Harmony Biosciences reported unaudited net product revenue of $243 million for the fourth quarter of 2025, a 20% year‑over‑year increase from $201.3 million in Q4 2024. Full‑year 2025 revenue reached $868 million, up 21% from $714.7 million in 2024, reflecting sustained demand for its flagship drug WAKIX. The company added roughly 400 new patients in Q4, bringing the average patient count to about 8,500, a key driver of the revenue lift.
WAKIX remains the only FDA‑approved non‑scheduled treatment for narcolepsy, and its recent pediatric approval—effective for patients aged six and older—has broadened the addressable market. The 400 new patients in Q4 were largely attributable to the pediatric indication, which has accelerated adoption in both the United States and international markets. The company’s pricing strategy, coupled with a high‑margin product mix, has allowed it to maintain healthy gross margins despite modest increases in operating expenses.
Management guided 2026 WAKIX revenue to $1.0 billion–$1.04 billion, a projection that positions the drug for blockbuster status and signals strong confidence in continued market penetration. The guidance represents an upward revision from prior estimates and underscores the company’s belief that the pediatric expansion will sustain growth momentum. The guidance also reflects expectations of incremental patient additions and the potential for higher average sales per patient as the product matures.
Beyond WAKIX, Harmony is advancing next‑generation pitolisant formulations—GR and HD—intended to extend exclusivity into the 2040s. The company has also filed patents to protect these new formulations and is progressing a Phase 1 study of BP1.15205, an orexin‑2 receptor agonist, with data anticipated in mid‑2026. These pipeline activities illustrate a broader strategy to diversify revenue streams and mitigate reliance on a single product.
President and CEO Jeffrey M. Dayno emphasized the company’s momentum, stating, “WAKIX is on track to generate over $1 billion in revenue in 2026, and the pediatric approval has opened a new growth engine that will accelerate patient adoption.” His remarks highlight the company’s focus on execution and confidence in its long‑term growth trajectory.
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