PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) reported another quarter of double-digit revenue growth and solidified its position as a profitable, late-stage biotech leader, driven by continued momentum from its flagship product WAKIX® and progress across a growing pipeline.
Second-quarter 2025 net revenue rose 16% year-over-year to $200.5 million, fueled by a net increase of 400 patients and bringing the company’s average patient base to 7,600. Net income for the quarter was $39.8 million, or $0.68 per diluted share, compared to $11.6 million a year ago. On a non-GAAP basis, adjusted net income rose to $53.8 million, or $0.92 per diluted share—a 116% increase from Q2 2024.
The growth was supported by broader commercial reach, including engagement with approximately 9,000 healthcare providers, and expanding use of WAKIX in the narcolepsy space. Harmony reaffirmed full-year revenue guidance between $820 million and $860 million.
“We are on track to announce the Phase 3 readout for ZYN002 in the third quarter, which represents a potentially transformative moment for these patients and for Harmony,” said President and CEO Jeffrey M. Dayno, M.D. “Harmony is building a commercially durable business with a robust pipeline and clear path to delivering long-term value for patients, providers, and shareholders alike.”
Pipeline Momentum
The company expects topline results from its Phase 3 RECONNECT study of ZYN002 in Fragile X syndrome in Q3. If successful, ZYN002 could become the first approved treatment for Fragile X in the U.S., addressing an estimated 80,000 patients. Harmony holds global rights to the product.
Additionally, first-in-human trials of its orexin-2 agonist BP1.15205 are set to begin in the second half of 2025. Phase 3 registrational trials for high-dose pitolisant (Pitolisant HD) in narcolepsy and idiopathic hypersomnia (IH) are expected to launch in Q4, with potential FDA approvals by 2028.
The company also reported progress in its rare epilepsy franchise, with two Phase 3 studies underway for EPX-100 in Dravet and Lennox-Gastaut syndromes, and continued development of EPX-200.
Financial Strength and Strategic Investment
Operating expenses totaled $114.2 million in the second quarter, down 4.3% from the prior year. The decrease was driven by lower R&D costs, despite new investments in its pipeline and a $15 million upfront payment to CiRC Biosciences as part of a new regenerative medicine research collaboration targeting treatment-resistant epilepsy and narcolepsy.
Harmony ended the quarter with $672.3 million in cash, cash equivalents, and investments, up from $576.1 million at the end of 2024.
Patent Protection and Legal Wins
In June, Harmony reached a settlement with Lupin Limited over generic challenges to WAKIX, ensuring market exclusivity until at least 2030, with pediatric extension. The company continues to defend its intellectual property in ongoing litigation with other generic challengers.
With a strong balance sheet, continued profitability, and a deep pipeline spanning sleep/wake and neurobehavioral disorders, Harmony is positioning itself for sustained growth well beyond 2025.
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