ZVRA

EX-99.1

2 zvra-20261103xex991earnings.htm

EX-99.1

Document

Exhibit 99.1

Zevra Reports Third Quarter 2026 Financial Results and Corporate Update

$37.8 million net revenue for Q3 2026, driven by $34.0 million in revenue from MIPLYFFA

45% increase in total net revenue over Q3 2025

Operational execution fueled strong cash position of $270.9 million

Company to host conference call and webcast TODAY, November 3, 2026, at 4:30 p.m. ET

BOSTON, Mass., November 3, 2026 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases, today reported its financial results for the third quarter ended September 30, 2026.

“In the third quarter, we made continued progress across our business, building on MIPLYFFA's commercial performance in the U.S. and advancing our pipeline in support of our mission to redefine what’s possible in bringing life-changing therapies to people living with rare disease,” said Neil F. McFarlane, Zevra's President and Chief Executive Officer. “We remain focused on reaching more people living with Niemann-Pick disease type C, advancing celiprolol for vascular Ehlers-Danlos syndrome, and pursuing European access to arimoclomol. Our strong financial position enables us to advance these priorities while continuing to make arimoclomol available to eligible patients through our global Expanded Access Program.”

MIPLYFFA® (arimoclomol) Highlights

•U.S.: Received 13 MIPLYFFA prescription enrollment forms for Niemann-Pick disease type C (NPC) during Q3 2026, bringing the total to 197 since product launch.

•EU: The Company requested a re-examination of its Marketing Authorisation Application for arimoclomol for the treatment of NPC and is awaiting the outcome of the process.

•Global Expanded Access Program (EAP): As of September 30, 2026, 134 patients were enrolled in the global EAP.

•Following the publication of its pediatric data in Molecular Genetics and Metabolism Reports, Zevra met with the U.S. Food and Drug Administration (FDA) to discuss a potential supplemental New Drug Application (sNDA) for MIPLYFFA in infants less than 24 months of age. Company anticipates filing sNDA in Q1 2027.

Pipeline and Innovation Highlights

•Enrolled six patients in the event-driven Phase 3 DiSCOVER trial of celiprolol for the treatment of Vascular Ehlers-Danlos Syndrome during Q3 2026, bringing the total number of enrolled patients to 72, with a total of four confirmed events. The Company recently engaged with the FDA for a Type C meeting to discuss a potential submission strategy for celiprolol.

Q3 2026 Financial Highlights

•Revenue, Net: $37.8 million for Q3 2026, which includes $34.0 million of MIPLYFFA net revenue, $0.2 million of OLPRUVA net revenue, and $3.6 million in net reimbursements from our global EAP. This was an increase in total net revenue of $11.7 million compared to $26.1 million in Q3 2025.

•Cost of Product Revenue: $1.8 million for Q3 2026, excluding non-cash intangible asset amortization. Cost of product revenue for Q3 2025 was $1.2 million, excluding non-cash intangible asset amortization.

•Operating Expenses: $24.1 million for Q3 2026, which includes non-cash stock compensation expense of $2.7 million. Total operating expenses for Q3 2025 were $20.4 million.

◦R&D expense was $4.9 million for Q3 2026, which was an increase of $1.5 million compared to $3.4 million for Q3 2025, due primarily to our ongoing investment in arimoclomol efforts and in the celiprolol development program.

◦SG&A expense was $19.1 million for Q3 2026, which was an increase of $2.2 million compared to $16.9 million for Q3 2025, due primarily to commercial and infrastructure related costs.

•Net income (loss): Net income of $19.2 million, or $0.31 per basic and $0.26 diluted share for Q3 2026, compared to a net (loss) of $(0.5) million, or $(0.01) per basic and diluted share for Q3 2025.

◦In Q3 2026, the Company recognized $5.1 million in noncash income due to fair value adjustments related to warrant and contingent value rights (CVR) liability compared to $(5.5) million of noncash expense in Q3 2025.

•Cash Position: Cash, cash equivalents and investments were $270.9 million as of September 30, 2026. Based on its current operating forecast, the Company believes available financial resources are sufficient to execute on its strategic priorities.

•Common and Fully Diluted Shares O/S: As of September 30, 2026, total shares of common stock outstanding were 59,439,959, and fully diluted common shares were 68,968,909, which included 6,999,571 shares issuable from outstanding awards under equity incentive plans, and 2,529,379 shares issuable upon exercise of warrants.

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 third quarter 2026.

A link to the audio webcast is accessible on t

SEC.gov | Request Rate Threshold Exceeded

U.S. Securities and Exchange Commission

You’ve Exceeded the SEC’s Traffic Limit

Your request rate has exceeded the SEC’s maximum allowable requests per second. Your access to SEC.gov will be limited for 10 minutes.

Current guidelines limit each user to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests. To ensure that SEC.gov remains available to all users, we reserve the right to block IP addresses that submit excessive requests.

The block will be lifted automatically by waiting 10 minutes. Continuing to exceed the SEC’s maximum allowable request rate during the time-out period will extend the duration of the time-out period. To ensure fair access for all users, please reduce the rate of your requests and visit SEC.gov again after the 10 minute time-out period has passed.

For best practices on efficiently downloading information from SEC.gov, including the latest EDGAR filings, visit sec.gov/developer. You can also sign up for email updates on the SEC open data program, including best practices that make it more efficient to download data, and SEC.gov enhancements that may impact scripted downloading processes. For more information, contact opendata@sec.gov.

For more information, please see the SEC’s Web Site Privacy and Security Policy. Thank you for your interest in the U.S. Securities and Exchange Commission.

Reference ID: 0.cf06d217.1785967428.9aa52499

More Information

Internet Security Policy

By using this site, you are agreeing to security monitoring and auditing. For security purposes, and to ensure that the public service remains available to users, this government computer system employs programs to monitor network traffic to identify unauthorized attempts to upload or change information or to otherwise cause damage, including attempts to deny service to users.

Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. §§ 1001 and 1030).

To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. We reserve the right to block IP addresses that submit excessive requests. Current guidelines limit users to a total of no more than 10 requests per second, regardless of the number of machines used to submit requests.

If a user or application submits more than 10 requests per second, further requests from the IP address(es) may be limited for a brief period. Once the rate of requests has dropped below the threshold for 10 minutes, the user may resume accessing content on SEC.gov. This SEC practice is designed to limit excessive automated searches on SEC.gov and is not intended or expected to impact individuals browsing the SEC.gov website.

Note that this policy may change as the SEC manages SEC.gov to ensure that the website performs efficiently and remains available to all users.

Note: We do not offer technical support for developing or debugging scripted downloading processes.

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