Financial Performance - Revenue for the three months ended March 31, 2025, was $20,401,000, a significant increase from $3,425,000 in the same period of 2024, representing a growth of 494%[17] - Net loss for the first quarter of 2025 was $3,099,000, compared to a net loss of $16,622,000 in the same quarter of 2024, showing an improvement of 81.4%[19] - Basic and diluted net loss per share improved to $0.06 for the three months ended March 31, 2025, compared to $0.40 for the same period in 2024[17] - For the three months ended March 31, 2025, Zevra Therapeutics reported a net loss of $3.1 million, a significant improvement compared to a net loss of $16.6 million for the same period in 2024, representing an 81.4% reduction in losses[26] - The company generated net cash used in operating activities of $8.2 million for Q1 2025, down from $16.2 million in Q1 2024, indicating a 49.3% improvement in cash flow management[26] Assets and Liabilities - Total current assets decreased to $81,573,000 as of March 31, 2025, down from $86,027,000 as of December 31, 2024, a decline of 5.3%[16] - Total liabilities decreased to $131,685,000 as of March 31, 2025, from $138,461,000 as of December 31, 2024, a reduction of 4.5%[16] - Cash and cash equivalents increased to $37,340,000 as of March 31, 2025, up from $33,785,000 as of December 31, 2024, an increase of 8.5%[16] - Total stockholders' equity increased to $41,023,000 as of March 31, 2025, from $39,666,000 as of December 31, 2024, an increase of 3.4%[16] - Long-term debt amounted to $60.1 million as of March 31, 2025, compared to $59.5 million as of December 31, 2024, indicating a slight increase of about 1.01%[81] Expenses - Research and development expenses for the first quarter of 2025 were $3,258,000, down from $12,277,000 in the same period of 2024, a decrease of 73%[17] - Selling, general and administrative expenses increased to $19,545,000 in Q1 2025, compared to $9,931,000 in Q1 2024, an increase of 96.5%[17] - Total operating expenses for the three months ended March 31, 2025, were $22.8 million, a slight increase of $0.6 million compared to $22.2 million for the same period in 2024[185] Revenue Sources - Sales of MIPLYFFA reached $17.1 million for the three months ended March 31, 2025, following the FDA approval of its NDA on September 20, 2024[85] - The Company recognized revenue related to the French AC of $2.3 million for the three months ended March 31, 2025, compared to $2.2 million in the same period of 2024[87] - The AZSTARYS License Agreement generated revenue of $0.9 million for the three months ended March 31, 2025, down from $1.2 million in the same period of 2024[89] Clinical Developments - The FDA approved MIPLYFFA® for Niemann-Pick disease type C on September 20, 2024, marking it as the first FDA-approved treatment for this ultra-rare disease[27] - The company has a pipeline that includes KP1077, which has received orphan drug designation from the FDA for the treatment of idiopathic hypersomnia, a rare neurological sleep disorder[29] - The Phase 2 clinical trial for KP1077 is expected to conclude in March 2024, providing meaningful information for Phase 3 trial design[170] - MIPLYFFA has demonstrated a halting of disease progression through 12 months of treatment, with no safety findings of concern reported in over 600 patients[155] Stock and Financing - The company has authorized 250 million shares of common stock, with 56,255,055 shares issued as of March 31, 2025[95] - The company raised approximately $64.5 million from the August 2024 Offering, selling 10,615,385 shares at a public offering price of $6.50 per share[199] - The Credit Agreement provided a senior secured loan facility of $100.0 million, with $60.0 million funded on the closing date[205] Cash Management - As of March 31, 2025, the company had cash, cash equivalents, and investments totaling $68.7 million[193] - The company believes its available cash and cash equivalents are sufficient to fund existing and planned capital requirements for at least the next twelve months[213] - Market conditions may impact the viability of financial institutions holding the company's cash, potentially affecting access to funds[214]
Kempharm(KMPH) - 2025 Q1 - Quarterly Report