Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — GT30, Stockholm (October 2017)
25 slides from Xbrane Biopharma AB's conference presentation, Oct 12, 2017
Slide 1: Investor presentation – 12 October 2017, GT30, Stockholm
PIONEER ING HIGH DEMAN D COMPLEX GENER ICS Investor presentation – 12 October 2017, GT30, Stockholm XBRANE BIOPHARMA AB
Slide 2: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • LONG TERM AMBITION
Slide 3: Significant biosimilar/complex generic market opportunity emerging
SIGNIFICANT BIOSIMILAR/COMPLEX GENERIC MARKET OPPORTUNITY EMERGING 100 BEUR 80 BEUR 30 BEUR Total sales of off-patent originator drugs 2.5 BEUR 2.5 Total sales of BEUR biosimilars and generics 2008 2015 2020 2025
Slide 4: Xbrane provides affordable medicines to a global population
XBRANE PROVIDES AFFORDABLE MEDICINES TO A GLOBAL POPULATION SPHEROTIDE: MITIGATE PROGRESSION OF PROSTATE CANCER XLUCANE: PREVENT BLINDNESS AMONGST ELDERY 4
Slide 5: Attractive risk/reward profile
ATTRACTIVE RISK/REWARD PROFILE Novel drugs Biosimilars/ Complex Small molecule generics generics Development cost: + $1 billion <$100 million <$10 million Likeliehood of success: 10% 50-75% 90% Price to originator 100% 70-80% Down to 10% drug: Differentiators: • Patent protection • Development capab
Slide 6: Xbrane has development capability and proprietary low cost production tech
XBRANE HAS DEVELOPMENT CAPABILITY AND PROPRIETARY LOW COST PRODUCTION TECH BIOSIMILARS LONG ACTING INJECTABLES • 16 employees, 7 PhDs, 89 scientific • 4 employees (2 PhDs), external articles, 1 patent development team of 6 scientists • Patented low cost production • Deep expertise and know how in te
Slide 7: Experienced organisation with deep expertise in Sweden and Italy
EXPERIENCED ORGINASATION WITH DEEP EXPERTIESE IN SWEDEN AND ITALY MANAGEMENT TEAM BOARD OF DIRECTORS MARTIN ÅMARK SAEID ESMAEILZADEH CEO Ph.d, Chairman of the board • M Sc. in Industrial Engineering and Management from Lith and MBA INSEAD • Professor in Material Chemistry from Stockholms universitet
Slide 8: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • LONG TERM AMBITION
Slide 9: Xlucane – prevent blindness amongst elderly
XLUCANE – PREVENT BLINDNESS AMONGST ELDERLY • Biosimilar of Lucentis® with global sales of 3.2 BUSD, global segment sales of approx. 8 BUSD (VEGFa inhibitor market) • Used in treatment of several severe eye diseases that leads to deteriorated vision and in worst case blindness amongst elderly • Curr
Slide 10: Patented technology up to 8x as productive in production of proteins
PATENTED TECHNOLOGY UP TO 8X AS PRODUCTIVE IN PRODUCTION OF PROTEINS PATENTED TECHNOLOGY: REGULATING PRODUCTION RESULTS: +8X MORE PRODUCTIVE AND UP TO 85% LOWER INTENSITY IN E.COLI INCREASE OVERALL PRODUCTIVITY PRODUCTION COST VS. STANDARD SYSTEMS STANDARD SYSTEMS: Production cost (index) ON AND OFF
Slide 11: Biosimilars/complex generic development focus is analytical similarity
BIOSIMILARS/COMPLEX GENERIC DEVELOPMENT FOCUS IS ANALYTICAL SIMILARITY BIOSIMILAR/COMPLEX GENERICS NOVEL DRUGS Pilot scale production and analytical similarity Production and analytical GMP commercial scale characterization production and analytical similarity Phase I/II Phase I/III Phase III
Slide 12: Xlucane program overview
XLUCANE PROGRAM OVERVIEW DEVELOPMENT STEPS • PROGRAM OVERVIEW • Achieved high level of analytical similarity in accordance with EMA/FDA requirements Pilot scale production and analytical similarity • High yield expression technology leads to low COGS • Scale up in collaboration with CMO BiotechPharm
