Zevra (NASDAQ: ZVRA) swings to Q1 profit and repays term loan
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Zevra Therapeutics reported a strong turnaround in the first quarter of 2026, driven by higher product revenue and a major asset sale. Net revenue rose to $36.2 million, up 78% from Q1 2025, led by $24.6 million from MIPLYFFA and contributions from OLPRUVA, expanded access reimbursements, and AZSTARYS royalties.
The company recorded net income of $37.9 million, or $0.60 per diluted share, versus a loss a year earlier, largely reflecting a $43.3 million gain on the sale of its SDX portfolio and related proceeds of $40.5 million in the quarter. Zevra also prepaid the $63.1 million principal on its term loan, ending the period debt-free with $236.8 million in cash, cash equivalents and securities as of March 31, 2026.
Positive
- Revenue growth and profitability: Q1 2026 net revenue rose 78% year over year to $36.2 million, and Zevra moved from a $3.1 million net loss in Q1 2025 to $37.9 million in net income.
- Strengthened balance sheet: The $50.0 million SDX portfolio sale produced $40.5 million of net proceeds in Q1 2026, enabling full prepayment of the $63.1 million term loan and leaving the company debt-free with $236.8 million in cash, cash equivalents and securities.
Negative
- Earnings quality heavily influenced by one-time gain: Q1 2026 net income includes a $43.3 million gain on the SDX portfolio sale; adjusted net income excluding this and related items is $11.5 million, or $0.18 per diluted share.
Insights
Zevra posts strong Q1 growth, uses SDX sale to eliminate debt and build cash.
Zevra Therapeutics delivered Q1 2026 net revenue of $36.2 million, up 78% year over year, with MIPLYFFA contributing $24.6 million. Additional revenue came from OLPRUVA, expanded access reimbursements, and AZSTARYS royalties, showing multiple commercial streams.
Profitability was driven partly by a one-time $43.3 million gain on the SDX portfolio sale, which also provided $40.5 million of net proceeds in the quarter. The company used this and its cash to prepay $63.1 million of term debt, ending March 31, 2026 with $236.8 million in cash, cash equivalents and securities and no long-term debt.
Zevra reports 59.1 million common shares outstanding and 68.9 million fully diluted shares as of March 31, 2026. Management states that current financial resources are sufficient to execute strategic priorities, including advancing MIPLYFFA in Niemann-Pick disease type C and the celiprolol DiSCOVER trial in Vascular Ehlers-Danlos Syndrome.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Net revenue: $36.2 million
MIPLYFFA net revenue: $24.6 million
Net income: $37.9 million
+5 more
8 metrics
Net revenue
$36.2 million
Q1 2026 net revenue, up 78% from $20.4 million in Q1 2025
MIPLYFFA net revenue
$24.6 million
Component of Q1 2026 net revenue
Net income
$37.9 million
Q1 2026 net income vs. $3.1 million net loss in Q1 2025
Adjusted net income
$11.5 million
Q1 2026 non-GAAP adjusted net income excluding SDX gain and related items
Cash, cash equivalents and securities
$236.8 million
Balance as of March 31, 2026
SDX portfolio sale gain
$43.3 million
One-time gain on sale of future royalties, intellectual property and other assets in Q1 2026
Term loan principal repaid
$63.1 million
Term loan principal prepaid in full, eliminating long-term debt
Shares outstanding
59,114,850 shares
Common stock outstanding as of March 31, 2026
Key Terms
Expanded Access Program, Orphan Medicinal Product, Special Protocol Assessment, loss on extinguishment of debt, +2 more
6 terms
Expanded Access Program medical
"As of March 31, 2026, 122 patients were enrolled in the global EAP."
A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.
Orphan Medicinal Product regulatory
"Arimoclomol has been designated an Orphan Medicinal Product by the EMA."
A medicine designated by regulators for the prevention, diagnosis or treatment of a rare disease or condition that affects only a small number of people. Think of it as a custom tool made for a niche problem; that label usually brings special regulatory benefits such as fee waivers, tax credits, priority review and a period of market exclusivity. For investors, that designation can raise a drug’s commercial value and lower development risks, since it improves the chance of approval and future sales despite a small patient pool.
