DGAP-News: Press Release: 4SC's successful development continues in third quarter of 2012
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Quarter Results
Press Release: 4SC's successful development continues in third quarter
of 2012
08.11.2012 / 07:31
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Press Release
4SC's successful development continues in third quarter of 2012
- Consolidated financial results improved in third quarter and first nine
months
- Key value-creating milestones achieved in drug development
Planegg-Martinsried, Germany, 8 November 2012 - 4SC AG (Frankfurt, Prime
Standard: VSC), a biotech company specialising in the research and
development of drugs for cancer and autoimmune diseases, today announced
that it has further continued its successful development in the 2012
financial year. The consolidated financial results according to IFRS
published by the Company for both the third quarter and the first nine
months of 2012 show substantial year-on-year improvements. The most
important event during the third quarter was the publication of excellent
clinical data for 4SC's lead anti-cancer compound resminostat in liver
cancer.
As a result of increased revenue and reduced operating expenses, the
Company, which is currently still recording losses according to plan, has
improved its operating result. In the first nine months of 2012, 4SC
reduced its operating loss by 14% year on year, to EUR 12.32 million.
Revenue development in the first nine months - which shows a year-on-year
increase of 134% to EUR 1.03 million - was boosted by the launch of the
early-stage research commercialisation business at the beginning of the
year by the Company's subsidiary 4SC Discovery GmbH. The decline in
operating expenses by 10% to EUR 13.38 million in the first nine months of
2012 is in particular attributable to the fall in research and development
costs compared with the previous year due to the successful conclusion of a
number of clinical trials and the reduction of administrative costs.
As at 30 September 2012 the Company had funds of EUR 15.8 million. Based on
the forecast of further expense and revenue planning, this will ensure the
Company's financing until the end of 2013.
In the third quarter, 4SC has achieved decisive milestones in its
operational drug research and development activities.
Operating highlights in the 4SC Group in the third quarter of 2012
The operating highlight in the third quarter of 2012 was the publication in
September of excellent Phase II trial data on 4SC's anti-cancer compound
resminostat in second-line therapy of liver cancer (HCC). In this
difficult-to-treat patient group, for which no therapy option is currently
available, the combination therapy of resminostat with the cancer drug
sorafenib achieved a median overall survival of 8.0 months. To the best of
the Company's knowledge, this is the highest figure so far achieved in
clinical trials in comparable liver cancer patient groups.
Another significant development in the field of drug development was the
strengthening of patent protection for resminostat in China. Due to the
high incidence of liver cancer, this country has strategic importance for
the future marketing of resminostat.
In the field of early-stage research, work started on a research
partnership between 4SC Discovery GmbH and the Mainz-based biotech company
Ribological GmbH for the discovery of new anti-cancer compounds. Shortly
after the end of the reporting period, 4SC Discovery GmbH was also granted
research funding of EUR 600,000 for the development of personalised cancer
drugs.
Important strategic decisions were also made and implemented at Group
level. A capital increase with gross proceeds of around EUR 12.6 million
was successfully completed at the beginning of the quarter. 4SC AG's
Supervisory Board was further strengthened by the appointment of two new
members: the experienced pharma managers Dr Irina Antonijevic (Sanofi) and
Mr Klaus Kühn (former CFO at Bayer AG).
Dr Ulrich Dauer, CEO of 4SC commented:
'We are very satisfied with our third-quarter performance. The outstanding
clinical trial results with resminostat in liver cancer were especially
pleasing. This improves our position in the ongoing talks with potential
pharma partners and regulatory agencies for our planned Phase III
registration trial in this indication. The marketing of our early-stage
research by 4SC Discovery GmbH is also proceeding along positive lines.
This can be seen in the new collaboration with Ribological and the research
grant of EUR 600,000 received from the Munich m4 biotech cluster. As a
result of the excellent clinical data from our lead compound resminostat,
the promising development of 4SC Discovery GmbH and our stronger financial
foundation due to the successful capital increase completed in summer of
2012, we believe we are well prepared for the upcoming developments.'
Financial results and cash flows in the third quarter and first nine months
of 2012
The 4SC Group, comprising 4SC AG and its wholly-owned subsidiary 4SC
Discovery GmbH, reports consolidated figures according to International
Financial Reporting Standards (IFRS) for the first nine months and the
third quarter of the 2012 financial year from two operating segments. The
Development segment comprises the drug development programmes for
resminostat, vidofludimus, 4SC-202, 4SC-203, 4SC-205 and 4SC-207. The
Discovery&Collaborative Business segment comprises the activities
involved in drug discovery and early-stage research plus subsequent
commercialisation, and, in particular, service business related to drug
discovery and optimisation.
Consolidated revenue amounted to EUR 0.29 million in the third quarter of
2012 and EUR 1.03 million in the first nine months of 2012. It is composed
of revenue from research collaborations and the pro rata reversal of the
deferred income item for resminostat in connection with the partnership
with Japanese pharmaceutical company Yakult Honsha from the previous year.
