DGAP-News: Press Release: 4SC announces financial results for a successful year 2012
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Final Results
Press Release: 4SC announces financial results for a successful year
2012
25.03.2013 / 07:30
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Press Release
4SC announces financial results for a successful year 2012
- Consolidated results considerably improved due to rising revenue and
reduced costs
- Key value-creating milestones achieved in drug development
- Conference call for analysts, investors and media to be held today at
3pm CET
Planegg-Martinsried, 25 March 2013 - 4SC AG (Frankfurt, Prime Standard:
VSC), a discovery and development company of targeted small molecule drugs
for cancer and autoimmune diseases, today announced the financial results
of the Group managed by 4SC AG (4SC) in accordance with International
Financial Reporting Standards (IFRS) for the financial year ended 31
December 2012.
As a result of substantially increased revenue and reduced operating
expenses, the Company, which is currently still recording losses according
to plan, has improved its operating result considerably. In the 2012
financial year, 4SC reduced its operating loss by 29% year on year, to EUR
13.37 million. In comparison to 2011, revenue showed a fivefold increase,
rising to EUR 4.35 million in 2012. The main driver here was the launch of
the Company's early-stage research marketing subsidiary 4SC Discovery GmbH
at the beginning of 2012.
4SC had funds of EUR 12.06 million at the end of the 2012 financial year.
These funds, however, did not yet include the cash inflow of EUR 2.5
million from BioNTech AG in connection with a licensing agreement concluded
in December 2012 The existing funds in connection with the current forecast
of further expense and revenue planning will ensure the Company's financing
into the third quarter of 2014.
Key events in the 4SC Group in 2012 and the first months of 2013
In drug development (Development segment):
- Publication of excellent clinical data from the Phase II SHELTER study
with the anti-cancer drug resminostat in advanced hepatocellular
carcinoma (HCC): The combination therapy of resminostat and sorafenib
achieves a median overall survival of eight months. To the best of
4SC's knowledge this is the highest value recorded to date in
comparable second-line therapy studies in HCC (January, May and
September 2012).
- Clinical development of resminostat starts in Japan with a Phase I
trial in Japanese cancer patients, conducted by 4SC's development
partner Yakult Honsha (May 2012).
- Publication of positive interim results from the clinical phase I/II
SHORE trial with resminostat in combination therapy with FOLFIRI
chemotherapy in patients with advanced colon cancer: The results prove
the safety and tolerability of combined administration (December 2012).
- Publication of positive clinical results from the Phase I AEGIS trial
with the anti-cancer compound 4SC-205 in tumour patients: All primary
trial objectives are achieved; a comprehensive safety and tolerability
profile is established; and a study amendment is initiated in order to
further investigate the compound (December 2012).
- Publication of positive preclinical data for vidofludimus as proof of
the broad potential of the compound regarding autoimmune diseases
(February and June 2012).
In early-stage researchconducted by the Group subsidiary 4SC Discovery
GmbH (Discovery&Collaborative Business segment):
- Start of service provision partnerships in the field of drug discovery
and optimisation with Henkel KGaA (April 2012), Ribological GmbH (July
2012) and BioNTech AG (February 2013).
- Receipt of a milestone payment from an earlier joint research venture
with pharmaceutical company Sanwa Kagaku Kenkyusho Co., Ltd., Japan
(April 2012).
- Receipt of a research grant of EUR 600,000 from the m4 biotech cluster
in Munich for the development of personalised cancer drugs (October
2012).
- Conclusion of an exclusive licensing agreement with Mainz-based
biopharmaceutical company BioNTech AG in the field of cancer
immunotherapy: 4SC Discovery receives an upfront payment of EUR 2.5
million and is entitled to possible future milestone and royalty
payments (December 2012).
- Signing of an exclusive research and license agreement with the Danish
pharmaceutical company LEO Pharma A/S for the joint research,
development and commercialisation of a new therapy option for the
treatment of psoriasis: 4SC Discovery receives an upfront payment of
EUR 1 million and is entitled to possible future milestone payments of
up to EUR 95 million as well as royalties (February 2013).