Slide 13: Xlucane: achieved high level of analytical similarity
XLUCANE: ACHIEVED HIGH LEVEL OF ANALYTICAL SIMILARITY Primary structure Purity The percentage of the actual The amino acid sequence specific protein relative to potential impurities Biological activity Higher order structure The actual biological effect on The way the amino acid sequence has human c
Slide 14: Xlucane: the commercial opportunity
XLUCANE: THE COMMERCIAL OPPORTUNITY ORIGINATOR SALES PRICE PENETRATION TREATMENT DAYS 4 EU average biosimliar price as % of EU average biosimilar penetration vs. EU average increase in treatment days of originator originator product from launch of biosimilar to 2015 90% 100% $3.2BN G-CSF 110% 80% HG
Slide 15: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • LONG TERM AMBITION
Slide 16: Spherotide - mitigate progression of cancer
SPHEROTIDE - MITIGATE PROGRESSION OF CANCER • Worlds first generic to Decapeptyl® with global sales of 0.5 BUSD, global segment sales of approx. 3 BUSD (GnRH analogues) • Regulate hormone levels to mitigate progression of cancer (prostate cancer and breast cancer) • Also used in treatment of endomet
Slide 17: GMP certified production line for long acting injectables
GMP CERTIFIED PRODUCTION LINE FOR LONG ACTING INJECTABLES TECHNOLOGY PRODUCTION FACILITY • Proprietary equipment – low cost approach • GMP certified as of February 2017 Active ingredient (API) encapsulated in microsphere of biodegradable polymer Active ingredient (API) released in controlled way ove
Slide 18: Spherotide program overview
SPHEROTIDE PROGRAM OVERVIEW DEVELOPMENT STEPS • PROGRAM OVERVIEW • Achieved high level of analytical similarity for 1 month and Pilot scale production and 3 month formulations analytical characterization • Similar PD/PK behaviour in mini-pigs/rats as originator • Proprietary commercial scale GMP pro
Slide 19: Spherotide: the commercial opportunity
SPHEROTIDE: THE COMMERCIAL OPPORTUNITY ORIGINATOR SALES (2015) PRICING PENETRATION Average generic price as % of originator price Average generic penetration (%) 625 100 100 500 MUSD 500 Americas 75 75 Expected span for Spherotide Average penetration around 65% Middle East and Africa 375 M USD Asia
Slide 20: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • LONG TERM AMBITION
Slide 21: Xbrane long term ambition
XBRANE LONG TERM AMBITION Become a world leading Build strong local developer of biosimilars and Lead on proprietary low competence in complex generics production cost technology biosimilar/complex generics • Contribute actively to global • Expand technological • Strong local resource and health equ
Slide 22: Appendix
XBRANE APPENDIX
Slide 23: Shareholders and share data
SHAREHOLDERS AND SHARE DATA LIST OF SHAREHOLDES, 2017-09-30 MARKET CAP DEVELOPMENT OVER TIME (SINCE XBRANE IPO) Shareholder No. of shares Ownership, % XBRANE Share price development 120 Serendipity Ixora AB 1,295,723 21.75% 100 Paolo Sarmientos 327,295 5.49% 80 Försäkringsaktiebolaget Avanza pension
Slide 24: Xbrane valuation considerations
XBRANE VALUATION CONSIDERATIONS SELECTED RELEVANT BIOSIMILAR LICENSING DEALS PEER GROUP VALUATION Current market Number of Lead biosimilar Originator Up-front Lead biosimilar candidate Date Company Partner Milestones Royalties Other Company capitalization products in candidate product payment develo
Slide 25: 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