DGAP-News: 4SC Announces Financial Results 2009
(firmenpresse) - 4SC AG / Final Results
30.03.2010 07:30
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Planegg-Martinsried, Germany - 30 March, 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC) a drug discovery and development company focused on
autoimmune and cancer indications, today announced its financial results
for 2009 in accordance with International Financial Reporting Standards
(IFRS) for the year ended 31 December, 2009.
Highlights:
- Value of the product pipeline increased through the commencement of a
total of four Phase II studies
- Commencement of two Phase II studies with vidofludimus (4SC-101) in
rheumatoid arthritis (proof-of-concept) and inflammatory bowel disease
(exploratory)
- Commencement of Phase II study with resminostat (4SC-201) in
hepatocellular cancer and study centre initiation for Phase II study in
Hodgkin's lymphoma
- Preparations completed for the commencement of respective Phase I study
for both oncology compounds 4SC-203 and 4SC-205 at the beginning of
2010.
- Completed successful capital increase in November - raised gross
proceeds of EUR 30 million
Revenue in the reporting period declined compared to 2008 from EUR 3.0
million to EUR 1.9 million, as additional licensing revenue of EUR 750
thousand was generated in the prior year. Due to the increased number of
clinical development programmes in progress, research and development costs
increased from EUR 11.5 million to EUR 14.2 million. The loss for the year
increased to EUR 16.1 million from EUR 11.9 million in 2008. In comparison
the successful capital increase completed in November 2009, in which 4SC
raised gross proceeds of EUR 30 million, ensured a considerable extension
of the cash position to EUR 35.6 million as at 31 December, 2009. The
further development of the product portfolio has been secured until at
least the end of 2011.
Ulrich Dauer, Chief Executive Officer, commented on the course of business,
'2009 was a turnkey year in the twelve year company history of 4SC. Through
the excellent work delivered by our team we commenced a total of four Phase
II studies by early 2010 with our lead compounds vidofludimus and
resminostat. The results of these clinical studies, which are expected in
2010 and 2011 respectively and if positive should increase the company
valuation considerably and make both compounds more attractive to
interested parties from the global pharmaceutical and biotechnology
industry. The capital increase in November 2009 has provided the conditions
required to reach the development goals we have set for ourselves by the
end of 2011.'
Considerable Progress in the Clinical Pipeline
4SC achieved considerable progress in the further development of its
clinical pipeline in the reporting period. For the small-molecule
vidofludimus (4SC-101) a proof-of-concept Phase IIb study in rheumatoid
arthritis (RA), and an exploratory Phase IIa study in inflammatory bowel
disease (IBD), were commenced. For the oncology compound resminostat
(4SC-201) the first Phase II trial was commenced in August 2009 in
hepatocellular carcinoma (HCC), an indication with a large medical need. At
the beginning of January 2010 the Company commenced the second
proof-of-concept study in Hodgkin's lymphoma (HL).
Beyond this all preparations were completed to commence Phase I trials with
the two oncology compounds 4SC-203 and 4SC-205 after the close of the
reporting period, in January and February 2010 respectively. The clinical
pipeline now includes four compounds in six clinical trials in autoimmune
and oncology indications. With exception of 4SC-203 the small-molecules are
all orally available.
Vidofludimus, a small-molecule, is the most advanced product in the
pipeline. Its therapeutic effect is based on a dual mechanism. For one, it
inhibits the dihydroorotate dehydrogenase enzyme (DHODH) which is required
for the division of rapidly proliferating cells. This inhibits the division
of activated T and B cells, which is much higher during inflammation. For
another, preclinical studies in animal models have shown that vidofludimus
suppresses the signaling cytokine, Interleukin-17 (IL-17), that plays an
important role in inflammatory processes. In a poster presentation at the
Digestive Disease Week (DDW) in Chicago, USA, the world's largest
gastrointestinal conference, 4SC presented the potential of vidolfludimus
as an IL-17 inhibitor.
Vidofludimus is currently in two Phase II studies. For the treatment of RA
this compound is classified as part of the group of synthetic Disease
Modifying Anti-Rheumatic Drugs (DMARDs), which slow and inhibit the
progression of the disease. The 'COMPONENT' study in the indication RA was
commenced in November 2009. It is a randomised, two-arm, double-blind,
placebo-controlled international multi-centre Phase IIb study enrolling 244
patients. The study is evaluating the efficacy of this compound on the
background of the RA standard of care therapy methotrexat (MTX). The
primary endpoint of the study is ACR20. The secondary endpoints include
ACR50, ACR70, and DAS28. Safety, tolerability, pharmacokinetics will be
analysted and biomarkers will also be evaluated.
