PAION AG / Release of an announcement according to Article 37x of the WpHG
[the German Securities Trading Act]
07.11.2012 07:30
Interim report according to Article 37x of the WpHG, transmitted by
DGAP - a company of EquityStory 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 2012
ACCORDING TO § 37X WPHG
FOR THE PERIOD FROM 1 JANUARY TO 30 SEPTEMBER 2012
- Record revenues of EUR 24,5 million
- Net profit of EUR 15.8 million
- Cash and cash equivalents amounting to EUR 20.1 million
- Financial guidance Increased and new outlook for the financial year 2012
- Successful development of a sales force for Remifentanil-PAION
- Phase II / III study in anaesthesia initiated by Ono
- Phase II study for ICU sedation initiated by Ono
- Completion of Phase Ib study with Solulin in Haemophilia
Aachen (Germany), 07 November 2012 - 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 2012.
Revenues in the first nine months of 2012 amounted to EUR 24.5 million and
increased by EUR 21.4 million compared to the prior-year period. The
revenues relate in the amount of EUR 20.1 million to the sale of
Desmoteplase to Lundbeck. The income for the first nine months of 2012
amounted to EUR 15.8 million meaning an increase of EUR 20.9 million
compared to the prior-year period.
Dr Wolfgang Söhngen, CEO of PAION commented: 'We are proud of our
achievements in the last months, because we have accomplished a lot
more than many expected last year around the same time. The
agreements with Lundbeck and Yichang, and the start of the Phase
II / III study by Ono give us flexibility to pursue our strategic
repositioning. The rapid development progress by Ono demonstrates
the potential of Remimazolam and gives us the opportunity to
leverage unexpected synergies earlier than expected, which will
also be supported by the planned launch of Remifentanil-PAION.
We consider this as a significant overall value increase of our lead
program,which will open up further opportunities.'
Development and Commercialisation Activities
In the first nine month of 2012 important strategic decisions were made in
order to position the company as a commercial provider of specialized
products in anaesthesia. The key element of this strategy is PAION's lead
compound Remimazolam.
The collaboration with Ono shows intense progress. In the reporting period,
a partnering of Remimazolam with Yichang was completed. Even in the event
of further out-licensing it remains the goal, to actively participate in
selected European countries in the marketing. For the out-licensing of
Remimazolam in countries outside of Japan and China PAION does not give a
timeline
In order to establish an independent platform in the anaesthesia market
successfully, the distribution rights for the short-acting opioid
Remifentanil were acquired in Germany and it was started to build a lean
sales organization. It is envisaged that Remifentanil and potentially other
products will be used to prepare the ground for the commercialisation of
Remimazolam. Based on the results of the market research and market access
study conducted in 2011, PAION believes that Remimazolam is an excellent
drug candidate to serve as a focal point for the commercial anaesthesia
platform.
Portfolio Update
Remimazolam
In July 2012 PAION signed an exclusive licence agreement with Yichang for
Remimazolam in China. For territories outside of Japan and China, PAION
does not give a timeline for partnering.
The collaboration with Ono is going extremely well. Back in May 2012, a
Phase II study in Japan has been completed successfully. On 5 November 2012
Ono announced the initiation of a Phase II/III study in anaesthesia. The
enrolment of the first patient will trigger a milestone payment of three
million USD from Ono Pharmaceutical which is expected by the end of this
year. Furthermore a Phase II study in ICU sedation was initiated. Thus, the
development program by ONO is being progressed rapidly, broader and ahead
of schedule.
Based on this, it is appropriate to pool the resources of both development
partners. PAION is evaluating to expand the Japanese data package to
European anaesthesia studies in order to adjust the dossier to the European
requirements.
Furthermore, synergies could arise from the successful use of Remifentanil
in the hospital market. From discussions held so far the sales force active
since the third quarter had with anaesthesiologists a great medicinal and
pharma economic interest in the combined use of Remifentanil-PAION and
Remimazolam derived. Taking this feedback and the development by Ono into
account PAION will evaluate the development of Remimazolam in the
indication anaesthesia as a lead indication.
Remifentanil-PAION
The in August 2012, announced acquisition of distribution rights for
Remifentanil-PAION was an important step in building an anaesthesia
portfolio and for the planned forward integration. In the reporting period
the building of a lean sales organization focused on the anaesthesia market
has been initiated successfully. The sales force will focus initially on
the marketing of Remifentanil. However, it is intended for the future that
the sales force will market after a successful launch also Remimazolam and
other yet to be acquired anaesthesia products in addition to
Remifentanil-PAION. The launch of Remifentanil-PAION is announced for the
first quarter of 2013.
The ultra-short effect of the opioid Remifentanil-PAION is an essential
element in the 'Fast-Track' approach. This concept means benefits for the
patient, physicians, nurses, and is reducing the treatment costs. The good
tolerability, efficacy and rapid degradability of Remifentanil patients,
who were given Remifentanil during surgery, often spared them the stay in
the ICU. Remifentanil-PAION is therefore an ideal companion product for the
anaesthetic Remimazolam which is under development, which is according to
the studies carried out characterized also by the advantages of
compatibility and effectiveness and rapid biodegradability as it is
degraded by the same mechanism as Remifentanil.
