Form 8-K
8-K — CATALYST PHARMACEUTICALS, INC.
Accession: 0001193125-26-216929
Filed: 2026-05-11
Period: 2026-05-11
CIK: 0001369568
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — d845745d8k.htm (Primary)
EX-99.1 (d845745dex991.htm)
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8-K
8-K (Primary)
Filename: d845745d8k.htm · Sequence: 1
8-K
NASDAQ false 0001369568 0001369568 2026-05-11 2026-05-11
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): May 11, 2026
CATALYST PHARMACEUTICALS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
Delaware
001-33057
76-0837053
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
355 Alhambra Circle
Suite 801
Coral Gables, Florida
33134
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (305) 420-3200
Not Applicable
Former Name or Former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class
Name of Exchange
on Which Registered
Ticker
Symbol
Common Stock, par value $0.001 per share
NASDAQ Capital Market
CPRX
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01
Other Events
On May 11, 2026, the Company issued a press release announcing its results of operations for the three months ended March 31, 2026 and providing a business update. A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
99.1
Press release issued by the Company on May 11, 2026.
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Catalyst Pharmaceuticals, Inc.
By:
/s/ Michael Kalb
Michael Kalb
Executive Vice President and CFO
Dated: May 11, 2026
3
EX-99.1
EX-99.1
Filename: d845745dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Catalyst Pharmaceuticals Reports First Quarter 2026 Financial Results
Delivered Q1 2026 Total Revenues of $149.4 Million
Results include 28% YoY Increase in Net Product Revenues from FIRDAPSE® &
AGAMREE®
Reported Cash and Cash Equivalents of $755.9 Million and No Funded
Debt as of March 31, 2026
CORAL GABLES, Fla., - May 11, 2026 - Catalyst Pharmaceuticals, Inc. (“Catalyst” or
“Company”) (Nasdaq: CPRX), today reported financial results for the first quarter of 2026 and provided a business update.
Financial
Highlights
For the Three Months Ended March 31,
2026
2025
% Change
(In thousands, except per share data)
Product Revenue, net
$
149,343
$
141,400
5.6
%
FIRDAPSE Product Revenue, net
$
98,859
$
83,731
18.1
%
AGAMREE Product Revenue, net
$
36,713
$
22,042
66.6
%
FYCOMPA Product Revenue, net
$
13,771
$
35,627
(61.3
%)
GAAP Net Income
$
63,734
$
56,737
12.3
%
Non-GAAP Net Income *
$
100,262
$
86,596
15.8
%
GAAP Net Income Per Share - Basic
$
0.52
$
0.47
10.6
%
Non-GAAP Net Income Per Share – Basic*
$
0.82
$
0.71
15.5
%
GAAP Net Income Per Share – Diluted
$
0.50
$
0.45
11.1
%
Non-GAAP Net Income Per Share – Diluted*
$
0.79
$
0.68
16.2
%
As of March 31, 2026 and December 31, 2025
(In thousands)
Cash and Cash Equivalents
$
755,859
$
709,171
6.6
%
*
Statements made in this press release include non-GAAP financial
measures. Such information is provided as additional information and not as an alternative to Catalyst’s financial statements presented in accordance with U.S. generally accepted accounting principles (“GAAP”).
These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst’s current financial performance. Catalyst believes that the non-GAAP
financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst’s operating results in a manner that Catalyst believes is focused on the performance of ongoing
operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies.
First Quarter 2026 Financial Highlights
The Company delivered strong first quarter 2026 results.
•
Total Q1 2026 product revenue, net was $149.3 million, a 5.6% year-over-year increase. Promoted products,
FIRDAPSE® & AGAMREE®, totaled $135.6 million, a 28.2% year-over-year increase.
•
FIRDAPSE Q1 2026 product revenue, net was $98.9 million, an 18.1% year-over-year increase, primarily driven
by increases in sales volumes.
