DGAP-News: PAION AG / Key word(s): Half Year Results PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2011 10.08.2011 / 08:05 --------------------------------------------------------------------- PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2011 - PAION receives USD 3 million milestone payment from Ono Pharmaceutical for start of Japanese Phase II with Remimazolam in the indication anaesthesia - Revenues increased by 26.4% to EUR 2.8 million and the loss for the period decreased by 33.2% to EUR -2.9 million (year-on-year) - Ongoing partnering discussions with potential licensees for out-licensing of Remimazolam and M6G - Positioning of Solulin in the indications haemophilia and radiation injury Aachen (Germany), 10 August 2011 - The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today reports its consolidated financial result according to International Financial Reporting Standards (IFRS) for the first half-year 2011. Revenues in the first half-year 2011 increased by EUR 0.6 million (26.4%) to EUR 2.8 million compared to the prior-year period due to USD 3 million milestone payment received in the second quarter 2011 from Ono Pharmaceutical. The loss for the first half year of 2011 amounted to EUR 2.9 million meaning a decrease of EUR 1.4 million (33.2%) compared to the prior-year period. Dr Wolfgang Söhngen, CEO of PAION commented, 'Next to the active discussions with potential licensing partners for the partnering of Remimazolam, a deep analysis of the market potential of Remimazolam as well as the development of Solulin in our new lead indication haemophilia was the focus of all activities of the first half-year 2011. We are excited about the progress of Remimazolam in Japan. Due to the milestone payment by our licensing partner Ono, we were able to considerably improve our financial situation.' Overview H1 2011 Development & Commercialisation Activities In the first half year of 2011 the partnering process for Remimazolam and M6G was continued on an intensive basis. Based on the excellent results of the Phase IIb trial with Remimazolam in colonoscopy, PAION is currently in discussion with a selected number of interested parties. Findings from a marketing study conducted early 2011 confirm the market potential of Remimazolam and the current significant need for anaesthetics/sedatives with an excellent safety profile and a fast onset of action. Among the interested companies are both globally operating pharmaceutical companies as well as companies having an interest in either the US or EU market. In May 2011 Ono initiated the first Phase II trial with Remimazolam in Japan, which triggered a milestone payment of USD 3 million. Regarding the substance M6G for the treatment of peri-operative pain discussions are also ongoing to continue the development together with several partners in regional deal structures. Following the announcement of positive preclinical data in the indication haemophilia in December 2010, PAION has selected haemophilia as the new lead indication for Solulin. In the first half year of 2011 a number of activities were undertaken to substantiate the safety and efficacy profile of Solulin in preclinical and ex vivo studies. Apart from the positioning in this indication, the possible use of Solulin for the treatment of radiation injury is being further evaluated. Finance Revenues in the first half-year 2011 increased by EUR 0.6 million (26.4%) to EUR 2.8 million compared to the prior-year period. Research and development expenses of EUR 3.0 million in the first half-year of 2011 decreased by EUR 1.3 million (30.3%) compared to the prior-year period. This decrease is mainly caused by the Phase IIb study conducted with Remimazolam in the previous year. The main research and development focus in the first half-year 2011 was on Remimazolam and Solulin. General administrative and selling expenses increased in the first six months of 2011 by EUR 0.3 million (14.3 %) to EUR 2.6 million. The increase results from higher selling expenses in connection with partnering activities. The loss for the first half-year of 2011 amounted to EUR 2.9 million meaning a decrease of EUR 1.4 million (33.2%) compared to the prior-year period. Cash and cash equivalents decreased by EUR 2.8 million in the first six months 2011 and amounted to EUR 12 million. As of 30 June 2011 PAION's remaining equity facility amounted to EUR 13.2 million. Outlook PAION's major goals for 2011 are the out-licensing of Remimazolam, the production of Remimazolam study medication in preparation of a Phase III study programme, the out-licensing of M6G as well as further development of Solulin. Furthermore, PAION expects in 2011 extensive development activities by the cooperation partners Lundbeck (Desmoteplase), Ono (Remimazolam) and Acorda (GGF2). Revenues in 2011 will include the milestone payment of EUR 2.1 million received from Ono in the first half-year 2011 for the development progress with Remimazolam and the systematic release of deferred income related to the non-refundable milestone payment of EUR 8 million received in 2008 from Lundbeck. This deferred income is now expected to account for EUR 1.1 million instead of EUR 1.5 million in 2011. This change reflects the amended timelines and guidance for the anticipated filing of Desmoteplase (first half of 2014), which was announced by our partner Lundbeck today. Apart from the change regarding Desmoteplase, the financial Outlook made on 23 March 2011 with the publication of the financial results 2010 remains unchanged. The cash and cash equivalents secure a cash reach until the middle of 2012. This does not account for further cash inflows from existing and future partners or from the equity facility. ### Key Consolidated Financial Figures, IFRS |[![CDATA[|[pre|]]]|] (all figures in KEUR unless Q2 Q2 H1 2011 H1 2010 otherwise noted) 2011 2010 Revenues 2,455 1,494 2,824 2,235 Research and development expenses -1,643 -1,870 -3,033 -4,353 General administrative and selling expenses -1,109 -1,127 -2,550 -2,230 Net result for the period -364 -1,456 -2,892 -4,327 Earnings per share in EUR for the period (basic) -0.01 -0.06 -0.11 -0.18 Earnings per share in EUR for the period (diluted) -0.01 -0.06 -0.11 -0.18 H1 2011 H1 2010 Cash flows from operating activities -3,100 -4,755 Cash flows from investing activities -36 -14 Cash flows from financing activities 328 -293 Change in cash and cash equivalents -2,833 -5,020 Average number of group employees 26 29 30 June 31 Dec. 2011 2010 Intangible assets 9,723 10,571 Cash and cash equivalents 12,049 14,882 Equity 9,436 11,968 Non-current liabilities 9,577 10,483 Balance sheet total 22,933 26,836 Equity ratio 41.1% 44.6% |[![CDATA[|[/pre|]]]|] The full annual financial report will be available as from 10 August 2011 on our corporate website at http://www.paion.com/en/berichte-2011. 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, 10 August 2011 at 2 p.m. CET (1 p.m. GMT, 8 a.m. US Eastern Time) to present the financial results of the first half-year 2011, highlight the most important events of this period and provide further details on the company's latest developments. 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 218270 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/. To connect, please enter 137341533 in the field 'Weblogin' and 218270 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 web page after the call. About PAION PAION is a biopharmaceutical company headquartered in Aachen, Germany and has a second site in Cambridge, UK. The company is specialized in developing and commercializing innovative drugs for the hospital-based treatment in indications for which there is a substantial unmet medical need. PAION has a 'Search & Develop' business model, which is based on its core expertise in drug development. Where appropriate, particularly during the late stages of the clinical development, PAION seeks to collaborate with experienced partners. 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 --------------------------------------------------------------------- 10.08.2011 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory 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 (Prime Standard); Freiverkehr in Berlin, Düsseldorf, Hamburg, München, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 134985 10.08.2011
DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST HALF-YEAR 2011
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