DGAP-News: PAION AG REPORTS RESULTS FOR THE FISCAL YEAR 2009
(firmenpresse) - PAION AG / Final Results
16.03.2010 07:30
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
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Aachen (Germany), 16 March 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
reports its consolidated financial result according to International
Financial Reporting Standards (IFRS) for the fiscal year ended 31 December
2009.
- Cash and cash equivalents of the company at the end of the reporting
period amounted to EUR 22.9 million (31 December 2008: EUR 36.1
million) securing a cash reach at least until mid 2011.
- Group revenues amounted to EUR 1.5 million and decreased due to lower
reimbursements for research and development against 2008 (EUR 3.2
million).
- The net loss in 2009 amounts to EUR 13.0 million, an increase by EUR
0.4 million compared to the corresponding prior-year period.
- Research and development expenses increased by EUR 1.9 million to EUR
10.6 million compared to the corresponding prior-year period. This
increase is primarily attributable to the broader product pipeline,
primarily the costs for the development of CNS 7056.
Dr. Wolfgang Söhngen, CEO of PAION, commented: 'We look back on a very
successful year 2009 through the rapid clinical progress with our biggest
value driver CNS 7056 in three successful completed clinical trials
including the proof of concept. Therewith we further increased the interest
of the pharma industry in that product. The ongoing Phase III studies of
Lundbeck with Desmoteplase lay the foundation for a further increase in the
value with this product.
A strong increase of the share price and a marked rise of the trading
volume shows, that the capital market honours our successful business
strategy.Overview 2009
The development focus in 2009 was on our short-acting anaesthetic/sedative
CNS 7056. This compound was in the preclinical development phase in the
middle of 2008. A focussed and rapid development programme meant that
within 18 months of starting the first in man study, three trialshave been
successfully completed including a Phase II study.
After completing the first in man proof of concept study in January 2009,
PAION initiated a Phase Ib as well as a Phase IIa study in April 2009. The
data from the Phase Ib study strengthened the safety as well as the
efficacy profile ofthe substance for procedures up to 30 minutes. In
reference to the safety it was shown that the effect of CNS 7056 can be
reversed by the established antagonist flumazenil and no re-sedation of the
volunteers was observed. With regard to the efficacy it was demonstrated
that an adequate sedation level could be maintained for a period of 30
minutes during a colonoscopy.
The Phase IIa study studied patients undergoing a diagnostic endoscopy of
the upper gastrointestinal tract and showing improved efficacy of a single
dose over the standard therapy midazolam.
The data from both studies demonstrate a good tolerability of CNS 7056
during the interventions and confirm the rapid onset and offset of the
sedative effect. These results have led to an increased interest from
potential pharma partners and users. PAION intends to confirm the
clinically relevant improvement over the gold standard ina larger study.
In2009, Desmoteplase also regained recognition from the capital market.
Our partner Lundbeck has invested substantial efforts in the project since
taking on world-wide rights early in 2008. With the ongoing Phase III
studies, Desmoteplase is back on track as a key value driver for PAION.
Discussions with the US licencing authority (FDA) have also had a positive
impact on this. The FDA confirmed the prospect of fast track review on the
premise of positive trial results. Without further expenditures (as
Lundbeck covers all development costs) PAION profits from the development
progress in the form of development and commercial milestone payments up to
EUR 63 million.
Our second Phase III substance M6G also made an important step forward in
2009. During the third quarter PAION received valuable feedback from the
FDA on M6G in which the remaining development path was defined for approval
in the USA. In addition it was confirmed by the FDA that the substance is
regarded as a new chemical entity. This generates a new momentum for the
ongoing partnering discussions.
After the takeover by PAION in the scope of the CeNeS acquisition in 2008,
it was decided to base the further development of CNS 5161 on third-party
financing. Such financing could not be secured by year end 2009. The
existing development co-operation for CNS 5161 with Ergomed was hence
terminated and activities discontinued during the first quarter 2010.
After availability of the Phase I study results in 2008 PAION offered
Solulin to potential partners. The out-licencing discussions with various
interested parties however could not be completed successfully. As a result
it was decided during the first quarter 2010 to complete the ongoing set of
preclinical investigations, which may provide positive data to support
further partnering activities. Until these data are available, partnering
activities will be put on hold.
