Formycon Reports 83% Revenue Increase in 2023

Formycon, a Germany-based biosimilar manufacturer, shared that its revenues for 2023 were 83% higher than in 2022 (€45.5 million [$48.8 million]), reaching a total of €77.7 million ($81.2 million), according to its annual earnings report.

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"We look back on a very successful financial year with significant progress in development projects and deliver strong preliminary financial figures for the Formycon Group. We have made significant progress in all areas – from clinical development, regulatory milestones and key commercial partnerships to substantial revenue increases and stable financing," stated Formycon CEO Stefan Glombitza, PhD.

The company attributed part of its success to more market launches for FYB201, also known as Cimerli (ranibizumab-eqrn), as well as progress in the development of FYB202, an ustekinumab biosimilar, and FYB203, a biosimilar for aflibercept, which both have applications under review with the FDA and European Medicines Agency.

Formycon received milestone payments from Fresenius Kabi regarding FYB202. The 2 companies have been in an exclusive commercialization partnership for several global markets since February 2023. Of the payments received in 2023, one was a payment anticipated for 2024 that was partially paid in advance and reported in the 2023 financial report as a “correspondingly deferred, expected success payment.”

Formycon highlighted that it will replace the "consolidated net result" financial indicator with "adjusted Group EBITDA" in future reports. This change is due to the net result being heavily influenced by factors like fair value assessments and interest rates, which can lead to volatility and not accurately reflect operational performance. The group net result includes noncash adjustments, totaling €75.8 million ($81.3 million) in 2023, exceeding the forecasted range. Adjusted Group EBITDA, focusing on revenue from the FYB201 project, reached €13.3 million ($14.3 million) in 2023, mainly driven by increased earnings from Bioeq. The company said that the adjustment should provide a clearer view of Formycon's operational performance.

The marketing of the FYB201 has expanded to 17 countries globally, leading to increased revenue and net earnings. Direct participation in marketing FYB201 generated approximately €4.1 million ($4.4 million) in revenue. Additionally, a significant portion of FYB201 revenue, derived from a 50% equity investment in Bioeq AG, totaled €11.8 million ($12.7 million) for 2023, contributing to the adjusted Group EBITDA indicator, reflecting overall operating performance, including FYB201's marketing success.

By the end of 2023, Formycon Group's working capital rose to about €38.9 million ($41.7 million), surpassing the forecasted range of €15.0 million ($16.1 million) to €25.0 million ($26.8 million). This increase, along with cash and equivalents of €27.0 million ($29.0 million), was attributed to a successful business year and a capital increase in February 2023, raising €70.1 million ($75.2 million).

"The positive development of our key financial figures and the progress made in our projects confirm that we are clearly on track. We continue to pursue our strategy of investing sustainably in our biosimilar pipeline in order to ensure the rapid and parallel progress of our projects. We want to consolidate our position as one of the few pure play biosimilar developers and further expand this position in a dynamic environment," said Enno Spillner, chief financial officer of Formycon.

For future insights, Formycon plans to expand its portfolio with a new project, FYB210, an undisclosed biosimilar in development. Additionally, FYB206, a biosimilar candidate for Keytruda (pembrolizumab), is set to enter clinical development in 2024. However, the move will lead to substantial investments from 2024 to 2026. Formycon has strategically chosen to develop FYB206 independently until the completion of a phase 1 clinical trial, aiming for greater internal value creation. These investments won't impact the income statement or EBITDA due to cost capitalization.