• WKN: A0B65S
  • ISIN: DE000A0B65S3
  • Land: Deutschland

Nachricht vom 13.03.2013 | 07:30


PAION AG / Key word(s): Final Results

13.03.2013 / 07:30


- Record turnover of EUR 26.8 million (2011: EUR 3.2 million)

- Net profit of EUR 16 million (2011: EUR -13.7 million)

- Focus in 2013 on Phase II trial for Remimazolam in General Anaesthesia to begin in the 2nd half of 2013

- Financing of PAION secured until end of Q1 2015 including all costs for the Remimazolam Phase II European trial in General Anaesthesia

Aachen (Germany), 13 March 2013 - 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 2012.

Total revenues in 2012 increased by EUR 23.6 million to EUR 26.8 million compared to the previous year. The revenues relate in the amount of EUR 20.1 million to the sale of Desmoteplase to Lundbeck in February 2012. The income for 2012 amounted to EUR 16 million, an increase of EUR 29.7 million compared to the prior-year period.

Dr Wolfgang Söhngen, CEO of PAION commented, 'It was the right decision to let Desmoteplase go at the beginning of 2012. This gave us the necessary degree of freedom to sign a deal on Remimazolam with Yichang Humanwell in China the third largest pharma market in the world and to focus on evaluating the best possible route to market for Remimazolam in the US or EU. The impressive progress of the Remimazolam development program of our partner Ono in Japan and our intensive efforts to set up a small sales team for Remifentanil in anaesthesia have delivered significant input to this process. Despite having to postpone the launch of Remifentanil due to massive price erosion our intensive dialogue with anaesthetists has delivered invaluable and important hints for our development concept to make Remimazolam Phase III ready in anaesthesia. Based on the recent regulatory feedback we assume we will only need one additional Phase III trial for an EU filing. We are now in a comfortable position to wait until completion of the Ono Phase II/III study in 2014 in parallel to our own development and to use the resulting value for the continued funding of Remimazolam's development in Europe.'

Development Activities

In 2012 important strategic decisions were made ​​in order to position the company sustainably as a commercial provider of specialized products in anaesthesia. The key element of a viable strategy for this market is PAION's lead compound Remimazolam. PAION remains committed to its vision 'PAIONeer in Anaesthesia' and maintains its plan to launch suitable companion products to prepare for market entry of Remimazolam in Europe.

During 2012, PAION focussed on the development and partnering of Remimazolam. In March 2012 PAION signed an exclusive option agreement with Yichang for Remimazolam in China. The completion of this licensing agreement was announced in July 2012.

For the Japanese market Remimazolam is currently being developed in anaesthesia by Ono Pharmaceutical. In May 2012, Remimazolam successfully completed a Phase II trial in General Anaesthesia in Japan. A Phase II/III trial of Remimazolam in General Anesthesia was started by Ono in November 2012. The results of the study are expected in 2014 (source: Furthermore, Ono started a Phase II trial in ICU sedation in November 2012. The results of this study are expected by end 2013 (Source:

In February 2013, PAION held a formal scientific advice meeting with the German regulatory authority on the European clinical development program for Remimazolam in General Anaesthesia. Currently, PAION is in advanced preparation to conduct a European Phase II trial with Remimazolam, in General Anaesthesia in cardiovascular surgery. The start of this study is expected in the 2nd half of 2013.

Pending the outcome of the planned and ongoing trials, PAION assumes that one Phase II and one Phase III trial in General Anaesthesia in addition to the Japanese Phase II/III trial will be sufficient for EU approval. In preparation for the European Phase III trial, further scientific advice meetings are planned with European regulatory authorities. PAION expects to start this trial in 2014.

In October 2012 PAION completed a Phase Ib study for the treatment of haemophilia with Solulin. The available data showed that Solulin has the expected effect in haemophilia patients. Due to the focus of the available resources on anaesthesia PAION is currently in discussions regarding a transfer of project data to interested third parties.

In June 2012 it was announced, that PAION Deutschland GmbH received a grant worth EUR 0.7 million from the federal ministry of education and research (BMBF) for research in the area of thrombomodulin - mutants (PN13). The project will last until 2014.

The project is in a very early stage of development. The resulting Solulin mutants could not be tested using the standard methods. Therefore, further research will require a higher financial expenditure than expected, which is not covered by the current funding. Therefore, PAION is currently looking for a project partner who continues the research or closes the financing gap.

In August 2012, PAION acquired the distribution rights for the generic opioid Remifentanil. Due to a significant unexpected price erosion in the German Remifentanil market over the last six months, PAION has decided to put on hold the launch of generic Remifentanil into the German market. Together with its manufacturer PAION will further evaluate the prevailing market conditions before taking a final decision on Remifentanil.

Beginning of March 2013, Acorda announced positive results of the Phase I trial with GGF2. The study identifies a maximum tolerated dose of GGF2 and the preliminary efficacy measures shows that GGF2 improves heart function.

Acorda has discussed the findings from the study with the FDA and has reached agreement on the next clinical study of GGF2 in heart failure. This study will primarily investigate further the safety profile of GGF2 across a range of doses, and will continue to explore efficacy outcomes.

The FDA has granted Fast Track designation for GGF2 for the treatment of heart failure.


Revenues of the fiscal year amounted to EUR 26.8 million and increased compared to the previous year by EUR 23.6 million. The revenues were mainly generated by the sale of Desmoteplase to Lundbeck for EUR 20.1 million. Furthermore, the revenues relate in the amount of EUR 2.5 million to the complete release of deferred income, resulting from a milestone payment received in 2008 from Lundbeck, in the amount of EUR 2.4 (USD 3 million) to a milestone payment from Ono for the start of the Phase III study with Remimazolam in Japan and in the amount of EUR 1.8 to the licence agreement with Yichang.

