Formycon (FYB) Company Presentation summary

Company overview

• Established in 2012 in Munich, Formycon is a pure-play biosimilar company with 250 employees from over 30 countries, focusing on R&D and agile development of multiple biosimilar projects.

• Business model is based on income from success payments and royalty streams, leveraging a hybrid value chain with in-house development and partnered manufacturing/commercialization.

• Mission centers on easing financial strains on healthcare systems and improving patient access to vital medicines.

Market opportunity and dynamics

• Over 40 blockbuster drugs with >$200 billion in global sales are losing exclusivity by 2032, creating significant biosimilar opportunities.

• Biosimilars are the fastest-growing pharma segment, with US biosimilar sales CAGR at 97% (2015–2021); growth expected to continue, especially in the US.

• Biosimilar development has a high probability of success, with approval rates significantly higher than for innovative drugs.

Pipeline and product highlights

• Three biosimilars approved, one launched in 20 countries; four additional candidates in development, including late-stage and preclinical programs.

• FYB201 (Lucentis® biosimilar) has >40% US and >80% UK market share, launched in 20 countries.

• FYB202 (Stelara® biosimilar) approved in US and EU, with settlements for launch in US (by Feb 2025), Europe, and Canada; 100% project rights retained.

• FYB203 (Eylea® biosimilar) approved in US and EU, with royalty-based income and commercial partnerships in place.

• FYB206 (Keytruda® biosimilar) in Phase I and III trials, targeting a $25 billion market, with 100% project rights.