ZEVRA THERAPEUTICS, INC. Q3 FY2024 earnings call

• MIPLYFFA was approved and launched, with 90 prescription enrollment forms submitted as of October 31, exceeding expectations. Also received a rare pediatric disease priority review voucher (PRV) with MIPLYFFA's approval, intending to monetize it for future growth.
• OLPRUVA's launch was affected by low patient awareness and reimbursement hurdles, with only 3 prescription enrollment forms in the third quarter. Adjusted strategy to focus on patient segments with greatest potential to benefit.
• Pipeline achievements: Completed end of Phase II meeting for KP1077 in idiopathic hypersomnia (IH) with clear Phase III path; met goal of dosing new patients in reinitiated Phase III program for celiprolol.
• Developed 2025 strategic plan around four pillars: commercial excellence, pipeline and innovation, talent and culture, corporate foundation.

In the third quarter, net revenue was $3.7 million, including $2.6 million in net reimbursements from the French EAP for arimoclomol and $1.1 million of royalties and other reimbursements under the AZSTARYS license. For commercial products, MIPLYFFA and OLPRUVA, net revenue for OLPRUVA was de minimis in the third quarter, and MIPLYFFA is expected to have its initial shipment in Q4.

• Expect MIPLYFFA to have initial shipment in Q4. Actively monitoring PRV market to monetize for non-dilutive capital. For KP1077, exploring strategic alternatives to advance clinical development and commercialization. Intend to provide update on celiprolol in early 2025 regarding its business case.

• OLPRUVA launch impacted by low patient awareness and reimbursement hurdles in the UCD market. Uncertainties related to strategic alternatives for pipeline programs like reprioritizing resources and discontinuing some development activities.

Q: Can you give a sense of the remaining steps for patients who have received reimbursement approval to get drugs shipped to them and average time to get submitted prescription form to reimbursement approval?

A: Jason, we are well on our way to getting the drug in channel and the 30% of benefits investigations approved as of October 31 will get first shipment as soon as drug hits specialty pharmacy. For enrollments, no additional hurdles regardless of whether patient was in EAP or not.

Q: How do we think about modeling the sales in fourth quarter '24, timing for EU expansion, and value of PRV?

A: Plan to have first shipment of drug to specialty pharmacy and revenue in Q4. EU is a priority but timing not specified yet as in process of dialog with EMEA. PRV market has seen higher transactions, actively monitoring to monetize for non-dilutive capital.