Pipeline and Regulatory Progress
Resubmissions of BLAs for biosimilars to Simponi, Eylea (high-dose and low-dose), Prolia and Xgeva are in the final stage of completion; EMA marketing authorization application submitted for AVT16 and AVT80 (Entyvio); AVT29 (high-dose Eylea) on track for EMA submission in 2026 and first patients enrolled in pivotal study supporting a 2028 U.S. submission.
Commercial Momentum and Market Share Gains
AVT02 (Humira biosimilar) became the fastest-growing Humira biosimilar in the U.S., achieving ~10% market share; commercial presence expanded to over 90 countries; newly approved products (AVT03, AVT05, AVT06) began contributing incremental revenues in Europe, U.K. and Japan.
Manufacturing Diversification Agreement
Signed strategic manufacturing agreement with Fujifilm Biotechnologies to diversify capacity and add U.S.-based supply; technology transfer initiated with product supply to the U.S. expected to begin in H2 2027, supporting future launches and supply resilience.
Adjusted EBITDA Improvement
Adjusted EBITDA was $24 million in Q1 2026, up from $21 million in Q1 2025 (≈+14%), with EBITDA margin improving to 23% from 15% a year earlier (an improvement of 8 percentage points).
Gross Margin Stability
Reported gross margin of 57% for Q1 2026, a modest improvement of 6 basis points versus the same period last year, reflecting a balanced mix of product and licensing revenues.
Full-Year Guidance and Longer-Term Growth Outlook
Full-year 2026 revenue guidance of $650–$700 million (targeting continued double-digit growth vs. 2025) and adjusted EBITDA guidance of $180–$220 million; company expects stronger manufacturing output and material margin improvement entering 2027.