Harmony Biosciences Reports Record Q4 Net Revenue and Ambitious 2025 Pipeline

Harmony Biosciences Holdings Inc. (NASDAQ: HRMY) announced on February 25, 2025 its financial results for the quarter and full year ended December 31, 2024, marking a milestone with record net revenue figures. In its latest SEC filing on Form 8-K, the company detailed that Q4 2024 net revenue reached $201.3 million – the highest level in its history – while full-year net revenue climbed to $714.7 million. The accompanying press release, filed as Exhibit 99.1, highlighted durable double-digit sales growth and robust performance of its key product, WAKIX®, which the company views as having the potential to exceed a $1 billion opportunity in the adult narcolepsy market.

The filing also included an investor presentation (Exhibit 99.2) available on the company’s website. The presentation provided further insights into Harmony Biosciences’ strategic and clinical initiatives, outlining a catalyst-rich pipeline for 2025. Notable among these is the plan to initiate Phase 3 registrational trials for Pitolisant HD targeting narcolepsy and idiopathic hypersomnia later this year, as well as the commencement of a pivotal study for Pitolisant GR expected to provide topline data in the later part of 2025. Additionally, the presentation emphasized an anticipated topline data readout from a Phase 3 registrational trial of ZYN002 in Fragile X syndrome slated for the third quarter of 2025.

Further underlining its strategic focus, the investor presentation detailed the company’s efforts to extend its pitolisant franchise through provisional intellectual property protection lasting until 2044. Harmony Biosciences is also pursuing expanded indications and additional clinical programs focused on sleep/wake disorders, neurobehavioral conditions, and rare forms of epilepsy, aiming to drive both patient growth and revenue over the coming years.

Financial highlights from the report include a notable increase in GAAP net income, which grew by 86% in the fourth quarter compared to the previous year, along with an increase in non-GAAP adjusted net income per diluted share to $1.08 from $0.73. At the end of 2024, the company reported $576 million in cash, cash equivalents, and investments, and it has provided full-year 2025 guidance in the range of $820 million to $860 million.

Harmony Biosciences cautioned that the presentation and related forward-looking statements are subject to risks and uncertainties, as detailed in its filings with the Securities and Exchange Commission. The company reiterated that actual results could differ materially from those anticipated due to various factors, including market competition and inherent clinical and operational risks.

Overall, the record financial performance and robust pipeline developments underscore Harmony Biosciences’ commitment to addressing unmet medical needs while advancing its growth strategy across multiple therapeutic areas.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Harmony Biosciences’s 8K filing here.

Harmony Biosciences Company Profile

Harmony Biosciences Holdings, Inc, a commercial-stage pharmaceutical company, focuses on developing and commercializing therapies for patients with rare and other neurological diseases in the United States. The company offers WAKIX (pitolisant), a molecule with a novel mechanism of action for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.