DGAP-News: Press Release: 4SC announces improved financial results for the third quarter and first nine months of 2013
(firmenpresse) - DGAP-News: 4SC AG / Key word(s): Quarter Results/Miscellaneous
Press Release: 4SC announces improved financial results for the third
quarter and first nine months of 2013
07.11.2013 / 07:31
---------------------------------------------------------------------
Press Release
4SC announces improved financial results for the third quarter and first
nine months of 2013
Planegg-Martinsried, Germany, 7 November 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 for the 4SC Group in accordance with International
Financial Reporting Standards (IFRS) for the third quarter and first nine
months of 2013.
Operating highlights in Q3 (1 July - 30 September 2013):
- Resminostat: Expression of ZFP64 biomarker and other patient
characteristics strongly correlate with patient survival in liver
cancer (HCC) and Hodgkin's lymphoma; study results presented at ILCA
(Washington) and ECCO (Amsterdam) research conferences
- Resminostat: Partner Yakult Honsha starts clinical development in
non-small-cell lung cancer (NSCLC) in Japan, making this the fourth
tumour indication
- 4SC-202: Patent protection in China, Hong Kong and the USA expanded
significantly
- 4SC Discovery: Partnership with Panoptes Pharma initiated in the field
of inflammatory eye diseases
- Process of focusing the development strategy and adjusting the
corporate structure completed
Financial highlights for the first nine months (1 January - 30 September
2013):
- Revenue increases by 262% to EUR 3.72 million (9M 2012: EUR 1.03
million)
- Operating result improves by 33% to EUR -8.25 million and by 41% to EUR
-7.23 million after adjusting for one-off extraordinary factors (9M
2012: EUR -12.32 million)
- Earnings per share improve by 41% to EUR -0.16 (9M 2012: EUR -0.27)
- Liquid funds amounting to EUR 6.75 million secure the Company's
financing into the third quarter of 2014
Enno Spillner, CEO of 4SC AG, commented:
'In the third quarter, we continued the successful implementation of our
programme for concentrating on 4SC's long-term value drivers by reducing
our operating costs, streamlining our administrative activities and
conducting a targeted reorganisation of our R&D work. In our business
operations, centre stage is currently taken by resminostat, our promising
compound for the treatment of liver cancer (HCC), for which we want to
start a pivotal trial in mid-2014. Our goal is to achieve market approval
for resminostat as a personalised cancer therapy based on the impressive
new biomarker data. We successfully expanded the activities of our
subsidiary 4SC Discovery GmbH in the field of research collaboration and we
are working on additional funding models and partnerships for our
development candidates.'
Telephone conference
Today, 7 November 2013, 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 reporting period and
beyond. To participate in the telephone conference, please use the
following dial-in data:
+49-6103-485-3001 (Germany)
+44-207-153-2027 (UK)
+1-480-629-9822 (USA)
+49-6103-485-3001 (other countries)
Conference-ID: 4647613
After the conference call, an audio replay will be available at www.4sc.com
under Investors / Events&Presentations / Conference Calls&Webcasts.
Detailed financial review (9 months 2013 and Q3 2013)
The 4SC Group, which comprises 4SC AG and its wholly-owned subsidiary 4SC
Discovery GmbH, reports consolidated figures for the Group and financial
figures for the two operating segments Development (the clinical
development of the compounds resminostat, 4SC-202, 4SC-205 and vidofludimus
consolidated within 4SC AG) and Discovery&Collaborative Business (drug
discovery and early-stage research activities as well as their
commercialisation through the service business and research collaborations
of 4SC Discovery GmbH). The figures for the 4SC Group are reported below;
for more information on segment reporting, see the full 9-month
consolidated financial report at http://4sc.de/investors/financial-reports.
9 months 2013:
In the first nine months of 2013, revenue increased by 262% year on year to
EUR 3.72 million (9M 2012: EUR 1.03 million). This increase is mainly due
to two factors: the cooperation agreements 4SC Discovery GmbH signed with
BioNTech AG and LEO Pharma A/S, Denmark, in December 2012 and February 2013
and revenue from costs allocated by 4SC AG to cooperation partners for
developing and carrying out compound production.
