Harmony Biosciences (HRMY) investor relations material

Recent commercial performance and market dynamics

• WAKIX has shown steady quarter-over-quarter growth for six years, with record patient adds in Q2 and Q3, driven by improved sales execution and marketing focus.

• Patient access has improved due to payer wins and streamlined processes, resulting in faster and more successful dispensing.

• Growth is seen across all patient types, including switchers, add-ons, and treatment-naive, reflecting the polypharmacy nature of the narcolepsy market.

• The narcolepsy market is expanding, with 80,000 diagnosed and another 80,000–90,000 undiagnosed patients, offering significant growth potential.

• WAKIX maintains a balanced NT1/NT2 patient mix and continues to grow in both segments.

Payer landscape and competitive outlook

• Entry of Xyrem generics is expected to lower oxybate therapy costs but mainly impact branded oxybates, with minimal effect on other brands.

• WAKIX, as the only non-scheduled product, is not subject to step therapy with oxybates, potentially benefiting from payer dynamics.

• Combination therapy with oxybates and WAKIX may become more common as oxybate prices decrease.

Orexin agonist developments and strategic positioning

• Anticipated orexin agonist launches, such as Takeda’s oveporexton, are expected to have a gradual impact, with initial uptake limited to NT1 and no pediatric indication.

• WAKIX is expected to retain its unique position due to its non-scheduled status, broad utility, and strong physician perception.

• The company is advancing its own orexin-2 agonist, with phase I PK/PD studies underway and initial clinical data expected in 2026.

• The orexin-2 agonist demonstrates high potency and selectivity, aiming for once-daily dosing and broad application across NT1, NT2, and IH.