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Harmony Biosciences (HRMY) investor relations material

Harmony Biosciences Q3 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2025 earnings summary4 Nov, 2025

Executive summary

  • Q3 2025 net revenue reached $239.5M, up 29% year-over-year, driven by WAKIX® growth and record patient numbers, with over 8,100 average patients on therapy.

  • Net income for Q3 2025 was $50.9M GAAP ($0.87/diluted share) and $63.5M non-GAAP ($1.08/diluted share), both up from the prior year.

  • Cash and investments totaled $778.4M at quarter end, supporting a robust late-stage pipeline and strategic growth.

  • Raised full-year 2025 net revenue guidance to $845–$865M, reflecting strong commercial execution and patient growth.

  • Advanced late-stage pipeline with multiple Phase 3 programs, including pitolisant HD and GR, and ongoing epilepsy and Orexin 2 agonist studies.

Financial highlights

  • Net product revenue for Q3 2025 was $239.5M, up from $186M in Q3 2024, a 29% year-over-year increase.

  • Non-GAAP adjusted net income for Q3 2025 was $63.5M ($1.08/diluted share), up from $57.3M ($0.99/diluted share) in Q3 2024.

  • Gross profit for Q3 2025 was $179.8M (75.1% margin); operating income was $65.5M.

  • Operating expenses rose to $114.3M, mainly due to increased R&D and a $15M milestone for ZYN002 trial enrollment.

  • Cash and investments totaled $778.4M at quarter-end, up $106M sequentially.

Outlook and guidance

  • Full-year 2025 revenue guidance raised to $845–$865M, citing strong patient growth and commercial execution.

  • Late-stage pipeline expected to have up to five Phase 3 registration programs by year-end.

  • Anticipate regulatory milestones for pitolisant GR and HD, and first-in-human studies for BP1.15205 in 2026.

  • Management expects existing liquidity to fund operations and investing activities for at least 12 months.

  • Confident in achieving $1B annual revenue in narcolepsy before loss of exclusivity.

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Frequently asked questions

Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company that develops and sells novel therapies for people with rare diseases. It offers Naurex, an investigational drug to treat depression; Wakix, an oral treatment for excessive sleepiness; SPRITAM rapidly disintegrated tablets to treat nighttime seizures; and EVKOTEBO for prevention of recurrent seizures in people with partial-onset epilepsy. The company was formerly known as Axsome Therapeutics, Inc. and changed its name to Harmony Biosciences Holdings, Inc. in January 2019. Harmony Biosciences Holdings, Inc. was founded in 2017and is headquartered in Plymouth Meeting, Pennsylvania.

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