The Company's loss from operating activities improved by 33% to EUR 8.25
million in the first nine months of the year on the back of higher revenue
and a 10% reduction in operating expenses (9M 2012: EUR -12.32). After
adjusting for one-off extraordinary factors of EUR 1.02 million associated
with the change in the development strategy and corporate structure
implemented in the second quarter of 2013, the operating loss in the first
nine months of the year was EUR 7.23 million, down 41% on the prior-year
figure. The loss for the period decreased by 33% to EUR 8.19 million in the
first nine months (9M 2012: EUR -12.14 million). Earnings per share
improved by 41% to EUR -0.16 (9M 2012: EUR -0.27) because there was also a
higher average number of shares in the 9-month comparison due to the
capital increase completed in July 2012.
This results in an average monthly outflow of cash from operations
amounting to EUR 0.59 million in the first nine months of 2013 (9M 2012:
EUR 1.31 million). As at 30 September 2013, the Company thus had cash and
available-for-sale securities totalling EUR 6.75 million, compared with EUR
12.06 million as at 31 December 2012. Based on the current planning, 4SC
expects these funds to be sufficient to secure the Company's financing into
the third quarter of 2014. The start of a registration trial in advanced
liver cancer (HCC) has not been taken into account in this planning.
Q3 2013:
Compared with the third quarter of the previous year, consolidated revenue
was up again in the reporting quarter, increasing significantly to EUR 1.77
million (Q3 2012: EUR 0.29 million). This fact plus the 19% reduction in
operating expenses resulted in a 54% decrease in the loss from operations
to EUR 2.08 million in the third quarter (Q3 2012: EUR -4.50 million). The
loss for the period decreased by 53% to EUR 2.11 million (Q3 2012: EUR
-4.46 million), resulting in earnings per share of EUR -0.04 (Q3 2012: EUR
-0.09).
Detailed review of operations (Q3 2013):
In the third quarter of 2013, 4SC completed the process of focusing its
development strategy and adjusting its corporate and personnel structures.
The Company advanced its defined research and development activities and
achieved key operating milestones. Operations at 4SC mainly focused on
further developing its epigenetic lead compound resminostat in the
indication of advanced liver cancer (HCC).
Development segment (clinical development activities of 4SC AG)
Resminostat:
New study results for resminostat were presented at two scientific
conferences (ILCA, Washington, and ECCO, Amsterdam) in September 2013: The
biomarker analysis of two Phase II trials with resminostat in liver cancer
(HCC) and Hodgkin's lymphoma (HL) revealedthat patients with a high level
of the ZFP64 biomarker apparently respond especially well to treatment with
resminostat. Around two-thirds of patients exhibit elevated ZFP64 blood
levels before treatment commenced. This translates into a statistically
significant (p=0.04) doubling of overall survival for this patient group.
In the indication of advanced liver cancer (HCC), further patient
characteristics before the start of treatment with resminostat correlate
with an extension of overall survival. 4SC will apply these results in
designing the planned registration trial with resminostat in advanced HCC,
so as to make further progress towards market approval for resminostat in
combination with the potential predictive biomarker ZFP64 as a personalised
cancer therapy in the indication of liver cancer (HCC).
Yakult Honsha Co., Ltd., 4SC's exclusive partner for the development and
marketing of resminostat in Japan since 2011, commenced a clinical Phase
I/II trial in the indication of non-small-cell lung cancer (NSCLC) in July
2013. Alongside liver cancer, colorectal cancer and Hodgkin's lymphoma,
this marks the clinical development of resminostat in a fourth tumour
indication.
4SC-202:
The Company succeeded in significantly expanding patent protection after
having been granted a patent in China and obtaining notifications of
allowance in Hong Kong and the United States for its second epigenetic
anti-cancer compound, 4SC-202, thus extending the duration of patent
protection.
