Xbrane Biopharma Ab · OMXSTO:XBRANE
Xbrane Biopharma Ab — Investor Presentation (March 2024)
28 slides from Xbrane Biopharma Ab's investor presentation, March 2024
Slide 1: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE March 2024 rane – 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 addresses global health challenges by developing affordable biosimilars
Xbrane addresses global health challenges by developing affordable biosimilars Core competence Differentiation Develop biosimilars from Patented platform cell line to market approval technology for lowest and partner for sales and production cost marketing Our purpose: “Enable equal Mid-term strateg
Slide 4: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a rapidly growing market Xbrane – a platform biosimilar developer Ximluci® – ongoing commercialisation in Europe & UK Attractive portfolio addressing USD 27bn in originator sales
Slide 5: 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. 40% of global market, 10-15% p.a. growth1 growth2 Produced via chemical synthesis Produced via recombinant DNA technology Followed on by
Slide 6: Biosimilar development – faster, cost-effective & low risk
Biosimilar development – faster, cost-effective & low risk Pre-clinical Phase I Phase III Biosimilar 78 95 Likelihood of Approval1 developme % % nt process Cost effectiveness Development time Capital requirement Prob. of success Improved patient 7 years +€100 million MEDIUM - HIGH access Discovery &
Slide 7: Biosimilars rapidly claim majority of reference product market share
Biosimilars rapidly claim majority of reference product market share Rapid biosimilars uptake leading to USD 11.5bn in Favorable margins & price global sales (2021) discounts Branded products WW annual Biosimilars WW annual sales Biosimilars have in recent launches USD million sales USD million ta
Slide 8: Biosimilar market expected to grow to USD 74bn by 2030
Biosimilar market expected to grow to USD 74bn by 2030 Biologics with >USD 260bn in sales lose Biosimilar market to grow by 17% per year exclusivity by 2032 through to 2030 Estimated cumulative global annual peak sales, USD billion Global biosimilar sales, USD billion 74 61.5 54.5 51.6 % 17 .a. 35.4
Slide 9: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a rapidly growing market Xbrane – a platform biosimilar developer Ximluci® – ongoing commercialisation in Europe & UK Attractive portfolio addressing USD 27bn in originator sales 9
Slide 10: Xbrane´s modular platform technology enables significant yield advantage
Xbrane´s modular platform technology enables significant yield advantage Proprietary host cell line Productivity enhancing Process and analytical library technologies methods + + Library of proprietary Productivity and quality Specific production process genetically engineered cell- enhancing
Slide 11: Diverse development portfolio addressing a €27bn market
Diverse development portfolio addressing a €27bn market Originator peak sales estimate 2026* (€ billion) Biosimilar Ximluci® BIIB801™ Xdivane™ Xdarzane™ Current candidate portfolio Branded biologics Therapeuti Ophthalmology Immunology Oncology Oncology c area Patent 2020 (US) 2024 (US) 2029 (US) 202
Slide 12: World-leading partnerships secured with >€80m in upcoming milestones
World-leading partnerships secured with >€80m in upcoming milestones Product Ximluci® BIIB801TM Commercial Partner Territory Global ex. China Global Type Co-development License Upfront €7.5m USD 8m > €80m (pending) Milestones / Cost coverage €40-50m USD 80m Royalties/ profit sharing 50% EBITDA profi
Slide 13: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a rapidly growing market Xbrane – a platform biosimilar developer Ximluci® – ongoing commercialisation in Europe & UK Attractive portfolio addressing USD 27bn in originator sales 13
Slide 14: Ximluci® – addressing a global underserved market
Ximluci® – addressing a global underserved market Lucentis® used in treatment of severe eye Global unmet medical need due to high drug diseases cost 5 million affected eyes Europe & US, 50% treated Affected vision Normal vision Untreated Lucentis Eylea Avastin 0.8 1.1 2.5 0.6 13 million affected eye
Slide 15: Ximluci® development update – FDA BsUFA date in April 2024
