company accounted for the acquisition of FYCOMPA® as an asset acquisition because substantially all of the fair value of the assets acquired is concentrated in a single asset, the FYCOMPA® product rights. The FYCOMPA® product rights consist of certain patents and trademarks, at-market contracts and regulatory approvals, marketing assets, and other records, and are considered a single asset as they are inextricably linked. ASC 805-10-55-5A includes a screen test, which provides that if substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the assets acquired are not considered to be a business. ASC 805 requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes consideration given.

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


Inventory	$	4,100
Prepaid expenses and other current assets (samples)		130
Prepaid commercialization expenses		1,576
Property and equipment, net		433
License and acquired intangibles for FYCOMPA®		158,143
Accrued preclinical and clinical trial expenses		(174	)
Total purchase consideration	$	164,208

The straight-line method is used to amortize the license and acquired intangibles, as disclosed in Note 9 (License and Acquired Intangibles, Net).

LICENSE AGREEMENT FOR AGAMREE® (VAMOROLONE). In July 2023, the Company completed its acquisition from Santhera of an exclusive license for North America for AGAMREE® (vamorolone), a treatment for patients suffering with DMD which was approved by the FDA on October 26, 2023. On March 13, 2024, the Company announced the U.S. commercial launch of AGAMREE® for the treatment of DMD in patients aged two years or older. The license is for exclusive commercial rights in the U.S., Canada, and Mexico, as well as the right of first negotiation in Europe and Japan should Santhera pursue partnership opportunities in those jurisdictions. Additionally, the Company will hold North American rights for any future approved indications of AGAMREE®. The Company made an all-cash initial payment of $75 million at the closing of the acquisition to acquire the license.

Under the license agreement, the Company pays: (i) royalties to the licensor until the later of expiration of product exclusivity or ten years from the first commercial sale of AGAMREE® equal to 5% of net sales (as defined in the license agreement) in North America for any calendar year for sales equal to or less than $100 million (prior to December 31, 2025 only), 7% of net sales for sales in excess of $100 million and up to $200 million, 9% of net sales for sales in excess of $200 million and up to $300 million, 11% of net sales for sales in excess of $300 million; and (ii) royalties to the third-party licensor of the rights sublicensed to the Company until the later of expiration of product exclusivity or ten years from the first commercial sale of AGAMREE® equal to 7% of net sales (as defined in the license agreement) in North America for any single calendar year for sales equal to or less than $250 million, 8.5% of net sales for sales in excess of $250 million and up to $500 million, 10% of net sales for sales in excess of $500 million and up to $750 million, 12% of net sales for sales in excess of $750 million and up to $1 billion, 13% of net sales for sales in excess of $1 billion and up to $2 billion and 15% of net sales for sales in excess of $2 billion. Furthermore, the Company may pay Santhera sales-based milestones of up to $105 million as well as up to 11% percent royalties for all additional indications and milestones of up to $50 million for the first three additional indications.

Simultaneously, the Company made a strategic equity investment into Santhera by acquiring 1,414,688 of Santhera’s post reverse-split ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares immediately following the transaction), which are traded on the SIX Swiss Exchange, at an investment price of CHF 9.477 per share (corresponding to a mutually agreed volume-weighted average price prior to signing), with the funds invested into Santhera to be used by Santhera for Phase IV studies in DMD and further development of additional indications for AGAMREE®. The Company may also be obligated under certain circumstances to make milestone payments and to pay royalties to Santhera.

13.

Agreements (continued).

The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of AGAMREE® and the strategic equity investment (in thousands):


Initial cash payment	$	75,000
Investment in Santhera		13,465
Transaction costs		6,513
Total purchase consideration	$	94,978

The transaction has been accounted for as an asset acquisition in accordance with ASC 805-50. The Company accounted for the transaction as an asset acquisition because substantially all of the fair value of the assets acquired is concentrated in a single asset, the rights to develop, commercialize and manufacture AGAMREE®. The AGAMREE® rights consist of certain licenses and regulatory approvals and are considered a single asset as they are inextricably linked. ASC 805-10-55-5A includes a screen test, which provides that if substantially all of the fair value of the assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, the assets acquired are not considered to be a business. Additionally, the Company did not acquire a substantive process. ASC 805 requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes consideration given. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the non-financial assets based on relative fair values.

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


License and acquired intangibles for AGAMREE® (vamorolone) (IPR&D)	$	81,513
Investment in Santhera(i)		13,465
Total purchase consideration	$	94,978

(i)

The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023.

In accordance with FASB ASC 730-10-25, as AGAMREE® (vamorolone) had not achieved regulatory approval when acquired, the portion of the purchase price allocated to the IPR&D asset acquired (which includes all transaction costs related to the transactions with Santhera) was immediately expensed to research and development. Milestone payments made are either expensed as research and development or capitalized as a developed asset based on when regulatory approval is obtained. As the transaction is accounted for as an asset acquisition under U.S. GAAP, the Company will recognize all sales-based milestone and royalty payments in cost of sales as revenue from product sales is recognized.

Following the approval of the NDA for AGAMREE® on October 26, 2023, the Company became obligated to make a milestone payment of $36 million to Santhera. The $36 million payment was made during the fourth quarter of 2023. The Company capitalized the $36 million payment which is amortized using the straight-line method over the product’s estimated useful life of 10.5 years.

The strategic equity investment in Santhera is accounted for as an investment in equity securities, and is recognized as a non-current asset, as the Company does not intend on selling the shares within 12 months. Since Santhera shares have a readily determinable fair value, the investment will be measured quarterly at fair value with changes reported in earnings in other income (expense), net in the accompanying consolidated statements of operations and comprehensive income (loss).

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.

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
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	119,266,561	107,121,549
Common stock, shares outstanding	119,266,561	107,121,549

Operating Leases - Schedule of Supplemental Cash Flow Information Related To Lease (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$ 391	$ 379
Right-of-use assets obtained in exchange for lease obligations:
Operating leases	$ 67	$ 67

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) - USD ($)
$ in Thousands

3 Months Ended

9 Months Ended

Sep. 30, 2024

Sep. 30, 2023

Sep. 30, 2024

Sep. 30, 2023

Revenues:

Total revenues

$ 128,695

$ 102,688

$ 349,914

$ 287,636

Operating costs and expenses:

Cost of sales

^[1]

19,277

14,167

47,202

36,158

Research and development

3,284

83,662

8,850

91,178

Selling, general and administrative

^[1]

45,880

33,560

133,548

91,674

Amortization of intangible assets

9,345

8,487

28,033

23,506

Total operating costs and expenses

77,786

139,876

217,633

242,516

Operating income (loss)

50,909

(37,188)

132,281

45,120

Other income (expense), net

6,296

(833)

9,801

2,684

Net income (loss) before income taxes

57,205

(38,021)

142,082

47,804

Income tax provision (benefit)

13,321

(7,257)

34,129

11,238

Net income (loss)

$ 43,884

$ (30,764)

$ 107,953

$ 36,566

Net income (loss) per share:

Basic

$ 0.37

$ (0.29)

$ 0.92

$ 0.34

Diluted

$ 0.35

$ (0.29)

$ 0.87

$ 0.32

Weighted average shares outstanding:

Basic

118,931,153

106,568,137

117,976,056

106,133,077

Diluted

125,407,279

106,568,137

124,519,838

113,751,370

Net income (loss)

$ 43,884

$ (30,764)

$ 107,953

$ 36,566

Other comprehensive income (loss) (Note 4):

Unrealized gain (loss) on available-for-sale securities, net of tax of $0, $1, $4 and $3, respectively

(4)

(14)

(9)

Comprehensive income (loss)

43,884

(30,768)

107,939

36,557

Product revenue, net [Member]

Revenues:

Total revenues

126,424

102,617

347,518

287,398

License and other revenue [Member]

Revenues:

Total revenues

$ 2,271

$ 71

$ 2,396

$ 238

[1]	exclusive of amortization of intangible assets

Accumulated Other Comprehensive Income - Summary of Reclassifications out of Accumulated Other Comprehensive Income (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract]
Beginning balance	$ 0	$ 19	$ 14	$ 24
Other comprehensive loss before reclassifications	0	(4)	(14)	(9)
Amount reclassified from accumulated other comprehensive income	0	0	0	0
Net current period other comprehensive gain (loss)	0	(4)	(14)	(9)
Ending balance	$ 0	$ 15	$ 0	$ 15

- Definition

Amount, after tax, of accumulated increase (decrease) in equity from transaction and other event and circumstance from nonowner source.

+ References + Details

- Definition

Amount after tax of reclassification adjustments of other comprehensive income (loss).

