DGAP-News: PAION AG
/ Key word(s): Preliminary Results/Capital Increase
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- Fully underwritten almost EUR 8 million capital increase with subscription rights
- Group financial figures 2020 in line with forecast, increase in revenues and positive net result for the year 2020
- Successful launches in Japan, China and the U.S.
PAION will receive gross proceeds of almost EUR 8 million from the capital increase with subscription rights. Moreover, PAION will draw down the third tranche of the financing agreement with the European Investment Bank (EIB) in the amount of EUR 7.5 million.
PAION will use the net proceeds from the capital increase to prepare commercial launches for its product portfolio in selected European countries and for general corporate purposes.
Commercial partner activities
In China, licensee Yichang Humanwell also successfully launched remimazolam in the third quarter of 2020. By the end of 2020, Yichang Humanwell reported having launched Ruima(R) (remimazolam) to hospitals in 31 Chinese provinces.
Remimazolam sales in Japan and China combined have reached EUR 2.6 million in 2020. This generally translates to EUR 0.3 million royalties based on the agreed royalty rates, of which EUR 0.1 million could be recorded as revenues in fiscal year 2020. After the balance sheet date, PAION and Mundipharma have agreed on an amendment of the royalty calculation. A corresponding contract amendment is currently being put in place based on which the remaining EUR 0.2 million royalties will be recognized as revenues in fiscal year 2021.
In the U.S., licensee Acacia Pharma launched BYFAVO(TM) (remimazolam) in January 2021 and has recently reported that the launch is proceeding extremely well.
Preliminary 2020 Financial Results:
According to preliminary figures, revenues increased to EUR 19.7 million in fiscal year 2020, compared to EUR 8 million in the previous year, and resulted primarily from milestone payments in connection with the market approvals of remimazolam in the U.S., Japan and China, as well as the license extension for remimazolam signed with Hana Pharm in January 2020 to include six additional countries in Southeast Asia.
Research and development expenses amounted to EUR 10.3 million (prior-year period: EUR 13.1 million) and mainly relate to the EU Phase III study in general anesthesia.
Primarily in the context of establishing a supply chain and preparing for the commercialization of remimazolam, general administrative and selling expenses increased by EUR 2.5 million year-on-year to EUR 7.5 million in the reporting period.
Net income in fiscal year 2020 amounted to EUR 2.2 million compared to a net loss of EUR 7 million in the previous year.
The preliminary consolidated annual figures are thus in line with the forecast. PAION AG plans to publish the annual financial report for fiscal year 2020 on 30 March 2021 after 5 pm CEST.
"The year 2020 marked a turning point for PAION, with outstanding milestones such as the first approvals of remimazolam in the major pharmaceutical markets U.S., Japan and China, and followed by successful launches by our partners," commented Dr. Jim Phillips, CEO of PAION AG. "Our recent in-licensing of the critical care products GIAPREZA(R) and XERAVA(R) confirmed our decision to build our own infrastructure for the commercialization of our product portfolio in selected European countries. With the soon anticipated European approval of remimazolam in procedural sedation, we look forward to commercialize a third product in Europe. The launches of these three products in other major pharma markets have been proceeding well, and we therefore expect similar strong interest from hospitals in Europe to utilize these novel products addressing important unmet medical needs."
In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. In January 2021, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Byfavo(R) in procedural sedation. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(R), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and XERAVA(R) for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
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.
This release does not constitute an offer of securities for sale or a solicitation of an offer to purchase securities of PAION AG in the United States or any other jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. The securities of PAION AG may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"). The securities of PAION AG have not been, and will not be, registered under the Securities Act.
19.03.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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