Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (September 2022)
34 slides from Xbrane Biopharma AB's investor presentation, September 2022
Slide 1: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE September 2022 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 – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer • Xbrane is a world-leading biosimilar developer with a patented high-yield platform ensuring lowest possible production cost Platform biosimilar developer with lowest • Commercial agreement with three major global pharmaceutical companies: STADA, Bausch
Slide 4: Xbrane - a world-leading biosimilar developer
Xbrane - a world-leading biosimilar developer Addressing one of the fastest growing segments in pharma Lead product Ximluci® to be launched in Europe in Q1 2023 Platform biosimilar developer with lowest production cost Attractive development portfolio 4
Slide 5: Biosimilars are follow-on products to biologics post patent expiry
Biosimilars are follow-on products to biologics post patent expiry Pharmaceuticals Small Molecules Biologics Molecular Weight: Molecular Weight: ͠ 180 Dalton ͠ 150,000 Dalton → Produced via chemical synthesis → Produced via recombinant DNA technology → 60% of global market, 1-3% p.a. growth → 40% of
Slide 6: Biosimilars – fast & cost effective path to market with significantly reduced risk
Biosimilars – fast & cost effective path to market with significantly reduced risk Discovery & Development Pre-clinical Phase I Phase II Phase III Novel Likelihood of Approval1 10% 50% biological drug Development time Capital requirement Prob. of success Premium pricing ~10-12 years > €1 billion LOW
Slide 7: Biosimilars claim majority of originator product’s market in just few years
Biosimilars claim majority of originator product’s market in just few years EU biosimilar market share by volume US biosimilar market share by volume Average of 2-3 biosimilars per originator product and price discount of 20-40% 7 Source: IQVIA, Bernstein
Slide 8: Biosimilars – accessible, life critical biologics realizing significant cost savings
Biosimilars – accessible, life critical biologics realizing significant cost savings Biosimilars significantly increase access… …and realize significant savings Treatment days per capita Europe US Biosimilar savings USD billion 0.9 120 100% 0.8 104 100 0.7 15% 0.6 80 0.5 60 0.4 0.3 40 0.2 18 19 20%
Slide 9: Biosimilar market expected to grow to USD 80b in 2026 (17% CAGR 20-26E)
Biosimilar market expected to grow to USD 80b in 2026 (17% CAGR 20-26E) Biologics market outgrowing pharma Biosimilar market expected to reach USD 80 billion in 2026 Total global biologics market size (USD billion) Total global biosimilars market size (USD billion) $582 $445 $79 $288 $219 $178 $30 2
Slide 10: Xbrane - a world-leading biosimilar developer
Xbrane - a world-leading biosimilar developer Addressing one of the fastest growing segments in pharma Lead product Ximluci® to be launched in Europe in Q1 2023 Platform biosimilar developer with lowest production cost Attractive development portfolio 10
Slide 11: Ximluci® is a biosimilar candidate to Lucentis®
Ximluci® is a biosimilar candidate to Lucentis® 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 e
Slide 12: Ximluci® is a highly similar biologic to Lucentis®
Ximluci® is a highly similar biologic to Lucentis® Biosimilar attribute to Lucentis® Ximluci® Comment Identical amino-acid sequence Comparative Analytical → Involving +10 Ximluci® batches vs. +20 Highly similar structure Assessment Lucentis® batches Highly similar binding properties → Comprehensive
Slide 13: Ximluci® is addressing the €11.7b retinal anti-VEGF market
Ximluci® is addressing the €11.7b retinal anti-VEGF market Retinal anti-VEGF market (€ billion) Lucentis® and Eylea® similar in profile and pricing 14 Off-label Average 12 no doses 6-8 6-8 6.7 6-8 first year: 10 Price per €600 €800 €800 €100* unit EU: 8 8.3 6.8 Price per 6.9 €1850 €100* 6 5.9 unit U
Slide 14: Ximluci® European launch planned for Q1 2023
Ximluci® European launch planned for Q1 2023 2021 2022 2023 Ximluci® pivotal phase III trial Regulatory process EU Production launch volume Regulatory process US Jun 2021 Feb 2022 July 2022 Nov 2022 Q1 2023 Interim read-out Top-line data Lucentis® LoE EU EU Approval EU Launch Positive CHMP opinion a
Slide 15: STADA & Bausch + Lomb to commercialize Ximluci® across an €11.7b market
STADA & Bausch + Lomb to commercialize Ximluci® across an €11.7b market €6.6 billion retinal anti-VEGF market €5.1 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 relati
Slide 16: STADA’s upcoming Ximluci® launch in its European stronghold markets
STADA’s upcoming Ximluci® launch in its European stronghold markets Europe STADA launch readiness Europe retinal VEGF inhibitor market € million → Dedicated biosimilar team of +200 professionals 5000 4000 → Dedicated field sales force under build-up Others 3000 → Successful launch and sales of 5 bio
Slide 17: Ximluci® clinical phase III data is being presented at top retinal forums
