13.04.2016 - Epigenomics - Investor Presentation - April 2016
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Detecting Cancer in Blood<br />
Company presentation
Safe harbor statement<br />
Forward Looking Statements<br />
This communication contains certain forward-looking statements, including, without limitation, statements containing the words<br />
“expects”, “future”, “potential” and words of similar import. Such forward-looking statements involve known and unknown risks,<br />
uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or<br />
achievements, or industry results, to be materially different from any future results, performance or achievements expressed or<br />
implied by such forward-looking statements. Such factors include, among others, the following: uncertainties related to results of<br />
our clinical trials, the uncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, the<br />
absence of sales and marketing experience and limited manufacturing capabilities, attraction and retention of technologically skilled<br />
employees, dependence on licenses, patents and proprietary technology, dependence upon collaborators, future capital needs and<br />
the uncertainty of additional funding, risks of product liability and limitations of insurance, limitations of supplies, competition from<br />
other biopharmaceutical, chemical and pharmaceutical companies, environmental, health and safety matters, availability of licensing<br />
arrangements, currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, acts of war,<br />
and other factors referenced in this communication. Given these uncertainties, prospective investors and partners are cautioned not<br />
to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking<br />
statements to reflect future events or developments.<br />
1<br />
4/13/<strong>2016</strong>
Saving lives through blood-based cancer detection<br />
Our high-performing, minimally-invasive tests have<br />
the potential to radically improve cancer detection.<br />
By leveraging our expertise in epigenetics as well as<br />
our product pipeline and strong IP, we are uniquely<br />
positioned to drive patient access to cancer testing<br />
through liquid biopsy.<br />
2<br />
4/13/<strong>2016</strong>
Targeting the most deadly cancers<br />
Annual cancer deaths<br />
US population<br />
158,080<br />
Pipeline addressing potential other<br />
solid tumor indications<br />
26,120<br />
40,890 41,780<br />
49,190<br />
Prostate Breast Pancreas Colorectal Lung<br />
3 4/13/<strong>2016</strong><br />
Source: American Cancer Society, Cancer Facts & Figures <strong>2016</strong>, annual figures
Colorectal cancer (CRC): Early detection saves lives<br />
Diagnosed in<br />
Stage I or II<br />
Diagnosed in<br />
Stage IV<br />
9 out of 10 survive<br />
5 years<br />
1 out of 10 survive<br />
5 years<br />
4 4/13/<strong>2016</strong><br />
Source: American Cancer Society, Cancer Facts & Figures 2015
CRC: One in three in the USA remains unscreened<br />
35%<br />
Unscreened eligible<br />
population<br />
65%<br />
Screened population<br />
23 to 30 million eligible Americans are not screened for CRC<br />
5 4/13/<strong>2016</strong><br />
Source: Centers for Disease Control and Prevention, “Vital Signs”, November 2013;<br />
American Cancer Society Cancer Facts and Figures, 2015.
American Cancer Society screening goal: 80% by 2018<br />
Stagnant screening rate<br />
over the past years<br />
Screening<br />
gap<br />
80%<br />
60%<br />
63%<br />
65% 65%<br />
2002 2008 2010 2012 2018<br />
6<br />
4/13/<strong>2016</strong><br />
Source: Data from the BRFSS survey reported in MMWR 60(26)884-889, MMWR 62(44):881-888.