In the previous year, revenue was EUR 0.22 million (Q3 2011) and EUR 0.44
million (9M 2011), respectively. The Development segment accounted for EUR
0.22 million (Q3 2012) and EUR 0.67 million (9M 2012) of total revenue,
while the Discovery&Collaborative Business segment already generated
revenue of EUR 0.07 million (Q3 2012) and EUR 0.36 million (9M 2012) in the
relatively short period of time since 4SC Discovery GmbH commenced
operations at the beginning of the year.
Operating expenses in the third quarter of 2012 were EUR 4.80 million, down
5% compared with the prior-year quarter (Q3 2011: EUR 5.07 million).
Operating expenses in the first nine months of 2012 totalled EUR 13.38
million, a year-on-year decrease of 10% (9M 2011: EUR 14.83 million).
On account of the lower number of clinical trials compared to the
prior-year period, 4SC managed to reduce research and development costs by
12.4% to EUR 9.93 million in the first nine months of 2012 (9M 2011: EUR
11,331 million). At 74%, they continue to account for the lion's share of
operating expenses. In the quarterly comparison, research and development
costs slightly rose, from EUR 3.79 million (Q3 2011) to EUR 3.86 million
(Q3 2012). This is mainly due to the increased preparatory expenditure for
the advanced trials planned with resminostat (Phase III trial in liver
cancer) and vidofludimus (Phase IIb trial in inflammatory bowel disease).
Administrative costs in the third quarter of 2012 decreased by 27.4% to EUR
0.82 million, mainly due to lower consulting costs(Q3 2011: EUR 1.13
million). Administration costs in the first nine months of 2012 amounted to
EUR 2.85 million, a year-on-year reduction of 8% (9M 2011: EUR 3.1
million).
Increased revenue and lower operating expenses triggered a substantial
year-on-year improvement of the result from operating activities. In the
first nine months of 2012, the Company reduced its operating loss by 14%
year-on-year to EUR 12.32 million (9M 2011: EUR 14.39 million). The net
loss in the first nine months of 2012 improved by no less than 17% to EUR
12.14 million (9M 2011: EUR 14.68 million). In the third quarter of 2012,
the year-on-year figure for operating loss improved by 7% to EUR 4.5
million (Q3 2011: EUR 4.85 million). The net loss in the third quarter
amounted to EUR 4.46 million (Q3 2011: EUR 4.75 million).
In the first nine months of 2012, the average operating cash burn rate was
EUR 1.31 million. In the prior-year period, the operating cash burn rate
(9M 2011: EUR 0.94 million) was positively influenced by the upfront
payment of EUR 6 million received from Yakult Honsha in April 2011 under
the terms of the license agreement for resminostat in Japan.
Funds as at 30 September 2012 were EUR 15.8 million and therefore at the
same level as at the end of the previous year (31 Dec. 2011: EUR 15.8
million), mainly due to the successful capital increase in summer 2012.
4SC Group outlook
4SC is issuing the following outlook with regard to the subsequent
financial and operational business development in 2012 and beyond:
- In the indication of advanced liver cancer (HCC), 4SC is focusing
efforts on securing a Phase III registration trial with the anti-cancer
compound resminostat. 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 together with a pharmaceutical partner.
- 4SC is preparing a Phase IIb trial with vidofludimus in inflammatory
bowel disease (Crohn's disease indication). This study is to be
initiated together with a partner after the successful conclusion of
negotiations with potential partners and further preparatory work
required for the trial.
- 4SC expects to receive interim results before the end of 2012 from the
clinical Phase I/II SHORE trial with resminostat in colon cancer. Data
from the Phase I trial with the anti-cancer compound 4SC-205 (AEGIS
study) are also scheduled to be published in the course of the year.
Completion of the dose escalation study with the anti-cancer compound
4SC-202 (Phase I TOPAS trial) has been postponed to 2013, since the
very high tolerability of the compound means that further, additional
dosages can be investigated to determine the optimum therapeutic dose.
- 4SC Discovery GmbH: It is the company's continued goal to generate
additional revenue in the collaboration 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 aims at developing its lead compounds,
resminostat and vidofludimus, into marketable products and generate
cash inflows to finance 4SC's operating business.
- According to current planning, the average monthly operating cash burn
rate in 2012 will be around EUR 1.40 million. Assuming that the monthly
operating cash burn rate in 2013 will be significantly lower, the
Company's existing funds in connection with the current forecast of
further expense and revenue planning will ensure its financing until
the end of 2013.
The complete consolidated 9-month financial 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
English, in which the Management Board of 4SC AG will report on the
principal developments in the period under review. To participate in the
telephone conference, please use the following data:
Date: 8 November 2012
Time: 3:00 pm CET (9:00 am EST)
Dial-in numbers:
+49-6103-485-3000 (Germany)
+44-207-153-2027 (UK)
+1-480-629-9822 (USA)
+49-6103-485-3000 (other countries)
Conference ID: 4573536
Approximately two hours after the start of the conference, an audio replay
of the conference call will be made 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 high unmet
medical needs 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
30 September 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 AG
Jochen Orlowski, Corporate Communications&Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49-89-7007-63-66
MC Services
Raimund Gabriel, Mareike Mohr
raimund.gabriel(at)mc-services.eu, Tel.: +49-89-2102-2830
The Trout Group
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1-646-378-2947
End of Corporate News
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08.11.2012 Dissemination of a Corporate News, transmitted by DGAP - a
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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(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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