In March 2009, 4SC commenced the exploratory Phase IIa 'ENTRANCE' study for
the treatment of IBD with vidofludimus. This is an open-label, one arm,
multi-centre study in which 24 patients will take a 35mg dose once-daily
over 12 weeks. The goal is to reduce the dose of steroids to zero, which
will initially be given in parallel and as a standard of care therapy. The
primary endpoint is the number of patients that can be reduced to zero
doses of steroids whilst responding to vidofludimus. The secondary endpoint
will evaluate to what extent steroid treatment can be reduced.
Two further Phase II studies were commenced with resminostat. The most
advanced oncology compound is a pan-histone deacetylase (HDAC) inhibitor.
This drug class is characterised by a mechanism of action that modifies the
DNA structure of tumour cells, triggering cell differentiation and
programmed cell death (apoptosis). HDAC inhibitors have the potential to
enable the long term control of cancer as they halt tumour progression and
can induce tumour regression. In Phase I results with resminostat in spring
2009, 11 of the 18 patients a stabilisation of cancer was observed. The
drug was well tolerated and showed a very good and differentiated
pharmacological profile. These results were presented by 4SC at ASCO, the
world's largest cancer conference, in Orlando, Florida, USA, in June 2009.
In September, 2009, the data was presented at the European
multidisciplinary cancer conference ECCO-ESMO in Berlin, Germany.
Resminostat is already being investigated in two Phase II studies in
advanced HCC and HL. In 2010 4SC plans to expand the application potential
by testing it in combination with a standard chemotherapy. To this end 4SC
is currently preparing a clinical study in colorectal cancer patients to
examine resminostat in combination with the FOLFIRI chemotherapeutic
regimen in a second line setting focusing on tumors harboring KRAS
mutations.
The in August 2009 commenced 'SHELTER' study is assessing resminostat as a
second-line therapy and is a two-arm, multicenter, open-label study.
Resminostat is being evaluated as a monotherapy and as a combination
treatment with sorafenib, the only approved first-line therapy for advanced
stages of the disease, in up to 50 patients. The primary endpoint is
progression free survival rate (PFSR 12) after twelve weeks. The secondary
endpoints include the analysis of time to progression (TTP), the
progression-free survival rate after six weeks (PFSR 6), PFSR beyond 12
weeks and overall survival. The drug's safety, tolerability and
pharmacokinetics will also be investigated, as will biomarkers.
In December 2009, the study centres were initiated for the second Phase II
study. The 'SAPHIRE' study in up to 33 patients with HL recruited the first
patient in January 2010. It is an one-arm, multicenter and international
open-label study. The primary endpoint is the objective overall response
rate (ORR) of refractory or relapsed patients. The secondary endpoints
include assessment of progression free survival (PFSR), time to progression
(TTP), duration of response (DOR) and overall survival (OS) as well as the
analysis of safety, tolerability, pharmacokinetics and biomarkers.
Beyond these Phase II studies 4SC was able to diversify the risk profile of
its product pipeline through the preparation for the start of two further
oncology compounds. In December 2009 preparations were completed for the
start of 4SC-203 in a Phase I study in healthy volunteers. This
multi-target kinase inhibitor was developed jointly with the company
ProQinase GmbH, Freiburg, Germany, and will be developed in Acute Myeloid
Leukemia (AML) a particularly aggressive type of blood cancer. In this
randomised, double-blind and placebo controlled study, 4SC-203 will be
administered intravenously and 50 healthy volunteers will participate.
The pipeline was also broadened with 4SC-205, an Eg5 kinesin inhibitor,
when the German regulatory agency BfArM approved the study protocol. In
February 2010 the first patient was treated in the Phase I 'AEGIS' study.
Eg5 is of crucial importance to cell division and is only expressed in
actively dividing cells.
Financial Results 2009
Revenue in 2009 declined from EUR 3.0 million to EUR 1.9 million
year-on-year as additional revenue of EUR 750 thousand in the 2008
financial year was generated from the licensing agreement with
Erlangen-based ViroLogik GmbH, whilst revenue in the current financial year
stems from research cooperation agreements alone.
The clearly increased number of clinical programmes resulted in an
approximately 25% increase of research and development costs compared to
2008, from EUR 11.5 million to EUR 14.2 million. For one, the further
development of 4SC's maturing product pipeline resulted in higher external
costs for both services and materials as well as increased scheduled
amortisation. For another, this was due to the increase in staff costs
because the development team was expanded. In addition, administrative
costs rose from EUR 3.0 million to EUR 3.4 million compared to the previous
year.
The decreased revenues in conjuction with the rising expenses lead to the
higher operating loss of just under 30% from EUR 12.7 million to EUR 16.4
million to the prior year. The basic and diluted earnings per share were
EUR- 0.54 (2008: EUR- 0.51). This slight rise compared to the net loss
resulted from the total average volume of shares outstanding in 2009 of
29.8 million shares which was higher than in 2008 with 23.4 million.
