Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (May 2021)
29 slides from Xbrane Biopharma AB's investor presentation, May 25, 2021
Slide 1: Building a World-Leading Biosimilar Developer
STO: XBRANE May 2021 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 : phase III Lucentis® biosimilar partnered with STADA and Bausch + Lomb addressing XlucaneTM –a €10b retinal anti-VEGF market2 +€100m annual • Multiple near-term triggers: net-income • Mid 2021: Top-line phase III data, potential drug • Q3/Q4
Slide 4: 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
Slide 5: Introduction to biosimilars
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer
Slide 6: 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 7: 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 8: 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 9: High barriers of entry limits competition amongst biosimilar developers
High barriers of entry limits competition amongst biosimilar developers High barriers of entry Xbrane has proven track-record • Cell-line to development • Complex development in-house capabilities and production • Patented high yield / low • Need for high yield / low cost platform technology cost te
Slide 10: 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 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 b
Slide 11: Xbrane is one of few publicly traded companies addressing the biosimilar market
Xbrane is the one of few publicly traded companies globally, directly addressing the biosimilar market growing with 25% on annual basis Global biosimilar market growing with 25% per year Strong growth drivers Global biosimilar market (€b) 100 Patent expiry of multiple blockbuster 1 biologics 80 5% I
Slide 12: Xbrane has a portfolio addressing +€11b of originator sales
Xbrane has a portfolio addressing +€11b of originator sales Originator Patent Sales Development Expected Commercialization Candidate Indication Next milestone Product Expiry 2020 Phase Launch Partner • Age-related macular degeneration • Diabetic macular 2020/22 Mid 2021 XlucaneTM €3.1b Phase III 202
Slide 13: Xlucane
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 13
Slide 14: 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 15: Top-line data from Xlucane pivotal phase III trial expected in mid 2021
Top-line data from XlucaneTM pivotal phase III trial expected in mid 2021 2020 2021 2022 XlucaneTM pivotal phase III trial • 583 wAMD patients across 15 countries and 135 clinics • Parallell double blinded equivalence trial with 12 month treatment schedule Regulatory process EU and US • Change in vi
Slide 16: The retinal anti-VEGF market generates annual net-sales of +€10b
The retinal anti-VEGF market generates annual net-sales of +€10b Retinal anti-VEGF market (€b) Lucentis and Eylea similar in profile and pricing Off-label 12 Average no 6-8 6-8 6.7 6-8 9 : 10% 10.4 doses first ’16-’1 10.1 10 CAGR year: 9.4 Price per €600 €800 €800 €100* 8.2 unit EU: 8 7.6 6,8 Price
Slide 17: Bausch + Lomb and STADA addressing the €10b retinal anti-VEGF market
Bausch + Lomb and STADA addressing the €10b retinal anti-VEGF market €6b retinal anti-VEGF market €4b retinal anti-VEGF market • €3.6b eye product and pharma specialist • €2.6b generic and biosimilar specialist • Existing ophthalmic sales force with strong • Dedicated cross European biosimilar team
Slide 18: Xlucane expected to generate net-income of +€100m three years after launch
XlucaneTM expected to generate net-income of +€100m three years after launch x 25% market share Lucentis® annual sales €3.1b1 x 50% price discount Implied annual sales €800m – Costs & profit splits XlucaneTM annual sales €400m XlucaneTM annual net-income +€100m 18 Note (1): Annual sales for Lucentis
Slide 19: Xlucane – significant potential upside beyond +€100m net-income target
XlucaneTM – significant potential upside beyond +€100m net-income target Potential upside +€100m Annual Annual net- net- Taking market Market expansion income share from Taking market share through more patients income from off-label Avastin® target Eylea® and doses per patient target Adressable Sal
Slide 20: Xcimzane
Building a world-leading biosimilar developer Introduction to biosimilars XlucaneTM Building a world-leading biosimilar developer 20
Slide 21: Xcimzane is the only publicly known biosimilar candidate to Cimzia
XcimzaneTM is the only publicly know biosimilar candidate to Cimzia® – a Rheumatoid Arthritis and Psoriasis drug XcimzaneTM is the only biosimilar candidate to Cimzia® is a niche €1.8b TNF inhibitor Cimzia under development globally Rheumatoid Arthritis (RA) Psoriasis Relative yield (g/L) (%) Xbrane
Slide 22: 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 allows regulation of production intensity… …leading to higher yield and lower cost O™ Relative yield (g/L) (%) LEM OTOR OM PR LEMO Standard LEMO™ GENE 100% PLASMID Dimmer 80% switch MARK 60% ER 12x 5x 3x
Slide 23: Xdivane is a frontrunner biosimilar candidate to Opdivo
XdivaneTM is a frontrunner biosimilar candidate to leading €6b immuno- oncology product Opdivo® Opdivo® is a leading €6b immuno-oncology Xdivane® is a frontrunner biosimilar candidate to product Opdivo® • High yield /low cost based on platform technology • On path to market approval at time of paten
Slide 24: Xbrane's set-up allows for initiation of one new biosimilar programme per year
Xbrane’s set-up allows for the initiation of one new biosimilar programme per year State-of-the-art pilot scale development lab established at Campus Solna (2000 m2) 80 companies Fermentation • Experienced team with capability to take products to market approval; 50 employees – 38% PhDs Purification
Slide 25: Xbrane has a stringent and proven target selection process
Xbrane has a stringent and proven target selection process Biological blockbusters World-leading high potential low risk portfolio Increase accessibility of 1 biologics Realize meaningful 2 savings LoE LOE in in + 7over years 7 years +2028 biological blockbusters Risk reduced and 3 diversified portf
Slide 26: Xlucane provides blueprint for upcoming development programs
XlucaneTM provides blueprint for upcoming development programs Approx. yearly development €5m €15*m €5m expense: *assuming 50% co-funding EU/US Pre-clinical Phase I and III reg. 2-3 years 3 years 1 year Approval Commercial scale manufacturing 95% Partnering with 50/50 78% co-funding of continued dev
Slide 27: Ambition to become cash-flow positive late 2023/early 2024
Xbrane´s ambition to become cash-flow positive late 2023/early 2024 while building broader portfolio …can be achieved with XlucaneTM as blueprint for coming Xbrane’s ambition… development programs 2021 2022 2023 2024 2025 • XlucaneTM EU / US approval 2022 Candidate and net-income of +€100m 2025 Xluc
Slide 28: 2021-2023 Milestones
2021-2023 Milestones Complementary deals in China, Japan and LATAM MAA BLA Xlucane™ filing filing Top-line phase III data Launch 2021-2023: Initiating development of 3 new biosimilar candidates H1 2021 H2 2021 H1 2022 H2 2022 2023 Xcimzane™ Xcimzane™ Xdivane™ Deal with Demonstrating Demonstrating co
Slide 29: Building a world-leading biosimilar developer
Building a world-leading biosimilar developer • XlucaneTM : phase III Lucentis® biosimilar partnered with STADA and Bausch + Lomb addressing XlucaneTM –a €10b retinal anti-VEGF market2 +€100m annual • Multiple near-term triggers: net-income • Mid 2021: Top-line phase III data, potential drug • Q3/Q4