WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy
On Track to Extend the Pitolisant Franchise into the 2040s With Next-Gen Pitolisant Formulations
Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026
Robust Late-Stage Pipeline with Five Ongoing Phase 3 Registrational Clinical Trials in Five Distinct CNS Indications
PLYMOUTH MEETING, Pa.–(BUSINESS WIRE)–Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced strong preliminary, unaudited net product revenue for Q4 and full year 2025 of approximately $243 million and $868 million, respectively. The company continues to build on six consecutive years of revenue growth. On track to extend the pitolisant franchise, Harmony fortifies its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential. Harmony will highlight its commercial performance and pipeline advancements at its presentation at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 4:30 p.m. PT / 7:30 p.m. ET in San Francisco, CA.
“With WAKIX on track to achieve revenue of over $1 billion in narcolepsy in 2026, Harmony is entering its next phase of growth with significant momentum,” said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. “Our proven commercial engine is driving exceptional performance with WAKIX, our next-gen formulations are positioned to extend and expand the pitolisant franchise well into the 2040s, and we continue to advance our late-stage pipeline with five ongoing Phase 3 registrational trials toward five distinct CNS indications. As a profitable, self-funding biotech with a strong balance sheet, we are well positioned to build out our pipeline and expand our commercial portfolio to drive long-term value creation.”
Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX (Preliminary and Unaudited)
- Preliminary, unaudited net product revenue for the quarter ended December 31, 2025, was approximately $243 million, compared to $201.3 million for the same period in 2024
- Increase of ~400 patients to achieve ~8,500 average number of patients in Q4 2025; representing the third consecutive quarter of ~400+ patient adds
- Preliminary, unaudited net product revenue for the full year ended December 31, 2025, was approximately $868 million, compared to $714.7 million for the full year ended December 31, 2024, representing ~21% growth year on year