Zevra Therapeutics(ZVRA) - 2024 Q4 - Annual Results

Financial Performance - FY 2024 net revenue was $23.6 million, with Q4 2024 product net revenue reaching a record $10.2 million[1] - Net revenue for the year ended December 31, 2024, was $23,612,000, a decrease of 14% from $27,461,000 in 2023[39] - The net loss for FY 2024 was ($105.5) million, or ($2.28) per share, compared to a net loss of ($46.0) million, or ($1.30) per share in FY 2023[9] - Net loss for 2024 was $105,511,000, compared to a net loss of $46,049,000 in 2023, representing a 129% increase in losses[39] Revenue Sources - MIPLYFFA generated $10.1 million in net revenue for Q4 2024, while OLPRUVA contributed $0.1 million[12] Operating Expenses - Operating expenses for FY 2024 totaled $97.0 million, with R&D expenses at $42.1 million, reflecting a $2.3 million increase from FY 2023[9] - Total operating expenses increased to $96,963,000 in 2024, up 31% from $74,120,000 in 2023[39] - Research and development expenses rose to $42,095,000 in 2024, an increase of 5% from $39,806,000 in 2023[39] - Selling, general and administrative expenses surged to $54,868,000 in 2024, up 60% from $34,314,000 in 2023[39] - SG&A expenses for Q4 2024 were $16.1 million, an increase of $1.4 million compared to Q4 2023[12] Cash and Investments - As of Dec. 31, 2024, cash, cash equivalents, and investments were $75.5 million, with a cash runway forecast extending into 2029[9] - Cash and cash equivalents decreased to $33,785,000 as of December 31, 2024, down from $43,049,000 in 2023[41] Assets and Liabilities - Total assets increased to $178,127,000 in 2024, compared to $172,327,000 in 2023[42] - Total liabilities rose to $138,461,000 in 2024, up from $110,463,000 in 2023, indicating a 25% increase[41] Share Information - The weighted average number of shares outstanding increased to 46,251,239 in 2024 from 35,452,460 in 2023[39] Regulatory and Market Activities - Zevra initiated the commercial launch of MIPLYFFA on Nov. 21, 2024, following FDA approval on Sep. 20, 2024[5] - The company plans to file for regulatory approval of MIPLYFFA in the EU in the second half of 2025[5] - The company received 109 total prescription enrollment forms for MIPLYFFA as of Dec. 31, 2024[5] - Zevra entered into an asset purchase agreement for the sale of a Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million[8] Focus on Rare Diseases - The company has received Orphan Drug designation for both Celiprolol and KP1077, indicating a focus on rare disease treatments[31][32]