Zevra Therapeutics (ZVRA) Q3 2026 earnings summary

Executive summary

• Q3 net revenue rose 45% YoY to $37.8 million, including $34.0 million from MIPLYFFA; net income was $19.2 million versus a $0.5 million loss in Q3 2025.

• Priorities include expanding MIPLYFFA access, pursuing EU access to arimoclomol, and advancing celiprolol; cash, cash equivalents and investments totaled $270.9 million at quarter-end.

Financial highlights

• Q3 revenue increased $11.7 million to $37.8 million from $26.1 million YoY; nine-month revenue was $113.6 million versus $72.3 million.

• Q3 operating expenses were $24.1 million, including $4.9 million R&D and $19.1 million SG&A; operating income was $11.6 million.

• Q3 net income was $19.2 million, or $0.31 basic and $0.26 diluted EPS, versus a $0.5 million loss and $0.01 loss per share in Q3 2025.

• Nine-month reported net income was $65.9 million versus $71.1 million in 2025; 2026 included a $43.3 million Commave sale gain, while 2025 included a $148.3 million PRV-sale gain.

• Nine-month operating cash flow was $33.2 million, versus $7.1 million used in 2025; investing cash flow was $76.2 million and financing cash use was $49.7 million.

Outlook and guidance

• MIPLYFFA sNDA for patients under 24 months is planned for Q1 2027 following FDA Type B meeting feedback; the pediatric substudy found no new safety signals.

• CHMP opinion on arimoclomol re-examination was expected in Q4 2026; the European approval outcome remains uncertain.

• Celiprolol submission strategy and timing remain subject to FDA discussions, trial data and development of a statistical analysis plan.

• Available financial resources and expected operating cash flow were considered sufficient for planned needs for at least 12 months; near-term cash flow may be minimal or negative.

• 2027 SG&A is not expected to increase meaningfully from 2026, with no major marketing-spend changes anticipated.