Ximluci® development update – FDA BsUFA date in April 2024 2022 2023 2024 Regulatory process EU Production launch volume* Regulatory process US Drug substance process scale-up Pre-filled syringe development March April 2024 H2 2024 Q1 2025 July 2022 June 2023 Q2 2024 Feb 2022 2023 Expected US US lau
Slide 16: Ximluci® Launched across approx. 40% of €5 billion ex-US market
Ximluci® Launched across approx. 40% of €5 billion ex-US market Retinal anti-VEGF sales (ex US) Ximluci position € million Ximluci ® #2 in biosimilar market Q4 2023 1500 Xbrane expectation End-user volume grew with 25% vs. Q3 2023 that 1000 biosimilars Captured close to 1% of the approx. €300
Slide 17: US poses a significant opportunity for Ximluci®
US poses a significant opportunity for Ximluci® - FDA BsUFA date in April 2024 Retinal anti-VEGF sales (US) Opportunity for Ximluci USD Approx. USD 150m / quarter additional annual Ximluci BsUFA date for Ximluci ® in April 2024 million 2500 market from off label Avastin1 Handful of interested pa
Slide 18: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a rapidly growing market Xbrane – a platform biosimilar developer Ximluci® – ongoing commercialisation in Europe & UK Attractive portfolio addressing USD 27bn in originator sales 18
Slide 19: Cimzia® is a differentiated €2.1 billion TNFa inhibitor
Cimzia® is a differentiated €2.1 billion TNFa inhibitor Cimzia® is a differentiated TNFa inhibitor Cimzia® generated €1.8 billion in sales 2021 Cimzia® sales (€ Rheumatoid Psoriasis millions) Arthritis (RA) 2500 ‘17 – ’22: 2000 CAGR 8% 1500 1000 500 Cimzia® is a TNFa inhibitor that reduce immune r
Slide 20: BIIB801™ – the only publicly known Cimzia® biosimilar under development
BIIB801™ – the only publicly known Cimzia® biosimilar under development Partnership with Biogen with attractive BIIB801™ programme terms Out-licensing of global rights Pilot scale process established Xbrane responsible for and fund pre-clinical Ongoing tech-transfer/scale-up to selected deve
Slide 21: Well-positioned & commercially attractive oncology biosimilar portfolio
Well-positioned & commercially attractive oncology biosimilar portfolio Opportunity to make a Oncology biosimilar €48 billion of annual reference difference portfolio product sales Combined annual expected Annual per patient Originat peak reference product sales cost of >USD 100K or € billion 2028
Slide 22: Upcoming key milestones
Upcoming key milestones H1 2024: Ximluci® out-licensing of North American rights H1 2024: Ximluci® FDA approval H1 2024: XdivaneTM out-licensing Q3 2024: BIIB801 milestone payments contingent upon successful scale-up H2 2024: Ximluci® US launch Q1 2025: Reaching positive operating cash-f
Slide 23: Appendix
Xbrane – a world-leading biosimilar developer Appendix 23
Slide 24: Experienced management team and board
Experienced management team and board Management Board of Directors Martin Åmark Siavash Bashiri David Vikström Anders Wallström Anders Tullgren Eva Nilsagård Karin Wingstrand Mats Thorén CEO COO & Head of CTO Head of Manufacturing Chairman of the Director of the Director of the Director of the Bios
Slide 25: Latest financials & shareholder list
Latest financials & shareholder list Shareholder list (December 2023) Financial highlights Investor Name Ownership, Shares % SEK m 2023 2022 Ashkan Pouya 3,270,298 10.97 Bengt Göran Westman 2,448,379 8.21 Revenue 238,7 57,6 STADA Arzneimittel AG 1,570,989 5.27 Avanza Pension 1,459,292 4.90 Håkan Stö
Slide 26: Details on Rights Issue
Details on Rights Issue Partially secured rights issue of approx. SEK 343 million with warrants amounting up to an additional approx. SEK 78 million, as approved at the EGM held 22 February Approx. SEK 285 million secured through a combination of subscription undertakings and intentions of approx.
Slide 27: Use of Proceeds
Use of Proceeds The net proceeds from the Rights Issue, provided that the Rights Issue is subscribed to the amount intended to be covered by subscription commitments and intentions, as well as guarantee commitments, will primarily finance: Launch of Ximluci® in US and launch of Ximluci PFS (appr
Slide 28: Convertible Bond Restructuring
Convertible Bond Restructuring Outstanding debt SEK 219 million (nominal amount) One-off amortization of SEK 63 million from net-proceeds from announced rights issue Remaining outstanding debt of SEK 156 million Resumed bi-monthly amortization from January 2025 onwards Duration until May 2027
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