Celltrion (068270) Investor presentation summary

Journey and biosimilar opportunity

• Milestones: founded in 2002; Plant 1 received cGMP certification in 2007; Remsima became the first mAb biosimilar approved by EMA in 2013; a Europe and U.S. direct-sales network followed in 2019–2022.

• Zymfentra received FDA approval in October 2023 as a novel subcutaneous infliximab drug, marking a progression from biosimilar development to innovation.

• Biosimilars are projected to generate $383bn in cumulative global savings from 2023 to 2027, with a stated range of $290bn–$476bn.

• The 22-product pipeline is based on reference drugs with combined 2022 revenues; its target market size is projected to grow by 60% through 2025 and 90% through 2030.

Zymfentra launch

• 2024 launch planned for subcutaneous infliximab; positioned on more stable serum concentration and higher Ctrough levels.

• Administration time is presented as falling from 60 minutes to 1 minute.

• Positioning draws on infliximab’s established efficacy and safety profile and its use as a leading IBD therapeutic for over 20 years.

Biosimilar portfolio and industry strategy

• Biosimilar development faces high costs, fierce competition and distribution investment needs; the presentation identifies eight key established biopharma players and industry consolidation.

• Portfolio roadmap expands from 6 products in 2023 to 11 in 2025 and 22 in 2030; target reference-drug market sizes shown are $10bn, $96bn and $182bn, respectively.

• Two products had completed BLA/MAA submissions in 2023, with two additional products in clinical development.

• Pipeline spans autoimmune, oncology and other indications, including biosimilars targeting Eylea, Xolair, Prolia, Stelara and Actemra.