BioCryst Posts $601M ORLADEYO Revenue, $214M Profit and Pellets Launch
BioCryst generated $601 million in ORLADEYO revenue last year ($563 million excluding Europe) and reported $214 million in non-GAAP operating profit, marking its first full-year profitability. The company also launched ORLADEYO pellets for HAE patients aged two and up this quarter and set 2026 guidance of $625–645 million, a 13% rise.
1. Strong ORLADEYO Growth and Profitability Pivot
BioCryst ended last year with ORLADEYO revenue of $601 million, or $563 million excluding its European business, and recorded $214 million in non-GAAP operating profit, marking a transition to full-year profitability.
2. Pediatric ORLADEYO Pellets Launch
The company launched ORLADEYO pellets for hereditary angioedema patients aged two and up, anticipating pharmacy availability by early April. With over 1,500 ORLADEYO prescribers—primarily community allergists—and an estimated pediatric HAE population of 1,100–1,200, the company expects gradual prophylaxis adoption among children.
3. 2026 Guidance and Revenue Mix
2026 guidance of $625–645 million implies about 13% growth versus $563 million ex-Europe, factoring in a $50 million annualized revenue reduction from the European divestiture. Medicare paid-rate improvement from 50% to nearly 90% boosts affordability for roughly 20% of patients, supporting steady patient growth.
4. Navenibart Phase 3 Timeline
Navenibart, designed for patients on injectable prophylaxis, demonstrated 90–92% attack reductions at three- and six-month dosing in phase 1b/2 trials. The pivotal phase 3 study plans final patient enrollment by mid-year, with six- and 12-month data expected by late next year to underpin an FDA filing.