Quarterly ResultAug 4, 2026, 08:08 AM
Harmony Biosciences Q2 Revenue $261.3M; BP-205 Phase 1 Data Positive
AI Summary
Harmony Biosciences reported record Q2 2026 net revenue of $261.3 million for WAKIX, marking a 30% year-over-year increase, and reaffirmed its full-year 2026 net revenue guidance of $1.0 billion to $1.04 billion. The company also announced encouraging Phase 1 single ascending dose (SAD) data for its orexin-2 agonist BP-205, demonstrating favorable pharmacokinetic and safety/tolerability profiles, supporting its potential as a best-in-class treatment for multiple CNS indications. Harmony is advancing its pipeline with plans to initiate Phase 2 studies for BP-205 in mid-2027 and anticipates key data readouts for other pitolisant formulations and EPX-100 in 2027-2028.
Key Highlights
- Q2 2026 net product revenue for WAKIX was $261.3 million, a 30% increase year-over-year.
- Estimated average WAKIX patients increased by 450 to 8,950 in Q2 2026.
- Harmony Biosciences reiterated its full-year 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.
- Q2 2026 net income was $75.4 million, or $1.28 per diluted share, up 90% from Q2 2025.
- Cash, cash equivalents, and investments totaled $962.5 million as of June 30, 2026.
- Phase 1 SAD data for BP-205 showed a rapid Tmax of 30-75 minutes and a mean half-life of approximately 25 hours.
- Pitolisant GR NDA was accepted by the FDA with a target PDUFA date of April 1, 2027.
- Topline data for EPX-100 Phase 3 trials in Dravet and Lennox-Gastaut syndromes are expected in 1H 2027.
Price Impact
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