DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2013
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Half Year Results
PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2013
07.08.2013 / 07:30
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PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2013
- Focus on Phase II trial for Remimazolam in General Anaesthesia - BfArM
approval for study start
- Exclusive option agreement with Hana Pharm for Remimazolam in South
Korea
- Complete repayment of a subordinated loan in the amount of EUR 7
million
- Financing of PAION secured until end of Q1 2015 including all costs for
the Remimazolam Phase II European trial in General Anaesthesia
Aachen (Germany), 07 August 2013 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, General Standard: PA8) today
reports its consolidated financial result according to International
Financial Reporting Standards (IFRS) for the first half-year 2013.
Revenues in the first half-year 2013 amounted to EUR 1.2 million and
decreased by EUR 21.6 million compared to the prior-year period. The
revenues in the amount of EUR 1.2 million relate to a milestone payment
from Yichang after completion of technology transfer. In total a net loss
of EUR -2.2 million has been incurred compared to a net income of EUR 15.9
million in the prior-year period. The prior-year period was marked by the
sale of Desmoteplase to Lundbeck in the amount of EUR 20.1 million.
Dr Wolfgang Söhngen, CEO of PAION commented: 'We are very pleased with the
course of the year. The recently announced option agreement with Hana Pharm
in South Korea, and Ono's completion of recruitment for the Phase III
program in the EU lead indication anaesthesia created additional momentum
for the ongoing discussions in other territories. Particularly in the U.S.,
we have attracted great interest for the US lead indication procedural
sedation with Remimazolam.'
Development and Commercial Activities
Remimazolam
In the first half of 2013 PAION focussed on the development and partnering
of Remimazolam. Already in July 2012 PAION signed an exclusive license
agreement with Yichang for Remimazolam in China. The technology transfer
was completed in March 2013 and triggered a payment of EUR 1.2 million.
In July 2013 PAION signed an exclusive option agreement with Hana Pharm for
Remimazolam in South Korea against an option payment of EUR 0.3 million. If
both parties successfully execute a final licensing agreement within a
certain exclusivity period, PAION will be eligible to receive upfront
payments of EUR 1 million, potential milestone payments of up to EUR 2
million and 10% royalties on sales in the South Korean market. The option
fee of EUR 0.3 million will be deducted from the upfront payment.
PAION's partner Ono Pharmaceutical is currently developing Remimazolam in
anaesthesia for the Japanese market as lead indication. A Phase II/III
trial of Remimazolam in General Anaesthesia was started by Ono in November
2012. The recruitment of the study was completed already in May 2013
significantly earlier than originally planned. The recruitment of the
second study in the Phase III program (American Society of
Anesthesiologists classification III or higher) in more severely sick
patients has also been completed. No significant adverse events have been
reported so far.
Furthermore, Ono initiated a Phase II trial in ICU sedation in September
2012. Due to an unclear pharmacokinetic result in long-term administration
in the study, Ono has decided the discontinuation of the study in August
2013. Overall all patients were sedated successfully and no significant
adverse events were reported. The next step will be to perform a batch of
pre-clinical experiments, perform PK modelling based on the plasma samples
and consider if a dose adjustment is necessary for new studies.
In February 2013, PAION held a formal scientific advice meeting with the
German regulatory authority on the European clinical development program
for Remimazolam in General Anaesthesia. Currently, PAION is in final
preparation to initiate an European Phase II trial with Remimazolam, in
General Anaesthesia in cardiovascular surgery. Recently the German
regulatory authority BfArM approved the start of the study, which is
expected in the second half of 2013.
Pending the outcome of the planned and ongoing trials, PAION assumes that
one Phase II and one Phase III trial in General Anaesthesia in addition to
the Japanese development program will be sufficient for EU approval. In
preparation for the European Phase III trial, further scientific advice
meetings are planned with European regulatory authorities. PAION expects to
start this trial in 2014.
Solulin/PN13
In October 2012 PAION completed a Phase Ib study for the treatment of
haemophilia with Solulin. The available data showed that Solulin has the
expected effect in haemophilia patients. Due to the focus of the available
resources on anaesthesia PAION is currently in discussions regarding a
transfer of project data to interested third parties.
In July 2012 it was announced, that PAION has received a grant worth EUR
0.7 million from the federal ministry of education and research (BMBF) for
research in the area of thrombomodulin - mutants (PN13). The project will
run until 2014. The project is in a very early stage of development. The
resulting Solulin mutants could not be tested using the standard methods.
Therefore, further research will require a higher financial expenditure
than expected, which is not covered by the current funding. Therefore,
PAION is currently looking for a project partner who continues the research
or closes the financing gap.
Remifentanil
In 2012, PAION acquired the distribution rights for the generic opioid
Remifentanil. Due to a significant unexpected price erosion in the German
Remifentanil market, PAION has decided to put on hold the launch of generic
Remifentanil into the German market in March 2013. The contract with the
manufacturer has been terminated in the meantime. The intensive dialogue
with anaesthetists has delivered valuable and important hints for the
development and the decision for the Phase II study with Remimazolam in
anaesthesia.
