Pitolisant Franchise Strategy
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Harmony Biosciences (NasdaqGM:HRMY) FY Earnings Call Presentation
2026-01-14 00:30
Financial Performance and Growth - Harmony Biosciences anticipates net revenue between $1 billion and $1.04 billion for 2026[16] - The company's revenue has grown consistently year-over-year, with $714.7 million in 2024, $868 million in 2025, and projected growth into 2026[52] - WAKIX net revenue has shown significant growth from $160 million in 2020 to over $1 billion projected for 2026[15] Pitolisant Franchise Strategy - The company is focused on growing the WAKIX franchise, extending it with Pitolisant GR, and expanding it with Pitolisant HD[8] - Pitolisant GR has the potential to extend the pitolisant franchise with utility patents filed to 2044[9] - Pitolisant HD has the potential to expand the pitolisant patient base into new indications[9] Pipeline Development - A Phase 1 clinical PK data for BP1.15205, a potential best-in-class Orexin 2 Receptor (OX2R) Agonist, is anticipated in mid-2026[42] - Topline data from ongoing global Phase 3 trials for EPX-100 in Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) are anticipated in 1H 2027[45, 47] - The company submitted an NDA for Pitolisant GR in Q2 2026, with an anticipated PDUFA date in Q1 2027[31] Market Opportunity - There are approximately 170,000 people living with narcolepsy in the U S, with over 50% undiagnosed[22]