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 2014 07.05.2014 / 07:30 --------------------------------------------------------------------- PAION AG REPORTS RESULTS FOR THE FIRST QUARTER 2014 - Revenues and net result for the period in line with plans - Gross proceeds of EUR 11.2 million from the capital increases - Cash and cash equivalents of EUR 20,6 million secure cash reach into the first quarter of 2016 - Conference call (in English) today at 2:00 pm CEST (1:00 pm BST/8:00 am EDT) Aachen (Germany), 07 May 2014 - The biopharmaceutical 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 2014. The first quarter results were as planned and PAION did not report any major revenues during the first quarter of 2014. In the prior year period, revenues amounted to EUR 1.2 million related to a milestone payment from Yichang after completion of a technology transfer agreement with respect to Remimazolam, PAION's short-acting anaesthetic/sedative. Research and development expenses increased in the first quarter of 2014 compared to the prior-year period due to increased development activities with Remimazolam. General administrative and selling expenses slightly decreased compared to the prior-year period. In total, a net loss of EUR 2.2 million was incurred in the first quarter of 2014 (Q1 2013: EUR -0.7 million). Cash and cash equivalents increased by EUR 7.4 million in the first quarter of 2014 mainly due to the capital increases conducted earlier this year minus the cash need for the operating business. As of 31 March 2014, PAION's cash and cash equivalents amounted to EUR 20.6 million. The cash and cash equivalents alone secure PAION's cash reach into the first quarter 2016. Dr Wolfgang Söhngen, CEO of PAION commented, "The focus of the first quarter this year was the preparation of the Remimazolam Phase III programs in EU and the US. The capital actions were undertaken in preparation for these trials. Primarily, we will use the proceeds to produce the study medication and to validate production at market scale. Furthermore, the analysis of the Phase II clinical study in the EU with Remimazolam was prepared and further consultations with the authorities in preparation for the Phase III program in the US and the EU were undertaken. Subject to a successful financing by mid-year we expect to initiate the Phase III trials in the US and the EU around year-end." Development and Commercial Activities In the first quarter of 2014, PAION focussed on the development and partnering of Remimazolam. In February 2014, only five months after the start of the trial, completion of recruitment of the Phase II clinical trial with the short-acting anaesthetic/sedative Remimazolam in the indication "General Anaesthesia" in patients undergoing cardiac surgery at the Leipzig Heart Center was announced. This EU Phase II trial design was randomized, propofol and sevoflurane (standard treatment) controlled and with the aim to evaluate the efficacy, tolerability and pharmacokinetics of Remimazolam during general anaesthesia in patients undergoing cardiac surgery using a heart-lung machine. After surgery a follow up sedation in the recovery room or in the intensive care unit (ICU) for up to 24 hours took place. A total of 90 patients were treated in the trial. No drug-related serious adverse events were reported. Results of the study are expected in the second quarter of 2014. Capital increases On 17 December, 2013, the Management Board decided with the approval of the Supervisory Board, based on the authorisation from the Annual General Meeting, to issue 2,777,777 new, no-par value bearer shares, at a subscription price of EUR 1.80 and granting pre-emptive rights to existing shareholders. Existing shareholders were able to subscribe to the new shares at a subscription ratio of 19:2 during the subscription period from 23 December 2013 to 9 January 2014. The U.S. institutional investor Capital Ventures International had undertaken to purchase all new shares that were not subscribed by existing shareholders or other investors in the rights offering at the subscription price. Upon completion of the capital increase, PAION's share capital increased to EUR 28,157,683. The capital increase was recorded in the commercial register on 13 January 2014 and led to a cash inflow of EUR 5 million. On 15 January 2014, the Management Board decided with the approval of the Supervisory Board and based on the authorisation of the General Meeting to issue 1,245,899 new bearer shares to Capital Ventures International in a private placement excluding existing shareholder pre-emptive rights. The new shares were issued at a price of EUR 2.4079 per share. As a result, PAION's share capital increased to EUR 29,403,582. The capital increase was recorded in the commercial register on 22 January, 2014 and led to a cash inflow of EUR 3 million. On 12 February, 2014, the Management Board decided to issue another 1,290,178 new bearer shares to Capital Ventures International in a private placement excluding existing shareholders' pre-emptive rights. The new shares were issued at a price of EUR 2.4553 per share and led to a cash inflow of EUR 3.17 million. As a result, PAION's share capital increased to EUR 30,693,760. The capital increase was recorded in the commercial register on 17 February 2014. Due to the three capital measures the Authorised Capital 2011 decreased to EUR 7,366,534.00. After the end of the reporting period, PAION announced on 11 April 2014 that it is planning a capital increase with subscription rights by issuing up to 18.5 million shares to fund the Phase III Remimazolam clinical trials in the US and EU. The resolution on this capital increase is planned to be adopted at the upcoming Annual General Meeting on 21 May 2014. Outlook PAION confirms its outlook for 2014 made on 12 March 2014 with the publication of the annual financial results for 2013. PAION's major goals for 2014 are the production development for Remimazolam, in particular the production of the test medication and the validation of the production in market scale, the preparation of a Phase III study with Remimazolam in Europe and the U.S., the successful completion of the capital increase to secure funding for the Phase III programmes in Europe and in the US as well as the out-licensing of Remimazolam in further regions. Furthermore, PAION expects the development activities of its cooperation partners Ono, Yichang, Hana Pharm, R-Pharm (all Remimazolam) and Acorda (GGF2) to continue. ### Key Consolidated Financial Figures, IFRS <pre> (all figures in KEUR unless otherwise noted) Q1 2014 Q1 2013 Revenues 4 1,217 Research and development expenses -1,602 -898 General administrative and selling expenses -879 -943 Net result for the period -2,207 -653 Earnings per share in EUR for the period (basic) -0.08 -0.03 Earnings per share in EUR for the period (diluted) -0.08 -0.03 Cash flows from operating activities -3,310 -977 Cash flows from investing activities 3 0 Cash flows from financing activities 10,664 -146 Change in cash and cash equivalents (incl. exchange rate differences) 7,352 -1,255 Average number of group employees 13 14 31 Mar. 31 Dec. 2014 2013 Intangible assets 3,455 3,494 Cash and cash equivalents 20,644 13,292 Equity 21,921 13,329 Non-current liabilities 25 28 Current liabilities 3,653 4,659 Balance sheet total 25,599 18,016 The full quarterly financial report will be available as from 07 May 2014 on our corporate website at http://www.paion.com/en/berichte-2014. 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) today at 2 p.m. CEST (1 p.m. BST, 8 a.m. EDT) to present the financial results of Q1 2014, highlight the most important events in the coming months and provide a pipeline and strategy update with a financial outlook. To access the call, participants from: Germany: may dial +49 69 20 17 44 210, from the U.K.: +44 207 153 9154 and from the U.S +1 877 423 0830 (other countries: please choose from D/UK/US numbers). When prompted, please enter the PIN 327669#. 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: http://www.anywhereconference.com?UserAudioMo...rence=1373 51751&PIN=327669. To connect, please just click on the link or enter 137351751 in the field "Weblogin" and 327669 in the field "PIN Code" on http://www.anywhereconference.com. The dial-in details for the conference call and the webcast link will also be 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 webpage after the call. 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 in 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. End of Corporate News --------------------------------------------------------------------- 07.05.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group 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 --------------------------------------------------------------------- 266796 07.05.2014