Discovery&Collaborative Business segment (early-stage research and
collaborations of 4SC Discovery GmbH)
In September 2013, the 4SC subsidiary 4SC Discovery GmbH transferred the
patent for a compound discovered in-house for combating inflammatory eye
diseases to the Austrian biotech company Panoptes Pharma Ges.m.H. In
return, 4SC Discovery received a 24.9% share in Panoptes Pharma and will
participate in future development successes in the form of milestone and
royalty payments.
Operational and financial Outlook for 2013 and beyond:
Resminostat:
4SC continues to work on preparations for a clinical Phase IIb/III
registration trial for resminostat as first-line therapy for HCC in
combination with the cancer drug sorafenib and in consideration of the
predictive biomarker ZFP64. The Company plans to start the trial around
mid-2014 after completing all the required preparations including securing
financing of the study's Phase IIb part and obtaining approval from the
regulatory authorities. 4SC is now talking to potential partners with the
aim of ensuring the financing and successful completion of the study.
Anti-cancer compounds 4SC-202 and 4SC-205:
4SC plans to publish the first results of the Phase I TOPAS dose-finding
study with 4SC-202 in patients with advanced haematological tumours in the
fourth quarter of 2013. 4SC expects results from the Phase I AEGIS study
with the compound 4SC-205 in patients with solid tumours to be available in
late 2013 or early 2014.
Vidofludimus:
For the compound vidofludimus in autoimmune diseases, activities are now
focusing on talks with potential external project partners with whose
support the Company plans to finance and conduct a Phase IIb trial in the
Crohn's disease indication.
4SC Discovery GmbH:
This Group subsidiary aims to secure further service and research
partnerships with pharmaceutical and biotech companies.
Financial outlook:
The funds of the 4SC Group are sufficient to secure 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 4SC's research and development
programmes will continue to run according to plan.
4SC expects its loss situation to continue in the short to medium term.
Taking into account the expected contribution to earnings of the activities
of 4SC Discovery GmbH and lower research and development costs, the
consolidated operating loss for 2013 - before extraordinary effects -
should improve further compared with the previous year. The one-off effects
from the adjustment of the Company's development strategy will increase the
consolidated loss by slightly less than EUR 1.0 million in 2013. As a
result of the restructuring, 4SC expects a significant reduction in annual
staff costs in the high six-digit euro range starting from the 2014
financial year.
The assumptions do not take into account the execution of the planned
pivotal liver cancer study. In this case, development costs can be
anticipated to rise substantially, which would in turn cause the cash burn
rate and operating loss to increase again.
Based on the operating performance of 4SC Discovery GmbH to date, the
Management Board of 4SC AG continues to expect this subsidiary to be able
to achieve a balanced cash flow from operating activities in the current
financial year.
End of press release
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 cancer and autoimmune 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 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 and biotech companies. Founded in 1997, 4SC had a
headcount of 78 employees (57 FTEs) at 30 September 2013. 4SC AG has been
listed on the Prime Standard of the Frankfurt Stock Exchange since December
2005.
Cautionary statement regarding forward-looking statements
This press release contains certain forward-looking statements. Any
forward-looking statement applies only on the date of this press release.
By their nature, forward-looking statements are subject to a number of
known and unknown risks and uncertainties that may or may not occur in the
future and as a result of which the actual results and performance may
differ substantially from the expected future results or performance
expressed or implied in the forward looking statements. No warranties or
representations are made as to the accuracy, achievement or reasonableness
of such statements, estimates or projections, and 4SC AG has no obligation
to update any such information or to correct any inaccuracies herein or
omission herefrom which may become apparent.
For more information please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Corporate Communications&Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49-89-7007-6366
MC Services
Raimund Gabriel
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
---------------------------------------------------------------------
07.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
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: 575381Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
238202 07.11.2013
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 07.11.2013 - 07:31 Uhr
Sprache: Deutsch
News-ID 313685
Anzahl Zeichen: 34796
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 330 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Press Release: 4SC announces improved financial results for the third quarter and first nine months of 2013"
steht unter der journalistisch-redaktionellen Verantwortung von
4SC AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
