DGAP-News: Press Release 4SC AG: 4SC Announces Financial Results for the First Quarter of 2012


DGAP-News: 4SC AG / Key word(s): Quarter Results/Miscellaneous
Press Release 4SC AG: 4SC Announces Financial Results for the First
Quarter of 2012

10.05.2012 / 07:30

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Press Release

4SC Announces Financial Results for the First Quarter of 2012 

Planegg-Martinsried, Germany - 10 May 2012 - 4SC AG (Frankfurt, Prime
Standard: VSC), a discovery and development company of targeted small
molecule drugs for autoimmune diseases and cancer, today announced the
consolidated financial results of the 4SC Group (4SC) in accordance with
International Financial Reporting Standards (IFRS) for the quarter ended 31
March 2012.

The Company has made a successful start to 2012. Both Group segments
achieved important milestones in the first months of the year. The
Development segment, which comprises the development of clinical drug
programmes as conducted by the Group's parent company 4SC AG, achieved
decisive progress for its lead products, the cancer drug resminostat and
vidofludimus, the compound to treat autoimmune diseases. The Drug Discovery
& Collaborative Business segment comprising early-stage pharmaceutical
research and its commercialisation by 4SC Discovery GmbH - which launched
operations at the beginning of the year - also achieved impressive initial
results.

Financial results and financial situation in the first quarter 2012

Consolidated revenue in the first three months of 2012 increased to
EUR0.365 million (Q1 2011: EUR0). The increase is due mainly to the
deferred income in the first quarter from the licensing partnership for
resminostat with the Japanese pharmaceutical company Yakult Honsha, into
which 4SC entered in 2011, and to revenue generated under research
collaboration projects.

Operating expenses stood at EUR4.19 million in the first quarter of 2012,
down 13% on the prior-year figure of EUR4.79 million. This reduction was
mainly triggered by the decline in research and development costs, which
fell by 21% to EUR2.92 million (Q1 2011: EUR3.68 million) because four of
the originally eight concurrent clinical studies were brought to a
successful completion in the meantime. Administrative costs rose by 6% to
EUR1.03 million year on year (Q1 2011: EUR0.97 million), principally as a
result of higher legal and consulting costs and an increase in costs
incurred for investor relations activities. 4SC was able to reduce its net
loss by 21%, from EUR4.70 million in the prior-year quarter to EUR3.70
million in the first quarter of 2012, mainly on the back of lower operating
expenses.

At 31 March 2012, 4SC had funds of EUR11.97 million (31.12.2011: EUR15.82
million). This represents an average monthly operational cash burn of
EUR1.28 million in Q1 2012.

4SC Group operational highlights in the first quarter of 2012

In clinical and preclinical drug development:

  - Publication of excellent clinical data from the Phase II SHELTER study
    with the anti-cancer drug resminostat in advanced liver cancer
    (hepatocellular carcinoma, HCC) - the primary endpoint was reached
    ahead of time (Jan. 2012).

  - Publication of preclinical data for vidofludimus, the compound for
    treating autoimmune diseases, which demonstrate the substance's unique
    anti-inflammatory mechanism of action (Feb. 2012).

In positioning the drug programmes in the competitive environment:

  - Granting of the composition-of-matter patent for resminostat in Taiwan.
    The patent authorities in three other Asian growth markets (South
    Korea, India, and the Philippines) have indicated that the granting of
    patent protection is imminent in the respective countries. Due to the
    high occurrence of liver cancer in the region, Asia-Pacific is of
    strategic importance (March 2012).

In early-stage research and research collaboration projects:

  - Realisation of a milestone payment under a completed research
    collaboration project with the Japanese pharmaceutical company Sanwa
    Kagaku Kenkyusho Co., Ltd. (SKK) following SKK's achievement of an
    agreed milestone for a drug candidate originally identified with the
    help of 4SC. The milestone payment goes to 4SC Discovery (March 2012).

  - After the reporting period: 4SC Discovery launches its first compound
    screening research collaboration with Henkel KGaA, just three months
    after commencing operations. Furthermore, 4SC Discovery agrees a
    strategic marketing cooperation in the field of drug discovery with
    CRELUX GmbH, a leading provider of services related to protein
    structure biology (April 2012).

Dr Ulrich Dauer, CEO of 4SC AG, commented: 'We are full of confidence
following the successful start to the 2012 financial year both in our
clinical compound programmes and our early-stage research. One highlight in
clinical development was the publication of the Phase II trial data for our
anti-cancer drug resminostat in advanced liver cancer (HCC) in January.
These data indicate that resminostat can offer a survival benefit for HCC
patients who no longer respond to sorafenib, the only approved cancer
therapy available to them today. We are confident that we will be able to
confirm these promising data over the course of the year when we present
the final results from this study. We are doing everything in our power to
ensure that we can launch a registration trial in this indication together
with a partner.'

