Harmony Biosciences(HRMY) - 2025 Q1 - Quarterly Results

Financial Performance - WAKIX® (pitolisant) net revenue for Q1 2025 was $184.7 million, representing a 20% growth year-over-year[1] - GAAP net income for Q1 2025 was $45.6 million, or $0.78 earnings per diluted share, compared to $38.3 million, or $0.67 earnings per diluted share for Q1 2024[12] - Non-GAAP adjusted net income for Q1 2025 was $60.4 million, or $1.03 earnings per diluted share, compared to $50.7 million, or $0.88 earnings per diluted share for Q1 2024[12] - Net product revenue for Q1 2025 was $184.733 million, a 19.5% increase from $154.615 million in Q1 2024[44] - Gross profit for Q1 2025 was $152.739 million, compared to $127.131 million in Q1 2024, reflecting a gross margin improvement[44] - Operating income for Q1 2025 was $56.245 million, up from $52.033 million in Q1 2024, showing operational efficiency[44] - Net income for Q1 2025 was $45.560 million, compared to $38.334 million in Q1 2024, representing an increase of 18.5%[44] - GAAP reported net income per diluted share rose to $0.78 in Q1 2025 from $0.67 in Q1 2024, marking a 16% increase[46] - Non-GAAP adjusted net income per diluted share increased to $1.03 in Q1 2025, up from $0.88 in Q1 2024, a growth of 17%[46] Expenses and Investments - Research and Development expenses increased by 56% to $34.5 million in Q1 2025 compared to $22.2 million in Q1 2024[15] - Total operating expenses were $96.5 million in Q1 2025, representing a 29% increase from $75.1 million in Q1 2024[15] - Research and development expenses increased to $34.540 million in Q1 2025 from $22.189 million in Q1 2024, indicating a focus on product development[44] - Stock-based compensation expense increased to $12,450,000 in Q1 2025 from $10,434,000 in Q1 2024, an increase of 19%[46] Patient and Product Development - The average number of patients on WAKIX increased to approximately 7,200 for Q1 2025, with approximately 7,300 patients at the end of the quarter[7] - Recruitment for the Phase 3 registrational trial of ZYN002 in Fragile X syndrome is complete, with topline data expected in Q3 2025[11] - The company is on track to initiate Phase 3 registrational trials in narcolepsy and idiopathic hypersomnia (IH) in Q4 2025[7] - The company plans to submit a supplemental New Drug Application (sNDA) for pitolisant in idiopathic hypersomnia, expanding its product indications[42] - Harmony Biosciences is focused on developing therapies for rare neurological diseases, addressing significant unmet medical needs[41] - The company has received FDA Fast Track designation for ZYN002 for the treatment of behavioral symptoms in patients with Fragile X Syndrome[34] Financial Guidance and Assets - 2025 net revenue guidance is projected between $820 million and $860 million[14] - Total assets as of March 31, 2025, were $1.055 billion, up from $999.200 million at the end of 2024[45] - Cash and cash equivalents increased to $488.998 million from $453.001 million, indicating improved liquidity[45] Other Financial Metrics - Non-cash interest expense for Q1 2025 was $166,000, slightly down from $180,000 in Q1 2024[46] - Depreciation expense decreased significantly to $7,000 in Q1 2025 from $163,000 in Q1 2024[46] - The income tax effect related to non-GAAP adjustments improved to $(3,776,000) in Q1 2025 from $(4,350,000) in Q1 2024[46] - Amortization expenses remained consistent at $5,961,000 for both Q1 2025 and Q1 2024[46] - The weighted average number of shares of common stock used in non-GAAP diluted per share calculations was 58,524,566 in Q1 2025, compared to 57,597,627 in Q1 2024[46]