Zevra (NASDAQ: ZVRA) swings to 2025 profit and appoints new CFO
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Zevra Therapeutics reported a strong turnaround for 2025, with net revenue of $106.5 million, up from $23.6 million in 2024, driven mainly by $87.4 million in MIPLYFFA net revenue and higher expanded‑access and royalty income.
The company generated 2025 net income of $83.2 million, or $1.40 basic EPS, compared with a prior-year net loss of $105.5 million, helped by a $148.3 million gain on sale of a priority review voucher and despite a $58.7 million intangible asset impairment.
Q4 2025 net revenue reached $34.1 million and net income was $12.2 million. Cash, cash equivalents and securities totaled $238.9 million as of December 31, 2025, supporting continued investment in MIPLYFFA, OLPRUVA and the celiprolol VEDS program.
The company highlighted progress for MIPLYFFA in Niemann‑Pick type C, including growing U.S. uptake and an EMA marketing application under review, and ongoing enrollment in the Phase 3 DiSCOVER trial for celiprolol. Zevra also relocated its headquarters to Boston and appointed Justin Renz as Chief Financial Officer, with a $520,000 base salary and options to purchase 300,000 shares vesting over four years.
Positive
- Major return to profitability: 2025 net income of $83.2 million (basic EPS $1.40) versus a $105.5 million loss in 2024, supported by strong revenue growth and other income.
- Rapid revenue expansion: Net revenue grew to $106.5 million from $23.6 million year over year, with MIPLYFFA net revenue increasing to $87.4 million and Q4 2025 revenue up to $34.1 million.
- Strengthened balance sheet: Cash, cash equivalents and securities reached $238.9 million as of December 31, 2025, and management indicates these resources are sufficient to execute strategic priorities.
- Advancing rare‑disease portfolio: EMA is reviewing the arimoclomol NPC application, MIPLYFFA access is expanding, and the Phase 3 DiSCOVER trial for celiprolol in VEDS continues enrollment under a Special Protocol Assessment.
Negative
- None.
Insights
Zevra swung to profitability on rapid revenue growth and a one-time voucher sale, while investing in rare-disease assets.
Zevra delivered net revenue of
Full‑year net income reached
Cash, cash equivalents and securities totaled
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): March 4, 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 March 9, 2026, Zevra Therapeutics, Inc., a Delaware corporation ("Zevra" or "the Company"), issued a press release announcing its financial results and corporate updates for the fourth quarter ended December 31, 2025, as well as information regarding a conference call and audio webcast to discuss its financial results and corporate updates scheduled for Monday, March 9, 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On March 4, 2026, the Company appointed Justin Renz as Chief Financial Officer and Treasurer, effective March 9, 2026, and as principal financial officer, effective March 10, 2026. On March 5, 2026, the Company issued a press release announcing the appointment of Mr. Renz as Chief Financial Officer, a copy of which is attached hereto as Exhibit 99.2 and is incorporated by reference herein. There are no family relationships between Mr. Renz and any directors or executive officers of the Company. The Company is not aware of any transaction involving Mr. Renz requiring disclosure under Item 404(a) of Regulation S-K.
Mr. Renz, age 54, served as Chief Financial and Operations Officer of Ardelyx, Inc., a commercial-stage biopharmaceutical company, from January 2023 to October 2025, and served as its Chief Financial Officer from June 2020 to January 2023. Beginning in 2017, Mr. Renz held various positions of increasing responsibility at Correvio Pharma Corp, a specialty pharmaceutical company, most recently as its President and Chief Financial Officer at the time of its acquisition by Advanz Pharma in May 2020. From 2014 to 2017, Mr. Renz was the Executive Vice President and Chief Financial Officer of Karyopharm Therapeutics, Inc. Prior to that, from 2006 to 2014, Mr. Renz held a variety of financial positions with Zalicus Pharmaceuticals Ltd., a biopharmaceutical company, including most recently as Executive Vice President and Chief Financial Officer at the time of its acquisition by Epirus Biopharmaceuticals, Inc. in 2014.
In connection with his employment, Mr. Renz and the Company have entered into an employment agreement (the “Employment Agreement”) effective as of March 9, 2026. Under the Employment Agreement, his annualized base salary will be $520,000. Mr. Renz will be eligible to receive an annual performance bonus with a bonus target of 45% of his annual base salary. Mr. Renz will also receive an option to purchase 300,000 shares of the Company’s common stock (the “Equity Award”) pursuant to and in accordance with the terms and conditions of Company’s Amended and Restated 2023 Employment Inducement Award Plan. The Equity Award will have an exercise price equal to the fair market value of a share of the Company’s common stock on the date of grant and will vest over four years, with one-fourth vesting on each of the first four anniversaries of the date Mr. Renz begins his employment with the Company. Mr. Renz will also be eligible to receive an annual equity grant as part of the Company’s annual equity award cycle beginning in 2027.