Special Protocol Assessment regulatory
"the DiSCOVER trial, a Phase 3 trial being conducted under a Special Protocol Assessment (SPA)"
A special protocol assessment is a formal, written agreement between a drug or device developer and a health regulator about the design, size and analysis plans of a pivotal clinical trial or study. It matters to investors because it reduces regulatory uncertainty—like getting a signed blueprint before building—by signaling that if the study follows the agreed plan and meets its goals, the regulator is unlikely to reject the results solely for design reasons, though it does not guarantee approval.
loss on extinguishment of debt financial
"one-time charges of $2.8 million in loss on extinguishment of debt"
Loss on extinguishment of debt is the accounting hit a company records when it retires or restructures a loan or bond for an amount that exceeds the debt’s recorded value—like paying more than the remaining balance to settle a loan early. It matters to investors because it reduces reported profit and can use cash, but may also cut future interest costs or signal financial stress; understanding it helps assess earnings quality and balance-sheet strength.
non-GAAP financial measures financial
"Adjusted net income and adjusted net income per share are non-GAAP financial measures."
Non-GAAP financial measures are numbers companies use to show their financial performance that exclude certain expenses or income. They help investors see how the company might perform without one-time costs or other unusual items, giving a different perspective from official reports. However, since they can be adjusted, they don’t always tell the full story and should be looked at alongside standard financial figures.
Marketing Authorization Application regulatory
"A Marketing Authorisation Application for the evaluation of arimoclomol for the treatment of NPC is under review"
A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.
Offering Details
earnings_snapshot
Offering
Offering Type
earnings_snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
__________________________________________________________________________________________
FORM 8-K
__________________________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 6, 2026
__________________________________________________________________________________________
(Exact Name of Registrant as Specified in Its Charter)
__________________________________________________________________________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (888 ) 958-1253
(Former Name or Former Address, if Changed Since Last Report)
__________________________________________________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
The (Nasdaq Global Select Market) | ||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 6, 2026, Zevra Therapeutics, Inc., a Delaware corporation ("Zevra" or "the Company"), issued a press release announcing its financial results and corporate updates for the first quarter ended March 31, 2026, as well as information regarding a conference call and audio webcast to discuss its financial results and corporate updates scheduled for Wednesday, May 6, 2026, at 4:30 p.m. ET. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in the press release, furnished as Exhibit 99.1 shall not be deemed “filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not incorporated by reference into any of Zevra's filings under the Securities Act of 1933, as amended, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits | ||||
| Exhibit No. | Description | |||||||
| 99.1 | Press Release dated May 6, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements 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. | |||||||||||
Date: May 6, 2026 | By: | /s/ Justin Renz | |||||||||
| Justin Renz | |||||||||||
| Chief Financial Officer and Treasurer (Principal Financial Officer) | |||||||||||
Exhibit 99.1
Zevra Reports First Quarter 2026 Financial Results and Corporate Update
Q1 2026 net revenue of $36.2 million, a 78% increase over Q1 2025
Completed $50.0 million sale of SDX portfolio to Commave Therapeutics
Operational execution fueled strong cash position of $236.8 million
Company to host conference call and webcast TODAY, May 6, 2026, at 4:30 p.m. ET
BOSTON, Mass., May 6, 2026 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today reported its financial results for the first quarter ended March 31, 2026.
“We made meaningful progress across the business in the first quarter, led by continued performance for MIPLYFFA, underscoring its role in addressing the needs of patients with Niemann-Pick disease type C,” said Neil F. McFarlane, Zevra's President and Chief Executive Officer. “We also completed the $50.0 million divestiture of the SDX portfolio, and we repaid our term loan debt, sharpening our strategic focus and strengthening our financial position as we execute on our 2026 priorities.”
