Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Limitations on effectiveness of controls and procedures
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer and our principal financial officer, e valuated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2025. Based on the evaluation of our disclosure controls and procedures as of December 31, 2025, our chief executive officer and our principal financial officer c oncluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Under the supervision and with the participation of our management, including our chief executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting. Management has used the framework set forth in the report entitled “ Internal Control – Integrated Framework (2013) ” published by the Committee of Sponsoring Organizations of the Treadway Commission to evaluate the effectiveness of our internal control over financial reporting. Based on its evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2025.
Our independent registered public accounting firm has not performed an evaluation of our internal control over financial reporting during any period in accordance with the provisions of the Sarbanes-Oxley Act. For as long as we remain a non-accelerated filer, we intend to take advantage of the exemption permitting us not to comply with the requirement that our independent registered public accounting firm provide an attestation on the effectiveness of our internal control over financial reporting.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our fiscal quarter ended December 31, 2025, that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
(a) Disclosure in lieu of reporting on a Current Report on Form 8-K.
None.
(b) Insider Trading Arrangements and Policies.
During the three-months ended December 31, 2025, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
ITEM 9C. DISCLOSURES REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this report:
(1) Index list to Financial Statements:
Page
Report of EY US LLP (PCAOB ID: 42 )
71
Consolidated Balance Sheets as of December 31, 202 5 , and 202 4
73
Consolidated Statements of Operations for the years ended December 31, 202 5 , and 202 4
74
Consolidated Statements of Comprehensive Inco me ( Loss ) for the years ended December 31, 202 5 , and 202 4
75
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 20 25 , and 202 4
76
Consolidated Statements of Cash Flows for the years ended December 31, 202 5 , and 202 4
77
Notes to Consolidated Financial Statements
78
(2) Financial Statement Schedules
All other schedules are omitted because they are not required or the required information is included in the financial statements or notes thereto.
(3) Exhibits
The exhibits listed in the accompanying Exhibit Index are filed or incorporated by reference as part of this report.
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Zevra Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Zevra Therapeutics, Inc. (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive income (loss), changes in stockholders' equity and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the account or disclosures to which it relates.
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Current Portion of Income Tax Payable
Description of the Matter
As disclosed in Notes B and O to the consolidated financial statements, the Company is subject to taxation in the United States and the Kingdom of Denmark. Tax liabilities may arise from interpretations and judgments made by the Company with regard to transfer pricing in the application of the relevant statutes, regulations, tax rulings and case law across the various jurisdictions. The Company uses significant judgment in (1) determining whether the technical merits of tax positions taken in the various jurisdictions are more-likely-than-not to be sustained based on applicable tax law and (2) measuring the related amount of tax liability that qualifies for recognition. The current portion of income tax payable includes $11.1 million attributable to the PRV sale, which included transfer pricing considerations.
Auditing the current portion of income tax payable related to the PRV sale was challenging because the measurement of the recognized tax payable is judgmental with regard to transfer pricing and is based on interpretations of statutes, regulations, tax rulings and case law in the various jurisdictions.
How We Addressed the Matter in Our Audit To test the measurement of current portion of income tax payable related to the PRV sale, our audit procedures included, among others, involving our tax professionals to assist in assessing the technical merits of the Company’s tax position through using our knowledge of and experience with the application of income tax laws by the relevant tax authorities and developing independent analyses in order to evaluate the amount recognized. We also assessed the Company’s data used to measure the amount of current portion of income tax payable related to the PRV sale and tested the clerical accuracy of the calculations.
/S/ Ernst & Young LLP
We have served as the Company’s auditor since 2022.
Orlando, Florida
March 9, 2026
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ZEVRA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
December 31,
2025 2024
Assets
Current assets:
Cash and cash equivalents $ 62,406 $ 33,785
Securities at fair value, current 128,605 35,711
Accounts and other receivables 23,258 10,509
Prepaid expenses and other current assets 6,998 4,052
Inventories, current 1,740 1,970
Total current assets 223,007 86,027
Securities at fair value, noncurrent 47,879 6,010
Inventories, noncurrent 879 10,999
Property and equipment, net 489 356
Operating lease right-of-use assets 1,212 657
Goodwill 4,701 4,701
Intangible assets, net 6,421 68,993
Other long-term assets 143 384
Total assets $ 284,731 $ 178,127
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable and accrued expenses $ 11,598 $ 25,456
Current portion of operating lease liabilities 419 420
Current portion of discount and rebate liabilities 12,188 5,929
Current portion of income tax payable 13,710 —
Other current liabilities 1,362 2,260
Total current liabilities 39,277 34,065
Long-term debt 61,928 59,504
Warrant liability 9,575 17,804
Income tax payable 7,029 14,431
Operating lease liabilities, less current portion 859 372
Discount and rebate liabilities, less current portion 9,693 7,655
Other long-term liabilities 1,713 4,630
Total liabilities 130,074 138,461
Commitments and contingencies (Note K)
Stockholders' equity:
Preferred stock:
Undesignated preferred stock, $ 0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of December 31, 2025 or December 31, 2024
— —
Common stock, $ 0.0001 par value, 250,000,000 shares authorized, 58,338,319 shares issued and 56,854,781 shares outstanding as of December 31, 2025; 55,246,401 shares issued and 53,670,709 shares outstanding as of December 31, 2024
6 5
Additional paid-in capital 588,458 555,302
Treasury stock, at cost ( 10,983 ) ( 10,983 )
Accumulated deficit ( 422,060 ) ( 505,289 )
Accumulated other comprehensive (loss) income ( 764 ) 631
Total stockholders' equity 154,657 39,666
Total liabilities and stockholders' equity $ 284,731 $ 178,127
See accompanying notes to consolidated financial statements
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ZEVRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Year Ended December 31,
2025 2024
Revenue, net $ 106,470 $ 23,612
Cost of product revenue (excluding $ 3,862 and $ 6,235 in intangible asset amortization for the years ended December 31, 2025, and 2024, respectively, shown separately below)
16,482 7,417
Intangible asset amortization 3,862 6,235
Impairment of intangible assets 58,710 —
Operating expenses:
Research and development 12,743 42,095
Selling, general and administrative 77,616 54,868
Total operating expenses 90,359 96,963
Loss from operations ( 62,943 ) ( 87,003 )
Other income (expense):
Gain on sale of PRV 148,325 —
Interest expense ( 7,977 ) ( 7,351 )
Fair value adjustment related to warrant and CVR liability 2,178 2,057
Fair value adjustment related to investments 149 ( 18 )
Interest and other income, net 6,946 2,175
Total other income (expense) 149,621 ( 3,137 )
Income (loss) before income taxes 86,678 ( 90,140 )
Income tax expense ( 3,449 ) ( 15,371 )
Net income (loss) $ 83,229 $ ( 105,511 )
Net income (loss) per share of common stock:
Basic $ 1.40 $ ( 2.28 )
Diluted $ 1.35 $ ( 2.28 )
Weighted-average shares of common stock outstanding:
Basic 55,311,308 46,251,239
Diluted 57,262,715 46,251,239
See accompanying notes to consolidated financial statements
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ZEVRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(in thousands)
Year Ended December 31,
2025 2024
Net income (loss) $ 83,229 $ ( 105,511 )
Other comprehensive (loss) income:
Foreign currency translation adjustment ( 1,395 ) 674
Other comprehensive (loss) income ( 1,395 ) 674
Comprehensive income (loss) $ 81,834 $ ( 104,837 )
See accompanying notes to consolidated financial statements
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ZEVRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(in thousands)
Common
Stock Additional
Paid-in
Capital Treasury
Stock Accumulated
Deficit Other
Comprehensive
Income (Loss) Total
Stockholders'
Equity
Balance as of January 1, 2024
$ 4 $ 472,664 $ ( 10,983 ) $ ( 399,778 ) $ ( 43 ) $ 61,864
Net loss — — — ( 105,511 ) — ( 105,511 )
Stock-based compensation expense — 14,906 — — — 14,906
Issuance of common stock in public offering (Note A) 1 64,516 — — — 64,517
Issuance of common stock in exchange for consulting services — 474 — — — 474
Issuance of common stock as part of the Employee Stock Purchase Plan — 1,058 — — — 1,058
Issuance of common stock for options exercised — 1,684 — — — 1,684
Other comprehensive income — — — — 674 674
Balance as of December 31, 2024
$ 5 $ 555,302 $ ( 10,983 ) $ ( 505,289 ) $ 631 $ 39,666
Net income — — — 83,229 — 83,229
Stock-based compensation expense — 12,634 — — — 12,634
Issuance of common stock in exchange for consulting services 75 75
Issuance of common stock as part of the Employee Stock Purchase Plan — 615 — — — 615
Issuance of common stock for options exercised or RSUs vested 1 3,182 — — — 3,183
Issuance of common stock for warrants exercised — 16,650 — — — 16,650
Other comprehensive loss — — — — ( 1,395 ) ( 1,395 )
Balance as of December 31, 2025
$ 6 $ 588,458 $ ( 10,983 ) $ ( 422,060 ) $ ( 764 ) $ 154,657
See accompanying notes to consolidated financial statements
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ZEVRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
Year Ended December 31,
2025 2024
Cash flows from operating activities:
Net income (loss) $ 83,229 $ ( 105,511 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Stock-based compensation expense 12,634 14,906
Impairment of intangible assets 58,710 —
Inventory obsolescence charge 11,681 5,746
Income tax expense 3,449 15,374
Depreciation and amortization expense 4,054 6,389
Non-cash interest expense 2,649 2,089
Non-cash lease expense 602 552
Fair value adjustment related to warrant and CVR liabilities ( 2,178 ) ( 2,057 )
Accretion on investments ( 3,128 ) ( 890 )
Fair value adjustment related to investments ( 149 ) 18
Loss on sublease and disposal of property and equipment 63 218
Consulting fees paid in common stock 75 474
Loss on foreign currency exchange rates 1,548 219
Gain on sale of PRV ( 148,325 ) —
Change in assets and liabilities:
Accounts and other receivables ( 11,977 ) 6,868
Prepaid expenses and other current assets ( 2,943 ) ( 2,228 )
Inventories ( 1,305 ) ( 8,874 )
Other long-term assets 451 —
Accounts payable and accrued expenses ( 15,587 ) ( 3,598 )
Discount and rebate liabilities 6,683 431
Operating lease liabilities ( 675 ) ( 626 )
Other liabilities ( 1,159 ) 835
Net cash used in operating activities ( 1,598 ) ( 69,665 )
Cash flows from investing activities:
Purchases of property and equipment ( 835 ) —
Disposals of property and equipment 448 —
Purchases of investments ( 309,986 ) ( 41,161 )
Maturities of investments 178,500 25,000
Proceeds from sale of PRV 150,000 —
Payment of royalty to XOMA — ( 6,000 )
Net cash provided by (used in) investing activities 18,127 ( 22,161 )
Cash flows from financing activities:
Proceeds from issuance of debt, net of lender fees — 58,990
Repayment of debt — ( 42,700 )
Proceeds from insurance financing arrangements — 1,082
Proceeds from Employee Stock Purchase Plan 615 1,058
Proceeds from issuance of stock — 64,516
Proceeds from issuance of common stock for options exercised 3,182 1,684
Proceeds from issuance of common stock for warrants exercised 8,639 —
Payments of principal on insurance financing arrangements ( 372 ) ( 431 )
Payment of deferred financing costs — ( 2,091 )
Net cash provided by financing activities 12,064 82,108
Effect of exchange rate changes on cash and cash equivalents 28 454
Net increase (decrease) in cash and cash equivalents 28,621 ( 9,264 )
Cash and cash equivalents, beginning of period 33,785 43,049
Cash and cash equivalents, end of period $ 62,406 $ 33,785
Supplemental cash flow information:
Cash paid for interest $ 5,329 $ 5,262
Right-of-use assets obtained in exchange for lease liabilities 1,115 419
See accompanying notes to consolidated financial statements
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ZEVRA THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A. Description of Business, Basis of Presentation, and Significant Transactions
Organization
Zevra Therapeutics, Inc. (the “Company” or “Zevra”) is a commercial-stage company with a late-stage pipeline committed to bringing life-changing therapeutics to people living with rare diseases. The Company is focused on expanding patient access, progressing our pipeline toward key milestones, and delivering meaningful outcomes for patients with significant unmet needs.
