Zevra Therapeutics (ZVRA) Q4 2025 earnings summary

Executive summary

• FY 2025 net revenue reached $106.5 million, with $87.4 million from MIPLYFFA and $34.1 million in Q4, reflecting strong commercial momentum and a 351% year-over-year increase.

• Net income for FY 2025 was $83.2 million ($1.40 basic EPS), reversing a prior year net loss.

• Expanded global access to MIPLYFFA, enrolling 113 patients in the EAP and securing new distribution agreements outside Europe.

• Submitted Marketing Authorisation Application to the EMA for arimoclomol, with ongoing regulatory engagement and Orphan Medicinal Product designation.

• Relocated headquarters to Boston to enhance collaboration and access to biotech talent.

Financial highlights

• Q4 2025 net revenue: $34.1 million, including $26.4 million from MIPLYFFA, $400,000 from OLPRUVA, $5.6 million from EAP, and $1.8 million from royalties.

• FY 2025 net revenue: $106.5 million, with $87.4 million from MIPLYFFA, $0.8 million from OLPRUVA, $13.0 million from EAP, and $5.0 million in royalties.

• FY 2025 operating expenses: $90.4 million, including $12.6 million non-cash compensation; R&D expense: $12.7 million (down $29.4 million YoY); SG&A: $77.6 million (up $22.7 million YoY).

• FY 2025 net income: $83.2 million ($1.40 basic EPS, $1.35 diluted), compared to a net loss of $105.5 million in 2024.

• Cash, cash equivalents, and investments at year-end: $238.9 million; total debt: $61.9 million.

Outlook and guidance

• Expect continued variability in quarterly enrollments and revenue due to the ultra-rare nature of NPC and patient identification dynamics.

• Confident in expanding the diagnosed patient base toward the estimated U.S. prevalence of 900, with 300-350 currently diagnosed.

• Ongoing investments in high-impact initiatives and geographic expansion, with flexibility for additional value creation.

• Focused on executing near-term growth opportunities in 2026 and advancing strategic priorities for rare disease therapies.

• Confident in financial flexibility to execute strategy independent of capital markets.