DGAP-News: PAION AG / Key word(s): Final Results
PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2013
12.03.2014 / 07:30
---------------------------------------------------------------------
PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2013
- Licensing deals for Remimazolam in South Korea, Russia/CIS and Turkey
- Positive BfArM scientific advice meeting on the European clinical
development programme for Remimazolam in February 2013
- Positive results from ONO's Phase-II/III-Study with Remimazolam in
November 2013
- Positive EOPII meeting with FDA in November 2013
- Recruitment for Phase II study in Heart Center Leipzig successfully
completed within 5 months
- Revenues and net result better than expected
- Successful capital measures significantly strengthens financial
situation - funding of PAION secured until Q1 2016
- Listing upgrade from General Standard back to the Prime Standard
planned
- Invitation to telephone conference on 12 March 2014
Aachen (Germany), 12 March 2014 - 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 2013 (1. January to 31. December).
Revenues in 2013 amounted to EUR 4.2 million and decreased compared to the
previous year by EUR 22.6 million. The revenues of the prior year mainly
related to the sale of all Desmoteplase rights to Lundbeck for EUR 20.1
million. Revenues in 2013 include a milestone payment from Yichang
Humanwell in the amount of EUR 1.2 million for the completed technology
transfer and upfront payments totalling EUR 3 million from license
agreements for South Korea, Russia/CIS and Turkey. The net loss in 2013
amounted to EUR 2.2 million compared to EUR 16 million net profit for the
previous year, which was a result of the sale of Desmoteplase rights to
Lundbeck.
PAION's management board decided on 11 March 2014 a listing upgrade from
the General Standard to the Prime Standard of the regulated market. PAION
will submit an application for admission of the shares in the Prime
Standard of the Frankfurt Stock Exchange. The change to the Prime Standard
is intended to increase the attractiveness of PAION shares and strengthens
its position vis a vis international investors through compliance with high
transparency requirements.
Dr Wolfgang Söhngen, CEO of PAION commented, "The year 2013 has paved the
way for a reassessment of PAION AG. The license agreements were important
steps to continue the "String of pearls" strategy in which we selectively
out-license Remimazolam in regional markets. We expect that the results of
the Phase II study in the indication "anaesthesia" at the Heart Center
Leipzig, which are expected to be available in the first half of 2014,
create a sound basis for our Phase III plans in Europe. In addition, the
positive meeting with the FDA was an important step for our Phase III plans
in the US. The positive phase III data from Ono represent an important
clinical evidence of the marketability of Remimazolam. The great interest
in the recent capital measures is finally a clear sign that our strategy is
supported by our shareholders. With the change back to the Prime Standard,
we want to document now again officially the high transparency standards
that apply in this segment, which always have been supported by us. This
should further strengthen the trust of our shareholders on a long term
basis."
License and Development Activities
Remimazolam
With success PAION focussed in 2013 on the development and partnering of
Remimazolam. As part of the signed exclusive license agreement with Yichang
Humanwell in July 2012 for Remimazolam in China the technology transfer was
completed in March 2013 and triggered a payment of EUR 1.2 million.
In October 2013 PAION signed an exclusive licence agreement with Hana Pharm
for Remimazolam in South Korea against an upfront payment of EUR 1 million.
In addition, milestone payments and royalties on sales have been agreed.
Also in October 2013 an exclusive licence agreement with R-Pharm for
Remimazolam in Russia and other CIS has been signed. PAION has received an
upfront payment in the amount of EUR 1 million and is entitled to receive
milestone and royalty payments.
In November 2013, it was announced that PAION and R-Pharm have extended
their licence agreement for Remimazolam to include Turkey. TR-Pharm, based
in Istanbul, is an affiliate of R-Pharm. PAION has received an upfront
payment in the amount of EUR 1.0 million and milestone and royalty payments
have been agreed.
In all partnerships, the data, which are being generated, are also
available for PAION and its other licence partners. PAION's goal is to add
further regional cooperation agreements.
Based on the fact that general anaesthesia is the more attractive business
case for the EU compared to procedural sedation, the company decided to
develop Remimazolam for general anaesthesia as the lead indication for
Europe. In February 2013, PAION held a formal scientific advice meeting
with the German regulatory authority BfArM on the European clinical
development programme for Remimazolam in the general anaesthesia
indication. After approval of a CTA (Clinical Trial Application) by the
BfArM, the European Phase II trial with Remimazolam in general anaesthesia
in cardiovascular surgery was started in September 2013 and recruitment was
completed in February 2014. A total of 90 patients were treated and as
expected no drug-related Serious Adverse Reactions have been reported.
Results of the study are expected to be available in the first half of
2014.
