DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2012
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Final Results
PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2012
13.03.2013 / 07:30
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PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2012
- Record turnover of EUR 26.8 million (2011: EUR 3.2 million)
- Net profit of EUR 16 million (2011: EUR -13.7 million)
- Focus in 2013 on Phase II trial for Remimazolam in General Anaesthesia
to begin in the 2nd half of 2013
- Financing of PAION secured until end of Q1 2015 including all costs for
the Remimazolam Phase II European trial in General Anaesthesia
Aachen (Germany), 13 March 2013 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, General Standard: PA8), today
reports its consolidated financial results according to International
Financial Reporting Standards (IFRS) for 2012.
Total revenues in 2012 increased by EUR 23.6 million to EUR 26.8 million
compared to the previous year. The revenues relate in the amount of EUR
20.1 million to the sale of Desmoteplase to Lundbeck in February 2012. The
income for 2012 amounted to EUR 16 million, an increase of EUR 29.7 million
compared to the prior-year period.
Dr Wolfgang Söhngen, CEO of PAION commented, 'It was the right decision to
let Desmoteplase go at the beginning of 2012. This gave us the necessary
degree of freedom to sign a deal on Remimazolam with Yichang Humanwell in
China the third largest pharma market in the world and to focus on
evaluating the best possible route to market for Remimazolam in the US or
EU. The impressive progress of the Remimazolam development program of our
partner Ono in Japan and our intensive efforts to set up a small sales team
for Remifentanil in anaesthesia have delivered significant input to this
process. Despite having to postpone the launch of Remifentanil due to
massive price erosion our intensive dialogue with anaesthetists has
delivered invaluable and important hints for our development concept to
make Remimazolam Phase III ready in anaesthesia. Based on the recent
regulatory feedback we assume we will only need one additional Phase III
trial for an EU filing. We are now in a comfortable position to wait until
completion of the Ono Phase II/III study in 2014 in parallel to our own
development and to use the resulting value for the continued funding of
Remimazolam's development in Europe.'
Development Activities
In 2012 important strategic decisions were made??in
order to position the company sustainably as a commercial provider of
specialized products in anaesthesia. The key element of a viable strategy
for this market is PAION's lead compound Remimazolam. PAION remains
committed to its vision 'PAIONeer in Anaesthesia' and maintains its plan to
launch suitable companion products to prepare for market entry of
Remimazolam in Europe.
Remimazolam
During 2012, PAION focussed on the development and partnering of
Remimazolam. In March 2012 PAION signed an exclusive option agreement with
Yichang for Remimazolam in China. The completion of this licensing
agreement was announced in July 2012.
For the Japanese market Remimazolam is currently being developed in
anaesthesia by Ono Pharmaceutical. In May 2012, Remimazolam successfully
completed a Phase II trial in General Anaesthesia in Japan. A Phase II/III
trial of Remimazolam in General Anesthesia was started by Ono inNovember
2012. The results of the study are expected in 2014 (source:
clinicaltrials.jp). Furthermore, Ono started a Phase II trial in ICU
sedation in November 2012. The results of this study are expected by end
2013 (Source: clinicaltrials.jp).
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 advanced
preparation to conduct a European Phase II trial with Remimazolam, in
General Anaesthesia in cardiovascular surgery. The start of this study is
expected in the 2nd 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 Phase II/III trial 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 June 2012 it was announced, that PAION Deutschland GmbH 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 last 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 August 2012, PAION acquired the distribution rights for the generic
opioid Remifentanil. Due to a significant unexpected price erosion in the
German Remifentanil market over the last six months, PAION has decided to
put on hold the launch of generic Remifentanil into the German market.
Together with its manufacturer PAION will further evaluate the prevailing
market conditions before taking a final decision on Remifentanil.
GGF2
Beginning of March 2013, Acorda announced positive results of the Phase I
trial with GGF2. The study identifies a maximum tolerated dose of GGF2 and
the preliminary efficacy measures shows 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, and will continue to explore efficacy outcomes.
The FDA has granted Fast Track designation for GGF2 for the treatment of
heart failure.
Finances
Revenues
Revenues of the fiscal year amounted to EUR 26.8 million and increased
compared to the previous year by EUR 23.6 million. The revenues were mainly
generated by the sale of Desmoteplase to Lundbeck for EUR 20.1 million.
Furthermore, the revenues relate in the amount of EUR 2.5 million to the
complete release of deferred income, resulting from a milestone payment
received in 2008 from Lundbeck, in the amount of EUR 2.4 (USD 3 million) to
a milestone payment from Ono for the start of the Phase III study with
Remimazolam in Japan and in the amount of EUR 1.8 to the licence agreement
with Yichang.
Net Income
The net income for the year amounted to EUR 16 million and increased by EUR
29.7 million compared to the previous year.
Development costs
Research and development expenses amounted to EUR 3.3 million and decreased
by EUR 8.6 million compared to the previous year (EUR 11.8 million). The
research and development expenses in the previous year included a EUR 6.1
million impairment charge on M6G. Without this effect the research and
development expenses decreased by EUR 2.5 million compared to the previous
year. The decrease is due to reduced development activities. The main
research and development focus in 2012 was on Remimazolam and Solulin.
