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Harmony Biosciences Reports Strong Q1 2025 Financial Results, Highlights Advancement of Its Pipeline and Upcoming Catalysts, and Reaffirms 2025 Revenue Guidance
WAKIX® (pitolisant) Net Revenue of $184.7 Million for First Quarter 2025; Representing 20% Growth Year-over-Year; Reiterates Guidance of $820-$860M Net
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"\nWAKIX® (pitolisant) Net Revenue of $184.7 Million for First Quarter 2025; Representing 20% Growth Year-over-Year; Reiterates Guidance of $820-$860M\n\n\n\nNet Income Grew 19% Year-over-Year, Building on Four Consecutive Years of Profitability; Increased Cash and Investments to Over $600 Million on Balance Sheet\n\n\n\nCompleted Recruitment of Phase 3 Registrational Trial of ZYN002 in Fragile X Syndrome; On Track for Topline Data in Q3\n\n\n\nBP1.15205, Potential Best in Class Orexin, Data to Be Presented at SLEEP 2025 Conference in June\n\n\n\nOn Track for Initiation of Next-Generation Pitolisant-HD Phase 3 Registrational Trials in Narcolepsy & IH in Q4\n\n\n\nConference Call and Webcast to be Held Today at 8:30 a.m. ET\n\n PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--\nHarmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong year-over-year revenue growth for WAKIX® of 20% in the first quarter 2025, on its way to a potential $1B+ opportunity in narcolepsy alone and poised for additional growth from its next-gen pitolisant development programs. The company has demonstrated four consecutive years of profitability and has grown its cash and investments position to over $600M.\n\n“Building off of our strong foundation of commercial success, we are poised for significant momentum throughout the rest of the year, driven by the upcoming catalysts from our robust, late-stage pipeline,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Our next major clinical milestone, topline data readout from our Phase 3 registrational trial of ZYN002 in patients with Fragile X syndrome, the RECONNECT Study, is on track for Q3. A positive readout could put us on a path toward the first ever approved treatment for this patient community. I am proud of the unique profile we have created at Harmony, a profitable, self-funding biotech company, with a robust pipeline, that has the potential to help hundreds of thousands of patients living with unmet medical needs while creating significant, long-term value.”\n\nFranchise Highlights\n\nSleep/Wake Franchise\n\nWAKIX in Narcolepsy\n\n\nNet Revenue was $184.7 million for Q1 2025\n\n\n2025 Net Revenue projected between $820 to $860 million\n\n\nThe average number of patients on WAKIX increased to approximately 7,200 for Q1 2025 and we exited the quarter ...