Xbrane Biopharma releases Year-end report 2021









Agreement with Biogen confirms Xbrane as a leading global biosimilar developer

Xbrane Biopharma AB’s (publ.) (”Xbrane”) Year-end report 2021 is now available on the Company’s website, www.xbrane.com.

Financial summary fourth quarter 2021

  • Revenue amounted to SEK 0.0m (0.0).
  • Other operating income was SEK 4.5m (3.2).
  • EBITDA was SEK–28.2m (–61.6).
  • R&D costs amounted to SEK 28.9m (–57.5) representing 79% (87) of total operating costs.
  • The net result for the period was SEK –32.5m (–63.1).
  • Earnings per share amounted to SEK –1.32 SEK (–3.01).
  • Cash and cash equivalents at the end of the period amounted to SEK 295.2m (243.1).

Financial summary full year 2021

  • Revenue amounted to SEK 0.0m (0,0).
  • Other operating income was SEK 15.6m (17.6).
  • EBITDA was SEK –168.4m (–213.1).
  • R&D costs amounted to SEK 160.6 (–197.3) representing 82% (84) of total operating costs.
  • The loss for the period was SEK 188.4m (–226.0).
  • Earnings per share amounted to SEK –7.77 (–12.48).
  • Cash and cash equivalents at the end of the period amounted to SEK 295.2 m (243.1).
  • The Board of Directors proposes that no dividend to be paid for the financial year 2021.

Numbers in parentheses refer to the corresponding period previous year.

Significant events during the fourth quarter 2021

  • In October, the company signed a cooperation agreement with AGC Biologics to upscale the existing manufacturing process of Xcimzane™ and manufacture 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 December, the company announced that it had started development of two new biosimilar candidates for the reference products Keytruda® and Darzalex®, respectively. Together with the development of Xdivane™, a biosimilar candidate for Opdivo®, this forms a biosimilar portfolio in oncology that corresponds to SEK 278bn in sales of the reference products, in 2021.
  • In December, it was announced that the company's shares are transferred to Nasdaq Stockholm's Mid Cap segment from January 3, 2022.

Significant events after the period

  • In February, an agreement was signed with Biogen Inc. to be a development and commercialization partner for Xcimzane™, a biosimilar candidate for Cimzia®. According to the agreement, Xbrane will be responsible for the preclinical development, after which Biogen will take over and run and finance the remaining development, including clinical studies. Biogen will pay an up-front fee of USD 8m and another USD 80m in milestone payments as well as royalties on future sales.
  • In February, complete top-line data was also published from the Xplore clinical equivalence study for Xlucane™, a biosimilar candidate for Lucentis®. According to Xbranes assessment, Xlucane™ met the primary outcome measure and no clinically meaningful differences were observed regarding secondary efficacy and safety measures.
  • Furthermore, the company announced in February that its subsidiary Primm Pharma had a positive cash flow through royalties from the outlicensing of IP and production equipment to its production partner ICI. Attempts to divest the subsidiary continue although the ongoing due diligence negotiations with the prospective buyer New FaDem have been paused.

Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on February 24, 2022, at 10.00 a.m. CET.

See below link and call-in details to the presentation below.

Web link: https://edge.media-server.com/mmc/p/43thqez6

Confirmation Code: 688 50 49

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