Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Event**: 44th JPM Healthcare Conference - **Date**: January 13, 2026 Key Industry Insights - **Core Focus**: Central Nervous System (CNS) disorders, particularly narcolepsy and related conditions - **Product Highlight**: WAKIX, a treatment for narcolepsy, is on track to achieve blockbuster status in 2026 with projected net revenue exceeding $1 billion Core Points and Arguments 1. **Momentum and Growth**: Harmony enters 2026 with significant momentum driven by three key factors: WAKIX performance, a robust late-stage pipeline, and a strong financial profile [2][3] 2. **WAKIX Performance**: WAKIX has shown five years of consecutive growth and profitability, with 2025 net revenue reported at $868 million, exceeding guidance [9][41] 3. **Pipeline Development**: Five phase three programs are advancing towards distinct CNS indications, setting up multiple catalysts for growth in the coming years [2][24] 4. **Pitolisant Franchise Expansion**: The introduction of Pitolisant GR (gastro-resistant formulation) and Pitolisant HD (high-dose formulation) aims to address unmet patient needs and expand the franchise [4][13] 5. **Market Opportunity**: There are approximately 80,000 diagnosed narcolepsy patients in the US, with an additional 90,000 undiagnosed, indicating significant growth potential for WAKIX [10][42] 6. **Commercial Strategy**: Harmony has improved its commercial operations, achieving broad formulary access (80% of lives covered) and enhancing patient support systems [11][27] 7. **Regulatory Milestones**: Anticipated NDA submission for Pitolisant GR in Q2 2026, with a PDUFA date expected in Q1 2027 [30][37] 8. **Financial Health**: Harmony maintains a strong balance sheet with over $770 million in cash, allowing for continued investment in pipeline development and business growth [44][45] Additional Important Insights - **Patient-Centric Approach**: The company emphasizes the importance of addressing patient needs, particularly in narcolepsy and related disorders, through innovative product formulations [4][14] - **Unique Product Profiles**: The differentiated profiles of Pitolisant formulations are expected to enhance clinical utility and market competitiveness [6][39] - **Future Catalysts**: Anticipated data readouts from ongoing trials in 2027 and 2028 for various CNS indications, including Prader-Willi syndrome and epilepsy programs [21][20] - **Business Development Focus**: Harmony is actively seeking strategic opportunities to expand its portfolio in the CNS space, particularly in orphan and rare diseases [44][45] This summary encapsulates the key points discussed during the conference, highlighting Harmony Biosciences' strategic direction, product pipeline, and market opportunities within the CNS industry.