Xbrane Biopharma Ab · OMXSTO:XBRANE
Xbrane Biopharma Ab — Investor Presentation (February 2022)
22 slides from Xbrane Biopharma Ab's investor presentation, February 2022
Slide 1: Building a World-Leading Biosimilar Developer
STO: XBRANE February 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 • Multiple near-term triggers: net-income • Q1 2022: US regulatory submission po
Slide 4: Introduction to biosimilars
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 taken 40% volume market share 12 months post launch
Biosimilars have taken 40% volume market share 12 months post launch EU biosimilar volume market share US biosimilar volume market share tim Filgras n o eti Ep tim ab ab ab t mum uzum ilgras p im ce b lix ma er Inf n Adali Peg-f Trast uxi Eta Ri t Average of 2-3 biosimilars per originator product an
Slide 8: Xbrane's proprietary technology enables high-yield & low unit cost
Xbrane’s proprietary technology enables high-yield & low unit cost LEMO™ – patented platform with superior yield… …leading to lower production cost Relative yield (g/L) (%) LEMOTM ”Dimmer 100% Standard ” system ”On/Off” 80% 60% 12x 5x 3x 40% 20% 0% Membrane Average of Antibody • Fixed cost per batch
Slide 9: Xbrane has a portfolio addressing €32 billion of reference product sales
Xbrane has a portfolio addressing €32 billion of reference product sales Reference Patent Sales Development Commercialization Candidate Indication Next milestone Product Expiry 2021 Phase Partner • Age-related macular degeneration Q1 2022 : US • Diabetic macular 2020/22 XlucaneTM €3.2b Registration
Slide 10: Xlucane
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 10
Slide 11: Xlucane is a biosimilar to Lucentis for treatment of severe eye diseases
XlucaneTM is a biosimilar to Lucentis® for treatment of severe eye diseases 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
Slide 12: Xlucane European regulatory approval expected H2 2022
XlucaneTM European regulatory approval expected H2 2022 2020 2021 2022 XlucaneTM pivotal phase III trial • 583 wAMD patients across 15 countries and 135 clinics • Met primary end-point: XlucaneTM demonstrating equivalence to Lucentis in BCVA improvement at week 8 Regulatory process EU and US • Xluca
Slide 13: The retinal anti-VEGF market generates annual net-sales of €11.7b
The retinal anti-VEGF market generates annual net-sales of €11.7b 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* 8 8,3 un
Slide 14: 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 15: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 15
Slide 16: Xbrane has established a powerful R&D engine
Xbrane has established a powerful R&D engine Diverse, qualified and motivated High yield platform technology State of the art lab facility team Relative yield (g/L) (%) Xbrane team LEMO Stand ard 60 100% 80% 40 60% 40% 20 20% 0% + + 0 Membrane Average of Antib ody protein 16 different fragment Q1 20
Slide 17: 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 response in 1000 auto-immun
Slide 18: Xcimzane is the only publicly known biosimilar candidate referencing Cimzia
XcimzaneTM is the only publicly known biosimilar candidate referencing Cimzia® under development globally High yield achieved thanks to Xbrane platform XcimzaneTM program technology Relative yield (g/L) (%) LEMOTM • Pilot scale process established ”Dimmer 100% Standard ” system • Ongoing tech-transf
Slide 19: Biogen as development and commercialization partner for Xcimzane
Biogen as development and commercialization partner for XcimzaneTM Attractive development and commercialization Biogen overview deal • Out-licensing of global rights to XcimzaneTM • Develops and commercializes biological drugs • Xbrane responsible for and fund pre-clinical with primary focus on seri
Slide 20: Building an oncology biosimilar portfolio
Building an oncology biosimilar portfolio Addressing €27 billion of combined annual Opportunity to make a difference reference product sales Combined annual reference product sales €b 30 25 20 Darzalex • Annual per patient drug cost of SEK 0.5-1 15 million - significant issues with accessibility Key
Slide 21: 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 • Multiple near-term triggers: net-income • Q1 2022: US regulatory submission po
Slide 22: Experienced management team and board
Experienced management team and board Management Board of Directors Martin Åmark Siavash Bashiri Anders Tullgren Eva Nilsagård Karin Wingstrand Mats Thoren David Vikström Anders Wallström Erik Domines CEO COO Chairman of the Director of the Board Director of the Director of the CTO Head of General C
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