Top-line and EBITDA Growth
Total revenues increased ~21% year-over-year to $593 million in 2025 and adjusted EBITDA rose 27% to $137 million (23% margin), reflecting strong licensing contributions and expanding commercial footprint.
Q4 Performance and Margin Strength
Q4 2025 revenues were $173 million, up 13% year-over-year, with licensing revenues representing 75% of Q4 revenue, gross margin of 66% for the quarter and adjusted EBITDA of $69 million (40% margin).
Licensing-Driven Profitability and Revenue Mix
Full-year revenue mix was split roughly evenly between product and licensing revenues; licensing milestone income materially boosted gross margins (FY gross margin ~61%) and translated into improved EBITDA and first-time positive full-year operating cash flow.
Improved Liquidity and Capital Raised
Raised nearly $300 million from capital markets in 2025, including $108 million convertible bonds and a $100 million senior term loan; year-end cash balance totaled $172 million, and listing on Nasdaq Stockholm broadened investor base.
Large, Advancing Pipeline
Alvotech now has ~30 biosimilars in development, targeting markets representing substantial opportunity; examples include positive pivotal PK results for the Entyvio biosimilar (supporting planned 2026 submissions), Keytruda collaboration targeting marketing application in 2028, and ongoing development of Eylea HD candidate targeting first regulatory submission in 2026.
Commercial Launches and Geographic Expansion
Multiple approvals and launches outside the U.S. in 2025 and early 2026: partners launched Selarsdi (Humira biosimilar) in the U.S. (Teva), AVT03/05/06 approvals and launches in Europe, UK and Japan, with several 'first-to-market' approvals (e.g., AVT05 first Simponi biosimilar in Europe and Japan) and further rest-of-world filings underway.
Market Share Traction
Notable share gains in key segments: Simlandi (AVT02) reached ~9% of the U.S. Humira market and became one of the faster-growing biosimilars in that franchise; Uzpruvo (Stelara biosimilar) holds >20% share in the European biosimilars segment.
Platform and Capability Strengthening
Strategic bolt-on acquisitions (Xbrane R&D team, Ivers-Lee assembly/packaging) and capacity expansions in Iceland and Stockholm increased R&D and downstream manufacturing capabilities, improving ability to advance multiple programs and serve global launches.
Operational Actions on Regulatory Observations
Company implemented a comprehensive remediation and quality improvement program following FDA inspection observations at the Reykjavik facility; most corrective actions were implemented by year-end and the company expects to resubmit affected BLAs in H1 2026, while the Reykjavik site remains FDA-approved and production for on-market products continues.