Page 1

idorsia Media Release July 27 , 2021 Ad hoc announcement pursuant to Art . 53 LR Idorsia announces financial results for the first half 2021 - Building momentum towards becoming a fully - fledged biopharmaceutical company Allschwil , Switzerland - July 27 , 2021 Idorsia Ltd ( SIX : IDIA ) today announced its financial results for the first half of 2021 . Business highlights Daridorexant for the treatment of insomnia under review with US FDA , EMA , and Swissmedic Nine scientific presentations for daridorexant shared at SLEEP 2021 Ponesimod to treat relapsing forms of multiple sclerosis was approved by the US FDA and the European Commission , Idorsia receives first income from the revenue - sharing agreement in respect to ponesimod Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage ( aSAH ) submitted to the Japanese Pharmaceuticals and Medical Devices Agency ( PMDA ) in March 2021 " SOS - AMI " Phase 3 registration study with selatogrel in suspected acute myocardial infarction ( AMI ) initiated in June 2021 Phase 2 study with ACT - 539313 for binge eating disorder initiated in March 2021 Results for MODIFY Phase 3 study with lucerastat for Fabry disease expected in Q4 2021 Results for PRECISION Phase 3 study with aprocitentan for resistant hypertension expected mid - 2022 Results for CARE Phase 2b study with cenerimod for systemic lupus erythematosus expected in Q4 2021 Financial highlights US GAAP operating expenses HY 2021 at CHF 265 million Non - GAAP operating expenses HY 2021 at CHF 248 million Guidance for 2021 : US GAAP operating expenses around CHF 665 million and non - GAAP operating expenses around CHF 620 million ( both measures include inventory build of around CHF 35 million and exclude unforeseen events ) Jean - Paul Clozel , MD and Chief Executive Officer , commented : " The company is making great progress with delivering on the strategic priorities we defined on Day 1 of Idorsia . Now , just 4 years after establishing the company , we are on the verge of transformation into the fully - fledged biopharmaceutical company we intended to be . The regulatory review and the commercial preparation for daridorexant are progressing well and the team keeps its focus on this important asset . I'm also particularly proud of our newest advancement in the pipeline as selatogrel entered Phase 3 being evaluated as an emergency intervention for suspected AMI at the onset of symptoms . Yet another exciting innovation to watch for Idorsia . "