Business
Harmony Biosciences Reports Strong First Quarter Financial Results and Acceleration of Its Growth Strategy; Advances Pitolisant Franchise to Extend Revenue Potential Beyond 2040; Strenghtens Sleep/Wake Leadership and Diversifies Into Rare Epilepsy
WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Extend WAKIX Exclusivity to September 2030: Pediatric Narcolepsy sNDA PDUFA Date of June 21, 2024; PWS Phase 3 TEMPO Study Initiated in March 2024 Pitolisant Franchise Revenue Potential Extended Beyond 2040 With Next-Generation Formulations; Reports Positive Pharmacokinetic Data on Next-Generation Formulation 1 (NG1); PDUFA Expected in 2026 Strengthens Leadership Position in Sleep/Wake with Licensing of TPM-1116, a Highly Potent and Selective Oral Orexin-2 Receptor Agonist Establishes Potential Billion Dollar Plus Rare Epilepsy Franchise Through Acquisition of Epygenix Therapeutics, Inc. Reiterates 2024 Net Product Revenue Guidance of $700 - $720 Million Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., April 30, 2024 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported year-over-year net revenue growth of 30 percent for the quarter ended March 31, 2024 and accelerated its growth strategy with the addition of a rare epilepsy franchise to its expanding pipeline of innovative, late-stage CNS assets. \"We believe Harmony is well-positioned to become the leading patient-focused CNS biotechnology company delivering innovative treatments to patients living with unmet medical needs. We have transformed our business by executing a best-in-class launch of WAKIX in narcolepsy, advancing our pipeline through life cycle management and new indications, and diversifying our portfolio through strategic business development, having closed three transactions over the past eight months,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony. “We now have three late-stage orphan/rare CNS franchises, each with potential peak sales opportunities of $1B to $2B, comprised of eight assets advancing across thirteen development programs. We expect our pipeline to deliver at least one new product or indication launch every year over the next five years, with multi-billion-dollar revenue potential extending beyond 2040. In addition, the durable commercial success of WAKIX is currently paving the way to surpassing $1 billion i...