ZVRA

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EX-99.1

2 zvra-20260506xex991earnings.htm

EX-99.1

Document

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

zvra-20260304false000143464700014346472026-03-042026-03-040001434647dei:FormerAddressMember2026-03-042026-03-04

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

Zevra Therapeutics, Inc (Exact Name of Registrant as Specified in Its Charter)

Delaware001-3691320-5894398 (State or Other Jurisdiction of Incorporation)(Commission File Number)(IRS Employer Identification No.)

101 Federal Street, Boston, MA 02110

(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) 1180 Celebration Boulevard, Suite 103, Celebration, FL 34747

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 classTrading Symbol(s)Name of each exchange on which registered Common Stock, par value $0.0001 per shareZVRAThe Nasdaq Stock Market LLC (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 Financi