Munich – Formycon AG has reported its preliminary consolidated financial results for fiscal year 2014, with sales revenue and other income totaling EUR 12.67 million (prior year: EUR 0.41 million). Operating expenses rose from EUR 1.25 million in the prior year to EUR 5.91 million due to ongoing product development activities at its Munich headquarters. EBITDA for the year was EUR 1.94 million (prior year: – EUR 6.64 million), while net income came in at EUR 0.86 million (prior year: – EUR 7.74 million). With these strong results, the company has delivered its first full-year profit in 2014, significantly ahead of its own earlier forecasts.

As of December 31, 2014, Formycon Group held a total of EUR 9.22 million in cash and marketable securities. Equity capital ended the year at EUR 13.11 million (prior year: EUR 12.25 million), leaving the company’s equity capital ratio (equity as percentage of total assets) almost unchanged from the prior-year level at 77.5 percent.

Because of the significant investments into building its drug development pipeline in 2013, Formycon had posted a loss of EUR 7.7 million for the prior fiscal year, as anticipated. These investments have now started paying out for the long term as the company successfully develops its own biosimilar products. Since December 2013, Formycon has already been earning significant income from the out-licensing of its first product to Santo Holding. As the licensed partner for this drug, Santo Holding is now financing the further clinical development, regulatory approval process and market launch of this first bioisimilar drug, towards the aim of global distribution.

Through its intensive R&D activities, Formycon has since managed to achieve a number of further milestones in the development of its three biosimilar candidates. As already announced, the company was able in December 2014 to moves its first biosimilar (FYB201) directly into the critically important phase III clinical trials on the basis of preliminary guidance received from the European Medicines Agency (EMA). Formycon is likewise now seeking scientific advice from the U.S. Food and Drug Administration (FDA). Development of the company’s two other biosimilar candidates (FYB 202 and FYB 203) continues to move forward according to plan.