PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2021
DGAP-News: PAION AG / Key word(s): Quarterly / Interim Statement
PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST QUARTER OF 2021
- Remimazolam launches in the U.S. and South Korea in the first quarter of 2021
- EU market approval received for remimazolam in procedural sedation in March 2021
- Good progress in commercialization of remimazolam in the U.S., Japan, China and South Korea through our partners
- Expansion of European product portfolio with GIAPREZA(R) and XERAVA(R); PAION further drives specialty pharma transformation
- Successful rights issue of EUR 7.8 million completed in April 2021
- Revenues of EUR 3.2 million
- Cash and cash equivalents of EUR 13.9 million as of 31 March 2021
Aachen (Germany), 12 May 2021 - The specialty pharmaceutical company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard) today reports its consolidated financial results according to International Financial Reporting Standards (IFRS) for the first quarter of 2021.
Dr. Jim Phillips, CEO of PAION AG, commented: "The first quarter of 2021 brought important progress in our transformation into a specialty pharma company. Our in-house developed remimazolam was approved in procedural sedation in the EU and successfully launched in other countries around the globe through partners. Another key to our future success has been the addition of GIAPREZA(R) and XERAVA(R) to our product portfolio in January, which allows the creation of a more efficient sales and marketing organization. We are now building our commercial organization and preparing launches for all three products in the second half of 2021, addressing important unmet medical needs."
Update and outlook on remimazolam
Procedural sedation: The European Commission approved Byfavo(R) in the EU (including European Economic Area (EEA) countries) in March 2021. The decision of the UK Medicines & Healthcare products Regulatory Agency (MHRA) on a potential approval in the UK is expected shortly.
General anesthesia: Based on the positive results in the Phase III trial in general anesthesia and the approval in procedural sedation, PAION plans to submit an extension of the market approval application (MAA) for remimazolam for general anesthesia until the end of 2021. The approval process for an extension application is generally faster than for an MAA.
Partner activities in the first quarter of 2021
In the U.S., the launch of remimazolam (trade name BYFAVOTM) by licensee Acacia Pharma (Acacia) was announced in January 2021. Initial feedback from the licensee on market response was very positive.
In South Korea, licensee Hana Pharm received market approval for ByfavoTM (remimazolam) in general anesthesia in January 2021 and launched in South Korea at the end of March 2021.
In March 2021, PAION and TTY Biopharm ("TTY") entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of remimazolam in Taiwan.
GIAPREZA(R) and XERAVA(R)
In April 2021, a rights issue was successfully completed with gross proceeds of EUR 7.8 million. The subscription rate was over 92%. Thereby, the share capital of PAION AG was increased to EUR 71,336,992.00 by using the Authorized Capital 2020 through the issuance of 5,095,499 new shares.
Results of operations, financial position and net assets
Revenues of EUR 3.2 million were recognized in the first quarter of 2021. Of this amount, EUR 2.6 million relate to milestone payments, and EUR 0.6 million relate to the sale of remimazolam API (active pharmaceutical ingredient) to licensees as well as royalties. Royalties from Japan for the first quarter of 2021 are not included in this amount since due to the amendment of the license agreement currently taking place, no corresponding calculation of royalties has been conducted yet by Mundipharma. The royalties from Japan for fiscal year 2020 in the amount of EUR 0.2 million, which are still to be recognized, are also not yet included in the revenues, as the contract amendment with Mundipharma was not yet signed as of the reporting date. In the prior-year period, revenues amounted to EUR 3.5 million and resulted entirely from milestone payments.
Cost of sales in the first quarter of 2021 amounted to EUR 0.5 million.
Research and development expenses in the first quarter of 2021 amounted to EUR 1.3 million (prior-year period: EUR 3.7 million) and decreased as planned, in particular against the background of the EU Phase III study in general anesthesia, which was successfully completed in the previous year.
Compared to the prior-year period, general administrative and selling expenses increased by EUR 2.0 million to EUR 3.8 million in the first quarter of 2021. General and administrative expenses increased by EUR 0.5 million to EUR 1.4 million and selling expenses increased by EUR 1.5 million to EUR 2.4 million. The increase in general and administrative expenses is mainly related to financing activities and the expansion of IT systems and infrastructure. Selling expenses increased as planned, particularly due to commercialization and supply chain activities for the three products Byfavo(R), GIAPREZA(R) and XERAVA(R) in Europe.
Earnings before interest and tax in the first quarter of 2021 amounted to EUR -2.6 million and decreased by EUR 0.5 million compared to the prior-year period (earnings before interest and tax in the prior-year period:
Cash and cash equivalents decreased by EUR 5.8 million in the first quarter of 2021. PAION had cash and cash equivalents of EUR 13.9 million as of 31 March 2021.
The decrease in cash and cash equivalents is mainly due to the cash flow from investing activities of EUR -18.6 million, which is mainly related to the in-licensing of the new products GIAPREZA(R) and XERAVA(R) in January 2021. This is partly offset by a positive cash flow from financing activities in the amount of EUR 12.5 million, mainly resulting from the draw-down of the first two tranches of the loan agreement with the EIB in the amount of EUR 12.5 million. The cash flow from operating activities amounted to EUR 0.3 million in the first quarter of 2021.
Equity decreased by EUR 3.7 million in the first quarter of 2021 to EUR 17.6 million as of 31 March 2021. The change is mainly due to the net loss for the period.
Risks and opportunities
Key consolidated financial figures, IFRS (unaudited)
In addition to Byfavo(R) (remimazolam), PAION is preparing to launch the two products GIAPREZA(R) (Angiotensin II) and XERAVA(R) (Eravacycline) in Europe. GIAPREZA(R) is 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. XERAVA(R) is a novel fluorocycline indicated 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).
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