Harmony Biosciences Expands It CNS-Focused Pipeline With Epilepsy Candidate, Q1 Earnings Beat Street View

Tuesday, Harmony Biosciences HRMY announced the acquisition of Epygenix Therapeutics, adding a rare epilepsy franchise to its expanding late-stage pipeline of central nervous system (CNS) assets.

Under the terms of the definitive agreement, Harmony paid $35 million in cash with the potential for payments of up to $130 million based on development and regulatory milestones. 

In addition, there are potential payments of up to $515 million if certain sales milestones are achieved.

“The acquisition of Epygenix gives us three distinct CNS franchises in late-stage development, each with a potential US peak sales opportunity of $1B-$2B,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer at Harmony Biosciences. 

“We have been strategically building a robust and diverse pipeline of innovative CNS assets for rare diseases that has transformed our business. This acquisition builds on our leadership position in sleep/wake and our franchise in neurobehavioral disorders…”

The acquisition includes clemizole hydrochloride (EPX-100), a potent, oral, centrally acting serotonin (5HT2) agonist. It is currently in a pivotal registrational clinical trial for Dravet syndrome in children and adults and is poised to enter Phase 3 for Lennox-Gastaut syndrome. 

A second investigational product, EPX-200, is a potent, oral, centrally active , and selective 5HT2C agonist and is currently in IND-enabling studies. 

Harmony Biosciences reported that the first quarter adjusted EPS of $0.88, up from $0.66 a year ago, beat the consensus of $0.62.

The company reported sales of $154.6 million, missing the consensus of $154.8 million.

The 30% growth versus the same period in 2023 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the US). 

The average number of patients on WAKIX increased by approximately 150 patients sequentially to approximately 6,300 for the quarter ended March 31, 2024.

Guidance: Harmony reiterates fiscal year 2024 net product revenue of $700 million to $720 million versus consensus of $710.8 million.

Price Action: HRMY shares are up 9.79% at $32.11 at the last check Tuesday.