Detecting Cancer in Blood. Company presentation

Transcription

1 Detecting Cancer in Blood Company presentation

2 Safe harbor statement 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, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: uncertainties related to results of our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologicallyskilled employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war, and other factors referenced in this communication. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments. 1

3 Saving lives through blood-based cancer detection Our high-performing, minimally-invasive testshave the potential to radically improve cancer detection. By leveraging our expertise in epigeneticsas well as our product pipeline and strong IP, we are uniquely positioned to drive patient accessto cancer testing through liquid biopsy. 2

4 Targeting the most deadly cancers Annual cancer deaths US population 158,080 Pipeline addressing potential other solid tumor indications 26,120 40,890 41,780 49,190 Prostate Breast Pancreas Colorectal Lung 3 Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures

5 Colorectal cancer (CRC): Early detection saves lives Diagnosed in Stage I Diagnosed in Stage IV 9 out of10 survive 5 years 1 * out of 10 survive 5 years 4 Source: American Cancer Society, Cancer Facts & Figures 2015; *rounded (13%)

6 CRC: One in three in the USA remains unscreened 35% Unscreened eligible population 65% Screened population About 23 million eligible Americans are not screened for CRC 5 Source: Centers for Disease Control and Prevention, Vital Signs, November 2013; American Cancer Society Cancer Facts and Figures, 2015.

7 American Cancer Society screening goal: 80% by 2018 Stagnant screening rate over the past years Screening gap 80% 60% 63% 65% 65% Source: Data from the BRFSS survey reported in MMWR 60(26) , MMWR 62(44):

8 EpiproColon receives FDA approval (April 12, 2016) First and only FDA-approved blood-based colorectal cancer screening test EpiproColon is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT). 7

9 Paradigm shift in colorectal cancer screening Imaging Methods Colonoscopy Flexible sigmoidoscopy Virtual colonography Stool Sampling occult blood in stool by FIT or gfobt Fecal DNA testing Liquid biopsy Septin-9 blood test 8

10 Opportunity for US market expansion 80% CRC screening goal by ACS 15% 65% Screening gap Screened population 12.3 million patients Closing the screening gap towards the 80% goal * Annual revenue ex laboratory 9

11 Simple for patients and health care providers Easy for the patient Part of routine visits No dietary restrictions Easy for the doctor Drives patient compliance Easy to explain Easy for the lab Runs on existing hardware No investment required 10

12 Epi procolon -Option for non-compliant patients Colonoscopy Patient managed based on colonoscopy outcome Standard of Care Further regular screening 11

13 Epi procolon detects tumor-specific DNA in blood 12

14 Test performance established in major studies Prospective pivotal study FIT comparison study ADMIT study Prospective, multicenter clinical study 7,941 screening-eligible individuals enrolled Sensitivity of 68% and specificity of 80% Multi-center, comparative clinical study EpiproColon vs. FIT test Sensitivity of EpiproColon was 73% vs. 68% of FIT-test Multi-center clinical study 420 patients, historically noncompliant with current screening guidelines 99.5% rate of adherence to EpiproColon Sensitivity: the percentage of cancer cases correctly identified Specificity: the percentage of healthy individuals correctly identified as negative 13

15 U.S. commercialization with partner Nation-wide distribution to target labs with Polymedco All incentives aligned between labs, partner and Epigenomics HQ Polymedco is the biggest distributor of CRC screening tests in the U.S. Ideally positioned (CRC focus) to address over 1,000 existing laboratory customers U.S. chart with target labs only illustrative 14

16 Strong outreach through multiple sales channels Reference Labs Local medical doctors Epigenomics Polymedco Academic Medical Centers Leading hospitals Key opinion leaders Integrated Networks Healthcare providers 15

17 Ideal partnership for commercial success Marketing Sales Distribution Customer support Billing Collection Product supply Reimbursement Regulatory KOLs Medical guidelines 16

18 Reimbursement process underway FDA label granted Health economics model completed CPT code Tier-1 code designated by AMA Inclusion in Medical Guidelines initiated National Coverage Determination in preparation 17

19 Strategic collaboration with BioChain in China Epi procolon approved in China by CFDA 1 BioChain started commercialization in 2015 Pricing and reimbursement discussions underway Septin9 test included in Chinese CRC Screening Guidelines China FDA names Epigenomics blood-based Septin9 colorectal cancer test a most innovative medical product for China Food and Drug Administration (CFDA)

20 blood test for detection of lung cancer About lung cancer Lung cancer test in development Performance Target indications Next steps Lung cancer is Based on Test sensitivity Follow-up after Initiation of #1 cancer killer positive results worldwide in low dose spiral CT High medical need for minimally invasive tests proprietary DNA methylation biomarkers, SHOX2 & PTGER4 was reported at 95% with a specificity of 64% in initial studies Future opportunity in screening of high risk patients clinical studies in 2016 (US/EU) 19 This project has received funding from the European Union s Horizon 2020 research and innovation programme under grant agreement No

21 Liquid biopsy will revolutionize cancer care Costs Compliance Disease management Liquid biopsy Early detection For me the biggest payoff in cancer research would be the discovery of biomarkers that can be measured inthe blood that reflect the presence of early-stage cancer. Dr. Leland Hartwell, March 2008, President, Ford Hutchison Cancer Research Center, Nobel Prize in Medicine and Physiology, 2001 Invasiveness Repeatability 20

22 R&D strategy Broad IP protection with over 50 active patent families 1 Biomarker discovery, confirmation and selection Test development 2 and validation of regulated in-vitro >20 proprietary diagnostic biomarkers in CRC, products lung cancer and other solid tumor indications 3 21

23 Key financial information FY 2015 FY 2014 Revenue 2,082 1,507 EBIT (Operating loss) 9,264 8,383 Net loss 8,985 8,854 Cash consumption 7,968 8,095 Dec 31, Dec 31, Liquid assets* 8,563 7,495 *cash and cash equivalents incl. marketable securities Liquid assets currently sufficient to fund operations into

24 Epigenomics share Share information Shareholder structure Types of shares Security code number ISIN Stock exchange ADR program Ratio Total shares outstanding Analyst coverage Registered shares A11QW5 DE000A11QW50 Frankfurt Stock Exchange, Prime Standard: ECX Sponsored Level 1 ADR 1 ADR = 5 common shares 19,108,009 1 (20.1m fully diluted) Edison, Equinet, First Berlin, Kempen& Co, Maxim BioChain 9.1% 2 Free float 90.9% 1 As of April 30, 2016; 2 According the published voting right notifications 23

25 Expected news flow topics 2016 FDA approval Start of clinical studies with Epi prolung Inclusion in medical guidelines 2016 Start of US commercialization Market adoption and reimbursement progress 24

26 Thank you for your attention! Contact Investor Relations Peter Vogt Investor & Public Relations Epigenomics AG T Ticker Bloomberg: ECX:GR Reuters: EXXG.DE Thomson ONE: ECX-XE ADR OTC: EPGNY Internet