+ References + Details

Operating Leases (Tables)

9 Months Ended

Sep. 30, 2024

Operating Lease, Lease Income [Abstract]

Lease, Cost

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


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease cost	$	108	$	108	$	323	$	323

Schedule of Supplemental Cash Flow Information Related To Lease

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


	For the Nine Months Ended September 30,
	2024		2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	391	$	379
Right-of-use assets obtained in exchange for lease obligations:
Operating lease	$	67	$	67

Schedule of Supplemental Balance Sheet related To Lease

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


	September 30, 2024		December 31, 2023
Operating lease right-of-use assets, net	$	2,301	$	2,508
Other current liabilities	$	393	$	369
Operating lease liabilities, net of current portion		2,889		3,188
Total operating lease liabilities	$	3,282	$	3,557

Lessee, Operating Lease, Liability, Maturity

Remaining payments of lease liabilities as of September 30, 2024 were as follows (in thousands):


2024 (remaining three months)	$	131
2025		537
2026		553
2027		570
2028		587
Thereafter		1,440
Total lease payments		3,818
Less: imputed interest		(536	)
Total	$	3,282

Agreements - Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values (Detail) - License Agreement For RUZURGI [Member] $ in Thousands	Jul. 11, 2022 USD ($)
Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values [Line Items]
License and acquired intangibles	$ 33,569
Acquired research and development inventory expensed from asset acquisition	4,130
Total purchase price	$ 37,699

Stock Compensation (Tables)

9 Months Ended

Sep. 30, 2024

Share-based Payment Arrangement [Abstract]

Stock-Based Compensation Expense

For the three and nine months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense as follows (in thousands):


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	402	$	372	$	1,314	$	1,062
Selling, general and administrative		4,022		3,438		15,766		8,938
Total stock-based compensation	$	4,424	$	3,810	$	17,080	$	10,000

Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail)	Sep. 30, 2024 Vote $ / shares shares	Dec. 31, 2023 $ / 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	119,266,561	107,121,549
Common stock, shares outstanding	119,266,561	107,121,549
Number of votes entitled for each share of common stock \| Vote	1

Stock Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 4,424	$ 3,810	$ 17,080	$ 10,000
Research and Development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	402	372	1,314	1,062
Selling, General and Administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation	$ 4,022	$ 3,438	$ 15,766	$ 8,938

Operating Leases - Operating Leases (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Lease, Cost [Abstract]
Operating lease cost	$ 108	$ 108	$ 323	$ 323

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2024	Nov. 04, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Entity Registrant Name	CATALYST PHARMACEUTICALS, INC.
Entity Central Index Key	0001369568
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Shell Company	false
Entity Filer Category	Large Accelerated Filer
Trading Symbol	CPRX
Entity Emerging Growth Company	false
Entity Small Business	false
Entity Address, State or Province	FL
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock, par value $0.001 per share
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		119,273,436
Entity Tax Identification Number	76-0837053
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	355 Alhambra Circle
Entity Address, Address Line Two	Suite 801
Entity Address, City or Town	Coral Gables
Entity Address, Postal Zip Code	33134
City Area Code	305
Local Phone Number	420-3200
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-33057

Collaborative and Licensing Arrangements

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Collaborative and Licensing Arrangements

11.

Collaborative and Licensing Arrangements.

Endo, Inc.

In December 2018, the Company entered into a collaboration and license agreement (Collaboration) with Endo, Inc. (formerly, Endo International plc) (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, Inc. (Par). Under the Collaboration, Endo assumed all development, manufacturing, clinical, regulatory, sales and marketing costs under the collaboration, while the Company was responsible for exercising commercially reasonable efforts to develop, or cause the development of, a final finished, stable dosage form of generic Sabril® tablets.

In July 2024, a termination and mutual release agreement was finalized between Endo and the Company that discontinued work on the collaboration for development and commercialization of vigabatrin. The end of the collaboration does not have a material impact on the Company's consolidated financial statements.

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 received an up-front payment, has received payment upon transfer of Marketing Authorization and delivery of commercial product, received payment for supply of FIRDAPSE®, and 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®. The Company has also agreed to the 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 in Canada.

11.

Collaborative and Licensing Arrangements (continued).

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.

In July 2024, the Company entered into a license, supply and commercialization agreement with KYE, for the commercialization of AGAMREE® in Canada granting KYE the exclusive Canadian commercial rights to market AGAMREE® in Canada for DMD and other indications.

Under the agreement, KYE will be responsible for obtaining regulatory approval of the product from Health Canada and the Company will supply product to KYE. Further, the Company received an upfront payment from KYE and will be eligible to receive further reimbursement, sales milestones and sales royalties for AGAMREE®.

These agreements are in form identified as collaborative agreements and the Company has concluded for accounting purposes that they also represent contracts with a customer. This is because the Company grants to KYE a license and provides supply of FIRDAPSE® and AGAMREE® in exchange for consideration, which are outputs of the Company’s ongoing activities. Accordingly, the Company has concluded that these collaborative arrangements will be accounted for pursuant to Topic 606.

Revenue from sales by KYE is recognized in the quarter in which the sales occurred.

Revenues from the arrangements with KYE for the three and nine months ended September 30, 2024 and 2023 were not material. Revenue is included in license and other revenue in the accompanying consolidated statements of operations and comprehensive income (loss). Expenses incurred, net have been included in selling, general and administrative expenses in the accompanying consolidated statements of operations and comprehensive income (loss).

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 latter 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.

There were revenues of $2.1 million from the arrangement with DyDo for both the three and nine months ended September 30, 2024, which consisted of a milestone payment earned upon DyDo receiving regulatory approval to commercialize FIRDAPSE® for the treatment of patients with LEMS in Japan and is included in license and other revenue in the accompanying consolidated statements of operations and comprehensive income (loss). There were revenues of $0 and $0.5 million from the arrangement with DyDo for the three and nine months ended September 30, 2023, respectively, which is included in product revenue, net in the accompanying consolidated statements of operations and comprehensive income (loss). Further, on September 24, 2024, DyDo advised the Company that the Ministry of Health, Labour and Welfare (MHLW) had approved DyDo's Japan NDA to commercialize FIRDAPSE® for the treatment of patients with LEMS in Japan and that DyDo expects to launch the product in Japan by the end of the fourth quarter of 2024.

Stockholders' Equity ( Share Repurchases ) - Additional Information (Detail) - Common Stock [Member] - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Mar. 31, 2021
Stockholders Equity [Line Items]
Aggregate share repurchased	0	0	0	0
Share Purchase Program [Member]
Stockholders Equity [Line Items]
Share repurchase program, authorised					$ 40

- Definition

Number of shares that have been repurchased during the period and have not been retired and are not held in treasury. Some state laws may govern the circumstances under which an entity may acquire its own stock and prescribe the accounting treatment therefore. This element is used when state law does not recognize treasury stock.

+ References + Details

Operating Leases

9 Months Ended

Sep. 30, 2024

Operating Lease, Lease Income [Abstract]

Operating Leases

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 5 years and options to terminate the lease within 6 and 7.6 years. The Company has 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.

Operating Leases (continued).

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


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Operating lease cost	$	108	$	108	$	323	$	323

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


	For the Nine Months Ended September 30,
	2024		2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$	391	$	379
Right-of-use assets obtained in exchange for lease obligations:
Operating lease	$	67	$	67

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


	September 30, 2024		December 31, 2023
Operating lease right-of-use assets, net	$	2,301	$	2,508
Other current liabilities	$	393	$	369
Operating lease liabilities, net of current portion		2,889		3,188
Total operating lease liabilities	$	3,282	$	3,557

As of September 30, 2024 and December 31, 2023, the weighted average remaining lease term was 6.6 years and 7.3 years, respectively. The weighted average discount rate used to determine the operating lease liabilities was 4.51% as of September 30, 2024 and December 31, 2023.

Remaining payments of lease liabilities as of September 30, 2024 were as follows (in thousands):


2024 (remaining three months)	$	131
2025		537
2026		553
2027		570
2028		587
Thereafter		1,440
Total lease payments		3,818
Less: imputed interest		(536	)
Total	$	3,282

Rent expense was approximately $0.1 million and $0.3 million for both the three and nine months ended September 30, 2024 and 2023, respectively.

Income Taxes

9 Months Ended

Sep. 30, 2024

Income Tax Disclosure [Abstract]

Income Taxes

14.

Income Taxes.

The Company’s effective income tax rate was 24.0% and 23.5% for the nine months ended September 30, 2024 and 2023, respectively. Differences in the effective tax and the statutory federal income tax rate of 21% are increased by state income taxes, fluctuations in the value of investments and anticipated annual permanent differences offset by equity compensation deductions.

The Company had no uncertain tax positions as of September 30, 2024 and December 31, 2023.

