Harmony Biosciences preliminary results indicate strong revenue growth, higher 2024 targets

PLYMOUTH MEETING, Pa. – Harmony Biosciences Holdings , Inc. (NASDAQ:) today announced a significant increase in its preliminary, unaudited net product revenue for both the fourth quarter and the full year of 2023, reflecting growth of approximately 31% and 33%, respectively. The company also provided a net product revenue forecast for 2024, estimating a range of $700 million to $720 million.

The revenue growth is attributed to the performance of WAKIX® (pitolisant), a medication approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. The average number of patients on WAKIX rose to around 6,150 by the end of the fourth quarter of 2023.

Harmony Biosciences’ President and CEO, Jeffrey M. Dayno, M.D., stated that the company is on track to potentially reach a billion-dollar opportunity with WAKIX in adult narcolepsy alone. The company’s financial strategy included repurchasing approximately 1.8 million shares of common stock for $50 million in the last quarter, totaling $100 million for the year. The remaining authorization for share repurchases stands at $150 million, with plans to continue these transactions opportunistically in 2024.

Looking ahead, Harmony Biosciences aims to grow the average number of patients on WAKIX to approximately 7,000, increase educational outreach, and expand its prescriber base. Additionally, the company is focusing on advancing and expanding its pipeline, including reporting pharmacokinetic data on new pitolisant-based formulations, driving patient enrollment in clinical trials for Fragile X syndrome and Prader-Willi syndrome, and completing reviews of Phase 2 data for Myotonic Dystrophy Type 1.

WAKIX, a selective histamine 3 (H₃) receptor antagonist/inverse agonist, has been commercially available in the U.S. since the fourth quarter of 2019. While its exact mechanism of action is unclear, it is believed to increase the synthesis and release of histamine, a neurotransmitter that promotes wakefulness.

The information in this article is based on a press release statement.

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