In the Group's development:
- Successful capital increase with gross proceeds of around EUR 12.6
million and expansion of shareholder base to include institutional
investors from France, Scandinavia and the Benelux countries. This
lifts the free float of 4SC's shares to 30% (July 2012).
- Strengthening the capabilities of 4SC AG's Supervisory Board by the
appointment of two new members: the experienced pharma managers Dr
Irina Antonijevic (Genzyme-Sanofi) and Klaus Kühn, former CFO at Bayer
AG (August 2012).
- Dr Ulrich Dauer steps down from his position on the Management Board
and as CEO effective 31 March 2013; he will be succeeded by CFO Enno
Spillner effective 1 April 2013 (March 2013).
Dr. Ulrich Dauer, CEO of 4SC AG, commented: 'For 4SC, 2012 was a highly
successful year. Completing the Phase II trial of resminostat in liver
cancer with such outstanding results strengthens our chances for further
development on the path to market maturity and our company's profile as a
global leader in the market for epigenetic cancer compounds. In addition,
other innovative substances from our pipeline also delivered positive
results in clinical trials. We are especially pleased that our subsidiary
4SC Discovery GmbH has managed to establish itself so well in the market
for pharmaceutical early-stage research.'
Enno Spillner, CFO of 4SC AG, continued: 'The positive start made by 4SC
Discovery GmbH gives us cause to hope that we can generate a balanced cash
flow from operations in our 'Discovery&Collaborative Business' segment
represented by 4SC Discovery as early as 2013. In the medium term, this
should mean 4SC can cover part of its capital requirements from its own
business. In 2012, we managed to quintuple consolidated revenue - due in
large part to the efforts of our subsidiary. In addition, we succeeded in
lowering our operating expenses by 9% and improve our operating result by
more than EUR 5 million. Due to the July 2012 capital increase and the
pleasing developments on the financial side of business operations, we have
a solid financial basis and are well prepared for the future.'
In conclusion, Dr Ulrich Dauer added, 'As announced previously, I decided
to resign for personal reasons effective at the end of March 2013 after
serving as the CEO of 4SC AG for 13 years. I regard it as a privilege to
have shaped 4SC over such a long period of time together with our unique
team of employees and my colleagues on the Management Board. I am convinced
that 4SC will continue its successful development in the future and I will
remain on amicable terms with the Company.'
Financial performance and cash flows in 2012
The 4SC Group, comprising 4SC AG and itswholly-owned subsidiary 4SC
Discovery GmbH, reports consolidated figures for the 2012 financial year
from two operating segments in accordance with International Financial
Reporting Standards (IFRS). The Development segment comprises the clinical
drug development programmes. The Drug Discovery&Collaborative segment
comprises the activities collectively handled by 4SC Discovery GmbH, namely
drug discovery and early-stage research plus subsequent commercialisation.
In 2012, consolidated revenue rose to EUR 4.35 million, representing more
than a fivefold increase year-on-year (2011: EUR 0.78 million). Revenue in
the Development segment amounted to EUR 1.4 million and comprised the pro
rata reversal of the deferred income item for the partnership agreed in
2011 for resminostat with Yakult Honsha Co., Ltd., plus costs charged on to
4SC's cooperation partners. In the first year of business operations for
4SC Discovery GmbH, the Discovery&Collaborative Business segment
contributed 68% (EUR 2.96 million) to consolidated revenue. This
contribution was made up of an advance payment of EUR 2.5 million from a
license agreement with BioNTech AG, plus income from several collaborative
service and research ventures.
Operating expenses fell by 9% year-on-year to EUR 17.75 million (2011: EUR
19.58 million). In 2012, research and development costs were lowered by 14%
to EUR 12.91 million (2011: EUR 15.01 million). Alongside targeted
reductions of costs, one key factor for the year-on-year decrease here was
the smaller number of ongoing clinical trials. At 73% (2011: 77%), the
costs for research and development continue to account for the lion's share
of operating expenses. Compared to the previous year, administrative costs
decreased by 1% to EUR 3.92 million (2011: EUR 3.96 million).
