Epigenomics AG · GETTEX:ECX
Epigenomics — Investor Presentation (March 2014)
25 slides from Epigenomics's investor presentation, March 2014
Slide 1: Epigenomics AG Corporate Presentation
Epigenomics AG Corporate Presentation March 2014 www.epigenomics.com
Slide 2: Safe Harbor
Safe Harbor Forward Looking Statements This communication contains certain forward-looking statements, including, without limitation, statements containing the words “expects”, “future”, “potential” and words of similar import. Such forward-looking statements involve known and unknown risks, uncer
Slide 3: Overview
Overview Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 3 | March 2014
Slide 4: Products and Competencies
Products and Competencies DNA methylation based diagnostic products for oncology Two products CE marked in EU – PMA for Epi proColon® under FDA review Epi proColon® for blood based colorectal Epi proLung® confirmatory tissue assay cancer screening for lung cancer diagnosis Addressing low complia
Slide 5: Overview
Overview Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 5 | March 2014
Slide 6: Colorectal Cancer: A Treatable Disease
Colorectal Cancer: A Treatable Disease 140,000 new cases and 50,000 deaths per year US$ 14bn spent annually on CRC care 60% diagnosed in later stages Higher incidence and mortality in minorities USPSTF recommendation: colonoscopy every 10y or annual FIT between age 50-75 1 in 3 US citize
Slide 7: Blood-Testing Helps to Increase Compliance
Blood-Testing Helps to Increase Compliance Accepted colonoscopy Opted for blood based test Refused colonoscopy Opted for stool test or no test 37% 14% 63% 83% 3% 97% Demonstrated acceptance of blood test for CRC Screening in study with 174 subjects1) Surveys by Huntsman Cancer Center in the US c
Slide 8: Epi proColon a Simple and Efficient Assay for CRC Screening
Epi proColon® a Simple and Efficient Assay for CRC Screening Single blood tube draw (EDTA purple top) as part of routine visits, no dietary restrictions Single epigenetic biomarker: methylated Septin9 real-time PCR test, runs on existing hardware (ABI 7500 Fast Dx, Roche LC 480, others) Easy
Slide 9: Epi proColon: Clinical Data
Epi proColon®: Clinical Data Prospective FIT screening study comparative PRESEPT Study FDA submission study EU CE Study5 February 20101 December 2011 December 2012 2011 Samples 7,940 7,940 3012 2504 Sensitivity 51%/67%2 68% 73%4 81% Specificity 91%/88%2 80% 82% 99% Septin9 Epi proColon® Assay / Kit
Slide 10: Epi proColon: Clinical Performance Data
Epi proColon®: Clinical Performance Data Higher sensitivity, lower specificity Prospective data generated for FDA submission CE marked product as offered in EU and Asia Specificity 97-99% Additional product benefits: Sensitivity 80% Equal capability (as determined in case to detect left
Slide 11: Regulatory Status of Epi proColon in the U.S.
Regulatory Status of Epi proColon® in the U.S. PMA submitted to the FDA in early 2013 Panel meeting is scheduled for March 26, 2014 Briefing document and panel materials under preparation – mock panels held Proposed Intended Use (summary): Epi proColon is a qualitative in vitro diagnostic test
Slide 12: Potential Future Claim Extension – Automation Project
Potential Future Claim Extension – Automation Project Off-the-shelf instrument No change to hardware required, customer can run other applications No extra reagents, just Epi proColon® kit Relatively small investment (~EUR25k) Technical support by instrument manufacturer 12 | March 2014
Slide 13: Overview
Overview Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 13 | March 2014
Slide 14: Joint Commercialization Agreement with Polymedco for the US
Joint Commercialization Agreement with Polymedco for the US Polymedco US market leader in the colorectal cancer screening field - $50m plus in sales Polymedco is ideally positioned (CRC focus) to address 1500+ existing CRC customers Epigenomics to transfer product at cost, gross margin split b
Slide 15: Three Pillars of US Market Penetration
Three Pillars of US Market Penetration Commercial Reimbursement Guidelines first 6m expert groups / LDT to IVD switch health economic data medical societies 6-18m early adopters reimbursement KOL studies Polymedco customer governmental support guidelines inclusion >18m base Pre-approval situation:
Slide 16: Broad Strategic Collaboration with BioChain in China
Broad Strategic Collaboration with BioChain in China Enormous market opportunity – CRC rapidly growing – 280m people screening eligible Stage 1: Initiation of 2 major patient clinical studies with the goal of gaining China Food and Drug Administration (CFDA) approval for Epi proColon® Stage 2:
Slide 17: Overview
Overview Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 17 | March 2014
Slide 18: Epi proLung - Market Introduction
Epi proLung® - Market Introduction CE-marked, marketed in Europe and Asia Biomarker: methylated SHOX2 gene Reflex test for the diagnosis of lung cancer Increasing awareness through publications and KOL driven studies Potential to develop into blood based assay Methylated SHOX2 allows rap
Slide 19: R&D Capabilities and Future Product Opportunities
R&D Capabilities and Future Product Opportunities •core capabilities Biomarker discovery, IVD test development, confirmation and selection validation and regulatory >20 proprietary prognostic, predictive, response, diagnostic, and screening biomarkers in cancer indications Potential to evaluate
Slide 20: Overview
Overview Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 20 | March 2014
Slide 21: Key Financial Information
Key Financial Information Operations in Germany and the U.S., 35 employees Raised EUR 12.5 million in gross proceeds through the issuance of shares and convertible securities in 2013 Secured financing of operations beyond potential FDA approval of Epi proColon® (in € thousand) Dec 31, 2013 Dec
Slide 22: Why Invest in Epigenomics....
Why Invest in Epigenomics.... The world’s first IVD blood test suitable for CRC screening: extensively validated in clinical trials proven utility in CRC early detection Not for sale or diagnostic use in the United States of America available as IVD in Europe under FDA review for the US mark
Slide 23: Thank you for your attention!
Thank you for your attention! Contact Investor Relations TICKER Europe U.S.A. Bloomberg: ECX:GR Antje Zeise Lauren Kwiecinski Reuters: EXXG.DE Manager Investor Relations Senior Associate Thomson ONE: ECX-XE Epigenomics AG The Trout Group LLC T. +49 30 24345 0 T. +1 646 378 2934 ADR OTC: EPGNY ir@epi
Slide 24: Contents
Contents Overview Epi proColon® • Unmet need & commercial opportunity • Product characteristics and performance • Commercial strategy Epi proLung® and future product opportunities Financial Information and Summary Appendix 24 | March 2014
Slide 25: Comparison Study Top Line Data: Cancer Detection by Stage
Comparison Study Top Line Data: Cancer Detection by Stage Epi proColon® pT0/Tis pT1 pT2 pT3 pT4 pTx unknown TOTAL Stage 0 / I 2/3 6/11 10/13 - - - 0/1 18/28 64.3% (45.8-79.3%) Stage II - - - 14/18 2/2 - - 16/20 80.0% (58.4-91.9%) Stage III - 0/1 0/2 14/19 1/1 - - 15/23 65.2% (44.9-81.2%) Stage IV -