Alvotech Q1 FY2026 earnings call

The first quarter focused on three priorities: progressing the FDA resubmission, maintaining high inspection readiness, and expanding commercial business globally including launch of three biosimilars across Europe and other markets. FDA began routine GMP surveillance inspection at Reykjavik facility ongoing. Implemented enhancements across quality system and operations. Resubmission of biologics license applications for biosimilars to Symfony, etc. is in final stage. Entered into manufacturing agreement with Fujifilm Biotechnologies. ABT02 is fastest-growing biosimilar to Humira in US with 10% market share. ABT04 and others have commercial progress. Submitted marketing authorization application to EMA for ABT16 and ABT80. ABT29 on track to submit to EMA in 2026 and enrolled first patients in Pivotal Study for US submission in 2028.

In the first quarter of 2026, total revenues were $106 million. Product revenues were $51 million, accounting for approximately 48.1% of total revenues. Licensing revenues were $55 million, accounting for approximately 51.9% of total revenues. Adjusted EBITDA was $24 million.

Target revenues in range of $650 - $700 million for full year 2026, representing continued double-digit growth vs 2025. Adjusted EBITDA expected in range of $180 - $220 million. Expect strong year-on-year growth in 2027 driven by commercialized product portfolio expansion, pipeline contributions and milestone revenues, and increasing manufacturing output post facility improvements.

Uncertainty from FDA inspection; impact of production slowdown due to facility improvements; impact of regulatory guidance changes; market competition risks.

Q: On the Fujifilm partnership and its implications, and market share position.

A: Fujifilm partnership is strategic for diversifying capacity, expect to introduce product for US market in second half of 2027. Simlandi has 60% exit share in US biosimilar market, ustekinumab in Europe has some flattening but still growth opportunity.

Q: On FDA remediation and production slowdown.

A: FDA inspection ongoing, expected to close this week, on track to resubmit pending BLAs in second quarter with target end of fourth quarter. Production slowdown due to remediation plan, anticipate resuming normal operations this quarter with aim to eliminate future risk.

Q: On Simlandi uptake and sales lag.

A: Simlandi uptake due to Humira product erosion and commercial execution, sales lag due to customer order pattern and invoicing.

Q: On impact of German reform and biosimilar launch timing.

A: German reforms may still present opportunity with multiplayer tender market, too early to comment precise launch timings for Dupixent biosimilars