BioCryst Q1 ORLADEYO Revenue Up 11%; Europe Navenibart License Brings $70M
BCRX•BioCryst reported Q1 ORLADEYO net revenue of $148.3 million, up 11% year-on-year (21% ex-Europe), and closed a European navenibart licensing deal with $70 million upfront plus up to $275 million in milestones. GAAP operating loss was $701.6 million on a $697.8 million in-process R&D charge; non-GAAP profit reached $54.2 million.
1. Q1 ORLADEYO Performance
ORLADEYO generated net revenue of $148.3 million in Q1 2026, an 11% year-on-year increase and 21% growth on a comparable basis excluding European sales, driven by strong new patient prescriptions.
2. European Navenibart Licensing
BioCryst granted European commercial rights to its investigational plasma kallikrein inhibitor navenibart to an affiliate of Neopharmed Gentili, receiving $70 million upfront and potential milestones up to $275 million plus tiered royalties of 18% to 30%.
3. Operating Results and Cash Position
GAAP operating loss was $701.6 million, primarily due to a $697.8 million in-process R&D charge from the Astria acquisition, while non-GAAP operating profit reached $54.2 million; cash, cash equivalents and investments totaled $260.8 million ($330.8 million pro-forma).
4. Pipeline Updates and Guidance
Enrollment in the pivotal ALPHA-ORBIT navenibart study is expected to complete by June end, supporting a potential US filing by late 2027; BCX17725 Phase 1 Part 4 dosing has begun with data due by year-end; full-year 2026 revenue and expense guidance remains unchanged.
