Harmony Biosciences (HRMY) 25th Annual Needham Virtual Healthcare Conference summary

Strategic priorities and pipeline overview

• Targeting over $1 billion in net revenue for WAKIX in its sixth year, with strong patient growth and expanded sales teams in 2026.

• Advancing pitolisant franchise with GR (gastroresistant) formulation NDA submission this quarter and PDUFA in Q1 next year, and HD (high dose) formulation in phase III trials for narcolepsy and IH, targeting 2028 PDUFA.

• New pitolisant formulation licensed with patent protection to 2042, aiming to address fatigue in broader CNS populations, including MS and Parkinson’s.

• Orexin program BP1.15205 progressing with phase I data expected mid-year and IND submission planned, aiming for broad CNS indications.

• EPX-100 epilepsy program in phase III for Dravet and LGS, with top-line data expected in 2027 and PDUFA in 2028.

Commercial execution and market positioning

• WAKIX growth driven by unique non-scheduled status, strong safety, and broad access, with recent payer wins and process improvements.

• Expanded field and reimbursement teams by 20% in early 2026 to support continued growth.

• Settled with six of seven ANDA filers, securing LOE to September 2029 and pediatric exclusivity to March 2030.

• GR formulation expected to recapture lapsed patients and address GI-related discontinuations, with a $300–500 million opportunity.

• HD formulation positioned as a new branded launch with up to 2x dose, targeting unique indications and a billion-plus opportunity.

Competitive landscape and differentiation

• Anticipates new orexin entrants will expand brand utilization rather than take share, with WAKIX maintaining a differentiated safety and efficacy profile.

• Polypharmacy remains common; WAKIX’s clean profile supports its use as an add-on therapy.

• Internal orexin program boasts high potency, novel scaffold, and clean preclinical safety, aiming for best-in-class status.