10.11.2015
Formycon AG DE000A1EWVY8
DGAP-News: Formycon AG: Formycon announces results for first nine months of 2015
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
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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.
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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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