If Mr. Renz’s employment is terminated by the Company without cause or he resigns for good reason, he will receive continued payment of his base salary for twelve months (the “Severance Period”), payment of an amount equal to his prorated annual target bonus for the year of termination, and acceleration of the vesting of stock awards that would have vested during the Severance Period. Receipt of the foregoing termination benefits will be subject to Mr. Renz’s execution of a separation agreement, including certain restrictive covenants and a general release of all claims, in a form acceptable to the Company.
The foregoing description of the principal terms of the Employment Agreement is qualified in its entirety by reference to the Employment Agreement, a copy of which is attached as Exhibit 10.1 and incorporated by reference herein.
Effective as of March 10, 2026, Mr. Renz will begin serving as principal financial officer, and Timothy Sangiovanni, the Company’s Senior Vice President, Finance and Corporate Controller, principal accounting officer and current principal financial officer, will cease serving as the principal financial officer.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits | ||||
| Exhibit No. | Description | |||||||
| 10.1 | Employment Agreement, effective as of March 9, 2026, by and between Justin Renz and the Company | |||||||
| 99.1 | Press Release dated March 9, 2026 | |||||||
| 99.2 | Press Release dated March 5, 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: March 9, 2026 | By: | /s/ Timothy J. Sangiovanni | |||||||||
| Timothy J. Sangiovanni, CPA | |||||||||||
| Senior Vice President, Finance and Corporate Controller | |||||||||||
Exhibit 99.1
Zevra Reports Fourth Quarter and Full Year 2025 Financial Results
Q4 net revenue of $34.1 million, representing 31% growth quarter-over-quarter
FY 2025 net revenue of $106.5 million, driven by growth in MIPLYFFA® net revenue to $87.4 million
2025 EPS of $1.40 basic and $1.35 diluted
Company to host conference call and webcast TODAY, March 9, 2026, at 4:30 p.m. ET
BOSTON, Mass., March 9, 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 fourth quarter and full year ended December 31, 2025.
“MIPLYFFA is making a meaningful difference for patients with Niemann-Pick disease type C, and its strong, accelerating performance reinforces our confidence in its long-term potential,” said Neil F. McFarlane, Zevra's President and Chief Executive Officer. “We have officially relocated our global corporate headquarters to Boston, enhancing our access to a deep and highly specialized talent pool. Looking ahead, we are focused on executing against multiple near-term growth opportunities in 2026, and believe we are well-positioned to execute on our strategic priorities to create meaningful value for the rare disease community and our shareholders.”
MIPLYFFA® (arimoclomol) Highlights
•U.S.: Received 24 MIPLYFFA prescription enrollment forms for Niemann-Pick disease type C (NPC) during Q4 2025, bringing the total to 52 in 2025 and 161 since product launch. Market access has reached 68% of covered lives, supporting broad access to MIPLYFFA.
•EU: A Marketing Authorisation Application for the evaluation of arimoclomol for the treatment of NPC is under review by the European Medicines Agency (EMA). Arimoclomol has been designated an Orphan Medicinal Product by the EMA. The review process is progressing as expected, and at year-end, the EMA sent their 120-day list of questions, which the Company is prepared to respond to within the regulatory 90-day clock stop period.
•Global Expanded Access Program (EAP): In Q4 2025, the Company executed a distribution agreement to broaden access to arimoclomol to select territories beyond Europe. As of December 31, 2025, 113 patients were enrolled in the global EAP.
Pipeline and Innovation Highlights
•Enrolled eight patients in the event-driven Phase 3 DiSCOVER trial for the treatment of Vascular Ehlers-Danlos Syndrome during Q4 2025, bringing the total number of enrolled patients at year-end to 52, with a total of one confirmed event. The Company has recently engaged the Food and Drug Administration (FDA) in a Type C meeting to discuss regulatory options to accelerate the development program.
Publication Highlights
•Four posters were presented at the 22nd Annual WORLD Symposium™ including new data for MIPLYFFA.
◦Four-year real-world data from the U.S. EAP demonstrated that it was well tolerated and stabilized disease progression in the overall cohort, and new data for the subgroup of adults in the EAP showed consistent results.
◦In the post hoc efficacy analysis of the randomized, placebo-controlled study, there was a statistically significant slowing of disease progression compared to placebo as early as three months after treatment initiation, with sustained and increasing benefit through 12 months, highlighting early onset of clinical effect in patients with NPC.
•Abstract titled “Analysis of NPC1 Genotypes: Findings from the U.S. Arimoclomol Expanded Access Program for Niemann-Pick Type C” (#P214) was accepted for poster presentation at the Annual Clinical Genetics Meeting on Friday, March 13, 2026.
