BioCryst Reports Full Year 2025 Financial Results and Provides Business Update

Core Insights - BioCryst Pharmaceuticals achieved full-year profitability for the first time in its history in 2025, driven by strong commercial execution and the highest level of new patient prescriptions for ORLADEYO in the U.S. since its launch [3] - The company maintained its revenue guidance for ORLADEYO in 2026, expecting between $625 million and $645 million [14][15] - BioCryst completed the acquisition of Astria Therapeutics, enhancing its hereditary angioedema (HAE) portfolio [3][4] Financial Performance - Total revenues for 2025 were $874.8 million, a significant increase from $450.7 million in 2024, with an operating profit of $341.0 million compared to an operating loss of $2.5 million in the previous year [6] - On a non-GAAP basis, total revenues were $592.9 million, reflecting a 45% year-over-year increase, and operating profit was $214.2 million, up 198% year-over-year [6][5] - The company recognized $243.3 million in revenue from the sale of its European ORLADEYO business [6] Business Developments - In October 2025, BioCryst sold its European ORLADEYO business to Neopharmed Gentili S.p.A., allowing for a streamlined operational structure focused on the U.S. market [4] - The FDA approved ORLADEYO oral pellets for children aged 2 to <12 years, marking it as the first targeted oral prophylactic therapy for this age group [4] - The acquisition of Astria Therapeutics included navenibart, an injectable monoclonal antibody currently in Phase 3 clinical development for HAE prophylaxis [4] Research and Development - Research and development expenses for 2025 were $136.6 million, a decrease of 5% year-over-year, reflecting increased program costs for BCX17725 and avoralstat, offset by lower personnel costs [7] - The Phase 3 program for navenibart is on track to support regulatory filing by the end of 2027, with positive interim results showing significant HAE attack suppression [4] Expense Overview - Sales and marketing expenses increased to $177.1 million, a 16% year-over-year rise, driven by distribution costs and pediatric launch support [8] - General and administrative expenses rose to $116.0 million, a 45% increase year-over-year, attributed to compensation and headcount growth [9] Financial Outlook - The company expects total revenue for 2026, including RAPIVAB®, to be between $635 million and $660 million, with non-GAAP operating expenses projected between $450 million and $470 million [14][15]