MIPLYFFA® (arimoclomol) Highlights
•U.S.: Received nine MIPLYFFA prescription enrollment forms for Niemann-Pick disease type C (NPC) during Q1 2026, bringing the total to 170 since product launch. Market access remains stable at 69% of covered lives.
•EU: A Marketing Authorisation Application for the evaluation of arimoclomol for the treatment of NPC is under review by the European Medicines Agency (EMA). The Company submitted its response to the EMA’s 120-day list of questions within the 90-day clock stop period, advancing the application along the standard review process. Arimoclomol has been designated an Orphan Medicinal Product by the EMA.
•Global Expanded Access Program (EAP): As of March 31, 2026, 122 patients were enrolled in the global EAP.
•In the Journal of Inherited Metabolic Disease, MIPLYFFA was included in the newly updated Clinical Practice Guidelines for the treatment and management of NPC.
Pipeline and Innovation Highlights
•Enrolled 10 patients in the event-driven Phase 3 DiSCOVER trial for the treatment of Vascular Ehlers-Danlos Syndrome during Q1 2026, bringing the total number of enrolled patients to 62, with a total of two confirmed events. The Company expects to hold a follow-up meeting with the Food and Drug Administration (FDA) in the second half of this year to explore pathways to accelerate clinical development.
Corporate Highlights
•Executed $50.0 million SDX portfolio sale to Commave Therapeutics, strengthening the balance sheet and supporting strategic priorities.
•Prepaid the principal balance on its $63.1 million term loan in full, resulting in a strong, debt-free balance sheet and enhanced financial and strategic flexibility.
Q1 2026 Financial Highlights
•Revenue, Net: $36.2 million for Q1 2026, which includes $24.6 million of MIPLYFFA net revenue, $0.3 million of OLPRUVA net revenue, $10.2 million in net reimbursements from our EAP, and $1.1 million in royalties and other reimbursements under the AZSTARYS® license agreement. This was an increase in total net revenue of $15.8 million compared to $20.4 million in Q1 2025.
•Cost of Product Revenue: $1.9 million for Q1 2026, excluding non-cash intangible asset amortization. Cost of product revenue for Q1 2025 was $1.3 million.
•Operating Expenses: $25.2 million for Q1 2026, which includes non-cash stock compensation expense of $3.1 million. Total operating expenses for Q1 2025 were $22.8 million.
◦R&D expense was $4.4 million for Q1 2026, which was an increase of $1.1 million compared to $3.3 million for Q1 2025 due primarily to an increase in third-party costs incurred and professional fees.
◦SG&A expense was $20.8 million for Q1 2026, which was an increase of $1.2 million compared to $19.5 million for Q1 2025, due primarily to an increase in professional fees, partially offset by a decrease in third party spending.
•Net income (loss): Net income of $37.9 million, or $0.62 per basic and $0.60 diluted share for Q1 2026, compared to a net loss of $(3.1) million, or $(0.06) per basic and diluted share, in Q1 2025.
◦In Q1 2026, the Company received $40.5 million of the $45.0 million in net proceeds from the sale of the SDX portfolio.
◦Excluding $43.3 million from the one-time gain on the sale of the SDX portfolio, one-time charges of $2.8 million in loss on extinguishment of debt and $7.2 million in loss on derivative liability and payoff premium related to the prepayment of the term loan in full, and $6.9 million in income tax expense related to the transaction, estimated adjusted quarterly net income would be $11.5 million, or $0.18 per diluted share.1
•Cash Position: Cash, cash equivalents and securities were $236.8 million as of March 31, 2026. Based on its current operating forecast, the Company believes available financial resources are sufficient to execute on its strategic priorities independent from the capital markets.
•Common and Fully Diluted Shares O/S: As of March 31, 2026, total shares of common stock outstanding were 59,114,850, and fully diluted common shares were 68,946,838, which included 7,302,609 issuable from outstanding awards under equity incentive plans, and 2,529,379 shares issuable upon exercise of warrants.