Pending the outcome of the planned and ongoing trials, PAION assumes that
the Phase II and one Phase III trial in general anaesthesia in addition to
the Japanese development programme will be sufficient for EU approval. In
preparation for the European Phase III trial, further scientific advice
meetings are planned with European regulatory authorities.
In the U.S., procedural sedation remains the lead indication. The market
potential appears to be very attractive in view of billions of spending due
to the necessary presence of anaesthesiologists when providing sedation
with one of the currently used drugs (Propofol).
The development programme required until market approval (Phase III
studies, associated development activities, production development) will be
prepared based on a positive End-of-Phase II Meeting with the FDA held in
October 2013. The objective of the development programme is to show that
Remimazolam is as quick as Propofol with respect to its efficacy (high
throughput by rapid onset and offset of sedation) and at the same time is
as good as Midazolam in terms of its safety profile. If this can be further
confirmed in the upcoming studies, it is possible that the FDA will grant a
label, which does not require the presence of an anaesthetist for providing
procedural sedation with Remimazolam.
The planned label is positively supported by the availability of a reversal
agent (Flumazenil is an antagonist for all benzodiazepines such as
Midazolam and Remimazolam) which can quickly terminate the effect of
Remimazolam in the event of an overdose, for example. Propofol does not
have such an antagonist, which is among other things, a reason why the
presence of an anaesthetist is required.
This is why PAION sees a very attractive business case for conscious
sedation in the U.S. market.
The recently completed capital measures in February 2014 have increased the
degrees of freedom for PAION and enlarged its cash reach. The proceeds will
be used mainly for the preparation of the Remimazolam Phase III development
program. For the implementation of the Phase III trials PAION is working on
financing through further license agreements and in addition is evaluating
various financing options.
PAION's partner Ono Pharmaceutical has completed the Phase III programme of
Remimazolam in anaesthesia as the lead indication for the Japanese market.
In November 2013 PAION reported headline data from Ono's Phase-II/III
study. Remimazolam achieved the primary endpoint and demonstrated good
safety data. All 375 patients achieved loss of consciousness and underwent
successful intubation. As expected the primary endpoint (efficacy) as a
general anaesthetic was achieved as expected by 100% of patients in all
groups. At the same time it could be demonstrated that Remimazolam has a
clinically meaningful lower negative impact on cardiac function as compared
to Propofol.
The recruitment of the second study in the Phase III programme (American
Society of Anaesthesiologists classification III or higher) in more
severely sick patients and the hepatic impairment study have also been
completed. No significant adverse reactions have been reported. The
clinical development programme for the indication of induction and
maintenance of general anaesthesia has been completed. The pharmacokinetic
and pharmacodynamic modelling is still ongoing to support filing. Filing
for marketing approval is expected in 2014.
Solulin/PN13
Solulin and PN 13 could possibly represent an improved therapeutic approach
in the treatment of haemophilia and various acute diseases associated with
hyperfibrinolysis (excessive dissolution of blood clots).
The available data of the Phase Ib study completed in October 2012 showed,
that Solulin has the expected effect in haemophilia patients. PAION
considers the potential for Solulin and PN 13 to be very attractive. 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 was
supposed to run until 2014. The project is in a very early stage of
development. The funding was used to produce Solulin mutants as a first
step. 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. As
PAION focuses all resources on Remimazolam, PAION has requested the
discontinuation of the grant by the BMBF. The project could only be
continued with third party funding.
GGF2
At the beginning of March 2013, Acorda announced 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 Phase Ib study started in October 2013 will primarily involve the
continued investigation of the safety profile but also the efficacy of GGF2
across a range of doses. In December 2013, the enrolment was paused pending
the review of additional preclinical data in coordination with the FDA. The
FDA has granted Fast Track designation for GGF2 for the treatment of heart
failure.
In total, further milestone payments of USD 2.5 million prior to market
approval and an additional milestone payment of USD 5 million are due upon
market authorisation; after that PAION will receive revenue dependent
royalties.
Finances
Revenues
Revenues of the fiscal year amounted to EUR 4.2 million and decreased
compared to the previous year by EUR 22.6 million. The revenues of the
prior year mainly related to the sale of Desmoteplase to Lundbeck (EUR 22.6
million), a milestone payment from Ono for the start of the Phase III study
with Remimazolam in Japan (EUR 2.4 million) and the out-licensing of
Remimazolam for China (EUR 1.8 million). The revenues of the fiscal year
relate to payments in connection with the licence agreements of Remimazolam
for the countries China, South Korea, Russia/CIS and Turkey signed in 2012
and 2013.