After the purchase of Flovagatran it was decided to conduct preclinical
studies in preparation of the clinical assessment during cardiac bypass
surgery. These studies were started in the first half of 2009. Technical
difficulties resulted in a delay until the second half of 2010.
Consolidated financial results for the fiscal year 2009
Revenues of KEUR 1,533 in fiscal year 2009 mainly comprise the monthly
release of deferred income of a non-refundable upfront payment received in
2008 in connection with the licence agreement concluded with Lundbeck (KEUR
1,455) and to a minor extent reimbursements of development services from
Lundbeck (KEUR 67; previous year: KEUR 1,702). The significant decline of
the reimbursements of development services for Desmoteplase compared to the
prior-year period indicates the successful completion of the know how
transfer.
Compared with the previous year, research and development expenses
increased in fiscal year 2009 by KEUR 1,857 to KEUR 10,586. The increase is
primarily attributable to the enlargement of the product pipeline in the
previous year. The main research and development focus was on CNS 7056
through the conduct of a Phase Ib and a Phase IIa study. Furthermore,
research and development expenses were incurred for M6G, Solulin,
Flovagatran and CNS 5161.
Compared with the previous year, general and administrative expenses
decreased in fiscal year 2009 by KEUR 3,199 to KEUR 4,348, which is mainly
due to one-off transaction and restructuring costs incurred in the
prior-year period. Furthermore, the cost reduction measures implemented in
2008 and beginning of 2009 came into full effect.
The loss for 2009 was EUR -13.0 million (prior-year period: EUR -12.6
million). Earnings per share amounted to EUR -0.53 (prior-year period: EUR
-0.60).
Cash and cash equivalents of the company at the end of the reporting period
amounted to EUR 22.9 million (31 December 2008: EUR 36.1 million) securing
a cash reach at least until mid 2011.
The total assets as of 31 December 2009 decreased by KEUR 13,763 compared
to 31 December 2008 and amounted to KEUR 35,550. The decrease was mainly
due to a lower equity through the loss ofthe period and lower cash and
cash equivalents. As of 31 December 2009 the equity ratio is 54.3%, which
means a decline compared to 31 December 2008 (63.9%). If the subordinate
loan and the deferred non-refundable upfront payment from Lundbeck were
recognised as economic equity, the equity ratio would increase to 87.9%
(previous year: 91.0%).
As of 31 December 2009 the total headcount at PAION Group amounted to 30
employees, of whom eight work for PAION UK Group. By comparison, the
headcount as of 31 December 2008 amounted to 33 employees.
Outlook
On the basis of the results achieved in 2009 in two clinical studies (Phase
Ib and Phase IIa) with CNS 7056 and the classification of M6G as new
chemical entity the main tasks for the subsidiaries in 2010 will be the
conduct of a clinical Phase IIb clinical study with CNS 7056 and the
closing of partnering agreements for CNS 7056 and M6G. Beyond that PAION
expects in 2010 extensive development activities by the cooperation
partners Lundbeck, Ono and Acorda and first milestone payments resulting
from these cooperations.
PAION's research and development expenses in 2010 relate mainly to
production development and a clinical Phase IIb study with CNS 7056 with
patients undergoing a colonoscopy. In January technically the regulatory
approval for the study was achieved as the time for FDA feedback within the
obligatory waiting period had lapsed. So PAION continued with the last
steps of the study preparation such as packaging of the clinical trial
material and setting up of sites. In early March prior the technical
initiation of the study the FDA requested that PAION submitted additional
analyses of the previously submitted data which PAION provided promptly.
The FDA informed PAION that they will come back with their initial
assessment by mid April. PAION is confident that the material that was
submitted will be satisfactory to initiate the trial and assumes a
recruitment period of approximately nine months once the study has been
initiated.
For the other projects in development only minor expenses are planned.
In parallel to PAION's development of CNS 7056, our cooperation partner Ono
has started the first clinical Phase I study in Japan in February. PAION
participates from the progress of development in the form of additional
development data and financially in the form of milestone payments and
royalties from launch onwards. PAION expects the first small milestone in
2010.
