Xbrane Biopharma AB · OMXSTO:XBRANE
Xbrane Biopharma AB — Investor Presentation (March 2018)
25 slides from Xbrane Biopharma AB's investor presentation, Mar 21, 2018
Slide 1: Investor presentation Xbrane Biopharma AB
PIONEER ING HIGH DEMAN D COMPLEX GENER ICS Investor presentation 2018-03-21 XBRANE BIOPHARMA AB
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 • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • SECOND WAVE TARGETS • TRIGGERS FOR 2018
Slide 4: Xbrane at a glance
XBRANE AT A GLANCE • Developer of biosimilars and generic long acting injectables • Low cost technology platforms • Patented high yield microbial protein expression platform for low cost biosimilar production • Proprietary low cost GMP certified production facility for encapsulation of peptides in P
Slide 5: Biosimilars/complex generics have attractive risk/reward profile
BIOSIMILARS/COMPLEX GENERICS HAS ATTRACTIVE RISK/REWARD PROFILE AND OFFERS DIFFERENTIATION OPPORTUNITY IN DEVELOPMENT AND PRODUCTION Novel drugs Biosimilars/ Complex Small molecule generics generics Development cost: + $1 billion <$100 million <$10 million Likelihood of success: 10% 50-75% 90% Price
Slide 6: Xbrane has patented technology up to 8x as productive in biosimilars
XBRANE HAS PATENTED TECHNOLOGY UP TO 8X AS PRODUCTIVE IN PRODUCTION OF BIOSIMILARS PATENTED TECHNOLOGY: REGULATING PRODUCTION RESULTS: +8X MORE PRODUCTIVE AND UP TO 85% LOWER INTENSITY IN E.COLI INCREASE OVERALL PRODUCTIVITY API PRODUCTION COST VS. STANDARD SYSTEMS STANDARD SYSTEMS: Production cost
Slide 7: Experienced team with deep expertise in pharmaceutical development
EXPERIENCED TEAM WITH DEEP EXPERTISE IN PHARMACEUTICAL DEVELOPMENT MANAGEMENT TEAM BOARD OF DIRECTORS Jointly involved in development of over 5 marketed products Jointly development lead of over 20 marketed drugs Jointly over 60 years of professional pharma experience Jointly over 100 years of profe
Slide 8: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • SECOND WAVE TARGETS • TRIGGERS FOR 2018
Slide 9: Xlucane is a biosimilar to Lucentis, targeting severe eye diseases
XLUCANE IS A BIOSIMILAR TO LUCENTIS®, TARGETING SEVERE EYE DISEASES AMONGST ELDERLY • Biosimilar of Lucentis® with global sales of USD 3.2 B, global segment sales of approx. USD 8 B (VEGFa inhibitor market) • Used in treatment of several severe eye diseases that leads to deteriorated vision and in w
Slide 10: Xlucane development program: path to approval
XLUCANE DEVELOPMENT PROGRAM: PATH TO APPROVAL 6 MONTHS PRIOR TO EU PATENT EXPIRY DEVELOPMENT STEPS STATUS COMMENTS • Achieved high level of analytical similarity in accordance with Pilot scale production and EMA/FDA requirements (SA from EMA/FDA) analytical similarity • High yield expression technol
Slide 11: 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 48380.02 - 48380.06 48379.82 - 48379.85 Expected mass
Slide 12: Xbrane estimates Lucentis poses a biosimilar market opportunity
XBRANE ESTIMATES THAT LUCENTIS POSE A USD 1 B BIOSIMILAR MARKET 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 t
Slide 13: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • SECOND WAVE TARGETS • TRIGGERS FOR 2018
Slide 14: Spherotide is world's first generic to Decapeptyl
SPHEROTIDE IS WORLDS FIRST GENERIC TO DECAPEPTYL • 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 end
Slide 15: Xbrane has a GMP certified production line for long acting injectables
XBRANE HAS A 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 contr
Slide 16: Spherotide development program: path to MAA submission
SPHEROTIDE DEVELOPMENT PROGRAM: PATH TO MAA SUBMISSION Q4 2019 DEVELOPMENT STEPS STATUS COMMENTS • Achieved high level of analytical similarity for 1 month and 3 month formulations Pilot scale production and analytical similarity • Similar PD/PK behaviour in mini-pigs/rats as originator demonstrated
Slide 17: Spherotide has demonstrated similar suppression of testosterone in mini pigs
SPHEROTIDE HAS DEMONSTRATED SIMILAR SUPPRESSION OF TESTOSTERONE IN MINI PIGS COMPARED TO ORIGINATOR •Performed by CiTox in Denmark under GLP conditions •5+5 minipigs receiving one dose of Spherotide 3,75 vs. Decapeptyl 3,75 •No significant difference in testosterone suppression 17 performed by Citox
Slide 18: Xbrane estimates Decapeptyl poses a generic market opportunity
XBRANE ESTIMATES THAT DECAPEPTYL® POSES A + USD 150 M GENERIC MARKET OPPORTUNITY; SPHEROTIDE WORLDS FIRST GENERIC 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 Spher
Slide 19: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • SECOND WAVE TARGETS • TRIGGERS FOR 2018
Slide 20: Xbrane is building a biosimilar powerhouse
XBRANE IS BUILDING A BIOSIMILAR POWERHOUSE First wave targets Publicly announced 100 BEUR second wave biosimilar targets Treatment of leukemia Annual sales 2017: +200 MUSD 80 BEUR No biosimilars in Europe/US despite patent expiration 30 BEUR Treatment of rheumatoid arthritis Total sales of Annual sa
Slide 21: Agenda
AGENDA • INTRODUCTION AND COMPANY SUMMARY • XLUCANE PROGRAM • SPHEROTIDE PROGRAM • SECOND WAVE TARGETS • TRIGGERS FOR 2018
Slide 22: Xbrane has so far successfully executed on its business plan
XBRANE HAS SO FAR SUCCESSFULLY EXECUTED ON ITS BUSINESS PLAN IMPORTANT TRIGGERS UPCOMING DURING 2018 GMP Out-licensing MAA EU Launch certification China Product peak sales Spherotide EU/US potential: Launch Iran license deal 150 MUSD Initiate clinical trial 2017 2018 2019 2020 2021 2022 Biosimilarit
Slide 23: Thank you
THANK YOU ‣Subscribe to newsletter: www.xbrane.com
Slide 24: Shareholders and share data
SHAREHOLDERS AND SHARE DATA LIST OF SHAREHOLDES, 2017-09-30 MARKET CAP DEVELOPMENT Shareholder No. of shares Ownership, % Serendipity Ixora AB 1,295,723 21.75% Paolo Sarmientos 327,295 5.49% Försäkringsaktiebolaget Avanza pension 260,461 4.37% Nordnet Pensionsförsäkring AB 188,657 3.17% Michael Löfm
Slide 25: 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
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