Zevra Therapeutics (ZVRA) Q2 2026 earnings summary

Executive summary

• Net revenue for Q2 2026 reached $39.7 million, up 53% year-over-year, driven by strong MIPLYFFA sales and expanded access program revenues.

• Net income for Q2 2026 was $8.8 million, down from $74.7 million in Q2 2025 due to prior-year one-time gains, with robust cash reserves of $260.2 million as of June 30, 2026.

• 184 prescription enrollment forms for MIPLYFFA received since launch, with 14 in Q2 2026, reflecting growing adoption across adult and pediatric populations.

• Expanded access programs for arimoclomol enrolled 132 patients globally, with ongoing EU regulatory re-examination.

• Completed the sale of SDX portfolio assets and terminated the AZSTARYS License Agreement, resulting in a $43.3 million gain in H1 2026.

Financial highlights

• Q2 2026 net revenue was $39.7 million, up $13.8 million (53%) from Q2 2025; MIPLYFFA contributed $30.2 million, OLPRUVA $0.2 million, global EAP $9.0 million, and AZSTARYS royalties $0.3 million.

• Operating expenses were $21.0 million, down from $24.2 million year-over-year; R&D expense increased to $4.5 million, SG&A decreased to $11.6 million.

• Cost of product revenue decreased to $1.5 million in Q2 2026 from $12.4 million in Q2 2025, improving gross margin.

• Net income was $8.8 million ($0.14 per share); adjusted net income excluding warrant charges was $15.2 million ($0.25 per share).

• Cash, equivalents, and investments totaled $260.2 million at quarter-end, up $23.4 million from Q1.

Outlook and guidance

• Sufficient liquidity to fund operations for at least the next twelve months and foreseeable future.

• Expect continued variability in ex-U.S. expanded access program (EAP) reimbursements, with French EAP stable at ~$2.5 million per quarter.

• Ongoing investment in MIPLYFFA growth, global expansion, and advancement of celiprolol for vEDS.

• Re-examination opinion from CHMP on arimoclomol expected in Q4 2026; continued engagement with FDA for celiprolol.

• Expenses expected to fluctuate due to clinical trials, regulatory activities, and pipeline expansion.