Catalyst Pharma (NASDAQ: CPRX) posts Q1 profit ahead of Angelini deal
Catalyst Pharmaceuticals reported solid first-quarter 2026 results with continued profitability and strong cash generation. Total revenues were $149.4 million, up from $141.4 million a year earlier, driven by higher FIRDAPSE and AGAMREE sales, partly offset by lower FYCOMPA revenue.
Net income rose to $63.7 million, with diluted earnings per share of $0.50. Operating income reached $73.2 million, supported by disciplined R&D and stable SG&A spending. Cash from operating activities was $59.6 million, lifting cash and cash equivalents to $755.9 million and total assets to $1.15 billion as of March 31, 2026, with minimal debt-like obligations.
The business remains highly concentrated in three rare-disease and neurology products—FIRDAPSE, AGAMREE and FYCOMPA—with one major U.S. distributor accounting for about 90% of product revenue. The company also highlights strong patent and licensing positions, including settlements that delay FIRDAPSE generics into the 2030s. After quarter-end, Catalyst signed a definitive merger agreement to be acquired by Angelini Pharma, which would turn Catalyst into a wholly owned subsidiary, marking a major strategic shift for shareholders.
Positive
- Strong profitability and cash generation: Q1 2026 net income was $63.7 million with $59.6 million of operating cash flow, lifting cash and cash equivalents to $755.9 million and supporting management’s view of sufficient funding for at least the next 12 months.
- Strategic merger agreement: The company entered into a definitive Agreement and Plan of Merger with Angelini Pharma, under which Catalyst would become a wholly owned subsidiary, representing a transformative event for shareholders.
Negative
- None.
Insights
Q1 shows durable cash-generating profile ahead of Angelini Pharma merger.
Catalyst Pharmaceuticals delivered Q1 2026 revenues of $149.4M and net income of $63.7M, reflecting healthy margins from its three marketed products. Product mix shifted toward FIRDAPSE and AGAMREE, while FYCOMPA revenue declined versus the prior-year period.
The company generated operating cash flow of $59.6M, boosting cash and cash equivalents to $755.9M as of March 31, 2026, against total liabilities of only $134.9M. This supports management’s view that current resources can fund operations for at least the next 12 months, even after a $14.6M share repurchase in the quarter.
Strategically, the signed Agreement and Plan of Merger with Angelini Pharma is pivotal, as it would transition Catalyst into a wholly owned subsidiary and likely end its stand-alone public-company status. Future filings around the merger’s closing conditions and timing will clarify the transaction’s ultimate impact on existing shareholders.
Key Figures
Key Terms
Orphan Drug Exclusivity regulatory
Paragraph IV Certification regulatory
Abbreviated New Drug Application (ANDA) regulatory
available-for-sale securities financial
Accumulated other comprehensive income financial
incremental borrowing rate financial
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
[Mark One]
For the Quarterly Period Ended
OR
Commission File No.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(IRS Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
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Ticker Symbol |
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Name of Exchange on Which Registered |
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Indicate by checkmark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such report(s), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “accelerated filer”, “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
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Accelerated Filer |
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Non-accelerated filer |
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Smaller reporting company |
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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 pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date
Table of Contents
CATALYST PHARMACEUTICALS, INC.
INDEX
PART I. FINANCIAL INFORMATION
Item 1. |
FINANCIAL STATEMENTS |
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Condensed consolidated balance sheets at March 31, 2026 (unaudited) and December 31, 2025 |
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Condensed consolidated statements of operations and comprehensive income for the three months ended March 31, 2026 and 2025 (unaudited) |
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Condensed consolidated statements of changes in stockholders’ equity for the three months ended March 31, 2026 and 2025 (unaudited) |
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Condensed consolidated statements of cash flows for the three months ended March 31, 2026 and 2025 (unaudited) |
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Notes to unaudited condensed consolidated financial statements |
7 |
Item 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
35 |
Item 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK |
49 |
Item 4. |
CONTROLS AND PROCEDURES |
49 |
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PART II. OTHER INFORMATION
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Item 1. |
LEGAL PROCEEDINGS |
50 |
Item 1A. |
RISK FACTORS |
50 |
Item 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
51 |
Item 3. |
DEFAULTS UPON SENIOR SECURITIES |
51 |
Item 4. |
MINE SAFETY DISCLOSURE |
51 |
Item 5. |
OTHER INFORMATION |
51 |
Item 6. |
EXHIBITS |
52 |
SIGNATURES |
53 |
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2
Table of Contents
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
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March 31, |
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December 31, |
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(unaudited) |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable, net |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Operating lease right-of-use asset, net |
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Property and equipment, net |
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License and acquired intangibles, net |
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Deferred tax assets, net |
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Investment in equity securities |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses and other liabilities |
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Total current liabilities |
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Operating lease liability, net of current portion |
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Other non-current liabilities |
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Total liabilities |
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Commitments and contingencies (Note 12) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Retained earnings |
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Accumulated other comprehensive income (loss) (Note 4) |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Table of Contents
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (unaudited)
(in thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2026 |
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2025 |
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Revenues: |
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Product revenue, net |
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$ |
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$ |
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License and other revenue |
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Total revenues |
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Operating costs and expenses: |
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Cost of sales (a) |
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Research and development |
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Selling, general and administrative (a) |
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Amortization of intangible assets |
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Total operating costs and expenses |
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Operating income |
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Other income, net |
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Net income before income taxes |
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Income tax provision |
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Net income |
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$ |
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$ |
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Net income per share: |
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Basic |
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$ |
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$ |
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Diluted |
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$ |
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$ |
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Weighted average shares outstanding: |
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Basic |
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Diluted |
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Net income |
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$ |
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$ |
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Other comprehensive income (Note 4): |
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Unrealized gain (loss) on available-for-sale |
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( |
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Comprehensive income |
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$ |
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$ |
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__________________________________
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Table of Contents
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (unaudited)
For the three months ended March 31, 2026 and 2025
(in thousands)
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Common Stock |
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Preferred |
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Shares |
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Amount |
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Additional |
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Retained |
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Accumulated |
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Total |
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Balance at December 31, 2025 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options for |
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— |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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( |
) |
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— |
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— |
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( |
) |
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Repurchase of common stock |
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— |
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( |
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( |
) |
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— |
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( |
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— |
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( |
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Other comprehensive gain (loss) |
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— |
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— |
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— |
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— |
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— |
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Net income |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2026 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
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Common Stock |
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Preferred |
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Shares |
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Amount |
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Additional |
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Retained |
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Accumulated |
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Total |
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Balance at December 31, 2024 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options for |
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— |
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— |
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— |
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Issuance of common stock upon |
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— |
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— |
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( |
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— |
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— |
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( |
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Other comprehensive gain (loss) |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Net income |
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— |
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— |
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— |
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— |
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— |
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Balance at March 31, 2025 |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Table of Contents
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited)
(in thousands)
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For the Three Months Ended |
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2026 |
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2025 |
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Operating Activities: |
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Net income |
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$ |
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$ |
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Adjustments to reconcile net income to net cash provided by (used in) operating |
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Depreciation |
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Stock-based compensation |
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Amortization of intangible assets |
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Deferred taxes |
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( |
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( |
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Accretion of discount |
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( |
) |
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( |
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Reduction in the carrying amount of right-of-use asset |
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Change in fair value of equity securities |
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( |
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( |
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(Increase) decrease in: |
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Accounts receivable, net |
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( |
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( |
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Inventory |
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( |
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Prepaid expenses and other current assets |
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Increase (decrease) in: |
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Accounts payable |
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( |
) |
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( |
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Accrued expenses and other liabilities |
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( |
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( |
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Operating lease liability |
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( |
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( |
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Net cash provided by (used in) operating activities |
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Investing Activities: |
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Purchases of property and equipment |
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( |
) |
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Net cash provided by (used in) investing activities |
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( |
) |
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Financing Activities: |
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Payment of employee withholding tax related to stock-based compensation |
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( |
) |
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( |
) |
Proceeds from exercise of stock options |
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Repurchase of common stock |
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( |
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— |
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Payment of liabilities arising from asset acquisition |
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( |
) |
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( |
) |
Net cash provided by (used in) financing activities |
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( |
) |
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Net increase (decrease) in cash and cash equivalents |
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Cash and cash equivalents – beginning of period |
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Cash and cash equivalents – end of period |
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$ |
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$ |
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Supplemental disclosures of cash flow information: |
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Cash paid for income taxes |
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$ |
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$ |
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Cash paid for interest |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Table of Contents
CATALYST PHARMACEUTICALS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 sells three commercial stage drug products, FIRDAPSE® (amifampridine), AGAMREE® (vamorolone), and FYCOMPA® (perampanel). The Company is currently seeking to further expand its product portfolio, with a focus on acquiring the rights to immediately and near-term accretive assets to treat rare (orphan) diseases across therapeutic areas, including clinical-stage opportunities with established proof of concept. 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 positive impact on those affected by these conditions.
The Company’s New Drug Application (NDA) for FIRDAPSE® 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 U.S. as a treatment for adults with LEMS. Additionally, 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). Further, 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). Additionally, in the second quarter of 2024, the FDA approved the Company’s supplemental New Drug Application increasing the indicated maximum daily dose of FIRDAPSE® for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of LEMS. Finally, Japan’s national healthcare regulatory agency, the Ministry of Health, Labour and Welfare (MHLW), approved the use of FIRDAPSE® for the treatment of patients in Japan with LEMS in 2024 and beginning in January 2025, FIRDAPSE® is commercially available in Japan for the treatment of patients with LEMS through a license and supply agreement with DyDo Pharma, Inc. (DyDo).
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® 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 currently selling 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®, a treatment for patients suffering from Duchenne muscular dystrophy (DMD). Additionally, the Company holds the North American rights for any future approved indications of AGAMREE®. AGAMREE® previously received FDA Orphan Drug and Fast-Track designations and 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. On March 13, 2024, the Company commercially launched AGAMREE® in the U.S.
The Company has devoted substantially all its efforts since inception 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 profits generated from sales of its drug products and through offerings of its securities. See Note 15 (Stockholders’ Equity).
Recent Developments
On May 6, 2026, the Company entered into an Agreement and Plan of Merger (the Merger Agreement) with Angelini Pharma S.p.A., an Italian Società per azioni (Angelini Pharma or Parent), and Angelini Cielo Inc., a Delaware corporation and wholly-owned subsidiary of Parent (Merger Sub), providing for the merger of Merger Sub with and into the Company (the Merger), with the Company surviving the Merger as a wholly-owned subsidiary of Parent.