- Definition

The entire disclosure for income tax.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 740
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-Name Accounting Standards Codification
-Section 55
-Paragraph 231
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482663/740-10-55-231

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12C
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12C

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Section 50
-Paragraph 12B
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-URI https://asc.fasb.org/1943274/2147482685/740-10-50-12B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477891/740-270-50-1

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
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-Paragraph 14
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479360/740-10-S99-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482603/740-30-50-2

+ Details

License and Acquired Intangibles, Net - Schedule of Finite Lived Intangible Assets (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Value	$ 227,712	$ 227,712
Accumulated Amortization	61,696	33,663
Net Carrying Value	166,016	194,049
License and Acquired Intangibles for RUZURGI [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Value	33,569	33,569
Accumulated Amortization	5,158	3,418
Net Carrying Value	28,411	30,151
License and Acquired Intangibles for FYCOMPA [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Value	158,143	158,143
Accumulated Amortization	53,395	29,673
Net Carrying Value	104,748	128,470
Licensed And Acquired Intangibles For AGAMREE [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Carrying Value	36,000	36,000
Accumulated Amortization	3,143	572
Net Carrying Value	$ 32,857	$ 35,428

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Agreements - Summary of Total Purchase Price Allocated to Acquired Assets (Detail) - USD ($) $ in Thousands	1 Months Ended
	Jul. 31, 2023	Jan. 31, 2023
Asset Acquisition [Line Items]
Total purchase consideration	$ 94,978
U.S. Rights for FYCOMPA [Member]
Asset Acquisition [Line Items]
Inventory		$ 4,100
Prepaid expenses and other current assets (samples)		130
Prepaid commercialization expenses		1,576
Property and equipment, net		433
License and acquired intangibles for FYCOMPA®		158,143
Accrued preclinical and clinical trial expenses		(174)
Total purchase consideration		$ 164,208

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Operating Activities:
Net income (loss)	$ 107,953	$ 36,566
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation	283	232
Stock-based compensation	17,080	10,000
Amortization of intangible assets	28,033	23,506
Deferred taxes	(11,943)	(18,701)
Accretion of discount	(796)	1,146
Reduction in the carrying amount of right-of-use asset	207	195
Acquired inventory samples expensed from asset acquisition	0	130
Acquired in-process research and development	0	79,288
Change in fair value of equity securities	1,647	568
(Increase) decrease in:
Accounts receivable, net	(4,752)	(37,610)
Inventory	(4,373)	1,870
Prepaid expenses and other current assets	(5,849)	(7,219)
Increase (decrease) in:
Accounts payable	(3,232)	623
Accrued expenses and other liabilities	44,948	(2,390)
Operating lease liability	(275)	(252)
Net cash provided by (used in) operating activities	168,931	87,952
Investing Activities:
Purchases of property and equipment	(468)	(138)
Payment in connection with asset acquisition	0	(162,293)
Acquisition of in-process research and development	0	(79,288)
Purchase of equity securities	0	(13,465)
Net cash provided by (used in) investing activities	(468)	(255,184)
Financing Activities:
Payment of employee withholding tax related to stock-based compensation	(204)	(529)
Proceeds from exercise of stock options	7,531	2,099
Payment of liabilities arising from asset acquisition	(11,799)	(11,762)
Proceeds from issuance of common stock	141,000	0
Payment of fees in connection with issuance of common stock	(296)	0
Net cash provided by (used in) financing activities	136,232	(10,192)
Net increase (decrease) in cash and cash equivalents	304,695	(177,424)
Cash and cash equivalents – beginning of period	137,636	298,395
Cash and cash equivalents – end of period	442,331	120,971
Supplemental disclosures of cash flow information:
Cash paid for income taxes	51,691	41,663
Cash paid for interest	1,301	650
Non-cash investing and financing activities:
Liabilities arising from asset acquisition	$ 0	$ 1,915

Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]
Prepaid manufacturing costs	$ 180	$ 2,005
Prepaid tax	6,166	1,238
Prepaid insurance	489	1,332
Prepaid subscriptions fees	1,870	1,299
Prepaid research fees	1,833	1,500
Prepaid commercialization expenses	4,543	3,038
Due from collaborative and licensing arrangements	0	138
Prepaid conference and travel expenses	1,233	771
Prepaid co-pay assistance program	1,561	863
Other	509	351
Total prepaid expenses and other current assets	$ 18,384	$ 12,535

License and Acquired Intangibles, Net - Schedule of Finite-Lived, Future Amortization Expense (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract]
2024 (remaining three months)	$ 9,345
2025	37,378
2026	37,378
2027	37,378
2028	7,705
Thereafter	36,832
Total	$ 166,016	$ 194,049

Investments - Summary of Available-for-Sale Investments by Security type (Detail) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Net Investment Income [Line Items]
Estimated Fair Value	$ 0	$ 94,523
Gross Unrealized Gains	0	18
Gross Unrealized Losses	0	0
Amortized cost	0	94,505
U.S. Treasuries—Cash equivalents [Member]
Net Investment Income [Line Items]
Estimated Fair Value	0	94,523
Gross Unrealized Gains	0	18
Gross Unrealized Losses	0	0
Amortized cost	$ 0	$ 94,505

- Definition

Amount of investment in debt security measured at fair value with change in fair value recognized in other comprehensive income (available-for-sale).

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 103
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-103

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(2)(i)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 5: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (bbb)(1)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (aa)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481800/320-10-50-2

Reference 8: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 320
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481830/320-10-45-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 942
-SubTopic 210
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-03(6))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478546/942-210-S99-1

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 326
-SubTopic 30
-Name Accounting Standards Codification
-Section 45
-Paragraph 1
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479130/326-30-45-1

+ Details

Agreements (Tables)

9 Months Ended

Sep. 30, 2024

Asset Acquisition [Line Items]

Schedule Of Total Purchase Price Was Allocated To The Acquired Assets Based On Their Relative Fair Values

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


License and acquired intangibles	$	33,569
Acquired research and development inventory expensed from asset acquisition		4,130
Total purchase price	$	37,699

Summary of Aggregate Amount Paid for the Assets Acquired

The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of FYCOMPA® (in thousands):


Base cash payment	$	160,000
Cash paid for pro-rated prepaid expenses		1,576
Reimbursement on base purchase price(i)		(3,238	)
Transaction costs(ii)		5,870
Total purchase consideration	$	164,208

(i)

Recorded in prepaid expenses and other current assets in the accompanying consolidated balance sheet as of the acquisition date and reimbursement was fully applied as of June 30, 2023.

(ii)

As of September 30, 2024, the full $5.9 million has been paid in cash.

Summary of Total Purchase Price Allocated to Acquired Assets

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


Inventory	$	4,100
Prepaid expenses and other current assets (samples)		130
Prepaid commercialization expenses		1,576
Property and equipment, net		433
License and acquired intangibles for FYCOMPA®		158,143
Accrued preclinical and clinical trial expenses		(174	)
Total purchase consideration	$	164,208

Vamorolone [Member]

Asset Acquisition [Line Items]

Summary of Aggregate Amount Paid for the Assets Acquired

The following table summarizes the aggregate amount paid for the assets acquired by the Company in connection with the acquisition of AGAMREE® and the strategic equity investment (in thousands):


Initial cash payment	$	75,000
Investment in Santhera		13,465
Transaction costs		6,513
Total purchase consideration	$	94,978

Summary of Total Purchase Price Allocated to Acquired Assets

The total purchase price was allocated to the acquired assets based on their relative fair values, as follows (in thousands):


License and acquired intangibles for AGAMREE® (vamorolone) (IPR&D)	$	81,513
Investment in Santhera(i)		13,465
Total purchase consideration	$	94,978

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment, net

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


	September 30, 2024			December 31, 2023
Furniture and equipment	$	962		$	494
Leasehold improvements		991			991
Software		433			433
Less: Accumulated depreciation		(1,006	)		(723	)
Total property and equipment, net	$	1,380		$	1,195

CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 442,331	$ 137,636
Accounts receivable, net	58,266	53,514
Inventory	20,017	15,644
Prepaid expenses and other current assets	18,384	12,535
Total current assets	538,998	219,329
Operating lease right-of-use asset, net	2,301	2,508
Property and equipment, net	1,380	1,195
License and acquired intangibles, net	166,016	194,049
Deferred tax assets, net	48,473	36,544
Investment in equity securities	14,842	16,489
Total assets	772,010	470,114
Current Liabilities:
Accounts payable	11,563	14,795
Accrued expenses and other liabilities	93,832	61,268
Total current liabilities	105,395	76,063
Operating lease liability, net of current portion	2,889	3,188
Other non-current liabilities	2,785	2,982
Total liabilities	111,069	82,233
Commitments and contingencies (Note 12)
Stockholders' equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at September 30, 2024 and December 31, 2023	0	0
Common stock, $0.001 par value, 200,000,000 shares authorized; 119,266,561 shares and 107,121,549 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	119	107
Additional paid-in capital	431,597	266,488
Retained earnings	229,225	121,272
Accumulated other comprehensive income (Note 4)	0	14
Total stockholders' equity	660,941	387,881
Total liabilities and stockholders' equity	$ 772,010	$ 470,114

Basis of Presentation and Significant Accounting Policies - Schedule Of Reconcile Basic And Dilutive Weighted Average Common Shares (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Weighted Average Number of Shares Outstanding Reconciliation [Abstract]
Basic weighted average common shares outstanding	118,931,153	106,568,137	117,976,056	106,133,077
Effect of dilutive securities	6,476,126		6,543,782	7,618,293
Diluted weighted average common shares outstanding	125,407,279	106,568,137	124,519,838	113,751,370

Organization and Description of Business - Additional Information (Detail) - USD ($) $ in Thousands, shares in Millions		9 Months Ended
	Jan. 09, 2024	Sep. 30, 2024	Sep. 30, 2023
Proceeds from Issuance of Common Stock		$ 141,000	$ 0
Public Offering [Member]
Stock Issued During Period, Shares, New Issues	10
Proceeds from Issuance of Common Stock	$ 140,700

Agreements - Summary of aggregate amount paid for the assets (Detail)
$ in Thousands

1 Months Ended

Jul. 31, 2023

USD ($)

Asset Acquisition [Line Items]

Total purchase consideration

$ 94,978

Vamorolone [Member]

Asset Acquisition [Line Items]

Initial cash payment

75,000

Investment in Santhera

13,465

^[1]

Transaction costs

6,513

Total purchase consideration

$ 94,978

[1]	The fair value of the investment in Santhera was determined based on the closing market price (CHF 8.25) of Santhera shares and the exchange rate (1.1537) of CHF to USD on the date the shares were transferred, July 19, 2023.

