Formycon AG — Earnings Release 2015

Sep 14, 2015

News Details

Corporate | 14 September 2015 08:30

Formycon announces positive financial results for first half of 2015

DGAP-News: Formycon AG / Key word(s): Half Year Results/Interim Report

2015-09-14 / 08:30

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Press Release // September 14, 2015

Formycon announces positive financial results for first half of 2015

– Strong levels of revenue and earnings

– Rising R&D expenditures as biosimilar drug candidates pushed forward

– Successful cooperation with licensing and sales partner Santo Holding

Munich – Formycon, the biosimilars company, has closed the first half of its fiscal year 2015 with very successful financial results. Consolidated revenue for the period ending June 30, 2015, was EUR 9.8 million, an increase of EUR 2.24 million over the prior-year period. Net income for the six-month period was EUR 1.53 million, with the decrease of almost EUR 1 million from the prior-year period due largely to increased material and staff expenses related to investments in projects to develop new biosimilar drugs. As of the period closing date, Formycon Group held more than EUR 20.56 million in consolidated cash and marketable securities. The company’s equity capital ratio rose from 83.4 percent to 89.8 percent.

Formycon AG, the parent and primary operating entity, as well as the entity conducting core R&D activities, reported unconsolidated revenue of EUR 7.1 million (prior-year period: 7.4 million) and unconsolidated after-tax earnings of EUR 1.65 million (2.41 million). The company continues to anticipate a full-year profit for both the consolidated group and the unconsolidated parent entity.

“We are very satisfied with these half-year results,” said Dr. Nicolas Combé, CFO of Formycon. “Because we are investing significant amounts into the development of our biosimilar candidates and are, moreover, in a growth phase, our expense levels have increased according to plan. These are investments which are serving to build our company’s long-term future.”

With out-licensing deals now signed with Santo Holding GmbH for two of the three product candidates currently in development, Formycon has a strong partner at its side. “This has put a solid foundation into place for our product candidates and their future market launch,” explained Combé. “Furthermore, this partnership gives us the financial flexibility to proceed deliberately and confidently with our own biosimilar development efforts, as we expand our R&D pipeline step by step.”

Under the terms of the licensing agreement signed in May 2015 for FYB203, the company’s second biosimilar drug, Formycon received a multi-million-euro up-front payment from Santo. Formycon will, moreover, receiving payments for further product development all the way through to regulatory approval. Since December 2013, when the company signed its out-licensing deal with Santo Holding for FYB201, its first product candidate, Formycon has been receiving ongoing payments. Its third project under development, FYB202, is currently in pre-clinical testing.

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.

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. Formycon aims to be first to present clinical data for each respective biosimilar product candidate and to partner these products with major pharmaceutical and generic companies for global commercialization.

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

ir@formycon.com // 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.

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2015-09-14 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.

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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

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394145  2015-09-14