Harmony Biosciences Holdings Inc. (Nasdaq HRMY) has reported record-breaking sales in 2024 for the narcolepsy medication WAKIX. It also forecasts higher revenues for 2025. This is as the company continues to advance several clinical trials, including one for non-THC cannabis cannabidiol treatments for rare genetic disorders.
According to the company, WAKIX has generated revenue of $201.3m in the fourth quarter. This is a 23 percent increase over the year 2023. The company anticipates that the treatment will generate between $820,000,000 and $860,000,000 in revenue this year.
Harmony has a number of pipeline projects, including ZYN002, dubbed by the firm as “the only synthetic cannabidiol manufactured pharmaceutically that is free from THC.” This drug comes in a gel formulation that is protected by a patent for transdermal application.
Harmony anticipates that results of a phase 3 trial testing ZYN002 for Fragile X Syndrome will be available by the third quarter 2025. It could be the first treatment approved for Fragile X syndrome, which is a condition that affects around 80,000 people in the U.S.
Harmony obtained the ZYN002 Program in 2023 through Harmony’s $60 million purchase of Zynerba Pharmaceuticals. Zygel (a synthetic cannabidiol) received the orphan drug designation by both U.S. regulators and European regulators, for Fragile X treatments, along with FDA Fast Track.
Jeffrey Dayno said that the Zynerba deal in 2023 was “an important milestone in Harmony’s strategic plan to develop a diverse portfolio of innovative products to meet unmet medical need and to drive our growth over time.”
Dayno stated in Harmony’s most recent announcement that “2025 has the potential to be a year of transformation for Harmony as we bring our pipeline into focus, and advance our strategy of long-term expansion.”
ZYN002 contains no THC (the compound responsible for the psychoactive effect of cannabis), so it could be considered a “non-scheduled” product.
Harmony posted a net profit of $145.5 millions for the entire year and $49.5 million in the fourth quarter. In 2024, the company had $576 millions in cash and investment.
In 2024, research expenses are expected to nearly double from $145.8 millions in 2018 to $145.8million.