Today Paion released its FY18 results, posting revenues at €2.8m, down from €5.8m in FY17. R&D expenses decreased by €5.7m to €12.2m and G&A expenses were down by €0.4m at €3.4m. Paion reported a net loss of €9.9m vs. €12.1m in the previous year.
According to the company, its FY18 sales resulted from remimazolam license agreements with Mundipharma (€2m), Hana Pharm (€0.5m) as well as Yichang Humanwell (€0.3m). Year-on-year decrease in R&D costs was associated with lower costs for Phase III and Phase I studies, as the company incurred the costs to a significant extent in FY17. Paion’s cash and cash equivalents amounted to €17.2m (FY17: €24.8m).
Paion expects to launch remimazolam in the U.S. market in 2020. In July 2018, the company started EU Phase III trial in general anesthesia and plans to complete patient recruitment by the end of 2019. Paion also anticipates further regulatory filings by the company’s licensees in other regions. In addition, the company hopes its growth in Europe will accelerate thanks to a promising pre-submission meeting with European Medicines Agency (EMA) for the indication procedural sedation.
Paion guides to FY19 sales at €8m, €7.5m of which will result from the planned regulatory filing for remimazolam in the U.S. by Cosmo. The company expects its R&D expenses will reach €13-15m due to the development of remimazolam. Income from tax credits is anticipated to reach c. €2m and G&A expenses will amount to €4-5m, depending on the volume of pre-commercial activities. Paion anticipates that FY19 net loss will be €7-10m.