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Xbrane Interim Report January June 2024
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Xbrane Biopharma AB’s (publ.) (”Xbrane”) Interim Report for January-June 2024, is as of today, available on the Company’s website, www.xbrane.com.
FINANCIAL OVERVIEW
SECOND QUARTER 2024*
• Revenue amounted to SEK 52.0 m (51.1).
• Other operating income was SEK 0.8 m (3.2).
• EBITDA amounted to SEK −54.7 m (−81.1).
• R&D costs amounted to SEK −116.3 m (−87.3), corresponding to 90 percent (84) of total operating costs.
• The loss for the period was SEK 70.5 m (−91.0).
• Earnings per share was SEK −0.05 (−0.15).
• Cash and cash equivalents at the end of the period amounted to SEK 72.8 m (315.6).
FINANCIAL OVERVIEW
FIRST HALF-YEAR 2024*
• Revenue amounted to SEK 66.1 m (112.9).
• Other operating income was SEK 6.1 m (7.3).
• EBITDA amounted to SEK −130.8 m (−129.5).
• R&D costs amounted to SEK −203.9 m (−145.3), corresponding to 89 percent (81) of total operating costs.
• The loss for the period was SEK 167.9 m (−149.4).
• Earnings per share was SEK −0.18 (−0.25).
• Cash and cash equivalents at the end of the period amounted to SEK 72.8 m (315.6).
*Figures in parentheses refer to the corresponding period of the previous year.
SIGNIFICANT EVENTS DURING
THE SECOND QUARTER 2024**
• In April, it was announced that the U.S. Food and Drug Administration (FDA) sent a Complete Response Letter (CRL) in response to Xbrane’s application for market approval for its ranibizumab biosimilar candidate (under the development name Xlucane) for the treatment of eye diseases.
• In May, it was announced that Xbrane and STADA had entered a partnership agreement with Valorum Biologics to commercialize the biosimilar candidate for Ranibizumab in the US. The three partners are committed to bringing the ranibizumab biosimilar candidate to the US market as quickly as possible, contributing to more treatment options that can reduce costs and increase patient access to biological drugs for serious eye diseases. Valorum will pay a license fee of up to USD 45 m, split between an upfront payment, regulatory and sales-related milestones, as well as royalties on net sales. The revenue shared equally by Xbrane and STADA.
SIGNIFICANT EVENTS
AFTER THE END OF THE QUARTER**
• In August, the company announced that it was regaining full rights to BIIB801. This followed a decision by Biogen Inc. to terminate the commercialization and license agreement between the companies. All rights to the product have therefore returned to Xbrane.
• In August, Xbrane updated on the continued out-licensing of Xdivane™ (Opdivo® biosimilar candidate) and XB003 (Cimzia® biosimilar candidate) and its financial position. Given the delay in FDA approval for Ximluci® and the unforeseen termination of the licensing agreement with Biogen, Xbrane must successfully out-license both Xdivane™ and XB003 in the coming months. The company’s Board and management believe that this is feasible as there is significant interest in XB003 due to the unique nature of the program, and that Xdivane™ is focused on markets outside the US with a reduced clinical program. The latter is based on positive feedback from the European Medicines Agency (EMA). The company’s Board and management are fully committed and working hard to achieve this and are also investigating other possible avenues to ensure shareholder value.
**See page 8 for more information
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