Harmony Biosciences (HRMY) Piper Sandler Virtual CNS Symposium summary

Key financial and product performance highlights

• Achieved record quarterly performance for WAKIX, supporting pipeline development and business transactions.

• Strong WAKIX sales enable advancement of BP-205 and other pipeline products.

• Commercial execution and team capabilities highlighted as drivers of growth.

BP-205 clinical development and outlook

• BP-205 features a novel, highly potent orexin 2 receptor agonist scaffold with favorable safety profile.

• Single ascending dose study showed rapid onset, dose proportionality, long half-life, and no major safety concerns.

• MAD study completed; insomnia and polyuria observed but not severe; full data expected Q4.

• IND opened in the US; sleep-deprived volunteer study to start, with top-line data in early 2027.

• Multiple phase II studies planned for CNS indications, targeting cognition, attention, mood, and fatigue.

Orexin agonist portfolio strategy

• Intends to build a broad orexin agonist portfolio for both rare and large CNS indications.

• Plans to differentiate assets by indication and market needs, with backup compounds in development.

• Timelines for additional orexin compounds not yet disclosed.