Munich – The first quarter of 2016 has been successful for the biosimilars company Formycon both in operational and financial terms. On the furthest-progressed development project FYB201, a biosimilar candidate for Lucentis®*, the first patient was enrolled in February of this year in the phase III study which is intended to support market approval in Europe and the USA. The study is being financed by and carried out under the responsibility of Formycon’s licensing partner Santo Holding/bioeq, as is all of the further development and subsequent marketing. Work has also begun on the development of a further biosimilar candidate. The program has now been given an official project status with the code FYB205.
At group level, sales revenues and other earnings totaled Euro 6.34 million, which represents an increase of Euro 3.34 million (previous year: Euro 3.0 million). From January to March, the EBITDA was Euro -0.02 million (Euro -0.3 million) based on a quarterly result of Euro -0.19 million (Euro -0.57 million). Stocks of liquid assets, which comprise cash, checks, bank deposits and securities, totaled Euro 15.29 million at the end of March. Including short-term receivables from deliveries and services worth Euro 7.48 million, Formycon held liquid assets of Euro 22.76 million on the day of reporting.
Revenues from sales and other earnings at Formycon AG totaled Euro 4.99 million. The quarterly result stood at Euro -0.33 million. Chief Financial Officer Dr. Nicolas Combé commented on the quarterly figures with these words: “We are very happy with how the first quarter has progressed and we have achieved further important milestones on our various projects. The financial results lay entirely within our forecasts. As already communicated, we anticipate a growth in sales to over Euro 20 million for the whole year at group level. The annual result will depend greatly on the time at which we partner our FYB202 project. We are already in negotiations with potential partners for this, however there is still a possibility that we will continue to manage the project on our own for a certain period.”
* Lucentis is a registered trademark of Genentech Inc.
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 antibody-based COVID-19 compounds.
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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.