Epigenomics AG · GETTEX:ECX

Epigenomics — Investor Presentation (October 2015)

35 slides from Epigenomics's investor presentation, October 2015

  1. Slide 1: Epigenomics AG

    Epigenomics AG October 2015 www.epigenomics.com

  2. Slide 2: Safe Harbor

    Safe Harbor  Forward Looking Statements This communication contains certain forward‐looking statem ments, including, without limitation, statements containing the words “expects”, “future”, “potential” and words of similar import. Such forward‐looking statements involve known and unknown risks, unc

  3. Slide 3: Overview

     Overview  Epi proColon® • Unmet need & commercial opp portunity for Epi proColon® proColon • Commercial strategy  Epi proLung® and future product o opportunities  Financial information and outlookk  Appendix 3 | October 2015

  4. Slide 4: DNA Methylation Diagnostic Products for Oncology

    DNA Methylation Diagnostic Pro oducts for Oncology Epi p pproColon® Epi p pproLung® g blood‐based tissue assay for colorectal cancer (CRC) screening1,2 lung cancer diagnosis1 Addressing low compliance to Aid in difficult to diagnose lung cancer currently available CRC screening development of blood

  5. Slide 5: Overview: Unmet need & commercial opportunity

     Overview  Epi proColon® • Unmet need & commercial opportunity for Epi proColon® • Commercial strategy  Epi proLung® and future product o opportunities  Financial information and outlookk  Appendix 5 | October 2015

  6. Slide 6: Fighting a Treatable Disease: Colorectal Cancer

    Fighting a Treatable Disease: Collorectal Cancer Public Health Impact Health Economic Impact 90% 5‐year 5 survival i l rate t in i stages t I and d II US$ 14 Bn CRC ttreatment t t costt p.a.2 >136,000 new cases and 50,000 deaths1 Over a third in late stage disease Colonoscopy every 10y Screeening 25

  7. Slide 7: Goal: Increase in Screening Participation to 80%+

    •Goal: Increase in Screening Partticipation to 80%+  Campaign C i byb ACS to get 80 0% screened d by b 2018  Reaching that goal would save over 200,000 lives1  Simple Si l blood bl d test t t can signif i ifficantly fi tl contribute t ib t tto thi this goall 1 http://onlinelibrary.wiley.com/doi/1

  8. Slide 8: Blood Testing: More Options for Physicians and Patients

    Blood Testing: More Options for Physicians and Patients Imaging methods Stool samp pling Blood based colonoscopy fecal occult bloo od (FOBT) flexible sigmoidoscopy immunochemical (FIT) Epigenomics: virtual colonography etc. methylated Septin9 ingestible devices etc. 8 | August 2015

  9. Slide 9: Demonstrated: Blood Testing Increases Compliance

    Demonstrated: Blood Testing Inccreases Compliance  63% refused f d colonoscopy l screening: i 8 opted for Septin9 blood test1 83%  Surveys in the U.S. confirm these results2  Patient choice of methods has shown to increase screening compliance3  Recently completed ADMIT trial in the U.S. d 99.5%

  10. Slide 10: Epi proColon: Simple and Efficient for Patients and Customers

    Epi proColon®: Simple and Efficieent for Patients and Customers  Easy E ffor th the patient ti t partt off routine ti e visits; i it no dietary di t restrictions t i ti  Easy for the doctor Septin9 (+): collonoscopy Septin9 (‐): return next year  Easy for the lab runs on existing hardware (valida

  11. Slide 11: Epi proColon: Powerful Screening Tool with Flexible Set Up

    Epi proColon®: Powerful Screening Tool with Flexible Set Up Epi proColon® Epi proColon® 2.0 CE (under US FDA review) (CE marked, CFDA) +++ test result test result positive (+) positive (+) follow‐up with follow‐up with 10 ml blood sample ‐ ++ colonoscopy colonoscopy Epi proColon® test result (3x15ul

  12. Slide 12: Epi proColon: Validated in Clinical Trials

    Epi proColon®: Validated in Clinical Trials US product1,2 China/EU d t3,4 product 34  US data generated in prospective trials for FDA submission1 +++ Sensitivity 68‐73% Sensitivity 75‐81%  Non‐inferiority to FIT Specificity: Specificity: demonstrated in head‐ head ‐ ++ 80 82% 80‐82% 97 99% 97‐99%

