Formycon shares fall on lower Q1 revenue, wider loss, guidance unchanged

Published 12/05/2025, 10:52
© Reuters

Investing.com -- Formycon AG (ETR:FYB) shares fell Monday after the company posted a sharp drop in first-quarter revenue and a wider loss, as milestone payments from a key biosimilar partnership failed to recur.

The German biopharmaceutical company reported revenue of €5.3 million for the first quarter, down from €17.7 million in the same period last year. 

The company posted an EBITDA loss of €13.2 million, compared with a loss of €5.5 million a year earlier.

The results reflect the absence of milestone revenues received in the first quarter of 2024 from the company’s commercialization partnership with Fresenius Kabi for FYB202, a biosimilar referencing Stelara.

Formycon confirmed its full-year 2025 guidance, forecasting revenue between €55 million and €65 million and an EBITDA loss of between €10 million and €20 million. 

The company maintained its expectation of reaching positive EBITDA as early as 2026 and no later than 2027. 

Consensus estimates compiled by FactSet currently project 2025 revenue at €62 million and an EBITDA loss of €18 million.

Revenue from FYB202, marketed as Otulfi, totaled €700,000 in the first quarter following its commercial launch in the United States and Europe. 

The product was available for roughly one month during the reporting period. In February, the company disclosed that price discounting for the product in the U.S. was deeper than initially anticipated. 

Formycon stated that revenue contributions from FYB202 are expected to increase over the course of the year.

The company said that following the first quarter, FYB202 received a product-specific Q-code in the United States, enabling reimbursement from both private and public payers.

Separately, the company noted that sales of FYB201, a biosimilar referencing Lucentis and marketed as Cimerli, will be temporarily paused in the United States beginning April 1, 2025. 

The pause, expected to last approximately one year, is being implemented by commercialization partner Sandoz (SIX:SDZ). 

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