Harmony Biosciences (NasdaqGM:HRMY) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAdam Zaeske - EVP and Chief Commercial OfficerJeffrey M. Dayno - President and CEOKumar Budur - Chief Medical and Scientific OfficerMatthew Beck - Investor RelationsPatrick Trucchio - Managing Director of Equity ResearchPoorna Kannan - Biotech Equity Research AssociateSandip Kapadia - CFO and Chief Administrative OfficerConference Call ParticipantsBhavin Patel - AnalystCorinne Johnson - AnalystDavid A ...

Harmony Biosciences (NasdaqGM:HRMY) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Speaker9I will now turn the call over to Matthew Beck from ASTR Partners. Please go ahead.Speaker8Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' fourth quarter 2025 financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today, i ...

Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Industry**: Biotechnology, specifically focusing on treatments for narcolepsy and epilepsy Key Points and Arguments Business Performance and Growth - Harmony Biosciences has established a strong commercial foundation, particularly with its product Wakix, which targets narcolepsy and is projected to be a $1 billion-plus opportunity in this market [2][3] - The company is profitable and self-funding its activities, allowing for continued growth in both its pipeline and commercial portfolio [3][4] Wakix Franchise - Wakix has shown consistent performance with a steady increase in patient numbers, reporting an increase of 400 patients in Q2 and 500 patients in Q3, leading to an upward revision of revenue guidance from $820-$860 million to $845-$865 million for the year [6][7] - The product is differentiated as the only non-scheduled treatment for narcolepsy, which is well tolerated and has a unique mechanism of action [8][10] - The company plans to maintain its competitive edge through life cycle management strategies, including new formulations such as gastro-resistant (GR) and high-dose (HD) versions of pitolisant [10][11] Pipeline Developments - Harmony is advancing its pipeline with new formulations and additional assets, including orexin-2 agonists currently in phase one clinical trials and EPX-100 for epilepsy in phase three trials [3][4] - Upcoming data presentations at the American Epilepsy Society meeting are expected to provide new efficacy data for EPX-100 [3] Market Dynamics and Competitive Position - The narcolepsy market is characterized by a high discontinuation rate of 30%-50% for medications, but once patients are stabilized on Wakix, they tend to remain on therapy [17] - The company emphasizes that Wakix's unique profile will remain competitive despite the introduction of generics in the market [15][16] Future Strategies - The GR formulation aims to provide a faster therapeutic effect without the need for titration, while the HD formulation targets improved efficacy and new indications for fatigue in narcolepsy patients [11][19] - Harmony is also exploring business development opportunities to expand its commercial portfolio and pipeline further [34] Challenges and Considerations - The company is currently assessing the future of its Cannabidiol Gel (ZYN002) program following disappointing phase three results, with plans to provide updates after a thorough data review [31][32] - The transition from a single product focus to a multi-franchise business model requires careful organizational growth to ensure all programs receive adequate attention [33] Additional Important Insights - The company has a robust commercial engine and is looking to leverage its balance sheet to drive further value through business development [34] - The ongoing clinical trials and product developments are expected to enhance Harmony's position in the biotechnology sector, particularly in the treatment of sleep disorders and epilepsy [3][4]