Solulin/PN13
Due to the focus of the available resources on anaesthesia and
restructuring the Phase Ib study had to be completed in October 2012 as the
enrolment lagged far behind the study objectives.
Solulin is being further evaluated for the treatment of radiation injury.
In July 2012, the preclinical efficacy of Solulin in radiation injury was
published in 'Nature Medicine'. Further preclinical studies are ongoing to
confirm the results.
The research on thrombomodulin mutants (PN 13) as a successor of Solulin in
haemophilia will continue until the project ends in 2014. For this
research, PAION has been granted in July 2012 public research funding from
the Federal Ministry of Education and Research (BMBF) in the amount of EUR
0.7 million EUR.
Finances
Revenues
Revenues in the first nine months of 2012 amounted to EUR 24.5 million and
increased by EUR 21.4 million compared to the prior-year period. The
revenues in the amount of EUR 20.1 million mainly relate to the sale of
Desmoteplase to Lundbeck. Furthermore the revenues relate in the amount of
EUR 2.5 million (prior-year period: EUR 0.4 million) to the complete
release of deferred income resulting from the milestone payment of EUR 8
million received from Lundbeck in 2008 and in the amount of EUR 1.8 million
through the license agreement with Yichang.
Net income
The income for the first nine months of 2012 amounted to EUR 15.8 million
meaning an increase of EUR 20.9 million compared to the prior-year period.
Development costs
Research and development expenses amounted to EUR 2.4 million in the first
nine months of 2012. This means a decrease of EUR 2.0 million compared to
the prior-year period. The decrease is due to reduced development
activities. The main research and development focus was on Remimazolam and
Solulin.
General administrative and selling expenses in the first nine month 2012
amounted to EUR 3.5 million. These include EUR 1.9 million administrative
expenses and EUR 1.6 million selling expenses. Administrative expenses
include restructuring costs and decreased by EUR 0.4 million 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 forward integration. Selling
expenses amounted to EUR 1.6 million, an increase of EUR 0.4 million
compared to the prior-year period.
Income taxes
The income taxes relate in the amount of EUR 2.5 million (tax expenses) to
an accrual for expected tax payments in connection with sale of
Desmoteplase to Lundbeck as well as in the amount of EUR 0.2 million (tax
income) to tax claims for reimbursement of parts of the research and
development costs from the British tax authorities.
Liquidity
Cash and cash equivalents on 30 September 2012 have increased compared to
31 December 2011 by EUR 12.6 million to EUR 20.1 million. This does not
include the payment of EUR 1.5 million received in October 2012. The cash
and cash equivalents alone secure a cash reach into 2014 including
repayment of the subordinated loan due in April 2013. Further cash inflows
from existing and future partners would extend the cash reach.
Business and Financial Outlook 2012
PAION increases its outlook for 2012 made on 08 August 2012 with the
publication of the half year report 2012 with expected revenues of
approximately EUR 26.8 million compared to EUR 24.5 million expected so
far. PAION further concentrates on the implementation of its strategic
realignment and focus on anaesthesia:
This includes the planned launch of Remifentanil-PAION and the evaluation
of a new lead indication for Remimazolam in anaesthesia. For territories
outside of Japan and China, PAION does not give a timeline for partnering.
Furthermore, PAION expects the continuation of the development activities
by its cooperation partners Ono and Yichang (Remimazolam) and Acorda
(GGF2).
###
Key Consolidated Financial Figures, IFRS (unaudited)
<pre>
(all figures in KEUR unless Q3 2012 Q3 2011 Q1-Q3 Q1-Q3
otherwise noted) 2012 2011
Revenues 1,650 243 24,454 3,066
Research and development expenses -590 -1,347 -2,376 -4,380
General administrative and selling -1,017 -979 -3,479 -3,529
expenses
Net result for the period -31 -2,164 15,847 -5,046
Earnings per share in EUR for the -0.01 -0.09 0.62 -0.20
period (basic)
Earnings per share in EUR for the -0.01 -0.09 0.62 -0.20
period (diluted)
Q1-Q3 Q1-Q3
2012 2011
Cash flows from operating activities 13,055 -5,043
Cash flows from investing activities -4 -41
Cash flows from financing activities -442 179
Change in cash and cash equivalents 12,622 -4,917
Average number of group employees 16 25
30.09.2012 31.12.2011
Intangible assets 4,001 4,013
Cash and cash equivalents 20,139 7,516
Equity 15,494 -464
Non-current liabilities 8,069 9,955
Balance sheet total 28,074 12,606
Equity ratio 55.2%
</pre>
About PAION
PAION is headquartered in Aachen, Germany and has a second site in
Cambridge, UK. The company is specialised in developing innovative drugs
for the hospital-based treatment in indications for which there is a
substantial unmet medical need. PAION extends its 'Search & Develop'
business model, by transforming into a 'Specialty Pharma Company', with a
focus on anaesthesia products.
Aachen, Germany, 7 November 2012
The Management Board
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.
07.11.2012 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: PAION AG: INTERIM REPORT BY MANAGEMENT FOR THE SECOND HALF OF THE YEAR 2012 ACCORDING TO § 37X WPHG FOR THE PERIOD FROM 1 JANUARY TO 30 SEPTEMBER 2012
| Source: EQS Group AG