PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported $243.8 million in fourth-quarter 2025 revenue and $868.5 million in full-year net product revenue from its narcolepsy drug WAKIX, the company announced.
Fourth-quarter revenue rose from $201.3 million in the same period in 2024, representing about 21% year-over-year growth.
Full-year 2025 revenue increased about 22% from $714.7 million in 2024.
The company said the average number of patients receiving WAKIX increased by roughly 400 during the fourth quarter to about 8,500 patients.
Harmony reported fourth-quarter net income of $22.5 million, or $0.38 per diluted share, compared with $49.5 million, or $0.85 per diluted share, in the same quarter of 2024.
For the full year, GAAP net income totaled $158.7 million, or $2.71 per diluted share, compared with $145.6 million, or $2.51 per diluted share in 2024.
Research and development expenses rose to $49.9 million in the fourth quarter from $34.7 million a year earlier.
Total operating expenses for the quarter were $136.7 million, compared with $91.1 million in the fourth quarter of 2024.
Jeffrey M. Dayno, president and chief executive officer of Harmony Biosciences, said the company expects continued growth for WAKIX.
“WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026,” Dayno said.
The company reaffirmed its 2026 revenue guidance for WAKIX of between $1.0 billion and $1.04 billion.
Harmony said the drug recently received U.S. Food and Drug Administration approval for treating pediatric cataplexy in patients with narcolepsy.
The company also said it has reached settlement agreements with three additional generic drug applicants seeking approval to market versions of WAKIX.
Under those agreements, the generic companies will not launch competing products before March 2030 if Harmony receives pediatric exclusivity for the drug.
Harmony said it is also developing additional formulations of pitolisant, the active ingredient in WAKIX.
A gastro-resistant version of pitolisant is expected to be submitted to the FDA for approval in the second quarter of 2026.
A higher-dose formulation is being evaluated in Phase 3 clinical trials for narcolepsy and idiopathic hypersomnia, with trial data expected in 2027.
The company is also conducting a Phase 1 clinical trial for an orexin-2 receptor agonist drug candidate known as BP1.15205, with clinical data expected in mid-2026.
Harmony Biosciences develops treatments for rare neurological disorders, including sleep disorders such as narcolepsy and idiopathic hypersomnia.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.