DGAP-News: PAION AG / Key word(s): Quarterly / Interim Statement
08.05.2019 / 07:30
The issuer is solely responsible for the content of this announcement.
PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2019
– Filing for market approval with remimazolam in the U.S. in April 2019
– Successful pre-submission meeting with EMA for the indication procedural sedation in the EU
– Cash and cash equivalents of EUR 15.6 million as of 31 March 2019
– Conference call (in English) today at 2:00 p.m. CEST (1:00 p.m. BST/9:00 a.m. EDT)
Aachen (Germany), 08 May 2019 – 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 2019.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: “In the first quarter we worked full steam on filing for market approval for remimazolam in the U.S. together with our partner Cosmo. The NDA filing by Cosmo in early April was an important milestone for both parties. We also discussed the procedural sedation indication in the EU with the EMA at a pre-submission meeting and received positive feedback. We are now evaluating whether filing for market approval in procedural sedation based on the U.S. development program may be possible later this year. In addition, we will continue to work intensively on conducting the ongoing Phase III study in the EU in general anesthesia over the next few months, as well as on supporting our partners in further regulatory activities.
Update on remimazolam development activities and outlook
With a regular course of the approval process, the U.S. market approval and subsequent launch of remimazolam can be expected in 2020.
At a pre-submission meeting with the EMA held in February 2019, the U.S. Phase III clinical development program, including key safety data and efficacy results, was discussed in relation to a potential regulatory filing in the EU. Based on the EMA feedback, PAION assumes that the existing data package is sufficient to be able to submit the Marketing Authorization Application (MAA) for remimazolam in procedural sedation in the EU. PAION is currently evaluating if filing for market approval for remimazolam in procedural sedation based on the completed U.S. development program could be possible still within this year.
Licensee activities in other territories
Chinese remimazolam licensee Yichang Humanwell submitted a market approval dossier to the Chinese National Medical Products Administration (NMPA) for remimazolam in the indication procedural sedation in November 2018. A potential market approval could happen end of 2019 at the earliest.
Japanese remimazolam licensee Mundipharma submitted a market approval dossier to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for remimazolam in the indication general anesthesia in December 2018. Market approval could be granted end of 2019 at the earliest.
In November 2018, Russian remimazolam licensee R-Pharm announced the successful completion of a Phase III trial in general anesthesia. R-Pharm currently plans to file for market approval in Russia by the end of 2019.
For Canada, PAION expects its remimazolam licensee Pharmascience to use the U.S. market approval dossier as the basis for their own filing for market approval.
PAION’s remimazolam licensee TR-Pharm (Turkey, the Middle East and North Africa) plans to file for market approval in Turkey based on the U.S. or Japanese dossier.
PAION’s remimazolam licensee Hana Pharm successfully completed patient recruitment of a Phase III trial in general anesthesia in October 2018. Before filing for market approval, the production process for remimazolam needs to be established in South Korea. Accordingly, Hana Pharm plans to file for market approval in 2020.
Results of operations, financial position and net assets
In the first quarter of 2019, no revenues were realized. In the prior-year period, revenues amounted to KEUR 257 and mainly related to the remimazolam license agreement for Japan with Mundipharma.
Research and development expenses amounted to KEUR 3,063 in the first quarter of 2019 (prior-year period: KEUR 3,360) and mainly relate to the ongoing EU Phase III study in general anesthesia.
General administrative and selling expenses increased by KEUR 190 to KEUR 985 in the first quarter of 2019 compared to the prior-year period. General administrative expenses increased by KEUR 43 to KEUR 789 and selling expenses increased by KEUR 147 to KEUR 196.
Tax income amounted to KEUR 667 in the first quarter of 2019 (prior-year period: KEUR 749) and relates 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 2019 amounted to KEUR 3,241 and increased by KEUR 116 compared to the prior-year period (net loss in the prior-year period: KEUR 3,125).
Cash and cash equivalents decreased by KEUR 1,615 in the first quarter of 2019. As of 31 March 2019, PAION’s cash and cash equivalents amounted to KEUR 15,612.
The decrease of cash and cash equivalents nearly entirely stems from cash flows from operating activities of KEUR -1,611. 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, receipt of the milestone payments from Mundipharma and Hana Pharm recognized as trade receivables at the beginning of the fiscal year as well as (further) changes of the working capital.
Risks and opportunities
PAION also plans small-scale pre-marketing activities for the preparation of an own commercialization subject to possible dates for filing its own market approval dossiers for remimazolam in Europe.
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=m4a804d5392d35e81f89dd501dcc8ad24
In Europe, PAION is currently focused on the development of remimazolam for general anesthesia, but is also evaluating the possibility of submitting a Marketing Authorization Application in procedural sedation based on the U.S. filing.
Development of remimazolam for intensive care unit (ICU) sedation is part of the longer-term life-cycle plan for remimazolam.
PAION’s vision is to become an acknowledged “PAIONeer” in sedation and anesthesia. PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
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