Harmony Biosciences Holdings (Nasdaq: HRMY) reported record sales for its narcolepsy treatment WAKIX in 2024 and projected stronger revenue for 2025, as the company advances several clinical trials including a non-THC cannabidiol treatment for a rare genetic disorder.
The company said Tuesday that WAKIX generated $201.3 million in revenue during the fourth quarter and $714.7 million for the full year, a 23% increase over 2023. The company expects the treatment to bring in revenue between $820 million and $860 million this year.
Among the pipeline highlights, Harmony is developing ZYN002, which the company described as “the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC.” The drug is formulated as a patent-protected gel for transdermal delivery through the skin.
Harmony expects results from a Phase 3 trial testing ZYN002 in Fragile X syndrome by the third quarter of 2025. If successful, it could become the first approved treatment for Fragile X, which affects approximately 80,000 patients in the U.S.
The ZYN002 program came to Harmony through its $60 million acquisition of Zynerba Pharmaceuticals in 2023. The synthetic cannabidiol drug, previously known as Zygel, received orphan drug designation from both U.S. and European regulators for Fragile X treatment, as well as FDA Fast Track designation.
When announcing the Zynerba acquisition in 2023, Harmony CEO Jeffrey Dayno called it “an important step in Harmony’s strategy to build a diversified portfolio of innovative assets to address unmet medical needs and drive our long-term growth.”
“2025 is set up to be a transformational year for Harmony, as our robust, late-stage pipeline comes into focus and we advance our long-term growth strategy,” Dayno said in the company’s latest announcement.
The company noted that because ZYN002 is made through a synthetic process rather than extracted from cannabis plants, it “has the potential to be a nonscheduled product if approved” since it contains no THC, the compound that causes cannabis’ psychoactive effects.
Harmony reported net income of $49.5 million for the fourth quarter and $145.5 million for the full year. The company ended 2024 with $576 million in cash and investments.
Research expenses nearly doubled to $145.8 million in 2024
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