1 Adjusted net income and adjusted net income per share are non-GAAP financial measures. Management believes that adjusted net income and adjusted net income per share provide useful information for investors, and management uses these supplemental measures to assess the Company’s operating performance. Adjusted net income and adjusted net income per share have limitations as analytical tools because they do not reflect all of the amounts associated with our results of operations as determined in accordance with U.S. GAAP. Additionally, they may not be comparable to similarly titled measures of other companies, including in our industry, limiting the usefulness of those measures for comparative purposes. Because of these limitations, these non-GAAP financial measures should be considered along with other operating and financial performance measures presented in accordance with U.S. GAAP. The presentation of these non-GAAP financial measures are not intended to be considered in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with U.S. GAAP.
Conference Call Information
Zevra will host a conference call and audio webcast TODAY at 4:30 p.m. ET to discuss its corporate update and financial results for the first quarter 2026.
A link to the audio webcast is accessible on the “Events & Presentations” page in the Investor Relations section of the Zevra's website at investors.zevra.com. A replay of the webcast will be available for 90 days beginning at approximately 5:30 p.m. ET on May 6, 2026.
Additionally, interested participants and investors may access the conference call by dialing either:
•(800) 245-3047 (United States)
•(203) 518-9765 (International)
•Conference ID: ZVRAQ126
About MIPLYFFA® (arimoclomol)
MIPLYFFA (arimoclomol) is Zevra’s approved therapy for the treatment of Niemann-Pick disease type C (NPC). Approved by the U.S. Food and Drug Administration on Sep. 20, 2024, MIPLYFFA (arimoclomol) increases the activation of the transcription factors EB (TFEB) and E3 (TFE3) resulting in the upregulation of coordinated lysosomal expression and regulation (CLEAR) genes. MIPLYFFA has also been shown to reduce unesterified cholesterol in the lysosomes of human NPC fibroblasts. The clinical significance of these findings is not fully understood. In the pivotal phase 3 trial, MIPLYFFA halted disease progression compared to placebo over the one-year duration of the trial when measured by the only validated disease progression measurement tool, the NPC Clinical Severity Scale. MIPLYFFA has also received Orphan Medicinal Product designation by the European Medicines Agency (EMA) for the treatment of NPC. The extensive data generated for MIPLYFFA has shown long-term, meaningful clinical outcomes with 5 and in some patients 7 years of patient experience across more than 270 NPC patients worldwide through a Phase 2/3 clinical trial, Open-Label Extension (OLE) study, Expanded Access Programs (EAP), and a pediatric sub-study, which is the most expansive clinical development program in NPC to date. Zevra has submitted a Marketing Authorization Application to the European Medicines Agency for the evaluation of arimoclomol for the treatment of Niemann-Pick disease type C.
INDICATIONS AND USAGE
MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions:
Hypersensitivity reactions such as urticaria and angioedema have been reported in patients treated with MIPLYFFA during Trial 1: two patients reported both urticaria and angioedema (6%) and one patient (3%) experienced urticaria alone within the first two months of treatment. Discontinue MIPLYFFA in patients who develop severe hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, stop MIPLYFFA and treat promptly. Monitor the patient until signs and symptoms resolve.
Embryofetal Toxicity:
MIPLYFFA may cause embryofetal harm when administered during pregnancy based on findings from animal reproduction studies. Advise pregnant females of the potential risk to the fetus and consider pregnancy planning and prevention for females of reproductive potential.
Increased Creatinine without Affecting Glomerular Function:
Across clinical trials of MIPLYFFA, mean increases in serum creatinine of 10% to 20% compared to baseline were reported. These increases occurred mostly in the first month of MIPLYFFA treatment and were not associated with changes in glomerular function.
During MIPLYFFA treatment, use alternative measures that are not based on creatinine to assess renal function. Increases in creatinine reversed upon MIPLYFFA discontinuation.
The most common adverse reactions in Trial 1 (≥15%) in MIPLYFFA-treated patients who also received miglustat were upper respiratory tract infection, diarrhea, and decreased weight.
Three (6%) of the MIPLYFFA-treated patients had the following adverse reactions that led to withdrawal from Trial 1: increased serum creatinine (one patient), and progressive urticaria and angioedema (two patients). Serious adverse reactions reported in MIPLYFFA-treated patients were hypersensitivity reactions including urticaria and angioedema.
