BioCryst Reports Fourth Quarter and Full Year 2024 Financial Results and Upcoming Key Milestones

Core Insights - BioCryst Pharmaceuticals reported a strong financial performance for Q4 2024, with ORLADEYO net revenue reaching $124.2 million, a 36.6% increase year-over-year, and total revenues of $131.5 million, up 40.8% year-over-year [1][10] - The company has raised its FY 2025 ORLADEYO net revenue guidance to between $535 million and $550 million, reflecting strong demand and positive early signs from Medicare patients [1][23] - BioCryst aims to achieve positive EPS and cash flow by the second half of 2025, building on a non-GAAP operating profit of $62.9 million in 2024 [1][27] Financial Performance - For FY 2024, total revenues were $450.7 million, a 36.0% increase from $331.4 million in FY 2023, primarily driven by ORLADEYO's performance [17] - The GAAP operating loss for FY 2024 was $2.5 million, significantly improved from a loss of $103.7 million in FY 2023 [21] - The net loss for FY 2024 was $88.9 million, or $0.43 per share, compared to a net loss of $226.5 million, or $1.18 per share, in FY 2023 [22] Product Development and Pipeline - BioCryst plans to expand the ORLADEYO label to children aged 2 to 11, with a New Drug Application (NDA) submission expected this year [2][6] - Initial clinical data from BCX17725 for Netherton syndrome and avoralstat for diabetic macular edema is anticipated by the end of 2025 [1][5] - The company is advancing its pipeline with a focus on rare diseases, aiming to provide differentiated therapies [5][6] Market and Commercial Strategy - The company noted that 73.5% of U.S. patients were on paid ORLADEYO products by the end of Q4 2024, an increase from 71.4% at the end of 2023 [7] - A market survey indicated that 97% of HAE treaters are considering prescribing ORLADEYO, with a significant increase in the likelihood of current prescribers to recommend it [7] - BioCryst has received final reimbursement for ORLADEYO in Portugal and is now reimbursed in all major Western European countries, except the Netherlands, which is expected in H1 2025 [7][8] Cost Management and Profitability Outlook - R&D expenses for Q4 2024 decreased to $49.4 million from $70.1 million in Q4 2023, while SG&A expenses increased to $80.5 million, reflecting increased commercial investment [11][12] - The company expects to maintain a revenue growth rate significantly outpacing operating expense growth, projecting a CAGR of around 20% for revenue over the next three years [26] - BioCryst anticipates achieving meaningful and sustainable profitability, with hundreds of millions in cash added to the balance sheet [9][26]