PAION's cooperation partner Lundbeck is currently conducting two Phase III
studies with Desmoteplase in stroke and expects to be able to file
marketing applications in 2012. Lundbeck bears all development costs and
pays to PAION milestones up to EUR 63 million and from market entry a
double-digit revenue share.
Acorda has made progress in the development of GGF2 (out licensed to Acorda
by PAION UK, formerly CeNeS, in 2002), as a result the first clinical study
is now expected to start in 2010. With the transition from preclinical to
clinical development the first milestone payments will become due. In case
of a positive development, milestone payments in total of USD 8.5 million
until approval and afterwards revenue dependent licence fees are payable to
PAION.
Revenues in 2010 will include, just as last year, the monthly release of
deferred income in connection with the non-refundable milestone payment in
the amount of EUR 8 million received from Lundbeck as well as first
milestone payments expected from the development progress with CNS 7056 and
GGF2. In addition PAION expects substantial revenues from intended
partnering agreements for CNS 7056 and M6G.
The budgeted expenses and the small revenues expected from the existing
licence agreements with Ono and Acorda will result in a significant net
loss at year end. However, the expected substantial revenues from the
intended licensing of CNS 7056 and M6G can significantly reduce the loss
for the period or - in the best case - even result in a net income.
###
Key Consolidated Financial Figures, IFRSThe full annual financial report 2009 will be available as from 16 March
(all figures in KEUR unless otherwise noted)
2009 2008
Profit and Loss Statement
Revenues 1,533 3,166
Research and development expenses -10,568 -8,729
General and administrative expenses -4,348 -7,546
Operating result -12,995 -13,799
Net loss for the period -13,037 -12,580
Number of shares outstanding (weighted average, 24,602,919 20,853,621
undiluted)
Number of shares outstanding (weighted average, 24,617,448 20,853,621
diluted)
Earnings per share in EUR (undiluted) -0.53 -0.60
Earnings per share in EUR (diluted) -0.53 -0.60
Balance Sheet
Intangible assts 11,380 11,336
Cash and cash equivalents 22,871 36,072
Equity 19,304 31,528
Non-current liabilities 12,033 13,426
Total assets 35,550 49,313
Equity ratio (percent) 54.3 63.9
Cash flow
Cash flow from operating activities -12,508 -4,589
Cash flow from investing activities -108 -435
Cash flow financing activities -658 -1,638
Employees
Group employees (average) 30 42
2010 on our corporate website at http://www.paion.com/en/berichte-2010.
Earnings call and webcast
In addition to the publication of the results, the Management Board of
PAION will host a public conference call (conducted in English) on Tuesday,
16 March 2010 at 2 p.m. CET (1 p.m. GMT, 9 a.m. EST) to present the
financial results of 2009, highlight the most important events of this
period and provide further details on the company's latest developments.
To access the call, participants from Germany may dial +49-69-201744210,
from the UK +44-20-71539154 and from the US +1-877-4230830 (other
countries: please choose from D/UK/US numbers). The participant PIN code is
996840, followed by the hash key (#). To allow for smooth processing we
suggest that you dial in ten minutes before the beginning of the call.
The conference call will be supplemented by a webcast presentation which
can be accessed during the call under the following link:
https://www.anywhereconference.com. In the field 'Web Login' please enter
107325417 and in the field 'PIN Code' 996840. After entering your name in
the specified field please click on 'Go'. The dial-in details for the
conference call and the webcast link are also available on our website
http://www.paion.com
The conference call will be recorded. Details on how to access the replay
will be posted on the same web page after the call.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in indications for which there is a substantial unmet medical
need. PAION has a 'Search&Develop' business model, which is based on its
core expertise in drug development. Where appropriate, particularly during
the late stages of the clinical development, PAION seeks to collaborate
with experienced partners.
Contact
Ralf Penner
Director Investor Relations&Public Relations
PAION AG
Martinstrasse 10-12, 52062 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner(at)paion.com
http://www.paion.com
Disclaimer:
This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.
16.03.2010 07:30 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Deutschland
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Hamburg, Stuttgart
End of News DGAP News-Service
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