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 patient adds exceeded 400 for the third consecutive quarter, reaching ~8,500 average patients in Q4 2025.

• Guidance for 2026 WAKIX net revenue set at $1B–$1.04B, targeting blockbuster status and supported by robust pipeline and commercial expansion.

• Settlements completed with six of seven ANDA filers, securing WAKIX franchise exclusivity potentially until March 2030 if pediatric exclusivity is granted.

• Advanced late-stage pipeline with five ongoing Phase 3 trials across CNS indications and NDA submission for Pitolisant GR planned for Q2 2026.

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), 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, reflecting increased R&D, commercialization, and litigation costs; full-year operating expenses increased 26% to $461.6M.

• Cash, cash equivalents, and investments at year-end 2025 totaled $882.5M, up from $576.1M at year-end 2024, supporting ongoing R&D and commercial activities.

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

• Gross profit for 2025 was $670.1M, up from $557.9M in 2024; operating income for 2025 was $208.5M, up from $190.8M in 2024.

Outlook and guidance

• 2026 WAKIX net revenue guidance reiterated at $1.0–$1.04B, driven by continued patient growth and new pediatric cataplexy indication.

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

• Expect increased R&D expenses in 2026 due to five ongoing Phase 3 programs and a planned sixth.

• Typical Q1 seasonality anticipated, with higher gross-to-net deductions and copay obligations.