Cashflow from operating activities was EUR- 14.6 million (2008: EUR- 9.4
million). Cashflow from investment activities generated inflows of EUR13.9
million (2008: outflows of EUR 22.8 million) of which the disposal of
financial instruments generated EUR 14.5 million in cash and cash
equivalents. The prior year was determined by the acquisition of the rights
to Nycomed's eight oncology projects for EUR 14 million. The cash flows
from financing activities in the reporting year were EUR 28.8 million
(2008: EUR 29.7 million). As in the prior year this was generated due to
the capital increase. Concurrently, loans of EUR 0.9 million were repayed
in January 2009.
Cash and cash equivalents at the end of the reporting period amounted to
EUR 35.6 million (2008: EUR 21.9 million). This increase is due to the
capital increase which was completed successfully in November. A total of
10,000,000 shares were placed at a price of EUR 3.00 per share, generating
gross proceeds of EUR 30.0 million at the top of the expected range and was
the largest capital increase of a German biotech company in 2009. The new
shares were admitted for trading at the Frankfurt Stock Exchange on 15
December 2009, leading to an increase of share capital to EUR 38,502,739.
The capital proceeds generated through the capital increase secure the
ongoing development of the current product pipeline until at least the end
of 2011. The largest shareholder of 4SC remains Santo Holding with a
holding of just under 50%. At the end of the financial period on 31
December, 2009, the equity capital of 4SC rose to EUR 50.9 million (2008:
EUR 37.1 million. The equity ratio increased from 90.4% 2008 to 94.4%.
Outlook
4SC's stated corporate goal remains to develop products until proof of
concept and then licensing these to interested companies from the global
pharmaceutical and biotechnology industry. With the considerably broadened
product pipeline the outlook for a significant increase in the valuation of
the company has been further improved due to potential clinical milestones
and development cooperations.
The capital proceeds generated through most recent capital increase will
enable the advancement and completion of the Phase II studies in RA and IBD
with the most advanced compound vidofludimus. The same is applicable to the
Phase II studies with the oncology HDAC-Inhibitor resminostat. In addition,
the product pipeline will be expanded with the already announced clinical
programmes.
For vidofludimus the company is expecting clinical results for both Phase
II trials in the current year, for which the IBD results will arrive in the
middle of the year. First results for the Phase IIb study in RA should
report by year end. In 2011, further results will be delivered from both
Phase II studies with resminostat. In 2010 the product portfolio will
continue to be expaned with the commencement of a Phase I/II study with
resminostat in combination with a chemotherapy and the Phase I commencement
with 4SC-202.
The expansion of the pipeline will result in an increase of research and
development costs in the coming year. Revenues from research cooperations
in 2010 are expected to be consistent to the prior year whilst remaining at
an overall operating loss for the year.
The complete financial report will be available from 8am at
www.4SC.com/investors.
Telephone Conference and Webcast
On Tuesday, 30 March, 2010, at 3pm CET (9am EST) 4SC will host a telephone
conference. The senior management team will inform about the key
developments in the financial year 2009 and will provide an update on the
development programmes.
Please dial 0800 10 12 072 from Germany, 0800 358 0886 from the UK and +1
877 941 2928 from the USA. For other countries please dial +49 629 589 990
805. The conference ID is 4265406.
Access to the presentation slides can be obtained at:
http://www.cyber-presentation.de/cgi-bin/visitors.ssp?fn=visitor&id=1163
Approximately two hours after the live presentation, an audio replay of the
conference will be available on the 'investors' section of the homepage
www.4sc.com.
For further information please contact:
4SC AG
Yvonne Alexander
Investor&Public Relations
Tel: +49 (0) 89 70 07 63 66
yvonne.alexander(at)4sc.com
MC Services (Europe)
Stefan Riedel
Tel.: +49 (0) 89 21 02 28 40
stefan.riedel(at)mc-services.eu
The Trout Group (USA)
Chad Rubin
Tel: +1 646 378 2947
crubin(at)troutgroup.com
Notes to Editor
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. The
company's lead oncology compound, resminostat (4SC-201), a pan histone
deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular
carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203
and 4SC-205, are in Phase I studies. 4SC develops drug candidates until
proof-of-concept in order to generate value creating partnerships with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties.
4SC was founded in 1997, has 91 employees, and is listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.
You will find further information under www.4sc.com.
Legal Note
This document may contain projections or estimates relating to plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject
to risks and uncertainties, many of which are beyond our control. Actual
results could differ materially, depending on a number of factors.
30.03.2010 07:30 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public(at)4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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