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2020-08-21

Xbrane Biopharma releases interim report for January – June 2020

Despite the prevailing Coronapandemic, Xbrane succeeded in establishing a partnership with Bausch + Lomb for Xlucane for the US and Canada during the quarter and raise SEK 146 M in a directed issue involving a number of new institutional investors.

Xbrane Biopharma AB’s (publ.) (”Xbrane”) interim report for January - June 2020 is now available on the Company’s website, www.xbrane.com.

Financial summary second quarter 2020

  • Revenue amounted to SEK 0 M (0).
  • The gross margin amounted to 0 percent (0).
  • Other operating income amounted to SEK 5.3 M (1.8).
  • EBITDA was SEK -51.6 M (-45.1*).
  • R&D expenses amounted to SEK 45.1 M (-40.8*) representing 77 percent (85*) of total operating expenses.
  • The loss for the period was SEK 53.4 M (-47.4*).
  • Earnings per share was SEK -3.11 (-5.63*).
  • Cash and cash equivalents at the end of the period amounted to SEK 232.5 M (171.4) which excludes the milestone payment from Bausch + Lomb received after the balance sheet date.

Financial summary of first six months 2020

  • Revenue amounted to SEK 0 M (0).
  • The gross margin was 0 percent (0).
  • Other operating income totaled SEK 10.2 M (3.0).
  • EBITDA was SEK -101.5 M (-79.0*).
  • R&D expenses amounted to SEK 92.6 M (-70.0*), representing 81 percent (83*) of total operating expenses.
  • The loss for the period was SEK 105.2 M (-83.3*).
  • Earnings per share was SEK -6.12 (-9.90*).

Significant events during the second quarter 2020

  • The ongoing Coronapandemic has entailed rapid changes to Xbrane’s business activities to comply with local government health guidelines. This has resulted in cancelled trips, a switch to digital meetings and the majority of employees not working in the lab have been working from home. The Xplore study has been kept open for recruitment but had a significantly reduced recruitment rate during March-May although this recovered in May. The work on Xplore follows the guidelines of local authorities as well as those of the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”). The safety of patients and clinical staff has been our highest priority. The uncertainty surrounding the development of the pandemic makes it difficult to predict the recruitment rate for the remainder of the study. We estimate that the last patient will be recruited by the end of the third quarter or the beginning of the fourth quarter 2020, depending on the impact of the Coronapandemic in the coming months. Given this timetable, we estimate that we will be able to apply as planned for and obtain market approval for Xlucane before Lucentis® loses its patent protection in the EU in July 2022.
  • In May, Xbrane and STADA formed a partnership with Bausch + Lomb for the commercialization of Xlucane in the US and Canada. Revenue for the first of potential several milestone payments is accrued over two years. The gross profits from future sales will be shared between Bausch + Lomb, Xbrane and STADA. Xbrane and STADA will share all income from Bausch + Lomb from the commercialization of Xlucane in the US and Canada equally.
  • The company carried out a targeted issue of SEK 146 M in May to new investors such as TIN Fonder, Swedbank Robur Ny Teknik and certain existing owners.
  • In May, the company signed an agreement to establish an expanded development lab in the Life Science cluster at Campus Solna. Occupancy is expected to take place in the first quarter of 2021.

Significant events after the period

  • The company announced that Susanna Helgesen will resign as CFO during the year.

Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on August 21, 2020, at 10.00 a.m. CET. See below link and call in details to the presentation below: https://edge.media-server.com/mmc/p/iacxcxxa

Standard international: +44 (0) 2071 928 338
UK (Local): +44 (0) 844 481 97 52
UK (Tollfree): 08 002 796 619
Sweden (Local): +46 (0) 850 692 180
Sweden (Toll Free): 020 012 51 60
US (Local): +1 646 741 31 67
US (Toll Free): +1 877 870 91 35

Confirmation Code: 4598698

*This period has been recalculated due to restatement, see Appendix 1 for the effects.

Contacts


Martin Åmark, CEO/ IR 
M: +46 (0) 763-093 777
E: martin.amark@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 €10.4b ophthalmic VEGFa inhibitor market. Xlucane is in phase III and marketing authorization is expected mid-2022. Xbrane has additionally four biosimilars in its pipeline targeting €8.7b 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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-08-21 08:00 CEST.

Attachments


Xbrane Q2 Report 2020

Författare Xbrane Biopharma

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