Paradigm shift in colorectal cancer screening<br />
Imaging Methods<br />
Colonoscopy<br />
Flexible sigmoidoscopy<br />
Virtual colonography<br />
Stool Sampling<br />
occult blood in stool<br />
by FIT or gFOBT<br />
Fecal DNA testing<br />
Liquid biopsy<br />
Septin-9 blood test<br />
7<br />
4/13/<strong>2016</strong>
Opportunity for US market expansion<br />
15%<br />
Screening gap<br />
$2 billion*<br />
80%<br />
CRC screening<br />
goal by ACS<br />
65%<br />
Screened<br />
population<br />
Closing the screening gap towards<br />
the 80% goal<br />
* Annual revenue ex laboratory<br />
8<br />
4/13/<strong>2016</strong>
High patient preference for blood test<br />
97%<br />
of patients refusing<br />
colonoscopy accepted<br />
minimal-invasive test<br />
83%<br />
of those patients<br />
chose a blood test<br />
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.<br />
BMC Gastroenterol 14: 183.<br />
9<br />
4/13/<strong>2016</strong>
Simple for patients and health care providers<br />
Easy for<br />
the patient<br />
Part of routine visits<br />
No dietary restrictions<br />
Easy for<br />
the doctor<br />
Drives patient compliance<br />
Easy to explain<br />
Easy for<br />
the lab<br />
Runs on existing hardware<br />
No investment required<br />
10<br />
4/13/<strong>2016</strong>
Epi proColon ® - Option for non-compliant patients<br />
Colonoscopy<br />
Patient<br />
managed<br />
based on<br />
colonoscopy<br />
outcome<br />
Standard of Care<br />
Further<br />
regular<br />
screening<br />
11<br />
4/13/<strong>2016</strong>
Epi proColon ® detects tumor-specific DNA in blood<br />
12<br />
4/13/<strong>2016</strong>
Test performance established in major studies<br />
Prospective<br />
pivotal study<br />
FIT<br />
comparison<br />
study<br />
ADMIT<br />
study<br />
Prospective, multicenter<br />
clinical study<br />
7,941 screening-eligible<br />
individuals enrolled<br />
Sensitivity of 68.2% and<br />
specificity of 80.0%<br />
Multi-center, comparative<br />
clinical study<br />
Epi proColon ® vs. FIT test<br />
Sensitivity of Epi proColon ®<br />
was 73.2% vs. 68.0% of<br />
FIT-test<br />
Multi-center clinical study<br />
420 patients, historically<br />
noncompliant with current<br />
screening guidelines<br />
99.5% rate of adherence to<br />
Epi proColon<br />
Sensitivity: the percentage of cancer cases correctly identified<br />
Specificity: the percentage of healthy individuals correctly identified as negative<br />
13<br />
4/13/<strong>2016</strong>
U.S. commercialization with partner<br />
Nation-wide distribution<br />
to target labs with Polymedco<br />
All incentives<br />
aligned between<br />
labs, partner and<br />
<strong>Epigenomics</strong><br />
HQ<br />
Polymedco is the<br />
biggest distributor<br />
of CRC screening<br />
tests in the U.S.<br />
Ideally positioned<br />
(CRC focus) to<br />
address over 1,000<br />
existing laboratory<br />
customers<br />
U.S. chart with target labs only illustrative<br />
14<br />
4/13/<strong>2016</strong>
Strong outreach through multiple sales channels<br />
Reference<br />
Labs<br />
Local<br />
medical<br />
doctors<br />
<strong>Epigenomics</strong><br />
Polymedco<br />
Academic<br />
Medical<br />
Centers<br />
Leading<br />
hospitals<br />
Key<br />
opinion<br />
leaders<br />
Integrated<br />
Networks<br />
Healthcare<br />
providers<br />
15<br />
4/13/<strong>2016</strong>
Ideal partnership for commercial success<br />
Marketing<br />
Sales<br />
Distribution<br />
Customer support<br />
Billing<br />
Collection<br />
Product supply<br />
Reimbursement<br />
Regulatory<br />
KOLs<br />
Medical guidelines<br />
16<br />
4/13/<strong>2016</strong>
Reimbursement elements<br />
17<br />
4/13/<strong>2016</strong>
Strategic collaboration with BioChain in China<br />
Epi proColon®<br />
approved in China<br />
by CFDA 1<br />
BioChain<br />
started<br />
commercialization<br />
in 2015<br />
Pricing and<br />
reimbursement<br />
discussions underway<br />
Septin9 test included in<br />
Chinese CRC Screening Guidelines<br />
Epi proColon® distribution and license agreement for Septin9 in place<br />
18 4/13/<strong>2016</strong><br />
1<br />
China Food and Drug Administration (CFDA)
lood test for detection of lung cancer<br />
About lung<br />
cancer<br />
Lung cancer test<br />
in development<br />
Performance<br />
Target<br />
indications<br />
Next steps<br />
Lung cancer is<br />
Based on<br />
Test sensitivity<br />
Follow-up after<br />
Initiation of<br />
#1 cancer killer<br />
positive results<br />
worldwide<br />
in low dose<br />
spiral CT<br />
High medical<br />
need for<br />
minimally<br />
invasive tests<br />
proprietary DNA<br />
methylation<br />
biomarkers,<br />
SHOX2 &<br />
PTGER4<br />
was reported<br />
at 95% with a<br />
specificity of<br />
64% in initial<br />
studies<br />
Future<br />
opportunity<br />
in screening<br />
of high risk<br />
patients<br />
clinical studies<br />
in <strong>2016</strong> (US/EU)<br />
19<br />
4/13/<strong>2016</strong><br />
This project has received funding from the European Union’s Horizon 2020 research and innovation<br />
programme under grant agreement No 672680.