On September 20, 2024, the U.S. Food and Drug Administration (“FDA”) approved the New Drug Application (“NDA”) for MIPLYFFA ® (arimoclomol), an orally-delivered treatment for Niemann-Pick disease type C (“NPC”), which is an ultra-rare and progressive neurodegenerative disease. MIPLYFFA, the first FDA-approved treatment for NPC, is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients two years of age and older. MIPLYFFA has also been granted orphan medicinal product designation for the treatment of NPC by the European Commission. The Company's other commercial stage asset, OLPRUVA ® (sodium phenylbutyrate) for oral suspension, is approved by the FDA for the treatment of certain urea cycle disorders (“UCDs”).
Additionally, the Company has a pipeline of investigational product candidates, including celiprolol for the treatment of Vascular Ehlers-Danlos syndrome (“VEDS”) in patients with a confirmed type III collagen mutation and KP1077, the Company's clinical development product candidate being developed to treat idiopathic hypersomnia (“IH”), a rare neurological sleep disorder, and narcolepsy. The sole active pharmaceutical ingredient of KP1077 is serdexmethylphenidate (“SDX”), the Company's proprietary prodrug of d-methylphenidate (“d-MPH”). The FDA has granted KP1077 orphan drug designation for the treatment of IH.
Basis of Presentation
The Company prepared the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the Company’s opinion, reflect all adjustments, including normal recurring items that are necessary. All significant intercompany accounts and transactions have been eliminated in consolidation.
Registration Statements on Form S-3
On February 5, 2024, Zevra filed a registration statement on Form S-3 (File No. 333-276856) registering an aggregate of 2,269,721 shares of Zevra’s common stock. On April 5, 2024, the Company filed an amendment to such registration statement, which was declared effective on April 8, 2024.
On June 4, 2024, the Company filed a registration statement on Form S-3 (File No. 333-279941) (the “June 2024 Registration Statement”) under which the Company may sell securities, including as may be issuable upon conversion, redemption, repurchase, exchange or exercise of securities, in one or more offerings up to a total aggregate offering price of $ 350.0 million, $ 75.0 million of which was allocated to the sale of the shares of common stock issuable under the 2024 ATM Agreement (as described further below). The registration statement was declared effective on June 13, 2024.
August 2024 Offering
On August 8, 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. and William Blair & Company, L.L.C., as representatives of the several underwriters named therein (collectively, the “Underwriters”), in connection with the offering, issuance and sale by the Company of 9,230,770 shares of the Company’s common stock at a public offering price of $ 6.50 per share, pursuant to the June 2024 Registration Statement and a related prospectus supplement dated August 8, 2024, filed with the SEC (the “August 2024 Offering”). Under the terms of the Underwriting Agreement, the Company also granted the Underwriters an option exercisable for 30 days to purchase up to an additional 1,384,615 shares of its common stock at the public offering price, less underwriting discounts and commissions, which the Underwriters exercised in full on August 9, 2024. The August 2024 Offering closed on August 12, 2024. Total shares issued were 10,615,385 . Net proceeds from the offering were approximately $ 64.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company is using the net proceeds of the offering to support the commercialization of its approved products and the continued development of its product candidates, and for other general corporate purposes.
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Entry into 2024 ATM Agreement
On July 12, 2024, the Company entered into an equity distribution agreement (the “2024 ATM Agreement”) with Citizens JMP Securities LLC (“Citizens JMP”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $ 75.0 million through Citizens JMP as its sales agent. The issuance and sale, if any, of common stock by the Company under the 2024 ATM Agreement will be made pursuant to the June 2024 Registration Statement, the accompanying prospectus, and the related prospectus supplement dated July 12, 2024. Citizens JMP may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act. Citizens JMP will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Citizens JMP a commission equal to 3.0 % in the aggregate of the gross sales proceeds of any common stock sold through Citizens JMP under the 2024 ATM Agreement. As of December 31, 2025, no shares have been issued or sold under the 2024 ATM Agreement.
Reclassifications
Certain reclassifications were made to the 2024 consolidated financial statements to conform to the classifications used in 2025. These reclassifications had no impact on the consolidated net income (loss), changes in stockholder's equity, or cash flows previously reported.
B. Summary of Significant Accounting Policies
Use of Estimates
The preparation of these consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of the warrant liability and discount and rebate liabilities, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities.
Concentration of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit and investments with multiple financial institutions, the balances of which frequently exceed insured limits, and accounts receivable, which are concentrated amongst a limited number of customers.
Cash and Cash Equivalents
The Company considers any highly liquid investments with an original maturity of three months or less to be cash equivalents.
Investments
The Company maintains investment securities that are classified as available-for-sale securities for which the Company has elected the fair value option under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 825, Financial Instruments . As such, these securities are carried at fair value with unrealized gains and losses included in fair value adjustment related to investments on the consolidated statements of operations. The securities primarily consist of U.S. Treasury securities and corporate bonds and are included in securities at fair value in the consolidated balance sheets. As of December 31, 2025, and 2024, the Company held securities with an aggregate fair value of $ 176.5 million and $ 41.7 million, respectively, that contained an aggregate unrealized gain of approximately $ 149,000 and an aggregate unrealized loss of approximately $ 18,000 , respectively. For securities held at December 31, 2025, $ 128.6 million mature within one year and $ 47.9 million mature in one to three years. Applying fair value accounting to these debt securities more accurately represents the Company's investment strategy due to the fact that excess cash is currently being invested for the purpose of funding future operations. Interest income is recognized as earned using an effective yield method giving effect to the amortization of premium and accretion of discount and is based on the economic life of the securities. Interest income is included in interest and other income, net, in the consolidated statements of operations.
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Variable Interest Entities
The primary beneficiary of a variable interest entity (“VIE”) is required to consolidate the assets and liabilities of the VIE. When the Company obtains a variable interest in another entity, it assesses at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE, and if so, whether the Company is the primary beneficiary of the VIE based on its power to direct the activities of the VIE that most significantly impact the VIE's economic performance and the Company's obligation to absorb losses or the rights to receive benefits from the VIE that could potentially be significant to the VIE.
To assess whether the Company has the power to direct the activities of the VIE that most significantly impact the VIE's economic performance, the Company considers all the facts and circumstances, including the Company's role in establishing the VIE and the Company's ongoing rights and responsibilities. The assessment includes identifying the activities that most significantly impact the VIE's economic performance and identifying which party, if any, has the power to direct those activities. In general, the parties that make the most significant decisions affecting the VIE (management and members of the Board of Directors) are deemed to have the power to direct the activities of a VIE.
To assess whether the Company has the obligation to absorb losses of the VIE or the rights to receive benefits from the VIE that could potentially be significant to the VIE, the Company considers all of its economic interests that are deemed to be variable interests in the VIE.
This assessment requires judgment in determining whether these interests, in the aggregate, are considered potentially significant to the VIE. As of December 31, 2025, and 2024, the Company identified Acer Therapeutics, Inc. (“Acer”) to be the Company's sole interest in a VIE. As Zevra is the final decision maker for all of Acer's research, development, and commercialization of drug candidates that it is producing, the Company directs the activities of Acer that most significantly impact its performance. Therefore, the Company is the primary beneficiary of this VIE for accounting purposes and consolidates the assets and liabilities of the VIE.
Goodwill and Intangible Assets
Goodwill represents the excess of the consideration transferred over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company establishes its reporting units based on the organizational structure and has determined it has one reporting unit. In performing its analysis, in accordance with ASC 350, the Company has the option to first assess qualitatively whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount, including goodwill. In performing qualitative assessments, the Company considers, among other factors, macroeconomic conditions, the Company’s overall financial performance (including, but not limited to, comparisons to prior periods, current period internal expectations, and comparable peer companies), broader industry and market considerations, and the trading price performance of the Company’s common stock.
The Company's goodwill balance was $ 4.7 million as of December 31, 2025, and 2024. As of December 31, 2025, and 2024, the Company completed its annual qualitative assessment under ASC 350 to determine whether the existence of events or circumstances indicated that it was more likely than not that the fair value of its reporting unit was less than its respective carrying value. The Company concluded that based on the relevant events and circumstances, it was more likely than not that the reporting unit’s fair value exceeded its related carrying value and therefore no quantitative assessment was required. No goodwill impairment charges were recorded for the years ended December 31, 2025, or 2024.
Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each IPR&D project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated and begin amortization. The Company evaluates IPR&D for impairment on an annual basis, during the fourth quarter, or more frequently if impairment indicators exist. The Company’s IPR&D balance was $ 2.0 million as of December 31, 2025, and 2024. No IPR&D impairment charges were recognized for the years ended December 31, 2025, or 2024.
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As of December 31, 2025, and 2024, the Company had a definite-lived intangible asset, net related to the acquisition of OLPRUVA of $ 0 and $ 61.3 million, respectively. The Company recorded an intangible asset impairment charge in the consolidated statements of operations for the year ended December 31, 2025 as a result of a triggering event indicating the asset's carrying amount may not be recoverable (see Note S). Prior to the impairment, this asset was amortized on a straight-line basis over the OLPRUVA useful life of thirteen years . The Company reviews the estimated useful lives of its intangible assets on an ongoing basis. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $ 2.6 million and $ 5.9 million for the years ended December 31, 2025, and 2024, respectively.
