Harmony Biosciences (HRMY) Q4 2025 earnings summary

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.