Formycon Stock: Share Price Plunges 40% on US Market Concerns

Formycon, a prominent biosimilar manufacturer, experienced a severe market setback as its stock price plummeted by more than 40% to €28.60 on Monday. The dramatic decline was triggered by the company's announcement of potential significant write-downs in its product portfolio due to challenging pricing conditions in the US market. Two key drug candidates face substantial financial implications: FYB202, developed in partnership with Fresenius Kabi, may require write-downs approaching nine figures due to higher-than-anticipated price discounts. Additionally, FYB201 is expected to incur write-downs ranging from high single-digit to low double-digit millions following price negotiations.

FDA Decision Brings Cost Relief

Despite market turbulence, the company received positive news from the US Food and Drug Administration regarding its biosimilar candidate FYB206. Following constructive discussions, Formycon has decided to terminate its Phase III study early, as therapeutic comparability with the reference product can be demonstrated through existing studies and analytical programs. This strategic move is expected to generate substantial cost savings in the high double-digit million euro range, with the company maintaining its key forecast indicators for 2024 unchanged.