In connection with the XOMA License Agreement, the Company paid XOMA a regulatory milestone payment of $ 6.0 million upon approval of MIPLYFFA in September 2024, which is included in intangible assets, net in the consolidated balance sheets. This definite-lived intangible asset is amortized on a straight-line basis over the MIPLYFFA patent life of approximately five years and is reviewed periodically for impairment. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $ 1.3 million and $ 0.3 million for the years ended December 31, 2025 and 2024, respectively.
Property and Equipment
The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three to ten years . Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in the consolidated statements of operations.
Impairment of Long-Lived Assets
Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset group may not be recoverable. When such events occur, the Company compares the carrying amount of the asset group to the undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, an impairment loss is recorded for the difference between the carrying value and fair value of the asset group. Beyond the definite-lived intangible asset impairment disclosed in Note S, no other impairment occurred for the years ended December 31, 2025, or 2024.
Gain on Sale of PRV
The Company received a transferable rare priority review voucher (“PRV”) in conjunction with the FDA approval of MIPLYFFA. On February 26, 2025, the Company and its subsidiary, Zevra Denmark A/S, entered into an asset purchase agreement with a buyer, pursuant to which the Company agreed to sell the PRV to the buyer for aggregate proceeds of $ 150.0 million, payable in cash, upon the closing of the sale. On April 1, 2025, the asset sale was consummated and title of the PRV transferred to the buyer, resulting in net proceeds of $ 148.3 million to the Company. The PRV did not have a carrying value at the time of sale. In accordance with ASC 610-20, Gains and Losses from the Derecognition of Nonfinancial Assets, the net proceeds from the sale were recorded as a gain on sale of PRV in the Company's consolidated statements of operations for the year ended December 31, 2025.
Revenue Recognition
The Company recognizes revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers (“ASC 606”) and, as a result, follows the five-step model when recognizing revenue: 1) identifying a contract; 2) identifying the performance obligations; 3) determining the transaction price; 4) allocating the price to the performance obligations; and 5) recognizing revenue when the performance obligations have been fulfilled.
Product Revenues, net
Net revenues from product sales are recognized at the transaction price when the customer obtains control of the Company's product, which occurs at a point in time, typically upon receipt of the product by the customer. The Company's current single customer for product sales of MIPLYFFA and OLPRUVA is a specialty pharmacy provider.
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In accordance with ASC 606, the Company recognizes revenue when fulfilling its performance obligation by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received. The Company's net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC 606 and are recorded as a reduction of revenue. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. All estimated reserve liabilities related to commercial products are recorded within the current portion of discount and rebate liabilities in the consolidated balance sheets.
Expanded Access Program
Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under an expanded access program (“EAP”) in France, and in select territories outside Europe. An EAP is a program giving specific patients access to a drug that is not yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currently no appropriate treatment are considered for expanded access programs. Further, to be considered for the expanded access program, the drug must have proven efficacy and safety and must either be undergoing price negotiations or seeking marketing approval.
In accordance with ASC 606, the Company recognizes revenue when fulfilling its performance obligation under the global EAP by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received. Revenue is recognized net of sales deductions, including discounts, rebates, applicable distributor fees, and revenue-based taxes.
The French Health Authorities and the manufacturer have agreed to a price for sales under the EAP in France, but the final price depends on the terms and conditions negotiated with the French Health Authorities, following market authorization. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the medicinal product is authorized in France must be repaid. The repayment is considered in the clawback liability. An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for estimating the expected final price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar medicinal products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized medicinal products. The limited available relevant market information for directly comparable commercialized medicines within rare disease increases the uncertainty in management's estimate.
Licensing Agreements
The terms of the Company’s licensing agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments may result in licensing revenues.
As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price may include such estimates as independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if it can be satisfied at a point in time or over time, and it measures the services delivered to the licensee, which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore, revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
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Upfront Fees : If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time.
Milestone Payments : At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative licensing revenues and earnings in the period of adjustment.
Acquired IPR&D and Milestones Expenses
In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to IPR&D projects are expensed as acquired IPR&D and milestones expense in the consolidated statements of operations unless the project has an alternative future use. These costs include upfront and development milestone payments related to R&D collaborations, licensing arrangements, or other asset acquisitions that provide rights to develop, manufacture and/or sell pharmaceutical products. Where contingent development milestone payments are due to third parties, prior to regulatory approval, the payment obligations are expensed when the milestone results are achieved. Regulatory and commercial milestone payments made to third parties subsequent to regulatory approval are capitalized as intangible assets and amortized to intangible asset amortization over the remaining useful life of the related product.
Inventories
The value of inventories is recorded at net realizable value. The Company determines the cost of its inventories, which include amounts related to materials and manufacturing overhead, on a first-in, first-out basis. Inventories that are not expected to be sold within 12 months are classified as inventories, noncurrent.
The Company may scale-up and make commercial quantities of its product candidates prior to the date it anticipates that such product will receive final regulatory approval. The scale-up and commercial production of pre-launch inventory involves the risk that such products may not be approved for marketing on a timely basis, or ever. This risk notwithstanding, the Company may scale-up and build pre-launch inventory of products that have not received final regulatory approval when the Company believes such action is appropriate in relation to the commercial value of the product launch opportunity. We capitalize inventory costs associated with our products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval. The Company had no pre-approval inventory on our consolidated balance sheets as of December 31, 2025, or 2024. Inventory used in clinical trials is also expensed as research and development expense, when selected for such use. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical manufacturing campaign. The cost of finished goods inventory that is shipped to a customer to support the Company’s patient assistance programs is expensed when those shipments take place. As of December 31, 2025, and 2024, the Company did not have pre-launch inventory that qualified for capitalization.
The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded as a component of cost of product revenue in the consolidated statements of operations. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write downs of inventory may be required. Additionally, the Company’s products are subject to strict quality control and monitoring, which is performed throughout the manufacturing process. In the event that certain batches or units of product do not meet quality specifications, the Company will record a charge to cost of product revenue, to write down any unsaleable inventory to its estimated net realizable value. For the years ended December 31, 2025, and 2024, the Company recognized charges of approximately $ 11.7 million and $ 5.7 million, respectively, related to write-downs for unsaleable inventory.
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Cost of Product Revenue
The components of cost of product revenue are royalties and expenses directly attributable to revenue. To date, the Company has generated revenue from product sales of MIPLYFFA and OLPRUVA, reimbursements received under the global EAP, royalties or net sales milestone payments generated under the Collaboration and License Agreement with Commave Therapeutics SA (the “AZSTARYS ® License Agreement”), and consulting agreements.
Prior to our acquisition of the assets of Orphazyme A/S (“Orphazyme”) in May 2022, Orphazyme had entered into an asset purchase agreement with LadRx Corporation, which was assigned to XOMA (US) LLC, a wholly-owned subsidiary of XOMA Corporation (“XOMA”), in June 2023 (“XOMA License Agreement”). Under the XOMA License Agreement, XOMA is entitled to a mid-single digit percentage royalty with respect to net sales of MIPLYFFA as well as milestone payments based on future potential sales and regulatory milestones. On August 30, 2023, Acer and Relief Therapeutics SA (“Relief”) entered into an exclusive license agreement (the “Relief License Agreement”). Pursuant to the Relief License Agreement, Zevra was obligated to pay royalties of 10 % of U.S. net sales of OLPRUVA up to a maximum of $ 45.0 million, plus specified regulatory milestones, for total payments to Relief of up to $ 56.5 million. On April 10, 2025, the rights to this royalty were sold to Soleus Capital Management L.P.
In connection with the AZSTARYS License Agreement, the Company pays Aquestive Therapeutics, Inc. (“Aquestive”) a royalty equal to 10 % of all regulatory milestone and royalty payments.
Accounts and Other Receivables
Accounts and other receivables consist of receivables from MIPLYFFA and OLPRUVA product sales, receivables under the AZSTARYS License Agreement, the global EAP, and income tax receivables and other receivables due to the Company. Receivables under the AZSTARYS License Agreement are recorded for amounts due to the Company related to reimbursable third-party costs as well as milestones and royalties on product sales. Receivables under the global EAP are recorded for product sales of MIPLYFFA in France and select territories outside of Europe. The Company provides reserves against receivables for estimated losses that may result from a customer's inability to pay. Receivables are evaluated to determine if any reserve or allowance should be recorded based on consideration of the current economic environment, expectations of future economic conditions, specific circumstances and the Company’s own historical collection experience. Amounts determined to be uncollectible are charged or written-off against the reserve.
Research and Development
Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clinical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred.
The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the consolidated statements of operations as the Company receives the related goods or services.
The Company enters into contractual agreements with third-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of the service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known. The Company periodically confirms the accuracy of the estimates with the service providers and make adjustments, if necessary.
Patent Costs
Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the consolidated statements of operations.
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Income Taxes
The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely than not to be realized.
The Company is subject to taxation in the United States (including federal, state, and local jurisdictions) and the Kingdom of Denmark. Generally, the Company is subject to examination by tax jurisdictions from 2021 to 2024 tax years as the statute of limitation (excluding net operating loss carryforwards) are 3 to 4 years in the United States and Kingdom of Denmark. Tax liabilities may arise from interpretations and judgments made by the Company with regard to transfer pricing in the application of the relevant statutes, regulations, tax rulings and case law across the various jurisdictions. The Company uses significant judgment in (1) determining whether the technical merits of tax positions taken in the various jurisdictions are more-likely-than-not to be sustained based on applicable tax law and (2) measuring the related amount of tax liability that qualifies for recognition. The United States federal and state tax jurisdictions can audit the net operating loss carryforwards from the tax years in which the statute of limitation has expired but can only adjust the net operating loss carryforwards. No income tax returns are currently under examination by taxing authorities.
Uncertain tax positions are recognized only when the Company believes it is more likely than not that the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense.
On December 22, 2017, the U.S. government enacted H.R. 1, “An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018” (“Tax Act”). Effective January 1, 2018, the Tax Act provides for a new global intangible low-taxed income (“GILTI”) provision. Under the GILTI provision, certain foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets are included in U.S. taxable income. The Company has not recorded any deferred taxes for future GILTI inclusions as any future inclusions are expected to be treated as a period expense and offset by net operating loss carryforwards in the United States.
Stock-Based Compensation
The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers and directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees using a fair value approach under ASC subtopic 505-50. The Company values equity instruments and stock options granted using the Black-Scholes-Merton (“BSM”) option pricing model.