For further information about the Merger Agreement and the Merger, see the Company's Current Report on Form 8-K filed on May 7, 2026 reporting on the terms of the Merger Agreement and the proposed Merger. See Note 17 (Subsequent Events).
7
Table of Contents
Capital Resources
Based on the Company's current financial condition, including its profitability, cash flows generated from operations and forecasts of available cash, the Company believes it has sufficient funds to support operations for at least the next 12 months.
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.
On January 9, 2024, the Company completed a public offering of
8
Table of Contents
In the opinion of management, the accompanying unaudited interim condensed 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 condensed consolidated statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2025 included in the 2025 Annual Report on Form 10-K filed by the Company with the SEC. Interim results are not necessarily indicative of the results to be expected for any future period or for the full fiscal year.
U.S. Treasuries held at March 31, 2026 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 the Company's condensed consolidated balance sheets.
The Company records available-for-sale securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) (in stockholders’ equity). Realized gains and losses are included in other income, net in the condensed consolidated statements of operations and comprehensive income and are derived using the specific identification method for determining the cost of securities sold. Interest income is recognized when earned and is included in other income, net in the condensed consolidated statements of operations and comprehensive income. The Company recognizes a charge when the declines in the fair value below the amortized cost basis of its available-for-sale securities are judged to be as a result of a credit loss. The Company considers various factors in determining whether to recognize an allowance for credit losses including whether the Company intends to sell the security or whether it is more likely than not that the Company would be required to sell the security before recovery of the amortized cost basis. If the unrealized loss of an available-for-sale debt security is determined to be a result of a credit loss the Company would recognize an allowance and the corresponding credit loss would be included in the condensed consolidated statements of operations and comprehensive income. The Company has not recorded an allowance for credit loss on its available-for-sale securities. See Note 3 (Investments).
In July 2023, the Company made a strategic equity investment into Santhera by acquiring
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Table of Contents
Products that have been approved by the FDA or other regulatory authorities, such as FIRDAPSE®, AGAMREE® and FYCOMPA®, 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®, AGAMREE® and FYCOMPA® 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. The Company records a write-down equal to the difference between the cost of the inventory and the estimated net realizable value to cost of sales within the accompanying condensed consolidated statements of operations and comprehensive income.
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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.
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 (triggering events). 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.
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.
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Fair Value Measurements at Reporting Date Using (in thousands) |
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Balances as of |
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Quoted Prices in |
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Significant Other |
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Significant |
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||||
Cash and cash equivalents: |
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||||
Money market funds |
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$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
U.S. Treasuries |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Investment in equity securities: |
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||||
Equity securities |
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$ |
|
|
$ |
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|
$ |
— |
|
|
$ |
— |
|
||
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|
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Fair Value Measurements at Reporting Date Using (in thousands) |
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Balances as of |
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Quoted Prices in |
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Significant Other |
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Significant |
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||||
Cash and cash equivalents: |
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||||
Money market funds |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
Investment in equity securities: |
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|
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|
||||
Equity securities |
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$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
||
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 licensing arrangements. 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®.
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Table of Contents
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. 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. These sales are generally subject to contracts held with managed care organizations and government agencies.
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 30 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 months ended March 31, 2026 and 2025.
During the three months ended March 31, 2026 and 2025, 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 March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
FIRDAPSE® |
|
$ |
|
|
$ |
|
||
AGAMREE® |
|
|
|
|
|
|
||
FYCOMPA® |
|
|
|
|
|
|
||
Total product revenue, net |
|
$ |
|
|
$ |
|
||
Reserves for Variable Consideration: Revenue from product sales is recorded at the net sales price (transaction price), which includes estimates of variable consideration (gross-to-net adjustments) 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 as accrued revenue allowances (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 analysis 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 described below as of March 31, 2026 and, therefore, the transaction price was not reduced further during the three months ended March 31, 2026 and 2025. 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. Adjustments to prior-period revenues due to such variances are immaterial for all periods presented.
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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 condensed consolidated statements of operations and comprehensive income. However, if the Company has determined such services received are not distinct from the Company’s sale of products to its customers, these payments have been recorded as a reduction of revenue within the condensed consolidated statements of operations and comprehensive income through March 31, 2026 and 2025, as well as a reduction to accounts receivable, net on the condensed consolidated balance sheets.
Prompt Payment Discounts: The Company provides certain 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 condensed 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 condensed 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 condensed 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.
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Table of Contents
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 condensed consolidated balance sheets. For Medicare, the Company historically estimated 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; however, the coverage gap program was replaced with a redesign of the Medicare program under the Inflation Reduction Act (IRA).
While most components of the new Medicare program began in 2025, the inflation penalty portion was effective as of 2024. Specifically, the program imposes manufacturer rebates on certain Part B and Part D drugs when prices rise faster than the rate of inflation. The Company has estimated this impact and has accounted for these inflation-related rebates, as well as the other components of the program, as a reduction of product revenue to the extent they apply to its drug portfolio. Similar to the coverage gap rebates, the associated reserve is accrued for as a current liability, which is included in accrued expenses and other liabilities on the condensed consolidated balance sheets.
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 condensed 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 condensed consolidated statements of operations and comprehensive income.
Revenues from Collaboration and Licensing Arrangements:
The Company analyzes license and collaboration arrangements pursuant to FASB ASC Topic 808, Collaborative Arrangement Guidance and Consideration (Topic 808), to assess whether such arrangements, or transactions between arrangement participants, involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities or are more akin to a vendor-customer relationship. In making this evaluation, the Company considers whether the activities of the collaboration are considered to be distinct and deemed to be within the scope of the collaborative arrangement guidance or if they are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement.
For elements of collaboration arrangements that are not accounted for pursuant to guidance in Topic 606, an appropriate recognition method is determined and applied consistently, generally by analogy to the revenue from contracts with customers guidance.
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Table of Contents
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. Revenue is included in product revenue, net in the Company’s condensed consolidated statements of operations and comprehensive income.
The agreements provide for milestone payments upon achievement of development, regulatory and commercial 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. Revenue is included in license and other revenue in the Company’s condensed consolidated statements of operations and comprehensive income.
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. Revenue is included in license and other revenue in the Company’s condensed consolidated statements of operations and comprehensive income.
Payments to and from the collaborator are presented in the statements of operations and comprehensive income 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.
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.
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Table of Contents
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 March 31, 2026, 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®, AGAMREE® and FYCOMPA® 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®, although the Company is in the process of securing a second supplier. 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 March 31, |
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|
|
2026 |
|
|
2025 |
|
||
Customer A |
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% |
|
|
% |
||
Total |
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|
% |
|
|
% |
||
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 existed annually for calendar years from the Effective Date through 2025 of $
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 $
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Table of Contents
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 2022. 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. See Note 14 (Income Taxes).
Diluted net income per common share is computed by dividing net income by the weighted average number of common shares outstanding, increased by the assumed conversion of other potentially dilutive securities during the period.
The following table reconciles basic and diluted weighted average common shares:
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Basic weighted average common shares outstanding |
|
|
|
|
|
|
||
Effect of dilutive securities |
|
|
|
|
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|
||
Diluted weighted average common shares outstanding |
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|
|
|
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|
||
Outstanding common stock equivalents totaling approximately
The following table illustrates information about significant segment expenses, inclusive of stock-based compensation:
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
Selling |
|
|
|
|
|
|
||
General and administrative (a) |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
__________________________________________
(a)
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Table of Contents
In July 2025, the FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets which amends ASC 326, Financial Instruments—Credit Losses, introducing a practical expedient and an accounting policy election for certain entities in estimating expected credit losses for current accounts receivable and current contract assets arising from transactions within the scope of ASC 606, Revenue from Contracts with Customers. Under the practical expedient, entities may assume that current conditions as of the balance sheet date remain unchanged for the remaining life of the asset when developing forecasts. The ASU is effective for annual reporting periods beginning after December 15, 2025 and interim reporting within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods. The Company adopted this guidance on a prospective basis as of January 1, 2026 and elected the practical expedient. The updated guidance did not have a material impact on the Company's condensed consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software which updates the requirements for capitalization of internal-use software, removing all references to project stages and clarifying the threshold to be applied to begin capitalizing. The Company may apply the guidance using a prospective, retrospective or modified transition approach. This ASU is effective for annual periods beginning after December 15, 2027, and for interim periods within those fiscal years. The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated financial statements and related disclosures.
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Table of Contents
Available-for-sale investments were as follows (in thousands):
|
|
Estimated |
|
|
Gross |
|
|
Gross |
|
|
Amortized |
|
||||
At March 31, 2026: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasuries - Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
At December 31, 2025: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasuries - Cash equivalents |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
There were
The estimated fair values of available-for-sale securities at March 31, 2026, by contractual maturity, are summarized as follows (in thousands):
|
|
March 31, |
|
|
Due in one year or less |
|
$ |
|
|
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Equity securities: |
|
|
|
|
|
|
||
Net gains (losses) recognized during the period on equity |
|
$ |
|
|
$ |
|
||
Unrealized net gains (losses) recognized during the period on equity securities still held at the reporting date |
|
$ |
|
|
$ |
|
||
There were
20
Table of Contents
The following table summarizes the changes in accumulated other comprehensive income (loss), net of tax from unrealized gains (losses) on available-for-sale securities (in thousands), the Company’s only component of accumulated other comprehensive income (loss) for the three months ended March 31, 2026 and 2025.
