Harmony Biosciences (HRMY) Goldman Sachs 45th Annual Global Healthcare Conference summary

Commercial performance and growth outlook

• WAKIX achieved over $582 million in sales last year and is on track for $700–$720 million this year, with strong double-digit growth expected to continue.

• The product has outperformed historical analogs in its first five years, exceeding patient goals annually.

• WAKIX benefits from broad clinical utility and non-scheduled status, allowing access to a wider prescriber base.

• Penetration among non-oxybate REMS-enrolled doctors is about 33% since launch, with continued growth in both REMS and non-REMS segments.

• The narcolepsy market includes 80,000 diagnosed patients in the U.S., supporting ongoing expansion.

Competitive landscape and market dynamics

• Despite generic oxybates entering the market, WAKIX has maintained strong formulary position and growth.

• The market is seen as non-competitive, with all brands growing as education and diagnosis rates improve.

• WAKIX’s unique mechanism and non-scheduled status differentiate it from competitors, especially in polypharmacy settings.

• No negative impact observed from generics or once-nightly oxybate introductions.

Pipeline and lifecycle management

• Submission of sNDA for idiopathic hypersomnia (IH) is planned for the second half of the year, leveraging strong response rates and real-world evidence.

• Two next-generation pitolisant programs are in development: high-dose (HD) for enhanced efficacy and gastro-resistant (GR) for improved GI tolerability.

• The HD program targets both excessive daytime sleepiness and fatigue, while GR addresses GI disturbances affecting up to 88% of Type 1 narcolepsy patients.

• The franchise aims for extension into the mid-2040s, with an orexin-2 agonist to maintain leadership in the sleep-wake space.