  13. Slide 13: Regulatory Status of Epi proColon

    Regulatory Status of Epi proColo on® U.S.A.:  PMA under review by US FDA since eearly 2013  Advisory Panel Meeting and responsee letter: FDA request for additional data supportinng assumption that blood test will increase compliance to CRC screening  ADMIT trial successfully completed inn May 201

  14. Slide 14: Overview: Commercial strategy

     Overview  Epi proColon® • Unmet need & commercial opp portunity for Epi proColon® proColon • Commercial strategy  Epi proLung® and future product o opportunities  Financial information and outlookk  Appendix 14 | October 2015

  15. Slide 15: Joint Commercialization Agreement with Polymedco

    Joint Commercialization Agreem ment with Polymedco  Market M k t leader l d ini the th CRC screening i field fi ld >10M FIT tests sold annually  Ideally positioned (CRC focus) to address >1,500 existing laboratory customers Epigenomics: CHANNEL MANUFACTURING Joint Eff fforts: IP Polymedco: REGULAT

  16. Slide 16: Value Chain of Septin9 blood-based CRC Screening

    Value Chain of Septin9 blood blood‐bas bassed CRC Screening pays COS1 profit share ‐ Guidelines ‐ sells to US$ 75‐902 laboratories orders test provides result Reference Laboratories Healthcare Professionals invoices US$ 1412 payers ‐ Payors ‐ 1 Cost of sales(COS) 2 Company estimates 16 | October 201

  17. Slide 17: Blood Testing to drive Market Expansion

    Blood Testing to drive Market Exxpansion  Health economic benefit demonstrateed1 Septin9 based screening proven to t be cost‐effective Incremental U.S. marke et opportunity estimated in excess of US S$ 1 Bn annually2 1 U. al 2 Company and Analyst estimates U Ladabaum et al. 17 | October 2015

  18. Slide 18: Key Elements for Successful U.S. Market Penetration

    Key Elements for Successful U U.S. S Market Penetration Reimbursement Medical Guidelines months expert groups / first 6 generate health economic data medical societies onths 7‐18 ensure reimbursement selected KOL studies mo 7 nths >18 governmental t l endorsement d t guideline id li inclusion i l i

  19. Slide 19: Strategic Collaboration with BioChain in China

    Strategic Collaboration with BioC Chain in China  Stage 1: Epi proColon proColon® approved in Chinaa by CFDA1  BioChain has started its commercializattion in 2015  Pricingg and reimbursement discussionss underwayy  Stage St 2: 2 License Li tto d develop l and d commerccialize i li SSeptin9 ti 9

  20. Slide 20: Chinese Guideline for Colon Cancer Diagnosis

    Chinese Guideline for Colon Cancer Diagnosis  Publication of the Chinese Guideline on Screening, S Endoscopic Diagnosis and Treatment of o Early Colorectal Cancer on June 30, 2015.  Septin9 test has been clearly stated as a method m for screening early colon cancer  Guideline authored 50+ leading

  21. Slide 21: Overview: Epi proLung and future products

     Overview  Epi proColon® • Unmet need & commercial opp portunity for Epi proColon® proColon • Commercial strategy  Epi proLung® and future produ uct opportunities  Financial information and outlookk  Appendix 21 | October 2015

  22. Slide 22: Epi proLung: Diagnosis of Lung Cancer

    Epi proLung®: Diagnosis of Lung Cancer  Diagnosis of lung cancer in bronchial lavage  Biomarker: methylated SHOX21  CE‐marked IVD test in Europe 1 Kneip et al al., „SHOX2 SHOX2 DNA Methylation Is a Biomarker for the Diagnosis of Lung Cancer in Plasma Plasma”. Journal of Thoracic Oncology Oncology

  23. Slide 23: Epi proLung: Diagnosis of Lung Cancer

    Epi proLung®: Diagnosis of Lung Cancer Epi proLung® plus cytology1 combineed resulted in clinical sensitivity of 98% 1 Klauschen et al al., „Performance Performance of Epi prroLung in combination with cytology in bronchial lavage samples from clinical routine routine“. In preparation 23 | October 20

  24. Slide 24: Epi proLung: Next Steps

    Epi proLung®: Next Steps  Development of blood‐based version underway  Demonstrated applications in treatment response monitoring1  More rapid and sensitive determination than CT scan  Possible initial application pp in ffollow‐up p off positive p results in low dose spiral CT  Attractive futur

