Harmony Biosciences(HRMY) - 2025 Q3 - Earnings Call Presentation

Financial Performance - Q3 2025 net product revenue reached $239.5 million, a 29% increase year-over-year compared to $186.0 million in Q3 2024[6, 36] - The company raised its full-year 2025 revenue guidance to $845 million - $865 million[6] - Non-GAAP adjusted net income increased by 11% from $57.3 million in Q3 2024 to $63.5 million in Q3 2025[36] - Cash, cash equivalents, and investments increased to $778.4 million in Q3 2025, a 54% increase compared to $504.7 million in Q3 2024[36, 38] WAKIX Performance - WAKIX average patients reached 8,100[11] - Approximately 500 average patient additions, representing the highest quarterly increase since launch[11] - Strong payer coverage of WAKIX at >80% of lives[11] Pipeline Development - The company plans to initiate Phase 3 registrational trials for Pitolisant HD in narcolepsy and IH in Q4 2025[20, 21] - Topline data from the pivotal bioequivalence study of Pitolisant GR is expected in Q4 2025[25, 33] - Phase 3 registrational trials are ongoing for EPX-100 in Dravet Syndrome (ARGUS study) and Lennox-Gastaut Syndrome (LIGHTHOUSE study), with topline data anticipated in 2026[19, 31, 33] - The Phase 3 RECONNECT study for ZYN002 in Fragile X Syndrome (FXS) did not meet the primary endpoint due to a higher-than-expected placebo response rate, and a review of the full data set is ongoing[19, 28]