Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (March 2023)
29 slides from Xbrane Biopharma AB's investor presentation, March 2023
Slide 1: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE March 2023 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 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 technology for cell line to market approval and lowest production cost partner for sales and marketing Our purpose: Mid-term strategic focus “Enab
Slide 4: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a → Biosimilar market to grow to USD 74bn by 2030 as blockbuster biologic patents expire rapidly growing market → Delivering value to society - increased accessibility and significant savings Xbrane – a platform → Unique, proprietary high-y
Slide 5: 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 50bn in originator sales
Slide 6: Biosimilars are follow-on products to biologics launched post patent expiry
Biosimilars are follow-on products to biologics launched post patent expiry Pharmaceuticals 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 ide
Slide 7: Biosimilar development – faster, cost-effective & low risk
Biosimilar development – faster, cost-effective & low risk Pre-clinical Phase I Phase III Likelihood of Approval1 78% 95% Biosimilar Development time Capital requirement Prob. of success Cost effectiveness 7 years €100 million MEDIUM - HIGH Improved patient access Discovery & Development Pre-clinica
Slide 8: 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 global sales (2021) Favorable margins & price discounts Branded products WW annual sales Biosimilars WW annual sales → Biosimilars have in recent launches taken +70% USD million USD
Slide 9: 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 exclusivity by 2032 Biosimilar market to grow by 17% per year through to 2030 Estimated cumulative global annual peak sales, USD billion Global biosimilar sales, USD billion 74.0 61.5 54.5 51.6 35.4 32.9 1
Slide 10: 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 50bn in originator sales 10
Slide 11: 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 12: Diverse development portfolio addressing a €53bn market
Diverse development portfolio addressing a €53bn market Originator peak sales estimate 2026* (€ billion) Biosimilar Ximluci® BIIB801™ Xdivane™ Xtrudane™ Xdarzane™ Current portfolio candidate Branded biologics Therapeutic Ophthalmology Immunology Oncology Oncology Oncology area 2020 (US) 2024 (US) 20
Slide 13: World-leading partnerships secured with >€100m in upcoming milestones
World-leading partnerships secured with >€100m in upcoming milestones Product Ximluci® BIIB801TM Commercial Partner Territory Global ex. China North America Global Type Co-development License License Upfront €7.5m USD 5m USD 8m > €100m (pending) Milestones / Cost coverage €40-50m Undisclosed USD 80m
Slide 14: 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 50bn in originator sales 14
Slide 15: Ximluci® – addressing a global underserved market
Ximluci® – addressing a global underserved market Lucentis® used in treatment of severe eye diseases Global unmet medical need due to high drug cost 5 million affected eyes Europe & US, 50% treated Affected vision Normal vision Untreated Lucentis Eylea Avastin 0.6 2.5 2.5 1.1 0.8 13 million affected
Slide 16: Ximluci® – European & UK launch underway in Q1 2023
Ximluci® – European & UK launch underway in Q1 2023 2022 2023 2024 Regulatory process EU Production launch volume* Regulatory process US Drug substance process scale-up Pre-filled syringe development H1 2024 Feb 2022 July 2022 Q1 2023 Q2 2024 Expected US Top-line data Lucentis® LoE EU EU & UK Launch
Slide 17: Ximluci® is addressing the €12.8bn retinal anti-VEGF market
Ximluci® is addressing the €12.8bn retinal anti-VEGF market Retinal anti-VEGF market (€ billion) Lucentis® and Eylea® similar in profile and pricing Off-label 14 Average no doses 6-8 6-8 5 6.7 6-8 0.6 12 first year: Price per 10 €660 €1000 €1000 €1000 €100* unit EU: 8 Price per $1200 $2000 $2000 $23
Slide 18: STADA & Bausch+Lomb to commercialize Ximluci® across a €12.8bn market
STADA & Bausch+Lomb to commercialize Ximluci® across a €12.8bn market €7.8bn retinal anti-VEGF market €5 billion retinal anti-VEGF market → USD3.4 billion eye product and pharma specialist → €2.6 billion generic and biosimilar specialist → Existing ophthalmic sales force with strong relationships →
Slide 19: STADA’s Ximluci® launch in Europe addresses a €4bn market
STADA’s Ximluci® launch in Europe addresses a €4bn market Europe – a €4bn market opportunity STADA well-prepared for a successful launch Ximluci® overview → Dedicated biosimilars team within STADA Global Equivalent to Lucentis® Europe retinal VEGF inhibitor market € million (dosing, administration,
Slide 20: 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 50bn in originator sales 20
Slide 21: Cimzia® is a differentiated €1.8 billion TNFa inhibitor
Cimzia® is a differentiated €1.8 billion TNFa inhibitor Cimzia® is a differentiated TNFa inhibitor Cimzia® generated €1.8 billion in sales 2021 Rheumatoid Arthritis Psoriasis Cimzia® sales (€ millions) 2000 1500 1000 → Cimzia® is a TNFa inhibitor that reduce immune response in auto-immune diseases 5
Slide 22: BIIB801™ – the only publicly known Cimzia® biosimilar under development
BIIB801™ – the only publicly known Cimzia® biosimilar under development BIIB801™ programme Partnership with Biogen with attractive terms → Out-licensing of global rights → Pilot scale process established → Xbrane responsible for and fund pre-clinical → Ongoing tech-transfer/scale-up to selected drug
Slide 23: Well-positioned & commercially attractive oncology biosimilar portfolio
Well-positioned & commercially attractive oncology biosimilar portfolio Opportunity to make a difference Oncology biosimilar portfolio €48 billion of annual reference product sales Originator Combined annual expected peak → Annual per patient cost of reference product sales >USD 100K 2028 (US) Xdiva
Slide 24: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer Biosimilars – a → Biosimilar market to grow to USD 74bn by 2030 as blockbuster biologic patents expire rapidly growing market → Delivering value to society - increased accessibility and significant savings Xbrane – a platform → Unique, proprietary high-y
Slide 25: Appendix
Xbrane – a world-leading biosimilar developer Appendix 25
Slide 26: Financial calendar & recent news-flow
Financial calendar & recent news-flow > 31 Mar 2023: Annual report 2022 > 31 May 2023: Interim report January – March 2023 > 31 Aug 2023: Interim report January – June 2023 > 17 Jan 2023: STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis® > 11 Nov 20
Slide 27: Experienced management team and board
Experienced management team and board Management Board of Directors Martin Åmark Siavash Bashiri David Vikström Anders Wallström Erik Domines Anders Tullgren Eva Nilsagård Karin Wingstrand Mats Thorén CEO COO & Head of CTO Head of Manufacturing General Counsel Chairman of the Director of the Directo
Slide 28: Latest financials & shareholder list
Latest financials & shareholder list Shareholder list (31 December 2022) Financial highlights Investor Name Shares Ownership, % SEK thousands FY 2022 FY 2021 Serendipity Group 3,177,367 11.6 Bengt Göran Westman 2,152,686 7.8 Revenue 57,618 10,709 Swedbank Robur Fonder 1,808,479 6.6 Nordnet Pensionsf
Slide 29: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE Xbrane – a World-Leading Biosimilar Developer 29
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