Earnings per Share
The Company uses the two-class method to compute net income (loss) per common share because the Company has issued securities, other than common stock, that contractually entitle the holders to participate in dividends and earnings of the Company. The two-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings. Holders of each series of the Company’s convertible preferred stock and select warrants are entitled to participate in distributions, when and if declared by the board of directors, that are made to common stockholders and, as a result, are considered participating securities.
Segment and Geographic Information
Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker (“CODM”) in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. See Note C for further information.
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Foreign Currency
Assets and liabilities are translated into the reporting currency using the exchange rates in effect on the balance sheet dates. Equity accounts are translated at historical rates, except for the change in retained earnings during the year, which is the result of the income statement translation process. Revenue and expense accounts are translated using the weighted average exchange rate during the period. The cumulative translation adjustments associated with the net assets of foreign subsidiaries are recorded in accumulated other comprehensive income (loss) in the accompanying consolidated statements of stockholders’ equity.
Debt Issuance Costs
Debt issuance costs incurred in connection with financing arrangements are recorded as a reduction of the related debt on the consolidated balance sheets and amortized over the life of the respective financing arrangement using the effective interest method.
Warrants
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic 480, Distinguishing Liabilities from Equity (“ASC 480”) and FASB ASC Topic 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the issuing company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital on the consolidated statements of changes in stockholders’ equity at the time of issuance. For warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and on each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss in other expense, net, on the consolidated statements of operations. The fair value of the warrants was estimated using the BSM option pricing model.
New Accounting Pronouncements Recently Adopted
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (“Topic 740”): Improvements to Income Tax Disclosures . ASU 2023-09 establishes new income tax disclosure requirements in addition to modifying and eliminating certain existing requirements. Under the new guidance, entities must consistently categorize and provide greater disaggregation of information in the reconciliation of the effective tax rate to the statutory tax rate and must also further disaggregate income taxes paid. The Company adopted ASU 2023-09 for the year ended December 31, 2025 using a retrospective approach and included the required disclosures in the Notes to the Consolidated Financial Statements for income taxes. This standard update did not affect the Company’s results of operations.
New Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU No. 2024-03, Income Statement: Reporting Comprehensive Income-Expense Disaggregation Disclosures (“Subtopic 220-40”): Disaggregation of Income Statement Expenses . The new standard requires disclosure of specified information about certain costs and expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026 and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
C. Segment Information
Zevra manages its business activities on a consolidated basis and operates as a single operating segment dedicated to the research and development, manufacturing, commercialization and sale of innovative medicines and therapies. The Company primarily derives its revenue from MIPLYFFA and OLPRUVA product sales, reimbursements received under the global EAP, and royalties or net sales milestone payments generated under the AZSTARYS License Agreement. The accounting policies of the segment are the same as those described in Note B.
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Zevra's CODM is the Company's Chief Executive Officer, Neil F. McFarlane. The CODM uses net income (loss), as reported in the Company's consolidated statements of operations, in evaluating performance of its segment and determining how to allocate resources of the Company as a whole, including investing in its research and development, commercialization efforts, and acquisition strategy. The CODM does not review assets in evaluating the results of the segment, and, therefore, such information is not presented.
The following table presents the operating results of the Company's segment for the years ended December 31, 2025 and 2024:
Year Ended December 31,
2025 2024
Total revenues $ 106,470 $ 23,612
Less significant segment expenses:
Research and development directly identified to programs 7,710 22,532
Research and development not directly identified to programs 5,033 19,562
Selling, general and administrative directly identified to programs 26,755 18,094
Selling, general and administrative not directly identified to programs 50,861 36,775
Other segment items:
Impairment of intangible assets 58,710 —
Income tax expense 3,449 15,371
Interest income ( 7,573 ) ( 3,159 )
Depreciation and amortization expense 4,054 6,389
Interest expense 7,977 7,351
Other (income) expense, net (a) ( 133,735 ) 6,208
Segment net income (loss) $ 83,229 $ ( 105,511 )
(a) Other (income) expense, net included in segment net income (loss) includes the gain on the sale of the PRV in the current year, foreign currency exchange gains and losses, cost of product revenue (excluding intangible asset amortization), fair value adjustments related to warrant and contingent value right (“CVR”) liabilities, fair value adjustment related to investments, and other overhead expenses.
The Company holds long-lived assets in the United States of $ 2.2 million and $ 13.4 million as of December 31, 2025 and 2024, respectively. The Company holds long-lived assets in Europe of $ 0.4 million and $ 0.5 million as of December 31, 2025 and 2024, respectively.
D. Inventories
The components of inventory are summarized as follows (in thousands):
December 31,
2025 2024
Raw materials $ 7 $ 7,928
Work in progress 1,780 3,260
Finished goods 832 1,781
Total inventories $ 2,619 $ 12,969
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E. Accounts and Other Receivables
Accounts and other receivables consist of the following (in thousands):
December 31,
2025 2024
Commercial accounts receivable $ 9,876 $ 4,010
Receivables related to product reimbursements 10,998 5,380
Royalties accounts receivable 1,786 786
Other receivables 598 333
Total accounts and other receivables $ 23,258 $ 10,509
As of December 31, 2025, and 2024, no r eserve or allowance for doubtful accounts had been established.
F. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
December 31,
2025 2024
Prepaid insurance $ 946 $ 1,037
Other prepaid expenses and current assets 6,052 3,015
Total prepaid expenses and other current assets $ 6,998 $ 4,052
G. Property and Equipment
Property and equipment consists of the following (in thousands):
December 31,
2025 2024
Laboratory equipment $ — $ 463
Furniture and office equipment 222 200
Computers and hardware 439 701
Leasehold improvements 139 710
Finance lease right-of-use assets 3 8
Total property and equipment 803 2,082
Less: accumulated depreciation and amortization ( 314 ) ( 1,726 )
Property and equipment, net $ 489 $ 356
The estimated useful lives of property and equipment are as follows:
Useful Life
Asset Category (in years)
Furniture and office equipment 5 - 10
Computers and hardware 3 - 7
Leasehold improvements 15 years or remaining lease term
Depreciation and amortization expense related to property and equipment was $ 0.2 million for both years ended December 31, 2025 and 2024 .
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H. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consist of the following (in thousands):
December 31,
2025 2024
Accrued payroll $ 4,700 $ 6,126
Accrued professional fees 826 863
Accounts payable 2,478 13,075
Other accrued expenses 3,594 5,392
Total accounts payable and accrued expenses $ 11,598 $ 25,456
I. Debt Obligations
Secured Promissory Note
On August 30, 2023, the Company and Nantahala Capital Management, LLC (“NCM”), certain of its affiliates and certain other parties (collectively with NCM, “Nantahala”), entered into a secured promissory note payable by Zevra to Nantahala in the original principal amount of $ 5.0 million (the “Nantahala Note”). The Nantahala Note initially bore interest at 9.0 % per annum, payable quarterly in arrears in cash. The interest rate increased to 12.0 % per annum effective March 1, 2024, as the Nantahala Note remained unpaid six months from its issue date. The additional 3.0 % interest would have been paid in shares of Zevra's common stock based on the volume weighted average trading price of Zevra's common stock during the twenty consecutive trading days ending on the date before such interest payment date. Beginning on the first interest payment date following the second anniversary of the Nantahala Note, and on each interest payment date thereafter, Zevra was required to make $ 0.6 million amortization payments on the Nantahala Note until it was paid in full. All principal and unpaid interest on the Nantahala Note would have been due on August 30, 2026, the third anniversary of the Nantahala Note. Zevra was entitled to prepay the Nantahala Note at any time without penalty.
The Nantahala Note was secured by Zevra’s interest in Acer's assets. The Company used the proceeds from the Nantahala Note, along with $ 12.0 million in cash and 98,683 shares of Zevra's common stock, to acquire Acer's term loans. In April 2024, the Nantahala Note was repaid in full and terminated. At the time of repayment, Nantahala elected to receive a cash payment in lieu of shares of Zevra's common stock in exchange for the additional 3.0 % interest accrued for the period from March 1, 2024 through April 5, 2024.
Margin Account
On January 26, 2023, the Company and Wells Fargo, as lender, entered into a revolving margin account agreement. The Company's investments were used as collateral for the loan and the amount the Company was able to borrow was limited to 80 - 90 % of its outstanding investment balance held with Wells Fargo. The margin account bore interest at the Prime rate minus 225 basis-points. In April 2024, the Company repaid the outstanding balance under the margin account with Wells Fargo, and upon such repayment, the margin capabilities were removed from the account.
Term Loans
On April 5, 2024 (the “Term Loans Closing Date”), the Company entered into a credit agreement (the “Credit Agreement”) with HCR Stafford Fund II, L.P., HCR Potomac Fund II, L.P., and Perceptive Credit Holdings IV, LP (collectively, the “Lenders”), and Alter Domus (US) LLC, as administrative agent (the “Administrative Agent”).
Under the terms of the Credit Agreement, the Lenders provided a senior secured loan facility to the Company in the aggregate principal amount of $ 100.0 million, which is divided into three tranches as follows: (i) $ 60.0 million, which was funded in full on the Term Loans Closing Date; (ii) $ 20.0 million, which was available to the Company in up to two drawings, each in an amount not to exceed $ 10.0 million, at the Company’s option until October 5, 2025; and; (iii) $ 20.0 million, which was available to the Company upon approval by the FDA of the NDA for MIPLYFFA for the treatment of NPC, at the Company’s option until December 31, 2024 (collectively, the “Term Loans”). The Company did not draw down the amounts described in (ii) and (iii) above prior to their applicable expiration dates.
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The principal amount of the Term Loans outstanding (the “Outstanding Principal Amount”) historically bore interest at a rate equal to 3-Month Term Secured Overnight Financing Rate (“SOFR”) plus 7.00 % per annum. As the net product sales for the calendar year ending December 31, 2025 exceeded $ 100.0 million, the Outstanding Principal Amount will bear interest at 3-Month Term SOFR plus 6.00 % per annum beginning on January 1, 2026. In all cases, the 3-Month Term SOFR rate is subject to a floor of 4.00 % per annum. Interest is payable quarterly in arrears on the last day of each calendar quarter. The Company has the option to pay up to 25 % of the interest in-kind beginning on the Term Loans Closing Date, through and including June 30, 2026. The Company has recognized approximately $ 3.1 million and $ 1.4 million of interest-in-kind as of December 31, 2025, and 2024, which is included in long-term debt in the consolidated balance sheets. The Term Loans will mature on the fifth anniversary of the Term Loans Closing Date. In connection with the Credit Agreement, the Company incurred approximately $ 2.2 million of costs, which primarily consisted of underwriting, legal and other professional fees, and are included as a reduction to the carrying amount of the related debt liability and are deferred and amortized over the remaining life of the financing using the effective interest method.
