Xbrane Biopharma Reports Full Year 2025 Results, FDA Issues CRL for Ranibizumab Biosimilar

Xbrane Biopharma reported full year 2025 revenue of SEK 152.4 million (148.1), of which SEK 67.5 million (63.4) relates to product sales of Ximluci and SEK 84.9 million (81.4) relates to nonrecurring license revenue. The profit for the period was SEK 127.2 million (–266.2), with earnings per share of SEK 0.08 (–0.22).

On October 20, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company's Biologics License Application (BLA) for its ranibizumab biosimilar candidate for the treatment of retinal diseases. The CRL cited observations following a re-inspection of one of Xbrane's contract manufacturers. On November 19, Xbrane updated its timeline for resubmitting the BLA to the FDA for its ranibizumab biosimilar, which is expected to occur once the corrective work is completed, in March 2026.

On June 2, Xbrane completed its transaction with Alvotech and in connection with this, a gain on the divestment of operations after tax amounting to SEK 168.9 million was recognized. Cash flow was bolstered by the Alvotech deal and a SEK 240 million share issue.

For the fourth quarter 2025, revenue amounted to SEK 9.1 million (65.8), of which SEK 8.9 million (11.5) relates to product sales of Ximluci and SEK 0.2 million (54.3) relates to nonrecurring license revenue. EBITDA amounted to SEK –21.9 million (13.8). Loss for the period was SEK 26.5 million (–53.2).

For the full year, other operating income amounted to SEK 11.2 million (11.7). EBITDA amounted to SEK –13.6 million (–77.3). R&D costs amounted to SEK –76.8 million (–162.0) corresponding to 60 percent (68) of total operating costs. Cash and cash equivalents at the end of the period amounted to SEK 86.6 million (124.3).

On October 13, an extraordinary general meeting resolved to approve the Board's decision to carry out a reverse share split at a ratio of 1:125, whereby 125 shares would be consolidated into 1 new share. The total number of shares in the company will decrease through the reverse split from 2,575,668,555 shares to 20,605,348 shares (rounded down). The general meeting also resolved to reduce the share capital by SEK 298,424,074.25 to SEK 279,004,914.461063 to cover the previous years' losses and to reduce the share capital by SEK 276,944,379.661063 to SEK 2,060,534.80 for allocation to unrestricted equity.

On October 16, the company announced that an agreement had been signed with Fenja Capital II A/S regarding a conditional financing solution. On November 24, the Board decided to issue 420,517 warrants to Fenja Capital II A/S within the framework of the agreement signed on October 16.

On November 4, the company announced that the first patient had been included in the clinical study for Xdivane. The Board of Directors proposes that no dividend be paid for the 2025 financial year.