Investments - Summary Of Net Gains And Losses On Equity Securities (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Investments, Debt and Equity Securities [Abstract]
Net gains (losses) recognized during the period on equity securities	$ 1,759	$ (568)	$ (1,647)	$ (568)
Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date	$ 1,759	$ (568)	$ (1,647)	$ (568)

Accumulated Other Comprehensive Income

9 Months Ended

Sep. 30, 2024

Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract]

Accumulated Other Comprehensive Income

Accumulated Other Comprehensive Income.

The following table summarizes the changes in accumulated other comprehensive income, net of tax from unrealized gains (losses) on available-for-sale securities (in thousands), the Company’s only component of accumulated other comprehensive income for the three and nine months ended September 30, 2024 and 2023.

There were no reclassifications out of accumulated other comprehensive income during the three and nine months ended September 30, 2024 and 2023.


	Total Accumulated Other Comprehensive Income
Balance at June 30, 2024	$	—
Other comprehensive loss before reclassifications		—
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		—
Balance at September 30, 2024	$	—

Balance at December 31, 2023	$	14
Other comprehensive loss before reclassifications		(14	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(14	)
Balance at September 30, 2024	$	—

Accumulated Other Comprehensive Income (continued).


	Total Accumulated Other Comprehensive Income
Balance at June 30, 2023	$	19
Other comprehensive loss before reclassifications		(4	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(4	)
Balance at September 30, 2023	$	15

Balance at December 31, 2022	$	24
Other comprehensive loss before reclassifications		(9	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(9	)
Balance at September 30, 2023	$	15

Operating Leases - Schedule of Supplemental Balance Sheet related To Lease (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Assets and Liabilities, Lessee [Abstract]
Operating lease right-of-use assets, net	$ 2,301	$ 2,508
Other current liabilities	$ 393	$ 369
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Liabilities, Current	Liabilities, Current
Operating lease liabilities, net of current portion	$ 2,889	$ 3,188
Total operating lease liabilities	$ 3,282	$ 3,557

License and Acquired Intangibles, Net - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]
Amortization of intangible assets			$ 28,033	$ 23,506
Impairment charges recognized on definite-lived intangibles	$ 0	$ 0	$ 0	0
Finite-Lived Intangible Assets, Remaining Amortization Period	5 years 8 months 12 days		5 years 8 months 12 days		6 years 6 months
License and Acquired Intangibles for RUZURGI [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-lived intangible asset, useful life	14 years 6 months		14 years 6 months
Amortization of intangible assets	$ 500	600	$ 1,700	1,800
License and Acquired Intangibles for FYCOMPA [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-lived intangible asset, useful life	5 years		5 years
Amortization of intangible assets	$ 7,900	7,900	$ 23,700	21,800
Licensed And Acquired Intangibles For AGAMREE [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-lived intangible asset, useful life	10 years 6 months		10 years 6 months
Amortization of intangible assets	$ 900	$ 0	$ 2,600	$ 0

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

Basis of Presentation and Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

INTERIM FINANCIAL STATEMENTS

INTERIM FINANCIAL STATEMENTS. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP), and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (SEC) for reporting of interim financial information. Pursuant to such rules and regulations, certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted. The consolidated balance sheet as of December 31, 2023 included in this Form 10-Q was derived from the audited financial statements and does not include all disclosures required by U.S. GAAP.

In the opinion of management, the accompanying unaudited interim consolidated financial statements of the Company contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position of the Company as of the dates and for the periods presented. Accordingly, these consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2023 included in the 2023 Annual Report on Form 10-K filed by the Company with the SEC. The results of operations for the nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for any future period or for the full 2024 fiscal year.

PRINCIPLES OF CONSOLIDATION

PRINCIPLES OF CONSOLIDATION. The consolidated financial statements include the Company’s accounts and those of its wholly-owned subsidiary, Catalyst Pharmaceuticals Ireland, Ltd. (Catalyst Ireland). All intercompany accounts and transactions have been eliminated in consolidation. Catalyst Ireland was organized in 2017.

USE OF ESTIMATES

USE OF ESTIMATES. The preparation of financial statements in conformity with 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

CASH AND CASH EQUIVALENTS. The Company primarily invests in high credit-quality instruments in order to obtain higher yields on its 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 a significant amount of its cash and cash equivalents deposited in money market accounts with two financial institutions.

INVESTMENTS

INVESTMENTS. At September 30, 2024 investments consisted of an investment in equity securities. At December 31, 2023, investments consisted of U.S. Treasuries and an investment in equity securities. Such investments are not insured by the U.S. Federal Deposit Insurance Corporation.

There were no U.S. Treasuries held at September 30, 2024 and U.S. Treasuries held at December 31, 2023 were classified as available-for-sale securities. 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.

The Company records available-for-sale securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (in stockholders’ equity). Realized gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive income (loss) and are derived using the specific identification method for determining the cost of securities sold. Interest income (expense) is recognized when earned and is included in other income (expense), net in the consolidated statements of operations and comprehensive income (loss). The Company recognizes a charge when the declines in the fair value below the amortized cost basis of its available-for-sale securities are judged to be 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 (loss). The Company has not recorded an allowance for credit loss on its available-for-sale securities. See Note 3 (Investments).

In July 2023, the Company made a strategic equity investment into Santhera by acquiring 1,414,688 of Santhera’s post reverse-split ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares immediately following the transaction). The investment is denominated in Swiss Francs. The Company has determined that it does not have significant influence over the operations of Santhera and accordingly the investment in Santhera’s ordinary shares is recorded under ASC 321, Equity Securities, with changes in fair value, inclusive of changes resulting from movements in foreign exchange rates, in other income (expense), net in the consolidated statements of operations and comprehensive income (loss).

ACCOUNTS RECEIVABLE, NET

ACCOUNTS RECEIVABLE, NET. Accounts receivable are 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, current and future economic and market conditions and individual customer circumstances. The Company has not historically experienced any significant credit losses. All customer accounts are actively managed. At September 30, 2024 and December 31, 2023, the Company determined that an allowance for expected credit losses was not required. No amounts were written off during the periods presented.

INVENTORY

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. 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®, FYCOMPA® and AGAMREE® 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 forms of FIRDAPSE®, FYCOMPA® and AGAMREE® utilized for both commercial and clinical programs are identical and, as a result, the inventories have 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. Prepaid expenses and other current assets consist primarily of prepaid manufacturing, prepaid tax, prepaid insurance, prepaid subscription fees, prepaid research fees, prepaid commercialization expenses, prepaid co-pay assistance program, 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 costs consist 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, 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, as per Company policy. 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 and software, from five to seven 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.

BUSINESS COMBINATIONS AND ASSET ACQUISITIONS

BUSINESS COMBINATIONS AND ASSET ACQUISITIONS. The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an asset acquisition. If the screen test is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the requirements of a business. If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable.

See Notes 12 (Commitments and Contingencies) and 13 (Agreements) for further discussion of the Company’s exclusive license agreement with Jacobus Pharmaceutical Company, Inc. (Jacobus), for the rights to develop and commercialize RUZURGI® in the U.S. and Mexico, which the Company accounted for as an asset acquisition under ASC 805-50. See Note 13 (Agreements) for further discussion on the Company’s acquisitions of the U.S. rights to FYCOMPA® from Eisai, and on the exclusive license for North America acquired from Santhera for AGAMREE®, both of which the Company accounted for as asset acquisitions under ASC 805-50.

INTANGIBLE ASSETS, NET

INTANGIBLE ASSETS, NET. Identifiable intangible assets with a finite life are comprised of licensed rights and other acquired intangible assets and are amortized on a straight-line basis over the respective estimated useful life.

The Company reviews intangible assets with finite lives for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist, an impairment test is performed to assess the recoverability of the affected assets by determining whether the carrying amount of such assets exceeds the undiscounted expected future cash flows. If the affected assets are deemed not recoverable, the Company would estimate the fair value of the assets and record an impairment loss.

