PAION AG / Release of an announcement according to Article 37x of the WpHG
[the German Securities Trading Act]
06.11.2013 07:30
Interim report according to Article 37x of the WpHG, transmitted by
DGAP - a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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INTERIM REPORT BY MANAGEMENT FOR THE SECOND HALF OF THE YEAR 2013
ACCORDING TO § 37X WPHG
FOR THE PERIOD FROM 1 JANUARY TO 30 SEPTEMBER 2013
- Exclusive licence agreements with Hana Pharm for Remimazolam in South
Korea and R-Pharm in Russia were signed shortly after the reporting
period
- Start of Phase II trial for Remimazolam in General Anaesthesia at
Leipzig Heart Centre
- Increase of revenue forecast for 2013 from EUR 1.5 million to EUR 3.2
million
Aachen (Germany), 06 November 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 the period from 1 January to 30
September 2013.
Revenues in the first nine months 2013 amounted to EUR 1.5 million and
decreased by EUR 22.9 million compared to the prior-year period. The
revenues in the amount of EUR 1.2 million relate to a milestone payment
from Yichang Humanwell after completion of technology transfer and to the
option agreement with Hana Pharm for the amount of EUR 0.3 million. In
total a net loss of EUR -3.5 million has been incurred compared to a net
income of EUR 15.8 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 satisfied with
the commercial and clinical development progress in 2013. The agreements
with Hana Pharm and R-Pharm are important steps in our 'String of Pearls'
partnering strategy in which we license out Remimazolam in selective
regional markets. The on target recruitment of the Phase II anaesthesia
study at the heart center Leipzig will allow us to achieve a sound basis
for our Phase III plans in the EU. Together with the rapid development
progress by Ono this underscores the potential of Remimazolam. We expect
the results of our Phase II and Ono's Phase III in General Anesthesia in
the first half of 2014.'
Development and Commercial Activities
Remimazolam
In 2013 PAION focussed on the development and partnering of Remimazolam. In
July 2012 PAION signed an exclusive license agreement with Yichang
Humanwell 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, potential milestone payments of up to EUR 2 million and 10%
royalties on sales in the South Korean market have been agreed. Hana Pharm
will manage and finance the development and marketing approval process in
South Korea.
Also in October 2013 an exclusive licence agreement with R-Pharm for
Remimazolam in Russia and other CIS has been signed. PAION will receive an
upfront payment in the amount of EUR 1 million, potential milestone
payments of up to EUR 3 million and low double digit royalties on net sales
in the CIS. R-Pharm will manage the development and marketing approval
process in the CIS. R-Pharm intends to market Remimazolam in all
indications with the lead indication anaesthesia and plans to start a
bridging study in anaesthesia as soon as possible.
PAION's goal is to add further cooperation's for the markets outside of
China, Japan, South Korea and Russia. However PAION will give no specific
forecast for the timing of additional partnerships.
PAION's partner Ono Pharmaceutical is currently developing Remimazolam in
anaesthesia for the Japanese market as the 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 and the hepatic impairment study have also been completed. No
significant adverse events have been reported. The Japanese development
program for the indication of induction and maintenance of general
anaesthesia is completed and filing is expected in 2014.
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 to discontinue the study in August 2013.
Overall all patients were sedated successfully and no significant adverse
events were reported. The planned pre-clinical experiments and additional
PK modelling based on the plasma samples is underway. The results will be
the basis for a dose adjustment, if necessary, for new studies.
In February 2013, PAION held a formal scientific advice meeting with the
German regulatory authority BfArM on the European clinical development
program for Remimazolam in General Anaesthesia. After approval through the
BfArM the European Phase II trial with Remimazolam in General Anaesthesia
in cardiovascular surgery was started in September 2013. Results of the
study are expected in the first half of 2014.
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. To finance the
future development program PAION is working on additional license
agreements and is evaluating other funding options. PAION expects results
of the Phase II (PAION) and Phase III (Ono) in General Anaesthesia in the
first half of 2014.
Solulin/PN13
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 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, the project will
only be continued with third party funding.
GGF2
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 will primarily investigate further the safety profile of
GGF2 across a range of doses, will continue to explore efficacy outcomes
and the start of the study was announced by Acorda on 8 October 2013. 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 in the first nine months 2013 amounted to EUR 1.5 million and
decreased by EUR 22.9 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 and to the option agreement with Hana Pharm for the amount
of EUR 0.3 million. The prior-year period was marked by the sale of
Desmoteplase to Lundbeck for the amount of EUR 20.1 million.