To report SUSPECTED ADVERSE REACTIONS, contact Zevra Therapeutics, Inc. at toll-free phone 1-844-600-2237 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.
Drug Interaction(s):
Arimoclomol is an inhibitor of the organic cationic transporter 2 (OCT2) transporter and may increase the exposure of drugs that are OCT2 substrates. When MIPLYFFA is used concomitantly with OCT2 substrates, monitor for adverse reactions and reduce the dosage of the OCT2 substrate.
Use in Females and Males of Reproductive Potential:
Based on animal findings, MIPLYFFA may impair fertility and may increase post-implantation loss and reduce maternal, placental, and fetal weights.
Renal Impairment:
The recommended dosage of MIPLYFFA, in combination with miglustat, in patients with an eGFR ≥15 mL/minute to <50 mL/minute is lower than the recommended dosage (less frequent dosing) in patients with normal renal function.
MIPLYFFA capsules for oral use are available in the following strengths: 47 mg, 62 mg, 93 mg, and 124 mg.
About OLPRUVA®
OLPRUVA (sodium phenylbutyrate) is Zevra’s approved treatment for the treatment of certain UCDs. OLPRUVA (sodium phenylbutyrate) for oral suspension is a prescription medicine used along with certain therapies, including changes in diet, for the long-term management of adults and children weighing 44 pounds (20 kg) or greater and with a body surface area (BSA) of 1.2 m2 or greater, with UCDs, involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). OLPRUVA is not used to treat rapid increase of ammonia in the blood (acute hyperammonemia), which can be life-threatening and requires emergency medical treatment. For more information, please visit www.OLPRUVA.com.
Important Safety Information
Certain medicines may increase the level of ammonia in your blood or cause serious side effects when taken during treatment with OLPRUVA. Tell your doctor about all the medicines you or your child take, especially if you or your child take corticosteroids, valproic acid, haloperidol, and/or probenecid.
OLPRUVA can cause serious side effects, including: 1) nervous system problems (neurotoxicity). Symptoms include sleepiness, tiredness, lightheadedness, vomiting, nausea, headache, confusion, 2) low potassium levels in your blood (hypokalemia) and 3) conditions related to swelling (edema). OLPRUVA contains salt (sodium), which can cause swelling from salt and water retention. Tell your doctor right away if you or your child get any of these symptoms. Your doctor may do certain blood tests to check for side effects during treatment with OLPRUVA. If you have certain medical conditions such as heart, liver or kidney problems, are pregnant/planning to get pregnant or breast-feeding, your doctor will decide if OLPRUVA is right for you.
The most common side effects of OLPRUVA include absent or irregular menstrual periods, decreased appetite, body odor, bad taste or avoiding foods you ate prior to getting sick (taste aversion). These are not all of the possible side effects of OLPRUVA. Call your doctor for medical advice about side effects. You may report side effects to U.S. FDA at 1-800-FDA-1088.
About Celiprolol
Celiprolol is Zevra’s investigational clinical candidate for the treatment of Vascular Ehlers-Danlos Syndrome (VEDS). Celiprolol has been granted Orphan Drug and Breakthrough Therapy designations by the U.S. FDA. Zevra recently restarted enrollment in the DiSCOVER trial, a Phase 3 trial being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. FDA. Celiprolol’s mechanism of action is designed to reduce the mechanical stress on collagen fibers within the arterial wall through vascular dilation and smooth muscle relaxation.
About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. The Company is focused on broadening access through geographic expansion opportunities, progressing its pipeline toward key milestones, and delivering meaningful therapeutics. The commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disease, provides a strong corporate foundation and validates its ability to advance therapies from development to market. Zevra's vision is realized through disciplined execution of its strategic plan and core values — patient centricity, integrity, accountability, innovation, and courage — which guide its efforts to deliver long-term value.
For more information, please visit www.zevra.com or follow us on X and LinkedIn.