FAIR VALUE OF FINANCIAL INSTRUMENTS

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 September 30, 2024 and December 31, 2023, the fair value of these instruments approximated their carrying value.

FAIR VALUE MEASUREMENTS

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 September 30, 2024		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	$	335,850	$	335,850	$	—	$	—
Investment in equity securities:
Equity securities	$	14,842	$	14,842	$	—	$	—


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of December 31, 2023		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	$	18,256	$	18,256	$	—	$	—
U.S. Treasuries	$	94,523	$	94,523	$	—	$	—
Investment in equity securities:
Equity securities	$	16,489	$	16,489	$	—	$	—

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 (ROU) assets, net, 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

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.

The Company accounts for share repurchases by charging the excess of the repurchase price over the repurchased common stock’s par value entirely to retained earnings. 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

REVENUE RECOGNITION.

Product Revenues:

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.

The Company recognizes revenue when its customers obtain 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. For FIRDAPSE® and AGAMREE®, subsequent to receiving FDA approvals, the Company entered into an arrangement with one distributor (the Customer), which is the exclusive distributor of FIRDAPSE® and AGAMREE® in the U.S. The Customer subsequently resells FIRDAPSE® and AGAMREE® 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® and AGAMREE®.

During 2023, the Company sold FYCOMPA® in the U.S. commercial market through a Transition Service Agreement with a U.S. subsidiary of Eisai to major wholesalers and specialty pharmaceutical distributors. These sales are often subject to contracts held with managed care organizations and government agencies. The distribution services under the Transition Services Agreement ended on December 31, 2023, and beginning on January 1, 2024, the Company commenced direct sales of FYCOMPA® in the U.S. commercial market.

Product Revenue, Net: The Company recognizes revenue on product sales when its customers obtain control of the Company’s products, which occur 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 60 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 three and nine months ended September 30, 2024 and 2023.

During the three and nine months ended September 30, 2024 and 2023, substantially all of the Company’s product revenues were from sales to customers in the U.S.

The following table summarizes the Company’s net product revenue disaggregated by product (in thousands):


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
FIRDAPSE®	$	79,303	$	66,224	$	223,517	$	188,648
FYCOMPA®+		32,075		36,393		99,035		98,750
AGAMREE®*		15,046		—		24,966		—
Total product revenue, net	$	126,424	$	102,617	$	347,518	$	287,398

_________________

+FYCOMPA® net product revenue for the nine months ended September 30, 2023 is for the period between January 24, 2023 (date of acquisition) and September 30, 2023.

*AGAMREE® net product revenue for the nine months ended September 30, 2024 is for the period between March 13, 2024 (date of commercial launch) and September 30, 2024.

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, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its 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 its customers) or a current liability (if the amount is payable to a party other than its customers).

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 September 30, 2024 and, therefore, the transaction price was not reduced further during the three and nine months ended September 30, 2024 and 2023. 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, Allowances and Wholesaler Fees: The Company provides its customers 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. To the extent the services received are distinct from the sale of products to its customers, these payments are classified in selling, general and administrative expenses in the Company’s consolidated statements of operations and comprehensive income (loss). However, if the Company has determined such services received are not distinct from the Company’s sale of products to its customers, these payments have been recorded as a reduction of revenue within the consolidated statements of operations and comprehensive income (loss) through September 30, 2024 and 2023, as well as a reduction to accounts receivable, net on the consolidated balance sheets.

Prompt Payment Discounts: The Company provides its customers 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 its products, that have 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 liabilities in the consolidated balance sheets.

Product Returns: Consistent with industry practice, the Company offers its customers 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 or master agreement. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period in which 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. Return payments related to the sale of products 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 liabilities in the consolidated balance sheets.

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 paid for the product and the ultimate selling price to the qualified healthcare providers. The Company also participates in programs with government entities and other parties, including covered entities under the 340B Drug Pricing Program, whereby pricing on FYCOMPA® is extended below wholesaler list price to participating entities (the FYCOMPA® Participants). These entities purchase FYCOMPA® through wholesalers at the lower program price and the wholesalers then charge the Company the difference between their acquisition cost and the lower program price.

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 or at the time of a resale to a FYCOMPA® Participant by a wholesaler, and the Company generally issues credits for such amounts within a few weeks of the customer or wholesalers’ notification to the Company of the resale. Reserves for chargebacks consist primarily of chargebacks that the customer or wholesalers have claimed, but for which the Company has not yet issued a credit, as well as an estimate of chargeback claims that the Company expects to receive associated with its products, that have been recognized as revenue, but remains in the distribution channel at the end of each reporting period.

Government Rebates: The Company is subject to discount obligations under state Medicaid, Medicare and other government programs. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue. For reserves related to the sale of its products, there is an establishment of a current liability, which is included in accrued expenses and other 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.

Payor Rebates: The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses and other liabilities on the consolidated balances sheets.

Bridge and Patient Assistance Programs: The Company provides FIRDAPSE® and AGAMREE® 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® or AGAMREE® while the Company is determining the patient’s third-party insurance, prescription drug benefit or other third-party coverage for FIRDAPSE® or AGAMREE®. The Patient Assistance Program provides FIRDAPSE® or AGAMREE® free of charge for longer periods of time for those who are uninsured or functionally uninsured with respect to FIRDAPSE® or AGAMREE® because they are unable to obtain coverage from their payor despite having health insurance, to the extent allowed by applicable law.

The Company provides FYCOMPA® free of charge to uninsured patients who satisfy pre-established criteria through a Patient Assistance Program. In addition, Catalyst provides programs to assist patients through the process for obtaining reimbursement approval for their FYCOMPA® prescriptions from their insurers. Catalyst also provides support for patients using FYCOMPA® through an Instant Savings Card Program.

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 (loss).

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 latter 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 statements 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.

See Note 11 (Collaborative and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements.

RESEARCH AND DEVELOPMENT

RESEARCH AND DEVELOPMENT. Costs incurred in connection with research and development activities are expensed as incurred. These costs consist of direct and indirect costs associated with specific projects, as well as fees paid to various entities that perform research-related services for the Company.

The Company records upfront and milestone payments made to third parties under licensing and collaboration arrangements that occur before a compound receives regulatory approval as acquired in-process research and development (IPR&D). IPR&D acquired as part of an asset acquisition with no alternative future use is expensed immediately to research and development. Milestone payments made after regulatory approval are capitalized as a developed asset and unless the asset is determined to have an indefinite life, the Company amortizes its definite-lived intangible assets using the straight-line method, which is considered the best estimate of economic benefit, over their estimated useful lives.

ADVERTISING EXPENSE

ADVERTISING EXPENSE. Advertising costs are expensed as incurred. The Company incurred approximately $2.5 million and $7.6 million in advertising costs during the three and nine months ended September 30, 2024, respectively, and approximately $1.7 million and $5.4 million during the three and nine months ended September 30, 2023, respectively, which are included in selling, general and administrative expenses in the Company’s consolidated statements of operations and comprehensive income (loss).

STOCK-BASED COMPENSATION

STOCK-BASED COMPENSATION. The Company recognizes expense in the consolidated statements of operations and comprehensive income (loss) 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

CONCENTRATION OF RISK. The financial instruments that potentially subject the Company to concentration of credit risk are cash equivalents, 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 products, FIRDAPSE® and AGAMREE®, in the U.S. 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 related to these products. The Company sells its product, FYCOMPA®, directly to major wholesalers and specialty pharmaceutical distributors and indirectly to managed care organizations and government agencies. The creditworthiness of its customers 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 creditworthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions.

As of September 30, 2024, the Company had three FDA approved products, which makes it difficult to evaluate its current business, predict its future prospects, and forecast financial performance and growth. The Company had invested a significant portion of its efforts and financial resources in the development and commercialization of its lead product, FIRDAPSE®. The Company expects sales of FIRDAPSE®, FYCOMPA®, and AGAMREE® to constitute virtually all of the Company’s product revenue for the foreseeable future.

The Company relies exclusively on third parties to formulate and manufacture its products and any future drug candidates. The commercialization of its products 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®. The Company relies on the same third-party manufacturers for FYCOMPA® as utilized by Eisai prior to the Company’s acquisition of the U.S. rights to the product in January 2023. It also relies on Santhera and its supplier as its sole source of supply for AGAMREE®. 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.

The following table illustrates the approximate percentage of the Company’s total net product revenue attributed to the Company’s largest customers for the periods presented:


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023
Customer A		74.6	%		64.5	%		71.5	%		65.6	%
Customer B*		—			35.5	%		—			34.4	%
Customer C		9.4	%		—			10.0	%		—
Total		84.0	%		100.0	%		81.5	%		100.0	%

ROYALTIES

ROYALTIES. Royalties incurred in connection with the Company’s license agreement for FIRDAPSE® and AGAMREE®, as disclosed in Note 13 (Agreements), are expensed to cost of sales as revenue from product sales is recognized.