There were no reclassifications out of accumulated other comprehensive income (loss) during the three months ended March 31, 2026 and 2025.
|
|
Total Accumulated |
|
|
Balance at December 31, 2025 |
|
$ |
|
|
Other comprehensive loss before reclassifications |
|
|
|
|
Net current period other comprehensive gain (loss) |
|
|
|
|
Balance at March 31, 2026 |
|
$ |
|
|
|
|
Total Accumulated |
|
|
Balance at December 31, 2024 |
|
$ |
|
|
Other comprehensive loss before reclassifications |
|
|
( |
) |
Net current period other comprehensive gain (loss) |
|
|
( |
) |
Balance at March 31, 2025 |
|
$ |
( |
) |
Inventory consists of the following (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Raw materials |
|
$ |
|
|
$ |
|
||
Work-in-process |
|
|
|
|
|
|
||
Finished goods |
|
|
|
|
|
|
||
Total inventory |
|
$ |
|
|
$ |
|
||
The Company identified approximately $
21
Table of Contents
Prepaid expenses and other current assets consist of the following (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Prepaid manufacturing costs |
|
$ |
|
|
$ |
|
||
Prepaid tax |
|
|
|
|
|
|
||
Prepaid insurance |
|
|
|
|
|
|
||
Prepaid subscriptions fees |
|
|
|
|
|
|
||
Prepaid research fees |
|
|
|
|
|
|
||
Prepaid commercialization expenses |
|
|
|
|
|
|
||
Prepaid conference and travel expenses |
|
|
|
|
|
|
||
Prepaid co-pay assistance program |
|
|
|
|
|
|
||
Interest receivable |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total prepaid expenses and other current assets |
|
$ |
|
|
$ |
|
||
22
Table of Contents
The Company has an operating lease agreement for its corporate office that commenced in March 2021 for approximately
The components of lease expense were as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Operating lease cost |
|
$ |
|
|
$ |
|
||
Supplemental cash flow information related to lease was as follows (in thousands):
|
|
For the Three Months Ended |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Cash paid for amounts included in the measurement of lease liabilities: |
|
|
|
|
|
|
||
Operating cash flows |
|
$ |
|
|
$ |
|
||
Right-of-use assets obtained in exchange for lease obligations: |
|
|
|
|
|
|
||
Operating lease |
|
$ |
|
|
$ |
|
||
Supplemental balance sheet information related to lease was as follows (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Operating lease right-of-use assets, net |
|
$ |
|
|
$ |
|
||
Other current liabilities |
|
$ |
|
|
$ |
|
||
Operating lease liabilities, net of current portion |
|
|
|
|
|
|
||
Total operating lease liabilities |
|
$ |
|
|
$ |
|
||
As of March 31, 2026 and December 31, 2025, the weighted average remaining lease term was
Remaining payments of lease liabilities as of March 31, 2026 were as follows (in thousands):
2026 (remaining nine months) |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total lease payments |
|
|
|
|
Less: imputed interest |
|
|
( |
) |
Total |
|
$ |
|
Rent expense was approximately $
23
Table of Contents
Property and equipment, net consists of the following (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Furniture and equipment |
|
$ |
|
|
$ |
|
||
Leasehold improvements |
|
|
|
|
|
|
||
Software |
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Total property and equipment, net |
|
$ |
|
|
$ |
|
||
The following table presents the Company’s intangible assets at March 31, 2026 (in thousands):
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|||
Intangible assets: |
|
|
|
|
|
|
|
|
|
|||
License and acquired intangibles for RUZURGI® |
|
$ |
|
|
$ |
|
|
$ |
|
|||
License and acquired intangibles for FYCOMPA® |
|
|
|
|
|
|
|
|
|
|||
License and acquired intangibles for AGAMREE® |
|
|
|
|
|
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|||
The following table presents the Company’s intangible assets at December 31, 2025 (in thousands):
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
|||
Intangible assets: |
|
|
|
|
|
|
|
|
|
|||
License and acquired intangibles for RUZURGI® |
|
$ |
|
|
$ |
|
|
$ |
|
|||
License and acquired intangibles for FYCOMPA® |
|
|
|
|
|
|
|
|
|
|||
License and acquired intangibles for AGAMREE® |
|
|
|
|
|
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
|
|||
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
The following table presents future amortization expense the Company expects for its intangible assets (in thousands):
2026 (remaining nine months) |
|
|
|
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
2030 |
|
|
|
|
Thereafter |
|
|
|
|
Total |
|
$ |
|
At March 31, 2026 and December 31, 2025, the weighted average amortization period remaining for intangible assets was
There were
24
Table of Contents
Accrued expenses and other liabilities consist of the following (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Accrued preclinical and clinical trial expenses |
|
$ |
|
|
$ |
|
||
Accrued professional fees |
|
|
|
|
|
|
||
Accrued compensation and benefits |
|
|
|
|
|
|
||
Accrued license fees |
|
|
|
|
|
|
||
Accrued purchases |
|
|
|
|
|
|
||
Operating lease liability |
|
|
|
|
|
|
||
Accrued revenue allowances |
|
|
|
|
|
|
||
Accrued income tax |
|
|
|
|
|
|
||
Due to licensor |
|
|
|
|
|
|
||
Accrued interest payable |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Current accrued expenses and other liabilities |
|
|
|
|
|
|
||
Operating lease liability – non-current |
|
|
|
|
|
|
||
Other – non-current |
|
|
|
|
|
|
||
Non-current accrued expenses and other liabilities |
|
|
|
|
|
|
||
Total accrued expenses and other liabilities |
|
$ |
|
|
$ |
|
||
KYE Pharmaceuticals, Inc.
In August 2020, the Company entered into a collaboration and license agreement with KYE, for the commercialization of FIRDAPSE® in Canada. Under the agreement, KYE assumes all selling and marketing costs under the collaboration, while the Company is responsible for supply of FIRDAPSE® based on KYE’s purchase orders.
Under the terms of the agreement, the Company received (i) an up-front payment, (ii) payment upon transfer of Marketing Authorization, and (iii) continues to receive payment for supply of FIRDAPSE®. Further, the Company will receive milestone payments and a sharing of defined net profits 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.
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 was responsible for obtaining regulatory approval of the product from Health Canada and the Company supplies 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®.
Both of these agreements are in form identified as collaborative arrangements, although 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 are recognized in the quarter in which the sales occurred.
Revenues from the arrangements with KYE were not material for the three months ended March 31, 2026 and 2025, and are included in license and other revenue in the accompanying condensed consolidated statements of operations and comprehensive income and consisted of royalties. Expenses incurred, net have been included in selling, general and administrative expenses in the accompanying condensed consolidated statements of operations and comprehensive income.
25
Table of Contents
DyDo Pharma, Inc.
On June 28, 2021, the Company entered into a license and supply agreement with 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 earned an up-front payment and certain regulatory milestones and may earn sales-based milestones for FIRDAPSE®, as well as revenue on sales of 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 existed at the point in time in which the right to the license was granted. The Company determined the granting of the right to the license is distinct from the supply of FIRDAPSE® and represents a separate performance obligation in the agreement.
The agreement includes milestones that are considered a sales-based royalty in which the license is deemed to be the predominant item to which these milestones relate. Revenue will be recognized when the later of (a) the subsequent sale occurs, or (b) the performance obligation to which the sales-based royalty has been allocated has been satisfied. Additionally, the agreement includes regulatory milestone payments which represent variable consideration, and due to uncertainty are fully constrained and only recognized when the uncertainty is subsequently resolved. For clinical and commercial supply of the product, the Company will recognize revenue when DyDo obtains control of the Company’s product, which will occur at a point in time which is generally at time of shipment.
On September 24, 2024, DyDo advised the Company that the MHLW had approved DyDo's Japan NDA to commercialize FIRDAPSE® for the treatment of patients with LEMS and, on January 21, 2025, DyDo launched FIRDAPSE® in Japan.
There was $
26
Table of Contents
In May 2019, the FDA approved a NDA for RUZURGI®, Jacobus’ 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 ultimately prevailed in its litigation in September 2021 when the U.S. Court of Appeals for the 11th Circuit determined that the FDA's approval of RUZURGI® violated the Company's rights to Orphan Drug Exclusivity.
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 a patent case it filed against Jacobus to enforce its method of use patents, 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 paid the following consideration to Jacobus:
In January 2023, the Company received Paragraph IV Certification Notice Letters from three generic drug manufacturers (Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva), Hetero USA, Inc. (Hetero), and Lupin Pharmaceuticals, Inc. (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 Federal Food, Drug, and Cosmetic Act (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.
Additionally, in October 2023, the Company received a Paragraph IV Certification Notice Letter from a fourth generic drug manufacturer (Inventia Healthcare Limited (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.
In June 2024, Lupin converted five of its Paragraph IV Certifications in its ANDA to Paragraph III certifications acknowledging the validity and the 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 maintained its claims against Lupin for the remaining Paragraph IV certification for U.S. Patent No. 10,626,088 which is the patent expiring in 2037.
27
Table of Contents
Further, on January 8, 2025, the Company reached a settlement with Teva in which Teva agreed not to market a generic version of FIRDAPSE® in the U.S. any earlier than February 25, 2035, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the settlement agreement, the parties terminated all ongoing patent litigation between the Company and Teva regarding FIRDAPSE® patents pending in the U.S. District Court for the District of New Jersey. Later, on August 26, 2025, the Company reached a settlement with Lupin on substantially the same terms for market entry.
As of March 31, 2026, the pending FIRDAPSE® patent litigation against the remaining defendant, Hetero (for all of FIRDAPSE®’s Orange Book-listed patents), remains ongoing, and there could be no assurance as to whether the ongoing litigation with Hetero would allow a generic version of FIRDAPSE® to be marketed in the U.S. prior to February 25, 2035. At this time, this trial was scheduled to start on May 18, 2026, shortly before the expiration of the 30-month stay on May 26, 2026. See Note 17 (Subsequent Events) for a description of the recent settlement of this litigation.
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®. 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. As of the date of this report, three generic versions of the tablets and one generic version of the oral suspension are on the market.
Finally, 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.
28
Table of Contents
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 expanded its commercial territory for FIRDAPSE®, which originally was comprised of North America, to include Japan. Additionally, the Company’s commercial territory was further expanded under the license agreement in December 2023 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.
In January 2020, the Company was advised that BioMarin has transferred substantially all of its rights under the license agreement to SERB S.A. (SERB), and SERB is now the Company’s licensor under the license agreement.
Pursuant to the terms of the license agreement, the Company paid Jacobus a $
A minimum royalty payment existed annually for calendar years from the Effective Date through 2025 of $
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®.
29
Table of Contents
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 |
|
$ |
|
|
Acquired research and development inventory expensed from |
|
|
|
|
Total purchase price |
|
$ |
|
The straight-line method is used to amortize the license and acquired intangibles, as disclosed in Note 9 (License and Acquired Intangibles, Net).
