Strong Performance of MIPLYFFA
Third quarter net revenue reached $26.1 million, driven by $22.4 million from MIPLYFFA. Additionally, there were 8 new prescription enrollment forms received in the quarter, bringing the total to 137 since MIPLYFFA became commercially available a year ago.
European Market Expansion
A Marketing Authorization Application (MAA) has been filed with the European Medicines Agency for MIPLYFFA, and the application has been validated and is under review. The potential of expanding into the European market could significantly increase the patient base.
Patent and Market Access Progress
Zevra has established a solid patent position for MIPLYFFA and requested a patent term extension with the U.S. Patent and Trademark Office. Covered lives for MIPLYFFA increased to 66% in the third quarter, reflecting strong market access development.
Robust Financial Position
As of September 30, 2025, total cash, cash equivalents, and investments were $230.4 million, an increase of $12.7 million compared to the end of Q2 2025. The company believes available financial resources are sufficient to execute on strategic priorities.