The marketing authorization application for Xlucane™ in Europe initiates the process for the upcoming launch

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

Financial summary third quarter 2021

  • Revenue amounted to SEK 0.0m (0.0).
  • Other operating income amounted to SEK 3.5m (4.9).
  • EBITDA was SEK -39.5m (-54.2).
  • R&D expenses amounted to SEK -36.5m (-50.5) representing 79 percent (84) of total operating expenses.
  • The loss for the period was SEK -45.5m (-57.7).
  • Earnings per share was 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 amounted to SEK 11.1m (14.4).
  • EBITDA was SEK -140.1m (-151.5).
  • R&D expenses amounted to SEK -131.7m (-139.7) representing 83 percent (83) of total operating expenses.
  • The loss for the period was SEK -155.9m (-163.0).
  • Earnings per share was 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 period

  • 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 ™ 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 October, the Nomination Committee for the 2022 Annual General Meeting was established and announced.


Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on October 29, 2021, 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/xp3g5i77

Confirmation Code: 1692076

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 platform technology that provides significantly lower production costs compared to competing systems. Xbrane’s leading product Xlucane™, a Lucentis® biosimilar candidate, addresses the € 10.4bn ophthalmic VEGFa inhibitor market. Marketing authorization of Xlucane™ is expected for the second half of 2022. Xbrane has additionally two biosimilar candidates in its pipeline targeting € 7.9bn in originator sales. 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 2021-10-29 08:00 CEST.

Attachments

Xbrane Biopharma AB Q3 Report 2021 (English) FINAL 2021 10 28

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