Harmony Biosciences stock reaffirms buy rating ahead of Q4 results

On Friday, H.C. Wainwright research firm expressed continued confidence in shares of Harmony Biosciences Holdings Inc. (NASDAQ:HRMY), maintaining a Buy rating and a $75.00 price target for the company's stock.

The firm's analyst highlighted Harmony (JO:HARJ)'s recent pre-announcement of its 2024 preliminary net revenue and its guidance for 2025. Harmony anticipates fourth-quarter 2024 net product revenues of about $201 million, which aligns with both the analyst's and the consensus estimates. For the full year 2024, the company expects revenues of roughly $714 million, matching H.C. Wainwright's projection and slightly above the $712 million consensus.

Harmony's 2025 revenue guidance is set between $820 million and $860 million, which is slightly below H.C. Wainwright's estimate of $870 million but in line with the $859 million market consensus. The firm views this as a track towards a potential blockbuster status for the company's lead product, WAKIX, which is approved for treating both type 1 and type 2 narcolepsy.

The analyst also pointed out that Harmony is awaiting a decision from the FDA on a supplemental New Drug Application for WAKIX in treating idiopathic hypersomnia, expected in the first quarter of 2025, with approval potentially coming later that year.

Furthermore, Harmony is set to present additional preclinical data on BP1.15205, an OX2R agonist, at the SLEEP 2025 Annual Conference in June, with the potential to initiate first-in-human studies in the third quarter of 2025 if an Investigational New Drug application is accepted.

In addition to these developments, Harmony expects to release top-line data from a pivotal Phase 3 trial evaluating ZYN002, a cannabidiol gel, in Fragile X syndrome by the third quarter of 2025. A Phase 3 trial for pitolisant-HD in narcolepsy and idiopathic hypersomnia is planned to begin in the fourth quarter of 2025.

The company has also initiated a Phase 3 study with EPX-100, clemizole hydrochloride, for Lennox-Gastaut syndrome in the fourth quarter of 2024. These milestones underscore Harmony's progress in its product pipeline and potential growth areas.

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