DGAP-News: PAION AG REPORTS RESULTS FOR THE FIRST QUARTER

DGAP-News: PAION AG / Key word(s): Quarter Results PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2015 13.05.2015 / 07:30 --------------------------------------------------------------------- PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2015 - Key financials for the period in line with plans - Initiation of U.S. Phase III program of Remimazolam for procedural sedation - Cash and cash equivalents of EUR 53.2 million - Sufficient funds for Phase III programs with Remimazolam in the EU and U.S. including the filing process - Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am EDT) Aachen (Germany), 13 May 2015 - The specialty pharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today reports its consolidated financial results according to International Financial Reporting Standards (IFRS) for the first quarter 2015. The first quarter results were as planned. As in the prior-year period, no significant revenues were generated. Research and development expenses increased significantly compared to the first quarter 2014 due to intensified development activities with Remimazolam, particularly in connection with the preparation and initiation of the Phase III programs. General administrative and selling expenses increased compared to the prior-year period as a result of increased staff and higher selling expenses due to the conduct of pre-marketing and market access activities. In total, a net loss of EUR 4.7 million has been incurred in the first quarter of 2015 compared to a net loss of EUR 2.2 million in the prior-year period. Cash and cash equivalents decreased by EUR 5.7 million in the first quarter of 2015 compared to 31 December 2014 and amounted to EUR 53.2 million as of 31 March 2015. Thus, PAION has sufficient funds to conduct the Phase III programs with Remimazolam in the EU and U.S. including the filing process, and to continue the ongoing pre-marketing and market access activities. Dr. Wolfgang Söhngen, CEO of PAION, commented, "The focus of the first quarter 2015 was preparing the start of the Phase III programs in the U.S. and in Europe. With the start of the Phase III program in the U.S. as planned, we have reached another important milestone on the road to the commercial success of Remimazolam. The EU preparations are ongoing with full swing as well." Development and Commercial Activities In the first quarter of 2015, PAION focussed on the development of Remimazolam. The dialogue with the FDA, which started in 2013 based on the positive End-of-Phase II Meeting, served the purpose to define all the details of approval requirements for Remimazolam in the indication "procedural sedation" and has been completed. The agency commented on the study protocols and other aspects of the rest of the development program such as the production of the substance and some accompanying preclinical and Phase I protocols. This was a constructive and iterative process. The Phase III study protocols were submitted to the FDA in November 2014. In the end of February 2015, PAION received feedback from the FDA, adjusted the study protocols accordingly and resubmitted the changes to the institutional review boards (IRBs, or Ethics Committee). Finally, the first Phase III study was started at the end of the first quarter. The initiation of the Phase III trial in patients undergoing colonoscopies marks the start of PAION's Phase III clinical program, which includes a second pivotal Phase III trial in patients undergoing bronchoscopies and a third smaller safety trial in high-risk patients undergoing colonoscopies. In parallel, three Phase I studies are being conducted by PAION. The Phase III colonoscopy clinical trial is a prospective, double-blind, randomized, placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing colonoscopies for diagnostic or therapeutic reasons. Patients are randomized to receive Remimazolam, midazolam or placebo in addition to fentanyl to achieve moderate sedation. The primary objective of this study is to investigate the short-term sedation and hence the success of a colonoscopy compared to placebo and midazolam. The primary endpoint is the successful completion of the colonoscopy procedure with no requirement for alternative sedatives. The completion of patient recruitment is expected before the end of 2015. In the second quarter of 2015, PAION expects the start of the second U.S. Phase III clinical trial of Remimazolam for procedural sedation during bronchoscopy. Recently, the first study sites have been initiated. The bronchoscopy study forms the second pivotal trial of the Remimazolam Phase III program and is a prospective, double-blind, randomized, placebo- and midazolam-controlled, U.S. multicenter study in 460 patients undergoing bronchoscopies. Interactions with the European Medicines Agency (EMA) for the EU lead indication "anesthesia" were completed. The upcoming development program until filing for market approval was discussed. Based on this scientific advice, the study protocols have been completed and submitted to the national agencies and IRBs. For the EU, PAION expects the study start of the Phase III program towards the end of the first half/beginning of the second half of 2015. Outlook 2015 PAION confirms its outlook for 2015 made on 18 March 2015 with the publication of the annual financial results for 2014. PAION's major goals for 2015 are the start and the conduct of the Phase III development programs with Remimazolam in the U.S. and the EU, the production development for Remimazolam, in particular the finalization of the study medication and the validation of the production at market scale, as well as the continuation of pre-marketing and market access activities. In addition, PAION is further actively working on finding a solution for Japan. This also includes completing the know-how transfer from Ono, as the Japanese data have to be integrated into the EU and U.S. filings. Moreover, PAION expects the development activities of its cooperation partners Yichang Humanwell, Hana Pharm, R-Pharm, Pendopharm (all Remimazolam) and Acorda (GGF2) to continue. ### Key Consolidated Financial Figures, IFRS (all figures in KEUR unless otherwise noted) Q1 2015 Q1 2014 Revenues 33 4 Research and development expenses -5,763 -1,602 General administrative and selling expenses -1,337 -879 Net result for the period -4,703 -2,207 Earnings per share in EUR for the period (basic) -0.09 -0.08 Earnings per share in EUR for the period (diluted) -0.09 -0.08 Cash flows from operating activities -5,761 -3,310 Cash flows from investing activities -4 -3 Cash flows from financing activities 3 10,664 Change in cash and cash equivalents (incl. exchange rate differences) -5,717 7,352 Average number of group employees 26 13 31 Mar. 31 Dec. 2015 2014 Intangible assets 3,640 3.440 Cash and cash equivalents 53,195 58.912 Equity 58,482 62.607 Non-current liabilities 14 17 Current liabilities 3,821 3.924 Balance sheet total 62,317 66.548 The full quarterly financial report will be available as from 13 May 2015 on our corporate website at http://www.paion.com/en/berichte-2015. Earnings call and webcast Conference 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 13 May 2015 at 2 p.m. CEST (1 p.m. BST, 9 a.m. EDT) to present the financial results of the first quarter 2015, highlight the most important events and provide a pipeline and strategy update and financial outlook. To access the English call starting at 2 p.m., participants may dial from * Germany +49 (0) 69 7104 45598, * UK +44 (0) 20 3003 2666 and * U.S. +1 212 999 6659 * Other countries: please use the UK number When prompted, you will be asked to give the password "PAION". The conference call will be supplemented by a webcast presentation which can be accessed during the call under the following link: www.meetingzone.com/presenter?partCEC=6578291. About PAION PAION AG is a publicly listed specialty pharmaceutical company headquartered in Aachen, Germany, with further sites in Cambridge, UK, and New Jersey, U.S. The company has a track record of developing hospital-based treatments for which there is substantial unmet medical need. PAION's strategy is to participate in the commercialization of Remimazolam and extend its business with a focus on anesthesia/critical care products. Remimazolam is the building block for its future marketing activities. 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. --------------------------------------------------------------------- 13.05.2015 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP 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: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News-Service --------------------------------------------------------------------- 356565 13.05.2015