Eisai was eligible to receive a contingent payment of $
Royalties commencing on the expiration of the last patent for the product for each calendar year during the royalty term equal to
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 |
|
$ |
|
|
Cash paid for pro-rated prepaid expenses |
|
|
|
|
Reimbursement on base purchase price(i) |
|
|
( |
) |
Transaction costs(ii) |
|
|
|
|
Total purchase consideration |
|
$ |
|
30
Table of Contents
The acquisition of FYCOMPA® was 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 |
|
$ |
|
|
Prepaid expenses and other current assets (samples) |
|
|
|
|
Prepaid commercialization expenses |
|
|
|
|
Property and equipment, net |
|
|
|
|
License and acquired intangibles for FYCOMPA® |
|
|
|
|
Accrued preclinical and clinical trial expenses |
|
|
( |
) |
Total purchase consideration |
|
$ |
|
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
Simultaneously, the Company made a strategic equity investment into Santhera by acquiring
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):
31
Table of Contents
Initial cash payment |
|
$ |
|
|
Investment in Santhera |
|
|
|
|
Transaction costs |
|
|
|
|
Total purchase consideration |
|
$ |
|
The transaction was 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® (IPR&D) |
|
$ |
|
|
Investment in Santhera(i) |
|
|
|
|
Total purchase consideration |
|
$ |
|
In accordance with FASB ASC 730-10-25, as AGAMREE® 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. The Company may be obligated to pay Santhera sales-based milestones of up to $
Following the approval of the NDA for AGAMREE® on October 26, 2023, the Company became obligated to make a milestone payment of $
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 to sell 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, net in the accompanying condensed consolidated statements of operations and comprehensive income.
32
Table of Contents
The Company’s effective income tax rate was
The Company had
Preferred Stock
The Company has
Common Stock
The Company has
Share Repurchases
In October 2025, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $
2023 Shelf Registration Statement
On September 8, 2023, the Company filed a shelf registration statement with the SEC to sell up to $
For the three months ended March 31, 2026 and 2025, the Company recorded stock-based compensation expense as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|||||
|
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Research and development |
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Stock Options
As of March 31, 2026, there were outstanding stock options to purchase
During the three months ended March 31, 2026 and 2025, the Company granted
During the three months ended March 31, 2026 and 2025, options to purchase
As of March 31, 2026, there was approximately $
Restricted Stock Units
The Company granted
As of March 31, 2026, there was approximately $
On May 6, 2026, the Company entered into an Agreement and Plan of Merger (the Merger Agreement) with Angelini Pharma S.p.A., an Italian Società per azioni (Angelini Pharma or Parent), and Angelini Cielo Inc., a Delaware corporation and wholly-owned subsidiary of Parent (Merger Sub), providing for the merger of Merger Sub with and into the Company (the Merger), with the Company surviving the Merger as a wholly-owned subsidiary of Parent. At the effective time of the Merger (the Effective Time), each share of the Company’s common stock, par value $
On May 7, 2026, the Company issued a press release announcing that it and its licensor, SERB, have entered into a settlement agreement (Settlement Agreement) with Hetero. This Settlement Agreement resolves the patent litigation brought by the Company and SERB in response to Hetero’s ANDA seeking approval to market a generic version of FIRDAPSE® (amifampridine) 10 mg tablets prior to expiration of the applicable patents. Pursuant to the terms of the Settlement Agreement, Hetero will not market its generic version of FIRDAPSE® in the United States any earlier than January 2035, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Settlement Agreement, the parties will terminate all ongoing patent litigation between the Company/SERB and Hetero regarding FIRDAPSE® patents pending in the U.S. District Court for the District of New Jersey. The Company previously settled similar litigation regarding ANDA applications for FIRDAPSE® with Teva, Inventia and Lupin. The Company also agreed to pay a litigation avoidance fee in the amount of $
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Introduction
Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is intended to provide an understanding of our financial condition, changes in financial condition and results of operations. The discussion and analysis is organized as follows:
OVERVIEW
We are 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. We currently sell three commercial stage drug products, FIRDAPSE® (amifampridine), AGAMREE® (vamorolone), and FYCOMPA® (perampanel) in the United States. We are also currently seeking to further expand our product portfolio, with a focus on acquiring the rights to immediately and near-term accretive assets to treat rare (orphan) diseases across therapeutic areas, including clinical-stage opportunities with established proof of concept and a clear regulatory pathway to approval. With an unwavering patient focus embedded in everything we do, we are committed to providing innovative, best-in-class medications with the hope of making a meaningful positive impact on those affected by these conditions.
Currently, we have a total of 74 field personnel supporting FIRDAPSE® and AGAMREE® which includes Regional Account Managers, Area Business Directors, National Account Directors, Thought Leader Liaisons and Area Marketing Directors. This also includes 17 Patient Access Liaisons and insurance navigation support personnel who support both FIRDAPSE® and AGAMREE® and 15 Medical Science Liaisons who help educate the medical community about scientific literature concerning our drug products and the diseases they treat.
When we launched AGAMREE® in March 2024, we utilized the FIRDAPSE® commercial and medical field-based forces to market AGAMREE®. Effective April 1, 2025, we separated these field-based forces into two distinct units, one for each function expressly focused on supporting FIRDAPSE® and one for each function expressly focused on supporting AGAMREE®, respectively. This strategic change was made in an effort to allow us to better focus the support for each product. Further, we have two National Account Directors on our commercial team who exclusively focus on the oncology market for Lambert-Eaton Myasthenic Syndrome (LEMS) patients who also have cancer.
Recent Developments
On May 6, 2026, we entered into an Agreement and Plan of Merger (the Merger Agreement) with Angelini Pharma S.p.A., an Italian Società per azioni (Angelini Pharma or Parent) and Angelini Cielo Inc., a Delaware corporation and wholly-owned subsidiary of Parent (Merger Sub), providing for the merger of Merger Sub with and into the Company (the Merger), with the Company surviving the Merger as a wholly-owned subsidiary of Parent.
For further information about the Merger Agreement and the Merger, see the Current Report on Form 8-K that we filed with the SEC on May 7, 2026 reporting with more particularity on the terms of the Merger Agreement and the proposed Merger.
FIRDAPSE®
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On November 28, 2018, we received approval from the U.S. Food & Drug Administration (FDA) for our new drug application (NDA) for FIRDAPSE® Tablets 10 mg for the treatment of adult patients (ages 17 and above) with LEMS, and in January 2019, we launched FIRDAPSE® in the U.S. Further, on September 29, 2022, the FDA approved our supplemental NDA (sNDA) to expand the indicated age range for FIRDAPSE® Tablets 10 mg for the treatment of LEMS to include pediatric patients six years of age and older. Additionally, on May 30, 2024, the FDA approved our sNDA increasing the indicated maximum daily dosage of FIRDAPSE® tablets for the treatment of patients with LEMS from 80 mg to 100 mg. We are also planning to evaluate FIRDAPSE® in the future for the treatment of other diseases.
We sell FIRDAPSE® in the U.S. through a field-based force experienced in neurologic, central nervous system or rare disease products consisting at this time of approximately 26 field personnel, including sales (Regional Account Managers and Area Business Directors), National Account Directors and Thought Leader Liaisons. This includes two National Account Directors and three Thought Leader Liaisons who exclusively focus on the oncology market for LEMS patients with cancer. We also use non-personal promotion to reach the 20,000 neurologists who are potential LEMS treaters and the 16,000 oncologists who might be treating a LEMS patient who also has cancer (principally small cell lung cancer). Finally, we make available for online ordering a no-cost LEMS voltage gated calcium channel (VGCC) antibody diagnostic testing program for use by physicians who suspect that one of their patients may have LEMS and wish to reach a definitive diagnosis.
Further, we are continuing to expand our digital and social media activities to introduce our products and services to potential patients and their healthcare providers. We also work with several rare disease advocacy organizations (including the Myasthenia Gravis Foundation of America, the National Organization for Rare Disorders, and the LEMS Family Association) to help increase awareness and level of support for patients living with LEMS and to provide education for the physicians who treat this rare disease and the patients they treat.
On August 6, 2025, we reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Cell Lung Cancer (SCLC) now include additions involving LEMS, amifampridine, and the tests for PQ- and N-type VGCC antibodies. The updated NCCN Guidelines® for SCLC relating to LEMS now include symptom specificity—characterized by proximal muscle weakness and autonomic dysfunction. Under "Signs and Symptoms of Small Cell Lung Cancer” (SCL-A 2 of 2), the guidelines recommend diagnosis through a neurological evaluation, ideally in consultation with a neurologist, which may include testing for PQ- and N-type VGCC antibodies. Additionally, under “Principles of Supportive Care” (SCL-D), the guidelines recommend that amifampridine should be considered as a treatment in consultation with neurology. We are currently working to increase awareness of these oncology clinical practice guidelines among oncology practices that treat patients with SCLC.
We are supporting the distribution in the U.S. of FIRDAPSE® through Catalyst Pathways®, our personalized treatment support program for patients who enroll in it. Catalyst Pathways® is a single source for personalized treatment support, education and guidance through the challenging dosing and titration regimen required to reach an effective therapeutic dose. The program also includes distributing the drug through a very small group of exclusive specialty pharmacies (primarily AnovoRx), which is consistent with the way that most drug products for ultra-orphan diseases are distributed and dispensed to patients. We believe that by using specialty pharmacies in this way, the task, which can be difficult, of navigating the health care system is far better for the patient needing treatment for their rare disease and the health care community in general.
In order to help patients with LEMS afford their medication, we, like other pharmaceutical companies that market drug products for orphan and ultra-orphan, rare diseases, have developed an array of financial assistance programs intended to reduce out-of-pocket costs in order to make FIRDAPSE® accessible and affordable. A co-pay assistance program has been designed to reduce commercial patients’ out of pocket costs to as little as $0 whenever possible (currently an average of less than $2 per month). Our co-pay assistance programs, including the one for FIRDAPSE®, are not available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Department of Veterans Affairs (VA), Department of Defense (DoD), or TRICARE. However, we have, at times, donated funds to one or more qualified, independent charitable foundations dedicated to providing assistance to any U.S. LEMS patients in financial need who meet those independent organizations' guidelines. In addition, we have a program in place to help patients who are uninsured and underinsured. Subject to compliance with applicable regulatory requirements, our goal is that no LEMS patient is ever denied access to their medication for financial reasons.
FIRDAPSE® is currently marketed for the treatment of LEMS in Canada through our exclusive sublicensee, KYE Pharmaceuticals, Inc. (KYE). We supply product to KYE at agreed upon prices and we are also eligible to earn sales milestones and sales royalties based on net revenues from sales of the product in Canada. Further, FIRDAPSE® is commercially available (since January 21, 2025) for the treatment of LEMS in Japan through our sublicensee for Japan, DyDo Pharma, Inc. (DyDo). We generate revenue from DyDo through the receipt of additional milestone payments, as such milestones are achieved, and a transfer price on the product supplied by us to DyDo (in lieu of royalties).
