Harmony Biosciences (NasdaqGM:HRMY) FY Conference Transcript

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.