Epigenomics AG · GETTEX:ECX
Epigenomics — Investor Presentation (February 2016)
28 slides from Epigenomics's investor presentation, Feb 29, 2016
Slide 1: Detecting Cancer in Blood
not commercially available in the U.S. Detecting Cancer in Blood Company presentation
Slide 2: Safe harbor statement
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 risk
Slide 3: Saving lives through blood-based cancer detection
Saving lives through blood-based cancer detection Our high-performing, minimally-invasive tests have the potential to radically improve cancer detection. By leveraging our expertise in epigenetics as well as our product pipeline and strong IP, we are uniquely positioned to drive patient access to ca
Slide 4: Targeting the most deadly cancers
Targeting the most deadly cancers Annual cancer deaths US population 158,080 49,190 40,890 41,780 26,120 Prostate Breast Pancreas Colorectal Lung 3 2/29/2016 Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures
Slide 5: Colorectal cancer (CRC): Early detection saves lives
Colorectal cancer (CRC): Early detection saves lives Diagnosed in Diagnosed in Stage I or II Stage IV 9 out of 10 survive 1 out of 10 survive 5 years 5 years 4 2/29/2016 Source: American Cancer Society, Cancer Facts & Figures 2015
Slide 6: CRC: One in three in the USA remains unscreened
CRC: One in three in the USA remains unscreened % 65% Unscreened eligible population Screened population 23 to 30 million eligible Americans are not screened for CRC 5 2/29/2016 Source: Centers for Disease Control and Prevention, “Vital Signs”, November 2013; American Cancer Society Cancer Facts and
Slide 7: American Cancer Society screening goal: 80% by 2018
American Cancer Society screening goal: 80% by 2018 Stagnant screening rate over the past years 80% Screening gap 65% 65% 63% 60% 2002 2008 2010 2012 2018 6 2/29/2016 Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
Slide 8: Epi proColon adds convenient CRC screening option
Epi proColon adds convenient CRC screening option Imaging Methods Stool Sampling Liquid biopsy Colonoscopy occult blood in stool Septin-9 blood test Flexible sigmoidoscopy by FIT or gFOBT Virtual colonography Fecal DNA testing 7 2/29/2016
Slide 9: Opportunity for US market expansion
Opportunity for US market expansion 15% Screening gap $2 billion* Closing the screening gap towards the 80% goal 80% 65% Screened CRC screening goal by ACS population * Annual revenue ex laboratory 8 2/29/2016
Slide 10: High patient preference for blood test
High patient preference for blood test % % of those patients chose a blood test of patients refusing colonoscopy accepted minimal-invasive test Source: Adler, A., et al. (2014). Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colon
Slide 11: Simple for patients and health care providers
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 2/29/2016
Slide 12: Epi proColon - Option for non-compliant patients
Epi proColon - Option for non-compliant patients Patient managed Colonoscopy based on colonoscopy outcome Standard of Care Further regular screening 11 2/29/2016
Slide 13: Epi proColon detects tumor-specific DNA in blood
Epi proColon detects tumor-specific DNA in blood 12 2/29/2016
Slide 14: Test performance established in major studies
Test performance established in major studies FIT Prospective ADMIT comparison pivotal study study study Prospective, multi- Multi-center, comparative Multi-center clinical study center clinical study clinical study 420 patients, historically 7,941 screening-eligible Epi proColon vs. FI
Slide 15: Recent FDA notification on status of Epi proColon
Recent FDA notification* on status of Epi proColon Epi proColon Final would be first approval and only FDA expected approved blood- in Q1/Q2 based colorectal 2016 cancer test on U.S. market Significant Only milestone minor topics towards FDA left to be approval clarified with the agency * published
Slide 16: Next steps towards approval
Next steps towards approval Secure reimbursement code Secure national availability upon launch Train and inform potential laboratory customers Build product inventory to serve initial demand Finalize FDA requirements 15 2/29/2016
Slide 17: U.S. commercialization with partner
U.S. commercialization with partner Nation-wide distribution to target labs with Polymedco All incentives aligned between labs, partner and Epigenomics HQ Ideally positioned Polymedco is the (CRC focus) to biggest distributor address over 1,000 of CRC screening existing laboratory tests in the U.S.
Slide 18: Strong outreach through multiple sales channels
Strong outreach through multiple sales channels Reference Local medical Labs doctors Leading Academic hospitals Epigenomics Medical Polymedco Centers Key opinion leaders Integrated Healthcare Networks providers 17 2/29/2016
Slide 19: Ideal partnership for commercial success
Ideal partnership for commercial success Marketing Product supply Sales Reimbursement Distribution Regulatory Customer support KOLs Billing Medical guidelines Collection 18 2/29/2016
Slide 20: Reimbursement elements
Reimbursement elements 19 2/29/2016
Slide 21: Strategic collaboration with BioChain in China
Strategic collaboration with BioChain in China Epi proColon® BioChain approved in China started by CFDA1 commercialization in 2015 Pricing and reimbursement Septin9 test included in discussions underway Chinese CRC Screening Guidelines Epi proColon® distribution and license agreement for Septin9 in
Slide 22: Blood test for detection of lung cancer
blood test for detection of lung cancer About lung Lung cancer test Performance Target Next steps cancer in development indications Lung cancer is Based on Test sensitivity Follow-up after Initiation of #1 cancer killer proprietary DNA was reported positive results clinical studies worldwi
Slide 23: Liquid biopsy will revolutionize cancer care
Liquid biopsy will revolutionize cancer care Disease manage- ment “ For me the biggest payoff in cancer research would be the discovery of Early biomarkers that can be Costs ” detection measured in the blood that reflect the presence of Liquid early-stage cancer. biopsy Dr. Leland Hartwell, March 20
Slide 24: R&D strategy
R&D strategy Broad IP protection with over 50 active patent families 3 2 Test development and validation of regulated in-vitro 1 >20 proprietary diagnostic biomarkers in CRC, products lung cancer and other Biomarker solid tumor discovery, indications confirmation and selection 23 2/29/2016
Slide 25: Key financial information
Key financial information 9M 2015 9M 2014 Revenue 1,324 1,095 EBIT (Operating result) -8,261 -5,390 Net loss -8,033 -5,906 Cash consumption -7,675 -5,948 Sep 30, Dec 31, 2015 2014 Liquid assets* 9,721 7,495 *cash and cash equivalents incl. marketable securities Liquid assets currently sufficient to
Slide 26: Epigenomics share
Epigenomics share Share information Shareholder structure Types of shares Registered shares Security code A11QW5 number ISIN DE000A11QW50 BioChain 9.1%2 Stock exchange Frankfurt Stock Exchange, Prime Standard: ECX Abingworth 4.9%2 ADR program Sponsored Level 1 ADR Free float 86.0% Ratio 1 ADR = 5 co
Slide 27: Expected news flow topics 2016
Expected news flow topics 2016 Start of Start of US commer- clinical cialization studies with Epi proLung® Inclusion in medical guidelines Market adoption and reimbursement progress FDA approval 26 2/29/2016
Slide 28: Thank you for your attention!
Thank you for your attention! Contact Investor Relations Peter Vogt Brian Korb Investor & Public Relations Managing Director Epigenomics AG The Trout Group LLC T. +49 30 24345 386 T. +1 646 378 2923 ir@epigenomics.com BKorb@troutgroup.com Ticker Bloomberg: ECX:GR Reuters: EXXG.DE Thomson ONE: ECX-XE