Royalties incurred in connection with the Company’s license agreement for RUZURGI®, as disclosed in Note 13 (Agreements), are expensed to cost of sales as revenue from product sales is recognized for any royalties in excess of the minimum annual royalty payment from July 11, 2022 (the Effective Date) through 2025. The minimum royalty payment that exists annually for calendar years from the Effective Date through 2025 of $3 million are included in the purchase price of the agreement.

INCOME TAXES

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 2020. 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 (LOSS)

COMPREHENSIVE INCOME (LOSS). U.S. GAAP requires that all components of comprehensive income (loss) be reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is net income (loss), plus certain other items that are recorded directly into stockholders’ equity. The Company’s comprehensive income (loss) is shown on the consolidated statements of operations and comprehensive income (loss) for the three and nine months ended September 30, 2024 and 2023, and is comprised of net unrealized gains (losses) on the Company’s available-for-sale securities.

NET INCOME (LOSS) PER COMMON SHARE

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

Diluted net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period.

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


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Basic weighted average common shares outstanding		118,931,153		106,568,137		117,976,056		106,133,077
Effect of dilutive securities		6,476,126		—		6,543,782		7,618,293
Diluted weighted average common shares outstanding		125,407,279		106,568,137		124,519,838		113,751,370

Outstanding common stock equivalents totaling approximately 5.1 million and 5.2 million were excluded from the calculation of diluted net income (loss) per common share for the three and nine months ended September 30, 2024, respectively, as their effect would be anti-dilutive. For the three months ended September 30, 2023, approximately 12.1 million shares of outstanding common stock equivalents were excluded from the calculation of diluted net income (loss) per common share because a net loss was reported and therefore their effect was anti-dilutive. Potentially dilutive options to purchase common stock for the three months ending September 30, 2023, had exercise prices ranging from $1.13 to $19.02. Outstanding common stock equivalents totaling approximately 2.0 million were excluded from the calculation of diluted net income (loss) per common share for the nine months ended September 30, 2023, as their effect would be anti-dilutive.

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

aa.

RECENTLY ISSUED ACCOUNTING STANDARDS. The Company did not adopt any accounting standards during the three and nine months ended September 30, 2024.

In November 2023, the FASB issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures (ASU 2023-07) which is intended to improve reportable segment disclosures primarily through enhanced disclosure of reportable segment expenses and requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. The new guidance is required to be applied retrospectively to all prior periods presented in the financial statements and is effective for the Company for fiscal periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company has one reportable segment and is evaluating the impact of the standard on the Company’s consolidated financial statements.

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures which requires significant disclosures about income taxes, primarily focused on the disclosure of income taxes paid and the rate reconciliation table. The new guidance will be applied prospectively and is effective for the Company for fiscal periods beginning after December 15, 2024. The Company is evaluating the impact of the standard on the Company’s consolidated financial statements.

Basis of Presentation and Significant Accounting Policies - Additional Information (Detail)					1 Months Ended	3 Months Ended		9 Months Ended		36 Months Ended
	Jul. 11, 2025 USD ($)	Jul. 11, 2024 USD ($)	Jul. 11, 2023 USD ($)	Jul. 11, 2022 USD ($)	Jul. 31, 2023 shares	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2024 USD ($) Segment shares	Sep. 30, 2023 USD ($) shares	Jul. 11, 2025 USD ($)	Mar. 31, 2021 USD ($)
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Maximum maturity period of cash and cash equivalent								three months
Maximum Amortization Period Of Compensation Cost On Straight Line Basis								3 years
Potential equivalent common stock excluded \| shares						5,100,000	12,100,000	5,200,000	2,000,000
Stock option exercise price range, Minimum \| $ / shares							$ 1.13
Stock option exercise price range, Maximum \| $ / shares							$ 19.02
Number of operating segments \| Segment								1
Asset acquisition equity interests issued or issuable number of shares issued \| shares					1,414,688
Asset acquisition percentage of outstanding ordinary shares					11.26%
Allowance for expected credit losses, written off								$ 0	$ 0
Debt securities, available-for-sale, current						$ 0		0
Share Purchase Program [Member] \| Common Stock [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Share repurchase program, authorised											$ 40,000,000
License Agreement For RUZURGI [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Minimum royalty	$ 3,000,000	$ 3,000,000	$ 3,000,000	$ 3,000,000						$ 3,000,000
Selling, General and Administrative Expenses [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Advertising Expense						$ 2,500,000	$ 1,700,000	$ 7,600,000	$ 5,400,000
Minimum [Member] \| Furniture and Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						5 years		5 years
Minimum [Member] \| Computer Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						3 years		3 years
Minimum [Member] \| Leasehold Improvements [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						5 years		5 years
Maximum [Member] \| Furniture and Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						7 years		7 years
Maximum [Member] \| Computer Equipment [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						5 years		5 years
Maximum [Member] \| Leasehold Improvements [Member]
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items]
Useful life of assets						10 years		10 years

Basis of Presentation and Significant Accounting Policies - Fair Value Measurement Specific to Assets or Liability (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Equity securities	$ 14,842	$ 16,489
U.S. Treasuries [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents		94,523
Money market funds [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Cash and cash equivalents	335,850	18,256
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Equity securities	14,842	16,489
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		94,523
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	$ 335,850	$ 18,256

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ 43,884	$ 40,794	$ 23,275	$ (30,764)	$ 37,762	$ 29,568	$ 107,953	$ 36,566

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
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-Name Accounting Standards Codification
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-Paragraph 2
-Subparagraph (SX 210.5-03(20))
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-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
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-Name Accounting Standards Codification
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/1943274/2147482907/825-10-50-28

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482765/220-10-50-6

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147483443/250-10-50-3

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (b)(2)
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480175/815-40-65-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
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-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-Name Accounting Standards Codification
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-Subparagraph (a)
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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Reference 17: http://www.xbrl.org/2003/role/exampleRef
-Topic 946
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-URI https://asc.fasb.org/1943274/2147479168/946-830-55-10

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-Name Accounting Standards Codification
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
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Reference 29: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
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-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
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-Topic 220
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Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
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-Name Accounting Standards Codification
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-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

