Harmony Biosciences Holdings, Inc. has released its 10-K report, providing an overview of the company's focus on developing and commercializing therapies for patients with rare and other neurological diseases in the United States. The company's product, WAKIX (pitolisant), was approved by the U.S. Food and Drug Administration in 2019 for the treatment of excessive daytime sleepiness in adult patients with narcolepsy, and subsequently for the treatment of cataplexy in adult patients with narcolepsy in 2020. Harmony Biosciences Holdings, Inc. is also exploring potential new indications for WAKIX, such as idiopathic hypersomnia, Prader-Willi Syndrome, and myotonic dystrophy, among others.
Financially, as of December 31, 2023, Harmony Biosciences Holdings, Inc. reported continued growth in the number of unique healthcare professional prescribers of WAKIX since its launch in 2019, with approximately 6,150 patients on WAKIX by the end of 2023. The company also secured formulary access for more than 80% of all insured lives in the United States. In terms of net product revenue, the company expects sales to increase over time, while provisions for sales discounts and allowances may fluctuate based on the mix of sales to different customer segments.
The cost of product sales is expected to increase as the company ramps up production to meet future demand for WAKIX and diversify its supply chain. Harmony Biosciences Holdings, Inc. has also significantly increased its research and development efforts as it advances its clinical programs in various indications, including idiopathic hypersomnia, Prader-Willi Syndrome, and myotonic dystrophy. The company's research and development expenses primarily include development programs for potential new indications for pitolisant, as well as expenses related to its team of Medical Science Liaisons and other third-party costs.
Overall, the company's financial metrics indicate a focus on expanding its product offerings and pipeline through acquisitions and the development of new formulations of pitolisant, with a strong emphasis on advancing clinical programs for potential new indications. As a result of these announcements, the company's shares have moved -4.8% on the market, and are now trading at a price of $31.41. For more information, read the company's full 10-K submission here.
