Interim report
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INTERIM REPORT Q1 2021 A strong start for PEPAXTO in the US Concopeptides Significant events JANUARY - MARCH • PEPAXTOⓇ was granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory multiple myeloma on 26 February • The US commercial launch of PEPAXTO was successfully initiated in mid March • PEPAXTO was included in the in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network® ( NCCN ) in Oncology in March • The leadership in Europe was in the begin ning of March strengthened with two new significant recruitments to build up European commercial organization ● Oncopeptides strengthened the balance sheet through a directed share issue of SEK 1,106 M ( USD 130 M ) . The share issue was completed in April AFTER THE REPORTING PERIOD ● PEPAXTO April net sales amounted to SEK 28.0 M ( USD 3.3 M ) An application for conditional marketing authorization of melflufen in the EU was submitted in mid April Patient enrollment in the phase 2 PORT study was completed in May Positive topline results from the phase 3 OCEAN study were announced on May 25 Financial overview JANUARY - MARCH Net sales amounted to SEK 19.4 M ( 0.0 ) Operating loss amounted to SEK 347.3 M ( loss : 296.9 ) • Loss for the period was SEK 234.7 M ( loss : 297.3 ) • Loss per share , before and after dilution , was SEK 3.45 ( loss : 5.37 ) Cash and cash equivalents amounted to SEK 372.5 M ( 617.8 ) on March 31 2.3 Sales USD M 1.4 Proforma cash SEK B Financial overview of the group ( SEK thousand ) Net sales Gross profit Gross margin Operating loss Loss before tax Earnings per share before and after dilution ( SEK ) Cash flow from operating activities Cash and cash equivalents at the end of the period R & D costs / operating expenses , % 2021 Jan - Mar 19,355 19,027 98 % -347,852 -347 852 -3,45 -386,714 372,453 49 % 7 Ongoing clinical trials 2020 Jan - Mar N / A -296,876 -297,327 -5.37 -312,841 617,786 72 % 2020 Jan - Dec N / A -1,591,279 -1,592,442 -25.57 -1,296,509 840,255 54 %