Vator Unicorn Summit 7th of March XBRANE BIOPHARMA AB (publ)

Transcription

1 P I O N EERIN G HIGH D EMA N D COMPL EX GENERICS Vator Unicorn Summit 7th of March 2017 XBRANE BIOPHARMA AB (publ) VATO R S EC U R I T I E S REGUL ATED BY THE SWEDISH FSA

2 XBRANE PROVIDES AFFORDABLE MEDICINES TO A GLOBAL POPULATION SPHEROTIDE: PREVENT PROGRESSION OF PROSTATE CANCER 2 XLUCANE: PREVENT BLINDNESS AMONGST ELDERY

3 XBRANE TARGETS THE EMERGING BIOSIMILAR AND GENERIC LONG ACTING INJECTABLE MARKET First wave targets XLUCANE BEUR» Patented low-cost technology» Originator sales 3,6 BUSD SPHEROTIDE» Worlds first generic» Iran BEUR» EU/US 2022/2021» Originator sales 0,5 BUSD» Iran BEUR» EU/US 2019 Total sales of off-patent originator drugs Total sales of biosimilars and generics 2,5 BEUR 2,5 BEUR

4 SPHEROTIDE: THE TECHNOLOGY Active substance encapsulated in microspheres made of biodegradable polymer Polymer degrades in controlled way after injection and releases active substance

5 SPHEROTIDE: GMP APPROVED FACILITY WITH CAPACITY TO COVER GLOBAL DEMAND OVERVIEW PRODUCTION FACILITY Located in Italy Production line for microsphere encapsulation (API from top EU supplier) Capacity to produce global sales of originator product GMP certified as of Feb 2017

6 SPHEROTIDE: THE COMMERCIAL OPPORTUNITY ORIGINATOR SALES MUSD Americas 375 PRICING PENETRATION Average generic Average generic price as % of originator price penetration (%) Middle East and Africa Expected span for Spherotide M USD Asia Europe Number of generic competitors Source: IMS Health, FDA *Calculated on basis of average penetration of 65% and 50% price reduction vs. originator Average penetration around 65% +150 MUSD annual sales potential* No generic competition Europe US Japan Iran China

7 SPHEROTIDE: REVENUE GENERATION Region Partner China Europe Rest of world Xlucane Iran Rest of world Middle East Spherotide 2016 Originator sales (MUSD) Annual peak product sales potential (MUSD)* License income potential (MUSD) (2 upfront in 2017) >8 30 Limited n/a 20** Limited *** Finalization of partnership Outlicensing ongoing Upfront Upfront Ongoing discussion s other Helvetic Biopharma Outlicensing ongoing Royalties** Product sales/ Royalties * to be shared by Xbrane and Xbrane commercialization partner. Indicatively 50/50 revenue sharing, but will differ from market to market. Peak product sales potential estimated on the basis of current market size assuming adequate pice reduction vs. originator,penetration in line with average generic/biosimilar penetration in respective region and equal market share as expected generic/biosimilar competitors **Xbrane gets royalty on sales in line with industry standard ***Based on deal structures of out-licensing of other ranibizumab biosimilars

8 XLUCANE: PATENTED TECHNOLOGY UP TO 8X AS PRODUCTIVE IN PRODUCTION OF PROTEINS PATENTED TECHNOLOGY: REGULATING PRODUCTION INTENSITY IN E.COLI INCREASE OVERALL PRODUCTIVITY Mycket socker tilsatt STANDARD SYSTEMS: ON AND OFF Optimal sockerkoncentration Lite socker tillsatt RESULTS: +8X MORE PRODUCTIVE AND UP TO 85% LOWER PRODUCTION COST VS. STANDARD SYSTEMS Production cost (index) XBRANE TECH: REGULATE PRODUCTION INTENSITY 75 Målprotein 85% 50 IPTG önskat mrna μm rhamnose PRODUCTION IN E.COLI CELLS VINNOVA-NYTT JUNI St Produktionskostnad an da rd sy st plemo Note: Based on average of in total 10 different customer projects ne 0 Xb ra T7RNAP LysY Typisk prisnivå för pet vanlig generika em T7RNAP

9 XLUCANE: POSITIVE IN-VITRO BIOSIMILARITY DATA Primary structure Purity The amino acid sequence The percentage of the actual specific protein relative to potential impurities Biological activity Higher order structure The way the amino acid sequence has folded itself due to bondings to itself Binding characteristics The way the protein binds to the specific target it is supposed to bind to in the human body VEGFa Ranibizumab Ranibizumab The actual biological effect on human cells when the protein binds to the specific target

10 XLUCANE: THE COMMERCIAL OPPORTUNITY ORIGINATOR SALES 4 3,6 B USD PRICE REDUCTION VS. ORIGINATOR EU average biosimliar price as % of originator 90 % EU average biosimilar penetration vs. originator % Rest of world 3 PENETRATION Filgrastim Somatropin EPO Asia 80 % 75 % Western Europe B USD Europe US 70 % 50 % 60 % 25 % 50 % 0% Global sales of Lucentis Source: IMS Health, FDA *Calculated on basis of average penetration of 65% and 50% price reduction vs. originator Filgrastim EPO Somatropin Years after launch +1,2 BUSD biosimilar market* Xbrane one of 3 competitors 7 8

11 XBRANE REVENUE GENERATION Region Partner China Europe Rest of world Xlucane Iran Rest of world Middle East Spherotide 2016 Originator sales (MUSD) Annual peak product sales potential (MUSD)* License income potential (MUSD) (2 upfront in 2017) >8 30 Limited n/a 20** Limited *** Finalization of partnership Outlicensing ongoing Upfront Upfront Ongoing discussion s other Helvetic Biopharma Outlicensing ongoing Royalties** Product sales/ Royalties * to be shared by Xbrane and Xbrane commercialization partner. Indicatively 50/50 revenue sharing, but will differ from market to market. Peak product sales potential estimated on the basis of current market size assuming adequate pice reduction vs. originator,penetration in line with average generic/biosimilar penetration in respective region and equal market share as expected generic/biosimilar competitors **Xbrane gets royalty on sales in line with industry standard ***Based on deal structures of out-licensing of other ranibizumab biosimilars

12 MILESTONES FOR 2017 H2: Closure of outlicensing deal in Europe H2: Initiation pivotal phase III clinical studies H1: Closure of outlicensing deal in China. License value of 8 MUSD H2: in Iran Q1: First batch delivered to partner in Iran for 7 MSEK H2: Closure of global outlicensing deal. Similar deals with license value + MUSD

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