Harmony Biosciences (HRMY) Q3 2024 earnings summary

Executive summary

• Achieved record Q3 2024 net revenue of $186.0M, a 16% year-over-year increase, with WAKIX surpassing $2B in cumulative net revenue since launch in 2019.

• Average number of patients on WAKIX grew to 6,800, supported by a growing prescriber base and strong market access coverage above 80%.

• Advanced a catalyst-rich pipeline with 13 development programs, including multiple late-stage and Phase 3 trials in sleep/wake, rare epilepsy, and neurobehavioral disorders.

• Commercial momentum driven by organic demand for WAKIX and expansion into additional rare CNS therapeutic areas.

• FDA approved WAKIX for excessive daytime sleepiness in pediatric narcolepsy in June 2024, expanding the product's market.

Financial highlights

• Q3 2024 net product revenue was $186.0M, up from $160.3M in Q3 2023; nine-month revenue reached $513.5M, up 24% year-over-year.

• Non-GAAP adjusted net income for Q3 2024 was $59.6M ($1.03 per diluted share), compared to $58.8M ($0.97 per share) in Q3 2023.

• GAAP net income for Q3 2024 was $46.1M ($0.79 per diluted share), up from $38.5M ($0.63 per share) year-over-year.

• Operating expenses rose 29% year-over-year to $81.6M, mainly due to pipeline and commercialization investments.

• Cash, cash equivalents, and investments totaled $504.7M as of September 30, 2024.

Outlook and guidance

• Reiterated 2024 net revenue guidance of $700–$720M, with WAKIX expected to achieve $1B+ in net sales in narcolepsy alone.

• Expects topline data from ZYN-002 Phase 3 RECONNECT trial in Fragile X syndrome by mid-2025 and sNDA submission for pitolisant in idiopathic hypersomnia in Q4 2024.

• Four Phase 3 registration studies expected to be ongoing by year-end, with potential for annual new product or indication launches over the next five years.

• Pitolisant franchise expected to drive durable patient and revenue growth into the mid-2040s, with patent protection extending to 2044.

• Management expects existing cash and investments to fund operations and investing activities for at least the next 12 months.