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2021-08-13

Xbrane Biopharma releases interim report for January – June 2021

The positive interim read-out from the phase III study Xplore paves way for marketing authorization application submission of Xlucane™ in 2021

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

Financial summary second quarter 2021

  • Revenue amounted to SEK 2.5m (0.0).
  • Other operating income amounted to SEK 3.6m (5.3).
  • EBITDA was SEK -54.8m (-51.6).
  • R&D expenses amounted to SEK -51.7m (-45.1) representing 83 percent (77) of total operating expenses.
  • The loss for the period was SEK -59.2m (-53.4).
  • Earnings per share was SEK -2.67 (-3.11).
  • Cash and cash equivalents at the end of the period amounted to SEK 129.3m (232.5).

Financial summary first six months 2021

  • Revenue amounted to SEK 2.5m (0.0).
  • Other operating income amounted to SEK 7.7m (10.2).
  • EBITDA was SEK -103.8m (-101.5).
  • R&D expenses amounted to SEK -97.8m (-92.6) representing 83 percent (81) of total operating expenses.
  • The loss for the period was SEK -110.4m (-105.2).
  • Earnings per share was SEK -4.97 (-6.12).
  • Cash and cash equivalents at the end of the period amounted to SEK 129.3m (232.5).

Significant events during the second quarter 2021

  • Xbrane held a virtual capital markets day in May and announced its ambition of generating a positive operating cash flow monthly through the net income from Xlucane™ at the end of 2023/beginning of 2024 and to initiate one new development project per year.
  • In June, top-line data was obtained from an interim read-out of the ongoing Phase III equivalence study Xplore with the Lucentis® biosimilar candidate Xlucane™. Xlucane™ reached the primary endpoint and demonstrated equivalent efficacy with Lucentis® in terms of change of BCVA (Best Corrected Visual Acuity) at the eighth week of treatment. The company then confirmed the plan to submit the marketing authorization application to the European Medicines Agency (EMA) during Q3 2021 and to the US Food and Drug Administration (FDA) in Q4 2021 on the basis of the interim read-out.
  • With the support of the authorization at the Annual General Meeting on May 6, 2021, Xbrane announced and implemented a directed new issue of SEK 380m at a subscription price of SEK 135 per share, at the end of June. The shares were registered and payment received in July, so the effects in the balance sheet and cash flow will not be seen until the next interim report for July-September 2021.

Significant events after the period

  • Xbrane Biopharma was officially certified as a Great Place to Work® by the Great Place to Work® Institute.


Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on August 13, 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/e2styz5g

Confirmation Code: 1974425
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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2021-08-13 08:00 CEST.

Attachments


Xbrane Biopharma AB Q2 Report FINAL VERSION 2021 08 12

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