Formycon reiterates 2025 guidance, expects stronger second half

Formycon AG reported first-half revenue of €9.0 million and an EBITDA loss of €17.9 million, while maintaining its full-year 2025 guidance for revenues of €55-65 million and an EBITDA loss of €10-20 million. The German biosimilar developer anticipates significantly stronger performance in the second half of 2025, particularly in Q4, driven by building momentum from its FYB202 (Stelara biosimilar) launch and the expected signing of a partnership deal for FYB206 (Keytruda biosimilar) which would include an upfront payment. Formycon reiterated its target of achieving positive EBITDA as early as 2026, but no later than 2027.

Analysis

Formycon AG (ETR:FYB) reported first-half 2025 results that underscore a significant reliance on future performance to meet its annual targets. With H1 revenue of €9.0 million and an EBITDA loss of €17.9 million, the company's reiterated full-year guidance for €55-65 million in revenue and a €10-20 million EBITDA loss implies a dramatic acceleration in the second half, particularly in the fourth quarter. This guidance is slightly more optimistic on revenue than the market consensus of €54 million. The expected H2 improvement is contingent on two key speculative events: the commercial ramp-up of its Stelara biosimilar (FYB202), which has generated only €1.7 million in its first four months, and the successful signing of a partnership deal for its Keytruda biosimilar (FYB206), which is anticipated to include a material upfront payment. While the company's timeline for reaching positive EBITDA by 2026-2027 provides a long-term target, the immediate investment thesis is heavily weighted on near-term execution and deal-making. Commentary from competitor Sandoz regarding a similar back-loaded performance for its own Stelara biosimilar lends some credibility to the market ramp-up thesis, but does not mitigate the firm-specific execution risk.

Key Decisions for Investors

• Investors should recognize the significant back-end loaded nature of Formycon's 2025 guidance, making the investment case highly dependent on successful commercial execution and sales momentum for its biosimilar FYB202 in the second half of the year.
• The anticipated partnership deal for the Keytruda biosimilar, FYB206, represents a critical near-term catalyst and a material risk; monitor announcements closely, as the timing and value of this deal are crucial for meeting financial targets.
• Given the current substantial EBITDA loss and a projected timeline to profitability of at least 2026, this opportunity is best suited for long-term investors with a high tolerance for event-driven risk inherent in the biosimilar development space.