DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2010
(firmenpresse) - PAION AG / Half Year Results
11.08.2010 07:30
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
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PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2010
- PAION expects Phase IIb study results with CNS 7056 / Remimazolam
towards the end of 2010
- PAION receives milestone payments from partners
- PAION substantially strengthens its financial position with an equity
facility and milestone payments, extending its cash reach until mid
2012
Aachen (Germany), 11 August 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for the first half-year which ended 30
June 2010.
- PAION's cash and cash equivalents of EUR 18 million as of 30 June 2010
and the expected cash inflows from a partial use of the equity facility
have secured a cash reach until the middle of 2012- based on the
current cost structure including the Phase IIb trial with CNS 7056 /
Remimazolam.
- Compared to the prior-year period, revenues increased by EUR 1.4
million to EUR 2.2 million, mainly due to the milestones from Ono and
Acorda. Research and development expenses decreased by EUR 1.1 million
compared to the prior-year period. The loss for the first six months of
2010 of EUR -4.3 million was EUR 2.6 million lower than the
corresponding prior-year period (EUR -6.9 million).
'We can be extremely satisfied with the first half year,' commented
Wolfgang Söhngen, CEO of PAION. 'With the conclusion of the Equity Facility
in combination with the milestone payments, we have considerably improved
our financial situation. We are now eagerly looking forward to the results
of the Phase IIb study with Remimazolam, which can be expected towards the
end of 2010.'
Overview First Half Year 2010
During the first half-year of 2010 PAION achieved important milestones.
PAION was able to start the Phase IIb study with CNS 7056 / Remimazolam in
May. The aim of this study is to refine the optimal dose regimen for Phase
III trials.
In April 2010 PAION's development partner Ono Pharmaceutical started the
first Japanese Phase I study with CNS 7056 / Remimazolam and thereby
triggered the first milestone payment of USD 1 million. Ono is developing
CNS 7056 / Remimazolam for the Japanese market, initially focussing on the
induction and maintenance of anaesthesia which requires continuous
infusion.
PAION's licence partner H. Lundbeck A/S presented data from a post-hoc
analysis using Desmoteplase in acute ischaemic stroke at the International
Stroke Conference in San Antonio, Texas; February 2010. Furthermore, in
March 2010 Lundbeck reported the start of a clinical Phase II trial with
Desmoteplase in the treatment of acute ischaemic stroke in Japan (DIAS-J).
This study is required for approval of the substance for the Japanese
market.
The IND (Investigational New Drug) application filed by our licencee Acorda
Therapeutics for the substance GGF2 was accepted by the FDA in April 2010.
This triggered milestone payments of USD 1 million. As a next step Acorda
plans to start a clinical Phase I study with GGF2 in heart failure
patients.
In addition to the clinical milestones, an important step to strengthen the
financial position of the company was to enter into an equity facility
agreement for EUR 15 million with Commerce Court Small Cap Value Fund Ltd.
(CCSCVF) managed by Acqua Capital Management Inc., Toronto, Canada. This
equity facility gives PAION the right to issue new shares out of the
existing authorised capital in multiple tranches to CCSCVF against a cash
contribution. PAION intends to use this facility in the first instance to
strengthen its cash position and extend its cash reach.
Consolidated financial results for the first half year 2010
Revenues in the first half of 2010 include EUR 0.7 million (USD 1 million)
which relates to a milestone payment from Ono for the start of the Phase I
study with CNS 7056 / Remimazolam in Japan and in the amount of EUR 0.7
million (USD 1 million) for two milestone payments from Acorda of USD 0.5
million each for the submission and subsequent approval of the IND for the
compound GGF2. Furthermore the revenues include the systematic release of
deferred income in connection with the licence agreement concluded with
Lundbeck (EUR 0.7 million) as well as the refund of development expenses by
Lundbeck.
Research and development expenses of EUR 4.4 million in the first half 2010
decreased by EUR 1.1 million compared with the corresponding prior-year
period of EUR 5.5 million. The main research and development focus was on
CNS 7056 / Remimazolam.
General and administrative expenses remained at the prior-year period level
in the first half year of 2010, amounting to EUR 2.2 million (prior-year
period: EUR 2.2 million).