FY 2025 Financial Highlights
•Revenue, Net: $106.5 million, which includes $87.4 million of MIPLYFFA net revenue, $0.8 million of OLPRUVA net revenue, $13.0 million in net reimbursements from our EAP, and $5.0 million in royalties and other reimbursements under the AZSTARYS® license agreement. For full year 2024, net revenue was $23.6 million, which was primarily driven by $10.1 million in MIPLYFFA net revenue, $0.1 million in OLPRUVA net revenue, $9.1 million in net reimbursements from our EAP, and $4.3 million in royalties and other reimbursements under the AZSTARYS® license agreement.
•Cost of Product Revenue: $16.5 million, excluding non-cash intangible asset amortization. Cost of product revenue for the year ended December 31, 2024 was $7.4 million.
•Operating Expenses: $90.4 million, which includes non-cash compensation expense of $12.6 million. Total operating expenses for the year ended December 31, 2024 were $97.0 million.
◦R&D expense was $12.7 million, which was a decrease of $29.4 million compared to $42.1 million for FY 2024 due primarily to a decrease in personnel-related costs, combined with a decrease in third-party costs.
◦SG&A expense was $77.6 million, which was an increase of $22.7 million compared to $54.9 million for FY 2024 due primarily to an increase in third-party costs related to MIPLYFFA, combined with an increase in personnel-related costs, professional fees, and other expenses associated with our commercial, medical and launch activities.
•Net Income (Loss): Net income of $83.2 million, or $1.40 per basic and $1.35 per diluted share for 2025, compared to a net loss of $(105.5) million, or $(2.28) per basic and diluted share for 2024. 2025 net income includes non-cash fair value adjustment of $2.2 million, non-cash stock-based compensation expense of $12.6 million, and non-cash intangible asset amortization expense of $3.9 million.
•Cash Position: Cash, cash equivalents and securities were $238.9 million as of December 31, 2025. Based on the Company’s current operating forecast, the Company believes it has sufficient resources and financial flexibility to execute on its strategic priorities independent from the capital markets.
•Common and Fully Diluted Shares O/S: As of December 31, 2025, total shares of common stock outstanding were 56,854,781, and fully diluted common shares were 67,939,395, which included 7,060,457 issuable from outstanding awards under equity incentive plans, and 4,024,157 shares issuable upon exercise of warrants.
Q4 2025 Financial Highlights
•Revenue, Net: $34.1 million for Q4 2025, which includes $26.4 million of MIPLYFFA net revenue, $0.4 million of OLPRUVA net revenue, $5.6 million in net reimbursements from the EAP, and $1.8 million in royalties and other reimbursements under the AZSTARYS® license agreement. For Q4 2024, total net revenue was $12.0 million, which includes $10.1 million of MIPLYFFA net revenue, $0.1 million of OLPRUVA net revenue, $1.1 million in net reimbursements from the EAP, and $0.7 million in royalties and other reimbursements under the AZSTARYS® license agreement.
•Cost of Product Revenue: $1.5 million for Q4 2025, excluding non-cash intangible asset amortization. Cost of product revenue for Q4 2024 was $1.4 million.
•Operating Expenses: $23.0 million for Q4 2025, which includes non-cash stock compensation of $4.3 million. Total operating expenses for Q4 2024 were $24.5 million.
◦R&D expense was $2.6 million for Q4 2025, which was a decrease of $5.8 million compared to $8.4 million for Q4 2024 due primarily to a decrease in personnel-related costs, combined with a decrease in third-party costs.
◦SG&A expense was $20.4 million for Q4 2025, which was an increase of $4.3 million compared to $16.1 million for Q4 2024, due primarily to an increase in third-party costs incurred, mainly due to higher spend on commercial products, combined with an increase in personnel-related costs.
•Net Income (Loss): Net income of $12.2 million, or $0.20 per basic and $0.19 per diluted share for Q4 2025, compared to a net loss of $(35.7) million, or $(0.67) per basic and diluted share for Q4 2024.
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 fourth quarter and full year 2025.
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 March 9, 2026.
Additionally, interested participants and investors may access the conference call by dialing either:
•(800) 579-2543 (United States)
•+1 (785) 424-1789 (International)
•Conference ID: ZVRAQ425
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 our growth; the U.S. launch and potential global expansion of MIPLYFFA®; submissions to, review by, and discussions with the EMA regarding arimoclomol; promise and potential impact of our preclinical or clinical trial data; the initiation, timing and results of any clinical trials or readouts; the potential benefits of any of our products or product candidates for any specific disease or at any dosage; future research and development activities; our strategic and product development objectives, including with respect to becoming a leading, commercially focused rare disease company; our financial position, including our cash balance and anticipated cash runway; and the timing of any of the foregoing. 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, to be filed with the Securities and Exchange Commission, 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
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 | |||||||||
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 | |||||||||||
| 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 | |||||||
Exhibit 99.2
Zevra Therapeutics Appoints Justin Renz as Chief Financial Officer
CELEBRATION, Fla., Mar. 05, 2026 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced the appointment of Justin Renz as Chief Financial Officer, effective March 9, 2026. Mr. Renz brings more than 25 years of financial leadership experience in the biopharmaceutical industry, including extensive expertise in capital markets, strategic transactions, and commercial-stage operations.
