By 5 July 2020, the FDA is due to announce its decision on remimazolam (ByFavo) for procedural sedation (PS). In Japan, Remimazolam (Anerem) was approved in January for general anaesthesia (GA). Paion guides to royalties of under €1m for 2020. In the EU, the possible approval for PS is due in H121. The GA European trial has closed early with 424 patients; this potentially gives launch from late 2021 with top-line data in H220. Paion is considering licensing or acquiring products to make a direct European salesforce economic. Until this happens, we base our valuation on a royalty deal. Due to a reappraisal of short- and longer-term costs, our indicative value is adjusted to €270m, formerly €317m. Paion is funded until H221 and has loan facilities to take cash until 2022 if needed.
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