Epigenomics AG · GETTEX:ECX
Epigenomics — Investor Presentation (September 2012)
34 slides from Epigenomics's investor presentation, September 2012
Slide 1: Corporate Presentation
Corporate Presentation September 2012 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: Leader in molecular diagnostics for early detection of cancer
Leader in molecular diagnostics with proprietary products for the early detection of cancer World’s first marketed blood based test for early detection of colorectal cancer – globally available as IVD and/or LDT test 3 | September 2012
Slide 4: Colorectal Cancer (CRC) Screening Saves Lives
Colorectal Cancer (CRC) Screening Saves Lives…. CRC is the second largest cancer killer in the US 140.000 new cases 50.000 deaths1 5-year survival for diagnosed and treated Stage I/II CRC: 90% CRC is curable if detected early 5-year survival2 enough with screening 73% without screening 46% 1)
Slide 5: Increasing Compliance is Key
Increasing Compliance is Key Colorectal Cancer 1 in 3 adults are not being screened. Colorectal cancer screening prevented about half of the expected new cases and deaths during 2003-2007. 35M not screened The percentage of adults screened for colorectal cancer increased 13% from 2002 to 2010. The e
Slide 6: The Best CRC Test is The One That Gets Done
The Best CRC Test is The One That Gets Done •[SCREENING SUCCESS] = [TEST SENSITIVITY] * [COMPLIANCE] Modality Test Sensitivity Compliance Screening Success Colonoscopy 95% 50% 45.5% iFOBT / FIT 70% 12% 8.4% Blood-based test* 70% 80%* 56% *Hypothetical data illustrating the role of compliance in a sc
Slide 7: Patients Believe in Blood Tests
Patients Believe in Blood Tests Patients would prefer a blood-based CRC test based on recent studies conducted by Epigenomics and partners Convenience of a blood-based test should lead to greater acceptance and adoption and lead to a higher compliance to colorectal cancer screening! To me Septin
Slide 8: The Benefit to Doctors and Patients
The Benefit to Doctors and Patients non-invasive no dietary/medication restrictions quick and easy, done anytime helps with screening resistant patients can be part of routine visits Septin9 test - a simple blood draw is enough 8 | September 2012
Slide 9: Detecting Methylated Septin9
Detecting Methylated Septin9 Test consists of one single proprietary epigenetic biomarker: methylated Septin9 gene Detection of free circulating tumor DNA in blood by real-time PCR test Gene Analytical sensitivity: down to 6 pg / ml Septin9 methylated specifically in Strong patent position:
Slide 10: Epi proColon: One Assay – One Marker
Epi proColon®: One Assay – One Marker Easy & fast: real-time PCR based, 8 hours time to result Compliant: cGMP manufactured, 21 CFR Part 820 and ISO 13485 compliant; runs on Roche LC480 and AB7500. US product runs on FDA cleared real-time PCR device (AB7500 Fast DX) CE marked for EU market A
Slide 11: Epi proColon 2.0: Powerful Screening Tool with Flexible Set Up
Epi proColon® 2.0: Powerful Screening Tool with Flexible Set Up 11 | September 2012
Slide 12: Epi proColon: Clinical Validation Study Data
Epi proColon®: Clinical Validation Study Data Prospective Most recent Clinical Case control screening study case control validation for study pivotal clinical trial study (EU) CE marking (EU) by LDT partner for FDA submission (high sensitivity (high specificity ARUP configuration) configuration) Sam
Slide 13: Clinical Validation Study Results (US Pivotal Trial)
Clinical Validation Study Results (US Pivotal Trial) Overall CRC detection rate: 68% (53-80% CI) Detection rate for adenomas and polyps not statistically significant (slightly above 20%) Low detection rate in pT1 tumors potentially due to lack of vascularization in early tumors CRC staging pT1
Slide 14: Fecal Immunochemical Test (FIT) Comparison Study
Fecal Immunochemical Test (FIT) Comparison Study FIT head-to-head comparison study protocol agreed with FDA and study started in Q2 Non-inferiority endpoint of Epi proColon® to FIT – 100 cancer cases (case control, retrospective, 2 weeks post colonoscopy) – 200 asymptomatic average risk individu
Slide 15: FDA Submission Status: to Be Completed in 2012
FDA Submission Status: to Be Completed in 2012 Module 2 software validation & Module 1 manufacturing and instrumentation quality system sections Module 3 analytical validation Premarket Pre-IDE meeting Preliminary data approval submission (PMA) Module 4 Q4/12 review and module clinical valid
Slide 16: Expected US Product Launch of Epi proColon in 2013
Expected US Product Launch of Epi proColon® in 2013 Pre- and post- Pre-launch Post-launch launch Private payer & CMS dialogue Create awareness through Guideline inclusion for reimbursement publications, medical •FDA approval conferences & symposia Adherence & compliance Enlist thought leaders & MAB
Slide 17: Building a Customer Base Ahead of US Approval
Building a Customer Base Ahead of US Approval Increased Adoption of Septin9 Continuous growth of Septin9 testing through LDT partners (Quest, ARUP and Gamma Dynacare) New LDT agreement signed with Companion DX in Texas (major reference lab in the Houston Texas Medical Center, the world’s largest
Slide 18: ColoVantage - Example of Successful Adoption of Septin9
