Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (May 2018)
28 slides from Xbrane Biopharma AB's investor presentation, May 2018
Slide 1: Investor presentation: Xbrane Biopharma AB
PIONEER ING HIGH DEMAN D COMPLEX GENER ICS Investor presentation XBRANE BIOPHARMA AB Pioneering biosimilar development
Slide 2: Disclaimer & Risk Factors
DISCLAIMER & RISK FACTORS DISCLAIMER An investment in the shares of Xbrane Biopharma AB (publ) (“Xbrane” or the “Company”) is associated with various risks. A number of factors influence, or can influence, Xbrane’s operations, both directly and indirectly. According to the Company, the key risk fact
Slide 3: Agenda
AGENDA • WHY INVEST IN THE BIOSIMILAR MARKET? • WHY INVEST IN XBRANE BIOPHARMA? • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • BIOSIMILAR PIPELINE
Slide 4: Why invest in biosimilars?
WHY INVEST IN BIOSIMILARS? • Biosimilar market expected to grow with +20 % CAGR 2017-2025 driven by; • Blockbuster biologics losing patent protection leading to +€100 B of accessible market for biosimilars in 20251. Biosimilars is a fast • Pressure from payers and regulators leading to rapidly incre
Slide 5: Biosimilars is a fast growing segment expected to grow with +20% CAGR 2017-2025
BIOSIMILARS IS A FAST GROWING SEGMENT EXPECTED TO GROW WITH +20% CAGR 2017-2025 Market drivers +• Blockbuster biologics patent expiration. €100B +• Pressure from payers and regulators. €80B +• Increased patient accessibility. €30B €25B Total sales of off-patent €15B biological drugs €5,5B €2.5B €2,5
Slide 6: Biosimilars pose opportunity to develop sizable high profitability products
BIOSIMILARS POSE OPPORTUNITY TO DEVELOP SIZABLE HIGH PROFITABILITY PRODUCTS Global biosimilar sales by molecule 2017 (€B) 1,5 €1.2 B 1 €0.7 B €0.6 B €0.6 B 0,5 €0.3 B 0 Filgrastim EPO HGH Infliximab Rituximab 2006 (EU) 2004 (EU) 2015 (EU) 2013 (EU) Patent expiry: 2008 2013 (US) 2013 (US) 2018 (US) 2
Slide 7: Biosimilars has low development risk compared to novel drugs
BIOSIMILARS HAS LOW DEVELOPMENT RISK COMPARED TO NOVEL DRUGS Phase I/II Phase III + NDA/BLA Biosimilars: 78% Novel drugs: 10% Biosimilars: 88% 89% Novel drugs: 20% 49% Source: Informa Pharma's Biomedtracker database
Slide 8: Agenda
AGENDA • WHY INVEST IN THE BIOSIMILAR MARKET? • WHY INVEST IN XBRANE BIOPHARMA? • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • BIOSIMILAR PIPELINE
Slide 9: Why invest in Xbrane Biopharma?
WHY INVEST IN XBRANE BIOPHARMA? Unique innovative • Company founded based on patented technological platform that yields up to 12x compared to standard patented high yield systems in E.coli. technology • Team jointly having been involved in development and commercialization of +30 pharmaceuticals. E
Slide 10: Unique innovative patented high yield technology
UNIQUE INNOVATIVE PATENTED HIGH YIELD TECHNOLOGY PATENTED TECHNOLOGY: REGULATING PRODUCTION RESULTS: UP TO 12X YIELD COMPARED TO STANDARD INTENSITY IN E.COLI INCREASE OVERALL PRODUCTIVITY SYSTEMS XBRANE YIELD ADVANTAGE OVER STANDARD SYSTEMS: STANDARD SYSTEM IN ACADEMIC PAPERS (indexed) ON AND OFF 14
Slide 11: Experienced team involved in development and commercialization of +30 pharmaceuticals
EXPERIENCED TEAM HAVING BEEN INVOLVED IN DEVELOPMENT AND COMMERCIALIZATION OF +30 PHARMACEUTICALS BOARD OF DIRECTORS MGMT TEAM Jointly development or commercialization lead of over 25 marketed drugs Jointly involved in development of over 5 marketed products Jointly over 100 years of professional ph
Slide 12: Portfolio of niche products with limited competition
PORTFOLIO OF NICH PRODUCTS WITH LIMITED COMPEITITION Originator sales Patent Biosimilar Candidate Biosimilar to (€B) expiry Development stage competition ”Leading biosimilar • 2-3 competitors Ranibizumab 2022 (EU) • Pivotal clinical trial being initiated 2018 targeting € 2.8 B Xlucane 2.8 for regula
Slide 13: Out-license deal with CR Pharmaceuticals for China concluded Q1 2018
OUT-LICENSE DEAL WITH CR PHARMACEUTICALS FOR CHINA CONCLUDED Q1 2018 – NEAR TERM LICENSING VALUE CREATION OPPORTUNITIES IN EUROPE AND US • CR Pharma is Chinas second largest pharma distributor with sales over $20 B • License agreement granting CR Pharma exclusive sales and marketing rights of Sphero
Slide 14: Agenda
AGENDA • WHY INVEST IN THE BIOSIMILAR MARKET? • WHY INVEST IN XBRANE BIOPHARMA? • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • BIOSIMILAR PIPELINE
Slide 15: Xlucane addresses unmet medical need in limited competitive field
XLUCANE ADDRESSES UNMET MEDICAL NEED IN LIMITED COMPETITIVE FIELD Significant market • Prevalence of +60 million, only 1.5-2.5 million patients treated with opportunity VEGFa inhibitors generating sales of +€7.6B • High level of analytical similarity to originator demonstrated Ready to enter • Agree
