Harmony Biosciences (HRMY) Q2 2024 earnings summary

Executive summary

• Achieved Q2 2024 net revenue of $172.8M, up 29% year-over-year, driven by strong WAKIX sales and increased patient uptake, with average patients on therapy reaching 6,550.

• Advanced late-stage clinical programs, including Pitolisant HD (PDUFA 2028), and launched WAKIX for pediatric narcolepsy after FDA approval.

• Expanded pipeline to 8 assets across 13 development programs, with acquisitions of Epygenix and Zynerba and in-licensing of TPM-1116 and an orexin-2 receptor agonist.

• Reiterated 2024 net revenue guidance of $700M–$720M, with a clear path to $1B in sales by 2030 and plans for annual new product or indication launches.

• Patent protection for WAKIX reinforced through 2030, with provisional patents for pitolisant GR and HD potentially extending exclusivity to 2044.

Financial highlights

• Q2 2024 net revenue was $172.8M, up from $134.2M in Q2 2023 (29% increase); gross profit was $140.7M (81.4% margin).

• Non-GAAP adjusted net income was $60.6M ($1.05 per diluted share), up from $45.9M ($0.76 per share); GAAP net income was $11.6M ($0.20 per share), down from $34.3M ($0.56 per share), mainly due to $25.5M licensing and $17.1M IPR&D charges.

• Operating expenses rose 92% year-over-year to $119.3M, driven by R&D, licensing, and acquisition costs.

• Cash, cash equivalents, and investments totaled $434.1M as of June 30, 2024; debt outstanding was $188.8M.

• Operating cash flow for H1 2024 was $73.8M, down from $79.6M in the prior year.

Outlook and guidance

• 2024 net revenue guidance reiterated at $700M–$720M, with management confident in continued WAKIX growth and pipeline expansion.

• Targeting approximately 7,000 average WAKIX patients by year-end, with a path to 9,000+ for $1B in sales by 2030.

• Expects to submit sNDA for pitolisant in idiopathic hypersomnia in H2/Q4 2024.

• Plans to launch at least one new product or indication annually over the next five years.

• Sufficient liquidity to fund operations and planned investments for at least the next 12 months.