Interim report
Page 1
Q3 2021 INTERIM REPORT JANUARY 1ST - SEPTEMBER 30TH Partnership with STADA Arzneimittel to commercialize Nefecon in Europe Financial summary for the Group Key Figures July 1 - September 30 , 2021 » Net sales amounted to SEK 198.2 million for the three months ended September 30 , 2021. No net sales were recognized for the three months ended September 30 , 2020 . >> Operating profit ( loss ) amounted to SEK 7.9 million and SEK ( 104.9 million ) for the three months ended September 30 , 2021 and 2020 , respectively . >> Earnings ( loss ) per share before dilution amounted to SEK 0.21 and SEK ( 2.77 ) for the three months ended September 30 , 2021 and 2020 , respectively . » Cash amounted to SEK 1,163.8 million and SEK 1,396.9 million as of September 30 , 2021 and 2020 , respectively . January 1 - September 30 , 2021 >> Net sales amounted to SEK 198.2 million and SEK 0.5 million for the nine months ended September 30 , 2021 and 2020 , respectively . >> Operating loss amounted to SEK 302.3 million and SEK 243.8 million for the nine months ended September 30 , 2021 and 2020 , respectively . >> Loss per share before dilution amounted to SEK 5.45 and SEK 6.09 for the nine months ended September 30 , 2021 and 2020 , respectively . Investor Presentation November 18 , 14:30 CET Audio cast with teleconference , Q3 2021 Webcast : https://tv.streamfabriken.com/calliditas-therapeutics-q3-2021 Teleconference : SE : +46856642695 | UK : +443333009264 | US : +16467224903 calliditas THERAPEUTICS Significant events in Q3 2021 » In July 2021 , Calliditas signed a loan agreement of up to the EUR equivalent of $ 75 million with Kreos Capital . >> In July 2021 , Calliditas and STADA Arzneimittel AG entered into a license agreement to register and commercialize Nefecon in the European Economic Area ( EEA ) member states , Switzerland and the UK valued at a total of EUR 97.5 million ( $ 115m ) in initial upfront and potential milestone payments , plus royalties . >> In August 2021 , Calliditas received FDA fast track designation for setanaxib in PBC . >> In August 2021 , Calliditas completed an accelerated book building procedure and resolved on a directed share issue in the amount of 2.4 million shares , raising proceeds of SEK 324.0 million ( $ 37.0m ) before transaction costs . >> In September 2021 , Calliditas announced that the FDA extended the PDUFA goal date for its New Drug Application ( NDA ) seeking accelerated approval for Nefecon to December 15 , 2021 . >> In September 2021 , Calliditas announced that the European Medicine Agency's ( EMA ) Committee for Human Medicinal Products ( CHMP ) decided to continue the assessment of the marketing authorization application ( MAA ) for Nefecon under standard procedure assessment timelines .