Report

Formycon - H121 update: Future markets take shape

Formycon progressed all key projects in H121. FYB201 (partnered with Bioeq) is a Lucentis biosimilar to treat neovascular age-related macular degeneration (nAMD). The US FDA is reviewing the BLA with an August 2022 decision due; the European EMA review should complete in mid-2021. FYB201 will be marketed by Teva in Europe and by Coherus in the US. FYB202 (a Stelara biosimilar in a joint venture with Aristo Pharma) is waiting for its Phase III readout in psoriasis. FYB203 (an Eylea biosimilar partnered with Klinge) is in late Phase III in nAMD. FYB207 is a novel COVID-19 therapy with a €12.7m grant and H122 Phase I/IIa trials planned. Formycon had €33.6m cash on 30 June 2021. H121 revenue was €20.3m (H120: €16.5m). The loss rose to €10.2m (FY20: loss of €5.9m) due to investment into unpartnered projects.
Underlying
Formycon AG

Formycon AG is a Germany-based company engaged in providing biosimilar drugs and formulations. 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 Company 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.

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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