Interim report
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IARAS IRRAS AB ( PUBL ) INTERIM REPORT JANUARY - MARCH 2021 Meaningful Commercial Acceleration Seen Globally First quarter , January - March 2021 • Net revenue amounted to SEK 4.0 million ( 1.6 ) . • Operating loss ( EBIT ) amounted to SEK -39.3 million ( -35.2 ) . • Loss after tax amounted to SEK -39.3 million ( -34.3 ) . • Earnings per share before and after dilution amounted to SEK -0.59 ( -1.19 ) . Important events during the quarter During Q1 , the IRRAS manufacturing facility was successfully inspected by the US Food and Drug Administration ( FDA ) and the California Department of Public Health ( CDPH ) and received its manufacturing license . The IRRAflow control unit can now be manufactured in - house . In Q1 , two comprehensive stroke centers in the US , Buffalo General Medical Center and West Virginia University , analyzed the outcomes from their IRRAflow evaluations , placed disposable stocking orders , and began commercial use of the system . During the quarter , IRRAS began to transfer its international regulatory activities to a new notified body , DEKRA . DEKRA completed audits of IRRAS quality system under ISO , MDR , and MDSAP guidelines , and in the near future , will assume the existing CE Mark certificates for IRRAflow . IRRAS is in negotiations with the European Investment Bank ( EIB ) regarding a financial partnership that could provide non - dilutive financing that will allow IRRAS to borrow 7-9M € over the coming years based upon the achievement of agreed - upon performance criteria . The negotiations are in advanced stages ; however , final approval is still subject to EIB's internal review . Key figures Net revenue , SEK million Gross margin , % Operating loss ( EBIT ) , SEK million EBIT margin , % Loss after tax EBITDA , SEK million EBITDA margin , % Return on equity , % Important events after the end of the quarter In April , the Board of Directors appointed Will Martin as President and Chief Executive Officer ( CEO ) of the Company . Will Martin , currently the company's President and Chief Commercial Officer , will assume his new role on July 1 , 2021. He will succeed current CEO , Kleanthis G. Xanthopoulos , Ph.D. , who will remain on IRRAS ' Board of Directors . Jan - Mar 2021 4.0 Neg -39.3 Neg -38.8 -34.8 Neg Neg Jan - Mar 2020 1.6 Neg -35.2 Neg -34.3 -31.4 Neg Neg Jan - Dec 2020 7.4 Neg -134.3 Neg -135.9 -118.0 Neg Neg IRRAS AB INTERIM REPORT JANUARY - MARCH 2021 1