Financial Performance & Guidance - BioCryst's Q2 2025 was strong, driven by increased ORLADEYO demand[14] - ORLADEYO revenue is expected to meet the previous guidance range of $580-600 million for FY25, even excluding Q4 2025 EU revenue[16] - The company anticipates achieving full-year operating profit in 2026 and positive net income & cash flows in 2026+[58] - Cash, cash equivalents, restricted cash & investments totaled $287 million as of June 30, 2025[63] - The company paid down $50 million of its senior credit facility in July 2025[62] ORLADEYO & Market Dynamics - Market research indicates a growing patient preference for oral administration of HAE long-term prophylaxis (LTP) since 2023[17] - Monte Carlo simulation projects ORLADEYO reaching a steady state of over 2,000 patients in the US by 2028[25] - ORLADEYO revenue advances to royalty-free tier (>$550M)[61] - The blended royalty rate for ORLADEYO is expected to decline to approximately 4% at peak sales once OMERS reaches its cap[67] Pipeline Development - The PDUFA target date for the pediatric NDA for ORLADEYO is December 12, 2025[32] - An IND has been cleared by the FDA for BCX17725, a targeted KLK5 inhibitor for treating Netherton syndrome (NS)[37]

BioCryst Pharmaceuticals (BCRX -2.33%), a biotechnology company specializing in oral treatments for rare diseases, released its second quarter earnings on August 4, 2025, reporting its strongest quarterly results to date. The headline news was the company's first significant profit on a generally accepted accounting principles (GAAP) basis, with GAAP revenue and non-GAAP earnings both outstripping Wall Street expectations. GAAP revenue was $163.4 million, 9.1% higher than the analyst consensus of $149.8 mil ...

Core Insights - BioCryst Pharmaceuticals reported its strongest financial performance in history for Q2 2025, driven by significant revenue growth and operating profit from ORLADEYO [2][6][7] Financial Performance - ORLADEYO net revenue reached $156.8 million, reflecting a 45% year-over-year increase [6][7] - Total revenues for Q2 2025 were $163.4 million, up 50% from $109.3 million in Q2 2024 [7] - Operating profit for Q2 2025 was $29.8 million, a 239% increase year-over-year, while non-GAAP operating profit was $57.0 million, up 160% [10] Market Dynamics - New patient prescriptions for ORLADEYO were the highest ever in a quarter, exceeding the first quarter of the launch by over 10% [6][4] - The U.S. market contributed 89.5% of global ORLADEYO net revenues in Q2 2025 [6] Debt Management - The company made an additional $50 million paydown of term debt and plans to retire all remaining term debt with proceeds from the sale of its European ORLADEYO business [14] Pipeline Development - BioCryst is on track to submit a new drug application for ORLADEYO granules for children aged 2 to 11 by December 12, 2025 [5] - The company expects initial data from two clinical programs by the end of 2025 [2][15] Cash Flow and Outlook - Cash, cash equivalents, and investments totaled $287.1 million as of June 30, 2025, with net cash utilization of $30.4 million for the quarter [13] - The company maintains its full-year 2025 global net ORLADEYO revenue guidance between $580 million and $600 million, excluding European revenue [15][16]

—Q1 2025 ORLADEYO net revenue of $134.2 million (+51 percent y-o-y)— —Full year 2025 ORLADEYO revenue guidance increased to $580 million to $600 million— —Company now expects to be profitable for full year 2025, a year ahead of schedule— —Company pays down $75 million of debt; saves approximately $23.5 million over life of loan— —NDA submitted for ORLADEYO oral granules for children with HAE aged 2-11— —U.S. IND open for BCX17725 for Netherton syndrome— RESEARCH TRIANGLE PARK, N.C., May 05, 2025 (GLOBE NEWS ...