ColoVantage™ - Example of Successful Adoption of Septin9 Laboratory-developed Septin9 test by Quest Diagnostics under Epigenomics license Available coast-to-coast in the US Approved by New York State Department of Health Actively promoted since early 2011 ColoVantage™ List price: $355 18 |
Slide 19: Epi proColon 2.0 CE in Europe & Beyond
Epi proColon® 2.0 CE in Europe & Beyond Available in Europe since 2012 through proprietary sales force in Switzerland, Austria and Germany Recommended retail price in most EU markets EUR 99 Key account marketing and sales strategy First French insurance company Swiss Life to reimburse Septin
Slide 20: Septin9: One Biomarker – Several Tests – Global Availability
Septin9: One Biomarker – Several Tests – Global Availability Septin9 Biomarker and assay technology proprietary to Epigenomics IVD Test Kits* / co-exclusive “group of 4” & distributors Option for the global mS9™ product license Epi proColon® Option for the Japanese EU/other EU/Asia/Pacific In develo
Slide 21: Epi proLung - Market Introduction
Epi proLung® - Market Introduction Marketed in Europe since mid-2010 Reflex test for the diagnosis of lung cancer Biomarker: methylated SHOX2 gene Performance evaluation results with case/control samples: 81% sensitivity 95% specificity Recent data by Charité Berlin confirmed clinical valu
Slide 22: Key Financials 6M 2012
Key Financials 6M 2012 Tightly controlled spending (incl. US commercial build-up) – funded well into 2013 (in € thousand) 6M 2012 6M 2011 Revenue 399 985 EBIT (Operating Results) -5,742 -5,715 (in € thousand) 06/30/2012 12/31/2011 Liquid Assets* 9,117 13,985 Number of Employees 44 61 * incl. marke
Slide 23: Shareholder Structure
Shareholder Structure As of June 30, 2012: 8,818,417 shares and 486,325 options outstanding 21.75 % 61.89 % Abingworth Free float 4.61 % Baker Bros 4.60 % VCG 3.85 % Omega 3.30 % Gilbert Gerber As of Aug 6, 2012 and according to voting rights notifications by the shareholders 23 | September 2012
Slide 24: Upcoming Milestones
Upcoming Milestones US PMA submission activities Q2: complete submission of 3rd PMA module Q4: complete enrollment of FIT comparison study Q4: complete PMA submission (4th module) Test enhancements Develop automation solutions European commercial objectives Keep targeting key European acco
Slide 25: Why Invest in Epigenomics
Why Invest in Epigenomics.... The world’s first IVD blood test for early detection of colorectal cancer: prospectively validated proven utility in CRC early detection globally available as IVD (EU) or LDT (US) in development as IVD for the US market IVD test for lung cancer diagnosis in the EU m
Slide 26: Financial Calendar 2012
Financial Calendar 2012 9-Month Report 2012 January 1 - September 30, 2012 Wednesday, November 7, 2012 26 | September 2012
Slide 27: Thank You for Your Attention!
Thank You for Your Attention! Contact Investor Relations TICKER Europe U.S.A. Bloomberg: ECX:GR Antje Zeise Christine Yang Reuters: EXXG.DE Manager Investor Relations Vice President Epigenomics AG The Trout Group LLC Thomson ONE: ECX-XE T +49 30 24345 0 T +1 646 378 2929 ir@epigenomics.com cyang@tro
Slide 28: Back-up slides
Back-up slides www.epigenomics.com
Slide 29: Septin9 Tests: Continuous Improvement as Assay Technology Evolved
Septin9 Tests: Continious Improvement as Assay Technology Evolved 100% 5.000 90% 4.500 Subjects tested (cumulative) 80% 4.000 Sensitivity / Specificity 70% 3.500 60% 3.000 50% 2.500 40% 2.000 30% 1.500 20% 1.000 10% 500 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Technology Development 1st Gen. Tests 2nd Gen
Slide 30: Comparison of Non-Invasive CRC Screening Methods
Comparison of Non-Invasive CRC Screening Methods Positive Method Specificity Sensitivity Predictive Value5 Epi proColon® 2.0 CE (high specificity 99.3% 80.6% 45.7% configuration)1 Guaiac FOBT2 97.7% 37.1% 10.1% OC-Sensa Micro qFIT1x3 93.7% 69.2% 7.5% OC-Sensa Micro qFIT3x4 89.8% 84.6% 5.6% 1 Tetzner
Slide 31: Performance Studies: Prospective Study Design
Performance Studies: Prospective Study Design Up to 30% of cases: Polyp resection (Polypectomy) in some cases: confirmation of pT1 tumors in pathology Establishment of diagnosis: Colorectal cancer (CRC): – stages I-IV Bowel prep, Diagnosis, – pathology: pT1-pT4 colonoscopy pathology Advanced Adenoma
Slide 32: Performance Studies: Case Control (Retrospective) Study Design
Performance Studies: Case Control (Retrospective) Study Design Up to 30% of cases: Polyp resection (Polypectomy) in some cases: confirmation of pT1 tumors in pathology •X AA or pT1 Tumor No blood draw since AA or pT1 already removed at time of colonoscopy Bowel prep, colonoscopy CRC or NED Asymptoma
Slide 33: Clinical Validation – Comparison Prospective and Case/Control Study
Clinical Validation – Comparison Prospective and Case/Control Study •Pivotal Trial – Prospectively Collected Samples 1 CRC staging pT1 pT2 pT3 pT4 pTx TOTAL Stage I 4/11 3/6 - - - 7/17 41% (22-64%) Stage II - - 10/12 - - 10/12 83% (55-95%) Stage III 0/1 2/2 5/6 1/1 - 8/10 80% (49-94%) Stage IV 1/1 3
Slide 34: Clinical Validation – Comparison Prospective and Case/Control Study
Clinical Validation – Comparison Prospective and Case/Control Study •sensitivity [%] •sensitivity [%] Only statistically significant different detection rate is seen in stage I cancers Difference is driven by performance on pT1 cancers which are not found in case/control cohorts 34 | September 2012