Interim report
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ARAS IRRAS AB INTERIM REPORT Commercial Growth Continues Second quarter , April - June 2021 • Net revenue amounted to SEK 5.1 million ( 1.2 ) . • Operating loss ( EBIT ) amounted to SEK -26.7 million ( -31.2 ) . • Loss after tax amounted to SEK -27.1 million ( -32.5 ) . • EPS before and after dilution amounted to SEK -0.40 ( -0.55 ) . Important events during the quarter JANUARY - JUNE 2021 Strengthened Balance Sheet A directed share issue in June generated proceeds of SEK 66 million before fees . The company received forgiveness for the 832,055 USD ( 6.9M SEK ) loan received as part of the US COVID - 19 Paycheck Protection Program ( PPP ) . ■ Key Quality System Certifications Received IRRAS transitioned its notified body partnership for global regulatory and quality system oversight to global leader , DEKRA . IRRAS received quality system certification under the EU Medical Device Regulation ( MDR ) 2017/745 and the Medical Device Single Audit Program ( MDSAP ) , which allows the company to seek regulatory approval in key markets , such as Australia and Brazil . Publication of case report Buffalo General Medical Center published a case report that documented clinical superiority of the IRRAflow system versus traditional passive drainage systems . 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 , % Period January - June 2021 • Net revenue amounted to SEK 9.1 million ( 2.8 ) . • Operating loss ( EBIT ) amounted to SEK -66.0 million ( -66.5 ) . • Loss after tax amounted to SEK -66.0 million ( -66.9 ) . EPS before and after dilution amounted to SEK -0.99 ( -1.52 ) . ● Management Transition Announced IRRAS announced that Kleanthis G. Xanthopoulos , Ph.D. would step down as CEO and remain on company's Board of Directors . CFO Sabina Berlin departed IRRAS , and Griffen Stapp , the company's Controller , assumed the role of Interim CFO . Important events after the quarter ■ New CEO Appointed Will Martin , the company's President and Chief Commercial Officer , assumed the role of President and CEO . Loan Agreement with European Investment Bank ( EIB ) Announced IRRAS signed a 10M EUR loan agreement that provides non dilutive financing for IRRAS to accelerate product development and clinical data generation in the EU . Quality System Certifications Expanded After an on - site audit , IRRAS ' new in - house manufacturing facility was added to its ISO 13485 : 2016 certification , and the MDSAP certificate was extended for 3 years . Apr - Jun 2021 5.1 Neg -26.7 Neg -27.1 -22.2 Neg Neg Apr - Jun 2020 1.2 Neg -31.2 Neg -32.5 -27.2 Neg Neg Jan - Jun 2021 9.1 Neg -66.0 Neg -66.0 -57.1 Neg Neg Jan - Jun 2020 2.8 Neg -66.5 Neg -66.9 -58.6 Neg Neg Jan - Dec 2020 7.4 Neg -134.3 Neg -135.9 -118.0 Neg Neg IRRAS AB INTERIM REPORT JANUARY - JUNE 2021 1