“Justin is a highly accomplished financial executive with a strong track record of driving growth and creating shareholder value across multiple biopharmaceutical organizations,” said Neil F. McFarlane, Zevra's President and Chief Executive Officer. “His strong financial leadership and experience driving performance across global markets will be instrumental as we execute our strategic plan to becoming a leading rare disease company.”
Mr. Renz most recently served as Chief Financial & Operations Officer at Ardelyx, where he had an active role in the launch and commercialization of two innovative, first-in-class medicines. Previously, he was President and Chief Financial Officer of Correvio Pharma, a global specialty pharmaceutical company dedicated to the commercialization of two cardiovascular and two infectious disease products. He also served as Executive Vice President, Chief Financial Officer and Treasurer at Karyopharm Pharmaceuticals and as Executive Vice President and Chief Financial Officer at Zalicus Inc.
“I am excited to join Zevra at this important stage of growth,” said Mr. Renz. “I look forward to working with the team to strengthen our financial foundation and enable continued innovation and access to transformative therapies.”
Mr. Renz holds a B.A. in Economics and Accounting from the College of the Holy Cross, an M.S. in Taxation from Northeastern University and an M.B.A. from Suffolk University. He is a Certified Public Accountant in Massachusetts.
About Zevra Therapeutics, Inc.
Zevra Therapeutics, Inc. is a purpose-driven, commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases. The company’s commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disorder, provides a strong corporate foundation and validates its ability to advance therapies. In addition, the company is broadening access through geographic expansion opportunities and has a pipeline of rare disease programs. Zevra is a patient-centric organization guided by our values of accountability, integrity, innovation and courage, with the goal of creating long-term value for patients, partners, and shareholders.
For more information, please visit www.zevra.com or follow us on X and LinkedIn.
Caution 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. 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, 2024, filed on March 12, 2025, Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2025, filed on November 5, 2025, as well as 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
Media Contact
Julie Downs
+1 (508) 246-3230
jdowns@zevra.com
FAQ
How did Zevra Therapeutics (ZVRA) perform financially in full-year 2025?
Zevra reported net revenue of $106.5 million in 2025, up from $23.6 million in 2024. The company generated net income of $83.2 million, or $1.40 basic and $1.35 diluted EPS, compared with a prior-year net loss of $105.5 million.
What were Zevra Therapeutics’ (ZVRA) Q4 2025 financial results?
In Q4 2025, Zevra posted net revenue of $34.1 million, including $26.4 million from MIPLYFFA. The company reported net income of $12.2 million, or $0.20 per basic share, compared with a net loss of $35.7 million in Q4 2024.
How important was MIPLYFFA to Zevra Therapeutics’ 2025 results?
MIPLYFFA was central to performance, generating $87.4 million in net revenue during 2025. U.S. prescription enrollments increased, market access reached 68% of covered lives, and an EMA Marketing Authorisation Application for Niemann‑Pick type C remained under active review.
What is Zevra Therapeutics’ cash position as of December 31, 2025?
As of December 31, 2025, Zevra held $238.9 million in cash, cash equivalents and securities. Management states this provides sufficient resources and financial flexibility to pursue strategic priorities without depending on capital markets, while supporting commercialization and pipeline programs.
Did Zevra Therapeutics record any significant one-time items in 2025?
Yes. Zevra recorded a $148.3 million gain on sale of a priority review voucher, boosting other income, and a $58.7 million impairment of intangible assets. These non‑recurring items materially affected 2025 reported operating results and overall profitability figures.
What leadership changes did Zevra Therapeutics announce in this filing?
Zevra appointed Justin Renz as Chief Financial Officer and Treasurer, effective March 9, 2026, and principal financial officer effective March 10, 2026. His employment agreement includes a $520,000 base salary and options to purchase 300,000 shares vesting over four years.
What progress is Zevra Therapeutics making in its celiprolol VEDS program?
Zevra’s celiprolol program for VEDS continued enrollment in the Phase 3 DiSCOVER trial, which is being run under a Special Protocol Assessment. By year-end 2025, 52 patients were enrolled with one confirmed event, and the company recently held a Type C FDA meeting.
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