Cautionary Note Concerning Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation statements regarding the expected timing of EMA review of our MAA for arimoclomol; the potential to accelerate development of the Company's treatment for Vascular Ehlers-Danlos Syndrome and the timing of a follow-up meeting with FDA; and the sufficiency of the Company’s available financial resources to execute on its strategic priorities. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2025, filed on March 9, 2026, Quarterly Report on Form 10-Q for the three months ended March 31, 2026, to be filed with the SEC, as well as and Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.
Investor Contact
Nichol Ochsner
+1 (732) 754-2545
nochsner@zevra.com
+1 (732) 754-2545
nochsner@zevra.com
Media Contact
Julie Downs
+1 (508) 246-3230
jdowns@zevra.com
+1 (508) 246-3230
jdowns@zevra.com
ZEVRA THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| Three months ended March 31, | ||||||||||||||
| 2026 | 2025 | |||||||||||||
| Revenue, net | $ | 36,220 | $ | 20,401 | ||||||||||
Cost of product revenue (excluding $316 and $1,615 in intangible asset amortization for the three months ended March 31, 2026, and 2025, respectively, shown separately below) | 1,897 | 1,345 | ||||||||||||
| Intangible asset amortization | 316 | 1,615 | ||||||||||||
| Gain on sale of future royalties, intellectual property, and other assets, net | 43,314 | — | ||||||||||||
| Operating expenses: | ||||||||||||||
| Research and development | 4,392 | 3,258 | ||||||||||||
| Selling, general and administrative | 20,783 | 19,545 | ||||||||||||
| Total operating expenses | 25,175 | 22,803 | ||||||||||||
| Income (loss) from operations | 52,146 | (5,362) | ||||||||||||
| Other (expense) income: | ||||||||||||||
| Loss on extinguishment of debt | (2,756) | — | ||||||||||||
| Loss on derivative liability | (7,216) | — | ||||||||||||
| Interest expense | (1,711) | (1,969) | ||||||||||||
| Fair value adjustment related to warrant and CVR liability | 968 | 4,874 | ||||||||||||
| Fair value adjustment related to investments | (216) | (3) | ||||||||||||
| Interest and other income, net | 3,589 | 543 | ||||||||||||
| Total other (expense) income | (7,342) | 3,445 | ||||||||||||
| Income (loss) before income taxes | 44,804 | (1,917) | ||||||||||||
| Income tax expense | (6,914) | (1,182) | ||||||||||||
| Net income (loss) | $ | 37,890 | $ | (3,099) | ||||||||||
| Net income (loss) per share of common stock: | ||||||||||||||
| Basic | $ | 0.62 | $ | (0.06) | ||||||||||
| Diluted | $ | 0.60 | $ | (0.06) | ||||||||||
| Weighted-average shares of common stock outstanding: | ||||||||||||||
| Basic | 58,405,955 | 54,095,543 | ||||||||||||
| Diluted | 60,230,490 | 54,095,543 | ||||||||||||
ZEVRA THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value amounts)
| March 31, 2026 | December 31, 2025 | |||||||||||||
| Assets | ||||||||||||||
| Current assets: | ||||||||||||||
| Cash and cash equivalents | $ | 95,595 | $ | 62,406 | ||||||||||
| Investments, current | 105,021 | 128,605 | ||||||||||||
| Accounts and other receivables | 22,098 | 23,258 | ||||||||||||
| Prepaid expenses and other current assets | 4,944 | 6,998 | ||||||||||||
| Inventories, current | 2,310 | 1,740 | ||||||||||||
| Total current assets | 229,968 | 223,007 | ||||||||||||
| Investments, noncurrent | 36,145 | 47,879 | ||||||||||||
| Inventories, noncurrent | — | 879 | ||||||||||||
| Property and equipment, net | 430 | 489 | ||||||||||||
| Operating lease right-of-use assets | 1,087 | 1,212 | ||||||||||||
| Goodwill | 4,701 | 4,701 | ||||||||||||
| Intangible assets, net | 6,105 | 6,421 | ||||||||||||
