not commercially available in the U.S.
Detecting Cancer in Blood Company presentation
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 technologically skilled 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.
Legal Product Disclaimer Products by Epigenomics that are referred to in this presentation, especially Epi proColon®, are not available and are not approved for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on our technology have not been established.
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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 cancer testing through liquid biopsy.
not commercially available in the U.S.
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Targeting the most deadly cancers Annual cancer deaths US population 158,080
Pipeline addressing potential other solid tumor indications
40,890
41,780
Breast
Pancreas
49,190
26,120
Prostate 3
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Colorectal
Source: American Cancer Society, Cancer Facts & Figures 2016, annual figures
Lung
Colorectal cancer (CRC): Early detection saves lives
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Diagnosed in Stage I or II
Diagnosed in Stage IV
9 out of 10 survive
1 out of 10 survive
5 years
5 years Source: American Cancer Society, Cancer Facts & Figures 2015
CRC: One in three in the USA remains unscreened
35% Unscreened eligible population
65% Screened population
23 to 30 million eligible Americans are not screened for CRC 5
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Source: Centers for Disease Control and Prevention, “Vital Signs”, November 2013; American Cancer Society Cancer Facts and Figures, 2015.
American Cancer Society screening goal: 80% by 2018
63%
Screening gap
Stagnant screening rate over the past years 65%
65%
2010
2012
80%
60%
2002 6
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2008
Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
2018
Paradigm shift in colorectal cancer screening
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Imaging Methods
Stool Sampling
Liquid biopsy
Colonoscopy Flexible sigmoidoscopy Virtual colonography
occult blood in stool by FIT or gFOBT Fecal DNA testing
Septin-9 blood test
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Opportunity for US market expansion
15%
Screening gap
$2 billion* Closing the screening gap towards the 80% goal
80% CRC screening goal by ACS
65%
Screened population
* Annual revenue ex laboratory
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High patient preference for blood test
97%
83% 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 colonoscopy in Germany. BMC Gastroenterol 14: 183.
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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
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Epi proColon - Option for non-compliant patients
Colonoscopy
Patient managed based on colonoscopy outcome
Standard of Care Further regular screening
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Epi proColon detects tumor-specific DNA in blood
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Test performance established in major studies
Prospective pivotal study
FIT comparison study
Prospective, multicenter clinical study
Multi-center, comparative clinical study
7,941 screening-eligible individuals enrolled
Epi proColon vs. FIT test
Sensitivity of 68.2% and specificity of 80.0%
Sensitivity of Epi proColon was 73.2% vs. 68.0% of FIT-test
ADMIT study
Multi-center clinical study 420 patients, historically noncompliant with current screening guidelines 99.5% rate of adherence to Epi proColon
Sensitivity: the percentage of cancer cases correctly identified Specificity: the percentage of healthy individuals correctly identified as negative 13
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Recent FDA notification* on status of Epi proColon Final approval expected
Epi proColon
would be first and only FDA approved blood-
in Q1/Q2 2016
based colorectal cancer test on U.S. market
Significant milestone
Only minor topics
towards FDA approval
left to be clarified with the agency
* published on Jan 8, 2016 14
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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
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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
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Strong outreach through multiple sales channels Reference Labs
Epigenomics Polymedco
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Leading hospitals
Academic Medical Centers
Integrated Networks
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Local medical doctors
Key opinion leaders
Healthcare providers
Ideal partnership for commercial success
Marketing Sales Distribution Customer support Billing Collection
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Product supply Reimbursement Regulatory KOLs Medical guidelines
Reimbursement elements
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Strategic collaboration with BioChain in China
Epi proColon® approved in China by CFDA1
BioChain started commercialization in 2015
Pricing and reimbursement discussions underway
Septin9 test included in Chinese CRC Screening Guidelines
Epi proColon® distribution and license agreement for Septin9 in place 20
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China Food and Drug Administration (CFDA)
blood test for detection of lung cancer
About lung cancer Lung cancer is #1 cancer killer worldwide High medical need for minimally invasive tests
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Lung cancer test in development
Performance
Based on Test sensitivity proprietary DNA was reported methylation at 95% with a biomarkers, specificity of SHOX2 & 64% in initial PTGER4 studies
Target indications
Next steps
Follow-up after positive results in low dose spiral CT
Initiation of clinical studies in 2016 (US/EU)
Future opportunity in screening of high risk patients
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 672680.
Liquid biopsy will revolutionize cancer care
“
Disease management Early detection
Costs
Liquid biopsy Invasiveness
Compliance Repeatability
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For me the biggest payoff in cancer research would be the discovery of biomarkers that can be measured in the 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
”
R&D strategy Broad IP protection with over 50 active patent families
3 2 1 Biomarker discovery, confirmation and selection
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>20 proprietary biomarkers in CRC, lung cancer and other solid tumor indications
Test development and validation of regulated in-vitro diagnostic products
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, 2015 8,563
Dec 31, 2014 7,495
Liquid assets* *cash and cash equivalents incl. marketable securities
Liquid assets currently sufficient to fund operations into 2017 24
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Epigenomics share Share information Types of shares
Registered shares
Security code number
A11QW5
ISIN
DE000A11QW50
Stock exchange
Frankfurt Stock Exchange, Prime Standard: ECX
ADR program
Sponsored Level 1 ADR
Ratio
1 ADR = 5 common shares
Total shares outstanding
18,700,1591 (20.1m fully diluted)
Analyst coverage
Edison, Equinet, First Berlin, Kempen & Co, Maxim
1
As of Feb 29, 2016; 2 According the published voting right notifications
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Shareholder structure
BioChain
9.1%2
Abingworth 4.9%2 Free float
86.0%
Expected news flow topics 2016
Start of clinical studies with Epi proLung®
FDA approval
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Start of US commercialization Inclusion in medical guidelines
2016
Market adoption and reimbursement progress
Thank you for your attention! Contact Investor Relations Peter Vogt Investor & Public Relations Epigenomics AG T. +49 30 24345 386
[email protected]
Ticker Bloomberg: ECX:GR Reuters: EXXG.DE Thomson ONE: ECX-XE ADR OTC: EPGNY
Internet www.epigenomics.com www.epiprocolon.com www.epiprolung.com 27
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