Harmony Biosciences Posts $243.8M Q4 Growth, Guides $1B+ WAKIX 2026 Sales
Harmony Biosciences reported Q4 WAKIX net product revenue of $243.8 million, up 21% year-over-year, and achieved full-year net product revenue of $868.5 million, marking six consecutive years of growth. The company reiterated 2026 WAKIX revenue guidance of $1.0–$1.04 billion, on track for blockbuster status.
1. 2025 Financial Highlights
Harmony Biosciences delivered WAKIX net product revenue of $243.8 million in Q4 2025, a 21% increase over Q4 2024’s $201.3 million, and posted full-year net product revenue of $868.5 million, up 22% from $714.7 million in 2024, marking its sixth straight year of growth and profitability.
2. 2026 WAKIX Revenue Guidance
The company reiterated full-year 2026 WAKIX net revenue guidance of $1.0–$1.04 billion, forecasting blockbuster status for pitolisant in narcolepsy and signaling continued commercial momentum for both existing and next-generation formulations.
3. Patent Settlements and Exclusivity
Harmony completed settlements with six of seven ANDA filers, delaying generic WAKIX launches until at least March 2030 if pediatric exclusivity is granted; the FDA granted a pediatric cataplexy indication on February 13, triggering full promotional efforts and an additional six months of regulatory exclusivity.
4. Late-Stage Pipeline and Catalysts
Key late-stage initiatives include a pitolisant GR NDA submission in Q2 2026 (PDUFA Q1 2027), five Phase 3 registrational trials across distinct CNS indications, and a Phase 1 orexin-2 agonist study with data expected mid-2026, positioning multiple near-term catalysts and long-term growth opportunities.