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6-K2026-06-08· deepseek-v4-flash

ALVO · Alvotech

0001171843-26-003974

SEC filing

Summary

Alvotech reports Q1 2026 revenue of $105.9M and announces FDA acceptance of BLA for AVT16, a proposed interchangeable biosimilar to Entyvio.

Key takeaways

Full analysis

Alvotech's Q1 2026 results reflect a transitional period as the company invests in quality improvements and pipeline progression. Total revenue of $105.9M declined 20% year-over-year, driven by reduced product revenue ($51.2M vs $109.9M) due to production slowdowns from facility enhancements. However, license and other revenue rose to $54.7M (from $22.9M), partially offsetting the decline. Cost of product revenue fell proportionally, resulting in a 57% gross margin. Operating profit was $9.7M, down slightly from $10.6M. Net profit was $1.0M compared to $109.7M in Q1 2025, which benefited from significant fair value gains on derivatives. Cash flow from operations was negative $60.4M, primarily due to working capital movements and interest payments. The company ended the quarter with $63.8M cash and $1.31B in borrowings. Management expressed confidence in recovering product revenues as normal operations resume, and reiterated full-year 2026 revenue guidance of $650-700M and adjusted EBITDA of $180-220M. The FDA acceptance of the BLA for AVT16 (proposed biosimilar to Entyvio) is a key regulatory milestone, with a 6-month review period and Teva responsible for US commercialization. Additionally, post-quarter resubmission of BLAs for AVT05 and AVT06, and the commencement of a pivotal study for AVT29 (high-dose Eylea biosimilar) underscore pipeline momentum. The strategic manufacturing agreement with FUJIFILM Biotechnologies diversifies supply and supports future launches.