Formycon (FYB) Q2 2026 earnings summary

Executive summary

• Achieved significant operational and strategic milestones in H1 2026, including completion of FYB206 clinical development, EU launch of FYB203, and expanded commercial portfolio with launches in Europe and planned US launch for Eylea® biosimilar in Q4 2026.

• Strengthened global commercialization through new licensing agreements and expanded manufacturing partnerships, notably with Lotus Pharmaceutical for FYB206 in Asia-Pacific and OneSource Specialty Pharma.

• Transformation initiatives reduced development timelines and costs by 30%, supporting sustainable growth and improved financial performance expectations.

• Benefited from regulatory changes reducing the need for Phase III studies for biosimilars, opening new market opportunities.

• FYB4Growth strategy advanced, focusing on portfolio expansion, geographic diversification, and cost efficiency.

Financial highlights

• Revenue rose to €25.8 million in H1 2026 from €9.0 million in H1 2025, driven by milestone payments, royalties, license income, and supply management.

• EBITDA improved to €-3.4 million from €-17.9 million year-over-year; adjusted EBITDA at €-6.9 million versus €-19.2 million.

• Net loss narrowed to €-14.6 million from €-54.2 million year-over-year.

• Working capital increased to €51.2 million as of June 30, 2026.

• Cash and cash equivalents stood at €51.8 million as of June 30, 2026.

Outlook and guidance

• Full-year 2026 guidance confirmed: revenue expected between €60–70 million, EBITDA €0–10 million, adjusted EBITDA €5–15 million, and working capital €20–30 million.

• Key revenue drivers for H2 2026 include milestone payments for FYB206 and royalty income from FYB202.

• FYB203 to launch in the U.S. in Q4 2026, with limited impact expected for 2026.

• FYB201 anticipated to regain U.S. market share, supporting royalty growth.

• Guidance confirmed; going concern secured.