- First patient enrolled in phase III registration study for FYB201 (ranibizumab)
- Expansion of the product pipeline with fourth biosimilar candidate
- Growth in sales and quarterly results as forecasted
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.