The financial result for the first half year 2010 decreased year on year by
EUR 0.1 million down to EUR -0.3 million. The main reasons for the decrease
are significantly lower money market interest rates as well as the
reduction in cash and cash equivalents compared to the prior-year period.
The total assets as of 30 June 2010 decreased by EUR 4.2 million compared
to 31 December 2009 and amounted to EUR 31.4 million. The decrease was
mainly due to a lower equity through the loss of the period and lower cash
and cash equivalents. As of 30 June 2010 the equity ratio is 50.9%, which
means a decline compared to 31 December 2009 (54.3%). If the subordinate
loan and the deferred non-refundable upfront payment from Lundbeck were
recognised as economic equity, the equity ratio would increase to 86.6%.
On average, PAION employed 29 employees in the first six months of 2010
(fiscal year 2009: 30 employees).
Outlook
PAION's clinical Phase IIb study with CNS 7056 / Remimazolam in patients
undergoing a colonoscopy is currently ahead of schedule. Initially nine
months were estimated for the patient enrolment phase. With the current
treatment rate the study is expected to complete this year. PAION aims to
have the compound ready for the clinical Phase III programme in 2011 and
expects that the Phase IIb data will enhance the value of CNS 7056 /
Remimazolam for potential partners.
Beyond that, PAION expects extensive development activities by its licence
partners in 2010, which could trigger further milestone payments from 2011
onwards. Our licence partner Lundbeck expects study completion of two
worldwide Phase III studies with Desmoteplase in acute ischaemic stroke in
2011 (DIAS-3) and 2012 (DIAS-4), respectively, and to be able to file for
market approval (MAA/NDA) in 2012. Acorda, our licence partner in the
development of GGF2, expects as the next step the start of the first
clinical study.
Revenues in 2010 will include 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 from the
development of CNS 7056 / Remimazolam and GGF2. Furthermore PAION expects
additional revenues from the intended partnering agreement for M6G.
PAION's research and development expenses in 2010 relate mainly to
production development and the clinical Phase IIb study with CNS 7056 /
Remimazolam. For the other projects in development only minor expenses are
planned. The budgeted expenses lead, after deduction of the revenues from
existing licence agreements, to a significant net loss for the year. The
expected revenues from the intended licensing of M6G would reduce the net
loss for the year.
As of 30 June 2010 PAION's cash and cash equivalents amounted to EUR 18
million. These, and the expected cash inflows from a partial use of the
equity facility, secure a cash reach until the middle of 2012. This does
not account for further upfront payments, milestone payments and cost
reimbursements from existing and future partners or an extensive or total
use of the equity facility, which could expand the cash reach.
###
Key Consolidated Financial Figures, IFRS
(all figures in KEUR unless Q2 2010 Q2 2009 H1 2010 H1 2009The full report will be available as from 11 August 2010 on our corporate
otherwise noted)
Revenues 1,494 383 2,235 788
Research and development expenses -1,870 -2,876 -4,353 -5,492
General administrative and selling -1,127 -1,115 -2,230 -2,267
expenses
Net result for the period -1,456 -3,564 -4,327 -6,891
Earnings per share in EUR for the -0.06 -0.14 -0.18 -0.28
period (basic)
Earnings per share in EUR for the -0.05 -0.14 -0.17 -0.28
period (diluted)
H1 2010 H1 2009
Cash flows from operating -4,755 -6,764
activities
Cash flows from investing -14 -43
activities
Cash flows from financing -293 -331
activities
Average number of group employees 29 30
30 June 31 Dec.
2010 2009
Intangible assets 11,811 11,380
Cash and cash equivalents 17,852 22,871
Equity 15,974 19,304
Non-current liabilities 11,330 12,033
Balance sheet total 31,353 35,550
Equity ratio 50.9% 54.3%
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
Wednesday, 11 August 2010 at 2 p.m. CEST (1 p.m. BST, 8 a.m. ET) to present
the financial results, 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 should 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
744475, 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
137325675 and in the field 'PIN Code' 744475. After entering your name in
the specified field please click on 'Go'. The dial-in details for the
conference call and the webcast link will also be 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.
11.08.2010 07:30 Ad hoc announcement, Financial News and Press 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 Hamburg, München, Berlin, Düsseldorf, Stuttgart
End of News DGAP News-Service
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