The Credit Agreement contains customary affirmative and negative covenants by the Company, which, among other things, will require the Company to provide certain financial reports to the Lenders within 60 days after the end of each of the first three fiscal quarters of each fiscal year and 105 days after the end of each fiscal year, meet certain minimum net product sales amounts, meet certain minimum liquidity, and limit the ability of the Company to, among other things, incur or guarantee additional indebtedness, conduct asset sales, incur liens, make dividends or distributions, conduct transactions with affiliates, and effect a consolidation or merger without consent. The obligations of the Company under the Credit Agreement may be accelerated upon customary events of default, including non-payment of principal, interest, fees and other amounts, covenant defaults, insolvency, material judgments, or inaccuracy of representations and warranties. The Term Loans are secured by a first priority perfected lien on, and security interest in, substantially all current and future assets of the Company and certain subsidiaries of the Company that are guarantors thereunder. The proceeds of the Term Loans were used to refinance certain existing indebtedness of the Company and its subsidiaries. The Company will use the remaining proceeds to pay fees and expenses related to the debt financing and commercialization of MIPLYFFA and OLPRUVA, and to further the development of its other product candidates.
Long-term debt consisted of the following (in thousands):
December 31,
2025 December 31,
2024
Notes payable $ 63,608 $ 61,552
Unamortized original issue discount ( 755 ) ( 921 )
Less: debt issuance costs ( 925 ) ( 1,127 )
$ 61,928 $ 59,504
Future minimum principal payments under the Term Loans as of December 31, 2025, are as follows (in thousands):
Year Ending December 31,
2026 $ —
2027 —
2028 —
2029 63,608
Total minimum payments 63,608
Less: unamortized debt discount, debt issuance costs and paid in kind interest ( 1,680 )
Long-term debt $ 61,928
J. Revenue, net
For the years ended December 31, 2025, and 2024, the Company record ed $ 106.5 million and $ 23.6 million, respectively, of revenue. Included in revenue for the year ended December 31, 2025 is a de minimis amount related to the licensing of certain IP.
Product Revenues, net
On December 27, 2022, the FDA approved OLPRUVA (sodium phenylbutyrate), a prescription medicine used along with certain therapy, including changes in diet, for the chronic management of adults and children with certain UCDs. For the years ended December 31, 2025, and 2024, sales of OLPRUVA were $ 0.8 million and $ 0.1 million.
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On September 20, 2024, the FDA approved MIPLYFFA (arimoclomol), an orally-delivered treatment for NPC, which is an ultra-rare and progressive neurodegenerative disease, for treatment in combination with miglustat. For the years ended December 31, 2025, and 2024, net sales of MIPLYFF A were $ 87.4 million and $ 10.1 million, respectively.
The Company currently utilizes a single specialty pharmacy provider as its sole distributor for both MIPLYFFA and OLPRUVA. The Company also enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of its products. All estimated reserve liabilities related to commercial products are recorded within the current portion of discount and rebate liabilities in the consolidated balance sheets. To commercialize MIPLYFFA and OLPRUVA in the United States, the Company has built marketing, sales, medical affairs, distribution, managerial and other non-technical capabilities or has made arrangements with third parties to perform these services. All revenues derived from sales of MIPLYFFA and OLPRUVA are in the United States.
Expanded Access Program
For the years ended December 31, 2025, and 2024, the Company recognized revenue related to the global EAP of $ 13.0 million and $ 9.1 million, respectively, net of a clawback liability of $ 6.1 million and $ 5.7 million, respectively, and other gross to net adjustments.
The total estimated reserve liability as of December 31, 2025, and 2024, was $ 15.3 million and $ 12.6 million, respectively. As of December 31, 2025, and 2024, this estimated reserve liability is recorded as discount and rebate liabilities in the consolidated balance sheets and is separated into current and long-term based upon the timing of the expected payment to the French regulators.
AZSTARYS License Agreement
The Company entered into a Collaboration and License Agreement (the “AZSTARYS License Agreement”) with Commave Therapeutics SA (formerly known as Boston Pharmaceuticals Holdings SA) (“Commave”), an affiliate of Gurnet Point Capital, L.P., dated September 3, 2019. Under the AZSTARYS License Agreement, as amended, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, including AZSTARYS, or any other product candidates containing SDX and developed to treat ADHD or any other central nervous system disorder. Corium Inc. was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Commave agreed to pay milestone payments up to an aggregate of $ 590.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS, additional fixed payments upon the achievement of specified U.S. sales milestones, and quarterly, tiered royalty payments based on a range of percentages of net sales (as defined in the AZSTARYS License Agreement). Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product.
The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and are not included in the transaction price, as the Company could not conclude that it is probable a significant reversal in the amount of cumulative revenue recognized will not occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal. For the years ended December 31, 2025, and 2024, the Company recognized revenue under the AZSTARYS License Agreement of $ 5.0 million and $ 4.3 million, respectively. There was no deferred revenue related to this agreement as of December 31, 2025, and 2024. All revenues recognized under this agreement were derived in the United States.
The AZSTARYS License Agreement is within the scope of ASC 606, as the transaction represents a contract with a customer where the participants function in a customer/vendor relationship and are not exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement.
Relief Exclusive License Agreement
Pursuant to the Relief License Agreement, Relief will hold exclusive development and commercialization rights for OLPRUVA in the EU, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia (“Geographical Europe”). The Company has the right to receive a royalty of up to 10 % of the net sales of OLPRUVA in Geographical Europe. For the years ended December 31, 2025, and 2024, the Company did not recognize any revenue under the Relief License Agreement. There was no deferred revenue related to this agreement as of December 31, 2025, and 2024.
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K. Commitments and Contingencies
Legal Matters
From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability is not probable, or the amount cannot be reasonably estimated and, therefore, an accrual has not been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates.
Litigation Related to the AZSTARYS License Agreement
In September 2024, the Company became engaged in a legal dispute regarding the AZSTARYS License Agreement. The litigation is currently in the discovery phase. The Company cannot predict with certainty the timing or ultimate outcome of this litigation or its potential impact on the Company's business, financial condition, or results of operations. At this time, the Company has not recorded any accrual for contingent liability associated with this matter. The AZSTARYS License Agreement remains in effect during this litigation, and both parties continue to perform their respective obligations thereunder. However, there can be no assurance that this dispute will not have an adverse impact on the Company's relationship with Commave or on the Company's business. The Company will continue to monitor developments in this matter and will assess the potential impact on the Company's financial statements in future periods. The Company expects to incur significant legal expenses in connection with this litigation, which may materially affect its results of operations in future periods.
As of December 31, 2025, and 2024, no accruals were made related to commitments and contingencies.
L. Stock and Warrants
Authorized, Issued, and Outstanding Common Shares
As of December 31, 2025, and 2024, the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized share s, 58,338,319 and 55,246,401 sh ares of common stock were issued as of December 31, 2025, and 2024, respectively, and 56,854,781 an d 53,670,709 sh ares of common stock were outstanding as of December 31, 2025, and 2024, respectively.
As of December 31, 2025, and 2024, the Company had reserved authorized shares of common stock for future issuance as follows:
December 31,
2025 2024
Outstanding awards under equity incentive plans 7,060,457 7,789,658
Outstanding common stock warrants 4,024,157 5,483,537
Possible future issuances under equity incentive plans 6,327,569 5,383,165
Possible future issuances under employee stock purchase plan 1,011,962 1,148,012
Total common shares reserved for future issuance 18,424,145 19,804,372
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Common Stock Activity
The following table summarizes common stock activity for the years ended December 31, 2025 and 2024:
Shares of
Common Stock
Balance as of January 1, 2024
41,534,668
Common stock issued in connection with a public offering (Note A) 10,615,385
Common stock issued in connection with restricted stock units 218,000
Common stock issued as compensation to third parties 92,988
Common stock issued in connection with vesting of performance-based awards 547,945
Common stock issued as a result of stock options exercised 469,563
Common stock issued as a result of the Employee Stock Purchase Plan 192,160
Balance as of December 31, 2024
53,670,709
Common stock issued as compensation to third parties 9,306
Common stock issued as a result of stock options exercised or RSUs vested 1,579,336
Common stock issued as a result of stock warrants exercised 1,459,380
Common stock issued as a result of the Employee Stock Purchase Plan 136,050
Balance as of December 31, 2025
56,854,781
Authorized, Issued, and Outstanding Preferred Stock
As of December 31, 2025, and 2024, the Company had 10,000,000 shares of authorized, unallocated preferred stock, As of December 31, 2025, and 2024, no shares of preferred stock were designated, issued, or outstanding.
Warrants to Purchase Common Stock
The Company has issued warrants to purchase common stock to various third parties, of which 4,024,157 r emain outstanding as of December 31, 2025, and are immediately exercisable. These warrants qualify as participating securities under ASC Topic 260, Earnings per Share , and are treated as such in the net income (loss) per share calculation (Note P). T he Company may be required to redeem these warrants for a cash amount equal to the BSM value of the portion of the warrants to be redeemed.
While the warrants are outstanding (but unexercised), the warrant holders will participate in any dividend or other distribution of the Company’s assets to its common stockholders by way of return of capital or otherwise. As of December 31, 2025, 1,459,380 of the warrants had been exercised. No warrants had been exercised as of December 31, 2024. The warrants have been evaluated to determine the appropriate accounting and classification pursuant to ASC 480 and ASC 815. Generally, freestanding warrants should be classified as (i) liabilities if the warrant terms allow settlement of the warrant exercise in cash and (ii) equity if the warrant terms only allow settlement in shares of common stock.
The Company determined that its outstanding warrants should be recorded as a liability and stated at fair value at each reporting period. Changes to the fair value of the warrant liability are recorded through the consolidated statements of operations as a fair value adjustment related to warrant and CVR liability. As of December 31, 2025, and 2024, the fair value of the liability associated with these warrants was app roximately $ 9.6 million an d $ 17.8 million , respectively. The fair value adjustment related to these warrants was $ 0.2 million of income and $ 1.7 million of loss for the years ended December 31, 2025, and 2024, respectively.
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M. Stock-Based Compensation
In November 2014, the Board of Directors of the Company (“the Board”), and in April 2015, the Company’s stockholders, approved the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), which became effective in April 2015. The 2014 Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. In June 2021, the Company's stockholders approved an Amended and Restated 2014 Equity Incentive Plan (the “A&R 2014 Plan”), following its adoption by the Board in April 2021, which, among other things, added 4,900,000 shares to the maximum number of shares of common stock to be issued under the plan and extended the annual automatic increases (discussed further below) until January 1, 2031 and eliminated individual grant limits that applied under the 2014 Plan to awards that were intended to comply with the exemption for “performance-based compensation” under Code Section 162(m). The maximum number of shares of common stock that may be issued under the A&R 2014 Plan was 12,079,711 as of December 31, 2025. The number of shares of common stock reserved for issuance under the A&R 2014 Plan automatically increases on January 1 of each year, beginning on January 1, 2016, and ending on and including January 1, 2031, by 4 % of the total number of shares of the Company’s capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the A&R 2014 Plan, on January 1, 2026, the common stock reserved for issuance under the A&R 2014 Plan automatically increased by 2,274,191 shar es.
