Plymouth Meeting, Pa. — November 4, 2025 — Leads & Copy — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported earnings of $239.5M for Q3 2025, a 29% year-over-year revenue increase for WAKIX®, driven by a record increase of approximately 500 patients.
The company, building on four years of revenue growth and profitability, has over $778 million in cash and investments. Harmony continues to strengthen its financial position, reinforcing its profile as a profitable biotech company with a robust pipeline and long-term growth potential.
Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences, expressed pride in the team’s execution and conviction in the late-stage pipeline, aiming to strategically enhance value and broaden the product portfolio.
Franchise highlights include:
Sleep/Wake Franchise:
- WAKIX in Narcolepsy: Net Revenue was $239.5 million for Q3 2025; 2025 Net Revenue guidance raised from $820-$860 million to $845-$865 million; Record increase of approximately 500 patients to achieve approximately 8,100 patients in Q3 2025.
- Pitolisant HD: IND submitted to the FDA; Phase 3 trials in narcolepsy and IH to begin in Q4 2025 with target PDUFA dates in 2028; Utility patents filed with potential exclusivity to 2044.
- Pitolisant GR: Topline data readout from bioequivalence study expected in Q4 2025; Topline data from dosing optimization study showed 100% of patients were able to initiate pitolisant GR at the therapeutic dose of 17.8mg; Utility patents filed with potential exclusivity to 2044.
- Orexin-2 receptor agonist: First-in-human study to commence in Q4 2025 with clinical data anticipated in 2026; Potential to be best-in-class orexin-2 receptor agonist.
Rare Epilepsy Franchise:
- EPX-100: Enrollment ongoing for Phase 3 trials in Dravet syndrome and Lennox-Gastaut syndrome, with topline data anticipated in 2026; Presenting data from the ARGUS open label extension study at the American Epilepsy Society Meeting in December 2025.
- EPX-200: Currently in the IND-enabling stage.
Neurobehavioral Franchise:
- ZYN002: Phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint; development program in 22q11.2 deletion syndrome paused pending data review.
Third Quarter 2025 Financial Results: Harmony Biosciences reported net product revenue of $239.5 million, a 29% year-over-year growth. Net income was $50.9 million ($0.87 per diluted share), compared to $46.1 million ($0.79 per diluted share) in Q3 2024.
Harmony’s operating expenses include Research and Development expenses were $55.0 million Sales and Marketing expenses were $29.5 million, General and Administrative expenses were $29.8 million; Total Operating Expenses were $114.3 million.
As of September 30, 2025, Harmony had cash, cash equivalents and investments of $778.4 million.
Full year 2025 net product revenue range raised from $820-$860 million to $845-$865 million.
A conference call is scheduled for today at 8:30 a.m. ET.
To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Contact:
Harmony Biosciences Investor Relations
484-539-9800
ir@harmonybiosciences.com
Source: Harmony Biosciences
