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 strong market expansion for FYB201 in 19 countries.

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

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

• Pipeline progress with regulatory milestones for FYB202 and FYB203, and initiation of clinical trials for FYB206.

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

Financial highlights

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

• Adjusted EBITDA for H1 2024 was -€2.1 million, improved from €1.1 million in H1 2023, driven by FYB201 sales.

• Cash and cash equivalents increased to €40.6 million as of June 30, 2024, up 50% from year-end 2023.

• Equity ratio improved to 61% post-share issue and debt reduction.

• Net sales from FYB201 reached €103M in H1 2024, up from €42M in H1 2023.

Outlook and guidance

• 2024 revenue expected in the range of €55–65 million, below 2023 due to milestone revenue timing.

• Adjusted EBITDA guidance raised to -€5M to +€5M for 2024.

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

• Focus remains on expanding the biosimilar pipeline and achieving medium-term EBITDA and cash flow profitability.

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