During the years ended December 31, 2025, and 2024, 1,193,883 and 1,177,545 stock options were exercised, respectively.
In June 2021, the Company's stockholders approved an Employee Stock Purchase Plan (the “ESPP ” ), following its adoption by the Board in April 2021. The maximum number of shares of common stock that may be issued under the ESPP is 1,500,000 . The first offering period under the ESPP began on October 1, 2021, and the first purchase date occurred on May 31, 2022. As of December 31, 2025, 488,038 shares have been issued under the ESPP.
In January 2023, the Board approved the 2023 Employment Inducement Award Plan (as amended, the “2023 Plan”). The maximum number of shares of common stock that may be issued under the 2023 Plan was 4,500,000 as of December 31, 2025.
In February 2025, the Board approved the Tenth Amended and Restated Non-Employee Director Compensation Policy (the “Non-Employee Director Compensation Policy”). The equity compensation granted pursuant to the Non-Employee Director Compensation Policy is granted under the A&R 2014 Plan.
Stock-based compensation expense recorded under the A&R 2014 Plan, ESPP and 2023 Plan is included in the following line items in the accompanying consolidated statements of operations (in thousands):
Year ended December 31,
2025 2024
Research and development $ 841 $ 5,819
Selling, general and administrative 11,793 9,087
Total stock-based compensation expense $ 12,634 $ 14,906
There was $ 0.2 million stock-based compensation expense related to performance-based awards recognized during the year ended December 31, 2025 resulting from the transition agreements entered into with certain former employees as noted below. There was $ 2.5 million stock-based compensation expense related to performance-based awards recognized during the year ended December 31, 2024.
As a result of transition agreements entered into with certain former employees and directors, the vesting for certain stock options, restricted stock units, and performance stock units was accelerated, resulting in a net increase in stock-based compensation expense of $ 1.5 million for the year ended December 31, 2025. The effects of this accelerated vesting are reflected in the table above within selling, general and administrative expenses. For the year ended December 31, 2024, similar transition agreements with certain former employees resulted in a net increase in stock-based compensation expense of $ 2.4 million which is reflected in the table above within research and development expenses.
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Stock Option Awards
The Company estimates the fair value of stock options using the BSM option pricing model, which requires the use of subjective assumptions, including the expected term of the option, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the option. The expected term represents the period of time the stock options are expected to be outstanding. Due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected term of the stock options, the Company uses the simplified method to estimate the expected term for its “plain vanilla” stock options. Under the simplified method, the expected term of an option is presumed to be the mid-point between the vesting date and the end of the contractual term. Some options, for example those that have exercise prices in excess of the fair value of the underlying stock, are not considered “plain vanilla” stock options. For these options, the Company uses an expected term equal to the contractual term of the option. Expected volatility is based on the Company’s historical volatility over the estimated expected term of the stock options. The Company assumes no dividend yield because dividends are not expected to be paid in the near future, which is consistent with the Company’s history of not paying dividends.
The Company recognizes compensation expense related to stock-based payment transactions upon satisfaction of the requisite service or vesting requirements. Forfeitures are estimated at the time of grant and revised based on actual forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Using the BSM option-pricing model, the weighted-average fair value of awards granted during the years ended December 31, 2025, and 2024, was $ 8.21 and $ 5.74 per share, respectively. The assumptions used to estimate fair value are as follows:
Year Ended December 31,
2025 2024
Risk-free interest rate 3.70 % - 4.39 %
3.82 % - 4.50 %
Expected term (in years) 5.50 - 6.25
5.50 - 6.25
Expected volatility 81.54 % - 87.31 %
89.85 % - 91.32 %
Expected dividend yield 0 0
The activity under the A&R 2014 Plan and 2023 Plan for the year ended December 31, 2025, is summarized as follows:
Number of
Options Weighted
Average
Exercise Price Weighted Average
Remaining
Contractual Term Aggregate
Intrinsic
Value
Outstanding balance at January 1, 2025
5,951,400 $ 7.25 6.79 $ 17,448
Granted 1,459,750 $ 8.21 — —
Exercised or released 1,193,883 $ 5.14 — $ 3,829
Canceled or forfeited 371,801 $ 5.81 — —
Expired 381,199 $ 25.58 — —
Outstanding balance at December 31, 2025 5,464,267 $ 6.80 6.63 $ 15,709
Exercisable at December 31, 2025 2,701,924 $ 6.97 4.90 $ 8,999
Vested and expected to vest at December 31, 2025 5,264,367 6.55 $ 15,312
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Information regarding currently outstanding and exercisable options as of December 31, 2025, is as follows:
Options Outstanding Options Exercisable
Exercise Price Number of
Shares Weighted Average
Remaining
Contractual Term Number of
Shares Weighted Average
Remaining
Contractual Term
$ 2.85 to $ 10.00
5,270,954 6.60 2,648,611 4.97
$ 10.01 to $ 30.00
141,875 9.71 1,875 3.31
$ 30.01 to $ 50.00
20,593 0.00 20,593 1.72
$ 50.01 to $ 70.00
12,021 0.73 12,021 0.73
$ 70.01 to $ 327.20
18,824 1.00 18,824 1.00
5,464,267 2,701,924
The total fair value of stock options vested during the years ended December 31, 2025 and 2024, was $ 7.6 million and $ 8.1 million , respectively.
Unvested stock options as of December 31, 2025 and 2024, were as follows:
Number of Unvested Shares
December 31,
Exercise Price 2025 2024
$ 2.85 to $ 10.00
2,622,343 3,552,095
$ 10.01 to $ 30.00
140,000 —
Total number of unvested stock options 2,762,343 3,552,095
As of December 31, 2025, there was $ 9.0 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the A&R 2014 Plan and 2023 Plan.
Restricted stock units
The following table summarizes the restricted stock unit activity under the A&R 2014 and 2023 Plan:
Shares Weighted-Average Grant Date Fair Value
Unvested balance at January 1, 2025
1,838,258 $ 5.32
Granted 679,876 7.79
Vested 758,421 5.57
Forfeited 163,524 6.55
Unvested balance at December 31, 2025 1,596,189 $ 6.13
As of December 31, 2025 there was $ 5.3 million of total unrecognized compensation cost related to restricted stock units.
N. Fair Value of Financial Instruments
The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.
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The Company uses a three-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs, when available, and to minimize the use of unobservable inputs when determining fair value. The three tiers are defined as follows:
• Level 1: Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
• Level 2: Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
• Level 3: Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.
The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts and other receivables, and accounts payable and accrued expenses approximate their respective fair values due to the short-term nature of such instruments.
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of December 31, 2025, and 2024 (in thousands):
Balance at
December 31,
2025 Quoted Prices
in Active
Markets for
Identical Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
CVR liability $ 1,540 $ — $ — $ 1,540
Warrant liabilities 9,575 — — 9,575
Total liabilities $ 11,115 $ — $ — $ 11,115
Securities:
U.S. Treasury securities $ 97,132 $ 97,132 $ — $ —
Corporate bonds 79,352 — 79,352 —
Total assets $ 176,484 $ 97,132 $ 79,352 $ —
Balance at
December 31,
2024 Quoted Prices
in Active
Markets for
Identical Assets
(Level 1) Significant
Other
Observable
Inputs
(Level 2) Significant
Unobservable
Inputs
(Level 3)
CVR liability $ 3,500 $ — $ — $ 3,500
Warrant liabilities 17,804 — — 17,804
Total liabilities $ 21,304 $ — $ — $ 21,304
Securities:
U.S. Treasury securities $ 35,711 $ 35,711 $ — $ —
Corporate bonds 6,010 6,010
Total assets $ 41,721 $ 35,711 $ 6,010 $ —
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Warrants
The common stock warrant liabilities were recorded at fair value using the BSM option pricing model. The following assumptions were used in determining the fair value of the warrant liabilities valued using the BSM option pricing model as of December 31, 2025, and 2024:
December 31, 2025 December 31, 2024
Risk-free interest rate 3.42 % - 3.67 %
4.08 % - 4.23 %
Volatility 57.28 % - 66.70 %
62.14 % - 68.68 %
Dividend yield — % — %
Expected term (years) 0.02 - 2.89
1.02 - 3.89
Weighted average fair value $ 2.38 $ 3.25
The following table is a reconciliation for the common stock warrant liabilities measured at fair value using Level 3 unobservable inputs (in thousands):
Balance as of December 31, 2024 $ 17,804
Change in fair value measurement of warrant liabilities ( 218 )
Warrants exercised ( 8,011 )
Balance as of December 31, 2025 $ 9,575
For the year ended December 31, 2025, the changes in fair value of the warrant liabilities primarily resulted from the volatility of the Company's common stock.
Contingent Consideration
Contingent consideration liabilities relate to the Company's liabilities arising in connection with the CVRs. The contingent consideration is classified as Level 3 in the fair value hierarchy. The fair value is measured based on a Monte Carlo simulation or a scenario-based method, depending on the earn-out achievement objectives, utilizing projections about future performance. Significant inputs include volatility and projected financial information, including projections representative of a market participant's view of the expected cash payments associated with the agreed upon regulatory milestones based on probabilities of technical success, timing of the potential milestone events for the compounds, and estimated discount rates.
The following table provides a reconciliation of the beginning and ending balances related to the contingent consideration liabilities for the CVRs (dollars in thousands):
Balance as of December 31, 2024 $ 3,500
Change in fair value measurement of contingent consideration liabilities ( 1,960 )
Balance as of December 31, 2025 $ 1,540
For the year ended December 31, 2025, the changes in fair value of contingent consideration primarily resulted from changes in the discount rates.
