The approval of Ximluci® in Europe positions Xbrane as a leading global biosimilar developer

Financial overview fourth quarter 2022

• Revenue amounted to SEK 17.3 m (2.8).
• Other operating income was SEK 0.5 m (1.7).
• EBITDA amounted to SEK –50.7 m (–28.2).
• R&D costs amounted to SEK –59.5 m (–28.9), corresponding to 82 percent (79) of total operating costs.
• The loss for the period was SEK –60.7 m (–32.5).
• Earnings per share was SEK –2.25 (–1.32).
• Cash and cash equivalents at the end of the period amounted to SEK 194.0 m (295.2).

Financial overview full-year 2022

• Revenue amounted to SEK 57.6 m (10.7).
• Other operating income was SEK 20.9 m (4.8).
• EBITDA amounted to SEK –149.6 m (–168.4).
• R&D costs amounted to SEK –199.6 m (–160.6), corresponding to 82 percent (82) of total operating costs.
• The loss for the period was SEK –172.5 m (–188.4).
• Earnings per share was SEK –6.75 (–7.98).
• Cash and cash equivalents at the end of the period amounted to SEK 194.0 m (295.2).
• The Board of Directors proposes that no dividend be paid for the financial year 2022.

Figures in parentheses refer to the corresponding period last year.

Significant events in the fourth quarter 2022

• After authorization from the annual general meeting on May 5, 2022, the company announced and carried out a directed share issue of 2,363,112 new shares at a subscription price of SEK 72 per share. Through the directed new issue, net cash of around SEK 170 m before transaction costs was realized.
• The European Commission granted marketing authorization for Ximluci® (ranibizumab) in November, a biosimilar to the reference drug Lucentis®. The approval followed the positive opinion the company received in September 2022 from the Committee for Medicinal Products for Human Use (CHMP). The marketing authorization for Ximluci® is held by Xbrane’s partner STADA Arzneimittel AG (STADA) and is valid in all 27 EU member states, as well as Iceland, Norway and Liechtenstein.
• Xbrane reported in December plans to submit the Biologics License Application (BLA) to the FDA in Q1 2023.

Significant events after the end of the quarter

• In January, marketing authorization was obtained for Ximluci® in the UK. STADA is preparing to launch Ximluci® in the UK in 2023

Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on February the 17th, 2023, at 10.00 a.m. CET. To participate please follow the links below.

See below link and call-in details to the presentation below

Webcast URL
https://edge.media-server.com/mmc/p/syxw4qq6
 
Conference call dial in details, Participants:
Online Registration:
https://register.vevent.com/register/BI875d79843368447494c388901b23019e