Formycon (FYB) H2 2024 earnings summary

Executive summary

• Achieved or exceeded 2024 guidance, with strong operational and financial performance despite Q4 challenges.

• Advanced late-stage pipeline with multiple regulatory approvals and launches in key markets for FYB201, FYB202, and FYB203.

• Uplisted to Prime Standard, joined SDAX and TecDAX, increasing capital market visibility.

• Strategic focus on biosimilars, expanding global presence, and preparing for sustainable profitability.

Financial highlights

• Sales and EBITDA exceeded targeted corridor; Adjusted EBITDA in the middle of expected range.

• Sales boosted by a one-off product sale and accelerated milestone revenue from early FYB202 approval.

• Revenues declined by ~10% year-over-year, less than anticipated.

• Cost of sales for FYB202 increased due to amortization post-approval; R&D costs rose with pipeline expansion.

• Net income impacted by significant impairments on FYB201 and FYB202 assets.

Outlook and guidance

• 2025 revenue expected at €55–65 million, driven by FYB202 launches and license income from FYB201.

• EBITDA guidance for 2025 is €10–20 million, reflecting ongoing pipeline investment.

• Adjusted EBITDA expected below 2024 due to U.S. pause of FYB201 sales.

• Positive EBITDA targeted as early as 2026, no later than 2027, contingent on resumed U.S. marketing and new launches.