Dr Dauer continued: 'We are particularly pleased that our young subsidiary
4SC Discovery GmbH has entered into its first research collaboration with
Henkel and announced a strategic collaboration with CRELUX just three
months after commencing operations. Just like the received milestone
payment from SKK, these successes validate our business model and our
strategic goal to generate additional revenue from our early-stage research
work to further strengthen our business. The upcoming operational and
clinical milestones for 2012 will be key for the successful future
development of our company. We look forward to this with optimism.'

4SC Group outlook 

4SC confirms the guidance it published in its consolidated financial
statements for 2011 on 29 March 2012:

  - 4SC is preparing a Phase IIb trial with vidofludimus in inflammatory
    bowel disease (IBD). It is intended to launch the trial in late
    2012/early 2013, ideally in collaboration with a pharmaceutical
    partner.

  - In the indication of advanced liver cancer (HCC), 4SC is focusing
    efforts on securing a pivotal study together with a pharmaceutical
    partner. If the outcome of the talks with the authorities and potential
    partners is successful, this study could be initiated in the first half
    of 2013.

  - In 2012, 4SC is expecting final data from the Phase II SHELTER study
    with resminostat in liver cancer and initial interim results from the
    Phase I/II SHORE study with resminostat in colorectal cancer. In
    addition, the ongoing Phase I studies with the anti-cancer compounds
    4SC-202 and 4SC-205 are also expected to be concluded.

  - 4SC Discovery GmbH: It is intended to generate additional revenue in
    the cooperation and services business with pharmaceutical companies and
    through the marketing of the Group's own drug programmes in early
    research phases.

  - 4SC is looking to enter into further licensing partnerships with
    pharmaceutical and biotechnology companies. Under the umbrella of such
    partnerships, the company wants to develop its lead compounds,
    vidofludimus and resminostat, into marketable products and generate
    cash inflows to finance 4SC's operating business.

  - Based on 4SC's expense and revenue planning for 2012, the existing
    funds will ensure the Company's financing beyond the first quarter of
    2013. According to this planning, the average monthly operating cash
    burn rate in 2012 will be around 10% higher than in 2011 (EUR1.07
    million). Research and development costs are expected to remain
    slightly below the 2011 level.

The complete quarterly report will be available for download at www.4sc.com
/ investors today from 7:30 am CET.

Telephone conference 

Today at 3:00 pm CET (9:00 am EST), 4SC will host a telephone conference,
in which the Management Board of 4SC will report on the principal
developments in the first quarter of 2012 and beyond.

To participate in the telephone conference, please use the following data:

Date: 10 May 2012

Time: 3:00 pm CET (9:00 am EST)

Dial-in numbers: 
+49-6103-485-3000 (Germany)
+44-207-153-2027 (UK)
+1-480-629-9725 (USA)
+49-6103-485-3000 (other countries)

Conference ID: 4537583

Approximately two hours after the live conference, an audio replay of the
conference call will be available at www.4sc.com under Investors / Events &
Presentations / Conference Calls & Webcasts.

Ends

About 4SC

The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops
targeted, small-molecule drugs for treating diseases with a high unmet
medical need in various autoimmune and cancer indications. These drugs are
intended to provide innovative treatment options that are more tolerable
and efficacious than existing therapies, and provide a better quality of
life. The Company's balanced pipeline comprises promising products that are
in various stages of clinical development. 4SC's aim is to generate future
growth and enhance its enterprise value by entering into partnerships with
leading pharmaceutical companies. Founded in 1997, 4SC had 90 employees at
31 March 2012. 4SC AG has been listed on the Prime Standard of the
Frankfurt Stock Exchange since December 2005.

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.

For more information please visit www.4sc.com or contact:

4SC 
Jochen Orlowski, Investor Relations & Public Relations
jochen.orlowski(at)4sc.com, Tel.: +49-89-7007-63-66

MC Services 
Raimund Gabriel
raimund.gabriel(at)mc-services.eu, Tel.: +49-89-2102-28-30 

Mareike Mohr 
mareike.mohr(at)mc-services.eu, Tel.: +49-89-2102-28-40

The Trout Group (USA) 
Chad Rubin 
Crubin(at)troutgroup.com, Tel.: +1-646-378-2947


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Language:    English                                                
Company:     4SC AG                                                 
             Am Klopferspitz 19a                                    
             82152 Martinsried                                      
             Germany                                                
Phone:       +49 (0)89 7007 63-0                                    
Fax:         +49 (0)89 7007 63-29                                   
E-mail:      public@4sc.com                                         
Internet:    www.4sc.de                                             
ISIN:        DE0005753818                                           
WKN:         575381                                                 
Listed:      Regulierter Markt in Frankfurt (Prime Standard);       
             Freiverkehr in Berlin, Düsseldorf, München, Stuttgart  
 
 
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