PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) has announced record-breaking financial results for 2024, driven by robust sales of their flagship product WAKIX® (pitolisant). The company reported $714.7 million in net revenue for the full year, a 23% increase compared to 2023, with fourth-quarter revenue hitting $201.3 million. Harmony ended the year with $576 million in cash, cash equivalents, and investments, and has provided guidance for 2025 with projected revenues between $820 million and $860 million.
2024 Financial Highlights
WAKIX, an FDA-approved treatment for narcolepsy, continued its upward trajectory, contributing to Harmony’s substantial growth. The quarter saw strong organic demand and widening clinical utility, with approximately 7,100 patients on WAKIX by year-end 2024. Fourth-quarter net income rose sharply to $49.5 million, or $0.85 per diluted share, compared to $26.6 million for the same period in 2023.
For the full year, Harmony posted a GAAP net income of $145.5 million, or $2.51 per diluted share, up from $128.9 million in 2023. Non-GAAP adjusted net income grew 24% to $233.9 million, or $4.04 per diluted share.
“Our 2024 performance reflects the strength of WAKIX and its differentiated position in the marketplace,” said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. “We see tremendous opportunity ahead as we continue to expand our pipeline and invest in innovative therapies for patients with unmet medical needs.”
2025 Milestones and Strategic Initiatives
Harmony’s development pipeline is set to deliver significant progress in 2025. The company will initiate two Phase 3 trials for its next-generation Pitolisant HD formulation in Q4, targeting narcolepsy and idiopathic hypersomnia. These trials aim to extend the pitolisant franchise through the 2040s. Additionally, Harmony expects topline data from its pivotal Phase 3 study of ZYN002 for Fragile X syndrome in Q3 2025, which could potentially lead to the first approved treatment for this condition.
Further developments include advancing its novel orexin-2 receptor agonist, set for first-in-human trials in the second half of 2025, and continued progress on its rare epilepsy portfolio, including EPX-100 and EPX-200.
“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,” added Dayno. “With major milestones ahead and the potential for at least one product or indication launch each year going forward, our pipeline has the ability to generate over $3 billion in net revenue as we continue building our leadership in the central nervous system space.”
Strengthening Intellectual Property
Harmony also achieved a favorable settlement in its first Abbreviated New Drug Application (ANDA) litigation, granting Novugen Pharma a license to sell a generic version of WAKIX beginning in January 2030, or earlier under certain conditions. The company is on track to secure pediatric exclusivity, which could extend regulatory protection by an additional six months.
2025 Guidance
For 2025, Harmony expects net product revenue between $820 million and $860 million, fueled by continued WAKIX sales growth and pipeline advancements. The company aims to maintain its trajectory toward realizing a $1 billion opportunity for WAKIX in the narcolepsy market alone.
With record financial performance, promising advancements in its pipeline, and a strong commitment to innovation, Harmony Biosciences is well-positioned to maintain momentum and solidify its leadership in the sleep/wake and broader CNS markets.
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