O. Income Taxes
For the tax years ended December 31, 2025 and 2024, income from continuing operations before taxes consists of the following:
Year ended December 31,
2025 2024
U.S. operations $ 27,140 $ ( 86,269 )
Foreign operations 59,538 ( 3,871 )
Total pretax income (loss) $ 86,678 $ ( 90,140 )
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Income tax expense (benefit)
Income tax expense (benefit) attributable to income from continuing operations consists of:
Year ended December 31, 2025
Current Deferred Total
U.S. federal $ 2,108 $ — $ 2,108
Foreign 11,187 ( 9,858 ) 1,329
State and local — 12 12
$ 13,295 $ ( 9,846 ) $ 3,449
Year ended December 31, 2024
Current Deferred Total
U.S. federal $ — $ — $ —
Foreign — 15,373 15,373
State and local — ( 2 ) ( 2 )
$ — $ 15,371 $ 15,371
Rate reconciliation
Income tax expense attributable to income from continuing operations for the years ended December 31, 2025 and 2024 differed from the amounts computed by applying the statutory U.S. Federal income tax rate of 21 percent to pretax income from continuing operations as a result of the following (in thousands, except amounts pertaining to rate which are shown as a percentage):
Year ended December 31,
2025 2024
U.S. Federal Statutory Income Tax Rate $ 18,202 21.00 % $ ( 18,929 ) 21.00 %
Domestic state and local income taxes, net of federal effect(a) 45 0.05 % ( 635 ) 0.70 %
Foreign tax
Denmark
Changes in valuation allowance 2,390 2.76 % ( 3,879 ) 4.30 %
Changes to deferred tax asset/liability due to adjustment or true-up ( 3,108 ) ( 3.59 ) % 3,989 ( 4.42 ) %
Other 421 0.49 % ( 39 ) 0.04 %
Effect of cross-border tax laws
Subpart F inclusions 10,752 12.40 % — 0.00 %
Other — — % 20 ( 0.02 ) %
Tax credits
Research credits 18,212 21.01 % 1,517 ( 1.68 ) %
Changes in valuation allowance ( 51,390 ) ( 59.28 ) % 10,236 ( 11.36 ) %
Nontaxable or nondeductible items 396 0.46 % 353 ( 0.39 ) %
Changes in unrecognized tax benefits ( 10,659 ) ( 12.30 ) % 16,115 ( 17.87 ) %
Changes to deferred tax asset/liability due to adjustment or true-up
Net operating losses 18,636 21.50 % 6,783 ( 7.53 ) %
Other ( 448 ) ( 0.52 ) % ( 160 ) 0.18 %
Total $ 3,449 3.98 % $ 15,371 ( 17.05 ) %
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(a) State taxes in Michigan for 2024 and in Michigan and Florida for 2025 made up the majority (greater than 50%) of the tax effect in this category.
Deferred tax asset (liabilities)
The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2025 and 2024 are presented below (in thousands):
December 31,
2025 2024
Deferred tax assets
Allowance for bad debts $ 340 $ 320
Accrued expenses 2,977 1,461
Reserve expenses 1,648 1,288
Stock compensation 6,352 5,711
Operating lease liabilities 339 108
Section 174 14,601 33,941
Plant and equipment 34 79
Intangibles 1,140 —
Net operating loss carryforwards 63,256 100,552
Credits 941 19,153
Other 57 583
Total deferred tax assets 91,685 163,196
Less: valuation allowance ( 91,498 ) ( 146,359 )
Deferred tax assets, net of valuation allowance 187 16,837
Deferred tax liabilities
Intangibles — ( 17,859 )
Operating lease assets ( 325 ) ( 82 )
Other ( 35 ) —
Total deferred tax liabilities ( 360 ) ( 17,941 )
Net deferred tax liabilities $ ( 173 ) $ ( 1,104 )
The valuation allowance for deferred tax assets as of December 31, 2025 and 2024 was $ 91.5 million and $ 146.4 million, respectively. The net change in the total valuation allowance for each of the years ended December 31, 2025 and 2024 was a decrease of $ 54.9 million and an increase of $ 11.9 million, respectively. The valuation allowance for both years was primarily related to U.S. domestic, state, and foreign net operating loss carryforwards as well as credit carryforwards that, in the judgment of management, are not more likely than not to be realized. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the periods in which those temporary differences are deductible.
At December 31, 2025, Zevra has $ 230.4 million in carryforwards for federal income tax purposes, which are available to reduce future federal taxable income. Of the total $ 230.4 million net operating loss carryforwards, $ 11.1 million, if not utilized, will begin to expire in 2029 and $ 219.4 million have no expiration date. The Company also has $ 312.2 million state net operating loss carryforwards which, if not utilized, will begin to expire in 2029.
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Unrecognized tax benefits
A reconciliation of the beginning and ending amounts of total unrecognized tax benefits for the years ended December 31, 2025 and 2024 are as follows (in thousands):
December 31,
2025 2024
Balance, beginning of year $ 16,115 $ —
Increase related to prior year tax positions — —
Decrease related to prior year tax positions ( 9,086 ) —
Increases related to current year tax positions — 16,115
Settlements — —
Lapse of Statute — —
Balance, end of year $ 7,029 $ 16,115
Included in the balance of unrecognized tax benefits at December 31, 2025 is a potential benefit of $ 7.0 million that, if recognized, would affect the effective tax rate on income from continuing operations.
The Company files income tax returns in the United States for federal and various state jurisdictions. Generally, the statute of limitations for income tax examinations is 3 to 4 years. As such, the Company is no longer subject to U.S. federal and state and local income tax examinations for years prior to 2021, although carryforwards that were generated prior to 2021 may still be adjusted upon examination by the Internal Revenue Service or a state tax department. The Company's Denmark subsidiary files a Denmark income tax return. The Denmark statute of limitations is 3 years and, as such, it is no longer subject to Denmark tax examinations for years prior to 2022. The Company is not under income tax examination in any material jurisdiction to date.
Current portion of income tax payable
The current portion of income tax payable of $ 13.7 million includes approximately $ 11.1 million attributable to the recognized tax impact of the sale of the PRV, which included transfer pricing considerations. The remainder of the current portion of income tax payable consists of $ 2.6 million.
P. Net Income (Loss) Per Share
The two-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings. Under the two-class method, for periods with net income attributable to common stockholders, basic net income attributable to common stockholders per share of common stock is computed by dividing the net income attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Undistributed net income attributable to common stockholders is computed by subtracting from net income the portion of current period earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the period’s earnings been distributed. No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities have no obligation to fund losses. Diluted net income attributable to common stockholders per share of common stock is computed under the two-class method by using the weighted average number of shares of common stock outstanding plus the potential dilutive effects of stock options and warrants. In addition to analyzing under the two-class method, the Company analyzes the potential dilutive effect of stock options and warrants under the treasury-stock method when calculating diluted income (loss) attributable to common stockholders per share of common stock, in which it is assumed that the stock options and warrants convert into common stock at the beginning of the period or date of issuance, if the stock option or warrant was issued during the period. The Company reports the more dilutive of the approaches (two-class or treasury-stock/if-converted) as its diluted net income (loss) attributable to common stockholders per share of common stock during the period.
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Diluted net loss per share of common stock is the same as basic net loss per share of common stock for the year ended December 31, 2024, because the effects of potentially dilutive items were anti-dilutive for the respective periods. The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted-average number of shares of common stock outstanding because their effect is anti-dilutive:
December 31,
2025 2024
Awards under equity incentive plans 1,571,228 1,148,012
Common stock warrants — 5,483,537
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding 1,571,228 6,631,549
A reconciliation from net income (loss) to basic net income (loss) attributable to common stockholders per share of common stock and diluted net income (loss) attributable to common stockholders per share of common stock for the years ended December 31, 2025, and 2024, is as follows (in thousands):
Year Ended December 31,
2025 2024
Basic net income (loss) per share of common stock:
Net income (loss) $ 83,229 $ ( 105,511 )
Earnings allocated to participating securities ( 5,644 ) —
Net income (loss) attributable to shares of common stock
77,585 ( 105,511 )
Less: Dividends declared or accumulated — —
Undistributed net income (loss) attributable to shares of common stock, basic
77,585 ( 105,511 )
Weighted-average shares of common stock outstanding 55,311 46,251
Basic net income (loss) per share of common stock
$ 1.40 $ ( 2.28 )
Diluted net income (loss) per share of common stock:
Net income (loss) attributable to shares of common stock $ 77,585 $ ( 105,511 )
Less: Fair value adjustment income related to warrant liability — —
Net income (loss) attributable to shares of common stock, diluted
77,585 ( 105,511 )
Weighted-average number of shares of common stock outstanding 55,311 46,251
Dilutive effect of outstanding stock options (as converted to common stock) 1,952 —
Weighted-average shares of common stock outstanding, diluted 57,263 46,251
Diluted net income (loss) per share of common stock $ 1.35 $ ( 2.28 )
Q. Leases
The Company has operating leases for office space and determines if an arrangement is a lease at contract inception. Lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date. The Company does not separate lease and non-lease components. Leases with a term of 12 months or less at commencement are not recorded on the consolidated balance sheets. Lease expense for these arrangements is recognized on a straight-line bases over the lease term. The Company’s leases have remaining lease terms of less than one year and up to approximately three years , and some which include options to terminate the leases within one year .
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The components of operating lease expense were as follows (in thousands):
Year Ended December 31,
2025 2024
Operating lease cost $ 747 $ 330
Short-term lease cost 127 177
Variable lease cost 36 39
Less: sublease income ( 144 ) ( 128 )
Total lease costs $ 766 $ 418
Supplemental cash flow information related to leases was as follows (in thousands):
Year Ended December 31,
2025 2024
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases $ 860 $ 405
Operating cash flows from short-term leases 127 225
Operating cash flows from variable lease costs 36 39
Right-of-use assets obtained in exchange for lease liabilities:
Operating leases 1,115 419
Supplemental balance sheet information related to operating leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate):
December 31,
2025 2024
Operating lease right-of-use assets $ 1,212 $ 657
Total operating lease right-of-use assets $ 1,212 $ 657
Current portion of operating lease liabilities $ 419 $ 420
Operating lease liabilities, less current portion 859 372
Total operating lease liabilities $ 1,278 $ 792
Weighted average remaining lease term 3 3
Weighted average discount rate 13.0 % 9.9 %
Maturities on lease liabilities were as follows (in thousands):
Year Ending December 31,
2026 $ 552
2027 542
2028 393
2029 39
Total lease payments 1,526
Less: future interest expense ( 248 )
Lease liabilities $ 1,278
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R. Employee Benefit Plan
The Company has a 401(k) retirement plan (the “401(k) Plan”) that covers substantially all employees. The Company may provide a discretionary match with a maximum amount of 4 % of the participant’s compensation, which vests immediately. The Company made matching contributions under the 401(k) Plan of approximately $ 0.3 million and $ 0.5 million for the years ended December 31, 2025, and 2024 , respectively.
The Company has a discretionary profit-sharing plan (the “Profit Sharing Plan”) that covers all employees. Employees become eligible participants in the Profit Sharing Plan once they have provided three years of service to the Company. The Company made no contributions to the Profit Sharing Plan in 2025 or 2024.
