Formycon AG / Key word(s): Final Results 30.03.2015 07:02 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer / publisher is solely responsible for the content of this announcement. --------------------------------------------------------------------------- Munich - Formycon AG has reported its preliminary consolidated financial results for fiscal year 2014, with sales revenue and other income totaling EUR 12.67 million (prior year: EUR 0.41 million). Operating expenses rose from EUR 1.25 million in the prior year to EUR 5.91 million due to ongoing product development activities at its Munich headquarters. EBITDA for the year was EUR 1.94 million (prior year: - EUR 6.64 million), while net income came in at EUR 0.86 million (prior year: - EUR 7.74 million). With these strong results, the company has delivered its first full-year profit in 2014, significantly ahead of its own earlier forecasts. As of December 31, 2014, Formycon Group held a total of EUR 9.22 million in cash and marketable securities. Equity capital ended the year at EUR 13.11 million (prior year: EUR 12.25 million), leaving the company's equity capital ratio (equity as percentage of total assets) almost unchanged from the prior-year level at 77.5 percent. Because of the significant investments into building its drug development pipeline in 2013, Formycon had posted a loss of EUR 7.7 million for the prior fiscal year, as anticipated. These investments have now started paying out for the long term as the company successfully develops its own biosimilar products. Since December 2013, Formycon has already been earning significant income from the out-licensing of its first product to Santo Holding. As the licensed partner for this drug, Santo Holding is now financing the further clinical development, regulatory approval process and market launch of this first bioisimilar drug, towards the aim of global distribution. Through its intensive R&D activities, Formycon has since managed to achieve a number of further milestones in the development of its three biosimilar candidates. As already announced, the company was able in December 2014 to moves its first biosimilar (FYB201) directly into the critically important phase III clinical trials on the basis of preliminary guidance received from the European Medicines Agency (EMA). Formycon is likewise now seeking scientific advice from the U.S. Food and Drug Administration (FDA). Development of the company's two other biosimilar candidates (FYB202 and FYB203) continues to move forward according to plan. Background: What are biosimilars? Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire - and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as "biosimilars". While the global market for these new-generation drugs 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. About Formycon: Formycon AG is a leading independent developer of biosimilars for global marketing and has become a recognized innovator in the field. The team of the company which has today become Formycon AG has extensive experience in the development of complex molecules. The company has already successfully licensed two protein-based product portfolios out to major pharmaceutical companies - in 2008 and 2011. Its specialist expertise allows the company to develop high-quality biosimilars that meet the strict requirements of the regulatory authorities in highly regulated countries and regions such as Europe and the USA. Formycon currently has three biosimilar candidates under development, the first of which has already been licensed out to Santo Holding GmbH, with further product development projects in the pipeline. Its aim is to be the first company in the world to present clinical data for each respective product candidate and on this basis to license these products out to major pharmaceutical and generics companies for further development. Alternatively, Formycon offers further development of its biosimilars all the way through to marketing authorization, as well as commercial production on behalf of its licensees. Contact: Formycon AG Fraunhoferstr. 15 82152 Martinsried/Planegg Germany phone +49 (0) 89 - 86 46 67 100 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. 30.03.2015 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 145 82152 Planegg-Martinsried Germany Phone: 089 864667 100 Fax: 089 864667 110 E-mail: Internet: www.formycon.com ISIN: DE000A1EWVY8 WKN: A1EWVY Listed: Regulated Unofficial Market in Berlin; Open Market (Entry Standard) in Frankfurt End of Announcement DGAP News-Service ---------------------------------------------------------------------------