Harmony Biosciences (HRMY) Q1 2026 earnings summary

Executive summary

• Q1 2026 net product revenue reached $215.4 million, up 17% year-over-year, driven by strong WAKIX demand despite market access headwinds and supported by higher unit sales and a price increase.

• Net income was $32.5 million ($0.55 per diluted share), down from $45.6 million ($0.78 per diluted share) in Q1 2025, primarily due to $32 million in upfront licensing and R&D expenses.

• Strategic priorities include protecting the pitolisant franchise, advancing new formulations and pipeline assets, and expanding business development for future growth.

• Leadership team expanded with new CFO and COO appointments to support the next phase of growth.

• Advanced pipeline with new license agreements, acquisitions, and clinical trial progress in rare neurological diseases.

Financial highlights

• Net product revenue for Q1 2026 was $215.4 million, up from $184.7 million in Q1 2025.

• Gross profit rose to $170.9 million, with gross margin at 79.3%, down from 82.7% year-over-year.

• Cost of product sold increased 39% to $44.5 million, mainly due to new royalties and licensing agreements.

• Operating expenses rose to $133.6 million, up 38% year-over-year, driven by R&D and licensing payments.

• Cash, cash equivalents, and investments totaled $870.5 million as of March 31, 2026, with $160 million in debt.

Outlook and guidance

• Full-year 2026 net revenue guidance reaffirmed at $1.0–$1.04 billion, with WAKIX expected to exceed $1 billion.

• NDA submission for Pitolisant GR planned for Q2 2026, with a potential PDUFA date in Q1 2027.

• Topline data from key Phase 3 trials (Pitolisant HD, EPX-100) anticipated in 2027.

• BP-205 Phase 1 PK data and U.S. IND submission expected mid-2026.

• Sufficient liquidity to fund operations and investing activities for at least the next 12 months.