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idorsia Media Release October 26 , 2021 Ad hoc announcement pursuant to Art . 53 LR Idorsia announces financial results for the third quarter 2021 - company progressing and launch preparations in key markets well underway Allschwil , Switzerland - October 26 , 2021 Idorsia Ltd ( SIX : IDIA ) today announced its financial results for the third quarter of 2021 . Business highlights Five Idorsia affiliates in key European markets ( France , Germany , Italy , Spain , UK ) established Daridorexant for the treatment of insomnia under review with US FDA ( Food and Drug Administration ) , EMA ( European Medicines Agency ) , Swissmedic , and Health Canada Clazosentan NDA for the treatment of cerebral vasospasm post aneurysmal subarachnoid hemorrhage ( aSAH ) under review with the Japanese Pharmaceuticals and Medical Devices Agency ( PMDA ) " SOS - AMI " Phase 3 registration study with selatogrel in suspected acute myocardial infarction ( AMI ) is recruiting Results for CARE Phase 2b study with cenerimod for systemic lupus erythematosus expected in Q4 2021 Decision on the lucerastat for Fabry disease program awaiting interim analysis of the open label extension study - expected by year - end Issuance of CHF 600 million senior unsecured convertible bonds to fund the development of the company into a leading biopharmaceutical company Financial highlights US GAAP operating expenses Q3 2021 at CHF 150 million Non - GAAP operating expenses Q3 2021 at CHF 139 million Guidance for 2021 : US GAAP operating expenses below CHF 665 million and non - GAAP operating expenses below 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 : " We are steadily advancing toward becoming a leading biopharmaceutical company . For this , we have set ourselves ambitious goals , one of which is to deliver at least three products to the market . Launch preparations for daridorexant , our most valuable asset to date , and clazosentan in Japan , are well under way . We have made a big step towards having a world class commercial organization by setting up affiliates in key markets at a fast pace . In terms of our potential new therapies , we are developing our diversified and balanced clinical portfolio with a scientific , data - driven approach . In summary , we are ready for our important product launches , we are making considerable strides across the entire company , and I am excited about our future . "