S. Goodwill & Intangible Assets
The Company's goodwill balance was $ 4.7 million as of December 31, 2025, and 2024. As of December 31, 2025, and 2024, the Company completed its annual qualitative assessment under ASC 350 to determine whether the existence of events or circumstances indicated that it was more likely than not that the fair value of its reporting unit was less than its respective carrying value. The Company concluded that based on the relevant events and circumstances, it was more likely than not that the reporting unit’s fair value exceeded its related carrying value and therefore no quantitative assessment was required. No goodwill impairment charges were recorded for the years ended December 31, 2025, or 2024.
The definite-lived intangible assets that are subject to amortization have been reviewed for impairment whenever events or changes in circumstances indicate that their carrying amounts may not be recoverable. In the second quarter of 2025, t he Company assessed the results of its refined commercial efforts related to OLPRUVA. This was determined to be a triggering event that could result in a decrease in future expected cash flows, and thus indicated the carrying amount of the OLPRUVA asset group may not be fully recoverable. The Company performed an undiscounted cash flow analysis over the OLPRUVA asset group and determined that the carrying value of the asset group is not recoverable. Future cash flows specific to OLPRUVA, which most significantly includes an estimate of forecasted revenues, are based on reasonable and supportable assumptions regarding the cash flows expected to result from the use of the asset and its eventual disposition. The Company then estimated the fair value of the asset group to measure the impairment loss for the period. The fair value measurement was based on Level 3 inputs including projected sales driven by market share and product sales price estimates, associated expenses, growth rates, and the discount rate used to measure the fair value of the net cash flows associated with this asset group. The Company recorded an intangible asset impairment charge of $ 58.7 million in the consolidated statements of operations for the year ended December 31, 2025. As of December 31, 2024, the Company had a definite-lived intangible asset, net, related to the acquisition of OLPRUVA of $ 61.3 million. There was no comparable impairment in the year ended December 31, 2024.
Prior to the impairment discussed above, the OLPRUVA definite-lived intangible asset was being amortized on a straight-line basis over the OLPRUVA patent life of 13 years. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $ 2.6 million and $ 5.9 million for the years ended December 31, 2025, and 2024, respectively.
In connection with the XOMA License Agreement, a regulatory milestone payment of $ 6.0 million was due to XOMA upon approval of MIPLYFFA in the United States, which the Company paid in October 2024. This definite-lived intangible asset is amortized on a straight-line basis over the MIPLYFFA patent life of approximately five years and is reviewed periodically for impairment. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $ 1.3 million and $ 0.3 million for the years ended December 31, 2025, and 2024, respectively.
For intangible assets subject to amortization, estimated amortization expense for the five fiscal years subsequent to December 31, 2025, is expected to b e as follows:
2026 $ 1,263
2027 1,263
2028 1,263
2029 632
2030 —
As of December 31, 2025, and 2024, non-amortizable intangible assets include in-process research and development of $ 2.0 million.
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T. Subsequent Events
The Company evaluated events and transactions occurring subsequent to December 31, 2025, through March 9, 2026 , th e date the accompanying financial statements were issued.
During this period, there were no subsequent events that required recognition in the accompanying consolidated financial statements, nor were there any additional non-recognized subsequent events that required disclosure.
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EXHIBITS
Exhibit No. Description
2.1*** Agreement and Plan of Merger dated as of August 30, 2023, by and among the Company Aspen Z Merger Sub, Inc., and Acer Therapeutics Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
2.2†
Asset Purchase Agreement by and among the Registrant, Zevra Denmark A/S and Orphazyme A/S, in restructuring, dated May 15, 2022 (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on May 16, 2022).
2.3+†
Asset Purchase Agreement dated February 26, 2025 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on May 13, 2025).
3.1*
Restated Certificate of Incorporation of Zevra Therapeutics, Inc.
3.2 Amended and Restated Bylaws, as currently in effect, of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on February 28, 2024).
4.1 Specimen stock certificate evidencing shares of Common Stock (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 12, 2021).
4.2 Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 12, 2025).
4.3 Form of Common Stock Purchase Warrant (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on November 20, 2023).
10.1#
Amended and Restated 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.1.1#
Form of Stock Option Grant Notice and Stock Option Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 File No. 333-202660) as filed with the SEC on March 11, 2015).
10.1.2#
Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 File No. 333-202660) as filed with the SEC on March 11, 2015).
10.1.3#
Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on May 14, 2019).
10.2#
2021 Employee Stock Purchase Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.3#
2023 Employment Inducement Award Plan and forms of award agreements thereunder (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
10.4#
Tenth Amended and Restated Non-Employee Director Compensation Policy effective February 15, 2025 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on May 13, 2025).
10.5#
Form of Indemnification Agreement with the Registrant's directors and executive officers (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.6#
Amended and Restated Employment Agreement by and between the Registrant and R. LaDuane Clifton, dated as of June 25, 2015 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 14, 2015).
10.6.1#
Amendment to Amended and Restated Employment Agreement by and between the Registrant and R. LaDuane Clifton, dated as of October 13, 2015 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on November 13, 2015).
10.6.2#*
Separation of Employment Agreement and General Release by and between the Registrant and R. LaDuane Clifton, dated November 19, 2025.
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EXHIBITS, CONTINUED
Exhibit No. Description
10.7#
Employment Agreement by and between the Registrant and Adrian Quartel, dated as of January 3, 2024 (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on March 12, 2025).
10.8#
Employment Agreement by and between the Registrant and Joshua Schafer, dated as of January 6, 2023 (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on March 12, 2025).
10.9#
Employment Agreement by and between the Registrant and Rahsaan Thompson, dated as of June 2 0 , 2024 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on August 1 4 , 2024).
10.10#
Employment Agreement, effective as of October 10, 2023, between the Registrant and Neil F. McFarlane (incorporated herein by reference to the Registrant's Current Report on 8-K as filed with the SEC on October 10, 2023).
10.10.1#
Amendment to the Employment Agreement by and between the Registrant and Neil F. McFarlane, dated as of May 7, 2024 (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on March 12, 2025).
10.11 Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of November 3, 2014 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.11.1
First Amendment to the L ease Agreement, b y and between the Registrant and BRE/COH FL LLC, dated as of April 21, 2015 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.11.2
Second Amendment to the Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of December 22, 2015 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.11.3
Third Amendment to the Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of July 15, 2016 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.11.4
F ourth Amendment to the Lease Agreement by and between the Registrant and BRE/COH FL LLC, dated as of September 4, 2025 (incorporated by reference to the Registrant’s Quarterly Report on Form 10- Q as filed with the SEC on November 5 , 2025).
10.12+
Collaboration and License Agreement, dated as of September 3, 2019, by and between the Registrant and Boston Pharmaceuticals Holdings SA (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on September 4, 2019).
10.12.1+
Amendment No. 1 to Collaboration and License Agreement, effective as of April 8, 2021, by and between the Company and Commave Therapeutics SA (formerly known as Boston Pharmaceuticals Holdings SA) (incorporated herein by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.13 Equity Distribution Agreement, dated July 1 2, 202 4 , by and among the Company and Citizens JMP Securities LLC (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on July 1 2, 202 4 ).
10.14 Registration Rights Agreement dated as of August 30, 2023, by and among the Registrant and each of the sellers party thereto (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
10.15 Contingent Value Rights Agreement, dated as of November 17, 2023, by and among Zevra Therapeutics, Inc., Computershare, Inc., and Computershare Trust Company, N.A. (incorporated by reference to the Registrant's Current Report on 8-K as filed with the SEC on November 20, 2023).
10.16†+
Credit Agreement dated as of April 5, 2024, by and among Zevra Therapeutics, Inc. and HCR Stafford Fund II, L.P., HCR Potomac Fund II, L.P., and Perceptive Credit Holdings IV, LP (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on May 9, 2024).
10.17#*
Amended and Restated E mployment Agreement by and between the Registrant and Timothy Sangiovanni, effective as of February 13, 2017 .
10.18†+*
Sublease Agreement, dated December 20, 2024, by and between Brownmed, Inc. and the Company.
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EXHIBITS, CONTINUED
Exhibit No. Description
19 Zevra Therapeutics, Inc. Amended and Restated Insider Trading and Window Period Policy (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on March 12, 2025).
21.1 Subsidiaries of the Company.
23.1* Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
24.1* Power of Attorney (included on signature page).
31.1* Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2* Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32.1** Certification of the Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2** Certification of the Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1# Zevra Therapeutics, Inc. Policy for Recovery of Erroneously Awarded Compensation, Effecti ve October 2, 202 3 (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
101.INS* Inline XBRL Instance Document.
101.SCH* Inline XBRL Taxonomy Extension Schema Document.
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101)
* Filed herewith
** Furnished herewith
*** Pursuant to Item 601(b)(2) of Regulation S-K, schedules and similar attachments have been omitted. The registrant hereby agrees to furnish a copy of any omitted schedule or similar attachment to the SEC upon request.
# Indicates management contract or compensatory plan.
+ Certain portions of the exhibit, identified by the mark, “[*]”, have been omitted because such portions contained information that is both (i) not material and (ii) the type that the Registrant treats as private or confidential.
† Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule will be furnished to the Securities and Exchange Commission upon request; provided, however, that the parties may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any document so furnished.
ITEM 16. FORM 10-K SUMMARY
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Zevra Therapeutics, Inc.
Dated: March 9, 2026
By: /s/ Neil F. McFarlane
Neil F. McFarlane
President and Chief Executive Officer
(Principal Executive Officer)
Dated: March 9, 2026
By: /s/ Timothy J. Sangiovanni
Timothy J. Sangiovanni, CPA
Senior Vice President, Finance and Corporate Controller
(Principal Financial and Accounting Officer)
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POWER OF ATTORNEY
KNOW ALL BY THESE PRESENTS, that each person whose signature appears below hereby constitute and appoint Neil F. McFarlane and Timothy J. Sangiovanni, and each of them (with full power to each of them to act alone), as his true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign any and all amendments to this report, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ Neil F. McFarlane
Neil F. McFarlane President and Chief Executive Officer
(Principal Executive Officer) March 9, 2026
/s/ Timothy J. Sangiovanni
Timothy J. Sangiovanni, CPA Senior Vice President, Finance and Corporate Controller
(Principal Financial and Accounting Officer)
March 9, 2026
/s/ Thomas D. Anderson
Thomas D. Anderson Director March 9, 2026
/s/ John B. Bode
John B. Bode Director March 9, 2026
/s/ Douglas W. Calder
Douglas W. Calder Director March 9, 2026
/s/ Tamara A. Favorito
Tamara A. Favorito Director March 9, 2026
/s/Alicia Secor
Alicia Secor
Director March 9, 2026
/s/ Alvin Shih
Alvin Shih, M.D.
Director March 9, 2026
/s/ Corey Watton
Corey Watton Director March 9, 2026
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