Alvotech Stock Earnings Reports

Alvotech focused Q1 2026 on progressing FDA resubmission, maintaining inspection readiness, and expanding commercial launches globally. An FDA routine GMP surveillance inspection at the Reykjavik site is ongoing and expected to conclude imminently; BLAs for biosimilars to Simponi, Eylea, Prolia and Xgeva are in the final resubmission stage. The company intentionally slowed certain manufacturing throughput in 2025–Q1 2026 to address quality/system enhancements and derisk future regulatory disruption. Commercially, Alvotech now has a presence in 90+ countries; AVT02 (Humira biosimilar) is the fastest-growing Humira biosimilar in the U.S. with ~10% share, and broader biosimilar uptake is growing (biosimilars ~60% exit share in U.S. Humira segment; ustekinumab biosimilars ~56% in Europe). Alvotech announced a manufacturing agreement with Fujifilm to diversify capacity and expect U.S.-based supply beginning H2 2027 following tech transfer. Q1 results: revenues $106M (down 20% YoY), adjusted EBITDA $24M (23% margin), gross margin 57%; product revenues $51M and licensing $55M. Cash at quarter-end $64M; operating cash flow negative $25M. Management expects manufacturing normalization through Q2 and targets full-year 2026 revenue of $650–700M and adjusted EBITDA of $180–220M, with a goal of achieving positive free cash flow in Q4 2026 and stronger growth in 2027 as product launches and pipeline milestones materialize.