Formycon (FYB) Q3 2025 earnings summary

Executive summary

• Revenue and earnings for the first nine months of 2025 aligned with expectations, with full-year guidance confirmed and significant pipeline progress achieved, including launches, regulatory milestones, and expanded partnerships.

• Operational expansion advanced through development, financing, and competitiveness, with a strategic focus on biosimilars, geographic diversification, and leveraging regulatory changes for cost efficiency.

• Commercial ramp-up for FYB202 (Stelara® biosimilar) underway, with strong Q4 sales momentum anticipated in the US and Europe.

• Achieved key milestones: completion of FYB206 phase I recruitment, first registration for FYB201 in sub-Saharan Africa, and settlement for FYB203 enabling US launch in Q4 2026.

• Liquidity strengthened by a €70 million bond issue and increased cash position.

Financial highlights

• Group revenue for 9M 2025 was €19.5 million, down from €41.1 million in 9M 2024, reflecting a shift from one-time license payments to recurring commercialization revenues.

• EBITDA for 9M 2025 was €-21.4 million (9M 2024: €-17.7 million); adjusted EBITDA was €-21.7 million (9M 2024: €2.9 million).

• Working capital increased to €83.2 million at Q3 end, supported by bond issuance.

• Cash and cash equivalents at period end were €79.5 million, up from €41.8 million at the end of 2024.

• Net loss for 9M 2025 was €-60.4 million, compared to €-20.9 million in 9M 2024.

Outlook and guidance

• Full-year 2025 revenue guidance of €55–65 million confirmed, with major revenue streams expected in Q4 from FYB202 and FYB206.

• EBITDA and adjusted EBITDA guidance unchanged at €-20 million to €-10 million; positive EBITDA targeted by 2026, or at the latest by 2027.

• Q4 revenue drivers include increased FYB202 royalties and anticipated licensing deals for FYB206.