Liquid biopsy will revolutionize cancer care<br />
Costs<br />
Compliance<br />
Disease<br />
management<br />
“<br />
Liquid<br />
biopsy<br />
Early<br />
detection<br />
For me the biggest payoff<br />
in cancer research would<br />
be the discovery of<br />
biomarkers that can be<br />
measured in the blood that<br />
reflect the presence of<br />
early-stage cancer.<br />
Dr. Leland Hartwell, March 2008,<br />
President, Ford Hutchison Cancer<br />
Research Center, Nobel Prize in<br />
Medicine and Physiology, 2001<br />
”<br />
Invasiveness<br />
Repeatability<br />
20<br />
4/13/<strong>2016</strong>
R&D strategy<br />
Broad IP protection with<br />
over 50 active patent families<br />
1<br />
Biomarker<br />
discovery,<br />
confirmation and<br />
selection<br />
Test development<br />
2 and validation of<br />
regulated in-vitro<br />
>20 proprietary<br />
diagnostic<br />
biomarkers in CRC,<br />
products<br />
lung cancer and other<br />
solid tumor<br />
indications<br />
3<br />
21<br />
4/13/<strong>2016</strong>
Key financial information<br />
FY 2015 FY 2014<br />
Revenue 2,082 1,507<br />
EBIT (Operating loss) 9,264 8,383<br />
Net loss 8,985 8,854<br />
Cash consumption 7,968 8,095<br />
Dec 31,<br />
Dec 31,<br />
2015<br />
2014<br />
Liquid assets* 8,563 7,495<br />
*cash and cash equivalents incl. marketable securities<br />
Liquid assets currently sufficient to fund operations into 2017<br />
22<br />
4/13/<strong>2016</strong>
<strong>Epigenomics</strong> share<br />
Share information<br />
Shareholder structure<br />
Types of shares<br />
Security code<br />
number<br />
ISIN<br />
Stock exchange<br />
ADR program<br />
Ratio<br />
Total shares<br />
outstanding<br />
Analyst<br />
coverage<br />
Registered shares<br />
A11QW5<br />
DE000A11QW50<br />
Frankfurt Stock Exchange,<br />
Prime Standard: ECX<br />
Sponsored Level 1 ADR<br />
1 ADR = 5 common shares<br />
18,904,084 1<br />
(20.1m fully diluted)<br />
Edison, Equinet, First Berlin,<br />
Kempen & Co, Maxim<br />
BioChain 9.1% 2<br />
Abingworth 4.9% 2<br />
Free float 86.0%<br />
1<br />
As of March 31, <strong>2016</strong>; 2 According the published voting right notifications<br />
23<br />
4/13/<strong>2016</strong>
Expected news flow topics <strong>2016</strong><br />
FDA<br />
approval<br />
Start of<br />
clinical<br />
studies with<br />
Epi proLung®<br />
Inclusion<br />
in medical<br />
guidelines<br />
<strong>2016</strong><br />
Start of<br />
US commercialization<br />
Market<br />
adoption and<br />
reimbursement<br />
progress<br />
24<br />
4/13/<strong>2016</strong>
Thank you for your attention!<br />
Contact <strong>Investor</strong> Relations<br />
Peter Vogt<br />
<strong>Investor</strong> & Public Relations<br />
<strong>Epigenomics</strong> AG<br />
T. +49 30 24345 386<br />
ir@epigenomics.com<br />
Ticker<br />
Bloomberg: ECX:GR<br />
Reuters: EXXG.DE<br />
Thomson ONE: ECX-XE<br />
ADR OTC: EPGNY<br />
Internet<br />
www.epigenomics.com<br />
www.epiprocolon.com<br />
www.epiprolung.com<br />
25<br />
4/13/<strong>2016</strong>
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