- WKN: A0B65S
- ISIN: DE000A0B65S3
- Land: Deutschland
Nachricht vom 13.03.2013 | 07:30
PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2012
PAION AG / Key word(s): Final Results
PAION AG REPORTS FINANCIAL RESULTS FOR THE FULL YEAR 2012
- 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.
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.'
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.
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: clinicaltrials.jp). Furthermore, Ono started a Phase II trial in ICU sedation in November 2012. The results of this study are expected by end 2013 (Source: clinicaltrials.jp).
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 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.
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.
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.
Business and Financial Outlook 2013
Development and Commercialisation Activities
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.
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
The full annual financial report will be available as from 13 March 2013 on our corporate website at http://www.paion.com/en/berichte-2013.
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: https://www.anywhereconference.com/. 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 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.
End of Corporate News
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