General administrative and selling expenses amounted to EUR 4.7 million and
decreased by EUR 0.1 million compared to the previous year. Administrative
expenses include restructuring costs and decreased by EUR 0.8 million to
EUR 2.6 compared to the prior-year period. Selling expenses include one-off
costs in connection with partnering activities, costs in connection with
the agreements with Lundbeck and Yichang as well as costs for the
preparation of the launch of Remifentanil. Selling expenses amounted to EUR
2.1 million, an increase of EUR 0.7 million compared to the prior-year
period.
Income Taxes
The income taxes relate in the amount of EUR 2.3 million to tax expenses in
connection with the net income for 2012 and in the amount of EUR 0.1
million to tax income from tax claims for reimbursement of parts of the
research and development costs from the British tax authorities.
Liquidity
Cash and cash equivalents on 31 December 2012 have increased compared to 31
December 2011 (EUR 7.5 million) by EUR 14.8 million to EUR 22.3 million.
Through the payment of EUR 1.5 million received at the beginning of March
2013 from Lundbeck in connection with the sale of the Desmoteplase rights
and EUR 1.2 million now due to successful completion of the Remimazolam
technology transfer from Yichang Humanwell, PAION has now a cash reach
until the end of Q1 2015. This includes the funds needed to perform the
European Phase II trial with Remimazolam in anaesthesia.
Further cash inflows from existing and future partners would strengthen the
cash position.
Business and Financial Outlook 2013
Development and Commercialisation Activities
PAION's major goals for 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 development activities by our partners Ono
(Remimazolam), Yichang (Remimazolam) and Acorda (GGF2).
PAION wants to develop itself into a specialty pharmaceutical company with
a focus on anaesthesia products. In this context, PAION seeks to retain
certain European marketing rights for Remimazolam, to market Remimazolam in
Europe itself or together with a partner. In case of a successful
out-licensing by way of a development cooperation, PAION would expect to
receive substantial payment, being either an upfront payment or sharing of
development costs, development milestone payments, a partial or complete
assumption of future development costs until market approval and royalties
from market approval onwards. In case of a pure marketing cooperation after
registration, PAION would expect in comparison a higher upfront payment and
higher royalties.
PAION benefits from the progress of Ono's development of Remimazolam in
Japan in the form of additional development data and benefits financially
in the form of milestone payments and royalties from launch onwards. This
also applies to Yichang.
In March 2013 Acorda announced results of the clinical Phase I study with
GGF2. Milestone payments of up to USD 7.5 million before and including
approval, and thereafter revenue-dependent licence fees are payable to
PAION if the further development is successful.
Financial Forecast
In 2013 revenues of EUR 1.2 million are expected. These relate to the
technology transfer with Yichang that was completed in March 2013.
Furthermore, it is aimed to receive an upfront payment or sharing of
development costs for the out-licensing of Remimazolam.
The restructuring executed in the previous year sustainably reduced the
cost structure. Because of the investment into the development of
Remimazolam the external research and development expenses will be higher
than the previous year. Costs for selling and general administration will
be lower than the previous year. The budgeted expenses will lead to a
significant loss in the mid to high single-digit million range in 2013. As
of 31 December 2012 PAION's cash and cash equivalents amounted to EUR 22.3
million. The cash at hand and the payment received from Lundbeck in March
2013 and the payment due from Yichang for completion of the technology
transfer secure a cash reach until the end of Q1 2015 including the
repayment of the subordinated loan due in April 2013.
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Key Consolidated Financial Figures, IFRS
(all figures in KEUR unless otherwise noted) 2012 2011The full annual financial report will be available as from 13 March 2013 on
Revenues 26,812 3,249
Research and development expenses -3,251 -11,825
General administrative and selling expenses -4,709 -4,815
Net result for the period 16,009 -13,684
Earnings per share in EUR for the period (basic) 0.63 -0.54
Earnings per share in EUR for the period (diluted) 0.63 -0.54
2012 2011
Cash flows from operating activities 15,475 -7,358
Cash flows from investing activities -33 -42
Cash flows from financing activities -590 30
Average number of group employees 14 26
31 Dec. 2012 31 Dec.
2011Intangible assets 3,848 4,013
Cash and cash equivalents 22,336 7,516
Equity 15,572 -464
Non-current liabilities 1,016 9,955
Current liabilities 11,748 3,115
Balance sheet total 28,336 12,606
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, 13 March 2013 at 2 p.m. CET (1 p.m. GMT, 9 a.m. EDT) to present
the financial results of 2012, highlight the most important events and
provide a pipeline and strategy update and financial outlook.
To access the call, participants from Germany may dial +49 69 20 17 44 210,
from the UK +44 207 153 9154 and from the US +1 877 423 0830 (other
countries: please choose from D/UK/US numbers). When prompted, please enter
the PIN 342639#. 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/. To connect, please enter 137345979 in
the field 'Weblogin' and 342639 in the field 'PIN Code'.
The dial-in details for the conference call and the webcast link will also
available on our website http://www.paion.com on the date of the call. The
conference call will be recorded. Details on how to access the replay will
be posted on the same webpage 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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