Ximluci® clinical phase III data is being presented at top retinal forums Xplore trial results to be published in Q1 2023 Presented in renounced retinal conferences Hamburg Chicago September 1st – 4th Sept 30th – Oct 3rd 2022 2022 17
Slide 18: Xbrane - a world-leading biosimilar developer
Xbrane - a world-leading biosimilar developer Addressing one of the fastest growing segments in pharma Lead product Ximluci® to be launched in Europe in Q1 2023 Platform biosimilar developer with lowest production cost Attractive development portfolio 18
Slide 19: Addressing global health challenges by enabling accessible healthcare
Addressing global health challenges by enabling accessible healthcare Xbrane – a purpose driven organization Towards becoming the global leading biosimilar developer Xbrane’s purpose is to enable health equality and bring people back to healthy lives through developing affordable biologics Broad por
Slide 20: Xbrane’s proprietary LEMO™ promoter enables high-yield & low unit cost
Xbrane’s proprietary LEMO™ promoter enables high-yield & low unit cost LEMO™ – patented platform regulates production intensity …leading to higher yield and lower cost TARGET Relative yield (g/L) (%) LEMO Standard LIVING PROTEIN CELL O2 100% LEMO™ Glucose Rhamnose 80% PLASMID 60% 12x 5x 3x 40% 20% 0
Slide 21: Validating, world-leading partnerships with >€150m in payable fees
Validating, world-leading partnerships with >€150m in payable fees Product Ximluci® BIIB801TM Commercial Partner Territory Global ex. China North America Global Type Co-development License License Upfront €7.5m USD5m USD8m >$150m Milestones / Cost coverage €40-50m Undisclosed USD80m Royalties/ profi
Slide 22: Xbrane development portfolio addresses a market of €53 billion
Xbrane development portfolio addresses a market of €53 billion 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 (
Slide 23: Differentiated, pure-play biosimilar developer with significant upside
Differentiated, pure-play biosimilar developer with significant upside First EU/US product launch 2021-2023 Celltrion addressable market, 62 69 Current USD bn 53 52 N.A. 20 22 Biosimilar Pure-play Y Y N Y N N N Current programmes 5 8 8 4 4 12 10 Enterprise value, USDm 177 2,294 N.A. 1,175 1,158 20,8
Slide 24: R&D engine with capacity to initiate one new development program annually
R&D engine with capacity to initiate one new development program annually Platform with LEMOTM as core technology Diverse, qualified and motivated team State of the art facility Relative yield (g/L) (%) Xbrane team LEMO Standard 100 100% 80 80% 60 60% 40% 40 20% 20 + + 0% 0 Membrane Average of Antib
Slide 25: Xbrane - a world-leading biosimilar developer
Xbrane - a world-leading biosimilar developer Addressing one of the fastest growing segments in pharma Lead product Ximluci® to be launched in Europe in Q1 2023 Platform biosimilar developer with lowest production cost Attractive development portfolio 25
Slide 26: 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 27: BIIB801 – the only publicly known Cimzia® biosimilar under development
BIIB801 – the only publicly known Cimzia® biosimilar under development BIIB801 program Partnership with Biogen with attractive terms → Pilot scale process established → Out-licensing of global rights → Ongoing tech-transfer/scale-up to selected drug → Xbrane responsible for and fund pre-clinical sub
Slide 28: Building an oncology biosimilar portfolio
Building an oncology biosimilar portfolio Opportunity to make a difference €48 billion of addressable annual reference product sales Combined annual expected peak reference product sales € billion 50 45 Darzalex 40 35 30 → Annual per patient cost of SEK 0.5-1 million - significant 25 Keytruda issues
Slide 29: Xbrane – a world-leading biosimilar developer
Xbrane – a world-leading biosimilar developer • Xbrane is a world-leading biosimilar developer with a patented high-yield platform ensuring lowest possible production cost Platform biosimilar developer with lowest • Commercial agreement with three major global pharmaceutical companies: STADA, Bausch
Slide 30: Appendix
Xbrane - a world-leading biosimilar developer Appendix 30
Slide 31: Upcoming milestones & recent news flow
Upcoming milestones & recent news flow > CHMP Opinion for Xlucane™ (expected September 2022) > Marketing authorisation from the EMA for Xlucane™ (expected November 2022) > Xlucane™ FDA-BLA submission (expected Q4 2022) > Xlucane™ launch in Europe (expected Q1 2023) > Feb 2022: Xbrane announced topli
Slide 32: 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 33: Latest financials & shareholder list
Latest financials & shareholder list Shareholder list (30 June 2022) Financial highlights Investor Name Shares Ownership, % SEK thousands Jan-Jun 2022 Jan-Jun 2021 Serendipity Group 3,177,367 12.7 Swedbank Robur Fonder 2,196,435 8.7 Revenue 22,821 5,090 Bengt Göran Westman 2,055,337 8.2 STADA Arznei
Slide 34: Xbrane – a World-Leading Biosimilar Developer
STO: XBRANE Xbrane – a World-Leading Biosimilar Developer 34
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