DGAP-News: Formycon AG / Key word(s): 9-month figures/Expansion Formycon AG: Formycon announces results for first nine months of 2015 10.11.2015 / 07:30 --------------------------------------------------------------------- Press Release // November 10, 2015 Formycon announces results for first nine months of 2015 - 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(R)*. 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. About Formycon: Formycon is a leading independent pure play developer of biosimilars and has become a recognized innovator in this field. The company has extensive experience in the development of complex biological molecules. Formycon's specialist expertise allows the company to develop high-quality biosimilars that meet the strict regulatory requirements of highly regulated markets such as Europe and the United States. Formycon currently has three biosimilars under development, with further product candidates already identified. Two biosimilar candidates have been licensed out to Santo Holding GmbH. About biosimilars: Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of these biotech drugs will lose their patent protection - and by 2020, medications with revenues of more than 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. While the global market for biosimilars is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise. Contact: Thorsten Schüller Corporate Communications and Investor Relations Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg/Germany phone +49 (0) 89 - 86 46 67 150 fax + 49 (0) 89 - 86 46 67 110 [email protected] // www.formycon.com Disclaimer: This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions which may be subject to variety of risks and uncertainties. The results actually achieved by Formycon AG may substantially differ from these forward-looking statements. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States. --------------------------------------------------------------------- 10.11.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: Formycon AG Fraunhoferstraße 15 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of News DGAP News Service --------------------------------------------------------------------- 410457 10.11.2015