Xbrane Biopharma releases interim report for January – June 2023
”Biological License Application for Ximluci® validated by FDA.”
Xbrane Biopharma AB’s (publ.) (”Xbrane”) interim report for January – June 2023, is as of today, available on the Company’s website, www.xbrane.com.
Financial overview second quarter 2023*
• Revenue amounted to SEK 51.1 m (18.9).
• Other operating income was SEK 3.2 m (8.2).
• EBITDA amounted to SEK –81.1 m (–28,4).
• R&D costs amounted to SEK –87.3 m (–52.9),
corresponding to 84 percent (89) of total operating costs.
• The loss for the period was SEK 91,0 m (–33.8).
• Earnings per share was SEK –3.22 (–1.35).
• Cash and cash equivalents at the end of the
period amounted to SEK 315.6 m (250.1).
Financial overview first-half year 2023*
• Revenue amounted to SEK 112.9 m (26.2).
• Other operating income was SEK 7.3 m (14.2).
• EBITDA amounted to SEK –129.5 m (–61.3).
• R&D costs amounted to SEK –145.3 m (–88.9),
corresponding to 81 percent (81) of total operating costs.
• The loss for the period was SEK 149.4 m (–69.9).
• Earnings per share was SEK –5.36 SEK (–2.79).
• Cash and cash equivalents at the end of the period amounted to SEK 315.6 m (250.1)
*Figures in parentheses refer to the corresponding period last year.
Significant events during the second quarter 2023*
• In April, Xbrane submitted a marketing authorization application for Ximluci® to the US Food &
Drug Administration, the FDA, (the US counterpart to the Swedish Medicines Agency).
• At the end of April, the company announced that STADA and Xbrane had won a framework agreement with the National Health Service (the NHS) in the UK regarding the supply of Ximluci®.
• With the support of the authorization from the Annual General Meeting on May 4, 2023, in the
company carried out a directed share issue in May of approximately SEK 125 m at a subscription price of SEK 73.1 per share. In connection with the directed new issue, a binding agreement was signed with CVI Investments Inc. regarding financing through convertible bonds of SEK 250m. **
• In mid-June, it was announced that the FDA had accepted the supplemental Biologics License Application (sBLA) for Xbrane’s biosimilar candidate to Lucentis® (ranibizumab). The regulatory process can therefore be initiated with a Biosimilar User Fee Amendment (BsUFA) goal date of April 21, 2024.
Significant events after the end of the quarter*
• In July, it was announced that STADA and Xbrane had agreed to discontinue the commercial licensing agreement for North America with their former partner, Bausch + Lomb. Bausch + Lomb will now focus on other strategic priorities.
*) See page 8 for more information.
**) Before transaction costs.
Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on August 29th, 2023, at 09.00 p.m. CET. See the link to the presentation below:
If you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions.
If you wish to participate via teleconference, please register on the link below. After registration you will be provided with phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.