Net Income
The net income for the year amounted to EUR 16 million and increased by EUR 29.7 million compared to the previous year.

Development costs
Research and development expenses amounted to EUR 3.3 million and decreased by EUR 8.6 million compared to the previous year (EUR 11.8 million). The research and development expenses in the previous year included a EUR 6.1 million impairment charge on M6G. Without this effect the research and development expenses decreased by EUR 2.5 million compared to the previous year. The decrease is due to reduced development activities. The main research and development focus in 2012 was on Remimazolam and Solulin.

General administrative and selling expenses amounted to EUR 4.7 million and decreased by EUR 0.1 million compared to the previous year. Administrative expenses include restructuring costs and decreased by EUR 0.8 million to EUR 2.6 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 the preparation of the launch of Remifentanil. Selling expenses amounted to EUR 2.1 million, an increase of EUR 0.7 million compared to the prior-year period.

Income Taxes
The income taxes relate in the amount of EUR 2.3 million to tax expenses in connection with the net income for 2012 and in the amount of EUR 0.1 million to tax income from tax claims for reimbursement of parts of the research and development costs from the British tax authorities.

Cash and cash equivalents on 31 December 2012 have increased compared to 31 December 2011 (EUR 7.5 million) by EUR 14.8 million to EUR 22.3 million. Through the payment of EUR 1.5 million received at the beginning of March 2013 from Lundbeck in connection with the sale of the Desmoteplase rights and EUR 1.2 million now due to successful completion of the Remimazolam technology transfer from Yichang Humanwell, PAION has now a cash reach until the end of Q1 2015. This includes the funds needed to perform the European Phase II trial with Remimazolam in anaesthesia.
Further cash inflows from existing and future partners would strengthen the cash position.

Business and Financial Outlook 2013

Development and Commercialisation Activities
PAION's major goals for 2013 are the start of a Phase II study with Remimazolam in anaesthesia, production development for Remimazolam and out-licensing of Remimazolam outside Japan and China. Furthermore, PAION expects the continuation of development activities by our partners Ono (Remimazolam), Yichang (Remimazolam) and Acorda (GGF2).

PAION wants to develop itself into a specialty pharmaceutical company with a focus on anaesthesia products. In this context, PAION seeks to retain certain European marketing rights for Remimazolam, to market Remimazolam in Europe itself or together with a partner. In case of a successful out-licensing by way of a development cooperation, PAION would expect to receive substantial payment, being either an upfront payment or sharing of development costs, development milestone payments, a partial or complete assumption of future development costs until market approval and royalties from market approval onwards. In case of a pure marketing cooperation after registration, PAION would expect in comparison a higher upfront payment and higher royalties.

PAION benefits from the progress of Ono's development of Remimazolam in Japan in the form of additional development data and benefits financially in the form of milestone payments and royalties from launch onwards. This also applies to Yichang.

In March 2013 Acorda announced results of the clinical Phase I study with GGF2. Milestone payments of up to USD 7.5 million before and including approval, and thereafter revenue-dependent licence fees are payable to PAION if the further development is successful.

Financial Forecast
In 2013 revenues of EUR 1.2 million are expected. These relate to the technology transfer with Yichang that was completed in March 2013. Furthermore, it is aimed to receive an upfront payment or sharing of development costs for the out-licensing of Remimazolam.

The restructuring executed in the previous year sustainably reduced the cost structure. Because of the investment into the development of Remimazolam the external research and development expenses will be higher than the previous year. Costs for selling and general administration will be lower than the previous year. The budgeted expenses will lead to a significant loss in the mid to high single-digit million range in 2013. As of 31 December 2012 PAION's cash and cash equivalents amounted to EUR 22.3 million. The cash at hand and the payment received from Lundbeck in March 2013 and the payment due from Yichang for completion of the technology transfer secure a cash reach until the end of Q1 2015 including the repayment of the subordinated loan due in April 2013.


Key Consolidated Financial Figures, IFRS

(all figures in KEUR unless otherwise noted) 2012 2011
Revenues 26,812 3,249
Research and development expenses -3,251 -11,825
General administrative and selling expenses -4,709 -4,815
Net result for the period 16,009 -13,684
Earnings per share in EUR for the period (basic) 0.63 -0.54
Earnings per share in EUR for the period (diluted) 0.63 -0.54
  2012 2011
Cash flows from operating activities 15,475 -7,358
Cash flows from investing activities -33 -42
Cash flows from financing activities -590 30
Average number of group employees 14 26
  31 Dec. 2012 31 Dec. 2011
Intangible assets 3,848 4,013
Cash and cash equivalents 22,336 7,516
Equity 15,572 -464
Non-current liabilities 1,016 9,955
Current liabilities 11,748 3,115
Balance sheet total 28,336 12,606


The full annual financial report will be available as from 13 March 2013 on our corporate website at

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, 13 March 2013 at 2 p.m. CET (1 p.m. GMT, 9 a.m. EDT) to present the financial results of 2012, highlight the most important events and provide a pipeline and strategy update and financial outlook.

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 342639#. 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: To connect, please enter 137345979 in the field 'Weblogin' and 342639 in the field 'PIN Code'.

The dial-in details for the conference call and the webcast link will also available on our website 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.

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 of 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.

Ralf Penner
Director Investor Relations / Public Relations
Martinstrasse 10-12, 52062 Aachen - Germany
Phone +49 241 4453-152

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

13.03.2013 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

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