Xbrane Biopharma

Xbrane Biopharma AB’s (publ.) (”Xbrane”) interim report for January – Mars 2023, is as of today, available on the Company’s website, www.xbrane.com.

Financial overview first quarter 2023

• Revenue amounted to SEK 61.8 m (7.3).
• Other operating income was SEK 4.0 m (6.0).
• EBITDA amounted to SEK –48,4 m (–32,9).
• R&D costs amounted to SEK –57.9 m (–28.9), corresponding to 76 percent*) (72) of total
operating costs.
• The loss for the period was SEK –58.4 m (–36.1).
• Earnings per share was SEK –2.12 (–1.44).
• Cash and cash equivalents at the end of the period amounted to SEK 118.7 m (301.5).

Figures in parentheses refer to the corresponding period last year.

Significant events during the first quarter of 2023

• In February, the Medicines & Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Ximluci® (ranibizumab) in the UK. STADA launched the product in the UK in Q1 2023.

SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER

• At the beginning of April, it was announced that Ximluci® had been launched in the main European markets. Ximluci® is the first product launched through a strategic collaboration between STADA and Xbrane. With the introduction of ranibizumab, STADA and Xbrane offer a cost-effective alternative to European patients.

• In April, Xbrane submitted a biologics license application (BLA) for Ximluci® to the US Food & Drug Administration, FDA, (the US counterpart to the Swedish Medicines Agency). Within 60 days, the FDA is expected to validate and decide on reviewing the application. After that, Xbrane expects a review process of around 10 months and approval may therefore be obtained in the first half of 2024.

• At the end of April, the company announced that STADA and Xbrane had won a framework agreement with the English National Health Service (the NHS) in the UK regarding the supply of Ximluci®. The agreement covers a significant part of the clinical demand for ranimizumab in the UK. The nominal total value of this framework agreement, which runs from April 1, 2023, to March 31, 2024, is GBP 70 m (about SEK 900 m), which is to be divided between two suppliers, with volumes to be defined by ability to supply and gain market share.

• Biosimilar competition for ranibizumab has the potential to increase patient access and create significant savings for the NHS in England.

• With the support of the authorization from the Annual General Meeting on May 4, 2023, the company carried out a directed share issue in May of approximately SEK 125 m2) at a subscription price of SEK 73.1 per share. In connection with the directed new issue, a binding agreement was entered into with CVI Investments Inc. regarding financing through convertible bonds of SEK 250 m2). The effects on the balance sheet and cash flow will only become visible in the upcoming interim report for April–June 2023.

1) See page 9 for more information on research and development costs.

2) Before transaction costs.

Xbrane Biopharma AB invites to a teleconference for investors, analysts and media on May 31th, 2023, at 11.00 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 can ask written questions.

https://ir.financialhearings.com/xbrane-biopharma-q1-2023/register

If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. 

https://conference.financialhearings.com/teleconference/?id=5002104