  25. Slide 25: R&D Capabilities and Future Product Opportunities

    R&D Capabilities and Future Product Opportunities Biomarker discovery, IVD test development, confirmation and selection validation and regulatory >20 proprietary prognostic, preedictive, response, diagnostic, and screening biomarke bi kers in cancer indications  Potential to evaluate and clinically

  26. Slide 26: Overview: Financial information and outlook

     Overview  Epi proColon® • Unmet need & commercial opp portunity for Epi proColon® proColon • Commercial strategy  Epi proLung® and future product o opportunities  Financial Fi i l information i f i and d outlo lookk  Appendix 26 | October 2015

  27. Slide 27: Key Financial Information

    Key Financial Information (in € thousand) 6M 2015 5 6M 2014 Revenue 854 812 EBIT (Operating Result) ‐5,733 5 733 ‐3,616 3 616 Net loss ‐5,623 ‐4,063 Cash consumption ‐4 681 ‐4,681 ‐3 140 ‐3,140 (in € thousand) Jun 30, 201 15 Dec 31, 2014 Liquid Assets** 10,637 7,495 * incl. marketable securities  L

  28. Slide 28: Shareholder Structure

    Shareholder Structure Type off shares registered shares s Security code number A1 11QW5 ISIN DE000A11 1QW50 Q Frankfurt Stock Exch hange, BioChain 9.1%2 Stock Exchange Prime Standarrd: ECX Abingworth 4.9%2 ADR program Sponsored Level 1 ADR D fi ld Deerfield 1%2 3.1% 3 Ratio 1 ADR = 5 common shares F

  29. Slide 29: Outlook 2015/2016 – Expected major milestones

    Outlook 2015/ 2016 – Expected major milestones Develop‐ CFDA ment approvall Launch blood‐ for BioChain‘s Start U.S. based BioChain‘s Septin9 Commer‐ Epi proLung® Septin9 S ti 9 test in cialization test test China 2015 2016 2017 FDA BioChain Start clinical CE‐marking Approval Septin9 validation study

  30. Slide 30: Why to Invest in Epigenomics

    Why to Invest in Epigenomics Epi proColon® the world’s th ld’ fi firstt IVD bl blood d test t t intended for CRC screening convenient N for Not f sale l or di diagnostic i use iin the h UUnited i d SStates off America A i accurate effective 30 | October 2015

  31. Slide 31: Thank you for your attention!

    Thank you for your attention! Contact Investor Relations TICKER Europe U.S.A. Bloomberg: ECX:GR Peter Vogt Brian Korb Reuters: EXXG.DE Investor & Public Relations Managing Director Thomson ONE: ECX‐XE ECX XE Epigenomics AG The Trout Group LLC T. +49 30 24345 386 T. +1 646 378 2923 ADR OTC: EPGNY ir@

  32. Slide 32: Appendix

     Overview  Epi proColon® • Unmet need & commercial opp portunity for Epi proColon® proColon • Commercial strategy  Epi proLung® and future product o opportunities  Financial Fi i l information i f i and d outlook l k  Appendix 32 | October 2015

  33. Slide 33: Methylated Septin9 – Blood Based Test for CRC Detection

    Methylated Septin9 – Blood Based Test for CRC Detection  Sim mple blood‐based tests widely seen as b t way to best t close l the th “screening “ i gap””  Epi proColon® is based on a single epiggenetic biomarker: methylated Septin9  Septtin9 in CRC tissue fully methylated in >95 5% of all cancers

  34. Slide 34: Possible Performance Improvement (post-hoc analysis)

    Possible Performance Improvem ment (post hoc analysis1,2) (post‐hoc +++ positive (+) re‐test with FIT: 65% sensitivityy (3% off allll cases) 96% specificity overall combined performance1 ‐ ++ “1 1 out of 3“ 3 ‐ ‐+ or “weak” positivees (15% of all cases) re‐test ‐ ‐ ‐ negative (‐) (82% of all casess)

  35. Slide 35: Comparison Study Top Line Data: Cancer Detection by Stage

    Comparison Study Top Line Dataa: Cancer Detection by Stage from head‐to‐head head to head FIT/Septin9 trial Epi p pproColon® pT0/Tis pT1 pT2 pT3 pT4 p 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

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