Munich – Formycon reports solid performance in fiscal year 2013 and a strong start in first quarter of 2014. For the first quarter of this year, Formycon AG has reported strong top-line and bottom-line growth, with revenue of EUR 5.832.904 compared to EUR 7.886 in the prior-year period. Earnings before interest, tax, depreciation and amortization (EBITDA) for the period were EUR 4.246 million, a dramatic gain from the EBITDA loss of EUR 1.558 million reported in the first quarter of 2013. Net income after tax for the first three months of this year was EUR 3.972 million, compared to a net loss of EUR 1.837 million in the prior-year quarter. On 31 March 2014, cash and securities amounted to approximately EUR 14 million.
The strong financial performance for the first quarter was mainly attributable to a downpayment from the successful out-licensing of its first biosimilar drug product, which Formycon will develop to enter clinical trials in the middle of 2015, as well as other development work for clients on a service-provider basis. The first biosimilar product will be developed by Formycon up to registration whereby the licensee, Santo Holding GmbH, will bear the full costs for the development and will be responsible for marketing and commercialization. The development of the company’s second biosimilar drug candidate is likewise proceeding according to plan. Originally planned for out-licensing in 2015, this product could be partnered already as early as the second half of 2014. Formycon is currently working to further expand the development pipeline of its biosimilar products.
Fiscal year 2013, which ended in line with plan, was marked by steady progress in the development of the company’s first two biosimilar drugs. The expenditures for these significantly exceeded revenues, leading to a tentative loss before tax of EUR 7.766 million and a net loss of EUR 7.767 million, compared to a loss of EUR 2.395 million in the previous fiscal year. The full-year loss per share for 2013 was thus EUR 0.90, compared to a per-share loss of EUR 0.47 in the previous fiscal year. Following its successful capital-raising measures in 2013, Formycon ended the year with equity capital of EUR 13.928 million, a significant increase for the year, and equal to approximately 80 percent of total assets. Formycon AG expects to end the current fiscal year 2014 with positive full-year EBITDA.
Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of an innovative COVID-19 drug FYB207.
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2020, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.