Formycon (FYB) H1 2024 earnings summary

Executive summary

• Achieved strong operational, commercial, regulatory, and clinical progress in H1 2024, including FDA approval for FYB203 and significant market expansion for FYB201 in 19 countries.

• Strategic investment from Gedeon Richter raised €83M, supporting pipeline development and future growth.

• Product pipeline advanced with FYB202 and FYB203 nearing commercialization, and FYB206 entering clinical trials for oncology indications.

• Upward revision to adjusted EBITDA and working capital guidance for 2024 due to strong product sales and earlier milestone payments.

• Settlement with Johnson & Johnson enables FYB202 launch in Europe and Canada; US entry expected by April 2025.

Financial highlights

• H1 2024 revenue was €26.9M, down from €43.8M in H1 2023 due to prior-year non-recurring milestone payments.

• EBITDA was -€16.9M (H1 2023: €7.3M); adjusted EBITDA was -€2.1M (H1 2023: €1.1M), driven by FYB201 sales.

• Net loss for H1 2024 was €10.1M, compared to a net profit of €1.8M in H1 2023.

• Working capital increased to €63.0M (H1 2023: €55.0M), supported by the capital increase.

• Cash and cash equivalents at €40.6M as of June 30, 2024 (Dec 31, 2023: €27.0M).

Outlook and guidance

• 2024 revenue expected at €55–65M, below 2023 due to milestone revenue timing.

• EBITDA forecast unchanged at -€25M to -€15M; adjusted EBITDA guidance raised to -€5M to +€5M.

• Working capital guidance increased to €35M–€45M, reflecting earlier milestone payments and deferred clinical costs.

• Focus on achieving midterm EBITDA and cash flow profitability as new assets reach market.

• Anticipated regulatory approvals for FYB202 and FYB203 in US and Europe in H2 2024 and early 2025.