GGF2
Beginning of March 2013, Acorda announces positive results of the Phase I
trial with GGF2. The study identified a maximum tolerated dose of GGF2 and
the preliminary efficacy measures showed that GGF2 improves heart function.
Acorda has discussed the findings from the study with the FDA and has
reached agreement on the next clinical study of GGF2 in heart failure. This
study will primarily investigate further the safety profile of GGF2 across
a range of doses, will continue to explore efficacy outcomes and is planned
for the second half of 2013. The FDA has granted Fast Track designation for
GGF2 for the treatment of heart failure.
Finances
Revenues
Revenues in the first half-year 2013 amounted to EUR 1.2 million and
decreased by EUR 21.6 million compared to the prior-year period. The
revenues in the amount of EUR 1.2 million relate to a milestone payment
from Yichang for technology transfer which has been completed in the
reporting period. The prior-year period was marked by the sale of
Desmoteplase to Lundbeck in the amount of EUR 20.1 million.
Net result
The net loss for the first half-year 2013 amounted to EUR -2.2 million. In
the prior-year period a net income of EUR 15.9 million has been reported.
This means a decrease of the net result of EUR 18.1 million compared to the
prior-year period.
Development of costs
Research and development expenses amounted to EUR 2.0 million in the first
half-year 2013 and relate mainly to Remimazolam. This means an increase of
EUR 0.2 million compared to the prior-year period. The increase is due to
increased development activities, in particular the preparation of the
planned Phase II study with Remimazolam and production development of
Remimazolam.
General administrative and selling expenses in the first half-year 2013
declined by EUR 0.6 million thousand to EUR 1.8 million. Administrative
expenses decreased compared to the prior-year period by EUR 0.3 million to
EUR 1.2 million. Selling expenses decreased compared to the prior-year
period by EUR 0.4 million to EUR 0.6 million.
Liquidity
Cash and cash equivalents decreased after scheduled repayment of the
subordinated loan (EUR 7 million) by EUR 8.2 million in the first half-year
2013. As of 30 June 2013 PAION's cash and cash equivalents amounted to EUR
14.2 million. The cash and cash equivalents alone secure based on the
current structure a cash reach until end of Q1/2015. This includes the
costs for the planned Phase II study with Remimazolam.
Business and Financial Outlook 2013
PAION confirms its outlook for 2013 made on 13 March 2013 with the
publication of the annual financial results of 2012. PAION's major goals
for the rest of 2013 are the start of a Phase II study with Remimazolam in
anaesthesia, production development for Remimazolam and out-licensing of
Remimazolam outside Japan and China. Furthermore, PAION expects the
continuation of the development activities by the cooperation partners Ono
(Remimazolam), Yichang (Remimazolam) and Acorda (GGF2).
In 2013 revenues of EUR 1.5 million are expected. These relate in the
amount of EUR 1.2 million to the technology transfer with Yichang which has
been completed in March 2013 and in the amount of EUR 0.3 million to the
option agreement which has been signed with Hana Pharm in July 2013. Should
the licensing agreement with Hana Pharm be closed in 2013 the revenues
would increase by EUR 0.7 million to EUR 2.2 million. Furthermore it is
aimed to receive upfront payments or sharing of development costs for the
out-licensing of Remimazolam in other territories.
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Key Consolidated Financial Figures, IFRS
(all figures in KEUR unless Q2 2013 Q2 2012 H1 2013 H1 2012The full annual financial report will be available as from 07 August 2013
otherwise noted)
Revenues 5 9 1,222 22,804
Research and development expenses -1,130 -623 -2,028 -1,786
General administrative and selling
expenses -880 -1,064 -1,823 -2,462
Result for the period -1,537 -1,810 -2,190 15,878
Earnings per share in EUR for the
period (basic) -0.06 -0.07 -0.09 0.63
Earnings per share in EUR for the
period (diluted) -0.06 -0.07 -0.09 0.63
H1 2013 H1 2012
Cash flows from operating
activities -875 14,468
Cash flows from investing
activities 0 -4
Cash flows from financing
activities -7,146 -293
Change in cash and cash
equivalents -8,174 14,182
Average number of group employees 13 18
30 June 31 Dec.
2013 2012
Intangible assets 3,537 3,848
Cash and cash equivalents 14,163 22,336
Equity 13,221 15,572
Non-current liabilities 839 1,016
Current liabilities 4,35011,748
Balance sheet total 18,410 28,336
on our corporate website at http://www.paion.com/en/berichte-2013.
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, 07 August 2013 at 2 p.m. CEST (1 p.m. BST, 9 a.m. EDT) to
present the financial results, highlight the most important events of this
period and provide a pipeline and strategy update.
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
531997, 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
137347185 and in the field 'PIN Code' 463238. 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 AG is a publicly-listed biotech company headquartered in Aachen,
Germany with a second site in Cambridge, UK. The company has a track record
of developing hospital-based treatments for which there is substantial
unmet medical need. PAION AG is transforming its business model from a pure
development company to a specialty pharmaceutical company with a focus on
anaesthesia products to take advantage of the unique profile of its main
compound, Remimazolam.
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.
End of Corporate News
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
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 (General Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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