Financial Performance & Growth - Harmony Biosciences achieved Q1 2025 net product revenue of $184.7 million, a 20% increase compared to $154.6 million in Q1 2024[10, 59] - The company reiterates its full-year 2025 revenue guidance of $820-$860 million[12] - Harmony Biosciences has over $600 million in cash, cash equivalents, and investments[5, 58] - WAKIX net revenue grew from $160 million in 2020 to $715 million in 2024[7] Pipeline Development & Catalysts - The company anticipates multiple milestones in 2025, with 6 Phase 3 development programs expected by year-end[62] - Topline data from the Phase 3 RECONNECT study of ZYN002 in Fragile X Syndrome is expected in Q3 2025[20, 22] - Phase 3 registrational trials of Pitolisant HD in narcolepsy and idiopathic hypersomnia are scheduled to begin in Q4 2025[20, 22, 41] - Preclinical data for BP1.15205, a potential best-in-class orexin-2 agonist, will be presented at SLEEP 2025 in June[20, 22, 24] Strategic Positioning & Market Opportunity - WAKIX is considered a potential $1B+ opportunity in narcolepsy alone[8, 12, 47] - The company is pursuing utility patents for pitolisant GR and pitolisant HD, potentially extending patent protection until 2044[20] - The company aims to establish a leadership position in CNS with a potential $3B+ opportunity[64]
Harmony Biosciences (HRMY) Earnings Call Presentation