Xbrane Biopharma Ab · OMXSTO:XBRANE
Xbrane Biopharma Ab — Q3 2024 Earnings Presentation
13 slides from Xbrane Biopharma Ab's earnings presentation, Oct 24, 2024
Slide 1: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE September 2024 Xbrane – a World-Leading Biosimilar Developer 1
Slide 2: Important information
Important information You must read the following before continuing. The following applies to this document and the information provided in this presentation by Xbrane Biopharma AB (publ) (the “Company”) or any person on behalf of the Company and any other material distributed or statements made in
Slide 3: Xbrane short term focus
Xbrane short term focus 1• Q4 2024: Out-license Xdivane and XB003 to ensure working capital needs 2• Q4 2024: Re-submit Ximluci BLA to FDA targeting approval Q2 2025 3• Q2 2025: Reach positive operational cash flow 3
Slide 4: Biosimilars are follow-on products to biologics launched post patent expiry
Biosimilars are follow-on products to biologics launched post patent expiry Biopharmaceuticals Small Molecules Biologics → 60% of global market, 1-3% p.a. growth1 → 40% of global market, 10-15% p.a. growth2 → Produced via chemical synthesis → Produced via recombinant DNA technology → Followed on by
Slide 5: Biosimilar portfolio addressing €27bn of reference product sales
Biosimilar portfolio addressing €27bn of reference product sales Reference product sales estimate 2028* (€ billion) Biosimilar Ximluci® XB003 Xdivane™ Xdarzane™ Current portfolio candidate Branded biologics Therapeutic Ophthalmology Immunology Oncology Oncology area 2020 (US) 2024 (US) Dec 2028 (US)
Slide 6: Xbrane´s modular platform technology enables significant yield advantage
Xbrane´s modular platform technology enables significant yield advantage Proprietary host cell line library Productivity enhancing technologies Process and analytical methods + + → Library of proprietary genetically → Productivity and quality enhancing → Specific production process methods engineere
Slide 7: Ximluci (Lucentis biosimilar) launched in 18 countries in Europe
Ximluci® (Lucentis® biosimilar) launched in 18 countries in Europe Ximluci® launched in 18 countries in Europe Position end of Q2, 2024 → Outside US retinal anti VEGF market of +€5 billion → Ximluci® value market share well above 1% of the approx. €1.2 billion ranibizumab market1 → Ximluci® position
Slide 8: US poses a significant opportunity for Ximluci
US poses a significant opportunity for Ximluci® US retinal anti VEGF : a ~$10 billion market Significant opportunity for Ximluci → Partnered with Valorum Biologics with $45m in license fees1, ~8 million units royalty on net-sales1 and supply with double digit mark-up 100% → BLA to be resubmitted Q4
Slide 9: Xdivane referencing Opdivo with $14billion in expected sales 2028
Xdivane referencing Opdivo® with $14billion in expected sales 2028 Opdivo® expected to generate net-sales of $14b in 2028 Xdivane ready to enter clinic during 2025 → Opdivo is an immuno-oncology drug used in treatment of → Xdivane is a biosimilar candidate referencing Opdivo several cancers includin
Slide 10: Streamlined clinical development plan agreed with EMA and FDA for Xdivane
Streamlined clinical development plan agreed with EMA and FDA for Xdivane 2024 2025 2026 2027 2028 2029 2030 Partnering LoE US LoE Europe Production of clinical Pivotal clinical trial MAA / BLA material • Scale up to • Single Pivotal clinical trial involving approx. 340 patients commercial scale • P
Slide 11: Oncology biosimilars have taken 75% volume share 3 years post launch in US
Oncology biosimilars have taken 75% volume share 3 years post launch in US US biosimilar volume market share vs. reference product (%) • On average 53% market share Year 3 post initial launch. • Oncology and ophthalmology : ~75% market share by year 3 • Immunology, filgrastim, epoetin alfa, and insu
Slide 12: XB003 can be the only biosimilar to €2.1b TNFa inhibitor Cimzia by launch
XB003 can be the only biosimilar to €2.1b TNFa inhibitor Cimzia® by launch Cimzia® is a differentiated TNFa inhibitor XB003 can be only biosimilar to Cimzia by launch → Cimzia® is the only TNFa inhibitor used in treatment → Difficult to develop and manufacture pegylated Fab of Psoriasis and Rheumato
Slide 13: Xbrane short term focus
Xbrane short term focus 1• Q4 2024: Out-license Xdivane and XB003 to ensure working capital needs 2• Q4 2024: Re-submit Ximluci BLA to FDA targeting approval Q2 2025 3• Q2 2025: Reach positive operational cash flow 13