Xbrane Biopharma

Regulatory Filings • Dec 13, 2021

Xbrane has initiated development of two new biosimilar candidates, building an oncology biosimilar portfolio targeting €23 billion in annual reference product sales

Xbrane Biopharma AB (publ) ("Xbrane" eller "Bolaget") (Nasdaq Stockholm: XBRANE), a leading biosimilar developer, has announced the initiation of developing two new biosimilar candidates referencing Keytruda® and Darzalex® respectively. Together with the continued development of Xdivane™, a biosimilar candidate referencing Opdivo®, this forms an oncology biosimilar portfolio addressing €23 billion of combined annual reference product sales. Due to the announcement, Xbrane will host a videoconference tomorrow Tuesday December 14th, 11.00-11.45, registration in the link below.

At the capital markets day held on May 17, 2021, Xbrane announced its ambition to start developing at least one new biosimilar candidate per year. Following a thorough strategic portfolio review and preparatory work during the fall of 2021, Xbrane´s board of directors decided to initiate the development of biosimilar candidates referencing Keytruda® and Darzalex®.

Keytruda® is a PD1 inhibitor used in oncology treatment with annual sales of €13 billion. Darzalex® is a CD38 inhibitor used in the treatment of Multiple Myeloma with annual sales of €3.8 billion. Together with Xdivane™, these new biosimilar candidates form an oncology biosimilar portfolio targeting €23 billion combined in annual reference product sales, which could be launched in 2028-2029 when the respective patents expire.

With the development of Xdivane™, Xbrane has expanded its high-yield protein expression platform into mammalian cells, resulting in five recently approved patents. Xbrane will leverage this platform for the upcoming programs with the aim of getting the lowest production costs amongst competing biosimilars on the market.

"With our high-yield platform technology, experienced team, and recently established development lab, we believe we are well positioned to accelerate the development of our portfolio. The development of this oncology biosimilar portfolio poses a real opportunity for us to make a sizable difference and to improve the accessibility of critical oncology products for millions of patients worldwide," says Martin Åmark, CEO of Xbrane

Webcast

Xbrane will host a webcast for investors, analysts, and media, where CEO Martin Åmark reasons around the strategic importance of the new oncology portfolio. The webcast is held tomorrow Tuesday December 14th, 11:00-11:45. Please register using the following link:

Weblink

https://tv.streamfabriken.com/press-conference-20211214

Participant dial in number teleconference

SE: +46850558375 UK: +443333009274 US: +16467224956

Contacts

Martin Åmark, CEO M: +46 76 309 37 77 E: martin.amark@xbrane.com

Anette Lindqvist, CFO/IR M: +46 76 325 60 90 E: anette.lindqvist@xbrane.com

About Us

Xbrane Biopharma AB develops biological drugs based on a platform technology that provides significantly lower production costs compared to competing systems. Xbrane's leading product Xlucane™, a Lucentis® biosimilar candidate, addresses the € 10.4bn ophthalmic VEGFa inhibitor market. Marketing authorization of Xlucane™ is expected for the second half of 2022. Xbrane has additionally two biosimilar candidates in its pipeline targeting € 7.9bn in originator sales. Xbrane's head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE.

For more information, visit www.xbrane.com.

This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2021-12-13 20:00 CET.

Attachments

Xbrane has initiated development of two new biosimilar candidates, building an oncology biosimilar portfolio targeting €23 billion in annual reference product sales