| Other long-term assets | 143 | 143 | ||||||||||||
| Total assets | $ | 278,579 | $ | 284,731 | ||||||||||
| Liabilities and stockholders' equity | ||||||||||||||
| Current liabilities: | ||||||||||||||
| Accounts payable and accrued expenses | $ | 11,688 | $ | 11,598 | ||||||||||
| Current portion of operating lease liabilities | 406 | 419 | ||||||||||||
| Current portion of discount and rebate liabilities | 13,172 | 12,188 | ||||||||||||
| Current portion of income tax payable | 20,354 | 13,710 | ||||||||||||
| Other current liabilities | 1,408 | 1,362 | ||||||||||||
| Total current liabilities | 47,028 | 39,277 | ||||||||||||
| Long-term debt | — | 61,928 | ||||||||||||
| Warrant liability | 6,797 | 9,575 | ||||||||||||
| Income tax payable | 6,871 | 7,029 | ||||||||||||
| Operating lease liabilities, less current portion | 741 | 859 | ||||||||||||
| Discount and rebate liabilities, less current portion | 9,479 | 9,693 | ||||||||||||
| Other long-term liabilities | 1,859 | 1,713 | ||||||||||||
| Total liabilities | 72,775 | 130,074 | ||||||||||||
| Commitments and contingencies | ||||||||||||||
| Stockholders’ equity: | ||||||||||||||
| Preferred stock: | ||||||||||||||
Undesignated preferred stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued or outstanding as of March 31, 2026, or December 31, 2025 | — | — | ||||||||||||
Common stock, $0.0001 par value, 250,000,000 shares authorized; 60,690,542 shares issued and 59,114,850 shares outstanding as of March 31, 2026; 58,338,319 shares issued and 56,854,781 shares outstanding as of December 31, 2025 | 6 | 6 | ||||||||||||
| Additional paid-in capital | 602,748 | 588,458 | ||||||||||||
| Treasury stock, at cost | (10,983) | (10,983) | ||||||||||||
| Accumulated deficit | (384,170) | (422,060) | ||||||||||||
| Accumulated other comprehensive loss | (1,797) | (764) | ||||||||||||
| Total stockholders' equity | 205,804 | 154,657 | ||||||||||||
| Total liabilities and stockholders' equity | $ | 278,579 | $ | 284,731 | ||||||||||
FAQ
How did Zevra Therapeutics (ZVRA) perform financially in Q1 2026?
Zevra reported Q1 2026 net revenue of $36.2 million, up 78% from $20.4 million in Q1 2025. Net income reached $37.9 million, or $0.60 per diluted share, compared with a net loss of $3.1 million, or $(0.06) per share, a year earlier.
What drove Zevra Therapeutics’ revenue growth in the first quarter of 2026?
Growth was led by MIPLYFFA with $24.6 million in net revenue, plus $0.3 million from OLPRUVA, $10.2 million in expanded access reimbursements, and $1.1 million in AZSTARYS royalties. Together, these streams increased total net revenue to $36.2 million, a 78% year-over-year rise.
How did the SDX portfolio sale impact Zevra Therapeutics’ Q1 2026 results?
Zevra completed a $50.0 million SDX portfolio sale, recognizing a $43.3 million gain and receiving $40.5 million of the $45.0 million in net proceeds during Q1 2026. This transaction significantly boosted reported net income and funded full repayment of the company’s term loan.
What is Zevra Therapeutics’ cash and debt position after Q1 2026?
As of March 31, 2026, Zevra held $236.8 million in cash, cash equivalents and securities. The company prepaid the $63.1 million principal balance on its term loan in full, resulting in no long-term debt and a stronger, more flexible balance sheet.
What are the key developments for Zevra’s MIPLYFFA and celiprolol programs?
For MIPLYFFA, Zevra reported stable U.S. market access at 69% of covered lives and an EMA Marketing Authorization Application under review. For celiprolol, 62 patients were enrolled in the Phase 3 DiSCOVER trial, with a planned follow-up FDA meeting in the second half of the year.