Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) reported its annual financial results, showcasing significant revenue growth driven by its lead product, WAKIX. The company, focused on rare neurological diseases, posted net product revenue of $868.5 million for the year ended December 31, 2025, compared to $714.7 million in the previous year, representing a 21.5% increase. This growth was attributed to an 18.3% increase in units shipped and a 7.0% price increase, partially offset by higher rebates of approximately 3.6%. The average number of patients on WAKIX in the fourth quarter of 2025 was approximately 8,500, with continued growth in unique healthcare professionals prescribing the medication.

Despite the revenue increase, Harmony Biosciences' cost of product sales also rose to $198.3 million, up 26.5% from $156.8 million in 2024. This increase was primarily due to triggering a higher royalty tier under the 2017 LCA earlier in 2025 compared to 2024. Research and development expenses increased by 30.0% to $189.6 million, driven by advancements in clinical trials for EPX-100, ZYN002, and Pitolisant GR/HD, as well as personnel costs and other research expenses, offset by a decrease in clinical development associated with pitolisant and a decrease in IPR&D charges. Sales and marketing expenses also saw an uptick of 7.8%, reaching $119.5 million, due to increased patient engagement and marketing activities. General and administrative expenses increased by 38.2% to $152.5 million, primarily due to higher legal and professional fees associated with patent lawsuits and settlements.

Strategic developments for Harmony Biosciences included the acquisition of Epygenix Therapeutics, Inc. in April 2024, expanding its portfolio into rare epilepsy with EPX-100 and EPX-200. In April 2024, the company also entered into a sublicense agreement with Bioprojet for BP1.15205, an orexin 2 receptor agonist. In June 2025, Harmony entered into a research collaboration, option and license agreement with CiRC Biosciences, Inc. for cell replacement therapy candidates. The company also continued to advance its next-generation pitolisant formulations, Pitolisant GR and Pitolisant HD, with Phase 3 registrational studies initiated for Pitolisant HD in narcolepsy and idiopathic hypersomnia.

Operationally, Harmony Biosciences reported that it had secured formulary access for more than 80% of all insured lives in the United States as of December 31, 2025. The company also highlighted its commitment to environmental, social, and governance (ESG) practices, with oversight from its Board and management. As of December 31, 2025, Harmony Biosciences had 293 full-time employees, with 135 dedicated to commercial functions and 103 to research and development. The company's cash, cash equivalents, and investments totaled $882.5 million, with outstanding debt of $165.0 million. Net income for the year was $158.7 million, or $2.76 per basic share and $2.71 per diluted share. The company anticipates that its existing capital resources will be sufficient to meet its operational liquidity needs for at least the next 12 months.

About Harmony Biosciences Holdings, Inc.

Harmony Biosciences is a neuroscience company focused on developing and commercializing treatments for rare neurological disorders. Its core product, WAKIX (pitolisant), addresses narcolepsy and related sleep disorders, offering a non-scheduled, first-in-class therapy with a novel mechanism. The company also advances pipeline candidates for hypersomnia, epilepsy, and neurobehavioral conditions, leveraging scientific innovation and strategic licensing to serve patients with limited treatment options.

This description was generated via AI from an annual report. Updated 9 months ago.

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