DGAP-News: PAION AG / Key word(s): Quarter Results PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST NINE MONTHS OF 2011 09.11.2011 / 07:30 --------------------------------------------------------------------- PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST NINE MONTHS OF 2011 - Reduced net loss for the period of EUR 5.1 million, down 30.9% compared to the prior year period - Updated financial plan ensures cash reach into the third quarter 2012 (without additional cash inflows and based on current structure) - Delay of out-licensing of Remimazolam and M6G due to difficult capital market conditions and restrained investments of the pharma industry - Production of Remimazolam API for Phase III completed - Start of a Phase Ib study with Solulin in the indication haemophilia Aachen (Germany), 09 November 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 nine months of 2011. Revenues in the first nine months of 2011 increased by EUR 0.5 million (17.7%) to EUR 3.1 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 nine months 2011 amounted to EUR 5.1 million decreasing by EUR 2.3 million (30.9%) compared to the prior-year period. Dr Wolfgang Söhngen, CEO of PAION commented, '2011 so far has been a challenging year for the biotech-industry as the financial environment and market sentiment has been unfavourable towards the sector. This affected particularly our partnering efforts for Remimazolam. However, given the impressive data from the Phase IIb study in colonoscopy, we remain convinced of the potential of Remimazolam as the new gold standard and as such confident in closing a deal.' Overview Q1-Q3 2011 Development & Commercialisation Activities In the first nine months of 2011 the efforts to find partners for Remimazolam and M6G were 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 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 a high safety profile and a fast onset and offset. Regarding the substance M6G for the treatment of peri-operative pain there are also discussions ongoing on continuing the development together with several partners in regional deal structures. Due to difficult capital market conditions and restrained investments of the pharma industry negotiations with partners pose a greater challenge to the company than expected. Therefore it is unlikely that the licensing agreements for Remimazolam and M6G will be closed in 2011. Presently the company is unable to predict a clear time frame for the out-licensing of these compounds. The partnering of Remimazolam is being pursued with highest priority. For the Japanese market Remimazolam is currently being developed in anaesthesia by PAION's partner Ono Pharmaceutical. In May 2011 Ono initiated the first Phase II trial of Remimazolam in Japan, which triggered a milestone payment to PAION of USD 3 million. 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. Solulin has the potential to significantly improve the existing treatment modalities for the patients. 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. On the basis of these data a clinical Phase Ib study was initiated in the indication haemophilia. Finance Revenues in the first nine months of 2011 increased by EUR 0.5 million (17.7%) to EUR 3.1 million compared to the prior-year period. Research and development expenses of EUR 4.4 million in the first nine months of 2011 decreased by EUR 2.2 million (33.4%) compared to the prior-year period. The decrease is due to reduced development activities. The main research and development focus in the first nine months of 2011 was on Remimazolam and Solulin. General administrative and selling expenses increased in the first nine months of 2011 by EUR 0.2 million (6.6 %) to EUR 3.5 million. The increase results from higher selling expenses in connection with partnering activities and market research. The loss for the first nine months of 2011 amounted to EUR 5.1 million decreasing by EUR 2.3 million (30.9%) compared to the prior-year period. Cash and cash equivalents decreased by EUR 4.9 million in the first nine months of 2011 and amounted to EUR 10 million. As of 30 September 2011 PAION's equity facility amounted to EUR 13.2 million. Development and Commercialisation Activities PAION's major goals for 2011 and 2012 are the out-licensing of Remimazolam and M6G as well as further development of Solulin. Furthermore, PAION expects extensive development activities by the cooperation partners Lundbeck (Desmoteplase), Ono (Remimazolam) and Acorda (GGF2). Financial Forecast Revenues in 2011 will include the milestone payment of EUR 2.1 million received from Ono for the development progress with Remimazolam and the systematic release of deferred income in the amount of EUR 1.1 million. This results from the non-refundable milestone payment of EUR 8 million received in 2008 from Lundbeck; the monthly release was reduced from August 2011 onwards. Research and development expenses will be considerably lower than the previous year. The out-licensing activities will lead to increased selling expenses compared to previous years, especially in connection with consulting services and success fees. The budgeted expenses will lead to a significant net loss in 2011. From the existing cooperations with Lundbeck, Ono and Acorda PAION expects the next cash inflows from 2012 onwards. Some of the milestone payments, which are expected in the future, are linked to milestone obligations for PAION, which would accordingly reduce the result. In case of a successful out-licensing PAION expects further cash inflows, in a substantial amount for Remimazolam and in a small amount for M6G from 2012 onwards. As of 30 September 2011 PAION's cash and cash equivalents amounted to EUR 10 million and the equity facility amounted to EUR 13,2 million. The cash and cash equivalents alone secure a cash reach into the third quarter 2012. This does not account for further cash inflows from existing and future partners or from the equity facility and implies an unchanged structure. Further upfront payments, milestone payments, cost reimbursements or cost cutting measures as well as the use of the equity facility could expand the cash reach. Cash inflows may also be used fully or in part for funding of additional development activities within the existing portfolio or new strategic investments. ### Key Consolidated Financial Figures, IFRS |[![CDATA[|[pre|]]]|] (all figures in KEUR unless Q3 Q3 Q1-Q3 2011 Q1-Q3 otherwise noted) 2011 2010 2010 Revenues 243 368 3,066 2,604 Research and development expenses -1,347 -2,226 -4,380 -6,579 General administrative and selling expenses -979 -1,082 -3,529 -3,312 Net result for the period -2,164 -2,992 -5,056 -7,319 Earnings per share in EUR for the period (basic) -0.09 -0.12 -0.20 -0.30 Earnings per share in EUR for the period (diluted) -0.09 -0.12 -0.20 -0.30 Q1-Q3 2011 Q1-Q3 2010 Cash flows from operating activities -5,043 -7,390 Cash flows from investing activities -41 -21 Cash flows from financing activities 179 -442 Change in cash and cash equivalents -4,917 -7,838 Average number of group employees 25 29 30 Sept. 31 Dec. 2011 2010 Intangible assets 10,022 10,571 Cash and cash equivalents 9,965 14,882 Equity 7,740 11,968 Non-current liabilities 10,132 10,483 Balance sheet total 21,093 26,836 Equity ratio 36.7% 44.6% |[![CDATA[|[/pre|]]]|] The full annual financial report will be available as from 09 November 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, 9 November 2011 at 2 p.m. CET (1 p.m. GMT, 8 a.m. EST) to present the financial results of the third quarter 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 700966#. 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 137341834 in the field 'Weblogin' and 700966 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 --------------------------------------------------------------------- 09.11.2011 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 --------------------------------------------------------------------- 145240 09.11.2011
DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST NINE MONTHS OF 2011
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