DGAP-News: PAION AG / Key word(s): Quarterly / Interim Statement
09.05.2018 / 07:30
The issuer is solely responsible for the content of this announcement.
PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2018
– Financial results in line with plan
– Cash position of EUR 22.1 million; cash reach into the second half of 2019
– Remimazolam market approval applications in preparation for the U.S. and Japan
– Phase III trial initiated in South Korea
– EU Phase III study planned to start in the second half of 2018
– Conference call (in English) today at 2:00 p.m. CEST (1:00 p.m. GMT/8:00 a.m. EDT)
Aachen (Germany), 09 May 2018 – 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 of 2018.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: “We expect the coming months to be busy as we and our partners steadily advance the development of remimazolam around the world. Importantly, the PAION team is working closely with partners Cosmo in the U.S. (procedural sedation) and Mundipharma in Japan (general anesthesia) to ensure they receive all the necessary data and documentation to complete the first market approval dossiers for remimazolam. In parallel, we will start the Phase III trial in general anesthesia still required for market approval in the EU for which preparations are going according to plan.”
Update on development activities
PAION is planning a study in general surgery close in design to the successfully completed Phase III program in general anesthesia in Japan, but in sicker patients, where the medical need to reduce hypotensive events is higher. The study is currently planned to start in the second half of 2018.
Partner activities in other territories
In August 2017, PAION’s remimazolam license partner for Russia, R-Pharm, announced the start of a Phase III study in general anesthesia in Russia. Completion of the study is expected still in the first half of 2018. Subsequently, R-Pharm plans filing for market approval which is currently planned end of 2018.
In December 2017, PAION entered into a license agreement with Mundipharma for Japan. Based on the positive pre-NDA meeting with the Japanese regulatory authority, PAION had started preparations for a market approval dossier for remimazolam. Mundipharma has now taken over this work with PAION’s support. Mundipharma currently plans to file for market approval in 2018.
PAION’s South Korean remimazolam license partner Hana Pharm has started a Phase III study with remimazolam in general anesthesia in South Korea in March 2018. Completion of the study is expected in 2018.
PAION’s Chinese remimazolam license partner Yichang Humanwell is going to conduct a Phase II study with remimazolam in general anesthesia and a Phase III study with remimazolam in procedural sedation in China.
Results of operations, financial position and net assets
Revenues in the first quarter of 2018 amounted to KEUR 257 compared to KEUR 2,051 in the prior-year period and relate primarily to the upfront payment received from Mundipharma in January 2018 under the remimazolam license agreement for Japan entered into in 2017. Revenues in the prior-year period mainly resulted from the license agreement with U.S. license partner Cosmo.
Research and development expenses amounted to KEUR 3,360 in the first quarter of 2018 and mainly related to preparatory activities for filing for market approval for remimazolam in procedural sedation in the U.S. The decrease of KEUR 719 compared to the prior-year period was mainly due to lower costs for Phase III studies as the recruitment and reporting activities of our external service providers are completed.
General administrative and selling expenses decreased by KEUR 208 to KEUR 795 in the first quarter of 2018.
Income taxes amounted to KEUR 749 in the first quarter of 2018 (prior-year period: KEUR 822) and relate to tax claims for reimbursement of a portion of research and development costs from the British tax authorities.
Net loss for the first quarter of 2018 amounted to KEUR 3,125 (prior-year period: KEUR 2,218). This means an increase of the net loss in the amount of KEUR 907 compared to the prior-year period. The change is mainly attributable to lower revenues on the one hand and lower research and development expenses than in the prior-year period on the other hand.
Cash and cash equivalents decreased by KEUR 2,755 in the first quarter 2018. As of 31 March 2018, PAION’s cash and cash equivalents amounted to KEUR 22,084.
The decrease of cash and cash equivalents nearly entirely stems from cash flows from operating activities of KEUR -2,752. These primarily result from the net loss adjusted for the current tax credit claim towards the British tax authorities which has not had a cash effect yet, as well as adjusted for the part of the upfront payment of EUR 1 million received from Mundipharma in January 2018 which has had a cash effect already but has not been recognized as revenues yet.
Risks and opportunities
Key consolidated financial figures, IFRS (unaudited)
Conference call and webcast
To access the call, participants should dial:
* 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, give the password “PAION”. The conference call will include a slide presentation which can be accessed during the call at: https://paion-events.webex.com/paion-events/j.php?MTID=m80f358cc31e1f6c0bff0a60b9456018f.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
PAION’s vision is to become an acknowledged “PAIONeer” in sedation and anesthesia.
09.05.2018 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
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