We control six U.S. patents for FIRDAPSE® that are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), the earliest of which expires in 2032 and the latest of which expires in 2037. Generic drug manufacturers were permitted to submit applications for the product challenging our patents starting in 2023 and the FDA is now permitted to approve such ANDA products following the expiration of our orphan drug exclusivity (ODE) on November 26, 2025, subject to any pending
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30-month stays of approval as required under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).
With respect to ANDA filers, in January 2023, we received Paragraph IV Certification Notice Letters from three generic drug manufacturers (Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva), Hetero USA, Inc. (Hetero), and Lupin Pharmaceuticals, Inc. (Lupin)) advising that they each had submitted an 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 protecting FIRDAPSE® that are listed in the Orange Book in connection with 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 Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, we had 45 days from receipt of the notice letters to determine if there were grounds to bring a lawsuit and, if so, to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court, which would trigger a statutory stay precluding the FDA from final approval of the subject ANDA until May 26, 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first in all cases. In that regard, after conducting the necessary due diligence, we 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 us 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. We subsequently dismissed all of our claims against Lupin related to those five patents but maintained our claim against Lupin for the remaining Paragraph IV certification for U.S. Patent No. 10,626,088, which is the patent expiring in 2037.
On January 8, 2025, we reached a settlement with Teva in which Teva agreed not to market a generic version of FIRDAPSE® in the U.S. any earlier than February 25, 2035, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the settlement agreement, the parties terminated all ongoing patent litigation between us and Teva regarding FIRDAPSE® patents pending in the U.S. District Court for the District of New Jersey. Later, on August 26, 2025, we reached a settlement with Lupin on substantially the same terms for market entry.
The pending FIRDAPSE® patent litigation against the remaining defendant, Hetero (relating to the FIRDAPSE® Orange Book-listed patents expiring in 2032, 2034 and 2037) was settled on May 6, 2026. This Settlement Agreement resolves the patent litigation brought by SERB and us in response to Hetero’s ANDA seeking approval to market a generic version of FIRDAPSE® prior to expiration of the applicable patents. Pursuant to the terms of the Settlement Agreement, Hetero will not market its generic version of FIRDAPSE® in the United States any earlier than January 2035, if approved by the FDA, unless certain limited circumstances customarily included in these types of agreements occur. In accordance with the Settlement Agreement, the parties will terminate all ongoing patent litigation between us and Hetero regarding FIRDAPSE® patents pending in the U.S. District Court for the District of New Jersey. We also agreed to pay a litigation avoidance fee in the amount of $11.0 million to Hetero as part of the settlement. As required by law, Hetero and we will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
AGAMREE®
On June 19, 2023, we entered into a License and Collaboration Agreement (AGAMREE® License Agreement) and an Investment Agreement (Investment Agreement) with Santhera Pharmaceuticals Holding AG (collectively, Santhera). Under the AGAMREE® License Agreement, we contracted to obtain an exclusive North America license, manufacturing and supply agreement for product candidate, AGAMREE®, a novel corticosteroid for the treatment of Duchenne muscular dystrophy (DMD). We also obtained the North American rights to any future approved indications for AGAMREE®. Under the Investment Agreement, we agreed to make a strategic investment into Santhera. Both transactions closed on July 18, 2023.
Finally, under our AGAMREE® License Agreement with Santhera, we agreed to purchase commercial supply of AGAMREE® from Santhera at agreed upon prices until we completed our process to transition to our own direct supplier. In that regard, we are in the process of transitioning final goods manufacturing to a U.S. location (estimated to be completed by the end of 2026).
Concurrent with the closing of the AGAMREE® License Agreement, we made a strategic investment into Santhera in which we acquired 1,414,688 of Santhera’s ordinary shares (representing approximately 11.26% of Santhera’s outstanding ordinary shares immediately following the transaction) at an investment price of CHF 9.477 per share, with the approximately $15.7 million USD in equity investment proceeds to be used by Santhera for Phase IV studies of AGAMREE® in DMD and future development of additional indications for AGAMREE®. On April 29, 2026, we filed a disclosure of significant shareholdings under the Swiss Financial Markets Infrastructure Act (FMIA) to disclose that our 1,414,688 shares of Santhera's ordinary shares represented 9.39% of Santhera's outstanding ordinary shares as of that date. On May 7, 2026, the closing price of Santhera’s common shares on the SIX Swiss Exchange was CHF 17.56 per share (approximately $22.55 USD based on then-current exchange rates).
When we launched AGAMREE® in March 2024, we utilized our FIRDAPSE® commercial and medical field-based forces to market AGAMREE®. Effective April 1, 2025, we separated these field-based forces into two units, one for each function expressly focused on
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supporting FIRDAPSE® and one for each function expressly focused on supporting AGAMREE®, respectively. This strategic change was made in an effort to allow us to better focus the support for each product.
Since April 1, 2025, we have sold AGAMREE® in the U.S. through a dedicated field-based force of approximately 16, including sales (12 Regional Account Managers and two Area Business Directors) and two Area Marketing Directors. We are further supporting the distribution of AGAMREE® through our Catalyst Pathways® patient services program to ensure that patients have access to a dedicated, personalized support team that assists families through the AGAMREE® patient journey, from answering questions to coordinating financial assistance programs for eligible patients. Additionally, we have also donated to qualified, independent charitable foundations dedicated to providing assistance to DMD patients in financial need who meet the independent organization's guidelines. Subject to applicable regulatory requirements, our goal is to ensure that no DMD patient is ever denied access to their medication for financial reasons.
DMD, the most common form of muscular dystrophy, is a rare and life-threatening neuromuscular disorder characterized by progressive muscle dysfunction, ultimately leading to loss of ambulation, respiratory failure, and fatality. Current standard treatment for DMD involves corticosteroids, which often come with significant side effects. It is estimated that between 11,000 and 13,000 people in the U.S. are affected by DMD, with approximately 70% of patients currently receiving a corticosteroid treatment. We believe that steroids are and will continue to remain the foundational therapy for DMD patients and dosed concomitantly with other therapies.
AGAMREE®’s unique mode of action is based on differential effects on glucocorticoid and mineralocorticoid receptors and modifying further downstream activity. As such, it is considered a novel corticosteroid that we hope has the potential to demonstrate a better tolerated side effect profile relative to traditional corticosteroids, while demonstrating comparable efficacy. This mechanism of action may allow vamorolone to emerge as an effective alternative to traditional corticosteroids in children, adolescents, and adult patients with DMD. In that regard, we are currently enrolling up to 250 patients in our SUMMIT registry study to evaluate long-term patient safety and quality of life data in patients treated with vamorolone, with the hope of offering a deeper understanding of the product's potential long-term benefits for patients, such as in the areas of growth parameters, bone health status (including the occurrence of fractures), BMI, cardiovascular status, muscular, hormonal and ophthalmologic status, QoL, and adverse events.
On October 13, 2023, Santhera announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive position in favor of AGAMREE® for the treatment of DMD patients aged four and older. In its recommendation for approval, CHMP acknowledged that there was a positive benefit-risk profile of AGAMREE® in such patient population, including certain safety benefits of AGAMREE® compared to traditional corticosteroids in the treatment of DMD. Further, on December 18, 2023, the European Commission (EC) granted to Santhera marketing authorization for AGAMREE® for the treatment of DMD in patients ages four years and older and on January 12, 2024 Santhera announced that AGAMREE® had received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom. Further, on January 15, 2024, Santhera announced that AGAMREE® was commercially launched in Germany. Additionally, on January 16, 2025, the National Institute for Health and Care Excellence (NICE) issued positive Final Guidance that recommends AGAMREE® for use in the National Health Service (NHS) in England, Wales and Northern Ireland for the treatment of DMD in patients four years of age and older and on February 13, 2025, Santhera announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement for AGAMREE® for the treatment of DMD. This agreement makes AGAMREE® the first product to receive an agreed federal price in Germany for the treatment of DMD in patients four years of age and older, independent of the underlying genetic mutation. Finally, on January 15, 2026, Santhera announced that the Swiss Agency for Therapeutic Products (Swissmedic) approved AGAMREE® for the treatment of DMD in patients four years of age and older.
Further, Santhera has recently reported on the results of two studies, the Guardian Trial and the Lionheart trial, which provide useful information about some of the issues that are intended to be covered in the SUMMIT study. In addition, at the recent Muscular Dystrophy Conference held in March 2026, we sponsored an industry forum in collaboration with Santhera on the topic of real-world experience in using vamorolone for the treatment of patients with DMD.
We are also evaluating life cycle management of AGAMREE® with the intention to explore the possibility of additional indications beyond DMD. In furtherance of that objective, we are currently conducting a Phase 1 study in healthy adults comparing a single dose of vamorolone, prednisone, and deflazacort, and studying the immunosuppressive effect of multiple ascending doses of AGAMREE®. This study will evaluate whether there is an immunosuppressive dose of vamorolone that might be considered for future indications and for the use of our product in conjunction with gene and cell therapies that are approved to treat DMD and require a concurrent immunosuppressive regimen of a corticosteroid when administered. We expect to have the results of both parts of this study during the second quarter of 2026. Further, we are hopeful that the recent addition of DMD to the Recommended Uniform Screening Panel by the U.S. Department of Health and Human Services will help support earlier detection of the disease and more timely access to treatment options.
Further, the joint steering committee that we established with Santhera at the time we obtained a license for AGAMREE® is actively collaborating on the lifecycle management and development of the product. There can be no assurance that we can develop and commercialize our product for the treatment of diseases other than DMD.
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In the U.S., AGAMREE® has New Chemical Entity exclusivity that expires in October 2028. AGAMREE® also has Orphan Drug Exclusivity expiring in October 2030. AGAMREE® is further protected by seven Orange Book listed patents expiring as early as May 28, 2029 and as late as July 16, 2040. The Company has also requested Patent Term Extension (PTE) and will update the relevant expiration date in the Orange Book upon a final determination by the U.S. Patent and Trademark Office (USPTO). On June 25, 2025, the FDA published a notice (Determination of Regulatory Review Period for Purposes of Patent Extension; AGAMREE®) in the Federal Register regarding the requested extension of patent numbers 8,334,279, 10,857,161, and 11,833,159, all of which currently expire on May 28, 2029, as listed in the FDA's Orange Book. With the publication of this notice, there is a 180-day period for third parties to submit comments and/or due diligence petitions to the FDA. If no comments or petitions are submitted within this period, the FDA will notify the USPTO so that the USPTO can then determine the length of the PTE for each patent for which an extension was requested. Upon completion of the PTE determination, USPTO will mail a Notice of Final Determination of PTE. We will then have one month from the mailing of the Notice of Final Determination to elect one of the three patents for an extension patent term.
