Summary:
Harmony Biosciences reported preliminary revenue for 2024, with Wakix generating $714 million, a 23% increase from 2023. The company outlined its 2025 key catalysts, including an FDA decision on pitolisant for idiopathic hypersomnia, the initiation of a pivotal trial for Pitolisant-HD in narcolepsy, and preclinical data for BP1.15205, an OX2R agonist. These milestones reflect Harmony’s commitment to advancing its neuroscience pipeline and expanding its portfolio to address unmet needs in sleep and neurological disorders.
Key Takeaways:
- Strong Revenue Growth for Wakix: Preliminary 2024 revenue for Wakix reached $714 million, representing a 23% increase, driven by its use in treating narcolepsy in adults and pediatric patients.
- Key 2025 Catalysts Announced: Harmony highlighted milestones for 2025, including an FDA decision on pitolisant for idiopathic hypersomnia and the launch of a pivotal trial for Pitolisant-HD to address unmet needs in narcolepsy.
- Pipeline Expansion with BP1.15205: The company is advancing BP1.15205, an OX2R agonist, with preclinical safety and efficacy data to be presented in Q2 2025 and a first-in-human study planned for Q3 2025.
Harmony Biosciences Holdings announced preliminary, unaudited net product revenues for Q4 and full year 2024 of $201 million and $714 million, respectively.
Harmony will be highlighting its catalysts for 2025 and other key milestones during its presentation at the 43rd Annual JP Morgan Healthcare Conference on Jan 15 at 2:15 pm ET.
“2025 is a pivotal year for Harmony Biosciences, as we focus on unlocking the full potential of our catalyst-rich neuroscience pipeline,” says Jeffrey M. Dayno, MD, president and chief executive officer of Harmony Biosciences, in a release. “Building upon our foundation of strong and continued revenue growth for Wakix, our multi-franchise pipeline has come into focus with value-creating catalysts expected each and every quarter this year. We are entering 2025 with strong momentum and a clear path toward long-term growth, building a company with the potential to deliver over $3 billion in net revenue going forward.”
Harmony’s Q4 and Full Year 2024 Net Product Revenue for Wakix
Preliminary, unaudited net product revenue for the quarter ended Dec 31, 2024, was approximately $201 million, compared to $168.4 million for the same period in 2023 for Harmony’s Wakix, indicated for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy.
Preliminary, unaudited net product revenue for the full year ended Dec 31, 2024, was approximately $714 million, compared to $582 million for the same period in 2023, representing ~23% growth in its fifth year on the market.
The average number of patients on Wakix increased by approximately 300 sequentially to approximately 7,100 for the quarter ended Dec 31, 2024.
Net revenue is projected between $820 to $860 million for 2025.
Key Catalysts for 2025
Harmony Biosciences highlights key catalysts for 2025:
- Q1 – US Food and Drug Administration (FDA) decision on file acceptance of pitolisant supplemental new drug appliance (sNDA) for idiopathic hypersomnia (IH)
- IH sNDA for pitolisant submitted in Q4 2024
- Potential FDA approval in 2025
- Q2 – Preclinical data for BP1.15205 (OX2R agonist) to be presented at SLEEP 2025
- Data to include preclinical safety and efficacy
- BP1.15205 on track for first-in-human study in Q3 2025
- Q3 – Topline data readout for ZYN002 from pivotal phase 3 trial in Fragile X syndrome (FXS)
- Potential for first and only approved treatment for patients with FXS
- Estimated 80,000 people living with FXS in the US; worldwide rights
- Q4 – Initiation of Pitolisant-HD pivotal phase 3 trial in narcolepsy
- Designed to address the largest unmet need in patients with narcolepsy by providing greater efficacy for both excessive daytime sleepiness and cataplexy
- Program to include novel endpoint to assess narcolepsy-related fatigue
- Preliminary IP filed out to 2044 to extend the pitolisant franchise
Robust, Multi-Franchise Pipeline
- Anticipates up to six phase 3 clinical development programs by year-end 2025
- Initiated pivotal phase 3 study in Lennox-Gastaut syndrome (LGS) for EPX-100 in Q4 2024
- EPX-100 is the most advanced 5HT2 (serotonin) agonist in clinical development
- Initiation of Pitolisant-GR pivotal bioequivalence study in Q1 2025 with readout anticipated Q3 2025
- Initiated pivotal phase 3 study in Lennox-Gastaut syndrome (LGS) for EPX-100 in Q4 2024
- Pipeline poised to deliver at least one new product or indication approval every year for the next four years (2028)
- Current pipeline has the potential to generate over $3B in net revenue
The financial information is preliminary, unaudited, and subject to change. It does not present all the information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2024.
Photo caption: Harmony’s Wakix
File photo/Harmony Biosciences
