PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported 17% first-quarter revenue growth for its narcolepsy drug WAKIX while advancing patent litigation, new formulations and pipeline programs aimed at extending the franchise into the next decade.
WAKIX net revenue increased to $215.4 million for the quarter ended March 31, from $184.7 million a year earlier. Harmony reaffirmed full-year guidance projecting WAKIX revenue between $1 billion and $1.04 billion in 2026.
The company attributed quarterly performance to continued patient demand despite seasonal reimbursement and market-access pressures typically seen during the first quarter.
Net income declined to $32.5 million, or $0.55 per diluted share, from $45.6 million, or $0.78 per diluted share, a year earlier. Harmony attributed the decline primarily to licensing-related expenses incurred during the quarter.
Research and development expenses more than doubled to $69.4 million, driven largely by $32 million in upfront payments tied to licensing agreements intended to support future development programs.
Harmony continued strengthening intellectual property protections surrounding pitolisant, the active ingredient in WAKIX, including an exclusive license agreement tied to an amorphous form of pitolisant protected through 2042.
The company also filed patent infringement litigation in April against AET Pharma US and Sandoz involving patents covering amorphous pitolisant hydrochloride formulations.
Chief Executive Officer Jeffrey Dayno described protection and expansion of the pitolisant franchise as central to the company’s long-term strategy.
“Protect the pitolisant franchise to ensure durability into the 2030s” remains one of the company’s primary strategic priorities, Dayno said.
Harmony reported average WAKIX patient counts of approximately 8,500 during the quarter and exited the period with roughly 8,600 patients receiving treatment.
The company received U.S. Food and Drug Administration approval in February for a pediatric cataplexy indication tied to WAKIX. Harmony stated that the approval supports an additional six months of pediatric exclusivity extending protection into March 2030.
Harmony also continues developing new formulations designed to extend the commercial life of pitolisant products.
Pitolisant GR, a gastro-resistant formulation intended to reduce gastrointestinal side effects, remains on track for a New Drug Application filing during the second quarter of 2026. A potential FDA decision is anticipated in the first quarter of 2027.
The company’s higher-dose pitolisant HD program remains in Phase 3 studies for narcolepsy and idiopathic hypersomnia, with topline data expected in 2027.
Harmony also highlighted progress with BP-205, its orexin-2 receptor agonist candidate being studied for sleep disorders and broader central nervous system conditions. Early clinical pharmacokinetic, safety and tolerability data are expected in mid-2026.
In epilepsy, the company continues enrolling Phase 3 registrational studies for EPX-100 in Lennox-Gastaut syndrome and Dravet syndrome, with topline data anticipated during the first half of 2027.
Harmony ended the quarter with $870.5 million in cash, cash equivalents and investments. The company noted that it remains focused on business development opportunities involving assets with potential revenue contribution between 2028 and 2032.
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