The earliest a generic manufacturer could submit an ANDA for vamorolone is October 26, 2027. If we were to pursue a patent infringement action of any such ANDA challenges of any of AGAMREE®’s Orange Book patents, then the automatic statutory 30-month stay would prevent FDA approval of such ANDA until April 26, 2031.
On July 23, 2024 we entered into a license, supply and commercialization agreement with KYE, which is already our sublicensee for FIRDAPSE® in Canada, granting KYE the exclusive Canadian commercial rights to market AGAMREE® in Canada for DMD and other indications. Under the agreement, KYE was responsible for obtaining regulatory approval of the product from Health Canada and on October 2, 2025, KYE announced that Health Canada has approved AGAMREE® for the treatment of DMD in boys four years of age and older. Under our sublicense agreement with KYE for this product, we will supply product to KYE and also receive sales milestones and sales royalties based on net revenues from sales of the product in Canada. We currently expect that KYE will launch the product in Canada sometime in 2026.
FYCOMPA®
On December 17, 2022, we entered into an agreement with Eisai Co., Ltd. (Eisai) for the acquisition of the U.S. rights to FYCOMPA® CIII. FYCOMPA® is a selective non-competitive antagonist of AMPA receptors, the major subtype of ionotropic glutamate receptors. It was the first, and still is the only, drug of its class to be approved for epilepsy. Studies suggest that AMPA receptor antagonism can lead to reduced overstimulation and anticonvulsant effects, as well as inhibiting seizure generation and spread. FYCOMPA® is a controlled substance and is approved with a boxed warning in its labeling. FYCOMPA® is used to treat certain types of focal onset seizures (seizures that involve only one part of the brain) in adults and children four years of age and older. It is also used in combination with other medications to treat certain types of primary generalized tonic-clonic seizures (also known as a “grand mal” seizure, a seizure that involves the entire body) in adults and children 12 years of age or older. Perampanel is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
On January 24, 2023, we closed our acquisition of the U.S. rights to FYCOMPA®. In connection with the acquisition, we purchased Eisai’s regulatory approvals and documentation, product records, intellectual property, inventory, and other matters relating to the U.S. rights for FYCOMPA®, in exchange for an upfront payment of $160 million in cash. We also agreed to pay Eisai royalty payments on net sales after all FYCOMPA® patents had expired, with such royalty payments reduced after generic equivalents enter the market. In conjunction with the closing of the asset purchase, we entered into a Supply Agreement under which Eisai agreed to manufacture FYCOMPA® for us for at least seven years at prices listed in the Supply Agreement (to be updated on a yearly basis).
Patent protection for FYCOMPA® tablets and oral solution expired in 2025, and, to our knowledge based on publicly available information, three ANDA filers for the tablet formulations have, to date, obtained approval for and are marketing a generic version of FYCOMPA® tablets and one ANDA filer has, to date, obtained approval for and is marketing a generic version of FYCOMPA® oral suspension. We continue to sell FYCOMPA® tablets and oral suspension despite the loss of exclusivity, although we ceased all marketing efforts for the product at the end of 2025.
Business Development
We continue to advance our strategic initiatives and portfolio expansion efforts, focusing on broadening and diversifying our rare (orphan) neurology product portfolio with innovative therapies that address critical unmet medical needs. In that regard, we are currently exploring immediate or near-term accretive, clinically differentiated and adequately de-risked opportunities, with a keen focus on rare (orphan) disease products across therapeutic areas and treatment modalities. These prospects include evaluating products and companies with existing commercial drug products or drugs in development, including clinical stage opportunities with established proof of concept and a clear regulatory pathway for approval, for potential licensing or acquisition. We maintain a well-established U.S. presence, which remains the cornerstone of our commercial strategy, while continuously evaluating strategic opportunities to expand our global footprint.
We employ a disciplined, comprehensive, and exhaustive approach to identifying and evaluating opportunities that we believe will add significant value to our company over the near, mid, and long-term. However, no definitive agreements have been entered into to date to acquire the rights to any additional products, and there can be no assurance that any of the Company's business development initiatives will be successful.
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Capital Resources
At March 31, 2026, we had cash and cash equivalents of approximately $755.9 million. Based on our current financial condition, including our profitability, cash flows generated from operations and forecasts of available cash, absent the use of cash to acquire potential business development opportunities, we believe that we have sufficient funds to support our operations for at least the next 12 months. There can be no assurance that we will continue to be successful in commercializing FIRDAPSE® and AGAMREE®, that our forecasts of revenues from sales of FYCOMPA® will be accurate now that the product has lost patent exclusivity, or that we will continue to be profitable and cash flow positive. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources” below for further information on our liquidity and cash flow.
Share Repurchase Program
On October 1, 2025, we announced that our Board of Directors has authorized a new share repurchase program to repurchase up to $200 million of shares of our common stock between October 1, 2025 and December 31, 2026. Repurchases under the new share repurchase program may be made through a variety of methods, including open market or privately negotiated purchases. The timing and amount of shares repurchased will depend on the stock price, business and market conditions, corporate and regulatory requirements, alternative investment opportunities, acquisition opportunities and other factors. We are not obligated to repurchase any specific amount of shares of common stock, and the new share repurchase program may be suspended or terminated at any time.
We are using existing cash on hand to fund our share repurchase program. We also believe that we can execute our share repurchase program without impairing the advancement of our business development strategy. In that regard, as of May 7, 2026, we had repurchased 1,740,713 shares of our outstanding common stock for an aggregate purchase price of approximately $39.9 million ($22.91 average price per share).
Basis of Presentation
Revenues.
During the three months ended March 31, 2026, we generated revenues from product sales of FIRDAPSE®, AGAMREE®, and FYCOMPA®. We expect these revenues to fluctuate in future periods based on our sales during such periods of our products.
We received approval from Health Canada on July 31, 2020, for FIRDAPSE® for the symptomatic treatment of LEMS and as of December 31, 2020, our sub-licensee KYE launched FIRDAPSE® in Canada. During the three months ended March 31, 2026, revenues generated under our collaboration agreement with KYE were immaterial. In July 2024, we announced that we had entered into a collaboration agreement with KYE for the commercialization of AGAMREE® in Canada. On October 2, 2025, KYE issued a press release reporting that its NDS to commercialize AGAMREE® in Canada had been approved by Health Canada.
On September 24, 2024, we were informed by DyDo that it had received approval of its New Drug Application for the sale of FIRDAPSE® in Japan. Further, DyDo advised us that they launched FIRDAPSE® in Japan in January 2025.
We expect revenues from both the KYE and DyDo agreements to be immaterial in 2026, as distribution ramps up in each jurisdiction and KYE begins to market AGAMREE® in Canada.
Cost of Sales.
Cost of sales consists of third-party manufacturing costs, freight, royalties, amortization related to milestone payments, and indirect overhead costs associated with sales of our products. Cost of sales may also include period costs related to certain inventory manufacturing services, inventory adjustments charges, unabsorbed manufacturing and overhead costs and manufacturing variances.
Research and Development Expenses.
Our research and development expenses consist of costs incurred for company-sponsored research and development activities, as well as support for selected investigator-sponsored research. The major components of research and development costs include acquired IPR&D, preclinical study costs, clinical manufacturing costs, clinical study and trial expenses, insurance coverage for clinical trials, consulting, and other third-party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs related to our product development efforts.
Prior to January 2023, all of our research and development resources had been devoted to the development of FIRDAPSE®, and until such time as we acquire or license new products we currently expect that our future development costs will be attributable principally to the continued development of FIRDAPSE®, and AGAMREE®.
Our cost accruals for clinical studies and trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical study and trial sites and clinical research organizations (CROs). In the normal course of our business we contract with third parties to perform various clinical study and trial activities in the on-going development of potential products. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events or milestones, the successful enrollment of patients, the allocation of responsibilities among the parties to the agreement, and the completion of portions of the clinical study or trial
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or similar conditions. The objective of our accrual policy is to match the recording of expenses in our condensed consolidated financial statements to the actual services received and efforts expended. As such, expense accruals related to preclinical and clinical studies or trials are recognized based on our estimate of the degree of completion of the event or events specified in the specific study or trial contract. We monitor service provider activities to the extent possible; however, if we underestimate activity levels associated with various studies or trials at a given point in time, we could be required to record significant additional research and development expenses in future periods. Preclinical and clinical study and trial activities require significant up-front expenditures. We anticipate paying significant portions of a study or trial’s cost before they begin and incurring additional expenditures as the study or trial progresses and reaches certain milestones.
Selling, General and Administrative Expenses.
During 2019, we began to commit funds to developing our commercialization program for FIRDAPSE® and we have continued to incur substantial commercialization expenses, including sales, marketing, patient services, patient advocacy and other commercialization related expenses as we have continued our sales and marketing program for FIRDAPSE®. We are also now incurring substantial commercialization expenses for AGAMREE®, as we continue commercialization of this product. We expect that such expenses for FYCOMPA® will substantially decline as a result of declining sales resulting from the loss of exclusivity of the product with the entry of generic competitors for this product.
Our general and administrative expenses consist primarily of salaries and personnel expenses for accounting, corporate, compliance, and administrative functions. Other costs include administrative facility costs, regulatory fees, insurance, and professional fees for legal (including litigation) cost, IT, accounting, and consulting services.
Amortization of Intangible Assets.
Amortization of intangible assets consists of the amortization of the FYCOMPA® product rights, which are amortized using the straight-line method over its estimated useful life of 5 years, the RUZURGI® product rights, which are amortized using the straight-line method over its estimated useful life of 14.5 years, and the AGAMREE® product rights, which are amortized using the straight-line method over its estimated useful life of 10.5 years.
Stock-Based Compensation.
We recognize expense for the fair value of all stock-based awards to employees, directors, and consultants in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). For stock options, we use the Black-Scholes option valuation model in calculating the fair value of the awards.
Income Taxes.
Our effective income tax rate is the ratio of income tax expense over our net income before income taxes.
Recently Issued Accounting Standards.