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

Agreements - Additional Information (Detail)					1 Months Ended		3 Months Ended			9 Months Ended			36 Months Ended
Agreements - Additional Information (Detail)	Jul. 11, 2025 USD ($)	Jul. 11, 2024 USD ($)	Jul. 11, 2023 USD ($)	Jul. 11, 2022 USD ($)	Jul. 31, 2023 USD ($) shares	Jul. 31, 2023 SFr / shares	Sep. 30, 2024 USD ($)	Dec. 31, 2023 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($)	Sep. 30, 2024 USD ($) SFr / shares	Sep. 30, 2023 USD ($)	Jul. 11, 2025 USD ($)	Oct. 26, 2023 USD ($)	Jul. 19, 2023
License Agreement [Line Items]
Research and development expenses							$ 3,284,000		$ 83,662,000	$ 8,850,000		$ 91,178,000
Asset acquisition equity interests issued or issuable number of shares issued \| shares					1,414,688
Asset Acquisition Percentage Of Outstanding Ordinary Shares					11.26%
U.S. Rights for FYCOMPA [Member]
License Agreement [Line Items]
Date on which strategic collaboration is entered into										Jan. 24, 2023
Payments to acquire productive assets										$ 164,200,000
Contingent consideration liability							$ 25,000,000			$ 25,000,000	$ 25,000,000
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										6.00%
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										12.00%
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred And Twenty Five Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										11.00%
Net sales royalty threshold										$ 125,000,000
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred And Twenty Five Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										22.00%
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										8.50%
Net sales royalty threshold										$ 100,000,000
U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										17.00%
Vamorolone [Member]
License Agreement [Line Items]
Payments to acquire productive assets					$ 75,000,000
Asset acquisition equity interests issued or issuable number of shares issued \| shares					1,414,688
Asset Acquisition Percentage Of Outstanding Ordinary Shares					11.26%
Asset Acquisition Investment Share Price \| SFr / shares											$ 9.477
Closing Market Price \| SFr / shares						SFr 8.25
Foreign Currency Exchange Rate, Translation															1.1537
Collaborative arrangement, milestone payment obligation														$ 36,000,000
Payment on milestone payment								$ 36,000,000
Capitalized amortized Cost								$ 36,000,000
Finite-lived intangible asset, useful life							10 years 6 months			10 years 6 months	10 years 6 months
AGAMREE [Member] \| Royalty Less Than Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										5.00%
AGAMREE [Member] \| Royalty More Than Hundred Million And Less Than Two Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										7.00%
AGAMREE [Member] \| Royalty More Than Two Hundred Million And Less Than Three Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										9.00%
AGAMREE [Member] \| Royalty More Than Three Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										11.00%
AGAMREE [Member] \| Royalty Less Than Two Hundred Fifty Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										7.00%
AGAMREE [Member] \| Royalty More Two Hundred And Fifty Million And Less Than Five Hundred Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										8.50%
AGAMREE [Member] \| Royalty More Than Five Hundred Million And Less Than Seven Hundred Fifty Million [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										10.00%
AGAMREE [Member] \| Royalty More Seven Hundred And Fifty Million And Less Than One Billion [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										12.00%
AGAMREE [Member] \| Royalty More Than One Billion And Less Than Two Billion [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										13.00%
AGAMREE [Member] \| Royalty More Than Two Billion [Member]
License Agreement [Line Items]
Percentage of royalty on net sales										15.00%
AGAMREE [Member] \| Royalty For Santhera Sales Based Milestones [Member]
License Agreement [Line Items]
Net sales based milestone to royalty threshold										$ 105,000,000
AGAMREE [Member] \| Royalty For Additional Indications And Milestones Of Up To Fifty Million More [Member]
License Agreement [Line Items]
Percentage of royalty payable to sales based milestone										11.00%
AGAMREE [Member] \| Royalty For Additional Indications And Milestones [Member]
License Agreement [Line Items]
Contingent consideration liability							$ 50,000,000			$ 50,000,000	$ 50,000,000
Minimum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										10,000,000
Minimum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Net sales royalty threshold										10,000,000
Minimum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred And Twenty Five Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Net sales royalty threshold										125,000,000
Minimum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										100,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than Hundred Million And Less Than Two Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										100,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than Two Hundred Million And Less Than Three Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										200,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than Three Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										300,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Two Hundred And Fifty Million And Less Than Five Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										250,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than Five Hundred Million And Less Than Seven Hundred Fifty Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										500,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Seven Hundred And Fifty Million And Less Than One Billion [Member]
License Agreement [Line Items]
Net sales royalty threshold										750,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than One Billion And Less Than Two Billion [Member]
License Agreement [Line Items]
Net sales royalty threshold										1,000,000,000
Minimum [Member] \| AGAMREE [Member] \| Royalty More Than Two Billion [Member]
License Agreement [Line Items]
Net sales royalty threshold										2,000,000,000
Maximum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										100,000,000
Maximum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Ten Million And Less Than Hundred Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Net sales royalty threshold										100,000,000
Maximum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										125,000,000
Maximum [Member] \| U.S. Rights for FYCOMPA [Member] \| Royalty More Than Hundred Million And Less Than Hundred And Twenty Five Million [Member] \| Royalty Agreement Terms [Member]
License Agreement [Line Items]
Net sales royalty threshold										125,000
Maximum [Member] \| AGAMREE [Member] \| Royalty Less Than Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										100,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Than Hundred Million And Less Than Two Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										200,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Than Two Hundred Million And Less Than Three Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										300,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty Less Than Two Hundred Fifty Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										250,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Two Hundred And Fifty Million And Less Than Five Hundred Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										500,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Than Five Hundred Million And Less Than Seven Hundred Fifty Million [Member]
License Agreement [Line Items]
Net sales royalty threshold										750,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Seven Hundred And Fifty Million And Less Than One Billion [Member]
License Agreement [Line Items]
Net sales royalty threshold										1,000,000,000
Maximum [Member] \| AGAMREE [Member] \| Royalty More Than One Billion And Less Than Two Billion [Member]
License Agreement [Line Items]
Net sales royalty threshold										$ 2,000,000,000
License Agreement with BioMarin [Member]
License Agreement [Line Items]
Date on which strategic collaboration is entered into										Oct. 26, 2012
Percentage of royalty on net sales										3.50%
Net sales royalty threshold										$ 100,000,000
Amount of minimum royalty payable maturity terms not met										$ 5,000,000
License Agreement with BioMarin [Member] \| Minimum [Member]
License Agreement [Line Items]
Royalty agreement period										7 years
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%
License Agreement For RUZURGI [Member]
License Agreement [Line Items]
Date on which strategic collaboration is entered into										Jul. 11, 2022
Minimum royalty	$ 3,000,000	$ 3,000,000	$ 3,000,000	$ 3,000,000									$ 3,000,000
Research and development expenses				4,100,000
Up front payment				$ 10,000,000
Asset acquisition purchase price consideration		$ 10,000,000	$ 10,000,000
License Agreement For RUZURGI [Member] \| Minimum [Member]
License Agreement [Line Items]
Percentage of minimum royalty payable to net sales										1.25%
License Agreement For RUZURGI [Member] \| Maximum [Member]
License Agreement [Line Items]
Percentage of minimum royalty payable to net sales										2.50%

Stock Compensation - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Proceeds from exercise of stock options			$ 7,531	$ 2,099
Number of options, Outstanding	13,026,223		13,026,223
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan	$ 6,200		$ 6,200
Expected remaining weighted average vesting period			2 years 9 months 18 days
Non-cash stock-based compensation expense	$ 800	$ 900	$ 4,500	$ 2,300
Common stock granted	0	0	35,693	0
Options to Purchase Common Stock [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of stock options exercised	745,195	91,748	1,901,467	1,196,614
Proceeds from exercise of stock options	$ 4,000	$ 200	$ 7,500	$ 2,100
Stock option granted, contractual term	7 years	7 years	7 years	7 years
Common stock unit granted	40,000	41,000	880,995	1,086,000
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan	$ 29,500		$ 29,500
Expected remaining weighted average vesting period			2 years 9 months 18 days
Non-cash stock-based compensation expense	$ 3,600	$ 2,900	$ 12,600	$ 7,700
Stock options to purchase shares of common stock	8,036,208		8,036,208

Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Dec. 31, 2023
Income Tax Disclosure [Abstract]
Unrecognized Tax Benefits that Would Impact Effective Tax Rate	$ 0		$ 0
Effective Income Tax Rate Reconciliation, Percent	24.00%	23.50%
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent	21.00%

Stock Compensation

9 Months Ended

Sep. 30, 2024

Share-based Payment Arrangement [Abstract]

Stock Compensation

16.

Stock Compensation.

For the three and nine months ended September 30, 2024 and 2023, the Company recorded stock-based compensation expense as follows (in thousands):


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Research and development	$	402	$	372	$	1,314	$	1,062
Selling, general and administrative		4,022		3,438		15,766		8,938
Total stock-based compensation	$	4,424	$	3,810	$	17,080	$	10,000

Stock Options

As of September 30, 2024, there were outstanding stock options to purchase 13,026,223 shares of common stock, of which stock options to purchase 8,036,208 shares of common stock were exercisable.

During the three and nine months ended September 30, 2024, the Company granted seven-year term options to purchase an aggregate of 40,000 and 880,995 shares, respectively, of the Company’s common stock to employees. The Company recorded stock-based compensation related to stock options totaling $3.6 million and $12.6 million, respectively, during the three and nine months ended September 30, 2024.

16.

Stock Compensation (continued).

During the three and nine months ended September 30, 2023, the Company granted seven-year term options to purchase an aggregate of 41,000 and 1,086,000 shares, respectively, of the Company’s common stock to employees. The Company recorded stock-based compensation related to stock options totaling $2.9 million and $7.7 million, respectively, during the three and nine months ended September 30, 2023.

During the three and nine months ended September 30, 2024, options to purchase 745,195 shares and 1,901,467 shares, respectively, of the Company’s common stock were exercised, with proceeds of $4.0 million and $7.5 million, respectively, to the Company.

During the three and nine months ended September 30, 2023, options to purchase 91,748 shares and 1,196,614 shares, respectively, of the Company’s common stock were exercised, with proceeds of $0.2 million and $2.1 million, respectively, to the Company.

As of September 30, 2024, there was approximately $29.5 million of unrecognized compensation expense related to non-vested stock option awards granted under the 2014 and 2018 Stock Incentive Plans. The cost is expected to be recognized over a weighted average period of approximately 2.8 years.

Restricted Stock Units

The Company granted no restricted stock units and 35,693 restricted stock units during three and nine months ended September 30, 2024, respectively. The Company granted no restricted stock units during the three and nine months ended September 30, 2023. During the three and nine months ended September 30, 2024, the Company recorded non-cash stock-based compensation expense related to restricted stock units totaling $0.8 million and $4.5 million, respectively. During the three and nine months ended September 30, 2023, the Company recorded non-cash stock-based compensation expense related to restricted stock units totaling $0.9 million and $2.3 million, respectively.

As of September 30, 2024, there was approximately $6.2 million of unrecognized compensation expense related to non-vested restricted stock units granted under the 2018 Stock Incentive Plan. The cost is expected to be recognized over a weighted average period of approximately 2.8 years.

Stockholders' Equity (2023 Shelf Registration Statement) - Additional Information (Detail) - USD ($)		9 Months Ended
	Jan. 09, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 08, 2023
Stockholders' Equity [Line Items]
Gross proceeds from issuance of common stock		$ 141,000,000	$ 0
2023 Shelf Registration Statement [Member]
Stockholders' Equity [Line Items]
Maximum dollar amount of common stock to be issued under shelf registration statement				$ 500,000,000
Stock issued during the period shares new issues	10,000,000
Gross proceeds from issuance of common stock	$ 140,700,000

Accrued Expenses and Other Liabilities

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Accrued Expenses and Other Liabilities

10.

