Harmony Biosciences
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Harmony Biosciences (HRMY) investor relations material

Harmony Biosciences Q4 2025 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q4 2025 earnings summary24 Feb, 2026

Executive summary

  • Achieved Q4 2025 net product revenue of $243.8M, up 21% year-over-year; full-year 2025 net product revenue reached $868.5M, a 22% increase from 2024, marking six consecutive years of growth and profitability.

  • WAKIX reached approximately 8,500 average patients in Q4 2025, with three consecutive quarters of 400+ patient adds, and is on track for blockbuster status in 2026.

  • Expanded commercial and field teams by 20% to support continued growth and launched a new online portal for patient access.

  • FDA approved WAKIX for cataplexy in pediatric patients, expanding its label and market opportunity.

  • Advanced late-stage pipeline with five ongoing Phase 3 trials across CNS indications and new pitolisant formulations targeting broader CNS disorders.

Financial highlights

  • Q4 2025 net income was $22.5M ($0.38/diluted share), down from $49.5M in Q4 2024; non-GAAP adjusted net income was $33.4M ($0.57/diluted share).

  • Full-year 2025 GAAP net income was $158.7M ($2.71/diluted share), up from $145.6M in 2024; non-GAAP adjusted net income was $211.0M ($3.60/diluted share).

  • Operating expenses for Q4 2025 rose 50% year-over-year to $136.7M; full-year operating expenses increased 26% to $461.6M, driven by R&D, commercialization, and litigation costs.

  • Cash, cash equivalents, and investments totaled $882.5M at year-end 2025, up from $576.1M at year-end 2024, reflecting $348.2M in cash generation from operations.

  • Cost of product sold increased 26% in Q4 2025 and 27% for FY 2025 compared to prior periods.

Outlook and guidance

  • 2026 WAKIX net revenue guidance reiterated at $1.0–$1.04B, reflecting continued strong demand and blockbuster potential.

  • Expect typical Q1 seasonality with higher gross-to-net deductions and inventory drawdown.

  • Significant increases in R&D investment anticipated in 2026 to support five ongoing Phase 3 programs and a planned sixth study.

  • Pitolisant GR NDA submission expected in Q2 2026, with PDUFA date in Q1 2027; pipeline includes five ongoing Phase 3 trials across CNS indications.

  • Business development remains a high priority, with capital deployment focused on expanding the pipeline and commercial portfolio.

Impact of pediatric exclusivity on WAKIX patent?
Pitolisant's lead broader CNS indication
Drivers of Q4 2025 G&A expense increase?
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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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