For discussion of recently issued accounting standards, please see Note 2, “Basis of Presentation and Significant Accounting Policies,” in the condensed consolidated financial statements included in this report.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make judgments, estimates, and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenues and expenses during the reporting periods. For a full discussion of our accounting policies, please refer to Note 2 on the Financial Statements included in our 2025 Annual Report on Form 10-K that we filed with the SEC on February 25, 2026. Our most critical accounting policies and estimates include accounting for revenue recognition (including adjustments for government rebates) and valuation of intangible assets. We continually evaluate our judgments, estimates and assumptions. We base our estimates on the terms of underlying agreements, our expected course of development, historical experience and other factors that we believe are reasonable based on the circumstances, the results of which form our management’s basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. There have been no material changes to our critical accounting policies and estimates from the information provided in Part II, Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our 2025 Annual Report on Form 10-K.
Results of Operations
Revenues.
For the three months ended March 31, 2026, we recognized total revenues of approximately $149.4 million, which included approximately $149.3 million in net product revenue (primarily in the U.S.), compared to total revenues of approximately $141.4 million,
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which included approximately $141.4 million in net product revenue (primarily in the U.S.), for the three months ended March 31, 2025. Total revenues for the three months ended March 31, 2026 and 2025 were as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
% |
|
||||
FIRDAPSE® |
|
$ |
98,859 |
|
|
$ |
83,731 |
|
|
|
15,128 |
|
|
|
18.1 |
|
AGAMREE® |
|
|
36,713 |
|
|
|
22,042 |
|
|
|
14,671 |
|
|
|
66.6 |
|
FYCOMPA® |
|
|
13,771 |
|
|
|
35,627 |
|
|
|
(21,856 |
) |
|
|
(61.3 |
) |
Product revenue, net |
|
|
149,343 |
|
|
|
141,400 |
|
|
|
7,943 |
|
|
|
5.6 |
|
License and other revenue |
|
|
47 |
|
|
|
21 |
|
|
|
26 |
|
|
|
123.8 |
|
Total revenues |
|
$ |
149,390 |
|
|
$ |
141,421 |
|
|
|
7,969 |
|
|
|
5.6 |
|
The increase of approximately $7.9 million in net product revenue when comparing the three months ended March 31, 2026 and 2025 was primarily driven by increases in sales volumes for both FIRDAPSE® and AGAMREE®.
Further, FYCOMPA® net product revenue decreased by approximately $21.9 million or 61.3% from the three months ended March 31, 2025 compared to the three months ended March 31, 2026, due to the generic entry following the loss of exclusivity in 2025. We expect that net product revenue for FYCOMPA® will likely continue to decrease in the future since generic competitors entered the market following the expiration of the '571 patent on May 23, 2025.
For the three months ended March 31, 2026 and 2025, we recognized $47 thousand and $21 thousand, respectively, in license and other revenue, which consisted of royalties.
Cost of Sales.
Cost of sales was approximately $14.5 million for the three months ended March 31, 2026, compared to approximately $17.9 million for the three months ended March 31, 2025. The decrease when comparing the three months ended March 31, 2026 to the three months ended March 31, 2025 was primarily due to a decrease in royalty obligations related to FIRDAPSE®. Cost of sales in all periods consisted principally of royalty payments, which are based on net revenue as defined in the applicable license agreements. For FIRDAPSE®, royalties are payable on the terms set forth below in Liquidity and Capital Resources—Contractual Obligations and Arrangements, and increase by 3% when net sales (as defined in the applicable license agreement) exceed $100 million in any calendar year. Cost of sales for FYCOMPA® for the three months ended March 31, 2026 consisted of product costs and excludes the amortization of the FYCOMPA® intangible assets. Cost of sales for AGAMREE® for the three months ended March 31, 2026 consisted of royalties payable on the terms set forth below in Liquidity and Capital Resources—Contractual Obligations and Arrangements, product costs and excludes the amortization of the AGAMREE® intangible asset. Royalties on sales of AGAMREE® in future years may increase as a percentage of net sales exceed certain amounts of net revenues over $100 million. See Note 13 of the "Notes to Condensed Consolidated Financial Statements" included elsewhere in this report.
Research and Development Expenses.
Research and development expenses for the three months ended March 31, 2026 and 2025 were approximately $2.7 million and $3.9 million, respectively, and represented approximately 3% and 5% of total operating costs and expenses, respectively. Research and development expenses for the three months ended March 31, 2026 and 2025 were as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
% |
|
||||
Salary and benefit expense |
|
$ |
1,018 |
|
|
$ |
1,112 |
|
|
|
(94 |
) |
|
|
(8.5 |
) |
Employee stock-based compensation expense |
|
|
462 |
|
|
|
425 |
|
|
|
37 |
|
|
|
8.7 |
|
Research and clinical trial expense |
|
|
1,141 |
|
|
|
2,090 |
|
|
|
(949 |
) |
|
|
(45.4 |
) |
Additional research and development expense |
|
|
40 |
|
|
|
260 |
|
|
|
(220 |
) |
|
|
(84.6 |
) |
Total research and development expenses |
|
$ |
2,661 |
|
|
$ |
3,887 |
|
|
|
(1,226 |
) |
|
|
(31.5 |
) |
Research and development expenses remained relatively consistent during the three months ended March 31, 2026 when compared to the same period in 2025. During the three months ended March 31, 2026, research and development expenses consisted of costs for company-sponsored research and development activities, support for selected investigator-sponsored research, and costs for development activities supporting our commercial products.
We expect that research and development activities may become more significant in the future if we seek to execute on the development of additional indications for FIRDAPSE® and AGAMREE® and on our portfolio expansion efforts.
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Selling, General and Administrative Expenses.
Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 were approximately $49.3 million and $46.9 million, respectively, and represented approximately 65% and 60% of total operating costs and expenses, respectively. Selling, general and administrative expenses for the three months ended March 31, 2026 and 2025 were as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|
Change |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
% |
|
||||
Selling |
|
$ |
29,661 |
|
|
$ |
29,901 |
|
|
|
(240 |
) |
|
|
(0.8 |
) |
General and administrative |
|
|
13,860 |
|
|
|
11,585 |
|
|
|
2,275 |
|
|
|
19.6 |
|
Employee stock-based compensation |
|
|
5,798 |
|
|
|
5,425 |
|
|
|
373 |
|
|
|
6.9 |
|
Total selling, general and administrative expenses |
|
$ |
49,319 |
|
|
$ |
46,911 |
|
|
|
2,408 |
|
|
|
5.1 |
|
For the three months ended March 31, 2026, selling, general and administrative expenses remained relatively consistent when compared to the same period in 2025. The increase in general and administrative expenses was primarily due to consulting fees related to multiple business initiatives, including business development activities.
We expect that selling, general, and administrative expenses will continue to be substantial in future periods as we continue to sell FIRDAPSE® and AGAMREE® and as we take other steps in an effort to continue to expand our business, offset in part by reduced selling, general, and administrative expenses as more generic FYCOMPA® becomes available in the marketplace. We further anticipate that general and administrative expenses will be impacted in the second quarter of 2026 by a litigation avoidance payment in connection with the settlement of our patent litigation with Hetero.
Amortization of Intangible Assets.
Amortization of intangible assets was approximately $9.7 million for the three months ended March 31, 2026 compared to $9.3 million for the three months ended March 31, 2025. Amortization of intangible assets consists of the amortization of the FYCOMPA® rights, which are amortized using the straight-line method over its estimated useful life of 5 years, the RUZURGI® rights, which are amortized using the straight-line method over its estimated useful life of 14.5 years and the AGAMREE® rights and a sales-based milestone, which are amortized using the straight-line method over its estimated useful life of 10.5 years.
Each fiscal quarter, we review the value of our intangible assets to determine if they are impaired. If we determine one or more of our intangible assets are impaired during a future period we would record a charge in the amount of that impairment.
Stock-Based Compensation.
Total stock-based compensation for the three months ended March 31, 2026 and 2025 was $6.3 million and $5.9 million, respectively. During the three months ended March 31, 2026 and 2025, grants were principally for stock options and restricted stock units related to year-end bonus awards and grants to new employees.
Other Income, Net.
We reported other income, net in all periods, primarily relating to interest on our investment of our cash and cash equivalents of approximately $11.0 million and $7.9 million for the three months ended March 31, 2026 and 2025, respectively. The increase in other income, net for the three months ended March 31, 2026 when compared to the same period in 2025 was primarily due to higher invested balances and an increase in the fair value of our investment in Santhera. Since Santhera’s shares are traded on the SIX Swiss Exchange, they have a readily determinable fair value, and as a result the investment is measured quarterly, at fair value, with changes reported in other income, net.
The components of other income, net were as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Interest income, net |
|
$ |
6,247 |
|
|
$ |
5,275 |
|
Net gains (losses) recognized during the period on |
|
|
4,750 |
|
|
|
2,644 |
|
Total other income, net |
|
$ |
10,997 |
|
|
$ |
7,919 |
|
Income Taxes.
Our effective income tax rate was approximately 24.3% and 20.4% for the three months ended March 31, 2026 and 2025, respectively. Differences in our effective tax and the statutory federal income tax of 21% are driven by state income taxes and anticipated annual permanent differences offset by equity compensation deductions. Our effective tax rate is affected by many factors, including the number
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of stock options exercised in any period, and our effective tax rate is likely to fluctuate in future periods (and may be higher than it was for the three months ended March 31, 2026).
We had no material uncertain tax positions as of March 31, 2026 and December 31, 2025.
Net Income.
Our net income was approximately $63.7 million for the three months ended March 31, 2026 ($0.52 per basic and $0.50 per diluted share) as compared to approximately $56.7 million for the three months ended March 31, 2025 ($0.47 per basic and $0.45 per diluted share).
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily through revenues from product sales and multiple offerings of our securities. At March 31, 2026 we had cash and cash equivalents aggregating $755.9 million and working capital of $808.0 million. At December 31, 2025 we had cash and cash equivalents aggregating $709.2 million and working capital of $746.9 million. At March 31, 2026, substantially all of our cash and cash equivalents were deposited with two financial institutions, and such balances were in excess of federally insured limits. Further, as of such date, substantially all such funds were invested in U.S. Treasuries and money market accounts.
On September 8, 2023, we 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, we completed a public offering of 10 million shares of our common stock under the 2023 Shelf Registration Statement, raising net proceeds of approximately $140.7 million.
Based on our current financial condition, including our profitability, cash flows generated from operations and forecasts of available cash, absent the use of cash to acquire potential business development opportunities, we believe that we have sufficient funds to support our operations for at least the next 12 months from the date of this report. There can be no assurance that we will remain profitable or that we will be able to obtain any additional funding that we may require in the future.