Accrued Expenses and Other Liabilities.

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


	September 30, 2024		December 31, 2023
Accrued preclinical and clinical trial expenses	$	869	$	1,015
Accrued professional fees		8,250		4,730
Accrued compensation and benefits		8,013		8,883
Accrued license fees		24,667		24,437
Accrued purchases		513		192
Operating lease liability		393		369
Accrued gross-to-net revenue liabilities*		47,455		6,877
Accrued income tax		—		729
Due to licensor		2,871		12,540
Accrued interest payable		352		1,031
Other		449		465
Current accrued expenses and other liabilities		93,832		61,268
Lease liability – non-current		2,889		3,188
Due to licensor – non-current		610		2,497
Other – non-current		2,175		485
Non-current accrued expenses and other liabilities		5,674		6,170
Total accrued expenses and other liabilities	$	99,506	$	67,438

* During 2023, the Company sold FYCOMPA® through a Transition Service Agreement with Eisai. Effective January 1, 2024, FYCOMPA® is being sold and distributed through a 3PL organization.

Accumulated Other Comprehensive Income (Tables)

9 Months Ended

Sep. 30, 2024

Accumulated Other Comprehensive Income (Loss), Net of Tax [Abstract]

Summary of Reclassifications out of Accumulated Other Comprehensive Income

There were no reclassifications out of accumulated other comprehensive income during the three and nine months ended September 30, 2024 and 2023.


	Total Accumulated Other Comprehensive Income
Balance at June 30, 2024	$	—
Other comprehensive loss before reclassifications		—
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		—
Balance at September 30, 2024	$	—

Balance at December 31, 2023	$	14
Other comprehensive loss before reclassifications		(14	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(14	)
Balance at September 30, 2024	$	—

Accumulated Other Comprehensive Income (continued).


	Total Accumulated Other Comprehensive Income
Balance at June 30, 2023	$	19
Other comprehensive loss before reclassifications		(4	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(4	)
Balance at September 30, 2023	$	15

Balance at December 31, 2022	$	24
Other comprehensive loss before reclassifications		(9	)
Amount reclassified from accumulated other comprehensive income		—
Net current period other comprehensive gain (loss)		(9	)
Balance at September 30, 2023	$	15

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statement of Comprehensive Income [Abstract]
Net of tax impact	$ 0	$ 1	$ 4	$ 3

Organization and Description of Business

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Description of Business

Organization and Description of Business.

Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the Company) is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult to treat diseases. The Company currently markets three drug products, FIRDAPSE® (amifampridine), FYCOMPA® (perampanel), and AGAMREE® (vamorolone). The Company is also currently seeking to further expand its product portfolio, with a focus on acquiring the rights to late-stage products to treat rare (orphan) central nervous system and adjacent rare (orphan) diseases. With an unwavering patient focus embedded in everything it does, the Company is committed to providing innovative, best-in-class medications with the hope of making a meaningful impact on those affected by these conditions.

The Company’s New Drug Application (NDA) for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome (LEMS) was approved in 2018 by the U.S. Food & Drug Administration (FDA), and FIRDAPSE® is commercially available in the United States (U.S.) as a treatment for adults with LEMS. Further, Canada’s national healthcare regulatory agency, Health Canada, approved the use of FIRDAPSE® for the treatment of adult patients in Canada with LEMS in 2020 and FIRDAPSE® is commercially available in Canada for the treatment of patients with LEMS through a license and supply agreement with KYE Pharmaceuticals, Inc. (KYE). In the third quarter of 2022, the FDA approved the Company’s supplemental New Drug Application approving an expansion of the FIRDAPSE® label to include pediatric patients (ages six and older). In the second quarter of 2024, the FDA approved the Company’s supplemental New Drug Application increasing the indicated maximum daily dose of FIRDAPSE® (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of LEMS.

On December 17, 2022, the Company entered into an asset purchase agreement with Eisai Co., Ltd. (Eisai) for the acquisition of the U.S. rights to FYCOMPA® (perampanel) CIII, a prescription medication used alone or in combination with other medicines to treat focal onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older and with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older. The Company closed the acquisition of the U.S. rights to FYCOMPA® on January 24, 2023 and is now marketing FYCOMPA® in the U.S.

In July 2023, the Company completed its acquisition from Santhera Pharmaceuticals Holdings (Santhera) of an exclusive license for North America for AGAMREE® (vamorolone), a treatment for patients suffering with Duchenne muscular dystrophy (DMD). The license is for exclusive commercial rights in the U.S., Canada, and Mexico, as well as the right of first negotiation in Japan should Santhera pursue partnership opportunities in that jurisdiction. Additionally, the Company holds the North American rights for any future approved indications of AGAMREE®. AGAMREE® has previously received FDA Orphan Drug and Fast Track designations. On October 26, 2023, the FDA approved AGAMREE® oral suspension 40 mg/ml for the treatment of DMD in patients aged two years and older, and on March 13, 2024, the Company began marketing AGAMREE® in the U.S.

The Company has devoted substantially all its efforts to selling its products, business planning, recruiting management and technical staff, acquiring operating assets, raising capital, and research and development. The Company has been able to fund its cash needs to date through offerings of its securities and from revenues from sales of its products. See Note 15 (Stockholders’ Equity).

Capital Resources

Based on forecasts of available cash, the Company believes that it has sufficient resources to support the currently anticipated operations for at least the next 12 months from the 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 business development activities, 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.

On January 9, 2024, the Company completed a public offering of 10 million shares of its common stock, raising net proceeds of approximately $140.7 million. The proceeds of the offering will be used to potentially acquire new products and for general corporate purposes.

Risks and Uncertainties

The Company is subject to risks and uncertainties that could affect its business in unforeseen ways.

Property and Equipment, Net

9 Months Ended

Sep. 30, 2024

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

Property and Equipment, Net.

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


	September 30, 2024			December 31, 2023
Furniture and equipment	$	962		$	494
Leasehold improvements		991			991
Software		433			433
Less: Accumulated depreciation		(1,006	)		(723	)
Total property and equipment, net	$	1,380		$	1,195

Basis of Presentation and Significant Accounting Policies

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Basis of Presentation and Significant Accounting Policies

Basis of Presentation and Significant Accounting Policies.

Basis of Presentation and Significant Accounting Policies (continued).


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of September 30, 2024		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	$	335,850	$	335,850	$	—	$	—
Investment in equity securities:
Equity securities	$	14,842	$	14,842	$	—	$	—

Basis of Presentation and Significant Accounting Policies (continued).


	Fair Value Measurements at Reporting Date Using (in thousands)
	Balances as of December 31, 2023		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	$	18,256	$	18,256	$	—	$	—
U.S. Treasuries	$	94,523	$	94,523	$	—	$	—
Investment in equity securities:
Equity securities	$	16,489	$	16,489	$	—	$	—

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.

REVENUE RECOGNITION.

Product Revenues:

Basis of Presentation and Significant Accounting Policies (continued).

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 three and nine months ended September 30, 2024 and 2023, substantially all of the Company’s product revenues were from sales to customers in the U.S.

The following table summarizes the Company’s net product revenue disaggregated by product (in thousands):


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
FIRDAPSE®	$	79,303	$	66,224	$	223,517	$	188,648
FYCOMPA®+		32,075		36,393		99,035		98,750
AGAMREE®*		15,046		—		24,966		—
Total product revenue, net	$	126,424	$	102,617	$	347,518	$	287,398

_________________

+FYCOMPA® net product revenue for the nine months ended September 30, 2023 is for the period between January 24, 2023 (date of acquisition) and September 30, 2023.

*AGAMREE® net product revenue for the nine months ended September 30, 2024 is for the period between March 13, 2024 (date of commercial launch) and September 30, 2024.

Basis of Presentation and Significant Accounting Policies (continued).

Revenues from Collaboration and Licensing Arrangements:

Basis of Presentation and Significant Accounting Policies (continued).

See Note 11 (Collaborative and Licensing Arrangements), for further discussion on the Company’s collaborative and licensing arrangements.

Basis of Presentation and Significant Accounting Policies (continued).

The following table illustrates the approximate percentage of the Company’s total net product revenue attributed to the Company’s largest customers for the periods presented:


	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2024			2023			2024			2023
Customer A		74.6	%		64.5	%		71.5	%		65.6	%
Customer B*		—			35.5	%		—			34.4	%
Customer C		9.4	%		—			10.0	%		—
Total		84.0	%		100.0	%		81.5	%		100.0	%

Basis of Presentation and Significant Accounting Policies (continued).

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


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2024		2023		2024		2023
Basic weighted average common shares outstanding		118,931,153		106,568,137		117,976,056		106,133,077
Effect of dilutive securities		6,476,126		—		6,543,782		7,618,293
Diluted weighted average common shares outstanding		125,407,279		106,568,137		124,519,838		113,751,370

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.

aa.

RECENTLY ISSUED ACCOUNTING STANDARDS. The Company did not adopt any accounting standards during the three and nine months ended September 30, 2024.