20.09.2016
Formycon AG DE000A1EWVY8
DGAP-News: Formycon AG: Formycon Reports First Half 2016 Financial and Operating Results
DGAP-News: Formycon AG / Key word(s): Quarter Results/Interim Report
Formycon AG: Formycon Reports First Half 2016 Financial and Operating
Results
20.09.2016 / 07:30
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Press Release // September 20, 2016
Formycon Reports First Half 2016 Financial and Operating Results
- Biosimilar projects continue to develop successfully over the first six
months
- Half-yearly figures on track
- Santo Holding (Deutschland) GmbH transfers project rights to Bioeq IP
AG joint venture company
Munich - The development of Formycon's biosimilar candidates has progressed
well during the first half of 2016. Biosimilar developer Formycon AG
announced this update today as it unveiled its 2016 half-year figures.
Formycon is currently working on four biosimilar development projects
(FYB201, FYB202, FYB203, FYB205) at different stages of preclinical and
clinical development.
The furthest-advanced is FYB201, a biosimilar candidate of the ophthalmic
drug Lucentis(R)* (ranibizumab), for which patients have been enrolled in a
global clinical phase III since the start of 2016 in collaboration with
bioeq GmbH. FYB201 is therefore the world's only Lucentis(R) biosimilar to
be in a phase III study, the final step in clinical development to gain
marketing approval. Formycon is pursuing the goal of marketing FYB201 via
its licensing partner as the first Lucentis(R) biosimilar following the
expiry of the drug's patent in the USA and Europe.
Further important milestones were reached during the first six months of
2016 on the development projects FYB202 and FYB203, which are in the pre-
clinical phase, including agreements with renowned biopharmaceutical
contract manufacturers. For FYB205, the company's latest biosimilar
project, which has been started in Q1 2016, a cell line development
agreement has been signed with a prestigious partner.
FYB203, which is partnered to Santo Holding (Deutschland) GmbH, is a
biosimilar candidate for Eylea(R)** (aflibercept) which, like Lucentis(R),
is used to treat neovascular, age-related macular degeneration (nAMD) and
other serious eye conditions. For FYB202 and FYB205, which both are not
partnered and fully owned by Formycon, the reference products have not been
disclosed so far.
With effect from April 1, 2016 Santo Holding (Deutschland) GmbH has, with
Formycon's approval, transferred the global commercialization rights for
FYB201 to the Swiss company Bioeq IP AG. Bioeq IP AG is a joint venture
company, the shares of which are held equally by Santo Holding AG and Swiss
Pharma International AG, a company of the Polpharma Group. Nothing will
change in relation to Formycon's forecast future licensing income as a
result of this transfer.
Through the expansion and progress of biosimilar projects, Formycon has
adapted its structures and in the process also further increased its
workforce, as it has done in previous years. At the half-year stage, the
company employed 65 people compared to 53 at the start of 2016. As
reported, from October 1, 2016, the experienced pharmaceutical manager Dr.
Stefan Glombitza will join the management board, which currently comprises
two members. Together with Dr. Carsten Brockmeyer (CEO) and Dr. Nicolas
Combé (CFO), Dr. Glombitza will take on the role of Chief Operating Officer
(COO) with special responsibility for the company's operational development
activities.
In economic terms, Formycon has concluded the first half of 2016 on
schedule. The Formycon Group's turnover was Euro 8.76 million, compared to
Euro 9.82 million in the same period the previous year. Formycon received
income from the development of its partnered biosimilar product candidates
FYB201 and FYB203. As planned, Formycon has invested further in its
biosimilar assets FYB202 and FYB205. As a consequence of this increased
research and development expenditure, the operating result stood at Euro
-1.17 million compared to Euro 1.5 million during the same period last
year.
The company's financial position remains consistently solid: Formycon holds
liquid assets of around Euro 17.8 million. Including short-term receivables
from deliveries and services worth Euro 2.95 million, Formycon's liquid
assets total around Euro 20.7 million (2015: 23.1 million). The Group's
equity ratio is over 93 percent. Based on income from its partnered
projects, the company continues to anticipate a rise in turnover to over
Euro 20 million for the current year. The annual result is greatly
dependent on whether the FYB202 project will be partnered in 2016.
Formycon AG, as the company's central development and operational unit,
achieved a turnover of Euro 7.1 million (previous year: 7.1 million) during
the first six months, with the result from the first half-year being Euro
-1.2 (1.7) million. The full half-year report is available on the Internet
at www.formycon.com/investors/financial-reports.
Dr. Brockmeyer says: "Following last year's excellent results, we have been
able to continue our path to success during the first six months of 2016,
enroll numerous patients in the phase III study with our leading biosimilar
candidate FYB201, achieve important milestones in FYB202 and FYB203, and
expand our product pipeline with the new biosimilar candidate FYB205. The
role of biosimilars in medical care is growing increasingly on a global
scale, and the demand for affordable biopharmaceuticals is rising. This
convinces us that we are on the right path with our biosimilar projects."
* Lucentis is a registered trademark of Genentech Inc.
**Eylea is a registered trademark of Regeneron Pharmaceuticals 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 four
biosimilars under development, of which two have been licensed out.
About biosimilars:
Since their introduction in the 1980s, biopharmaceuticals have
revolutionized the treatment of serious diseases such as cancer, diabetes,
rheumatoid arthritis, multiple sclerosis and eye diseases. 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 3.0 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 press release may contain forward-looking statements and information
which are based on our current expectations and certain assumptions.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, performance of the company, development of the products and the
estimates given here.
Such known and unknown risks and uncertainties comprise, among others, the
research and development, the regulatory approval process, the timing of
the actions of regulatory bodies and other governmental authorities,
clinical results, changes in laws and regulations, product quality, patient
safety, patent litigation, contractual risks and dependencies from third
parties. With respect to pipeline products, Formycon AG does not provide
any representation, warranties or any other guarantees that the products
will receive the necessary regulatory approvals or that they will prove to
be commercially exploitable and/or successful.
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.
---------------------------------------------------------------------------
20.09.2016 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.
Archive at 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, Tradegate Exchange;
Open Market (Entry Standard) in Frankfurt
End of News DGAP News Service
---------------------------------------------------------------------------
503177 20.09.2016
|
Weitere Ad-hoc und Unternehmensrelevante Mitteilungen zu
Formycon AG ISIN: DE000A1EWVY8 können Sie bei EQS abrufen
Biotechnologie , A1EWVY , FYB , XETR:FYB