Harmony Biosciences Holdings Inc

Latest Results (11.10.2025):

Harmony Biosciences Holdings Inc reported strong financial results for the second quarter of 2025, demonstrating significant growth in its WAKIX® franchise and reaffirming its full-year 2025 revenue guidance. The company remains on track to announce top-line data from its Phase 3 Fragile X registrational trial in the third quarter of 2025.

WAKIX® Franchise Growth

Net revenue for WAKIX® (pitolisant) reached $200.5 million in Q2 2025, marking a 16% year-over-year increase. The average number of patients using WAKIX® rose by 400, totaling 7,600 in the quarter.

Phase 3 RECONNECT Study

The Phase 3 RECONNECT study for Fragile X Syndrome (FXS) is designed to validate the positive findings from the Phase 2/3 CONNECT study. This initiative targets addressing the unmet needs of approximately 80,000 FXS patients.

Pipeline Advancements

Harmony is set to begin the first-in-human clinical trial of BP1.15205, a potential best-in-class Orexin-2 agonist, in the second half of 2025. Additionally, Phase 3 registrational trials for next-generation Pitolisant HD in narcolepsy and idiopathic hypersomnia are scheduled to commence in Q4 2025, with PDUFA dates expected in 2028.

Strong Patent Position

Harmony secured a settlement with Lupin Limited, ensuring that Lupin cannot launch a generic version of WAKIX® before January 2030, or July 2030 with pediatric exclusivity. This strengthens Harmony's intellectual property position and protects its market share.

Operating Expenses

In Q2 2025, Harmony reduced research and development expenses by 21.1% to $50.2 million compared to the same quarter in 2024. Sales and marketing expenses increased by 5.5% to $30.1 million, while general and administrative expenses rose by 24.6% to $33.9 million. Overall, total operating expenses decreased by 4.3% year-over-year to $114.2 million.