Presentation

Company Profile
Xbrane Biopharma AB develops and manufactures high quality and cost-effective biosimilars based on a patented platform technology. Xbrane’s leading product Xlucane, a Lucentis® biosimilar candidate, addresses the USD >12bn ophthalmic VEGFa inhibitor market. Xlucane’s marketing authorisation is expected around mid-2022. In addition, Xbrane has two additional biosimilars in its pipeline with the aim of adding at least one biosimilar each year. The company managed to partner Xlucane with STADA for Europe and with the worldwide ophthalmology leader Bausch+Lomb for North America – securing good commercial prospects.

Recent highlights
In June the company announced that Xlucane has met its primary endpoint in the phase 3 trial and is thus ready for submission to EMA and FDA. Following the positive clinical readout, the company carried out a directed share issue raising gross proceeds of SEK 380m to fund the company’s next steps that include the regulatory submissions, scale-up of Xcimzane production and its phase 1 trial initiation as well as the further development of Xdivane and initiation of new biosimilar programmes.

Outlook
We expect Xlucane’s regulatory submissions to EMA still within Q3 and FDA within Q4. Further, it is likely that the company will announce new regional partnering deals for Xlucane, such as for South America in the coming months. Market launch of Xlucane in the USD >10bn aVEGF market currently dominated by Lucentis and Eylea is expected by summer 2022.