PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported a 30% increase in second-quarter WAKIX revenue and nearly doubled net income, while advancing several pipeline programs intended to extend growth beyond its narcolepsy franchise.
Net product revenue for WAKIX rose to $261.3 million from $200.5 million a year earlier. Harmony reiterated full-year 2026 WAKIX revenue guidance of $1 billion to $1.04 billion.
Average patients increased by about 450 during the quarter to approximately 8,950.
Net income climbed to $75.4 million, or $1.28 per diluted share, from $39.8 million, or 68 cents per diluted share, a year earlier.
Cost of product sold increased 66% to $63.2 million, or 24.2% of product revenue, from $38.2 million, or 19% of revenue. Harmony attributed the increase primarily to new royalties associated with its Novitium license agreement.
Total operating expenses declined 5% to $108.8 million from $114.2 million.
Research and development expense fell 7% to $46.6 million, largely because the year-earlier period included a $15 million upfront payment tied to an agreement with CiRC.
Sales and marketing expense increased 13% to $34.1 million as Harmony expanded its field-based teams. General and administrative expense declined 17% to $28.1 million, reflecting the absence of a prior-year charge related to an abbreviated new drug application settlement.
Chief Executive Officer Jeffrey Dayno pointed to WAKIX growth as the financial base supporting further pipeline investment.
“With this strong foundation, we are aggressively advancing our pipeline, with our orexin-2 agonist BP-205 as the centerpiece,” Dayno stated.
Harmony also released initial Phase 1 single-ascending-dose data for BP-205, an orexin-2 receptor agonist being developed with Bioprojet and originally discovered by Teijin Pharma.
The company reported a time to maximum plasma concentration of 30 to 75 minutes and an average half-life of about 25 hours across dose groups, supporting potential once-daily dosing.
Harmony reported no serious or severe treatment-emergent adverse events in the single-dose study. The most common adverse events were headache in about 10% of participants, fatigue in about 4% and diarrhea in about 3%.
The company also reported no cardiovascular, hepatic or visual abnormalities in that portion of the study.
Multiple-ascending-dose data are expected in the fourth quarter. Harmony has an open U.S. investigational new drug application for BP-205 and plans to begin a Phase 1b study in sleep-deprived healthy volunteers during the third quarter, with data expected in early 2027.
Phase 2 trials evaluating BP-205 across multiple central nervous system indications are planned for mid-2027.
Harmony is also advancing new formulations of pitolisant.
The FDA accepted the new drug application for gastro-resistant pitolisant tablets in July and set a target action date of April 1, 2027. Harmony is targeting a commercial launch in the first half of 2027 if approved.
The company is separately running Phase 3 trials of a high-dose pitolisant formulation in narcolepsy and idiopathic hypersomnia, with topline data expected in 2027 and anticipated regulatory action in 2028.
A Phase 3 trial of WAKIX in Prader-Willi syndrome is expected to produce topline data in mid-2027. Completion of that study would satisfy the final requirement agreed with the FDA for pediatric exclusivity, which could add six months of regulatory exclusivity for WAKIX.
Harmony is also enrolling patients in two global Phase 3 trials of EPX-100 for Lennox-Gastaut syndrome and Dravet syndrome. Topline data are expected in the first half of 2027, with anticipated regulatory action in 2028.
The company continues to defend its pitolisant intellectual property portfolio. Harmony has settled with six of seven abbreviated new drug application filers and remains in litigation with AET Pharma US over patents covering polymorph and method-of-use claims.
A bench trial in that case has concluded, with closing arguments scheduled for Oct. 22, 2026. Harmony and Novitium also filed a separate patent infringement lawsuit in April against AET and Sandoz involving patents covering an amorphous form of pitolisant hydrochloride.
Harmony had $962.5 million in cash, cash equivalents and investments as of June 30, up from $882.5 million at the end of 2025.
The company is also evaluating business-development opportunities with potential revenue contributions between 2028 and 2032, with an emphasis on Phase 3, registration-stage and marketed assets in sleep-wake disorders, epilepsy and other central nervous system indications.
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