In the future, we may require additional working capital to support our operations depending on our future success with FIRDAPSE®, AGAMREE®, and FYCOMPA® sales, or the products we may acquire and continue to develop and whether our results continue to be profitable and cash flow positive. We may also need to raise additional capital to fund product acquisitions that are valued at more than our available cash. There can be no assurance as to the amount of any such funding that will be required for these purposes or whether any such funding will be available to us if and when it is required.
In that regard, our future funding requirements will depend on many factors, including:
We may raise additional funds through public or private equity offerings, debt financings, corporate collaborations or other means. We also may seek governmental grants for a portion of the required funding for our clinical trials and preclinical trials. We may further seek to raise capital to fund additional product development efforts or product acquisitions, even if we have sufficient funds for our planned operations. Any sale by us of additional equity or convertible debt securities could result in dilution to our stockholders. There can be no assurance that any such required additional funding will be available to us at all or available on terms acceptable to us.
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Cash Flows.
Our cash flow activities are summarized as follows (in thousands):
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash provided by operating activities |
|
$ |
59,587 |
|
|
$ |
60,043 |
|
Net cash used in investing activities |
|
|
(27 |
) |
|
|
— |
|
Net cash provided by (used in) financing activities |
|
|
(12,872 |
) |
|
|
3,060 |
|
Net increase in cash and cash equivalents |
|
$ |
46,688 |
|
|
$ |
63,103 |
|
The decrease in net cash provided by operating activities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to a $12.5 million sales-based milestone payment due upon the achievement of AGAMREE® net revenues of $100 million in a fiscal year, which was achieved in the fourth quarter of 2025 and paid in the first quarter of 2026. This was offset primarily by an increase in net income.
The increase in net cash used in investing activities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was due to purchases of property and equipment.
The increase in net cash used in financing activities for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 was primarily due to repurchases of common stock of approximately $14.6 million.
Contractual Obligations and Arrangements.
We have entered into the following contractual arrangements with respect to sales of FIRDAPSE®:
Further, we will pay royalties to our licensor on net sales in Japan equal to a similar percentage to the royalties that we are currently paying for non-U.S. sales under our original FIRDAPSE® License Agreement for North America.
For the three months ended March 31, 2026 and 2025, we recognized an aggregate of approximately $5.1 million and $11.6 million, respectively, of royalties payable under these license agreements, which is included in cost of sales in the accompanying condensed consolidated statements of operations and comprehensive income.
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For the three months ended March 31, 2026 and 2025, we recognized an aggregate of approximately $2.4 million and $1.2 million, respectively, of royalties payable to Jacobus.
We have entered into the following contractual arrangements with respect to sales of FYCOMPA®:
We have entered into the following contractual arrangements with respect to AGAMREE®:
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For both the three months ended March 31, 2026 and 2025, we recognized an aggregate of approximately $2.5 million of royalties payable under this license agreement, which is included in cost of sales in the accompanying condensed consolidated statements of operations and comprehensive income.
We also have entered into the following contractual arrangements:
Off-Balance Sheet Arrangements.
We do not have any off-balance sheet arrangements as such term is defined in rules promulgated by the SEC.
Caution Concerning Forward-Looking Statements
This report contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995. These include statements regarding our expectations, beliefs, plans or objectives for future operations and anticipated results of operations. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, “believes”, “anticipates”, “proposes”, “plans”, “expects”, “intends”, “may”, and other similar expressions are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or other achievements to be materially different from any future results, performances or achievements expressed or implied by such forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in the section entitled “Item 1A – Risk Factors.”
The continued successful commercialization of FIRDAPSE® (amifampridine), AGAMREE® (vamorolone), and FYCOMPA® (perampanel) CIII is uncertain. Factors that will affect our success include the uncertainty of:
47
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48
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Our current plans and objectives are based on assumptions relating to the continued sale of FIRDAPSE®, AGAMREE® and FYCOMPA® and on our plans to seek to acquire or in-license additional drug products. Although we believe that our assumptions are reasonable, any of our assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements we have made herein, which reflect our views only as of the date of this report, you should not place undue reliance upon such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Market risk represents the risk of changes in the value of market risk-sensitive instruments caused by fluctuations in interest rates, foreign exchange rates and commodity prices. Changes in these factors could cause fluctuations in our results of operations and cash flows.
Our exposure to interest rate risk is currently confined to our cash and cash equivalents that are from time to time invested in highly liquid money market funds and U.S. Treasuries. The primary objective of our investment activities is to preserve our capital to fund acquisitions and operations. We also seek to maximize income from our investments without assuming significant risk. We do not use derivative financial instruments in our investment portfolio. Our cash and investments policy emphasizes liquidity and preservation of principal over other portfolio considerations.
ITEM 4. CONTROLS AND PROCEDURES
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Other Litigation
From time to time we may become involved in legal proceedings arising in the ordinary course of business. Other than as set forth above, we believe that there is no litigation pending at this time that could have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or cash flows.
ITEM 1A. RISK FACTORS
There are many factors that affect our business, our financial condition, and the results of our operations. In addition to the information set forth in this quarterly report, you should carefully read and consider “Item 1A. Risk Factors” in Part I, and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II, of our 2025 Annual Report on Form 10-K filed with the SEC, which contain a description of significant factors that might cause our actual results of operations in future periods to differ materially from those currently expected or desired.
Tariffs could adversely affect our business.
President Donald Trump and Commerce Secretary Howard Lutnick have each signaled plans for the Administration to potentially tax pharmaceutical imports through tariffs. In furtherance of that goal, on April 16, 2025, the U.S. Department of Commerce posted a notice in the Federal Registry announcing that it would begin a probe "to determine the effects on national security of imports of pharmaceuticals and pharmaceutical ingredients" under section 232 of the Trade Expansion Act of 1962, as amended, the results of which could lead to tariffs on pharmaceutical imports.
We source our API and finished drug products from both U.S. and foreign suppliers. Additionally, we currently purchase AGAMREE® active ingredients from Santhera while working to complete our own manufacturer arrangements for the product and also purchase FYCOMPA® supplies from Eisai through at least the end of 2029, both of which source from outside of the U.S. If tariffs make purchases of materials from certain jurisdictions untenable, we may need to obtain materials from other sources, if possible, which could also increase our costs and delay our planned clinical trials and manufacture of our products and product candidates. Further, retaliatory tariffs introduced by other countries could affect the sales of our products outside of the United States. Finally, royalties owed as part of our license arrangements may be subject to tariffs. Any of these factors may adversely affect our financial condition or results of operations.
Most Favored Nation (MFN Pricing) of drug products could adversely affect our business.
The Trump Administration has discussed the possibility that pricing of drugs in other countries could be used to price drug products for sale in the U.S. Recently, President Trump sent letters to 17 major pharmaceutical companies with a list of demands, including MFN pricing to all drugs provided to Medicaid enrollees. He stated in the letter that he wants companies to guarantee that Medicaid, Medicare, and commercial market insurers pay such prices for all new drugs, and he gave the companies 60 days to comply. To date, 16 of the 17 largest pharmaceutical conglomerates have reached deals with the Administration for relief on this issue and on potential tariffs with other companies being invited to negotiate similar deals. To date, Catalyst has not been invited to do so.
There can be no assurance as to what impact such rules, if adopted, might have on our financial condition and results of operations.
If our proposed Merger does not close, or is delayed, we may experience financial and operational disruptions. In addition our stock price may decline if the Merger is perceived as uncertain to close.
On May 6, 2026, we entered into a Merger Agreement to be acquired by Angelini Pharma. The closing of the Merger is subject to the satisfaction or waiver of certain conditions, many of which are not within our full control. We currently expect that the Merger will be completed in the third quarter of fiscal year 2026. However, we may be unable to obtain and satisfy, or experience delays in obtaining and satisfying, required regulatory approvals, stockholder approvals, and other closing conditions. In addition, both we and Angelini Pharma may terminate the Merger Agreement for reasons specified therein. The announcement and pendency of the Merger could adversely affect our business and stock price, including if the Merger does not close or is delayed, for reasons including the following:
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Lawsuits may be filed against us and the members of our Board of Directors arising out of the proposed Merger, which may delay or prevent the proposed Merger or otherwise negatively affect our business and operations.
Putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against us, our Board of Directors and others in connection with the transactions contemplated by the Merger Agreement. The outcome of any such litigation is uncertain, and we may not be successful in defending against any such future claims. Lawsuits that may be filed against us, our Board of Directors or others could delay or prevent the Merger from being completed, divert the attention of our management and employees away from our day-to-day business, and otherwise adversely affect our business, results of operations, and financial condition. If the Merger is not consummated for any reason, litigation could be filed in connection with the failure to consummate the Merger.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Issuer Purchases of Equity Securities
In October 2025, the Company’s Board of Directors approved a share repurchase program that authorizes the repurchase of up to $200 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 October 1, 2025 and currently expires on December 31, 2026.
The following table presents information regarding repurchases by us of our common stock under the Share Repurchase Program during the three months ended March 31, 2026:
Period |
|
Total |
|
|
Average |
|
|
Total |
|
|
Maximum |
|
||||
January 1 - January 31, 2026 |
|
|
443,852 |
|
|
$ |
23.43 |
|
|
|
443,852 |
|
|
$ |
164,299 |
|
February 1 - February 28, 2026 |
|
|
171,913 |
|
|
$ |
24.27 |
|
|
|
171,913 |
|
|
$ |
160,127 |
|
March 1 - March 31, 2026 |
|
|
— |
|
|
$ |
— |
|
|
|
— |
|
|
$ |
160,127 |
|
Total |
|
|
615,765 |
|
|
|
|
|
|
615,765 |
|
|
|
|
||
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 5. OTHER INFORMATION
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ITEM 6. EXHIBITS
2.1 |
Agreement and Plan of Merger, dated as of May 6, 2026, by and among the Company, Parent and Merger Sub, incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K filed on May 7, 2026 (File No. 001-33057) |
|
|
31.1 |
Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
31.2 |
Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
32.1 |
Certification of Principal Executive Officer under Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
32.2 |
Certification of Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
101.INS |
Inline XBRL Instance Document–the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the Inline XBRL document |
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101.SCH |
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
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104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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Table of Contents
SIGNATURES
Pursuant to 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. |
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By: |
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/s/ Michael W. Kalb |
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Michael W. Kalb |
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Executive Vice President and Chief Financial Officer |
Date: May 11, 2026
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