Formycon AG — Earnings Release 2014

Mar 30, 2015

News Details

Corporate | 30 March 2015 07:02

Formycon Group announces preliminary results for fiscal year 2014

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.

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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
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.

30.03.2015 The DGAP Distribution Services include Regulatory Announcements,
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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

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