Harmony Biosciences(US:HRMY)2024-04-30 16:03Financial Performance - Harmony Biosciences reported Q1 2024 net product revenue of $154.6 million, a 30% increase compared to $119.1 million in Q1 2023[8, 53] - The company's Non-GAAP adjusted net income for Q1 2024 was $50.7 million, a 25% increase from $40.7 million in Q1 2023[62] - Harmony Biosciences has cash, cash equivalents, and investments totaling $453.6 million[53] - The company reiterates its 2024 net revenue guidance of $700-$720 million[68] WAKIX Growth and Potential - WAKIX is considered a potential $1 billion+ net revenue opportunity in adult narcolepsy alone[5, 7] - The average number of patients on WAKIX is approximately 6,300 and growing[11, 39] - WAKIX sales have shown durable growth into year five, with a 30% year-over-year increase[9, 52] Pipeline and Development - The company plans to submit an sNDA for Idiopathic Hypersomnia (IH) in the second half of 2024[5, 15] - A PDUFA date is set in 2026 for Next-Gen Formulation 1 (NG1)[5, 45] - Topline data for ZYN002 in the Phase 3 RECONNECT study for Fragile X syndrome (FXS) is expected in mid-2025[5, 43] - Topline data for clemizole hydrochloride (EPX-100) in a pivotal registrational trial for Dravet syndrome (DS) is expected in 2026[6, 27]