Munich – Formycon AG has announced its financial results for the first quarter of 2015, reflecting the continued advances of its biosimilar development projects in line with plan. The group’s revenue for the period was largely attributable to its licensing and development agreement with Santo Holding GmbH for FYB201, the first of its biosimilar drug projects. Expenses consisted mainly of research and development costs for its three pending biosimilar projects. Subsequent to the end of the quarter, an important operational milestone was reached with the signing of an out-licensing agreement for FYB203, which will provide a further boost to the company’s financial flexibility. As to FYB201, the farthest advanced of its development projects, preparations and consultations with U.S. and European regulatory authorities for the commencement of phase III clinical trials essential for final regulatory approval are proceeding according to plan.
In the first quarter of 2015, Formycon reported consolidated revenues of EUR 3.0 million (1Q 2014: EUR 5.8 million). The decline was due to the fact that the prior-year period included a one-time payment following the signing of the above-mentioned licensing agreement. Consolidated EBITDA for the period was negative EUR 0.3 million (1Q 2014: EUR 4.2 million), with the decline likewise attribute to the one-time payment in the prior-year period. Based upon the recently announced successful signing of a partnership deal for FYB203, the company has raised its full-year forecast for fiscal year 2015, which it now expects to end with positive 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.