• Significant rise in revenue as biotech company continues its profitable growth
  • Pivotal phase III clinical trial initiated for regulatory approval of FYB201 (ranibizumab)
  • Three additional biosimilar candidate drugs to be added to product Pipeline

Munich – Formycon, the biosimilars company, has announced a significant increase in its revenue for the first nine months of this year, thus continuing on its path of profitable growth. With the signing of its second out-licensing deal in May of this year with Santo Holding GmbH, financing is now fully in place to proceed with the development of its first two biosimilar product candidates, FYB201 and FYB203, all the way through to regulatory approval and market launch. In close partnership with bioeq GmbH, Formycon recently initiated a phase III clinical trial, pivotal for gaining market approval in Europe and the U.S., for FYB201, a biosimilar version of Lucentis®*. The first patient is to be accepted into the testing program over the coming weeks. Furthermore, Formycon is planning to begin development work on three additional biosimilar candidates from next year on, thereby further expanding its existing product pipeline and setting the foundations for continued growth.

Total consolidated revenue and other income for the period was EUR 14.71 million, an increase of EUR 5.73 million compared to the prior-year period (8.98m). EBITDA for the period from January to September was EUR 2.22 million (2.64m), while nine-month net income was EUR 1.51 million (1.81m). As of the end of September, the company’s holdings of cash, cash equivalents and marketable securities were EUR 17.12 million. Including also short-term receivables in the amount of EUR 5.7 million, Formycon thus has liquid assets of well over EUR 20 million at its disposal, roughly the twice the level at the end of the prior nine-month period (EUR 10,44 million).

Total revenue and other income for parent company Formycon AG alone, on an unconsolidated basis, was EUR 11.45 million, with nine-month net income of EUR 1.28 million. Dr. Nicolas Combé, CEO of Formycon, had this to say on the nine-month results: “We are putting our growth strategy into action deliberately and consistently, underscoring our company’s commitment as a leading independent developer of biosimilar drugs. Moreover, we see enormous demand on the market for these products, and thus we are now planning to expand our pipeline by three additional molecules. With these actions, we are putting the foundations into place to generate significant further value for our company and its shareholders. This path of profitable growth is a testimony to the superb work by our team, with which we are extremely satisfied.”

Formycon continues to anticipate a full-year profit, thereby confirming its existing guidance.

* Lucentis is a registered trademark of Genentech Inc.