Net result
Net loss for 2013 amounted to EUR 2.2 Million, representing a decrease of
EUR 18.2 million compared to the previous year. In 2012, a net profit of
EUR 16.0 million was achieved, which was mainly influenced by the final
lump-sum payment from Lundbeck.
Development of costs
Research and development expenses amounted to EUR 4.6 million and increased
by EUR 1.3 million compared to the previous year. The research and
development activities in 2013 focused on the clinical development and the
production development of Remimazolam.
General administrative and selling expenses amounted to EUR 3.3 million and
decreased by EUR 1.4 million compared to the previous year. This reduction
mainly relates to decreased selling expenses in the amount of EUR 0.9
million (Prior year: EUR 2.1 million). Selling expenses include internal
and external expenses in connection with out-licensing. The administrative
expenses have also decreased and amounted to EUR 2.4 million (Prior year:
EUR 2.6 million).
Liquidity
Cash and cash equivalents decreased after the scheduled repayment of the
subordinated loan (EUR 7 million) by EUR 9.0 million in 2013. As of 31
December 2013 PAION's cash and cash equivalents amounted to EUR 13.3
million. Cash and cash equivalents and the cash inflows of EUR 11.2 million
from the capital increase conducted in January and February 2014 secure a
cash reach into Q1 2016.
Business and Financial Outlook 2014
Outlook on development and commercialisation
PAION's major goals for 2014 are the production development for
Remimazolam, in particular the production of the test medication and the
validation of the production at market scale, the preparation of a Phase
III study with Remimazolam in Europe and the U.S. as well as the
out-licensing of Remimazolam in further regions. Furthermore, PAION expects
the development activities of its cooperation partners Ono, Yichang, Hana
Pharm, R-Pharm (all Remimazolam) and Acorda (GGF2) to continue.
PAION wants to evolve into a specialty pharmaceutical company with a focus
on anaesthesia products. In this context, PAION seeks to retain certain
marketing rights for Remimazolam for the European market in order 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 payments as upfront payments or through
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 to receive a comparably
higher upfront payment and higher royalties.
PAION benefits from the progress of development by Ono and the other
cooperation partners in the form of additional development data and
financially in the form of milestone payments and royalties from launch
onwards.
Financial outlook
In 2014 it is the company's aim to receive payments or achieve sharing of
development costs for the out-licensing of Remimazolam in further regions
and thus could account for the major share of revenues. In 2014 PAION could
in addition receive further milestone payments from the existing
cooperation agreements of up to EUR 1 million.
Because of the investment in the development of Remimazolam the research
and development expenses will be higher than in the previous year. Costs
for selling and general administration will be nearly on the same level as
in the previous year.
The budgeted expenses will lead to a significant high single-digit million
loss in 2014. The loss could be lower, if new licence agreements for
further regions can be closed.
The cash at hand and the payments received from capital increases in
January and February 2014 ensure a cash reach into the first quarter 2016.
In this period and thereafter, PAION expects to receive further milestone
payments from the existing cooperation agreements in case of successful
development of Remimazolam or the filing for and receipt of market approval
for Remimazolam in Japan and other regions. These milestone payments as
well as future upfront payments, milestone payments or cost reimbursements
would extend the cash reach but could also be completely or partly used to
fund further developments.
###
Key Consolidated Financial Figures, IFRS
<pre>
(all figures in KEUR unless otherwise noted) 2013 2012
Revenues 4,228 26,812
Research and development expenses -4,584 -3,251
General administrative and selling expenses -3,314 -4,709
Net result for the period -2,212 16,009
Earnings per share in EUR for the period (basic) -0.09 0.63
Earnings per share in EUR for the period (diluted) -0.09 0.63
Cash flows from operating activities -1,746 15,475
Cash flows from investing activities -5 -33
Cash flows from financing activities -7,163 -590
Intangible assets 3,494 3,848
Cash and cash equivalents 13,292 22,336
Equity 13,329 15,572
Non-current liabilities 28 1,016
Current liabilities 4,659 11,748
Balance sheet total 18,016 28,336
Average number of group employees 13 14
</pre>
The full annual financial report will be available as from 12 March 2014 on
our corporate website at http://www.paion.com/en/berichte-2014.
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, 12 March 2014 at 2 p.m. CET (1 p.m. GMT, 9 a.m. EDT) to present
the financial results of 2013, 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 590716#. 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:
www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=137350516&P
IN=590716. To connect, please just click on the link or enter 137345979 in
the field "Weblogin" and 590716 in the field "PIN Code" on
http://www.anywhereconference.com.
The dial-in details for the conference call and the webcast link will also
available on our website 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@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
---------------------------------------------------------------------
12.03.2014 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: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
E-mail: info@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
---------------------------------------------------------------------
256917 12.03.2014
DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2013
| Source: EQS Group AG