Interim report
Page 1
BIOPHARMA Science for high quality biosimilars The marketing authorization application for Xlucane ™ in Europe initiates the process for the upcoming launch Financial summary third quarter 2021 • Revenue amounted to SEK 0.0m ( 0,0 ) . • Other operating income was SEK 3.5m ( 4.9 ) . • EBITDA was SEK -39.5m ( -54.2 ) . Interim report January - September 2021 • R & D costs amounted to SEK -36.5m ( -50.5 ) , representing 79 percent ( 84 ) of total operating costs . • The loss for the period was SEK -45.5m ( -57.7 ) . • Earnings per share amounted to SEK -1.83 ( -2.99 ) . • Cash and cash equivalents at the end of the period amounted to SEK 383.4m ( 123.8 ) . Financial summary first nine months 2021 • Revenue amounted to SEK 0.0m ( 0.0 ) . • Other operating income was SEK 11.1m ( 14.4 ) . • EBITDA was SEK -140.1m ( -151.5 ) . • R & D costs amounted to SEK - 131.7m ( -139.7 ) , representing 83 % ( 83 ) of total operating costs . • The loss for the period was SEK -155.9m ( -163.0 ) . Earnings per share amounted to SEK -6.75 ( -9.49 ) . • Cash and cash equivalents at the end of the period amounted to SEK 383.4m ( 123.8 ) . Numbers in parentheses refer to the corresponding period last year . Significant events during the third quarter 2021 • In September , the company's partner STADA submitted a marketing authorization application for Xlucane ™ to the European Medicines Agency ( EMA ) , which was later validated by the agency . • In July , a directed new issue of SEK 380m before estimated transaction costs was registered , which Xbrane announced and implemented at the end of June . After the issue , the total number of shares and votes in the company amounts to 25,039,906 . The company's registered share capital amounts to around SEK 5,613,598 . • Xbrane Biopharma was officially certified as a Great Place to Work® by the Great Place to Work® institute . Significant events after the end of the quarter • In October , the company signed a cooperation agreement with AGC Biologics , with effective date September 30 , 2021 , for upscaling the established manufacturing process of Xcimzane ™ M and manu facture the majority of commercial scale batches for the upcoming Phase 1 and Phase 3 studies , and also comparative quality studies ( CAA ) to demonstrate biosimilarity , required for the marketing authorization application . • In October , Xbrane was granted six new patents by the Patent and Registration Office ( PRV ) . • In October , the Nomination Committee for the 2022 Annual General Meeting was established and announced . More detailed information on the above events can be found on pages 8-9 .