•
AGAMREE Q1 2026 product revenue, net was $36.7 million, compared to product revenue, net of
$22.0 million in Q1 2025. The results underscore continued sales volume growth and increasing prescriber engagement.
•
FYCOMPA® Q1 2026 product revenue, net was
$13.8 million, a 61.3% year-over-year decrease following loss of exclusivity in 2025.
First Quarter 2026 Additional Financial
Results
Cost of sales: Cost of sales for the first quarter of 2026 was $14.5 million, compared to $17.9 million in the first quarter
of 2025. In addition to the reductions to FIRDAPSE royalties that occurred at the end of 2025, in January 2026, the Company completed seven years from the date of first commercial sale of FIRDAPSE in the U.S. On that date, the royalty on net U.S.
sales that the Company previously paid to Catalyst’s licensor at a tiered rate of 7% to 10% of net U.S. sales of FIRDAPSE expired. Also, on January 1, 2026, as part of the Company’s acquisition and license agreement regarding
RUZURGI® (amifampridine) with Jacobus, the royalty rate the Company pays Jacobus on net U.S. sales of any amifampridine product increased from 1.5% to 2.5%. As a result, the overall royalty
rate that the Company pays to its upstream licensors for net U.S. sales of FIRDAPSE is 6%, which is down from a previous maximum rate of 18.5%.
Royalties
on AGAMREE include a base royalty of 7% of net sales up to $250 million with additional increases as net sales increase. This base royalty is due to the Company’s licensor, which reflects obligations owed by the licensor to its upstream
licensors as well as an additional royalty of 7% of net sales in excess of $100 million and up to $200 million with additional increases as net sales increase. This additional royalty is due to the licensor under the Company’s
agreement.
Research and development expenses: Research and development expenses for the first quarter of 2026
were $2.7 million, compared to $3.9 million in the first quarter of 2025.
Selling, general, and administrative
expenses: Selling, general, and administrative (SG&A) expenses for the first quarter of 2026 were $49.3 million, compared to $46.9 million in the first quarter of 2025.
Amortization of intangible assets: Amortization of intangible assets for the first quarter of 2026 were $9.7 million, compared
to $9.3 million in the first quarter of 2025.
Operating income: Operating income for the first quarter of 2026
was $73.2 million, compared to $63.4 million in the first quarter of 2025, representing an increase of approximately 15.6%.
GAAP
net income: GAAP net income for the first quarter of 2026 was $63.7 million ($0.52 per basic and $0.50 per diluted share), compared to GAAP net income of $56.7 million ($0.47 per basic
and $0.45 per diluted share) in the first quarter of 2025.
Non-GAAP net income: Non-GAAP net income for the first quarter of 2026 was $100.3 million ($0.82 per basic and $0.79 per diluted share), compared to non-GAAP net
income of $86.6 million ($0.71 per basic and $0.68 per diluted share) in the first quarter of 2025. Non-GAAP net income for all periods excludes from net income stock-based compensation,
depreciation, amortization of intangible assets, and the income tax provision.
Tax rate: The Company’s effective income tax rate was
24.3% and 20.4% for the three months ended March 31, 2026, and 2025, respectively. Differences in the effective tax and the statutory federal income tax rate of 21% are driven by state income taxes and anticipated annual permanent differences
offset by equity compensation deductions.
Cash and cash equivalents: Cash and cash equivalents were $755.9 million as
of March 31, 2026.
The Company’s Form 10-Q for the first quarter of 2026, filed with the U.S.
Securities and Exchange Commission on May 11, 2026, provides more detailed financial information and analysis of our financial condition and results of operations.
Business Outlook and Conference Call
In light of the
Company’s May 7, 2026 announcement, Catalyst will not be providing forward-looking guidance or updates to previously issued guidance. In addition, the Company will not host an earnings conference call or webcast reporting on its first
quarter 2026 results.
About Catalyst Pharmaceuticals, Inc.
Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven
track record of bringing life-changing treatments to the market, we focus on in-licensing, commercializing, and developing innovative therapies. Guided by our deep commitment to patient care, we prioritize
accessibility, ensuring patients receive the care they need through a comprehensive suite of support services designed to provide seamless access and ongoing assistance. Catalyst maintains a well-established U.S. presence, which remains the
cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint. Catalyst, headquartered in Coral Gables, Fla., has been recognized by Forbes as one of America’s Most Successful
Company in 2023, 2024, and 2025, and on the 2025 Deloitte Technology Fast 500™ list as one of North America’s Fastest-Growing Companies.
For more information, please visit Catalyst’s website at www.catalystpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst will continue to
be profitable and cash flow positive in 2026 and beyond, (ii) whether Catalyst will complete any acquisitions of additional products, and the timing of any such acquisitions, and (iii) those factors described in Catalyst’s Annual
Report on Form 10-K for the 2025 fiscal year, Catalyst’s Current Report on Form 8-K filed on May 7, 2026, Catalyst’s Quarterly Report on Form 10-Q for the first quarter of 2026, and its subsequent filings with the U.S. Securities and Exchange Commission (“SEC”), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC
are available from the SEC, may be found on Catalyst’s website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share and per share data)
For the Three Months Ended March 31,
2026
2025
Revenues:
Product revenue, net
$
149,343
$
141,400
License and other revenue
47
21
Total revenues
149,390
141,421
Operating costs and expenses:
Cost of sales (a)
14,475
17,911
Research and development
2,661
3,887
Selling, general and administrative (a)
49,319
46,911
Amortization of intangible assets
9,703
9,345
Total operating costs and expenses
76,158
78,054
Operating income
73,232
63,367
Other income, net
10,997
7,919
Net income before income taxes
84,229
71,286
Income tax provision
20,495
14,549
Net income
$
63,734
$
56,737
Net income per share:
Basic
$
0.52
$
0.47
Diluted
$
0.50
$
0.45
Weighted average shares outstanding:
122,254,171
121,472,468
Basic
Diluted
126,903,391
126,957,982
(a)
exclusive of amortization of intangible assets
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share and per share data)
For the Three Months Ended March 31,
2026
2025
GAAP net income
$
63,734
$
56,737
Non-GAAP adjustments:
Stock-based compensation expense
6,260
5,850
Depreciation
70
115
Amortization of intangible assets
9,703
9,345
Income tax provision
20,495
14,549
Non-GAAP net income
$
100,262
$
86,596
Non-GAAP net income per share:
Basic
$
0.82
$
0.71
Diluted
$
0.79
$
0.68
Weighted average shares outstanding:
Basic
122,254,171
121,472,468
Diluted
126,903,391
126,957,982
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31,
2026
December 31,
2025
(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents
$
755,859
$
709,171
Accounts receivable, net
130,834
126,477
Inventory
34,930
37,166
Prepaid expenses and other current assets
18,767
21,216
Total current assets
940,390
894,030
Operating lease
right-of-use asset, net
1,858
1,935
Property and equipment, net
994
1,037
License and acquired intangibles, net
121,971
131,674
Deferred tax assets, net
55,111
52,767
Investment in equity securities
27,286
22,536
Total assets
$
1,147,610
$
1,103,979
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$
7,151
$
11,202
Accrued expenses and other liabilities
125,247
135,950
Total current liabilities
132,398
147,152
Operating lease liability, net of current portion
2,235
2,350
Other non-current liabilities
280
209
Total liabilities
134,913
149,711
Total stockholders’ equity
1,012,697
954,268
Total liabilities and stockholders’ equity
$
1,147,610
$
1,103,979
Source: Catalyst Pharmaceuticals, Inc.
Investor Contact
Melissa Kendis, Catalyst Pharmaceuticals, Inc.
(305) 420-3200
IR@catalystpharma.com
Media Contact
Jed Repko / Mahmoud Siddig
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449
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Document and Entity Information
May 11, 2026
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