Formycon AG
XETRA:FYB
Formycon AG
Formycon AG engages in the manufacture of biosimilar drugs and formulations. The company is headquartered in Martinsried, Bayern and currently employs 159 full-time employees. The company went IPO on 2010-12-20. Its business activities are focused on the development and marketing of biopharmaceuticals that are similar to existing drugs, for which the patent protection is expiring. The firm focuses on treatments in the area of ophthalmology, immunology and other chronic diseases, covering all steps of biosimilar development process, from early-stage analysis of the originator drug to the preclinical and clinical testing phases, as well as the preparation of dossiers for marketing approval. Its biosimilar product pipeline consists of four candidates in pre-clinical and clinical testing phases, including FYB201, a biosimilar candidate for Lucentis; FYB202, a biosimilar candidate for Stelara; FYB203, a biosimilar candidate for Eylea, and FYB205.
Formycon AG engages in the manufacture of biosimilar drugs and formulations. The company is headquartered in Martinsried, Bayern and currently employs 159 full-time employees. The company went IPO on 2010-12-20. Its business activities are focused on the development and marketing of biopharmaceuticals that are similar to existing drugs, for which the patent protection is expiring. The firm focuses on treatments in the area of ophthalmology, immunology and other chronic diseases, covering all steps of biosimilar development process, from early-stage analysis of the originator drug to the preclinical and clinical testing phases, as well as the preparation of dossiers for marketing approval. Its biosimilar product pipeline consists of four candidates in pre-clinical and clinical testing phases, including FYB201, a biosimilar candidate for Lucentis; FYB202, a biosimilar candidate for Stelara; FYB203, a biosimilar candidate for Eylea, and FYB205.
Guidance Reaffirmed: Management confirmed full-year 2025 revenue and EBITDA guidance, expecting a strong, backloaded Q4.
Q3 Revenue: Reported Q3 2025 revenue of EUR 10.5 million, with total 9-month revenue at EUR 19.5 million, in line with prior expectations.
Major Q4 Drivers: Anticipated significant Q4 revenue from FYB202 royalties and potential double-digit million milestone payments from FYB206 licensing deals.
Cost Efficiency: Operational cost of sales has dropped significantly due to streamlined development and Phase III waivers, with R&D expenses also down versus last year.
Commercial Milestones: Completed patient recruitment for FYB206 Phase I, expanded product registration in Sub-Saharan Africa, and secured new commercial agreements for FYB202 and FYB203.
Cash Position: Ended Q3 with nearly EUR 80 million in cash, bolstered by a EUR 70 million bond issuance, ensuring sufficient liquidity for ongoing development.
Working Capital: Working capital stood at EUR 83 million at quarter end, elevated due to bond financing.
Market Traction: Otulfi (FYB202) is gaining traction in key geographies, with incremental Q4 sales expected from the CivicaScript deal.
