EQS-News

PAION AG publishes GROUP QUARTERLY STATEMENT for the first quarter of 2023 - Seite 2

Feedback on the use of the products continues to indicate good market acceptance. At the beginning of 2023, PAION again received positive feedback from customers about their experience with remimazolam in particular.

Based on the positive results of the European Phase III study in general anesthesia, PAION submitted an extension application of the marketing authorization for remimazolam for the indication general anesthesia to the EMA in December 2021. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on January 27, 2023, recommending approval of remimazolam for the induction and maintenance of general anesthesia in adults. This was finally followed by approval by the European Commission on April 03, 2023.

In addition, the UK Medicines & Healthcare products Regulatory Agency (MHRA) will also review a possible approval in the UK.

Licensees generated product sales of EUR 2.4 million in the first three months of 2023 (Q1 2022: EUR 0.9 million); this results in royalties for PAION of EUR 0.3 million (Q1 2022: EUR 0.1 million).

In the U.S., Pharmaceuticals had announced in early May 2023 that the Centers for Medicare & Medicaid Services ("CMS") has implemented a product-specific billing code for remimazolam. The introduction of this unique so-called "J-code" (reimbursement code) for remimazolam in the U.S. is an important step to facilitate reimbursement and expand patient access to remimazolam.

Furthermore, Taiwanese licensee TTY Biopharm has submitted the marketing authorization application for remimazolam in general anesthesia in March 2023.

 

Key financial figures

In the first quarter of 2023, revenues of EUR 2.3 million were realised. Of this amount, EUR 1.0 million is attributable to milestone payments and EUR 1.3 million to revenue from operating activities. In the same period of the previous year, revenues amounted to EUR 21.5 million, of which EUR 20.7 million resulted from patent sales and milestone payments and EUR 0.8 million from operating activities.