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PLYMOUTH MEETING, Pa. - Harmony Biosciences Holdings , Inc. (NASDAQ: NASDAQ:HRMY) today reported significant growth in its net product revenues for the fourth quarter and full year of 2024. The unaudited preliminary figures show a net revenue of approximately $201 million for the quarter ended December 31, 2024, and $714 million for the full year, marking an approximate 23% increase from the previous year. This growth aligns with the company's strong financial performance, maintaining an impressive 78.65% gross profit margin. According to InvestingPro analysis, the company's financial health score is rated as EXCELLENT, with particularly strong metrics in profitability and cash flow management.
The company anticipates a continued upward trajectory in 2025, projecting net revenues of between $820 to $860 million. This forecast aligns with Harmony (JO:HARJ) Biosciences' strategy to expand its neuroscience pipeline, which includes several potential catalysts expected throughout the year. InvestingPro data shows the company is currently trading below its Fair Value, suggesting potential upside opportunity. With a strong current ratio of 3.24 and more cash than debt on its balance sheet, the company appears well-positioned to fund its growth initiatives.
The first quarter may see the FDA decision on file acceptance of the supplemental New Drug Application (sNDA) for pitolisant for the treatment of Idiopathic Hypersomnia, with the possibility of approval within the year. In the second quarter, preclinical data for BP1.15205, an Orexin receptor agonist, is slated for presentation at the SLEEP 2025 conference, with a first-in-human study anticipated in the third quarter.
A pivotal Phase 3 trial for ZYN002 in Fragile X Syndrome is expected to produce topline data in the third quarter, potentially offering the first approved treatment for patients with this condition. The fourth quarter is set to mark the initiation of a pivotal Phase 3 trial of Pitolisant-HD in Narcolepsy.
Harmony Biosciences' robust pipeline is poised to deliver at least one new product or indication approval annually for the next four years, with the potential to generate over $3 billion in net revenue. The company has up to six Phase 3 clinical programs planned by the end of 2025, including a pivotal Phase 3 study in Lennox-Gastaut syndrome for EPX-100 initiated in the last quarter of 2024.
WAKIX, Harmony Biosciences' flagship product, is a first-in-class medication approved for the treatment of narcolepsy symptoms in adult and pediatric patients. The company has an exclusive license from Bioprojet to develop, manufacture, and commercialize pitolisant in the United States.
The financial information based on this press release is preliminary and unaudited, and it is subject to change. Harmony Biosciences will provide further details during its presentation at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025. For investors seeking deeper insights, InvestingPro offers comprehensive analysis including 8 additional ProTips and a detailed Pro Research Report, providing valuable context for the company's financial position and growth trajectory.
In other recent news, Harmony Biosciences reported robust Q3 momentum in 2024, with WAKIX net revenue reaching $186 million and total cumulative sales surpassing $2 billion since its launch. The firm has reaffirmed its 2024 revenue guidance between $700 million and $720 million, while also anticipating WAKIX to exceed $1 billion in the adult narcolepsy market.
In addition to these developments, Harmony Biosciences is advancing its pipeline, which includes new formulations of pitolisant and treatments for rare neurological diseases. The company maintains a strong financial position with a cash balance of approximately $505 million.
Harmony plans for annual product or indication launches over the next five years, potentially yielding over $3 billion in net revenue. Regulatory filings for next-generation formulations of pitolisant are expected in 2026 and 2028.
However, the firm is preparing for IP litigation, with a claims construction hearing scheduled for March 2024 and a trial in 2026. On a positive note, two recent challenges to the U.S. PTO regarding the company's patents were denied, securing their IP position until 2030.
Finally, Harmony is developing a specific measurement instrument to assess fatigue, a common symptom in narcolepsy patients, and is confident in the strength and validity of its patents despite the upcoming IP litigation.
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