Bolstered by gains in revenue with simultaneous reductions of costs, the
consolidated operating result improved markedly, rising by 29% to EUR
-13.37 million (2011: EUR -18.79 million). Accordingly, the consolidated
net loss for the year decreased in 2012 by 31% to EUR 13.22 million (2011:
EUR 19.07 million). The loss per share fell to EUR 0.29 (2011: loss of EUR
0.46). As a result of the capital increase completed in 2012, the average
number of outstanding shares in the reporting year rose to 46,170,059
shares (2011: 41,455,379 shares).
In the 2012 financial year, the average operating cash burn rate was EUR
1.26 million per month. In the previous year, the operating cash burn rate
(2011: EUR 1.07 million) had been 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.
The 4SC Group had funds of EUR 12.06 million at the end of the 2012
financial year (31 Dec 2011: EUR 15.82 million).
4SC Group outlook
4SC is issuing the following outlook as regards subsequent operational and
financial business development in 2013 and beyond.
Business outlook:
- In the advanced liver cancer (HCC) indication, 4SC is pursuing a Phase
III registration trial with the anti-cancer compound resminostat.
Assuming a successful outcome to ongoing talks with potential partners
and the completion of other trial preparations, the aim is to start
this study jointly with a pharmaceutical partner in the second half of
2013.
- 4SC aims to start a Phase IIb trial with vidofludimus in the Crohn's
disease indication. Activities are currently focusing on the search for
a suitable partner with whose support the trial can be conducted.
- In the ongoing Phase I/II SHORE trial, in which resminostat in
combination with FOLFIRI chemotherapy is being studied in the
colorectal cancer indication, 4SC expects the clinical efficacy data to
be available in the next 12-18 months. Initial interim results on
efficacy might be available as early as the end of 2013.
- 4SC aims to wrap up the Phase I dose escalation study with the
anti-cancer compound 4SC-202 (TOPAS trial) in the second half of 2013.
- 4SC expects results from the extended Phase I trial with the 4SC-205
anti-cancer compound (AEGIS trial) by mid-2013.
Financial outlook:
- In 2013, 4SC expects to see a continued improvement in the consolidated
operating result, driven by a further decrease in operating expenses -
especially from reductions to research and development costs - and the
anticipated revenue generated from activities involving 4SC Discovery
GmbH.
- Based on the strong performance of 4SC Discovery GmbH during the
current year, 4SC expects 4SC Discovery GmbH to be able to achieve a
balanced cash flow from operating activities as early as 2013.
- These existing funds in connection with the current forecast of further
expense and revenue planning will ensure the Company's financing into
the third quarter of 2014. This forecast is based on the assumption
that the average monthly operating cash burn rate in 2013 will be
approximately EUR 0.6 million and that the Company's research and
development programmes will run according to plan.
The complete annual report for the 2012 financial year will be available
for download at www.4sc.de/investors today from 7:30 am CET.
Telephone conference
Today at 3:00 pm CET (10:00 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 2012 financial year and beyond.
Investors, analysts and media representatives participating in the
teleconference can follow the presentation slides live at
www.audio-webcast.com(login: 4sc0313) and dial in to the conference call
using the following telephone numbers:
Date: 25 March 2013
Time: 3pm CET (10am US EST)
Dial-in numbers:
+49-6958-999-0806 (Germany)
+44-207-153-2027 (UK)
+1-480-629-9822 (USA)
+49-6958-999-0806 (other countries)
Conference-ID: 4608496
The complete webcast, including the presentation and audio recording, can
be followed from 3:00 pm CET (10:00 am EST) at the following link:
http://4sc250313-live.audio-webcast.com A replay of the telephone
conference and the webcast will also be available in the 'Investors'
section of www.4sc.com.
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 86 employees at
the end of 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
Mareike Mohr, Raimund Gabriel
mareike.mohr(at)mc-services.eu , Tel.: +49-89-2102-28-40
raimund.gabriel(at)mc-services.eu , Tel.: +49-89-2102-28-30
The Trout Group
Chad Rubin
Crubin(at)troutgroup.com, Tel.: +1-646-378-2947
End of Corporate News
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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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