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Regulatory press release

Xbrane Biopharma releases Year-end report 2021

Xbrane Biopharma
Download the release

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

Standard international: +44 (0) 2071 928 338
UK (Local): +44 (0) 844 481 97 52
UK (Tollfree): +44 (0) 800 279 66 19
Sweden (Local): +46 (0) 856 618 467
Sweden (TollFree): +46 (0) 20 012 51 60
US (Local): +1 646 741 31 67
US (TollFree): +1 877 870 91 35

Contacts


Martin Åmark, CEO
M: +46 76 309 37 77
E: martin.amark@xbrane.com

Anette Lindqvist, CFO/IR
M: +46 76 325 60 90
E: anette.lindqvist@xbrane.com

About Us


Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting SEK 332 billion in annual sales of the respective reference products, with the leading one under registration in Europe. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com  

This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2022-02-24 08:00 CET.

Attachments


Xbrane Biopharma Year End 2021

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