Net result
The net loss for the first nine months 2013 amounted to EUR -3.5 million.
In the prior-year period a net income of EUR 15.8 million has been
reported. This means a decrease of the net result of EUR 19.3 million
compared to the prior-year period.
Development of costs
Research and development expenses amounted to EUR 3.2 million in the first
nine months 2013 and relate mainly to Remimazolam. This means an increase
of EUR 0.8 million compared to the prior-year period. The increase is due
to increased development activities, in particular the Phase II study with
Remimazolam and further production development to prepare the Phase III
program and commercial supply of Remimazolam.
General administrative and selling expenses in the first nine months 2013
declined by EUR 1.0 million to EUR 2.5 million. Administrative expenses
decreased compared to the prior-year period by EUR 0.2 million to EUR 1.7
million. Selling expenses decreased compared to the prior-year period by
EUR 0.8 million to EUR 0.8 million.
Liquidity
Cash and cash equivalents decreased after scheduled repayment of the
subordinated loan (EUR 7 million) by EUR 9.3 million in the first nine
months 2013. As of 30 September 2013 PAION's cash and cash equivalents
amounted to EUR 13.0 million. After accounting for the costs for the
ongoing Phase II study with Remimazolam the cash and cash equivalents alone
secure a cash reach until end of Q1/2015 based on the current structure.
The additional income from the agreements with Hana Pharm and R-Pharm will
either be used to further invest in the development of Remimazolam or to
extend PAION's cash reach.
Business and Financial Outlook 2013
PAION updates its outlook for 2013 made on 13 March 2013 with the
publication of the annual financial results of 2012 and increases the
revenue forecast for 2013 to EUR 3.2 million. PAION continues to focus on
the conduct of the Phase II study with Remimazolam, the production
development for Remimazolam and the out-licensing of Remimazolam outside
Japan, China, South Korea and Russia. Furthermore, PAION expects the
continuation of the development activities by the cooperation partners
Acorda (GGF2), Ono and Yichang Humanwell and the initiation of the know-how
transfer to Hana Pharm and R-Pharm (all Remimazolam).
The expected revenues of EUR 1.5 million for fiscal year 2013 will increase
by EUR 1.7 million to EUR 3.2 million. These relate in the amount of EUR
1.2 million to the technology transfer with Yichang Humanwell which has
been completed in March 2013 as well as to licensing agreements with Hana
and R-Pharm Pharm concluded in October for EUR 1 million each.
###
Key Consolidated Financial Figures, IFRS (not audited)
<pre>
(all figures in KEUR unless
otherwise noted) Q3 2013 Q3 2012 Q1-Q3 2013 Q1-Q3
2012
Revenues 300 1,650 1,523 24,454
Research and development expenses -1,162 -590 -3,191 -2,376
General administrative and selling
expenses -643 -1,017 -2,465 -3,479
Result for the period -1,311 -31 -3,501 15,847
Earnings per share in EUR for the
period (basic) -0.05 -0.01 -0.14 0.62
Earnings per share in EUR for the
period (diluted) -0.05 -0.01 -0.14 0.62
Q1-Q3 2013 Q1-Q3
2012
Cash flows from operating
activities -2,056 13,055
Cash flows from investing
activities 0 -4
Cash flows from financing
activities -7,163 -442
Change in cash and cash
equivalents -9,344 12,622
Average number of group employees 14 16
30 Sep. 31 Dec.
2013 2012
Intangible assets 3,548 3,848
Cash and cash equivalents 12,992 22,336
Equity 11,975 15,572
Non-current liabilities 782 1,016
Current liabilities 4,469 11,748
Balance sheet total 17,226 28,336
</pre>
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.
06.11.2013 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Germany
Internet: www.paion.com
End of Announcement DGAP News-Service
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DGAP-IRE: IINTERIM REPORT BY MANAGEMENT FOR THE SECOND HALF OF THE YEAR 2013 ACCORDING TO § 37X WPHG FOR THE PERIOD FROM 1 JANUARY TO 30 SEPTEMBER 2013
| Source: EQS Group AG