Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (June 2022)
24 slides from Xbrane Biopharma AB's investor presentation, June 2022
Slide 1: Building a World-Leading Biosimilar Developer
STO: XBRANE June 2022 Building 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: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer • XlucaneTM : Lucentis® biosimilar candidate under registration partnered with STADA and Bausch XlucaneTM –a + Lomb addressing €11.7b retinal anti-VEGF market2 +€100m annual • Near-term triggers: net-income • 2022: US FDA re-submission potential drug • H
Slide 4: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer
Slide 5: Biosimilars are highly similar but not identical to originator biologics
Biosimilars are highly similar but not identical to originator biologics Gene Living cell Protein Biological originator • Gene introduced to cell instructing it • Separation of the protein as active drug: to produce target protein substance in drug, typically patent protected Biosimilar: • Gene inst
Slide 6: Biosimilar development is faster, cheaper and with lower risk
Biosimilar development is faster, cheaper and with lower risk Novel biological drug ~10-12 years Discovery & Development Pre-clinical Phase I Phase II Phase III €1b investment Likelihood of Approval1 10% 50% Biosimilar Pre-clinical Phase I Phase III ~6-7 years €100m investment Likelihood of Approval
Slide 7: Biosimilars have claimed 40% market share by volume 12 months post launch
Biosimilars have claimed 40% market share by volume 12 months post launch EU biosimilar market share by volume US biosimilar market share by volume tim Filgras n o eti Ep tim ab ab ab t mum uzum p ilgras im ce b lix ma er Inf n Adali Peg-f uxi Trast Eta Ri t Average of 2-3 biosimilars per originator
Slide 8: Xbrane's proprietary technology enables high-yield at low unit cost
Xbrane’s proprietary technology enables high-yield at low unit cost LEMO™ – patented platform with superior yield… …leading to lower production cost LEMOTM Relative yield (g/L) (%) 100% ”Dimmer” 80% Standard system 60% 12x 5x 3x 40% ”On/Off” 20% 0% Membrane protein Average of Antib ody fragment • Fi
Slide 9: Xbrane has been validated by world-leading partners
Xbrane has been validated by world-leading partners with +€150m in paid and committed license fees/cost coverage Product XlucaneTM BIIB801TM Commercial Partner Territory Global ex. China North America Global Type Co-development License License Upfront €7.5m USD5m USD8m > €150m Milestones / Cost cove
Slide 10: Xbrane development portfolio addresses a market of €53 billion
Xbrane development portfolio addresses a market of € 53 billion Originator peak sales estimate 2026* (€ billion) 9 53 26 13 3 2 Biosimilar candidate Xlucane™ Xlucane BIIB801 Xcimzane Xdivane™ Xdivane Xtrudane™ Xtrudane Xdarzane™ Xdarzane Current Current portfolio portfolio Branded biologics Therapeu
Slide 11: Xlucane
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 11
Slide 12: Xlucane is a biosimilar candidate to Lucentis
XlucaneTM 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
Slide 13: Xlucane European regulatory approval expected H2 2022
XlucaneTM European regulatory approval expected H2 2022 2021 2022 2023 XlucaneTM pivotal phase III trial Interim read-out Full study data Regulatory process EU Regulatory process US (update on timeline within short) EU patent expiry originator 13
Slide 14: Xlucane is a highly similar biologic compared to Lucentis
XlucaneTM is a highly similar biologic compared to Lucentis® Biosimilar attribute to Lucentis® XlucaneTM Comment Identical amino-acid sequence Analytical Assessment • Involving +10 XlucaneTM batches Highly similar structure Comparative vs. +20 Lucentis® batches Highly similar binding properties • Co
Slide 15: The retinal anti-VEGF market generates annual net-sales of €11.7 billion
The retinal anti-VEGF market generates annual net-sales of € 11.7 billion Retinal anti-VEGF market (€b) Lucentis® and Eylea® similar in profile and pricing Off-label 14 Average no 6-8 6-8 6.7 6-8 doses first 12 year: 1: 9 % AGR ’16-’2 Price per €600 €800 €800 €100* 10 C unit EU: Price per €1850 €100
Slide 16: Bausch + Lomb and STADA addressing the €11.7b retinal anti-VEGF market
Bausch + Lomb and STADA addressing the €11.7b retinal anti-VEGF market €6.6b retinal anti-VEGF market €5.1b retinal anti-VEGF market • USD3.4b eye product and pharma specialist • €2.6b generic and biosimilar specialist • Existing ophthalmic sales force with strong • Dedicated cross European biosimil
Slide 17: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 17
Slide 18: Sustainability and purpose is at the core of Xbrane's business
Sustainability and purpose is at the core of Xbranes business Biologics provide revolutionary However with limited accessibility Leading to an unsustainable situation treatments • Severe eye disease (anti-VEGFs) • ”…less than two percent of Americans use • “…the highest attainable standard of • Immu
Slide 19: Xbrane has established a powerful R&D engine
Xbrane has established a powerful R&D engine High yield platform technology Diverse, qualified and motivated team State of the art lab facility Relative yield (g/L) (%) Xbrane team LEMO Stand ard 80 100% 80% 60 60% 40 40% 20% 0% + 20 + 0 Membrane Average of Antib ody protein 16 different fragment Q1
Slide 20: 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 2020 Rheumatoid Arthritis (RA) Psoriasis Cimzia® sales (€ millions) 2000 1500 PsO CD • Cimzia® is a TNFa inhibitor that reduce immune 1000 AxSpA response in auto
Slide 21: BIIB801 is the only publicly known biosimilar candidate referencing Cimzia
BIIB801 is the only publicly known biosimilar candidate referencing Cimzia® under development globally High yield achieved thanks to Xbrane platform BIIB801 program technology Relative yield (g/L) (%) LEMOTM • Pilot scale process established ”Dimmer 100% Standard ” system • Ongoing tech-transfer/sca
Slide 22: Partnership with Biogen around BIIB801
Partnership with Biogen around BIIB801 Biogen overview Attractive development and commercialization deal • Out-licensing of global rights • Develops and commercializes biological drugs • Xbrane responsible for and fund pre-clinical with primary focus on serious neurological development and neurodege
Slide 23: Building an oncology biosimilar portfolio
Building an oncology biosimilar portfolio Addressing €48 billion of combined annual reference Opportunity to make a difference expected peak product sales Combined annual expected peak reference product sales €b 50 45 Darzalex 40 35 30 • Annual per patient drug cost of SEK 0.5-1 25 Keytruda million
Slide 24: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer • XlucaneTM : Lucentis® biosimilar candidate under registration partnered with STADA and Bausch XlucaneTM –a + Lomb addressing €11.7b retinal anti-VEGF market2 +€100m annual • Near-term triggers: net-income • 2022: US FDA re-submission potential drug • H