Formycon (FYB) Q3 2024 earnings summary

Executive summary

• Achieved major milestones in 2024, including two FDA approvals, two positive CHMP opinions, and one EC approval for biosimilars FYB202 (Stelara) and FYB203 (Eylea), with strong commercial launches in key markets.

• Expanded clinical pipeline with the initiation of FYB206 (Keytruda biosimilar) and addition of FYB210, bringing the portfolio to seven parallel programs and progressing several late-stage and new biosimilar projects.

• FYB201 (Lucentis biosimilar) launched in 20 countries, achieving over 40% US and over 80% UK market share.

• Transitioned from a development-focused to a commercial-stage company, supported by uplisting to Prime Standard, enhancing visibility, liquidity, and investor access.

• CEO contract extended to December 2027, ensuring management continuity.

Financial highlights

• Revenue for the first nine months of 2024 was €41.1 million, down from €60.2 million in 9M/2023, mainly due to lower milestone payments and development compensation.

• Adjusted EBITDA for 9M/2024 was €2.9 million (9M/2023: €3.5 million), with reported EBITDA at –€17.7 million, reflecting higher R&D and administrative costs.

• Royalties from FYB201 increased from €2.3 million to €6.0 million year-over-year, reflecting commercial ramp-up.

• Cash and cash equivalents at €33.8 million as of September 30, 2024, up 25% year-over-year.

• Equity ratio improved to around 60%, with balance sheet total at €951.6 million and equity at €566.0 million.

Outlook and guidance

• Full-year 2024 guidance confirmed: revenue €55–65 million, EBITDA –€25 to –€15 million, adjusted EBITDA –€5 to +€5 million, and working capital €35–45 million.

• Q4 2024 revenue expected around €20 million, with break-even EBITDA and stable cash position.

• Major CapEx commitment of €19 million for FYB206 clinical development in Q4.

• FYB202 (Stelara biosimilar) U.S. launch with Fresenius Kabi set for no later than February 22, 2025.

• Additional commercial partnerships for FYB203 (Eylea biosimilar) expected in the coming months.