Xbrane Biopharma AB's (publ.) ("Xbrane") Interim Report for January-September 2024, is as of today, available on the Company's website, www.xbrane.com.
FINANCIAL OVERVIEW
THIRD QUARTER 2024*
• Revenue amounted to SEK 66.8 m (58.9).
• Other operating income was SEK 2.7 m (2.7).
• EBITDA amounted to SEK -28.9 m (-81.6).
• R&D costs amounted to SEK -72.6 m (-81.5), corresponding to 86 percent (84) of total operating costs.
• The loss for the period was SEK 45.1 m (-81.2).
• Earnings per share was SEK -0.03 (-0.13).
• Cash and cash equivalents at the end of the period amounted to SEK 30.6 m (167.3).
FINANCIAL OVERVIEW
FIRST NINE MONTHS OF 2024*
• Revenue amounted to SEK 132.9 m (171.8).
• Other operating income was SEK 8.8 m (10.0).
• EBITDA amounted to SEK -159.6 m (-211.1).
• R&D costs amounted to SEK -276.5 m (-226.8), corresponding to 88 percent (82) of total operating costs.
• The loss for the period was SEK -213.0 m (-230.6).
• Earnings per share was SEK -0.19 (-0.38).
• Cash and cash equivalents at the end of the period amounted to SEK 30.6 m (167.3).
*Figures in parentheses refer to the corresponding period of the previous year.
SIGNIFICANT EVENTS DURING
THE THIRD QUARTER 2024**
• 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.
• In September, the company announced that it had a scientific advisory meeting with the US FDA regarding development of its Opdivo® biosimilar candidate Xdivane. The FDA agrees with the EMA's earlier feedback and believes that Xbrane's proposed clinical development plan could support a future application for market approval (BLA) in the US. The development plan includes a pivotal clinical study, thereby reducing the clinical development budget by at least 60%, from about EUR 120 m to EUR 50 m or less. This significantly increases Xdivane's attractiveness to potential commercialization partners. As previously announced, Xbrane is, together with a reputable advisor in the field of life science, engaged in an active out-licensing process with several interested potential partners and aims to conclude the process within the coming months.
SIGNIFICANT EVENTS
AFTER THE END OF THE QUARTER**
• In October the company updated on the ongoing out-licensing of Xdivane (Nivolumab Biosimilar Candidate) and XB003 (Cimzia® Biosimilar Candidate) and its financial position. The company has reached agreement negotiation stage with Xdivane and received the first non-binding proposals on XB003. The company has, via agreed prolonged payment plans vs. main suppliers, extended the timing to end of November 2024 until when an agreement needs to be finalized to, via an expected upfront payment, fulfill the Company's working capital requirements. Xbranes board and management is optimistic, given the advanced stage of agreement negotiation, to be able to close a partnership with Xdivane before the end of November 2024.
**See page 8 for more information
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Contacts
Martin Åmark, CEO
E: martin.amark@xbrane.com
Anette Lindqvist, CFO/IR
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 EUR 26 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci® is granted market authorization approval in Europe and was launched during 2023. 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 2024-10-24 08:00 CEST.