Slide 16: Current market at €7.6B and only 3-4% of potential patients treated
CURRENT MARKET AT €7.6B AND ONLY 3-4% OF POTENTIAL PATIENTS TREATED • Disease: Wet age-related macular degeneration and swelling in the retina caused by diabetes or by a blockage in the blood vessels.1 If untreated leading to blindness. • VEGFa inhibitor mode of action: binds to the growth factor VE
Slide 17: Xlucane ready to enter confirmatory clinical trials
XLUCANE READY TO ENTER CONFIRMATORY CLINICAL TRIALS Commercial scale production process and Confirmatory clinical trial MAA/BLA analytical similarity 2019/2020 2020/2021 2015-2018 High yield expression technology leads Agreement on design Submission to low COGS. of pivotal phase I/III anticipated tr
Slide 18: Xlucane has demonstrated high level of analytical similarity to originator
XLUCANE HAS DEMONSTRATED HIGH LEVEL OF ANALYTICAL SIMILARITY TO ORIGINATOR Quality of attribute Method Lucentis® Xlucane Comment Amino acid sequence LC-MS peptide mapping N/A N/A Identical. 100% coverage. Molecular mass (Da) LC-MS intact protein 48,380.02 - 48,380.06 48,379.82 - 48,379.85 Expected m
Slide 19: Global accelerated clinical program enabling global marketing authorization
GLOBAL ACCELERATED CLINICAL PROGRAM ENBLING GLOBAL MARKETING AUTHORIZATION Start Recruitment Treatment 9 months 12 months Xlucane • Multi-regional clinical trial with 160 sites 290 patients across Europe, US, India, China and Russia. • Enable Marketing Authorization across key markets globally. Luce
Slide 20: Xlucane has annual sales potential of +€250 million at high gross margin
XLUCANE HAS ANNUAL SALES POTENTIAL OF +€250 MILLION AT HIGH GROSS MARGIN +0.5 M patients treated with ranibizumab Expected biosimilar penetration +80% Pricing likely 20-40% below originator VEGFa inhibitor patients1 Average biosimilar penetration Europe2 Average biosimilar price vs. originator Europ
Slide 21: Agenda
AGENDA • WHY INVEST IN THE BIOSIMILAR MARKET? • WHY INVEST IN XBRANE BIOPHARMA? • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • BIOSIMILAR PIPELINE
Slide 22: Spherotide is the world's first generic to long acting triptorelin
SPHEROTIDE IS THE WORLDS FIRST GENERIC TO LONG ACTING TRIPTORELIN Significant market • GnRH analogues constitute a market of €32 B in treatment of mainly prostate opportunity and breast cancer with prevalence of approx. 10 million patients globally. • High level of in-vitro analytical similarity to
Slide 23: GnRH analogues used in treatment of prostate and breast cancer
GNRH ANALOGUES USED IN TREATMENT OF PROSTATE AND BREAST CANCER • Disease: Prostate cancer, breast cancer, endometriosis and myoma. • GnRH analogue mode of action: Suppresses testosterone/ estradiol production and thereby mitigate progression of hormone dependent cancers. • Prevalence/Patients treate
Slide 24: Spherotide ready to enter confirmatory clinical trials
SPHEROTIDE READY TO ENTER CONFIRMATORY CLINICAL TRIALS Commercial scale production process and Confirmatory clinical trial MAA analytical similarity 2019 2020/2021 2015-2018 Achieved high level of analytical Agreement on design Submission similarity for 1 month and 3 month of pivotal confirmatory an
Slide 25: Spherotide has annual sales potential of +€100 million
SPHEROTIDE HAS ANNUAL SALES POTENTIAL OF +€100 MILLION4 +0.4 M patients treated with triptorelin Expected penetration +65% Limited discount to originator* required Prostate and breast cancer patients1 Average generic penetration by region2 Average generic price as % of originator price3 +10 M +10 M
Slide 26: Agenda
AGENDA • WHY INVEST IN THE BIOSIMILAR MARKET? • WHY INVEST IN XBRANE BIOPHARMA? • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • BIOSIMILAR PIPELINE
Slide 27: Pipeline targeting opportunities with low competition leveraging proprietary high yield technology
PIPELINE TARGETING OPPORTUNITIES WITH LOW COMPETITION LEVERAGING PROPRIETARY HIGH YIELD TECHNOLOGY Xoncane Xcimzane Biosimilar to: Oncaspar (pegaspargase) Cimzia (certolizumab pegol) Originator sales: €0.2 B €1.4 B Patent expiry: Expired 2024 Competition: One public program for regulated markets No
Slide 28: Why invest in Xbrane Biopharma?
WHY INVEST IN XBRANE BIOPHARMA? Unique innovative • Company founded based on patented technological platform that yields up to 12x compared to standard patented high yield systems in E.coli. technology • Team jointly having been involved in development and commercialization of +30 pharmaceuticals. E